GENERAL MEDICAL COUNCIL
FITNESS TO PRACTISE PANEL (MISCONDUCT)
Wednesday 1 August 2007
Regents Place, 350 Euston Road, London NW1 3JN
Chairman: Dr Surendra Kumar, MB BS FRCGP
Panel Members: Mrs Sylvia Dean
Ms Wendy Golding
Dr Parimala Moodley
Dr Stephen Webster
Legal Assessor: Mr Nigel Seed QC
WAKEFIELD, Dr Andrew Jeremy
WALKER-SMITH, Professor John Angus
MURCH, Professor Simon Harry
(Transcript of the shorthand notes of T. A. Reed & Co.
Tel No: 01992 465900)
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
MARK ORLIN BERELOWITZ,
Cross-examined by MR MILLER, continued 1
Cross-examined by MR COONAN 11
Cross-examined by MR HOPKINS 25
Re-examined by MS SMITH 28
Questioned by THE PANEL 37
Further re-examined by MS SMITH 63
Further cross-examined by MR MILLER 64
Further cross-examined by MR COONAN 67
THE CHAIRMAN: Good morning, Dr Berelowitz, and good morning everyone. Mr Miller, you were in the middle of cross-examination of this witness.
DR MARK OLIN BERELOWITZ
Cross-examination by MR MILLER, continued
Q Dr Berelowitz, could I ask you about investigations in the gastroenterological side of looking at these children. Although Professor Walker-Smith, Dr Murch and Dr Thomson were consultants or honorary consultants in the Department of Paediatric Gastroenterology, they were by training paediatricians.
Q Whether they recommended that a child should have a colonoscopy or not obviously was a matter for their clinical judgment.
Q They were obviously the ones with the expertise to decide whether or not it was clinically justified and whether or not it was likely to lead to a diagnosis and, if possible, treatment. That was their job,.
Q Equally, as far as other investigations were concerned, it would, in the end, be a matter of their clinical judgment as to what other, if any, investigations were required.
A That would have been my view, yes.
Q I have in mind, specifically, lumbar puncture. You would not have expected one of the consultant paediatricians to have asked you, as a child psychiatrist, to say whether or not it was all right to do a lumbar puncture.
A Absolutely not, no.
Q Lumbar punctures are traditionally carried out by paediatricians in a variety of different areas, not necessarily limited to gastroenterology. It is what a paediatrician tends to do if they suspect some disease process or something else.
A Yes. For example, one day, when Dr Mike Thomson was consultant of the week on the general paediatric side, there was admitted under my care a teenage boy who was acutely psychotic and he had been travelling, and Mike came to me and said, “Do you think he needs a lumbar puncture?” It was a perfectly sensible suggestion. We discussed it. We decided: not that day: we would observe his clinical course. And a clear psychiatric diagnosis emerged, so he did not have the lumbar puncture. But I was grateful to Dr Thomson for making the suggestion. It made perfect clinical sense to consider it and have it in mind according to the patient’s clinical state. That was his proper job, as paediatrician of the week, to raise that with me.
Q If, for example, it was decided that it was appropriate to do a lumbar puncture to exclude something like a metabolic disorder, that would be a matter for the paediatricians for their work-up of investigations.
Q Looking at the thing overall, I think your position is that you did not see anything out of the ordinary in the tests that were being done on these children.
A No, especially since, over time, as it became clear that particular tests were not turning out to be informative, they were dropped.
Q Yes. I think that applied to lumbar puncture. And then, quite early on, MRI and EEG were also dropped.
A Yes. This led me to conclude that the clinicians were always being mindful of whether the test is justified, on balance, for the children. They were taking the children’s needs into account in deciding: “This test no longer seems to be justified, so we will drop it.”
Q With lumbar puncture, that stopped quite early on. You will not have seen it, but we have seen some correspondence form Dr Wakefield to Dr Pegg about MRI and EEG which no longer were used. I think what happened was that they were not getting anything that they considered to be important from those results.
