Tuesday, January 31, 2012

Day 12 GMC Fitness to Practice hearing for Andrew Wakefield

GENERAL MEDICAL COUNCIL

FITNESS TO PRACTISE PANEL (MISCONDUCT)



Tuesday 31 July 2007

Regents Place, 350 Euston Road, London NW1 3JN



Chairman: Dr Surendra Kumar, MB BS FRCGP


Panel Members: Mrs Sylvia Dean
Ms Wendy Golding
Dr Parimala Moodley
Dr Stephen Webster


Legal Assessor: Mr Nigel Seed QC




CASE OF:

WAKEFIELD, Dr Andrew Jeremy
WALKER-SMITH, Professor John Angus
MURCH, Professor Simon Harry


(DAY TWELVE)



(Transcript of the shorthand notes of T. A. Reed & Co.
Tel No: 01992 465900)



A P P E A R A N C E S


MS SALLY SMITH QC and MR CHRIS MELLOR and MR OWAIN THOMAS of counsel, instructed by Messrs Field Fisher Waterhouse, solicitors, appeared on behalf of the General Medical Council.

MR KIERAN COONAN QC and MR NEIL SHELDON of counsel, instructed by Messrs RadcliffesLeBrasseur, Solicitors, appeared on behalf of Dr Wakefield who was present.

MR STEPHEN MILLER QC and MS ANDREA LINDSAY-STRUGO of counsel, instructed by Messrs Eastwoods, Solicitors, appeared on behalf of Professor Walker-Smith who was present.

MR ADRIAN HOPKINS QC and MR RICHARD PARTRIDGE of counsel, instructed by Messrs Berrymans, Solicitors, appeared on behalf of Professor Murch who was present.








I N D E X




Page No

MARK ORLIN BERELOWITZ, Sworn

Examined by MS SMITH 1
Cross-examined by MR MILLER 57


THE CHAIRMAN: Good morning everyone again. Ms Smith, I think you were going to bring the new witness in this morning.

MS SMITH: Yes, sir. I am going to call Dr Berelowitz.

THE CHAIRMAN: Can I ask you to just wait for a second. Dr Moodley has something to say.

DR MOODLEY: I have declared this already but I am familiar with Dr Berelowitz because at some stage we worked in the same hospital.

MS SMITH: Thank you very much.

DR MOODLEY: You should be aware.

THE CHAIRMAN: First of all, Ms Smith, any observations?

MS SMITH: No, I have no observations except to thank Dr Moodley for that.

THE CHAIRMAN: Mr Coonan?

MR COONAN: Nothing, sir.

THE CHAIRMAN: And Mr Miller? Mr Hopkins? No. Thank you. You certainly can call Dr Berelowitz.

DR MARK ORLIN BERELOWITZ, Sworn
Examined by MS SMITH

(Following introductions by the Chairman)

Q Can you start off, please, by telling us your full name and address?
A I am Dr Mark Orlin Berelowitz. I am a consultant child and adolescent psychiatrist at the Royal Free Hospital in London.

Q Can you tell us first, Dr Berelowitz, how long have you been at the Royal Free Hospital?
A Since May 1993.

Q And what is your current post there?
A I am still a consultant child and adult psychiatrist with primary responsibility now for child and adolescent eating disorders, and also for attention deficit disorder. I am also a sub-dean of the Royal Free and University College London Medical School, but in a slightly unusual position in that I am a sub-dean for student welfare so I do not have academic responsibilities within the medical school, nor any administrative authority.

Q What post did you hold in 1996, which you know is the time with which we are concerned?
A Consultant child and adolescent psychiatrist at the Royal Free.

Q And at that time, in 1996, how long had you been a consultant?
A I had been a consultant since 1989, six or seven years.

Q There are a number of different topics that we have to cover, Dr Berelowitz. I will try and identify them as we go along, but the first one I want to ask you about is your role at the Royal Free in 1996 – your normal duties, leaving aside any matter arising out of the particular study with which you know we are concerned – but your normal duties. What was the principal part of your work at that stage?
A The core part of the job to which I was appointed in 1993 was to head what was called the paediatric liaison service. That is a service which helps children and families deal with psychological complications of severe physical illness. The second part was to deal with psychiatric emergencies coming through the A&E department. But shortly after I started at the Royal Free there were issues about reconfiguration of children’s services. So in addition to liaison and emergencies, we developed general child and adolescent mental health outpatient services, referrals from GPs and also second opinions. That was my work at the time.

Q As far as your liaison work was concerned, did you see children routinely as of right in that context, or were you asked to see them for specific purposes?
A We were always asked to see them. They were always someone else’s patients. We did aspire as of right to see very child with newly diagnosed inflammatory bowel disease, but we never quite got to that point. That was our aspiration. But we would never ever go up to the ward to see a child unless we had been specifically asked to.

Q You particularly mention the paediatric gastroenterology ward?
A Yes.

Q Did you have a particular involvement with that ward?
A We had general paediatrics and when I started at the Royal Free we had paediatric nephrology and then there was also, and still is, haematological oncology and haemophilia. I was involved with the general paediatric liaison and the nephrology and when nephrology left and gastro came, then I had a substantial involvement with the gastro liaison, but by no means the only person. Our liaison work is multi-disciplinary. We have very senior psychologists, child psychotherapists. We function as a team.

Q Could you just tell us in general terms, remembering that there are lay members on the Committee?
A Of course, thank you.

Q How did your work tie in with the gastroenterology department. Why would they want you to play a part in your liaison work?
A It might be something, as it were, relatively straightforward. A child goes from relative good health to severe inflammatory bowel disease in a short space of time. This is rather shocking for the child and the family. In a way, it is like a bereavement. There is a loss of health, a loss of innocence, a loss of naivety, a loss of some hope and a child or a family member might become really quite despondent, and the gastroenterologists appropriately had a low threshold for asking us to be involved, but often families would say, “Can we get some psychological help now that we have learned what the problem is?” So sometimes the families would be nudged in our direction by the gastroenterologist. Sometimes the families would be asking. But sometimes more technical issues would come up. For example, a child with ongoing inflammation and a little bit of infection, his mood seemed very low and then the job would be to work out, is the child depressed in his own right or does his mood seem low because of infection and inflammation and medication. So sometimes the work would be technically quite difficult and would need a lot of discussion.

Q You may to some extent have anticipated this question, but were you necessarily involved with the child, or might you also, or instead, be involved with advising the medical staff how to handle the child?
A I think, as it were, we talked about more patients than we saw directly. We had and still have a weekly meeting, a Thursday morning meeting, with gastroenterology, where we would go through almost all of the new patients not he ward and we would have a discussion about whether there was any psychological work to be done at all and, if so, was it within the remit of the doctors and nurses on the ward, or did they need to involve the specialist liaison team. We would by no means get involved with every patient.

Q You say you had, and have to this day, meetings every Thursday?
A Yes.

Q Who attends those meetings broadly?
A I am not attending them at the moment because of other commitments, but broadly from our team it will be a senior psychologist, a senior nurse, sometimes a doctor and from gastroenterology nurses, doctors, a social worker (when social workers are available), dieticians – a mix of people.

Q Turning on to another subject, I want to ask you when you first had knowledge of Dr Wakefield. Did that arise as a result of your involvement on a particular committee?
A In those days almost every hospital had a committee called a Consultant Staff Committee, which no longer exists in that form because in those days the consultant Staff Committee had administrative authority and would discuss new consultant appointments and the like. I clearly remember a meeting in which Dr Harvey, the chairman, was supporting Dr Wakefield’s appointment to the Trust. I cannot remember whether this is a meeting to which all consultants were invited, or whether I was there because of some modest administrative role. I cannot remember. It was a large meeting. It was the sort of meeting in which you discuss a wide range of business, including things that are of peculiar interest to consultants only, and then matters of much wider importance, like appointments of new staff.

Q I am sorry – did you say Dr Harvey? You had a recollection of Dr Harvey raising Dr Wakefield’s name?
A He was the chairman. From the chair, he was in support of Dr Wakefield’s appointment. I cannot whether someone from the floor, as it were, formally proposed Dr Wakefield’s appointment. I can only remember Dr Harvey talking about it.

Q And do you remember anything at all about the details of that appointment, or what it was or was not to include?
A Two things stuck in my mind. One is, I am pretty confident that Dr Harvey said something about Dr Wakefield doing research or being likely to do research in the field of multiple sclerosis. I am going from memory of eleven years ago, but that was one memory that stuck in my mind. The other issue that stuck in my mind was the difference between being called an Honorary Consultant and being called an Honorary something else, because I had a very distinguished non-clinical colleague or friend at another medical school, who was hoping that he would be appointed as an honorary consultant, because that would have significance for his salary compared to having another title. I was just tracking that, and I really was not paying attention to the detail of what sort of work Dr Wakefield was going to be doing.

Q Did there come a time when, in fact, you yourself came into direct contact with Dr Wakefield? Do you remember where you first met him?
A Oh yes. It was in the senior common room, part of the medical school, but senior staff of the hospital are eligible to be members of that and Dr Wakefield approached me and began asking me about what current thinking was about possible environmental causes of autism.

Q Were you able to give him any information about that?
A A little bit. I had been at the Maudsley for about 11 years as a trainee and then as a consultant. I was lucky enough to be senior registrar to Michael Rutter. I did not do any research with the autism team, but I knew what they were up to,.

Q Can I ask you this, Doctor? You said you were lucky enough to be registrar to Michael Rutter. Can you tell us why you say that?
A Professor Sir Michael Rutter is, to put it mildly, a very distinguished academic, particularly in the field of autism, and I think in those days we saw a new patient with autism every week for a very, very detailed and comprehensive assessment.

Q In very broad terms you say Dr Wakefield approached you and asked you about the possibility of environmental causes. Can you remember how you responded to that?
A Yes. Sorry, this is why I brought up Mike Rutter, because for the substantial first part of my time at the Maudsley all the talk had been about autism and genetics and not much else, but Mike Rutter’s team had begun to do research on very severely deprived children in Eastern European orphanages, and although the results had not been published yet I knew that they had become alerted to the possibility that extreme environmental deprivation could cause a condition pretty indistinguishable from autism, and that was quite a change in perspective for British academic child psychiatry. That is what I talked to Andy about.

Q Did you gain from him any understanding as to why he, as a gastroenterologist, was asking about autism, why he was interested in the subject?
A I cannot remember.

Q Do you remember taking Dr Wakefield to a particular research meeting that you used to attend?
A Yes. We all talked more, Dr Wakefield, Dr Murch, Professor Walker-Smith and myself, and Dr Wakefield began over time to talk about his ideas about how autism might be caused and I thought that it would be a good idea to take him to a meeting of the Child Psychiatry Research Society. The purpose of those meeting is for you to present the very beginnings of research ideas and open them up to a highly critical audience for criticism, and so I did that and Andy did the presentation.

Q Can you tell us, in broad terms, what the idea was that Dr Wakefield had had? What did he present about?
A I cannot remember all of what he was presenting, partly because as the person who introduced him I was on the stage and not in the audience, and also the purpose of my being there really was to look at how the audience was responding and to see what comments they came up with rather than to pay attention to the detail of what Dr Wakefield said. That is the purpose of the meeting, but he did put up lots of slides of the gut and he talked about gut permeability being affected by inflammatory bowel disease, and logic would say that he must have talked about the measles virus affecting gut permeability, but I cannot say that I know that he talked about it on the day.

Q What was the reaction, in broad terms, to the hypothesis that he was putting forward at that meeting?
A Professor Issy Kolvin, unfortunately now deceased, was chairing the meeting.

Q Who was he, before you go on?
A He was Professor of Child and Adolescent Psychiatry at the Tavistock Clinic and the Royal Free. The meeting took place at the Tavistock Clinic in Swiss Cottage. He was,
I would say, second only to Michael Rutter at the time in terms of successful autism research by a child psychiatrist in the UK, and also my mentor at the time, and after the meeting he said, “This is very interesting, and so pursue it. It could be very fruitful.” He said that to me personally. From the floor people asked questions. Nobody said, “This is a ridiculous idea, and why have you wasted our time with it?” People were respectfully curious.

Q Did you yourself discuss Dr Wakefield’s hypothesis or any proposed research he might have before you agreed to have an involvement?
A I then went to see Michael Rutter. I do not remember the date at which I went to see Mike Rutter, but at that stage a research project was forming and Mike said, “Go ahead and do the research, but try to do it properly”, because the field of autism is littered with so many false doors. A new idea comes along, nobody studies it properly, so it neither gets included or dismissed and it just kind of lingers there. Mike said, “Try to do proper research.”

Q Coming on to that project, first of all in broad terms, Doctor – and I will ask you about the detail in a moment – did there come a time when you were asked to become involved in the research?
A Yes.

Q Can you recall how it came about?
A I cannot precisely. That is one of my regrets about this research, that we do not have or I do not have a track record of minutes of meetings and the evolution of ideas. I do know that I was seeing children with autism on the ward before we were doing a research project. It was a new clinical problem for the nurses on the ward, to have children with autism and to learn how to communicate with them and deal with their behaviour and deal with pain relief. I also remember one very senior surgeon asking me to go with him when he was going to discuss a particular operation with the parents of a child with autism to see if I could help with the explanation and see what understanding the child would have. So we were thinking clinically about how to look after the, relatively speaking, large number of children with autism on the ward. The numbers were still pretty small, but relative to what was happening before – we were hardly seeing any. That is how I started being involved with the children. At some point a research project developed.

Q You say prior to you being asked to see a number of children you hardly saw any.
A In gastroenterology, yes.

Q In gastroenterology.
A Sorry, I should have been clear about that.

Q Did there come a time when there began to be more children with autism on the gastroenterology ward?
A Absolutely.

Q Did you understand why that was? If you had not been asked to meet children with autism before, why did you then start to become involved with children with autism on that ward?
A Because my understanding was that it became known that the gastro team had become interested in the possible relationship between autism and inflammatory bowel disease and measles/MMR.

Q Did you know anything, Doctor, about the method by which these children had been referred to the paediatric gastroenterology department?
A Absolutely not, no.

Q I want to ask you about how this project came into being. You have got some bundles of documents in front of you?
A Yes.

Q Would you go to the one which is marked FTP1, bundle 1, and go to page 200 please?
A (After a pause) Yes.

Q That is a document which we are all becoming familiar with, and no doubt you will recognise, which is the application to the ethics committee?
A Yes.

Q I am just asking you to orientate yourself at the moment. We see on that the involvement of Professor Walker-Smith, Dr Murch and Dr Wakefield at the top, and then your involvement as the collaborating department, Dr Harvey of the department of neurology and yourself in child psychiatry. Is that correct?
A Yes.

Q Is that your signature?
A It is, yes.

Q If we look at the end of that document, which is at page 233, we will see, if it assists at all in the question I am going to ask you, that that document was submitted in September 1996?
A Yes.

Q Can you help us as to the point at which the ethics committee application was submitted? We know the date, but do you have a recollection as to whether or not you had begun to see any of these children with autism prior to that application being submitted?
A I cannot possibly remember, no. I should say, like Peter Harvey I signed as the head of a clinical department. I did not go to the presentation at the ethics committee, I did not know when it was being presented, and I did not receive correspondence back from the ethics committee about the outcome. So I was then, and still am now, somewhat in the dark about specific dates. I was not one of the people being corresponded with.

Q You signed this application. I would like you to help the Panel as to your understanding of why there was a need for an application to the ethics committee, if you can help us on that?
A Because we were carrying out a research project and for research you always apply to the ethics committee.

Q You have told us that you did not have any correspondence with the ethics committee. Did you have, as far as you can recall, any contact with Dr Pegg, the chairman, or members of the committee, in relation to this project?
A Absolutely not, no, until very much later.

Q You obviously saw the application prior to its submission, because you signed it?
A Yes.

Q Did you have anything to do with the drafting of it? If it helps you just to run through it I am very happy to do so.
A Thank you.

Q If we just go to page 201 you see the title of the project and the objective, which was to test the hypothesis in genetically susceptible children that measles vaccination is associated with malabsorption of vitamin B12, and in the rapidly myelinating brain, which is particular susceptible to vitamin B12 deficiency, the latter predisposes to encephalopathy. We see the design of the study and then a list of the test the children had to undergo.
A Yes.

Q A structured assessment for disintegrative disorder, ileocolonoscopy, barium follow-through, MRI, EEG and various EP tests, lumbar puncture and blood and urine samples. Then we see the scientific background, and I will come back to that in detail, but you will see it sets out the disintegrative disorder, the definition?
A Yes.

Q Then, on page 203, enteritis and what that involves, and the role of B12 in that?
A Yes.

Q Going on, we will see set out two hypotheses – I am now on page 205 – in relation to the possible way in which enteritis and behavioural disorders could be linked. We see the references which are in the middle. Then on to page 208, subjects, with the selection criteria – presence of disintegrative disorder, symptoms and signs of intestinal dysfunction; parental request for investigation to be undertaken. Then 25 subjects needed, at the bottom of the page. No normal volunteers, no controls. Substances, funding and then the procedures or samples to be taken from the subjects, and we see,

“Would the procedure(s) or sample(s) be taken, especially for this investigation or as part of normal patient care?

Yes: in view of the symptoms and signs manifested by these patients all of the procedures and the majority of samples are clinically indicated. Additional intestinal biopsies (5 per patient) will be taken for viral analysis. DNA for genotyping will use blood cells isolated from the routine blood sample and will not require an additional sample”.

A Yes.

Q On the last page you see a reference to the discomfort that might be caused to patients who are undergoing these tests – page 210. Then there is a protocol attached to it. Lastly, there is a timetable, which is on page 231. You will see your own role is set out, proposed to be on a Wednesday.
A Yes.

Q With an asterisk by it, “Professor Wakefield to arrange”. Then following on from that, 232, there is the handout to the parents or guardians setting out the precise nature of the tests. We see in the second paragraph,

“We would like to carry out a series of tests which, we believe, will help us to establish the features of this possible disease. Our aim is to characterise the problem so that, for the future, we may be able to treat affected children and improve their wellbeing”.