Q Your own view, as I understand it, as someone with regular involvement with patients on the gastroenterology ward, was that if there was going to be a lumbar puncture, it would be better to be done at the same time as the colonoscopy because the child would be sedated or under general anaesthetic.
A The child would be sedated, in a very clean environment. It would seem to me the right time.
Q You may or may not be able to help, but I think you have run a Medline search, have you not, with search words “CSF” and “autism”?
Q Just for something to do, and found quite a number of studies from reputable centres where lumbar puncture is part of the protocol for the investigation of these children with autism.
A Yes, absolutely. Probably like everyone else involved in this business, I do spend time re-evaluating in my own mind what I did, what we did collectively, what we did institutionally and from time to time something comes to my mind and I go off and look it up. I looked up through Medline and through other means who was recently and is currently doing research on children with autism that would give lumbar punctures. And I was surprised at how many positive results came up – very prestigious people from prestigious organisations.
Q Yes, serious institutions doing it.
A Yes. In fact one of the same people, Professor Gilberg, who is also quoted as saying that the prevalence of autism has not changed, for the purposes of this argument has also recently been doing lumbar punctures on children with autism.
Q I would like us to turn to a slightly different matter. We have seen that the first report you wrote for Child 2 is dated 30 September. You saw him on 5 September on the ward. Ms Smith took you through, yesterday, the sequence of some of the children. There are brief notes in the case notes followed by a letter detailing your findings.
Q And there may be other letters which will surface, I do not know. Where you have said “Letter to follow” and we have been able to find it yet in the bundle, it may be they will come to light. But the pattern seems to be that you saw the children on the ward, said, “I’ll go away and think about it,” write your report and then detail what your findings were.
Q That was the pattern that you developed. Did it concern you at all, doctor, that whereas the Ethics Committee application had specified disintegrative disorder, as it turned out, with one possible exception – and I stress the word “possible” – you were seeing children who you were more commonly classifying at the time as being within the autistic spectrum of having Asperger’s; in other words, as it turned out, these children were autistic spectrum or Asperger’s rather than disintegrative disorder as a diagnosis. Did that concern you at all?
A No, it did not concern me at all for two reasons. Firstly, as I said yesterday, disintegrative disorder is an autistic spectrum disorder. There is no doubt about that. The only debate in my profession is whether or not we should retain the term or simply include it under autism more generally. So, intellectually, it did not give me cause for concern. Also, I always knew, from my point of view, we were doing a little study, a pilot study, to see what we learned. We were going to publicise what we found and see whether we or other people were interested in taking matters further. Of course I would have been terribly concerned if I had said that the children did not have disintegrative disorder and then they were published as having disintegrative disorder, but we found what we found and we published what we found and then we paused. So, to me, that seemed proper in terms of the rules at the time. I mean, nowadays, as I said yesterday, I have become incredibly pedantic, and I ring people up: “This little thing has come up. Are we still within the ethics brief?” And, as I said yesterday, frankly my colleagues find me a bit irritating in this regard because I have become so pedantic. There was no need to be that pedantic, I believe, ten years ago.
Q Did the fact that you were not finding a specific condition of disintegrative disorder mean that you could not write reports on these children because they did not come within that specific type definition?
A I had to write down what I found and I thought we must publish what we found, even if, or perhaps especially if, it weakens the original hypothesis. Then especially we should publish it.
Q The article has the 12 children, with their description of what your basic diagnosis was for each one, with the two queries of encephalitis, and disintegrative disorder appears to have disappeared from the radar at that point.
Q I am not suggesting that you should have had any concerns, but that did not bother you because you were writing up what you found.
A Yes. With my contemporary mindset, which is coloured with experience, as I said yesterday, today I think we might have written to the Chairman of the Ethics Committee after the first five or six cases saying, “We are finding autism in general, not particularly disintegrative disorder.” But I was not trying to count the diagnoses and we did pause after 12, so I am not uncomfortable with that. In this whole business, it is not one of the things that makes me particularly uncomfortable. And I have received no criticism in that regard from my colleagues in child psychiatry. No one has said, “Apparently you were looking for disintegrative disorder and you found something else,” because they would, I think, feel, as I do: well, we were looking within the autism spectrum
Q In fact, I think we have seen from your intervention, the letter that you wrote on 5 August 1997 – and we do not need to turn it up, but you were taken to it yesterday – that you were saying, “Really, we need to have a better definition than …” I cannot remember what the first draft said.
A Regressive behaviour disorder.
Q Regressive behaviour disorder. And you said pervasive developmental disorder would be a better description.
A Yes. Because it is the global term and people know exactly what it means.
MR MILLER: could we turn to The Lancet paper. I am going to ask you to look at a document first which needs to be inserted into bundle FTP2 at page 616a. (Document distributed)
Sir, I am in your hands. When Professor Walker-Smith gives evidence, I anticipate that he will say that behind this letter, which I am going to ask the witness to deal with on a different point, there was a copy of the draft of the paper. It is evident: the letter makes that clear. We have looked at it. It is identical to the one which we saw yesterday and which I am going to take the witness to. I do not know whether you feel, for the sake of completeness, we need to have another copy of the paper, because it was behind it – in which case we will simply copy it. The reason I am dealing with this is to put some timing as to when the copies of what are said to be the final draft were sent out, which we did not get yesterday. This witness has referred to a draft that he saw and Professor Walker-Smith will say, ‘Yes, I got exactly the same draft behind this letter,” and my only point is whether it is necessary to copy that when it says exactly the same thing, or whether we can short-circuit it by saying it is the same as the one in there.
THE CHAIRMAN: Do I understand the timing is different?
MR MILLER: No, it is exactly the same. It is to put some timing on it, with a date as to when he would have received his copy.
THE CHAIRMAN: I suppose we could take the one we already have, but I will ask the Legal Assessor.
THE LEGAL ASSESSOR: Would the most helpful and practical way to do this be to put this letter to the witness along with the draft. If he accepts what you put to him, we could make a note on this letter that page whatever it is that you are next going to refer to was the accompanying document.
MR MILLER: Thank you, sir. I was anxious about a whole lot more green paper going in where it is an identical document.
THE LEGAL ASSESSOR: If the evidence is as you anticipate, we can make a note on the letter of the page number of the accompanying document.
MR MILLER: Thank you very much, sir.
(To the witness): Dr Berelowitz, it is a complicated way of getting it in, but perhaps I could ask you. This is a letter dated 8 October from Dr Wakefield:
“Re: Ileal Lymphoid Nodular Hyperplasia Non-Specific Colitis and Developmental Disorder in Children: A New Syndrome”
Then there is a list of people to whom this was sent, which includes, at the bottom of it, Professor Walker-Smith. But I think there, as it were, in the batting order, that you appear in the article.
A Yes, it looks like it.
Q I am trying to jog your memory. Is this the sort of thing that you would have received as an author from Dr Wakefield with a draft of the document?
A I would have expected to receive it, but I cannot now remember whether I did.
Q Just in terms of timing, 8 October 1997, and it ends, “This is a letter to...”. It is a round robin. It has not just been addressed to Professor Walker-Smith. It is addressed to all of you. He has ticked it because he is the recipient of the letter in this case.
“Please find enclosed final version of the first Lancet paper on this subject describing the syndrome.”
Behind that letter was the document which you were asked to look at yesterday, page 758.
A That means that the paper that Dr Murch brought to me – he and I were not sure whether it was the final or penultimate – that was the final version that went in.
Q As far as we know. I am just effectively saying, by the time we get to the time when this letter is written, the document behind it was the document that we have at 758. Would you turn to page 758 in bundle 2, please.
Q By that time, if this is the copy of the document which was behind this letter, 8 October 1997, the title had been changed to reflect your suggestion, or part of your suggestion anyway?
Q Are we looking at the same document?