Then going on to the last page, which I have already referred to, which has the date on it, and after that a draft consent form.
A Yes.

Q Doctor, tell us if you do not remember, we understand that it is a very long time ago, but can you help us as to whether you did have anything to do with the actual drafting of that document?
A The writing of the document, no. I did have some input into the ideas underpinning the document. I assume I will be asked about that later.

Q I am going to take you back to page 202, which is the part which refers to disintegrative disorder. We know that that was one of the selection criteria and if you would just bear with me while I briefly read through the beginning of that paragraph,

“Disintegrative disorder (or Heller’s disease) occurs when normally developing children suddenly, or over a period of several months, show marked behaviour changes and developmental regression after age 2, often in association with some loss of co-ordination and bowel or bladder function”.

There is particular reference to a paper by Rutter.

“Behavioural changes include social withdrawal, reduced response to sounds, complete loss of communication, unusual sensory behaviours and development of simple rituals and hand and finger stereotypes, much like those of autistic children. However, disintegrative disorder differs from autism in the loss of motor and self-help skills and usually, too, in the lack of more complex stereotype behavioural patterns (although simple motor stereotypes may occur). This rare disorder can sometimes be linked to measles encephalitis, cerebral lipoidoses, leukodystrophies or other neurological disorder is eventually identified, initial medical tests are often negative and sometimes diagnoses of hysterical reactions are considered. Thus, it is important to repeat medical investigations if a child’s condition does not improve.

Two different courses are typical of children with regressions occurring after the first few years. Most common are regressions that extend over several months and then plateau, resulting in a developmental and behavioural pattern that looks much like autism with severe mental handicap. In some cases, deterioration continues, with increased motor dysfunction, development of seizures and localised neurological signs.

Another disorder that overlaps in symptomatology but that does not have quite so poor a prognosis is Landau-Kleffner syndrome of acquired aphasia with epilepsy. Children with this disorder lose receptive and expressive language, usually over a period of months, typically in conjunction with the development of seizures or transient EEG abnormalities. Some social withdrawal and unusual behaviours may occur, but usually relatively normal social relationships are maintained with parents and others known to the child. Non-verbal cognitive functioning remains intact. In most cases, the outlook for these children is better than for children with disintegrative psychoses or autism, and sometimes language is eventually regained”.

So there is a fairly detailed description, doctor. I really want to ask you, you told us that you did not write any of the application form. We see that the definitions are derived from writing by Rutter. Did you have any input into that description that you recall?
A Yes, and with hindsight I can see that the first paragraph, under the heading, “Disintegrative disorder” is excessively precise, although I do not think myself that that excess of precision was driven by any desire to mislead anybody.

Let me try to explain. Everyone has heard of autism, but in fact in my field people talk more about the “autistic spectrum disorders” or the “pervasive developmental disorders”. Over time, particularly since the 1970s, the international diagnostic criteria for autism have become more and more defined, and in a way narrower. So, for example, symptoms of autism, core autism have to be evident either before 13 months or 36 months depending on which classification system you look at for which year. If the child does not meet the criteria, the core narrow criteria, then we have to say that they have a pervasive developmental disorder not otherwise specified, or we have to say that they have one of the spectrum conditions.

The textbook, which is the bible of our field, Child and Adolescent Psychiatry, Modern Approaches, edited by Rutter, Taylor and Hersov, is clear that disintegrative disorder is one of the autism spectrum disorders. It is a pervasive developmental disorder on the autism spectrum. In fact there is debate today about whether it should be called anything other than autism. But at the time we were writing this, it was described as an autism spectrum disorder, but interestingly, for our work, the autism spectrum disorder perhaps most characterised by bowel problems.

I think with hindsight we were over precise. Leo Canner, in his original 1940s description of autism described gut problems. We were over precise. We should have said clearly in the application that we were looking at autistic spectrum disorders and maybe disintegrative disorder was the most likely candidate in the spectrum. But we ended up talking about disintegrative disorder for two reasons in the application. One I have already mentioned, that children are described as having more severe bowel problems than core autism. Secondly, with disintegrative disorder as it was described then, there can be a longer period of normal development before the developmental regression or deterioration occurs. If the child developed normally to the age of four, even if they then develop a condition that looks exactly like autism, the diagnostic rules do not permit us to say that the child has autism. But they do permit us to say that the child has disintegrative disorder.

So for two reasons we thought that really at quite a speculative level and bearing in mind it was only a little pilot study, that we would probably identify disintegrative disorder more often than core autism, and that is all. We talked about that and that is what went into the application.

Q Thank you for that, Dr Berelowitz.
A I am sorry it was long-winded.

Q Not at all. It was very helpful. I know that ultimately you had concerns about the description of this disorder and I am going to come on to that in a moment. Can I first of all ask you this? Tell us if you do not remember, but do you remember who actually drafted the description – it is obviously derived from Rutter as you told us, but do you remember who actually drafted it in the application?
A I just assumed it was Dr Wakefield, but I do not remember, no.

Q As far as disintegrative disorder, it describes it as a “rare” condition. Is that your experience, that it is rare?
A Yes.

Q It would appear that it has a very poor prognosis, from this description. Is that also your experience?
A Yes, but we do get into difficult territory of classification here. It is rare, but it is not studied as a separate entity. I mean huge epidemiological studies worldwide are done on the prevalence of autism. There is nothing comparable on the prevalence of disintegrative disorder and really there is strong debate within our field at the moment about whether or not we should talk about disintegrative disorder as a separate entity, or whether we should say, “This child’s autism seemed to have started a little later or seemed to have a more severe course”. So I am being pedantic because I am not sure if I am technically allowed to say it is a rare disorder or it is an unusual presentation of a relatively rare, very well known disorder.

Q You say there is debate about it in your field at the moment.
A Yes.

Q When you say at the moment you mean now, do you?
A Yes, and then, but certainly now.

Q Is there a distinction? Is this a subject, in your experience, that has become less defined on your explanation?
A I just remember a telephone conversation with Professor Ann Le Couteur in Newcastle. Her speciality is autism and she was telling me about an interesting intellectual debate in the field of developmental disorder research at the moment about whether this should be considered a separate entity or not, and there was an honourable substantial difference of opinion between leading people in the field.

Q Can you tell us, if a child is diagnosed particularly with disintegrative disorder, would you expect a different clinical course in the disease than if he was diagnosed with autism?
A Well, in general one would expect a more severe clinical course, but many children with core autism unfortunately do have a rather troubled and difficult clinical course too. But one would expect that if you are saying disintegrative disorder, you are wishing to convey to the parents and yourself that this child’s needs are likely to be very substantial.

Q You have told us that in hindsight this application may have been overly precise,
I think was the word you used.
A Yes.

Q What was the reason in particular for picking on this disorder, as far as you understood it?
A I do not know now. I wish that the application had said “pervasive developmental disorders, but we expect to find a high proportion of disintegrative disorder and this is
why …”

Q Did you have any close involvement with the design of the hypothesis that this study was attempting to test, Dr Berelowitz?
A I was not involved in any formal meetings in which a group of people sat down and said, “Is this investigation in or out?” Not at any stage. I am sure such meetings took place but I was not involved in those meetings.

Q I want to ask you about a different though slightly related subject, and that is the role that was played by Dr Harvey. Would you turn to page 214 of the ethics committee application. We see at the bottom: “Department of Neurology, Dr P Harvey” and “Responsibilities: full neurological assessment and investigation”. If you go on to the timetable on page 231, we see a reference to various neurological investigations, and, on Thursday, an appointment with Dr Harvey. He is a consultant neurologist, as we can see from that application. Was he a child or adult neurologist?
A Adult.

Q Was he an obvious choice to be involved in this study?
A The obvious choice was Dr Andrew Lloyd Evans, Developmental Paediatrician at the Royal Free.

Q What was your feeling about that particular issue? Did you have any preference?
A I did not speak to Dr Harvey about it, but I did ask Andrew if he would reconsider his decision not to be involved in the study and he would not reconsider it. At that stage it was already difficult and probably already a little bit personal, and Andrew Lloyd Evans was accountable to Professor Brent Taylor professionally and Professor Brent Taylor had at that stage expressed some of his critical views about the whole theme of the work. I did not ask Andrew Lloyd Evans why in the end he decided not to participate in the study. Clinically he would have been the right person, but he chose not to.

Q Whose responsibility was it to select who was going to be involved in the project as the neurologist? Did you have any responsibility as far as that was concerned or any power over the decision that was made?
A No. No to both those questions.

Q As far as the neurology aspect of things, can you explain to the Panel your understanding of your role and of Dr Harvey’s role?
A Professor Kolvin had said to me, “This could be an interesting area of study.” Professor Rutter had said, “If you’re going to do anything in this at all, try to study it properly.” I thought that we were doing a very modest pilot study to gather information which would allow us to conclude whether we would ever design a larger study at all and, if so, what the design of that study would be and who would need to be involved in that larger study. My role was to check at a clinical level, from a balance of clinical assessment and reading of the case notes, whether or not the children had a pervasive developmental disorder, and, if not, could I come up with another specific diagnosis. And my role did not go beyond that.

Q And Dr Harvey’s?
A Dr Harvey’s job was to carry out the neurological examination of the children, and
I believe, from correspondence I have read very subsequently, that he had a role in choosing some of the investigations.

Q I want to ask you about the investigations.
A I should add that it was always clear in my mind that if a major study was going to be mounted, it would need very different personnel. We never got to that point. But it was always perfectly clear that this was just a pilot.

Q Could we look at page 201 where the list of investigations is set out. The investigations that I particularly want to ask you about are the colonoscopies and the lumbar punctures. As far as the lumbar punctures were concerned, did you ask for those to be included in this study?
A No.

Q Did you have any say as to whether they should be and why they were going to be?
A I was not consulted about it. I knew they were going to be, and at the time I did not question it.

Q What was your understanding of the reason that lumbar punctures were being included?
A As it says on page 201, to look for certain substances that you can only find in the cerebral spinal fluid and not anywhere else. For research purposes, it is logical to consider doing a lumbar puncture if you think that a child’s brain has been dramatically changed by some external substance or external event. It makes sense. And plenty of people are doing research on autism at the moment, funded by NIH and other august bodies, that includes lumbar punctures because there is a research hypothesis which justifies the doing of a lumbar puncture.

Q You have said it is a logical thing to do if you are trying to identify some external impact on the brain.
A Yes.

Q What was your understanding of the reason for doing lumbar punctures?
A My understanding did not go beyond what was said in the ethics application. I am a child psychiatrist: I would not pretend to understand aspects of brain metabolism of immunology in the way that some of my colleagues on this then team were and are still able to understand. There were people much more expert than me on cytokines and various other things. That is not my area of expertise.

Q You have used the words “for research purposes’.
A Yes.

Q That it was an understandable test for research purposes.
A Yes.

Q Perhaps you have answered the next question I am going to ask you, but in this case did you understand that lumbar punctures were being included as part of normal clinical care or as a research tool?
A I guess we are all very much shaped by Alder Hey and Bristol, and my attitude to research and ethics applications is very much shaped by this experience, so I have become incredibly pedantic now and, when I am invited to participate in multi-centre research, I want to read everything and I ask tough questions and I irritate my colleagues.

Q Doctor, may I interrupt.
A To go back to 1996 ----

Q Yes. Thank you.
A To go back to 1996, I do not know what was required. I know what I thought. I thought we were doing research.

Q Thank you.
A What was required I cannot say, in terms of ethics committee rules then.

Q No, I am not asking you that, doctor. Also, remembering that we have a lay Committee, Alder Hey and Bristol, neither of them, had happened, and we are not in 2007.
I am asking you, because it is fair to these doctors, that we should think about this situation in 1996.
A That is what I am trying to do.

MS SMITH: You have told us that as far as you were concerned you thought these lumbar punctures were being done for research purposes. Was that your view in 1996?

MR MILLER: He did not say that.

MS SMITH: Perhaps I can ask the question again, although I thought the answer was clear. (To the witness): Did you understand these lumbar punctures to be for research purposes or for normal clinical care?
A I signed a research application. I thought we were doing research. It was clinical research, and the children received a lot of care and there were children who had had terrible untreated bowel problems who received excellent care and their quality of life was substantially improved as a result of their participation in this, but I thought that the piece of work that we were going to do on these first cases was research. I may have been wrong, but that is what I thought.

Q You have told us that you have experience of dealing with autistic children.
A Yes.

Q Would you have expected lumbar punctures ever to be part of the clinical work up for an autistic child?
A For a child presenting with a typical story of autism, absolutely not: there is no need to do a lumbar puncture. There is room for debate when the story is quite atypical and one wants to understand whether this child is somehow different from other children with autism. But for the average child with autism, clinically you do not need to do a lumbar puncture.

Q If the child is suspected of having disintegrative disorder, would the situation be different then?
A That is harder to say. One could easily find a standard template for the assessment of a child with autism. One would struggle to find in a journal or a textbook a standard template for the assessment of a child with suspected disintegrative disorder and I would expect any clinical team to follow their judgment about whether or not a lumbar puncture or any other unusual investigation might be needed. It depends on the story. I mean, if a child developed disintegrative disorder at the age of eight, one might be more likely to do a lumbar puncture than if they just fell outside Mike Rutter’s 36 month definition for core autism, because the child is more unusual, and whenever one is faced with an unusual clinical presentation it is fair to ask: “Do I need to try to understand something different about this child?”

Q You have told us that you, as the psychiatrist, did not request lumbar punctures to be included in these investigations. Tell us if you do not remember, but can you assist as to who did request lumbar punctures to be included in these investigations?
A No. I only know what I read subsequently in correspondence on this matter, but at the time I did not know.

Q Turning on to the colonoscopies, doctor, and I appreciate of course that you are not a gastroenterologist, and for that reason I am assuming that you had nothing to do with the decision that colonoscopies were to be performed? Is that correct?
A No.

Q Did you gain any impression at the time as to why colonoscopies were being performed?
A The paediatric gastro team at the Royal Free was rightly looked up to because they developed both the courage and the skill to do colonoscopies so as to establish clear diagnoses about what might be going on in the bowels of unwell children. They and I knew of children who had been failing to grow, and had abdominal pain and all sorts of other difficulties for two years. Then they would be referred to the gastro team and would have a colonoscopy and inflammatory bowel disease would be identified, and a clear treatment would be identified, and the child would grow and develop and be in school. That is what they were rightly famous for and I would have, and in fact did, refer my own child to them expecting that he would have a colonoscopy, because they used colonoscopies to eliminate guesswork, to find out what was actually happening in the bowel. When they said, “We need to do colonoscopies on these children because our judgment is that their clinical presentation is such that we have to look inside the bowel and see what is going on,” I did not question it at all. That is what they were exceptionally good at, and their skill and courage in this regard had helped huge numbers of children.

Q Can I just take you back to the question that I asked, Dr Berelowitz. Did you regard these colonoscopies – you have told us that you did not question the gastroenterologists, and I do not think anyone in this room would expect you to have done so – but can you tell us did you think they were being done as part of the clinical care of these children or part of the research project?
A I thought we were doing research, but I would not at any time have been surprised if the gastroenterologists had said, as they did say, “In any event our clinical practice would suggest that we need to do colonoscopies on these children,” because that is how they worked.

Q I want to ask you, just so we know what you have seen and what you have not, about some correspondence in 1998, Doctor. Would you go to your bundle 3 now, please.
A FTP3?

Q FTP3 – that is it, yes. Turn first of all to page 928. That was a letter from Professor Sir David Hull?
A Yes.

Q To Professor Zuckerman – a personal letter. We have read it a number of times. I am not going to read it to you again, but if it does not ring any bells, please take a moment to look at it again, but I think you ---
A I am familiar with this letter now, yes.

Q Would you turn on to page 933 – I am sorry. I think you will find page 933 is missing.
A I have it.

Q You have it, do you? Is it a letter to you from Professor Zuckerman?
A Yes.

DR WEBSTER: We do not have it.

MS SMITH: I will hand you up a copy. I am sorry about that. It was omitted.

THE CHAIRMAN: Actually we have 932 and 933 missing.

MS SMITH: You need not worry about 932, sir. That just happens to have been a letter from somebody else. It is not relevant to this. You do not have a 933. (Copies of page 933 distributed) This, Doctor, is a letter to you asking for your urgent comments on the letter that Professor Sir David Hull had written. Is that correct?
A Yes.

Q And was in July 1998?
A Yes.

Q Then, we go on to page 937 please. This is a letter which I know you were not copied into.
A Yes.

Q Do not worry about that for the moment because I am taking you to a short sequence of letters, and then I will ask you about them. That was a letter to Professor Zuckerman from Professor Walker-Smith, who had also been sent a copy of Sir David Hull’s letter?
A Yes.

Q And you will see he says:

“The original study covered by the Ethical Committee is now complete. He is quite incorrect to state that the initial findings showed that the children do not suffer long term bowel disorder. Most had non-specific colitis and lymphoid nodular hyperplasia.”

There is some discussion about whether the latter is a normal variant and he refers to a letter that had been written to The Lancet.

“Subsequently children have been seen on a basis of clinical need referred by doctors (GP’s, child psychiatrists and paediatricians) often on the initiative of parents. In this latter group of children a reduced number of tests are done normal ileo-colonoscopy, blood testing, plain X-ray of the abdomen and child psychiatric review.”

Then, if you go on to page 939, please, you see a letter that you were copied into, because you see it in the last paragraph. This is a letter to Professor Walker-Smith from Professor Zuckerman. He says: “I am copying my letter to” amongst other people, yourself. Do you see where I am?
A Yes.

Q At the bottom of the page. He says:

“I am reassured that the children with autism are investigated according to the clinical need and their clinical management. Nevertheless, it would be prudent to obtain ethical approval if, as I understand it, Andy Wakefield is collecting cases for report by publication, which is therefore a research project.”

He then mentions the source of funding, and I will return to that in a moment, but while we are at the letter, he refers to some of the funding being highly controversial and that advice from the Ethics Committee of the BMA had been sought.

“Please discuss these two matters with the Chairman of the Ethics Committee.

I am copying my letter to Roy Pounder, Mark Berelowitz and Michael Pegg…”.

A Yes.

Q I want to ask you, were you aware of Professor Walker-Smith’s indications that the investigations were clinical in nature at that time ?
A At some point I was certainly aware of that indication, but I cannot say exactly when I became aware.

Q Professor Walker-Smith is referring to “investigations”. Did you have any knowledge as to precisely what investigations were or were not being said to be clinical at that time?
A No.

Q And this may follow on rather obviously, Doctor, but did you have any input into the contents of the letters that Professor Walker-Smith was sending at the time?
A Not at all. I was not involved in composing them, and I was not a recipient of the letters. I did not get to see them until later.

Q Were you comfortable with Professor Walker-Smith making those judgments? Did you regard that as a matter with which you should have had an involvement, or did you regard it as a matter that was up to him?
A I regarded it as a matter for the individual clinicians who were ordering the investigations.

Q As far as you were concerned, did you regard yourself as in any way responsible for the invasive investigations, as opposed to the psychiatric assessment?
A The only thing that I needed to do for my work was to take a history from the family, and read the case notes. There were no other investigations that I needed for my part of the work.

Q That takes us back, in a timely way, to the actual timetable for the investigations and you will be pleased to hear I am going to ask you some questions about your own work. Would you go back to bundle 1, if you please, just so you have it in front of you. Will you go to the timetable, which is on page 231. We see that the only role that you are involved in on that timetable is on Wednesdays “Dr Berelowitz, Dept of Adolescent and Child Psychiatry” and, as I have already pointed out, an asterisk by that, and “Dr Wakefield to arrange”.
A Yes.

Q Can I ask you first, was that timetable in fact stuck to? Did you see them on Wednesdays?
A I rather doubt it. One of the things about being liaison child psychiatrist is that you have to be very responsive, and the diary has to be pretty flexible and I do not believe that I committed a particular part of Wednesday to seeing the children. I saw them when my diary and their clinical state and their availability best coincided.

Q Did you have any original input into that timetable?
A No.

Q When you in fact came to be called to see a child, did it cause you any concern or, indeed, did you give any thought to the actual sequence of the tests that were being carried out and whereabouts you came in them?
A At the time, and knowing what I knew then, my primary thought was about the child’s level of comfort following tests and sedation when I saw them, and not the particular tests themselves, or the outcomes of the tests, but what they had recently been through, say with bowel preparation. Was now a good time to meet with the child and the parent?

Q We can see from that timetable that you, and indeed Dr Harvey, were scheduled to see these children to make your assessment after they had undergone all the invasive testing?
A Yes.

Q At the time did that cause you any concerns, rather than looking back at it now?
A At the time, no.

Q Did you in fact have any reason to ask or to know when in practice these children had had lumbar punctures? I am sorry – I did not put that very clearly. You have told us you did not actually adhere to strictly seeing these children on a Wednesday afternoon?
A No.

Q When you did see them, would you have any reason to inquire whether they had undergone a lumbar puncture or not?
A No.

Q As far as you were concerned, when you saw the children, whose responsibility would it have been as to whether they were to be initially admitted for the study?
A I thought that all of the children were screened by Professor Walker-Smith or Dr Murch in outpatients before they were admitted. Then, when they were admitted, they would have been clerked in again by one of the junior doctors. But it would be at the outpatient screening level that strong indication would have been given about the likely direction that the child would follow.

Q Did you have anything to do with the issue of parental consent to the children being entered into the study?
A No. And from memory, the ethics application specifies who would be obtaining consent.

Q And who was it in your understanding was responsible for consent issues?
A I thought it was Professor Walker-Smith, Dr Murch and Dr Wakefield – one of the three of them, but I am going from memory. One could easily check the application.

Q You are very welcome to have a look, and it would be helpful if you did. I am not sure it actually specifies who is going to be taking it. If we go back to the hand-out, it may say. If we look at 201, there is some reference to it, but not as specific as you are suggesting. I do not know if this is what you are referring to or not. Under paragraph four on page 201. Are you with me?
A Yes.

Q Do you see where it says: “Design of the Study” – “Children, referred either by….”. If we go on with that, you see:

“…. admitted to Malcolm ward for a period of one week, under the care of Professor John Walker-Smith.”

Then it says:

“With fully informed parental consent, children will undergo the following investigations…”.

A Yes.

Q I am not sure if that is what you were referring to or not, but whether it is or not, does your answer to the question remain the same?
A Yes. In fact I was confusing things with 223, page 12, (ii), where it says:

“Referrals will be co-ordinated by [Dr Wakefield], [Professor Walker-Smith] and
[Dr Murch]…”

I am sorry – I got confused between those two things, but it was not part of the protocol that I obtained consent, and I would not have been in a position to obtain informed consent on tests and investigations outside of my own area of competence in any event.

Q Did you have any knowledge when you saw the children? Presumably you saw the parents as well?
A Yes.

Q And did you have any knowledge about what the parents understood about the nature of this study?
A We were working on trust then. I assume that when I was called, the parents had consented, begun to participate and knew what to expect from me, so I did not go over that with them.

Q Did you have any particular views yourself as to where you wanted or expected this study to lead?
A Expected? No. My mind was open. In terms of wishes, I was dreading the thought that we would somehow discover that the MMR caused more problems for children than had previously been thought. I was not going to welcome that at all. Relatively early on it became clear enough to me that we were not going to be heading in that direction, and I began to look forward with Simon Murch to the prospect of doing MMR-free research on the simpler question, “Is there a particular gut pathology the children with autism have?” So I thought we would be done with the MMR. I certainly was not hoping to find anything positive. My mind was open at the scientific level, but my hopes were to find a negative.

Q At this stage rather than later on, the stage with which we are concerned, your initial study which was written up, as we know, later at The Lancet, what was your understanding of what the research was trying to test?
A It was trying to test whether there was a connection between the MMR vaccination and the development of bowel pathology and/or a neuro-developmental disorder. But it was a pilot study so it could only have said something positive in that regard if, through the process of clinical assessment, we had learned something exceptional about these children, for example they had all had the vaccination at a different time from the usual time and they had all developed their symptoms in a particular kind of pattern immediately thereafter; or if something particular had shown up in the special investigations. But otherwise, if we were just looking at MMR at about 15 months and development of developmental disorder a few months later, and we had nothing more to go on, we could not possibly show any link between the two. So at this pilot level we would have had to have come up with something pretty unusual

Q If you had come up with something in the terms that you have identified, what would that have led to?
A I only know what it would have led to in my mind, which is going to the Dean and the Chief Executive and the Medical Director and asking them to take charge of matters, get independent reviews of all the cases, see what was learned, and if the independent reviews coincided with concerns of our team then there would have to be a very careful plan with the Department of Health and with a variety of organisations about how on earth to handle this. There is absolutely no doubt in my mind. To give a very mundane example, if one does a piece of research that suggests that residents of a particular suburb of Nottingham are at immediate environmental risk, you do not send the paper into the BMJ, you do something different about it. So, in my mind we would have been in no way triumphant, we would have had a very big problem and, I say, the first thing always is to check that your findings are accurate and then get political help. Then, for me, of course, we never ended up going that way because the paper said we did not identify a link and I truly, somewhat naively, thought that is the end of the matter.

Q We will come on to The Lancet shortly, Dr Berelowitz. There are a few more things
I want to ask you about your actual role in the study, and indeed about the specific children involved.
A Sorry if I digressed.

MS SMITH: Not at all, no. Sir, I see it is five to eleven and I am going on, as I say, to ask Dr Berelowitz about what he actually did as opposed to the normal clinical role, so I wonder if we might pause.

THE CHAIRMAN: Thank you, I think it will be a very appropriate time to adjourn and
I am sure Dr Berelowitz would also be pleased to have a little break.

THE WITNESS: Thank you, sir, yes.

THE CHAIRMAN: I forgot to mention it earlier on, Dr Berelowitz. At any stage if you think that you need a little break, sooner than we are anticipating, just give me a little nod of some kind and we will be very sympathetic to that request.

THE WITNESS: Thank you.

THE CHAIRMAN: We will now adjourn and resume at quarter past eleven. I have to remind you, Dr Berelowitz, you are under oath. Someone will look after you for a cup of tea or coffee, but please make sure that you do not discuss about this case with anyone as you are still in the middle of giving evidence.

THE WITNESS: Absolutely.

THE CHAIRMAN: Thank you.

(The Panel adjourned for a short time)

THE CHAIRMAN: Ms Smith?

MS SMITH: Thank you, sir.

(To the witness) Dr Berelowitz, I was just going on to a slightly different topic, and just so that you know where I am, I want to ask you a few general questions about how you approached the assessment of these children.
A Yes.

Q Then I am going to take you to the actual records relating to each of the children who you saw. Did you receive any actual instructions as to the role that you were to play when you saw each child?
A Did I receive any instructions?

Q Yes.
A Not that I can recall.

Q What did you understand your role to be?
A To make a clinical diagnosis.

Q When you say “a clinical diagnosis”, can you explain exactly what you mean by that phrase?
A Yes. Particularly with a condition like autism it is important to make a distinction between clinical diagnosis and research diagnosis. For research diagnosis in autism, then and now, certainly for any big research project one would be expected to use a standard research instrument, which requires training, prescribed training at a prescribed venue, and takes hours. A clinical diagnosis, which is reached much more commonly than research diagnosis and day-to-day practice is, as always in child psychiatry, based on a story. There are no blood tests that will help us, no special investigations. Does the story add up to the set of clinical symptoms described in the international classifications? Sometimes it takes a very long time to get the story and sometimes the story is, in a way, almost completely obvious from a three-line general practitioner letter. One needs to take each patient as they come and listen to the story, and that is what I did.

Q As far as your diagnosis was concerned, what was the purpose of it in the context of this study?
A Did the children have a pervasive developmental disorder which fitted with the hypothesis of the study.

Q You have told us, and we know that the hypothesis of the study involved the possible role played by MMR?
A Yes.

Q Was that something which you were able to have any input in?
A Sorry, in terms of design?

Q No, I am sorry, that was a loose question. When you actually saw the child and you came to a diagnosis, was any role played by MMR part of the consideration of that diagnosis, or not?
A I was always clear, and still am, that I could not have worked out whether the MMR caused anything, but I would have noted if there had been a particular story in relation to the evolution of the symptoms over time.

Q How did you know you were seeing a child who was to be included in this particular study?
A My then secretary would give me a message saying that I needed to go and see –
I think they were called Wakefield patients, but I am not completely sure.

Q What documentation did you have prior to seeing the patient?
A The documentation varied. There were always the Royal Free records. Sometimes in the Royal Free records there were detailed copies of records from other units. From memory sometimes there were separate folders which I think the parents had themselves, as some parents do, copies of letters and investigations and school reports and so on, and I would look at all the relevant information and talk to the family.

Q When you actually came to do the assessment you have said you talked to the family. What did you do as far as the child was concerned?
A From memory none of the children had sufficient language for me to interview them, but I am just going from memory now, so I would observe the child, looking at eye contact, reciprocity, seeking of physical comfort, hand-flapping, repetitive movements, other observable features of developmental disorders: and, of course, one is always interested in a child with autism whether they have any stranger anxiety. How do they react when you walk into the room? Because the child who is developing well notices you, is a little bit anxious, a little bit curious, looks to mummy or daddy for comfort, then becomes increasingly interested in you. A child with autism, sadly, is not like that, so I would look at what sort of attention the child paid to me.

Q Of the patients you saw you have told us you would have had some records available?
A Yes.

Q Would you have had the referral letter to the Royal Free? Can you help us?
A The referral letter to the Royal Free would have been in the file, but I did not necessarily read that.

Q Would you have been interested in previous diagnosis?
A Yes, absolutely.

Q Behavioural diagnosis?
A Yes.

Q Where would you get that from?
A From the records.

Q And from the parents?
A Yes.

Q How would you notify the other doctors involved in the study as to the conclusions that you had reached?
A I wrote letters, I think usually to Dr Wakefield, but some of them would have been to Professor Walker-Smith and Dr Murch I think. Also, I am pretty confident that we, at least sometimes, discussed diagnosis in the Thursday morning liaison meetings.

Q I want to ask you this, Doctor. Was there any difference between the interviews that you were carrying out on these children who were part of the study and an assessment that you might do as a normal part of your work for children who were not in the study? What was the difference, if any?
A Do you mean a difference between how I would assess a child with possible autism referred to me by the general practitioner or how I would work with a liaison patient on the ward who was not part of the study?

Q Those two that you have identified were both parts of your normal work, were they not?
A Yes.

Q Did either of them differ from the sort of assessment that you did for a child who was part of this study?
A Yes. With regard to liaison, members of the liaison team would call to solve clinical problems: The child is distressed. The child has come from another clinic with a medication that we are unfamiliar with, psychiatric medication. Are you familiar with this? What are its side effects? The child has become psychotic on steroid medication, or delirious, can we please intervene. There would always be a clinical problem to solve. With the children in this work I was not coming to solve a clinical problem, I was coming to clarify a diagnosis. So there was a very substantial difference between my ordinary liaison work and this piece of work.

Q That is what I was trying to ask you to explain, because you have used the phrase that you were coming to a “clinical diagnosis.” But, when you saw these children, the study children, if I can use that neutral term, although you used the word “clinical”, would you expect, other than reaching a diagnosis for the purposes of the study, to have any other input? For instance, would you expect to prescribe or stop a prescription, or suggest a follow up, matters of that kind?
A No. A liaison doctor in general has to be extremely careful not to intrude on established professional relationships, so if a child with established treatment for depression somewhere else comes to the Royal Free for treatment of a surgical condition and we get involved, it would be completely wrong of me to change the medication without, say, consulting with the child’s regular doctor and it would not be a good idea … If I thought that the child’s diagnosis was wrong, the proper thing would be again to speak to the treating team and have a conversation and really not to interfere, only to provide active treatment on liaison problems.

Q That is your normal liaison practice?
A That is the normal liaison practice, yes.

Q As far as the children in this study were concerned, did you have any input over and above a diagnosis?
A In the 1990s, no. I am being pedantic because I was asked to see one child subsequently and I wrote to Dr Murch about that child, but in the 1990s, no. The families were not asking for clinical help from me and nor was the gastro team. It was to clarify the diagnosis.

Q Just so that we are clear, Doctor, what were you providing the gastro team with a diagnosis for? For what purpose?
A For the study. But, I should insert a caution, that I think it is quite proper when any clinical team has a run of patients with a different sort of diagnosis from another field that they are not used to that they talk to a doctor who knows about those sorts of patients, whether they are doing a study or not, so that they can increase their familiarity with the history of that condition in the field, how diagnoses are reached, what kinds of treatments are used, what are the diagnostic pitfalls and so on. Whether there had been a study or not, if we had all known that more children with autism would be seen in the Royal Free I think it would be quite proper to say to my team, “Can you stay in touch with us about these patients until we are all much more familiar with them?” I am just being a bit pedantic.

Q Not at all, Doctor. So am I, so if you will forgive me, I am talking about the patients that you saw as part of the study, as you refer to it – and you used the word “pilot study” – that was subsequently written up in The Lancet article.
A Yes.

Q As far as your seeing those patients are concerned, you are saying you saw them for the purposes of a diagnosis?
A Yes.

Q I am asking you, in respect of those patients, what you were providing the diagnosis for?
A The study.

Q I would like, if I may, to turn to the individual patients whom you saw, Doctor. I will guide you through the records because I am sure you do not have a recollection of the details. Just so you know, I am going to deal with them in the chronological order that the children were in fact seen at the Royal Free and that means starting with Child 2. First of all, you should have on your table somewhere a laminated sheet, a single plastic laminated sheet, with an anonymisation key on it.
A I do, yes.

Q If you look at Child 2 you will see the name of that child to help you.
A Yes.

Q I should explain, I am not taking you to all the medical records in relation to this child, but simply to those which identify your role. Do you have all the patient records beside you?
A I have got a lot. I do not know if I have them all.

Q If you find Child 2 and you go to the Royal Free Hospital records, which have “RFHR” on them ---

THE LEGAL ASSESSOR: Ms Smith, are you dealing with these in the same order that he deals with them in his statement?

MS SMITH: No, sir, I am not.

THE LEGAL ASSESSOR: Can I assume that the letters in his statement are the letters of the surnames of children, so that I will not have to interrupt you every time you introduce a number to find it in his statement?

MS SMITH: Yes, you can, sir. The first is Child 2.

THE WITNESS: Can I just check with the Chairman, please? I assume that because we have an anonymisation system I should not refer to the names of the children?

THE CHAIRMAN: Yes. Dr Berelowitz, I know it is sometimes difficult, but if you can actually address them as “Child 2”, it will be helpful.
A Absolutely. I just want to check that.

Q However, we do know that sometimes the names do slip out. I have already directed the press that in case the name does slip out, either by you or by counsel, then the identity of the child is not to be divulged in any case. If it does happen, do not let it worry you a lot, but I would prefer you to try and call the child “Child 2.”
A I am grateful. And if I end up describing something which would be identifiable to that child’s parent, if they read about it in the press, that is just part of my job as a witness, is it?

THE CHAIRMAN: Yes. Again, you can call them Mr and Mrs 2. We will understand, but as I say, if it does happen to come out, do not worry.

MS SMITH: Could I ask you to turn to page 143 in the Royal Free records? This is a letter dated 30 September 1996 that you wrote in fact to, as he then was, Dr Murch, in relation to Child 2. I am not going to take you to the entire letter, but I am going to read out some brief parts mainly to remind the Panel who have seen this letter before.