Q So the title has changed and I think you were taken by Ms Smith yesterday to the passage on page 772, which you say expressed the sentiment which you had asked to be included?
Q And that was still in there?
Q At that time. So certainly some modifications had been made from some earlier draft ---?
Q --- which you must have seen. Really the purpose is simply to show that this was probably around October 1997 that that draft was circulated?
A Yes. I must have seen something else, because I made comments and then ---
Q You must have seen the first one?
Q Because it had a different title?
A Yes. And this paragraph ---
Q Exactly. You asked for that paragraph ---
A --- that was not in yet.
Q You asked for that paragraph to be inserted. Certainly in the draft that was behind this document in October 1997, that was still there?
Q So we can mark on ours “See page 758” if it is the same document. It is really only just to get some timing on when what is said to be the final version was being circulated?
Q Then, when we come to the paper, again Ms Smith ---
THE LEGAL ASSESSOR: Excuse me. Before you move on, Mr Miller, should people now write on page 616a, under the last line of that, as “See page 758”.
MR MILLER: Thank you, sir. (To the witness) I am sorry; that was rather laborious. It was just to see if we could ---
A I find it very helpful. Thank you.
Q We can see the way in which the drafts were sent. In that same bundle – in fact I think it is pretty well the next document.
A Yes, I have it.
Q The paper itself.
A I have it in front of me, yes.
Q Is not the position, Dr Berelowitz, that when The Lancet paper came to be written, so some time during 1997, you considered that the original hypothesis, or hypotheses, I suppose, were no longer valid, particularly that there was a causative role for MMR in enteritis and disintegrative disorder, on the evidence that had been found?
Q So whatever had been the hypothesis at the time that this study was contemplated, as far as you were concerned, MMR was not implicated on the basis of what your findings were?
A Yes. In addition, I had a technical view that if it was, carrying on doing a case series in the way that we were doing at the Royal Free would not give the answer. A different scientific approach would have to be brought to bear – a mixture of epidemiology and something else. But carrying on collecting cases ---
A --- was not going to give us the answer because of this temporal business. In effect, by the time you get to mid- to late 1997, effectively what was being written up in The Lancet paper were case studies of 12 children which seemed to suggest the existence of a new syndrome, which is what gave the paper its new title.
Q I think Professor Walker-Smith had something of a history of writing up case studies of children who had been investigated in various different areas?
A Absolutely, yes.
Q And had a reputation for it?
Q So the original study, with MMR as a central part of it, had effectively disappeared in your eyes?
Q You did not feel, Dr Berelowitz, that it was necessary for the case studies,
for the paper to state positively, “We originally started out with a hypothesis that MMR might be causally related but we are not longer considering that”? You did not think it was necessary to spell that out?
A We said we did not prove an association. The draft that I saw did not say, as the bottom of page 787 implies, “Nevertheless we are carrying on collecting patients, just in case we can find an association. We have, up to January 28, a further 40 patients who have been assessed.” The addendum, at the left hand column of 787. So I thought that we were writing for a scientific audience, not for a newspaper. We say to the scientific audience, “We did not prove an association.” And we explained in what I thought was the final draft some of the technical difficulties about trying to find the explanation through this sort of means anyhow. As I say, perhaps I was naïve, but probably a doctor should try to write for the scientific audience and not second-guess the public. We were writing for a scientific publication. I thought we were pretty clear – it is over.
Q First of all, leave aside what the position was in 1996, by the time you get to the publication of the article itself, you did not believe that the work behind the paper both by the paediatric gastroenterological department or your department had been done badly, did you?
A No. No.
Q Or unethically?
A No. No, I did not. I did not believe that. At the time I did not know about the funding, and possible vested interests. I did think, and perhaps this is just a child psychiatrist’s perspective, that people out there did need to know what parents believe, rightly or wrongly, because what parents believe influences their behaviour. The Department of Health and vaccine policy advisers need to know what parents believe, so they can take parents’ beliefs into account in the way that they try to promote vaccine uptake. So I thought there was a hidden, important message in here: “Some parents believe this very strongly.” And I thought the scientific community as a whole needed to know that. So I was happy overall with the paper – the version that I understood to be going in.
Q As far as your particular role is concerned, not the report of what the children may have said, but what the parents may have said; but the descriptions of the developmental disorder in the various children, as far as you were concerned, these were accurate descriptions of your finding?
Q Including the two “query viral encephalitis” or “encephalitis” patients – I think 8 and 10 – in which we have seen you raised the point about whether or not this was as a result of an encephalitis that they had this condition?
A Yes, because on pain of stating the obvious, I hope I will not be repeating myself. It leaves it open, say, to one of my colleagues to write to me and say, “We think you were looking in the wrong place with regard to autism, but your encephalitis cases are very interesting. Can we discuss this and compare notes, and maybe talk about a different hypothesis, so one publishes – accurately.
Q Sorry, I cut across you.
A No, I am done.
Q It was important to have those two; not just simply say, “They do not fit a template, therefore we do not write about them.” It was important to have them in as well for discussion?
Q Again, as far as you were concerned, you felt that the suggested link between bowel disease and autism was, and had become, more interesting than any suggested MMR link at that stage?
A More interesting, and by this time, because things had changed, clearly less provocative. So two important reasons for concentrating on the link between the bowel and autism, and not have anything to do with the MMR.
Q I have two quite specific questions. They may sound as though they are rather the same questions that I have asked, but they are important. You did not believe at the time that the work behind the paper established any link between MMR, autism and bowel disease and you did not believe that the paper itself, even in its published form, said that there was such a link?
A Absolutely not, to either of those questions.
Q And presumably we have had a little bit about what happened at the time of publication that presumably you did not believe that the publication of the paper itself would have serious public health implications? Just the paper.
A The paper itself left alone without any fanfare?
A I did not think it would have any public health implications, and to this day if nothing else had happened after the paper was published, I do not think it would have had any public health implications. And the scales began to fall from my eyes in the run-up to the press conference.
Q Can we just fast forward to the final topic I want to ask you about, which is what has been called “the retraction”.
Q I had been unaware about the significance of withdrawal of a paper. If a paper has been withdrawn then that sends a clear message, does it not, to the scientific community about the way in which the study which gave rise to it was conducted?
Q But what you were involved in, with the majority of the authors including Professor Walker-Smith and Professor Murch was a retraction of an interpretation of the paper?
Q And it takes up the points that you have just been making. Would you just look at bundle 3 – put aside bundle 2 for the moment. It is page 1210. This was published by The Lancet in 2004 on 6 March 2004. The retraction was done following discussion with the editor of The Lancet, was it not?
Q And refers back in the first paragraph to the original paper. You were not asked to look at the second paragraph, but it still is important.
“The main thrust of this paper ---”
That is the first paper –
“--- was the first description of an unexpected intestinal lesion in the children reported. Further evidence has been forthcoming in studies from the Royal Free Centre for Paediatric Gastroenterology and other groups to support and extend these findings.”
That just takes us forward because, as you said yesterday, you were a co-author on some later papers?
Q And others had written about it elsewhere.
“Whilst much uncertainty remains about the nature of these changes, we believe it important that such work continues, as autistic children can potentially be helped by recognition and treatment of gastrointestinal problems.”
You concur with that, do you not?
A Yes, although I am not involved with that now; but it was an important thing, as I said yesterday. It was important to try to understand this better.
A And to follow the Rutter principle: study it properly so that it either gets firmly included or firmly dismissed.
Q Perhaps the important thing is, it harks back to the original paper saying “This retraction does not affect that aspect of the paper which was valid, and remains valid”?
Q But you, as one of the authors, want to make it clear that no causal link was established between MMR vaccine and autism as the data were insufficient, which is what the paper had said?
Q And takes up the final point that if the possibility was raised, as it was, the consequence has had major implications for public health and therefore you, as one of the authors, wanted to lay that to rest – to retract that aspect of the interpretation?