“Thank you for asking me to see [Child 2], who I saw on the Ward on 5 September.
I saw him at the request of yourself and Andy Wakefield for the purposes of learning more about possible links between his presentation and measles vaccination and bowel disease, but it was not intended that I should have clinical child psychiatric responsibility for him. I saw him together with his mother”.

You then set out in the second paragraph his birth history and his mother’s account of the fact, in the third paragraph,

“At the age of 13 months she said he had 25 words, but he gradually lost these words over the next 7 or 8 months. She thought he began to be a bit clumsy at about 15 months”.

She then describes how at 20 months he went downhill, and you say,

“She very movingly described how at 20 months he was able to say ‘ball’ and ‘book’ and this deteriorated to ‘all’ and ‘ook’ and then to ‘or’ and ‘oo’…He began hand-clapping at 4 years”.

She said he did not hand hold any more but would come for a cuddle when he was hurt. You say,

“She has become confident that changes in diet affect his behaviour. She said that he has had diarrhoea from 20 months largely unabated. He used to be very hyperactive, but when he went on a fine gold type diet, they discovered that wheat was causing him difficulties and the removal of certain foodstuffs from his diet led to improvement.

At the age of 5 he appeared very ill with considerable abdominal pain and mother became concerned about Vitamin B12 deficiency”.

In the next paragraph,

“In terms of diagnoses she said he had been diagnosed as having a specific language disorder when he was under 4. This was clearly wrong. She said that at Harper House they said he was not autistic. He was reviewed by Harper House more recently and again she said the diagnosis was not of autism. He is about to see a metabolic specialist. His fragile X negative and his brain scan is normal, as is his EEG”.

At the bottom of the page,

“I observed [Child 2] while talking to [Mrs 2] and noticed that he had no eye contact and no language. He did not relate to people or objects in the expected way. He did not behave as though the other people in the room had minds of their own which were of interest to him.

I thought that the history and presentation were very typical of autism or a related disorder. [Mrs 2] explained to me that she had previously had someone tell her that the problem was that she was unable to accept the diagnosis of autism. I explained to her that I was not going to attempt to do the same myself and was merely noting that his presentation looked like autism, whatever it actually turned out to be. I must say
I thought the presentation was indeed very typical and I await the next patient with considerable interest”.

That was the first child whom you saw in this study.
A Yes.

Q If I can just turn back to the first paragraph, where you say it was not intended that you should have clinical child psychiatric responsibility and that you were seeing him at the request of Dr Murch and Dr Wakefield for the purpose of learning more about possible links between presentation and measles vaccination and bowel disease. Why did you expressly state all that in the first paragraph?
A At one level because I am a bit disorganised and a bit pedantic and I wanted to be absolutely clear at the time that I was being well organised. What I most wanted to make clear, I guess, is that many parents of children with developmental disorders are very distressed and they look to new people for new answers and I did not want to raise any expectation that I knew any more about autism than anybody else, and I was not promising Mrs 2 anything in particular; that really my job in the case of 2 was to help my colleagues at the Royal Free think more about this condition that they were becoming increasingly interested in.

Q This letter of course was not to Mrs 2, it was to Professor Murch.
A Yes.

Q I wondered why you felt it was important to set out that you did not have any clinical responsibility.
A For a very long time now I have been writing my letters on the basis that one day they will be read by parents, so I just wanted to be clear.

Q What about Professor Murch and indeed Dr Wakefield, if they were to see this letter, did you think they needed to be clear about your role?
A I cannot remember whether that was on my mind 11 years ago.

Q Your reference at the end to,

“I await the next patient with considerable interest”,

what was that a reference to? The next patient in what respect?
A With autism and bowel disease.

Q It is apparent from that letter that you saw Child 2 on the Malcolm Ward.
A Yes.

Q Would the assessment have taken, in broad terms, the pattern that you have already discussed with us; namely, looking at any records you had and discussing with the parent?
A Yes. I think it is implicit from the middle of the second page, 144, that I did not have the Harper House records. Harper House is a clinic in Hertfordshire that specialises in the diagnosis and treatment of autism.

Q The other thing that is clear from the record is that Child 2 in the past had had tests for Fragile X, and he had had a brain scan and EEG, all of which were normal.
A Yes.

Q As far as those tests were concerned, were they relevant to your specialism as opposed to the neurologist’s role?
A Yes. They would be relevant to my specialism because a number of general brain conditions can cause a child to behave as though he has autism.

Q So was it useful to you to know that they had all been found to be normal?
A It is a long time ago now and I do not know whether I was noting that more for my own benefit or to make sure that my gastro colleagues knew that these tests had once been done and this was how the mother was reporting them. I do not know.

Q We have the conclusion which you came to, which was that you thought the presentation was typical of autism. Is that correct?
A Yes.

Q If we go back in those records to page 23, please, we see a note at the bottom of the page for 11 November. Do you see where I am, where it says,

“Ward round Prof JAWS”.

That is Professor Walker-Smith, is it?
A Yes.

Q It then says,

“Discuss with Dr Berelowitz for your assessment”.

Is that correct?
A Yes.

Q Then if we go on to page 139, this is a very brief letter from you of 19 November, so one week later, again to Dr Murch, in fact, saying,

“I saw [Child 2] on 12 November. He had been on AL110”.

What is that?
A My gastroenterologist colleague would have to explain that, but it is an elemental diet, I believe, designed to cause as little inflammation to the gut lining as possible.

Q You say he had been on it for six weeks,

“His mother reported a dramatic improvement in his behaviour but I am afraid
I cannot see any change myself”.

A Yes.

Q Did you actually recall that meeting, doctor?
A I do not have my own copies of these notes. I know there is a child whose mother reported him as having improved dramatically while he was banging his knees against the window. I do not know if that is the same child or not. If it is the same child, then I recall the meeting; if not, then I do not.

Q When you say he was banging his knees against the window, can you tell us a little more about that? Was this Child 2?
A There was one child I saw who, when I went into his room – it was a single room on the ward – his mother said to me that he had improved dramatically. He was paying no attention to me. He was standing on his head on the bed and banging his knees very firmly against the window, so firmly that although I know the windows are indestructible, I could not stop myself just checking that there was a ledge outside. The mother said, “Look how well he is doing”, and I could not see it. I do not know whether this is Child 2 or another child. I believe I have referred to this in a letter, but I do not know whether it is Child 2 or another child.

I suppose, if I may say so before I forget, I guess an obvious implication of the letter of
19 November 1996 is that I was now saying something clinical. I was expressing a clinical view about someone I had previously seen for research purposes. I do not know how else to understand my letter, but if I am talking about improvement, I mean you could say it was research, but really it looks to me on the face of it a bit like a clinical letter.

Q When you say you had seen him for research purposes, you mean your original assessment.
A Yes. I mean, if that was for research purposes, I do not know about the timing of things, but now I am saying something clinical about him.

Q When you say you are saying something clinical, you mean you are saying that you saw him and his mother reported a dramatic improvement but you could not see any change.
A Yes.

Q Could this information – that is why I took you to the note in the ward round – be something you were asked by the gastroenterologist?
A I could have been, yes. “He has been on the diet. His mother says he is a lot better. Will you check him out and see?”.

Q If I may I am going to take you on to Child 4, so you can put those records away. Just remind yourself who Child 4 is, if it is of any help to you, and then go to the Royal Free Hospital records for Child 4, page 11. We see in respect of that child a note. Is that your note at the bottom of the page, 2 October?
A Yes.

Q “Seen for psychiatric assessment”, is that right?
A Yes.

Q “Detailed report to follow”.
A Yes.

Q As far as that child is concerned, doctor, in fact there is not a report from you – I hope you will take it from me – in the records. Can you assist us at all as to why that should be?
A Only indirectly. At that time I had a wonderful secretary who was nearing retirement and refused to switch from Word Perfect for DOS to Windows. She said she could not make the change before she retired. So her computer was not attached to the server and everything was stored on hard drive and floppy disks, and she was the person who wrote up all my dictation. There are two possible reasons. One is that I dictated it and sent it, but it is not retrievable now, either on anybody’s hard drive or in the file. To me that is the most likely possibility. I did not keep my own separate records, obviously, for patient confidentiality. The second possibility is that on one of our Thursday mornings, or at some other time, we discussed the patient’s diagnosis and I would have given a verbal explanation of what diagnosis I had come to and why.

Q As far as every child who you reviewed as part of this research is concerned, is it your recollection that you recorded on paper a diagnosis, or might you orally have discussed some of them?
A Sorry, did I record the history or did I communicate orally or in writing to the gastro colleagues?

Q Once you had done your interview, as far as you are aware did you always, in some way, convey your diagnosis?
A Well, I thought I did, but I do not have a way of checking.

Q Can I ask you this? The research data, did you have any responsibility for it, over and above seeing the patient and communicating?
A I merely sent my information in. I did not see the complete sets of data ever.

Q If by some chance you had missed, in other words you had said you were going to do a report and then you did not, whose responsibility would it have been to point that out to you?
A Whoever was the data manager.

Q Did you have any knowledge as to who that was in this study?
A Just in terms of the style and atmosphere of the team, I assumed it was Dr Wakefield, but I cannot say that I knew him formally to be the manager of the data.

Q That is all there is on that child. If we go on to Child 6, please, just to remind you, you can look at your anonymisation chart or the front page of the records. This child is the brother of Child 7, if that assists you. I do apologise, because I have asked you to go to the wrong file. This is a child where some of the records came in later and you have got a file called, “Additional Royal Free records”. It is actually called, “Additional Royal Free and GP records”.
A I have two of those.

Q Page 39. Is that your entry? The date is very hard to read in mine.
A Yes.

Q Can you read what it says for us?
A “Seen for routine examination. Letter to follow.”

Q Can you see the date?
A It is the something of November and I do not know whether it is 1996 or 1998 now.

Q I am sorry, the records are all over the place for this patient, that is why it is rather complicated. You should have a bundle entitled “Miscellaneous bundle” which is bundle 7. Do you have that bundle?
A I do.

Q At tab 22, page 335, is the research report that appears to have been collated by the study team. Is that a document with which you are familiar?
A I do not recall seeing these documents until the first time that I met with the GMC’s solicitors.

Q If you go on to page 337, you will see:

“The following was reported to Dr Mark Berelowitz by [Mrs 6] on 11.11.96:

• [Child 6] sat late ? due to obesity.
• Walked at 13 months
• ? not sure when speech developed but Mrs 6 sure that [Child 6] had perfect speech.”

It would appear that there was an interview with the mother on that occasion.
A Yes.

Q On page 337 the current behavioural diagnosis is at the bottom of the page:

“Aspergers Syndrome (most likely).”

A Yes.

Q Would you turn to FTP bundle 2, page 605d. This is a letter to the mother directly from Dr Wakefield,

“Further to our conversation the other day, I am writing to confirm that following assessment of your children at the Royal Free, in particular by Dr Berelowitz, the Consultant Child Psychiatrist …”

He then deals with Child 7’s diagnosis, which we will leave aside for a moment, and then:

“The diagnosis for Child 6 was likely to be Asperger’s Syndrome.”

Were you aware of that letter having been written by Dr Wakefield, do you recall?
A I do not recall it, no. And it is not copied to me.

Q No. Thank you, doctor. That deals with Child 6. Could we go on to Child. Would you look at the Royal Free Hospital records for Child 5 at page 9. At the top of the page:

“3.12.96, seen by child psychiatrist – letter to follow.”

Is that your signature again?
A Yes.

Q If we turn on, we find the letter in this case at page 354. This letter, on this occasion, is to Dr Wakefield, dated 4 December.

“Dear Andy,

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

Then you set out the birth history.

“However, from 18 months he began to lose his language, become 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 as 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 be done.”

First of all, would there be any reason why that letter would be sent to Dr Wakefield?
A It must be because, as I said at the start of the letter, Dr Wakefield asked me to see the child.

Q Again it seems to have followed the normal pattern of you having observed the child and talked to the mother. You have given a diagnosis of “developmental disorder, such as autism” but you then go on to say “he was a slightly unusual looking child” and “chromosomal studies need to be done”. Who would you have expected to have undertaken those studies?
A Either his host clinical team that looked after him long term or my gastroenterological colleagues at the Royal Free.

Q You asked for them to be done because you thought he was slightly unusual looking. What is the purpose of chromosomal studies, doctor, broadly, in an unusual looking child?
A To identify other, rarer, possible diagnoses.

Q Would you have needed those in order to feel confident about what you thought the likely diagnosis was?
A Somebody needed to check those before confirming the diagnosis. They may well, of course, have been done previously. I was not in a position to know.

Q If they had been done and you had been asked to consider your diagnosis in the light of them, would you expect the records to reveal that – if you had been asked to be further involved?
A Yes. But at that stage I would have been likely to turn to somebody like Dr Lloyd Evans for further advice.

Q Can you put those documents away and go on to Child 12, please. At page 18 there is a long note, doctor, apparently describing the behavioural situation. Is this entire note by you?
A I do not have a page number, but dated “10.1.97”?

Q Yes.
A That is me, yes.

Q Can you help us as to why we have a long note on this occasion, as opposed to a separate report? Would there have been any particular reason for that?
A I do not recall any particular reason. It could be anything, from my secretary being on leave (so me not being able to get something typed and thinking I needed to handwrite it) to that being quite a quiet consultation in which I was easily able to record things. But really
I could not do anything other than speculate.

Q I am not going to take you through the whole of that note, but it would be helpful if you could identify what you thought the probable diagnosis was.
A I was unsure about the diagnosis. I noted: language delay, possible attention deficit disorder and the features of Asperger’s Syndrome – an autism spectrum disorder.

Q You are adding that on as an explanation now, are you?
A Yes.

Q Rather than that being in the note.
A Sorry. No, I am adding that on as an explanation to the Panel. I should also add as an explanation to the Panel that Professor Tony Cox was the senior lecturer on
Sir Michael Rutter’s team at the Maudsley when I was the senior registrar.

Q You are referring to the note above which says, “Seen Tony Cox”.
A Yes. He was my number two boss, as it were, and also taught me about autism.

Q Is this note your understanding of what Tony Cox said?
A No, this was the parents’ recollection of what Professor Cox said.

Q It reads:

“Severe language problem. Not quite Asperger’s but does have autistic spectrum disorder.”

A Yes.

Q Perhaps we could go on to Child 8, please, again in the Royal Free Hospital records, at page 20. This is a referral to you in a rather different form, Dr Berelowitz.

“Dr Berelowitz,

Will you please see the above patient …

Problems: (1) Developmental delay … (2) …. [Child 8] is in Malcolm Ward for this week for investigation of ? disintegrative disorder/enteritis syndrome. She has always been slow compared to her elder sister but she had co-arctation of the aorta so it was attributed to that by her paediatrician. At 18/12 she was saying 2-3 words and walking. However, since then (post MMR) she has deteriorated dramatically. She has stopped vocalising and had some myoclonic jerks. She has also had screaming episodes.”

It appears to have been signed by the house-physician. Can you explain why that is in a slightly different form. Would that house-physician have been involved in the research project?
A I have no idea.

Q If we could go back to page 18, we see your letter back.
A Yes.

Q This time to Professor Walker-Smith. At page 19, we see that it was copied to Dr Wakefield.
A Yes.

Q It reads:

“Thank you for referring [Child 8] to me. There is a detailed history in the correspondence in the file and I will not go over all that history …”

You summarise it:

“After an uneventful first few months of life, mother noticed that [Child 8] was developing more slowly than her sister …. She was taken to a Developmental Paediatrician who noted a heart problem and she was found to have coarctatoin of the aorta which was operated on successfully when she was about 14 months old. Because of the surgery, her MMR was delayed until she was 19 months.

Mother reports that following the MMR there was a catastrophic deterioration in [Child 8’s] level of functioning. She lost all language, became docile, with poor coordination and was, from her mother’s point of view, a different person.

She developed diarrhoea from the age of 1 years. This has been chronic and there has been no direct or obvious correlation between her gut symptoms and her behavioural problems.

Now [Child 8] has no language. However, she is affectionate and responsive and makes good eye contact. She certainly tried very hard to communicate with me when I saw her.

I note that following the vaccination there was a period of fever, diarrhoea and developmental regression. I am therefore left wondering whether in fact she had post vaccination encephalitis rather than anything more complicated than that. I don’t think autistic spectrum diagnosis is merited here. I am sure that Andrew Lloyd Evans’ opinion would be valuable.

She is seeing Professor Anne le Couteur in Newcastle.”

Who is Professor le Couteur?
A Professor le Couteur is a good friend of mine. She was a couple of years ahead of me in child psychiatry training at the Maudsley. She went on to follow an academic career specialising in autism and did a lot of research with Mike Rutter’s team at the Institute of Psychiatry.

Q Can you assist us as to why this letter is addressed to Professor Walker-Smith with a copy to Dr Wakefield? The previous letter was to Dr Wakefield. Two before that were to Professor Murch. Was there any reason for who you would write back to?
A I can only speculate. Professor Walker-Smith was the head of the team. I have no idea who “ED004” is on page 20, so I wrote to the head of the team. But that is a post hoc speculation.

Q As far as your diagnosis is concerned, you said you think it was an encephalitis. Can you distinguish that to the Panel from the other behavioural diagnoses that you made? What is special about an encephalitis? Why do you say that you would like Andrew Lloyd Evans’ opinion?
A Firstly, why not autism? There were hints to take one in the direction of autism – loss of functioning and language problems. But this child, at the bottom of page 18, was “affectionate and responsive and makes good eye contact. Tired very hard to communicate with me…”. Therefore I could not make a diagnosis of autism in this child because she did not have the typical features. She was socially engaging, and working hard on social interaction. I said earlier, I paid attention to what the children made of me. She noticed me. She wanted interaction. So I could not make a diagnosis of an autism spectrum disorder. Encephalitis generally means inflammation of the brain and it can cover a whole range of things, ranging from a bit of fever, mild headache, to very severe changes in the functioning of the brain, temporary or permanent.

Q Why did you feel that the involvement of the child neurologist be helpful?
A This is the way that the work is intellectually divided up in our part of London, and in many parts of the country, that an averagely well-trained child psychiatrist should confidently be able to diagnose or exclude an autistic spectrum disorder, but when the clinical hunch is that something else went on which has changed the structure of a child’s brain you would want a developmental paediatrician or paediatric neurologist involved. There are some child psychiatrists specialising in learning difficulties or more neuro-psychiatrists than I am who might have been comfortable with making a confident diagnosis of encephalitis, but most of us, I think, would say, “Let us ask somebody else”.

Q Did you have anything to do with the decision to include this child in the study, Doctor?
A No. I did not discuss this with my colleagues. I deliberately tried to avoid thinking about who is going into the study and who is not. Please stop me if I am telling people what they already know. We design blind and double blind studies because we want to keep investigators and subjects ignorant of quite where the study is going, what sort of results are coming in. I was trying very hard not to count in my head “Three children with autism so far, one with possible disintegrative disorder” because I really deliberately did not want to know. My own standards would suggest to me that I could unconsciously begin to shape subsequent diagnoses, so I tried very hard to parachute in, do a discrete piece of work, send it off, not think about it again. But I have to say, this was my own standard that I set for myself and I did not discuss this with the rest of the team. So I was not counting.

Q This was a bit of personal blinding, if you like?
A Yes. Absolutely, yes.

Q Did you regard yourself as having any responsibility as to unblinding, if you like, assessing whether there was a pattern and who would be included and who was not. Was that anything to do with your role?
A No. And I do not remember a meeting at which we all sat down and worked out who is definitely in and who is on the margins. There may have been such a meeting; I do not remember it.

Q Child 10, could we go on to, please? It is child 10, volume 1 of the Royal Free records. Do you have volume 1?
A Yes.

Q Page 16. This is one of your notes which are now becoming familiar.
A Certainly, yes.

Q “Seen by child psychiatrist – Detailed report to follow.” That was 18 February 1997. Was that right?
A Yes.

Q If we go on to page 28, this time a letter to Professor Walker-Smith, dated 20 February 1997.

“I saw [Child 10] on Malcolm Ward on 18th February, 1997. In fact I saw [Child 10’s] father only as [Child 10] was sleeping, and father said mother would not wish to participate in a research interview.”

I do not know whether you remember this individual case, Doctor, but if you ---
A I am afraid not, no.

Q Perhaps you could talk more generally. When you met with the parents, you told us you had nothing to do with formal consenting, but would you have explained to them the nature of what you were doing with the child?
A Yes.

Q It would appear that described it in those terms. Is that correct?
A I would be careful to explain in terms that this was for us, and it was only going to be of indirect benefit for them, and I was not here to give clinical advice. I am sure that often I talked about research.

Q If we go into the third paragraph:

“In terms of [his] present state, he does not talk …. not yet potty trained … appears to have no bowel control and virtually no bladder control … friendly and affectionate, recognising his parents, seeking them out … enjoying cuddling with them.”

Going down to the bottom of the page, apparently normal development, a brilliant child up to 18 months.

“Then, according to father, he ‘just disappeared’. This was in June when he was about 15 months old. He had had his MMR at 12 months. In June he had a febrile illness, with fever, rash, vomiting and a low level of consciousness for three days. The GP diagnosed German Measles. Following this illness, he avoided eye contact and physical contact, his sleep became poor, his behaviour became obsessive. He lost interest in toys, parents and everything else except videos. …

He has begun to improve quite dramatically over the last six months.”

Then you will see:

“You will see from the above account that [Child 10] has certain features of autism and certain of the features of disintegrative disorder. However, in fact he does not meet the criteria for either of these two conditions. He is far too affectionate, by his father’s account, for a child with full-blown autism, and a clinical cause….”

A That should say “the clinical course”.

Q Thank you.

“… and the clinical course, apart from the bowel and bladder problems does not fit with disintegrative disorder.”

A “… does not really fit with disintegrative disorder.” Yes.

Q I am sorry?
A I say, “… does not really fit…”.

Q Forgive me. It was not a deliberate omission.

“… does not really fit with disintegrative disorder. Furthermore it is possible that he does not truly lack bowel and bladder control, but has merely not yet been successfully toilet trained. Only time will tell.

I was very troubled by certain things that father said to me. He said that I should mention the word autism to the mother, as she hated that word, and she was convinced that [10] had disintegrative disorder. The father did not know that disintegrative disorder is a condition with a very much worse prognosis than autism. He said that they had been in considerable communication with”

- and that is, in fact, Mrs 2, is it not, the mother of Child 2?
A Yes.

Q
“… and they may have picked up this misinformation from her. He did not say that but I wondered if that were the case.

I must say that I thought the most likely diagnosis was in fact an encephalitic episode, which led to some low grade generalised brain damage. You will see above that in the acute episode he had fever, rash, vomiting and a low level of consciousness for at least there days. Father deeply regrets not having had him admitted to hospital at that time.”

So that is the letter that you wrote to Professor Walker-Smith and, again, we see it was copied to Dr Wakefield. Do you remember anything about this interview, Doctor, and in particular the distinction that the father said mother had drawn between disintegrative disorder and autism?
A It is ---

Q Before you try and answer it, do you remember it?
A I was going to ---

Q Or are you speculating?
A I am sorry. I have to give a psychiatrist’s answer – forgive me. I have been a psychiatrist for 26 years now, just about. I do not remember the face. I very much remember without the face the conversation about different disorders, and I also, not surprisingly, remember the exquisite sadness of it all because it was deeply, deeply sad. I do not remember a face, but it was every such a sad story. That I remember, but were I to see
Mr 10 in the street – I would not know which part of the country he is from or what his face looks like – but I remember an exquisitely sad story. One is not troubled by a little bit of knowledge. One welcomes a little bit of knowledge, but one is troubled by inaccurate knowledge in a family member.

Q You say the father did not know that disintegrative disorder is a condition with a very much worse prognosis than autism. That is something you told him, is it?
A No. It was not my job to tell. My job was to be curious, but not the point of intruding on clinical care or people’s privacy. If he did not want to know, that was his business. I was not his child’s doctor. If he did not want to know, that was not my business. I was not his child’s doctor.

Q In this child, too, you seem to have come to a generalised conclusion that it was not clear exactly what was going on, but you thought the most likely diagnosis was an encephalitic episode. Is that fair?
A That is what I thought then. What would one do now in clinical practice, faced with a child like this? One would go through the history again. One would ask a developmental paediatrician and, in my team, we would find someone who has done this week long training in research diagnosis in pervasive developmental disorders and get them to carry out an interview if the family wanted to do that. It is possible that more detailed questioning would have taken one to autism, not otherwise specified or yes, indeed, disintegrative disorder, but in the 45 minutes to an hour that one has one the paediatric ward, with a sleeping child and only one parent, you go as far as you can. If clinically we wanted to be sure, I would involve a developmental paediatrician and I would try to get someone to do a research interview, because those diagnoses are so pure.

Q I have asked you this question ---
A I am sorry. I am going to need a brief comfort break, if I may please.

MS SMITH: Of course, yes.

THE CHAIRMAN: It is 12.30. I am just wondering whether it would be appropriate, maybe, to have an earlier lunch.

MS SMITH: I am entirely in your hands. I have nearly finished – I have one more child to go – but then I will be a little while with this doctor in relation to other matters.

THE CHAIRMAN: So there is obviously further to go yet. I think in that case we will take an earlier lunch now and we will resume at 1.30 p.m.

MS SMITH: Thank you, sir.

THE CHAIRMAN: I have to remind you once again the same thing that I did before.

THE WITNESS: I promise.

THE CHAIRMAN: You are under oath, and in the middle of giving evidence, so please do not discuss this with anyone.

(Luncheon Adjournment)

THE CHAIRMAN: Ms Smith?

MS SMITH: Dr Berelowitz, we were just having a brief conversation about Child 10, if you remember. I had a couple more questions to ask you about that.

THE CHAIRMAN: Just one moment. Just let me find something.

MS SMITH: Of course. (To the witness) As far as Child 10 is concerned, we have established the letter which set out what you thought the most likely diagnosis was on the basis of your relatively brief assessment?
A Yes.

Q An encephalitic episode.
A Yes.

Q Is that correct?
A Yes.

Q I wanted to ask you a question which I asked you in relation to the previous child, Child 8. You wondered whether she had some sort of encephalitis. I suspect the answer may be the same, but did you in respect of this child have any thoughts about whether or not it was appropriate to include him in the study, given the diagnosis you had come to? You told us with the previous child that you had adopted a reasonably blinding process. Does the same apply to this child?
A I did not think that we should be too narrow for the purposes of the pilot study. Dr Wakefield had some ideas in his mind about mechanisms whereby the MMR might cause particular brain or gut disorders. I was not hugely interested in the MMR. To me the question was more, “Is there something new that we ought to be learning about children with complex development disorders and their bowels?” If in the pilot study we were too, too narrow that could handicap any substantial research. At the time, and with hindsight, the right thing to do seemed to be to make the best diagnosis you can, and then report that diagnosis honestly in the paper.

Q As far as who or who was not included on the basis of whatever diagnosis, whose decision was that?
A As I said before, I do not remember being at a meeting in which there was a detailed discussion about who is in and who is not.

Q Can I turn on to the last child which we have any records of in relation to your part, which is Child 7, please. It is the Royal Free Hospital’s records for Child 7. Could I ask you to turn to page 85, please. This is a letter dated 17 January 1997?
A Yes.

Q From Professor Walker-Smith to you.

“This child will be admitted on 26 January 1997. He is a sibling of [Child 6] who is already in our protocol.”

A Yes.

Q
“In this case although there are some autistic features, the GP has not referred the child for full investigation. I would be grateful if we could have your quite detailed opinion concerning [Child 7] whole he is in hospital as to whether or not he falls within the autistic spectrum and any appropriate investigations could be done. He will be having the colonoscopy on Monday 27 January in the afternoon and he will be remaining in for the rest of the week. We would very much value your advice and help.”

So that was a letter from Professor Walker-Smith on this occasion. Let us go into the clinical notes on page 7, please. We will see above “Plan”:

“Colonoscopy one
Preps [preparations]
Autism protocol
Consent
Venflon, bloods”

Then on 7 January:

“WR [ward round] Prof
Colonoscopy today
For BAM [barium meal] + FT [follow through] Wed
To see Dr Berelowitz re autism
MRI, ECG
Dr Lloyd-Evans re development”

A Yes.

Q Going on to page 8, we see again “Plan” on 30 January:

“Psychosocial Meeting –

To be seen by Dr Berelowitz.”

Is that correct?
A It is not my writing.

Q No, but it appears to be a plan that you were going to see the child.
A Absolutely.

Q Could you turn to page 84. There seems to have been a slight hitch because
we get a letter to you again from Professor Walker-Smith.

“[Child 7] is the sibling of [Child 6], a child in our Autistic Study. In [Child 7’s] case the study did reveal some lymphoid nodular hyperplasia but the histology of the distal bowel was normal. However as he is currently symptomatic….”

Then there is a reference to the anti-inflammatory.

“I don’t believe you have yet seen [Child 7]. There is some confusion as to what his diagnosis is. His mother tells me that his behaviour is rather deteriorating. He has become rather more infantile than before and tends to shadow his brother. I would be most grateful if you could send an outpatient appointment to review him and to give us the benefit of your opinion concerning a possible DG. If it were convenient it might perhaps be helpful if you could also briefly review [Child 6] and have your opinion as to how he has responded to treatment.”

It would appear that for some reason there was not a review whilst he was an in-patient, is that correct, so Professor Walker-Smith is asking you to see him at a later stage?
A I cannot remember anything about this, so I can only say yes because that is what is in Professor Walker-Smith’s letter.

Q We do have a record of the eventual diagnosis by you, if you go back into the FTP bundle 2. I have taken to this before in relation to the brother, and it is page 605d, please. As I say, I took you to Child 6 in this letter and now we can see that it also deals with Child 7. The behavioural diagnosis in your view was of a developmental disorder on the autistic spectrum between Asperger’s and autism?
A Yes.

Q I am going to take you on. Those are the children where we have a record that you saw them, Doctor, and I have taken you to the references which constitute that record. I am now going to ask you about The Lancet paper and I think in that context we will deal with the children we do not have any records for. Would you go to The Lancet paper, please, which is in bundle 2 at page 783? You can put away the individual records if it gives you more room. (After a pause)
A Bundle 2.

Q FTP2, yes, and it is at page 783.
A Yes.

Q We see at the top of the paper that your name appears in the middle of the co-authors. Is that correct?
A Yes.

Q Does the order of the co-authors reveal anything, Doctor, on a paper at this time?
A At various times people have counted it important to be either at the beginning or at the end.

Q You are in the middle?
A Yes.

Q I do not mean that offensively; it is just a fact.
A It did not offend me. I was not consulted and I was happy enough with my lot.

Q Did your inclusion in the paper reflect the role that you had played, which you have already told us about, in seeing these children?
A Yes.

Q If we look under “Clinical Investigations” in the right-hand column on the first page, we see:

“We took histories, including details of immunisations and exposure to infectious diseases, and assessed the children. In 11 cases the history was obtained by the senior clinician …”,

Professor Walker-Smith:

“Neurological and psychiatric assessments were done by consultant staff …”,

and then we have:

“PH, MB with HMS-4 criteria”,

and is that “MB” a reference to you?
A Yes, and I did not proof read this because there is no such thing as HMS-4 criteria. It must be DSM-4 criteria, Diagnostic and Statistical Manual.

Q Are they in fact the criteria you would have used, the DSM, are you saying?
A DSM and ICD would both have been acceptable for these purposes.

Q If we go on down in that sentence:

“Developmental histories included a review of prospective developmental records from parents, health visitors and general practitioners. Four children did not undergo psychiatric assessment in hospital; all had been assessed professionally elsewhere, so these assessments were used as the basis for their behavioural diagnosis.”

I have taken you, Doctor, to the records of eight of these children. We do not have the records for one of them and you do not appear in the other three.
A Yes.

Q Might that reflect this observation, do you think?
A Yes.

Q You have told us you did not proof read this paper. Did you in fact have anything to do with the original writing of it?
A No, I had nothing to do with the original writing of the paper. I certainly commented on what was either the penultimate or the ultimate draft, I cannot know which. I commented quite strongly on the paper once it was in draft form, but I did not write it.

Q You say you commented on the draft, so you were provided with a draft copy, were you?
A Yes.

Q I will take you to your comments in a moment. Before I do so I just want to ask you some general questions. When you saw that draft, you could tell that there were 12 children involved, obviously?
A Yes.

Q Did you know the names of the 12 children who were going to appear in the paper?
A No.

Q Were you able from your recollection to identify those you had seen and what you had said about them from the information in the paper?
A No, I was not, and perhaps I should try to explain why. I was, for all practical purposes, a single-handed consultant at the Royal Free at that time. I had a part-time locum colleague. Effectively, all 400 new child psychiatry patients a year referred to my department would be discussed with me, plus I would supervise trainees for several hours a week and they would again discuss all their patients with me, and I went to two liaison meetings a week, gastro and general paediatrics. I heard about a lot of patients each week and I could not possibly have coped if I had kept them all in my mind all the time, so I would only keep in my mind those patients about whom I was worried or about whom I needed to be making clinical decisions. So once a piece of work was done – I could not have survived intellectually without closing the door on that work, so I did not have names in mind at all.

Q In those circumstances, was it possible for you to make any sort of independent assessment as to whether children had been appropriately or inappropriately included?
A No, not at all.

Q As far as you were concerned, who was responsible, who were you relying on to say which children should be included or excluded from the paper?
A It is only an assumption on my part, but my firm assumption was Andy and John and Simon.

THE CHAIRMAN: I am sorry, I did not quite get the ---?
A It is only an assumption, but my firm assumption was it was Dr Wakefield, Professor Walker-Smith and Dr Murch.

MS SMITH: The title of the paper we will see is “Pervasive Developmental Disorder”.
A Yes.

Q I would like to take you to a letter that you wrote, which is on page 504.
A Yes. I jump from 496 to 506.

Q You do not have page 504 in your bundle 2?
A It jumps from 496 to 506.

THE CHAIRMAN: None of us have, I think.

MS SMITH: None of you have. I do apologise for that, sir.

THE CHAIRMAN: The last page is 496 and then after that 506.

MS SMITH: I am so sorry, sir. We will make sure you have copies in a moment. (After a pause) I am sorry about these additions, sir. It is simply that documents were removed because they were the subject of discussion and now have to be put back in. (Documents circulated to the members of the Panel and the witness)

THE CHAIRMAN: That is not a problem, but I am just going to check it with you, that at this stage we do not need any of the papers from 497 to 503?

MS SMITH: Not at this stage, no, you do not, sir. We will ensure that papers are put back in.

THE CHAIRMAN: Thank you.

MS SMITH: We are now on page 504, sir.

(To the witness) Dr Berelowitz, this is a letter from you to Professor Walker-Smith dated
5 August 1997?
A Yes.

Q I am going to read it through and you will bear with me, Dr Berelowitz. I know you are familiar with it, but just to give the Panel an opportunity to see it. It is the first time we have looked at it.

“Dear John,

IBD/Autism Research

It seems clear from the events of the last few days that our research has already attracted complex publicity and is likely to attract more publicity when it is published in The Lancet. Furthermore, it has the potential for affecting vaccination up-take if it has not done so already. My own view is that it would be unwise to draw strong conclusions from our preliminary research about the wisdom of vaccinating children.

Therefore, I would like to be sure that 2 issues in our paper are emphasized: firstly, we need to check that we have spelled out the facts that the onset of autism and disintegrative disorder always occurs after the end of the first year of life and so no causal connection between vaccination and autism could possibly yet be drawn from our findings so far. Perhaps you would be good enough to re-read the manuscript and make sure that this issue carries the right sort of emphasis and that the possible causal link is not over-stated.