A Yes, yes.
Q And it is quite difficult, philosophically, to see what was being done by this because in your view, anyway, there would have been no need with the paper as written to have made that point, because the paper was clear that there was no link?
A A number of different things influenced me at the time. Dr Murch and I talked a lot. There was the issue about the change between the final draft and the published paper, and I asked Dr Murch to speak to the editor of The Lancet, and see if The Lancet had had an audit trail – final version, editorial changes, authors’ proofs changes. The Lancet at that time did not have such a trail, so Dr Murch and I did not know who made these changes. One can guess, but we did not know and to this day, I still do not know. But the changes looked to me on the face of it too significant to have been purely editorial. But The Lancet cannot tell us. So that troubled me. It is interesting being a seventh author. In my ordinary work I would be seeing parents for various things. Sometimes parents would say, “We are arguing about whether our youngest child, who we are not here about today, should have the MMR or not.” And I would say, “Why are you arguing about it?” And they would say, “Because of that paper in The Lancet that said there was a link.” And I would say, “I am the seventh author. The paper said there was no link.” And they would say, “Really?” For complex reasons it was seen by so many people as the paper that said there was a link. And then there was the possible bias, which I was asked about yesterday. So I thought we should withdraw. Now, Dr Murch did much more work than me on the subject, and I respect Dr Murch. This hearing will find what it finds, but I respect him. He was working incredibly hard on this. I was not really going to quibble with the wording. The working was okay – just let us withdraw it.
Q It is just finally laying to rest, if it be thought that you could take away from the paper a link with MMR, you cannot. That is what it is saying, is it not? You should not.
A I am sorry, I do not understand.
Q What it is saying is, if there are lingering doubts about what the paper said, there should not be any doubts because no link was established.
A Absolutely. If we cannot be clear about that in any other way, then let us withdraw the paper.
Q If you want the authors to say so, we say that.
A Loudly, yes!
MR MILLER: Thank you.
Cross-examined by MR COONAN
Q Good morning, doctor. I think yesterday we had reached the position in your evidence where you had described in conceptual terms and accepted the idea that there may well have been clinical care being carried out by the paediatricians, that is to say, by the paediatric gastroenterologists, but that there was another layer, an add-on – and this was your expression – of clinical research by you.
Q Also research by Dr Wakefield.
Q We have this image of ordinary clinical care generated by the clinical needs of the patients, of the children.
Q But outside that, the possibility of research elements or research dimensions by yourself and Dr Wakefield.
Q You had also described earlier in your evidence the idea that children had been seen, then there was an application to the ethics committee and then you thought you were doing research.
Q You ended up in effect – I say “ended up”; it came early in your evidence, but putting it altogether – that you said you thought you were doing research, but you may be wrong.
A That was not exactly what I wished to convey. This is such a difficult business, this discussion about the definition of what we were doing, I still cannot myself fully understand the semantics of it all. I thought I was doing research. I had not concluded from that therefore we were all doing research and only research. It is just that I was approaching it as though it was research.
Q I am grateful for that, Dr Berelowitz, because in the context of this case, it may be a dangerous leap to take to assume that therefore if there was a research dimension, therefore everybody was engaged in research. Do you follow?
A Yes, absolutely. I hope I have been clear enough about that.
Q I would just like to follow it through, because it may be that we can illustrate the point you have been making. You saw – and we know this, because of the evidence that you gave yesterday – a series of patients on the ward and you saw them both before and after the ethics committee application was made.
Q The Panel are dealing, as a matter of pure fact, with a series of 12 patients.
Q Those 12 patients straddle the period before the ethics committee application and after, do they not?
A That is right, yes.
Q Do I understand from your evidence that your approach as a child psychiatrist and your objective when you were asked to see these children was the same throughout the period of time that you were seeing these children?
A Overall, yes.
Q There may be differences in each of the individual children, but that may be because the clinical presentation of the children may have been somewhat different. I am not concerned with that. From your standpoint, your purpose and objective, as you described it yesterday, was the same?