Secondly, my preference would be to make a clear statement in the paper about vaccination. I would like to say: ‘This research is of a preliminary nature and we would not with General Practitioners or the general public to draw strong conclusions from it about whether or not individual children should be vaccinated against measles. Guidance about vaccination should be taken from the Department of Health in the usual way. If, in time, our further research leads to firmer conclusions, we might then have some comments about the risks of vaccination.’

Lastly, I have had some second thoughts about our title. I think that we should call this condition a ‘developmental disorder’ rather than a regressive behavioural disorder. This title is technically more correct, and will cut off in advance one potential area of criticism.”

Copies of this letter are sent to Dr Wakefield, Dr Murch, Professor Taylor and
Professor Roy Pounder. Can you tell us what you meant by that last paragraph and why you felt you had to cut off in advance a potential area of criticism?
A I would not want more to be read into that than should be. I simply thought that our wording was insufficiently precise, it was something that was easily correctable and should be corrected, and that is all I was thinking about. That last paragraph does not – it is a bit separate from the stronger concerns that I expressed above, that I was trying to express above, about what the impact of the paper might be. This last paragraph was much more for a scientific audience we needed to be precise, we should try to be precise.

Q Did you have concerns that the title that was apparently on the draft you saw of a regressive behavioural disorder was incorrect on the basis of the children whom you had seen?
A Firstly, it is not a behavioural disorder, it is much more complicated than that, and secondly, we could only call it regressive if every single child had regressed. So, it was both too vague and too precise at the same time. It is not a term in the child psychiatry vernacular, regressive behavioural disorder. I was not sure what it would mean to people, so much better to be conservative and use wording that was more precise. But as I say, that was more of a scientific point than a public health point.

Q Yes, I understand that, Doctor. I will ask you about the public health points in a moment.
A Okay.

Q At the moment I am on the scientific point. You have said here that the title is technically more correct, so I was just asking you whether you thought that the title “regressive disorder” to cover the disorders of the children whom you had seen – and
I understand you did not know precisely which children had been included – was technically incorrect?
A As I say, it is not a behavioural disorder, it is much more complex, and it was not clear that it was a regressive disorder.

Q Turning on to the other aspects of your letter, you ask in particular about statements and you have now just to me described them as a public health aspect. Was that the reason for your concern on the wording in the two respects you have set out?
A Yes.

Q You wrote this letter to Professor Walker-Smith and you copied in Dr Wakefield and Dr Murch. Why did you write to Professor Walker-Smith?
A He is head of the gastroenterology department and I thought that he would have ultimate say. At some stage Andy and I began communicating less and less with one another. I cannot put a date on it, but I might have begun to feel, even then, best to write to Professor Walker-Smith. But, I cannot put a date on that breakdown in communication.

Q Do you recall whether there was any further contact with Professor Walker-Smith in relation to the contents of that letter that you wrote to him?
A Not that I can recall. The title did change, but otherwise I cannot recall conversations about it.

Q You have said the title did change. You saw another draft after that, did you?
A This was before email, at least at the Royal Free, and drafts were being photocopied and handed around and I was not date-stamping something the day I received it, so it is impossible for me to know on what day I looked at a particular draft.

Q We all well understand that and I am not asking you to do that, but what I want to know is whether you saw a draft thereafter which did indeed include at least the terms of the amendments you suggested?
A I saw a draft. It is the “thereafter”. Let us take the “thereafter” as read. I saw a draft which said that these disorders tend to occur at the end of the first year of life and therefore one has to be careful about drawing any conclusions between a temporal link between vaccination and the onset of the disorder. There is a draft which said that.

Q Is that the first issue that you were concerned about in your letter?
A Yes.

Q If you just keep your finger in that letter and turn to page 758, please. Sir, I am going to add this into the Panel bundle. Dr Berelowitz has got it but you have not. (Document handed) As far as this is concerned, doctor, if we just look at page 758, we see the title is indeed now, “developmental disorder”.
A Yes.

Q Was that in accordance with the suggestion that you had made?
A Yes.

Q We do not need to go through the whole version, but can I ask you to turn to page 772? You will see in the middle of that page,

“The diagnosis of autism is usually made on symptoms starting in the first year of life, when children receive MMR. Despite the striking temporal association with MMR in many of these children, this factor must be taken into consideration when examining the apparent association described”.

Is that correct?
A I mean that is a correct reading of it, obviously. The wording is a little woolly because really we should have said, “starting at the end of the first year of life”.

Q Yes, but did it encompass, if you like, albeit you may think it a bit woolly, the spirit of what you were trying to convey?
A The spirit of my concern is encompassed here, yes.

Q Can you help us at all as to how you got hold of that copy? I do not mean how you got hold of it, but how did that draft come to your attention?
A Some years later, I cannot say exactly when, Dr Murch and I were discussing these matters, as we did, and from memory Dr Murch said, “I think that the paper got changed at the last minute. Look at what I thought was the final draft”, and he gave me a copy of it.

Q I want you to go back to the final version of the paper as it was published in The Lancet. You can take your finger out of the letter, if you still have it in there, and keep it in 772, and go to page 783, which is the published version. Is that right?
A Yes.

Q If you go into the discussion on that, on page 787 of the final version, do you see where, in the left hand column, second paragraph down, it says,

“If there is a causal link between measles, mumps and rubella vaccine and this syndrome, a rising incidence might be anticipated after the introduction of this vaccine in the UK in 1988. Published evidence is inadequate to show whether there is a change in incidence or a link with measles, mumps and rubella vaccine. A genetic predisposition to autistic-spectrum disorders is suggested by over-representation in boys”.

If you go back to page 772, the fifth line down,

“If there is a causal link with the MMR, then a rising incidence might be anticipated following its introduction in 1988. Despite the impression of a rise in autistic spectrum disorders, published data are inadequate to determine whether there is either a rise in incidence or a link with MMR”.

A Yes.

Q “The diagnosis of autism is usually made on symptoms starting in the first year of life “ –

This is the part I have read to you before –

“Despite the striking temporal association with MMR in many of these children, this factor must be taken into consideration”.

So that is your paragraph, if I can put that in inverted commas.
A Yes.

Q Then it goes on,

“A genetic predisposition to autistic spectrum disorders is suggested by over-representation in boys”.

So the final version, doctor, is the spirit at least of what you were suggesting should be put in, excluded?
A Yes.

Q Did you attend the press conference after the publication in The Lancet paper, doctor?
A Yes.

Q Did you have anything to do with the decision to call that press conference?
A Absolutely not, no.

Q As far as any statement in The Lancet paper about MMR vaccination and the possible temporal link, doctor, was it your view that the paper was clear on the lack of a link between MMR vaccine and behavioural disorders and enteritis?
A From my point of view the paper was mostly clear. On 787, “We did not prove an association”, I mean you cannot be clearer than that. In the next paragraph,

“If there is a link, one would need to demonstrate a rising incidence. This rising incidence has not been demonstrated”.

Q If you had thought that the study that you had been a part of had in fact been evidence of a closer association than that between MMR and these particular disorders, what would you have felt was the appropriate way of dealing with that?
A I think I spoke to that issue this morning; not to publish but to have someone else, an agreed set of people, look at the data in conjunction with the Department of Health. If the data then stood up, to give the issue over to rather more powerful people than ourselves to try and find a way of dealing with it, for the sake of the public health. But we were so far from that, we said quite the opposite. As I said this morning, I rather naively thought that we would end up saying to the general public and to the scientific community, “There does not seem to be anything here, let us study other things”.

Q I am turning on to another matter, doctor, and that is the question I have for you, which is, did you have any knowledge of any funding relating to the Legal Aid Board which was involved in any way in this study, or any knowledge of the MMR litigation being involved in any way, at the time I should say?
A I could foresee that if the study had taken us in the direction of a positive that litigation was a possibility. I had no thoughts about it beyond that, and I did not know that the subjects were litigants, as it were. The funding was nothing to do with me. I did not know about that.

Q I want to ask you, because your name appears on it, to look at a document at Bundle 1, page 121.
A Is that FTP1?

Q Yes, FTP1, page 121. This is a costing proposal, doctor, which was submitted to the Legal Aid Board and, as I say, I want to ask you about it because your name appears in it at page 122. Do you see there are costs set out in paragraph 3 in relation to enteritis disintegrative disorder cases?
A Yes.

Q Are you with me?
A Yes.

Q It sets out the costs of the tests to be carried out.

“Children will come into the paediatric gastroenterology ward under the care of Professor Walker-Smith. Costs for four nights stay for the child and their parent plus colonoscopy will be £1,750”.

Then it says MRI £1,00 and immunohistochemical tests £1,000. Then it says,

“The medical reports which will be the compilation of reports from the individual experts in each of the disciplines, including”,

and then your name appears in a list of doctors, “will cost £1,400”.

Did you have any knowledge of your name being included in that document?
A My name is gloriously misspelt and one tends to notice these things. I think if this had been put under my nose I think I would have noticed that my name was misspelt.

Q It appears to be claiming a fee for you in respect of a medical report. Do you know anything about that?
A Secondly, if there was a plan that doctors employed by the hospital and the medical school would do a piece of work for a fee, there would need to be a discussion about when and who gets paid for it and so on and so forth. I mean, does the doctor doing the work take the money or does the department take the money, who is accountable and so on and so forth. That was not discussed with me or with my clinical director at the time. Also, for what it is worth, I would have thought the fee is unrealistic because the cost of a report, even then, would not be £200 per specialist. These would be technically very difficult reports taking hours of time, so this seems to me like a pretty speculative document at a number of different levels.

Q Thank you for that, but what I really want to know is, did you know anything about it?
A No.

Q As far as you were concerned, was the question ever raised with you that you might be an expert in relation to this Legal Aid Board study?
A The question at some point was raised – I do not know whether it was in the senior common room or in clinical discussion – that we might end up being invited to be experts. But a business case, I was not part of the drawing up of a business case and I did not offer to anyone to be an expert.

Q Do you remember when the subject was raised with you at all?
A You are going back nine, 10, 11 years.

Q Tell us if you cannot assist.
A No, I cannot.

Q Can you assist as to whether it was after the publication in The Lancet article?
A I cannot. I doubt that the state of the relationship was such after the publication of The Lancet report that we would even have had a conversation about doing this kind of work together.

Q The relationship between who and who?
A Well, Dr Wakefield and I had such divergent views at the press conference and at the MRC meeting Dr Harvey’s and my views were beginning to diverge. I do not think I would have – we did not sit down and put together a proposal like this after the paper was published, absolutely not.

Q With that proposal there was a scientific protocol, and I just want to ask you about a page in that. Can you turn back, doctor, to page 104? This is the protocol which went with that costing proposal. If you go to 106 you will see a reference to yourself. Do you see where I am, “Child Psychiatrist Dr Berelowitz”?
A Yes.

Q Then if you go on to 114, please, “Neuro-psychiatric studies”, and we see underneath it, “Confirmation and characterisation of disintegrative disorder features of CAPA -- child and adolescent psychiatric assessment. ADI -- autism diagnostic interview”. Are they roles that you could have undertaken in this study?
A If I had chosen to participate in the study, and if I had gone off and been trained in the CAPA and the ADI – which I am not trained in and never have been.

Q Do you recall seeing that document with that statement of what your role was going to be?
A Not until I met with the GMC solicitors. Something like this does happen quite often in a completely non-sinister way. The other day I was rung up by the medical director of a psychiatric trust: some people in different parts of the country have approval for a type of project – and we get lots of those patients coming through the Royal Free – am I willing to put an expression of interest so that they can then begin to calculate, if the Royal Free was in, how many patients the sample would then comprise? I said, “Yes, of course.” So my name is on something expressing an interest, but that is several stages away from being a co-signatory to a formal research study. It often happens that people say, “Might you be interested?” “Can I tell people that you might be interested?” It is okay to do that.

Q Doctor, I have taken you to this document, but this scientific protocol, as we know, was also, in almost identical terms, submitted to the Ethics Committee at the time the ethics application was made. The part to which I have referred you relating to your role was identical. You have told us that it would not be unusual for your name to be put forward in an informal document. How would you feel about it in a formal proposal sent to the Legal Aid Board?
A Very unhappy indeed.

Q Could I ask you to go to FTP3, please, page 939? This letter, which was sent to Professor Walker-Smith from Professor Zuckerman, I referred you to this morning when
I was asking you about whether you knew what Professor Walker-Smith had or had not said about the investigations, but I am now asking you about it for a different reason because it also refers to the involvement in the funding of Dawbarns, Solicitors. This letter, on the face of it, appears to have been copied to you and is dated July 1998, so I want to ask you if you have any recollection of having received that letter and, hence, having at least some information about the involvement of litigation.
A I remember discussing the matters with Professor Zuckerman.

Q Do you remember when that was?
A No. As I said, I am the sub-dean for student welfare. At that time, the Royal Free was a stand-alone, little medical school and I was the only sub-dean for student welfare, and
I often had to pop in to see Professor Zuckerman to discuss particular students because he was the dean. We would spend time chatting about lots of things, including the MMR research, once we had finished talking about the students in question. I had understood that this matter was being dealt with and sorted out at a level in the medical school and the Trust which was way above me and I took no further steps, because, when the dean and the chief executive and the medical director and the head of department are on to something jointly, that should suffice. All the people with power and influence were appraised of the issue.

Q If it were the case that this study had involved either directly or indirectly money being given by the Legal Aid Board for research for litigation purposes, what would have been your attitude to that, doctor?
A That makes matters very difficult, because my diagnoses are dependent on a story and if the parents, consciously or unconsciously, have a vested interest in telling a particular kind of story that makes science a rather risky endeavour. That is from the parents’ side. In terms of data analysis, wording of the paper, the emphasis and tone, if one of the researchers stood to gain from proving a particular hypothesis that also makes the science very difficult indeed. That is why, in the end, even though the paper declared a negative, most of us still were keen to withdraw it.

Q I think it is right that there came a time when you did indeed join in with those who wished to retract the interpretation that had been put on The Lancet paper. Is that correct? You were one of those who signed the retraction?
A Yes. I mean, I had misgivings long before then. Indeed, I wrote to Professor Brent Taylor, head of community child health and head of the academic department in 2000, suggesting that we conduct an internal inquiry to clarify this. I do not have a response to this date. So I had concerns for a long time and, by then, Wakefield and I were not speaking to one another, but Dr Murch was very rigorous and thorough and he did a lot of diligent work and it all seemed to add up to a retraction and I was more than comfortable signing it. But I had had misgivings for a long time.

Q In fact, that retraction, we know, was in 2004. Just so the Panel can look at it, it is at page 1210, entitled “The retraction of an Interpretation”. This was 2004 and you say you had misgivings which you had expressed as early as 2000. You have told us of your concerns as to any involvement of litigation of the Legal Aid Board. Were they the nature of your misgivings or did you have other misgivings?
A My largest distress was to do with how the paper itself was being misrepresented even in the so-called quality press. It was resoundingly reported as the paper which proved a link between the MMR and this condition. Now, from what I have read on the internet,
Dr Wakefield did talk in a number of settings, including to Congress, about this being “the first of our seven or eight papers that prove the link” but I spent a fair amount of time ringing up newspaper editors and journalists and saying, “Have you read the paper?” One of the quality papers did a two-page spread one weekend on this and I rang the journalist: “Have you read the paper?” “No.” “Can I read this paragraph to you.” “Thank you. I did not realise it said that.” “Would you like me to send you a copy of the paper?” “Yes.” I rang up a health editor of a quality paper because a health correspondent had completely misquoted the paper. The editor said, “Ah, yes, you’re right.” I said, “Are you going to withdraw that little piece?” and he said, “What’s the point?” I am a psychiatrist; I am not a media expert.
I just became so upset at how resoundingly inaccurately this was reported – even in the BMJ two weeks ago, and I wrote to the editor of the BMJ about it. The crucial paragraph at the top of the page, even the BMJ got that wrong. That dismayed me and I was at a loss really – you know, “little me” – as to what on earth could be done to try to reverse this momentum.

Q Could we look briefly at the terms of the retraction.
A I am sorry, you know that I wrote to the chief executive of Channel 5 in dismay about the documentary that they were planning on showing. She wrote back saying they are going ahead anyhow.

Q Yes.
A So it went.

Q If we look at the terms of the retraction at page 1210, I think the relevant paragraph is the bottom paragraph:

“We wish to make it clear that in this paper no causal link was established between MMR vaccine and autism as the data were insufficient. However, the possibility of such a link was raised and consequent events have had major implications for public health. In view of this, we consider now is the appropriate time that we should together formally retract the interpretation placed upon these findings in the paper, according to precedent.”

Is that correct?
A Yes.

Q Were you comfortable with making that retraction?
A Yes. I was very sad, obviously, that it had come to this, but I was grateful to Dr Murch for doing all the groundwork and I was comfortable with making the retraction.
I was disappointed about some of the absences from the list of signatories.

Q You have mentioned the risks in your mind in relation to your own part, in that the parents might have been affected in what they told you if there were a litigation background.
A Yes.

Q You have also mentioned the possibility of some sort of vested interest on the part of the researcher if there were a litigation background.
A Yes.

Q Did those issues play a part in your wanting to be a signatory to the retraction?
A They played a part. I cannot say they were my only motivation but they played a substantial part.

Q I am going to turn to one last matter, doctor, you will probably be relieved to hear, and that relates to a particular study which was proposed in 1998 and was the subject of an application to the Ethics Committee relating to the use of transfer factor. Do you remember being invited or asked to become involved in a study involving transfer factor?
A Yes.

Q Who else was involved in that study?
A I am sorry, I cannot recall the names of all the people who were involved in the study. Dr Wakefield, Professor Walker-Smith and Dr Murch, on this side of the Atlantic, were certainly talking about being involved, but there were other names from the United States.