Q We know that you signed the ethics committee application – I do not think we need to turn it up again, but for the transcript it is our page 200 in bundle 1 – and the application was signed by you some time between the early part of August and the latter or mid part of September. The precise date does not matter for my purposes. Are you happy with that?
Q I think, as you told us, you had been a member of an ethics committee up until about 1995-ish.
A Ish, yes.
Q Therefore you would be familiar to a certain extent with the process by which applications are made.
Q I am not asking for detail.
A Yes. I was pausing a bit because obviously it is a rapidly changing process, but I do not think the rapid process of change had yet started in the mid 1990s.
Q You would be aware that applications in a general sense made to an ethics committee have to make their way through the process and the process takes time.
Q Even in 1995/1996, you do not rubber stamp applications, do you?
Q You learned at some stage that approval had been granted.
Q But you told us yesterday that you did not know when. As it turns out, it must have been some time after 18 December, as we have discovered, and could well have been some time on or after 7 January 1997, because that is the letter of approval.
Q For the purpose of the transcript and the Panel – I do not think we need turn it up again – it is volume 1, page 358. That is the time at which probably, would you agree, you would get to know that approval had been granted?
Q Let us just stand back and look at the children which you have seen before and after let us take 18 December. The exercise can be done in relation to 7 January, but I do not want to waste time. I will just take 18 December. The Panel are familiar with that date; it is set out in the documents and it is well in our minds. Yesterday, when you were giving your evidence initially, you told us that you had seen Child 2 and we know from the documents that you had seen Child 2 on 5 September and 12 November.
Q I do not want you to simply say yes. I am giving you that information, but could you please check it? I will give you the references. It is in the Royal Free notes for Child 2 at pages 143 and 139. I am going to give you a series of references. If they are wrong, I shall be corrected, but they are intended primarily for the Panel’s note and the transcript. That is 5 September and 12 November. You also saw Child 5 on 3 December 1996, for which you will need the Royal Free notes, page 9. That is 3 December.
Q Let us move on to Child 4. This is the Royal Free notes, page 11. That was 2 October 1996. Is that right?
Q Finally in this group, if you would go to the additional records for Child 6 and look at page 39. I think that is the document where there is a blurring of the precise date, but it is a date in November.
A Yes. It looks like November.
Q That is Child 6. So what we have here are you seeing four children before 18 December 1996.
Q Which was when Dr Pegg in effect stamped his approval on the application. The other four patients which you saw – could we just run through these in the same way? Child 12, if you would look at the Royal Free notes, page 18, you saw Child 12 on 10 January.
A That is correct, yes.
Q The next child is Child 8. If you look at the Royal Free notes, pages 18 and 20, we can deduce from that, can we not, that you saw Child 8 some time between 21 and 28 January 1997?
Q Next, Child 7. If you look at the Royal Free notes, page 8, I think we can deduce from that, can we not, that you saw Child 7 some time after 30 January 1997?
Q The precise date for my purposes does not matter, but it would have been after that date.
Q Finally, Child 10. If you look at the Royal Free notes at page 16, that was 18 February 1997.
Q That is a total of eight patients. The other four you told us you did not assess because those children had been assessed not long previously by those who were in a position to make a diagnosis.
Q Again, the precise details of that I am not concerned with for present purposes. I think we have reached the stage where you have agreed that you saw four children before Dr Pegg’s stamp, if I can use that expression, on 18 December and you saw four children after that. Indeed, looking at the dates which we have gone through, you saw four children after Dr Pegg’s letter of approval on 7 January 1997.
Q This is not intended in any way as a criticism at all, but on the face of it, with that sort of analysis, it may suggest that you were carrying out research before you had ethics committee approval. That cannot be right, can it?
A It is possible that is right, but I do not think so. When children with autism started coming to the Royal Free gastroenterology service, my colleagues asked me, quite properly, would I see them so that we can learn more about these children and the interplay at a clinical level between their developmental disorder and their bowel symptoms, and so it was appropriate for me to see them and I did.