Q We know that a patent application was made by Dr Wakefield relating to transfer factor. I can take you to it if you wish to be taken to it but I think I can probably deal with it simply by asking: did you know anything about any patent application?
A No.

Q When you were asked ----
A I am sorry, I did not know about a patent application by Dr Wakefield. From memory, there was an American bio-tech company, the one that apparently sent negative emails about me, that was interested in developing intellectual property in this area but I did not know about Dr Wakefield and a patent application.

Q When you were asked whether you would be interested in being involved, did you do some background scrutiny of the proposal? Did you have a look at what it involved?
A Yes.

Q Did you feel comfortable about it?
A No, absolutely not.

Q Can you tell us in brief terms, doctor, why you were not comfortable – from the point of view of your own role, obviously.
A There were several layers here. Firstly, there were American child psychiatrists named on the protocol and I looked them up on Medline and they had no track record of autism research. I thought: “This is not a good start.” Secondly, I could probably explain what transfer factor is, but I do not know what it looks like or how it works, and I do not know how it would work on a child’s brain. We needed a real expert in the brain biology of autism to have a view on this. I was the wrong sort of child psychiatrist for this study. I can help with diagnosis, confidently, if I am trained, but not on how transfer factor is going to work. So I said to members of the team – but I cannot remember who – that we needed to get other people involved and the name of Professor Anne le Couteur came up. I remember speaking to Anne on the mobile phone, while I was on holiday somewhere in mainland Europe, and she said should would be interested in talking more. She was not going to commit herself, but she would be interested in talking more.

Q Were you prepared to take any further part in it?
A Not as it currently stood. I was prepared to be a junior partner, provided a senior expert on autism took the lead from a child psychiatry point of view. I mean, I was going to be happy to learn from somebody else and to assist but I could not possibly have been the lead child psychiatrist myself.

Q Did you express any views to the three doctors you have said were involved, or any of them, as to whether you would do anything if the study went ahead in the terms in which it was being proposed?
A Could I just add one more scientific caution that I had before I come to that?

Q Yes, please.
A The other rather obvious difficult issue was what changes did we expect to occur in the children with autism and how were we going to measure those changes?
A It is very hard to do outcome research, even with something as simple as anorexia nervosa where you can weigh people, to figure out in what ways children’s autism was changing and why and what the duration of follow-up needed to be, and that was way out of my league – way out of most people’s league really. Very little outcome research is done in autism anywhere in the world. So we needed to find the right person to help with that. I felt that my comments were falling on deaf ears and so I said, rather unhappily, that I was going to go to Dr Pegg, and say, “I don’t like this, and there is child psychiatrist standing outside now” – because I am outside – “these are my reservations.”

Q You have said it was falling on deaf ears, but can you help us as to who you said that to?
A I cannot.

Q But can you even help us as to who it could have been?
A I cannot.

Q What happened as far as you were concerned after that? You have said to someone that you would discuss the matter with Dr Pegg, and what happened subsequently as far as your involvement was concerned, as far as you knew?
A Professor Walker-Smith called me up to his office and said…. He gave me a complex message, and to this day I still do not understand it. He said that my comments had led to a transatlantic exchange of emails, the content of which was so unpleasant about me that he could not bring himself to show it to me, but he wanted me to know that this existed.

Q Right.
A It was a complicated kind of message – as you might imagine, slightly disconcerting. I spoke to the site dean; I spoke to my clinical director. We learned that the application was not going ahead. I decided, with a little bit difficulty, to behave as though this was a professional matter and there was nothing personal to it, and I tried to close my mind to it.

Q You said you learned the study was not going ahead, and we know indeed that it did not ultimately, but I want to ask you to turn to page 675 in your FTP 2. This is the Research Ethics Committee application in respect of the study. Just to orientate you, Doctor, if you look at 677, you will see the title “A preliminary open-label study of the effect of …. transfer factor”. Are you with me?
A Sort of orientated, yes.

Q On 676 we see your name?
A Yes.

Q On 680 we see a plan of the Formal Behavioural Assessment at the top of the page.

“… will be undertaken by Dr M Berilowitz at each of the 3 visits (0, 6 & 12 months) to monitor the child’s progress and seek objective evidence of developmental change…”.

Did you ever agree to take that role in this study?
A There is an advantage in being called “Berelowitz” – I am mis-spelled again. I do not have the competence or the training to assess therapeutic change in children with autism. I do not, and never pretended to, and I could not possibly have undertaken to do this.

Q Do you recall ever seeing this application?
A Somehow I got the names of the American collaborators, so I had seen some paperwork but if I go back to Andy’s letter on 675 – the child has made substantial improvement – “substantial improvement” in what? Bowel symptoms? Autistic features? Which autistic features? More sociable? More language? Less repetitive movement? We never even got near to having a conversation about what we would be measuring, so I could not have agreed to participate.

Q If we go on to page 817, this is a letter that was sent to Dr Pegg because a member of the committee raised a difficulty as to the fact that there was no control group, and whether or not there might be a placebo effect. In other words, for the lay members of the committee, just the very fact of taking something which you think might make you feel better would be perceived as a possible advantage, and how you would tease that out from it being truly beneficial. Is that correct?
A Yes.

Q And we see in that letter to Dr Pegg:

“With respect to a control group, in this study we will not be using a control group. Any placebo effect would be expected to occur relatively early not to be sustained over the 6-month period. In contrast, we do not expect a rapid effect from this drug: rather that its action will take place over a sustained period. Dr Berelowitz has extensive experience in therapeutic trials involving autistic children and should be able to distinguish with confidence, the difference between placebo effect and the true benefit from the drug.”

Is that letter correct, Doctor, first of all? Did you have extensive experience in therapeutic trials involving autistic children?
A None.

Q And what about the suggestion that you would be able to distinguish the difference between placebo and the true benefit?
A It is a grave point and in many ways an upsetting point. But can I illustrate it in a fairly light-hearted way? I was telling Mrs Berelowitz, who is a social worker without formal scientific training, about this comment just after we had discussed whether or not we could afford to do something to the house. And she said, “If you had had that skill that Professor Walker-Smith said you had, we would not have discussions about whether we could afford anything because you would have such wonderful powers – you would be so rich.” We have double-blind placebo trials because no one can distinguish between placebo effect and therapeutic effect. I have not discussed this letter with Professor Walker-Smith. I do not know what drove him to write it. I can only assume that the meaning somehow got distorted at the point of delivery because he cannot believe this of me, or anyone else.

Q You say you did not have any involvement in this study, Dr Berelowitz. I understand, and you have made it clear, that you do not know a great deal about transfer factor.
A Yes.

Q Would you have supported the use of it in autism at that time? Would you have supported that as being an appropriate use?
A I would have said, “I am not the man to ask.”

MS SMITH: Thank you very much indeed, Dr Berelowitz. I have no further questions, but there are others who will.

THE CHAIRMAN: It is now ten to three and I do appreciate, Dr Berelowitz, that you have been once again going through a long stint of very close to an hour and twenty minutes, I think – thereabouts. We will now adjourn for twenty minutes and will resume at ten minutes past three. Dr Berelowitz, my usual reminder again, that you are still under oath and still in the middle of giving evidence.

THE WITNESS: Of course. Thank you.

THE CHAIRMAN: Afterwards counsel who are representing the doctors will be asking you questions.

THE WITNESS: Sir, can I ask a question about timing? I have put off my patients for the first part of tomorrow morning. Am I going to have to put them off for the whole of tomorrow morning? And what about tomorrow afternoon?

THE CHAIRMAN: I think it is obviously very difficult to say because to a certain extent the Panel is in the hands of the people who are representing the various parties.

THE WITNESS: Could someone give me a steer about this? I would be grateful.

THE CHAIRMAN: I have just been advised by the Panel Secretary – a very good suggestion – that during this adjournment she will contact all the parties and may be able to give you some kind of an estimate.

THE WITNESS: Thank you very much.

THE CHAIRMAN: Mr Miller, I think you wanted to say something?

MR MILLER: I was just about to say, I am, in fact, going to start cross-examination. It has been a long day anyway. This is quite a difficult area. I would have hoped that we are not going to be spending a long time after the break, and that the witness and everybody else can get a break, but if we were to rise slightly earlier than 4.30 4.45, I am pessimistic about this doctor’s commitments tomorrow afternoon. I have a number of matters to do deal with, as has Mr Hopkins. We are going to be, I would have thought, getting on for a full day tomorrow with Dr Berelowitz.

THE CHAIRMAN: Dr Berelowitz, you have actually heard. Can I also in answer to your first part, I think this is absolutely right; the time comes obviously when the Panel can only take the information in up to an extent, and they cannot take any more. I cannot really see us sitting any time beyond 4.30 – in fact, any time around 4.15 or thereabouts would probably be the best time.

MR MILLER: I would like to make a start, but I think it is quite dense, and it is one witness, which is one problem, so it works both ways. I can do some of my cross-examination this evening and then resume tomorrow morning.

THE CHAIRMAN: The other thing is that obviously this is a very complex case, and there are a lot of things that the Panel has to keep dissecting and analysing from the various things that are put in front of us. The Panel have asked me to say at some stage, and this is probably the appropriate time to do this, that they do not want to work under pressure of any kind. It is convenient for everybody to try to do things according to the timetable, but it is certainly not in anybody’s interest to try to work under pressure. I absolutely concur with that particular view. I think we obviously want to work, and work as much as we can, but I do not want my Panel members to work under pressure so the stage comes where justice can start getting into a bit of a risky area.

MR MILLER: Yes. Thank you, sir.

THE CHAIRMAN: I think we will resume at about quarter past three, and hopefully we will finish between quarter past four and four thirty.

MR MILLER: Thank you, sir.

(The Panel adjourned for a short time)

THE CHAIRMAN: Mr Miller? I believe you are going to start first.

MR MILLER: Yes.

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

THE WITNESS: Thank you.

Cross-examined by MR MILLER

MR MILLER: Doctor, there is quite a lot of ground to cover and I hope that we are not all going to do the same bits of ground, but we have to go back to the beginning again where you started off. In 1996/97 you had an establish relationship with the university department of paediatric gastroenterology?
A An established clinical relationship?

Q Yes.
A Yes, yes.

Q By that time, you had got to know the way in which it worked and had been involved in the clinical role in assisting some of the children who passed through that department?
A Absolutely.

Q And you would have known that that department numbered Professor Walker-Smith as head of department, Dr Murch as senior lecturer, Dr Mike Thomson as a consultant?
A Yes.

Q And there was another person whom we have not heard very much about and probably will not, Dr Phillips, who I think dealt with biopsies and processing those rather than with the patients?
A Yes. And I knew the first three well, and Dr Phillips hardly at all.

Q Of course, there was a support team of juniors?
A Yes.

Q And nurses, dieticians and the like. Dr Wakefield was not part of that time was he?
A No.

Q He was attached to the academic department of medicine, I think, and
Professor Pounder?
A That is what I thought, yes.

Q Although it is clear and it is demonstrated in this case that he had a research interest in inflammatory bowel disease, he had no clinical role in the department itself in treating patients. In other words, he was not seeing the children, investigating them, doing colonoscopies and the like?
A I am not sure that I know the answers to all of those points, but Mike Thomson, Professor Walker-Smith and Dr Murch (as he was then) were my close colleagues.

Q You have explained that it may not be easy, at first glance, to see what your link is with the paediatric gastroenterology department until you explain that in fact it is quite a difficult experience for the children to be involved in investigation and in treatment, and outside help is quite often required.
A Yes. I thought we had a good service and that we worked very well together.

Q Lest we get the picture that all that was coming through the department was autistic children with bowel disease, they would have been very much in the minority overall of children coming through and being looked after by the team?
A Absolutely.

Q You, I think, had been at the Royal Free, having left the Maudsley and taken up your position there in 1993, was it not?
A Yes. May 1993, I think.

Q Professor Walker-Smith, Dr Murch and Dr Phillips, I think, only transferred from Barts in September 1995?
A Yes.

Q And I think Dr Thomson was employed as a consultant shortly after that, so it was round the same time. He joined what was then to become the department?
A Yes.

Q Was there a previous paediatric gastroenterological team in place before they joined?
A No, there was not. There were then, and are still today, complex machinations about the location of general and specialist paediatrics in London. There was a specialist paediatric renal team at the Royal Free with whom our liaison service worked closely. Through complex machinations that I was not part of, renal went to Great Ormond Street, and gastro came from the Royal London to the Royal Free. We were very welcome.

Q So the unit was grafted on?
A Yes.

Q Bringing with them the expertise from the Barts and London?
A Yes.

Q Does it follow that your relationship with paediatric gastroenterology as a department started with this transfer from Barts to the Royal Free?
A Yes. We were obviously under a pretty steep learning curve because our liaison team was not experienced in inflammatory bowel disease, but we instantly clicked as colleagues and I thought we worked well together.

Q I am not going to dispute that with you, but it was something that in fact worked. You presumably understood that that is the way they worked at Barts as well. There had been this psychiatric liaison service at Barts at well which worked closely with the gastro team?
A Yes.

Q Over a period, I started by saying end 1995/96, but by the time we get to the spring/early summer of 1996 you would have been familiar with the way in which the department worked?
A Yes.

Q And on the consultant or honorary consultant side there were effectively three working consultants, seeing and investigating the children?
A Yes.

Q And sharing the workload between them as to who did what, depending on the time of the week?
A Yes. Quite how they shared it, I did not know, but they shared it.

Q That is quite important background because it shows why you are there and what expertise you could bring to bear in a clinical setting, in other words, to help these children who were being brought in. Just before we leave it, this was a unit with some considerable reputation, was it not?
A Absolutely, yes.

Q It was regarded as a top unit?
A Yes.

Q And in terms of investigation and trying to solve problems for these children, it had a reputation – I think you used the words – of having the courage and the skill to investigate them?
A Yes. Before I met them, and more strongly so after I met them, I was looking forward to a long clinical and academic collaboration with these colleagues.

Q In a way it is quite difficult to see from any documentation how this happened, but we have tried to piece it together. You became involved in what must have been a preliminary discussion about whether a study should be undertaken in the terms of what eventually became the application for ethical committee approval.
A Yes.

Q I think you tell us, although we have not got any dates, that it started with a discussion with Dr Wakefield about autism ---
A Yes.

Q --and whether it was considered to be a genetic disorder, and then his presentation of his early theories about the gut at the Tavistock Clinic as an invited speaker?
A Yes.

Q Would that have been some time at the beginning of 1996? Can we put any sort of time on that?
A I once looked up the date. I could look it up overnight if the Panel wishes. There are no minutes of the meeting. I can only look up the date.

Q But he spoke at that meeting and it is a forum for early ideas?
A Yes.

Q Are they limited purely to psychiatric issues?
A Child psychiatric issues.

Q I think you said it is quite a tough place to present?
A Pretty tough, yes, deliberately so, because if you have got a bad idea you want it knocked down quickly so you do not spend years trying to pursue a bad idea.

Q In fact, those ideas were not knocked down?
A Absolutely not, no.

Q Your mentor thought it was an interesting idea, did he not?
A Yes.

Q But after that time there must have been a discussion about the form of any study and as to the content of what went into the ethics committee application. I will let you answer that in a minute. At the end we know that it involved the gastroenterologists, a psychiatrist, and scientists and the histopathology department, but there must have been a discussion at which those individual units decided what part they could play, or agreed to play a part?
A Yes.

Q Am I right in thinking that that started in really quite a loose way, just general discussion about the fact that it would be interesting to look to see whether or not there was a link between bowel disease of whatever nature and autistic spectrum behaviour?
A Yes.

Q That became more solid. It would have had to become more solid for the application for ethics committee approval to be made?
A Yes.

Q Because it had to be spelled out what was going to be required?
A Yes.

Q In those discussions do I take it from your evidence that you understood that if you had a role to play, it was not the role which you had played and obviously continued in another setting to play, a clinical role in giving advice about the children who were there. It was a limited role of giving a psychiatric perspective on the behaviour of those who had been investigated by the gastroenterological department?
A Yes.

Q So you were there to identify evidence, if there were to be any, of developmental problems?
A Yes.

Q As you yourself have pointed out as you went through the notes, I think in certainly a couple of the cases which we have before us now there was a risk that you were taking on a slightly more clinical role as things advanced, but no more than to make suggestions, for instance in, I think it was the case of Child 2, that you had not seen any improvement in the behaviour, which the mother said?
A Yes.

Q And I think in relation to Child 8 you made the suggestion that she should be seen by a developmental paediatrician?
A Yes.

Q Which would not be on all fours with a research observer?
A Yes.

Q For the main you simply provided your view in pretty general terms about what you thought that you had observed?
A Yes.

Q Just before we leave your role, by no stretch of the imagination could this be seen as a research trial in which you were identifying in any detailed sense the precise problems which these children had. This was not an autism trial which you were conducting. Your role was to identify whether or not there were features that could be generally described as being within a spectrum?
A Yes, absolutely.

Q Had it been a much more formal trial and investigation about autism, the type of trial which you say may have been carried out by Sir Michael Rutter, then it would have taken a very different form?
A Yes.

Q Any discussions that you would have had would have taken place, obviously, before any formal study had been put together?
A One would have thought so.

Q Because you were a contributor to the psychiatric aspect which needed to be considered?
A Yes.

Q Can you just look at the application for ethics committee approval, please?
A Can you tell me where it is?

Q In the bundle FTP1. I think it starts around page 200. There are two dates on the document, the first 6/8/96 on page 200, but that appears on the face of it to be linked to the signature denoting approval of the head of department.
A Yes.

Q Then on page 233 the date of submission, which is 16 September 1996?
A Yes.

Q So it is probably safest to take it that 16 September is the date upon which, whenever it was put together, it was submitted to the ethics committee for approval?
A Yes.

Q In that application, and we have identified the position, not only is your department nominated as one of the departments collaborating in the study, where it says “Dept of Child Health (Child Psychiatry)” on page 200, but you personally are described as having a coordinating role. It is section 1.3 on page 213. Page 214 I think it is in fact. Your role there is in confirmation and characterisation of features of disintegrative disorder and you are the consultant psychiatrist and coordinating investigator?
A Yes.

Q I imagine you have no difficulty with that, that that is as you were described and that is the role that you felt that you were going to play?
A Yes.

Q You signed the application and presumably you read it, to whatever depth you felt was necessary for you to understand what your own role was?
A Yes.

Q As far as the term “disintegrative disorder” is concerned, although you were not the physical draftsman of the description about this condition, you had input, the expert input if you like, into how it was going to be described in this document?
A Yes.

Q Whether it was done by somebody else?
A Yes.

Q Did you give a lecture about this which was attended by Dr Wakefield at about this time?
A No, I did not, but thank you for raising that. A visiting colleague from Thailand who worked in developmental disorders in Thailand was attached to my department for two years as an observer, and he went off and did some reading and did a presentation and he said that just on the face of it, with a kind of face validity, logic would suggest that if there is a link it would be with disintegrative disorder. We
we all found that jolly informative and his background reading was pretty thorough. I clearly remember that meeting.

Q So looking forward without knowing what you were going to find, this seemed to be a good candidate. If there was going to be a regression caused by some environmental feature, then it might fit disintegrative disorder, temporarily anyway?
A Yes.,

Q That is the way in which you looked forward, so you were presumably happy with what was put in to the application in a descriptive sense of what this involved?
A Yes.

Q Did you discuss the protocol or any aspect of it with Professor Rutter? I know you said that you did discuss the study with him, but did you show him what was going to be involved?
A I do not think so, no.

Q I think what you have said is that there was positive feedback from Professor Kolvin and Professor Rutter about pursuing the research, but in Rutter’s case it was with the caveat that it ought to be done properly?
A Yes. I was thoughtful about the characters of both of my senior colleagues.
Professor Kolvin was a very, very cautious man, and so if he said this could be a good area of investigation you knew that he had thought more about the risks than about anything else, because he was so cautious, always scrupulously cautious. So when he said this could be a fruitful area for study, coming from Issy Kolvin that meant very, very fruitful area for study. Professor Rutter, famously scrupulously thorough and detailed, and he not surprising said, “If you’re going to do it, do it properly.” In terms he said, “Try to be thorough.”
Professor Rutter would have said to me, “Mark, I think you’re making a personal”, or “an academic” or “professional mistake here to be involved in this”, if he had thought that was the case. He would have had no hesitation in saying that to me.

Q Your role as contemplated – I am looking forward at the moment – was crucial, because it was envisaged, and indeed it turned out, that you were to be the judge for the purpose of the study of the development disorder, if any, from which these children suffered, to be put alongside – and we must not lose sight of it – the clinical findings, if any, identified by your gastroenterological colleagues?
A Yes.

Q So they are the two aspects of it. You had a good inside knowledge of how their department worked, but they would be the ones who would be doing the clinical investigations and making the findings?
A Yes.

Q Approval of this study was given on 18 December 1996, although communicated,
I think, at the beginning of January 1997. You yourself have been a member, I think, of a local research ethics committee, have you not?
A Much earlier, yes. Not at that time.

Q One which had jurisdiction over the Royal Free?
A Sadly, it is a test to me to how many committees one serves on. I have definitely been on a clinical ethics committee at the Maudsley. I think shortly after I arrived at the
Royal Free I was the children’s services representative on the research ethics committee of the Royal Free until Dr Murch arrived, and I thought he has got a better scientific background than me, and he is a physician and I am not, and I suggested that he take over from me. That seemed sensible.

Q I think we have heard from Dr Pegg that research ethics committees were in their infancy in 1996, and certainly you would have stopped working on the committee by then. Looking back on it, had things moved on since 1996?
A Extraordinarily so. In those days there was lots of chairman’s action. Things did not always have to go to the full committee. I had a telephone conversation with Dr Pegg some time in the last two years in which I said to him, “In 1996 what was the status of my signature on page 200? What did that mean”, and he said, “Mark, it meant whatever I, Dr Pegg, chose it to mean, because there was no national guidance at the time about what on earth that sort of signature meant.” Now, according to an audit in the BMJ, it takes about 40 hours to write a proposal to an ethics committee. It has changed dramatically between 1996 and today, and it has become, in some people’s minds, a reason not to do research, because it takes so many hours to complete the paperwork. Very, very different.

Q Historically we know, and we have seen it, that the date of submission is
16 September. Did you become aware when approval was granted for this particular application?
A Somebody would have told me either on the telephone or in one of our Thursday meetings, “We’ve got the go ahead from the ethics committee.”

Q Because obviously, as we have observed, you had quite an important part to play. You say somebody would have told you, “We’ve got the go ahead.”
A Yes.

Q We went through the children that you had seen with Ms Smith I think earlier in the afternoon or just before the midday break.
A Yes.

Q It is clear that a number of those children were seen in the gastroenterology department in the spring and summer of 1996, and autumn of 1996 as well, and indeed you were asked to assess some of those children again in the autumn of 1996.
A Yes.

Q So we know, to take a point of reference, that in terms of Child 2 you saw that child on 5 September and made a report on 30 September.
A Yes.

Q If you like I can turn it up. Remember it was the first one you were asked to have a look at.
A Yes.

Q As a matter of record, formal approval had not been obtained by that time?
A Yes.

Q Being, presumably, a regular visitor to the paediatric gastroenterology department it would have been obvious to you that children were being seen and investigated by the gastroenterologists throughout the summer and autumn of 1996, because you were being asked to see them and provide reports about them.
A Yes.

Q So it all gets a little unclear in terms of the precise timings, but in fact what the clinicians were doing – that is Walker-Smith, Murch and Thomson – was to see and investigate these children with a view to seeing what was wrong with them from a gastroenterological point of view throughout this period, but also with a view to treating them, and they just carried on seeing them throughout the summer and the autumn and you did your bit after they had been investigated?
A Yes.

Q This case to some extent has been bedevilled by the suggestion that it is either clinical care or research, it cannot be a combination of both, but clearly there can be clinical care provided, in this case by the department of gastroenterology, to which there is an add-on of your non-clinical role, research, and later Dr Wakefield’s non-clinical role, the other aspect of the research?
A Yes.

Q Indeed, the application itself is pretty clear on its face, is it not, if you look at page 209 of Bundle 1? Do you still have Bundle 1 there?
A Yes.

Q It is a question that is asked in the pro forma at page 209,

“Would the procedure(s) or sample(s) be taken, especially for this investigation, or as part of normal patient care?”

Answer,

“Yes: in view of the symptoms and signs manifested by these patients, all of the procedures and the majority of samples are clinically indicated. Additional intestinal biopsies (5 per patient) will be taken for viral analysis. DNA for genotyping will use blood cells isolated from the routine blood sample, and will not require an additional sample”.

So on the face of the application to the Ethics Committee, that is what was being said.
A Yes.

Q Indeed, that is what you understood to have been the position that has consistently been maintained by the paediatric gastroenterology department throughout.
A Yes, and I was not troubled by that position at the time.

Q We have been through it again when Ms Smith was taking you through the documentation earlier, but you were aware that that was the response given by Professor Walker-Smith when Professor Hull questioned the ethical position of continuing to investigate the children after the publication of The Lancet paper, and it is a position which you defended yourself, is it not, in a letter which you have alluded to but which we have not seen, to Professor Taylor in July 2000?
A Yes.

Q Earlier on I think you said you had written about it, effectively saying to Professor Taylor, if you want something done – let us look at the letter because it is not in the bundle and in fairness to you, since you have mentioned it, we can perhaps have a copy made available to you now. Sir, this is another green document and it has to be inserted, if it is going to be in chronological order, at 1116a, which is Bundle FTP3. (Document handed) Do you have a copy of that, doctor?
A Yes.

Q It is a letter you wrote, as Chairman of the Medical Advisory Committee, in July 2000 and we must remember that this is two years after the publication of The Lancet paper, the first Lancet paper.
A Yes.

Q It is written to Professor Taylor and it is headed, “Autistic Enterocolitis”,

“Thank you for coming to see me on 25 July. You mentioned that a paediatric gastroenterologist from Oxford, one Dr Sullivan, had contacted you about his concerns about research into the putative entity of ‘autistic enterocolitis’ at the
Royal Free. We discussed the fact that his services had been engaged by the vaccine companies as part of their litigation and that he had looked at some of the case notes of the children. He did not believe that there was anything significantly wrong with their bowels. We discussed the fact that he was by definition not an unbiased observer, but nevertheless his comments should be taken seriously.

We also discussed Dr Sullivan’s concern that there was no clinical or research indication for these children undergoing endoscopy. I explained to you that Professor Walker-Smith had been clear in a number of discussions that these children were being seen for clinical reasons, and that he and his colleagues were prescribing endoscopy on clinical grounds only and not on research grounds.

I further explained to you that this matter had been discussed by me with
Professor Zuckerman, the then Dean, as well as with the Medical Director, and had also been discussed in the past with the Divisional General Manager and the Specialty Group Chairman. In other words, my conversations had led me to believe that the Trust and the Medical School are entirely aware that the patients are seen and assessed, and where appropriate investigated and treated, on clinical grounds only. Where patients are subsequently written up, this is part of a case series which then gets written up because the clinical findings are interesting. It has been understood that for this reason specific ethical permission is not required, but if that is not the case, then clearly a different approach will need to be taken.

If Dr Furlano’s work on the lymphocyte distribution in the gut wall went beyond ordinary clinical work and into prospective research, clearly ethical approval should have been sought. It may indeed have been sought and obtained, and this can be easily checked.

If there is concern about the quality of the histological diagnoses” –

that is what is seen on the tissue slides, is it not?
A Yes.

Q Then:

“…then the best way to resolve this is to show the slides to an independent investigator who is blind to the clinical diagnoses. This point has been mentioned a number of times. I do not know of any objections coming from either Professor Walker-Smith, Dr Murch or myself about an independent investigator having a look at the tissues.

If an undertaking has been made to the Medical School to make the slides available to an independent investigator, but that undertaking has not been kept, then that would be a very serious matter indeed.

You said to me that you fear considerable adverse publicity for the Royal Free from this research. I am not sure whether this is because of Dr Sullivan’s comments or because of some other matter. I would suggest that if there are any concerns at all about the quality and probity of the research reports coming out of the Royal Free, there should be a meeting with yourself, Professor Spyer, Professor Pepys, Professor Walker-Smith, Dr Murch and myself to discuss this. Professor Black, the Medical Director, should also be present as there appears to be concerns about the appropriateness of clinical investigations. Certainly I am very concerned indeed that any queries about the quality of work be openly faced and dealt with. Equally, I am aware that constant sniping, where such sniping is not justified, can have a tremendously deleterious effect on people’s professional reputations and careers.
I would therefore encourage you to set up, with the Dean, a meeting which can deal with these matters firmly and, dare I say it, once and for all”.

You copied that to Professor Walker-Smith, Professor Stein, Professor Spyer and the Medical Director, Professor Black. Dealing with it colloquially, this looks like a letter effectively saying “Put up or shut up” to Professor Taylor. He has got concerns and they have to be met properly in a proper forum.
A Absolutely, I can add to that if asked.

Q Is this the letter to which you told the Panel earlier you had not received a reply?
A Yes. I mean, I can explain more about the background to the letter if the Panel wishes.

Q For the moment I do not think it is necessary. The point I was drawing out was to show that there had been a consistency of approach throughout about the clinical need for these investigations to be carried out. That had been made clear by Professor Walker-Smith at an earlier stage, and in 2000 you were saying to Professor Taylor, “That is the position that has been maintained, and the Medical School and the Trust knew about that being the position”. Earlier in this hearing we have seen correspondence with the Dean in which the point is made from Professor Hull’s intervention in 1998.
A Yes. I mean, I had a different status then. I was Chairman of the Medical Advisory Committee, that committee that Dr Harvey had chaired at the time that Dr Wakefield was appointed. I was going to become chairman and so I had more authority to go and talk to people and I had more responsibility. I was truly concerned that some people were now beginning to confuse the professional and the personal and were beginning to snipe and carp and undermine in a way that needed to be flushed out, either to put up or shut up. I was also, frankly, worried about double standards and I was worried about who, as it were, was going to bring down all this adverse publicity on the Royal Free, where this was going to come from, and I thought, “This is not right. It is not right for the individuals. It is not right for the Royal Free, for the Medical School, so let us get it out in the open”. If only we had. If only they had, because they had a responsibility for it.

Q You put forward a suggested solution, or solutions, but as you said, they were not taken up.
A No, and I do not know why not. I have some particular speculations as to why not, but I do not know why not.

Q We will deal with the facts.
A Absolutely.

Q Just to put your own position, not at this stage in 2000, but to put your own position in context, The Lancet paper concerned only 12 children and it says, and there will be evidence about it, that these were the first 12 children that were seen.
A Yes.

Q Many many more children were referred to the paediatric gastroenterology department after these children.
A Yes.

Q They were, in many if not most cases, investigated by colonoscopy and bowel findings, histological findings were made, and you made, as you did with the other 12, psychiatric assessments as to whether or not they had a developmental disorder.
A Yes, when called upon to do so. Not always.

Q No, but if it was considered appropriate, as you had done for the first 12 children, you provided that important role to make the link between what might be two positions.
A Yes.

Q This was not in any way in furtherance of what you described as your little study. This carried on, I think, for quite a long time – it may indeed be happening now, I do not know. But it was linked, was it not, to the continuing provision of service within the National Health which included investigation, diagnosis and treatment.
A Yes. I was taught a long time ago, I think when I was at Medical School but it may have been as a young psychiatrist, if a child with autism becomes very agitated, check whether or not they have an ear infection, because untreated ear infections in a child who does not know how to articulate his experience will be distressing and cause a deterioration in the child’s behaviour. I thought, here we were, my gastro colleagues were doing a considerable service in identifying another medical explanation – overflow, incontinence, diarrhoea, abdominal discomfort – that was causing distress in some children with autism. Members of the public took their own view about this, because they sought to be referred, it would appear.

Q So we have gone beyond your little study, and this is being provided on a regular basis.
A Yes.

Q I am sorry to do this piecemeal, but I wonder if you would look at another document. (Document handed) Sir, this is in the same bundle at page 1082a and b. It is two pages. The second page may look on the face of it lean, but it serves a purpose. It is a letter written to you, Dr Berelowitz, and we are talking now about March 1999. It is from Sister Liz McLean who was one of the sisters in the department. Do you remember her?
A No, I am sorry. I am sure I would remember her face.

Q It is a letter of that date, and all it does is say it is enclosing a list of children currently booked into the ward for admission up until July 1999.

“I have discussed this issue with the registrars and the ward administrator and have arranged that the nurses and the ward clerk will take responsibility for informing you when an autistic child is booked for admission. I have not had the opportunity to discuss this arrangement with Professor Walker-Smith but I hope it will be acceptable to all”.

Over the page there is a list of 17 patients who were booked in between March 1999 and 18 July 1999. Perhaps you agree, that it makes the point that long after The Lancet article, you and the paediatric gastroenterological department were in collaboration to provide the two aspects of this service.
A Yes.

Q Still admitting children to be investigated on the gastroenterological side and to have some formal diagnosis put on them in general terms by your team.
A Absolutely.

Q Indeed, you were, I think, co-author of at least two papers that came from the
Royal Free to report the findings, effectively continuation papers on the clinical findings and the suggested link between developmental disorder and gastrointestinal symptoms.
A Yes.

Q Which were published I think in 2000 and 2002.
A I cannot remember the dates, but I remember the papers.

Q By that stage, the MMR aspect had completely disappeared, had it not, from the papers that were being written.
A From the papers and from Dr Murch’s and my day-to-day discussions about the patients, both clinical and academic. It was always lurking there as an issue because of The Lancet paper and because I knew that the medical school and Dr Wakefield were grappling with one another about supervision and about public speaking and so on. So it was always around but it was not on the ward any more.

Q No. What was on the ward was investigating and making diagnoses and treating patients. That, after all, had underpinned the first 12, but the issues were clouded by what happened when the paper came to be published and what happened at about that time.
A Yes, and I think we were all happy to be working in a way in which we were not preoccupied with the MMR. That was not a focus of the families’ conversations, to the best of my recollection.

Q Jumping ahead, when we get to the publication of The Lancet paper, as I understand it, you were quite excited about continuing to see these patients, to see whether your future experience remained the same; in other words, that what you had appeared to have found with the first 12 patients was replicated with others who came after them, as far as the emergence of what was thought to be a new syndrome.
A Yes. Autism is a lifetime condition which is very, very upsetting for at least some families. One of the fathers in the study – I think in the study, but one of the fathers I met as part of this work – said to me that his own subjective view is – his child was sleeping on his chest – that if he left the room and never came back would it make any difference to his child. It was so sad. One can understand why so many distinguished people have tried to find out what is the cause of this condition and what might be the treatment. My gastro colleagues know more about the gut wall in children than most other people. If they were thinking there could be something here, then really, scientifically, it merited all of us devoting a couple of years to try to work out: Is this a fruitful area of study? And that was all. Dr Murch and
I, I think, were particularly happy to think we might have the opportunity to answer the question: Is there something different about the gut of all or some children with autism? That is what we were going to be focusing on. I thought it was legitimate and honourable work.

Q Thank you very much. I am sorry, you are back tomorrow morning.
A I will try to revive myself between now and then.

THE CHAIRMAN: First of all, thank you, Mr Miller, for finishing at a decent time.
(To the witness): Dr Berelowitz, again my same usual warning. It is a little bit more of a difficult situation now because you are going to have to be careful overnight now. You are still in the middle of giving the evidence, so it is very important that over the evening and the night you do not discuss about this case at all.

We will now adjourn and resume at 9.30.

(The Panel adjourned until 9.30 am on Wednesday, 1 August 2007)

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