Secondly, I was not myself corresponding directly with the ethics committee and I was not copied into the correspondence in either direction. I was trusting oral conversations with my colleagues about the state of play. Broadly, I said yesterday that I was not counting. Somebody told The Lancet that by January 1998 a further 40 patients had been assessed. So I was going on assessing patients and I had assumed that those who decided who was in and who was out would have the start date in mind. I said I did not remember the names of the patients or when I had seen them.
Q I have not got to 1998; I am just dealing with the position in 1996.
A But I started off clinically and we carried on.
Q That is the point, if I may say so. You started off clinically and as far as you were concerned, as you went on see the 12 – just the 12, doctor – you continued to see them clinically, did you not?
A Well, it is ever so difficult to try to think back to 1996/1997, especially because of what Dr Pegg said to me about the ethical rules being unclear then. Let me try to give a reasonably contemporary example from my own clinical practice to see if that helps.
A couple of years ago, I saw a teenage girl with depression. She turned out to have had recent glandular fever and she, because of reasons of stigma, was much happier with a diagnosis of glandular fever than of pure depression. This changed my threshold for talking to my depressed teenage patients about glandular fever and we began explaining to them and their parents that we found this quite a useful investigation and would they consider having this blood test as a clinical add-on? Then I spoke to my clinical director and said, “Clinical practice has changed a little bit. We are doing these blood tests. If we get a whole run of positive cases, we are going to have to see if we can convert this into research, in what sort of way.” Under the 2005 rules we would have had to ask those patients who I had already seen in terms, “Could I write you up for research?” So it is quite easy to see how you do something clinical and then something comes up which you think the professional world needs to know about, so it starts to be called research and then you have a system and so you think – a sort of pro forma of tests to do – so you think, “Well, it’s time that I ran this by the ethics committee.” So at least to me, that explains why it can look a little unclear at any particular point as to whether we were doing pure research or clinical research or sometimes just ordinary clinical work.
Q Exactly. The conceptual lines at that time were very blurred, were they not?
Q Quite clearly, your assessment of that to some extent at least has been corroborated by Dr Pegg.
A Yes. He could not have been clearer about how unclear the rules were.
Q Exactly. Again, looking at the conceptualisation of this, which I hope you might find a helpful term to employ in this area about what was going on at the time, when one looks at the ethics committee application in respect of 17296, that clearly was an application in respect of a study which clearly had research elements in it, did it not?
Q It clearly had a research dimension within it, but that was a project or a study which was due to start, but only when ethics committee approval had been given?
Q It was to be therefore a prospective vehicle, was it not?
Q So therefore could only have begun operating at the earliest from 7 January 1994, which was the approval letter.
Q 1997. You are quite right.
A I have thought about this, I have agonised over this and especially following the conversations with Dr Pegg, it is not clear to me to this day whether ethical approval was truly needed at a very formal level if these were current patients who were being mostly worked on clinically. I still find it hard to understand.
Q Whichever way – is this fair – you slice this, you do not get a clear picture from the ethical stand point. Is that fair?
A Absolutely not. We are all victims of the fact that the rules were so unclear at that time.
Q When we look at a document which you were shown yesterday – for which we need to look again at volume 3, page 1116a – a document dated 28 July 2000, Mr Miller asked you questions about it in relation to, as you described it, the “sniping and griping” that was taking place at that time. I am not asking you about this letter from that standpoint but it is the sentiments which you were expressing – this was in 2000 – in the third paragraph on the first page. You were saying that, as a result of conversations, you are of the view 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.”
That really is a reflection, is it not, of the evidence that you have just been giving to the Panel?
A I did not keep a diary and I certainly did not go around with a tape recorder, but I had more senior status then and, in response to Brent Taylor, whose views I had to take seriously, I went around and talked to a lot of people, frankly, and then came back and responded to Brent.
Q Whether it was to Professor Taylor or anybody else, those were your views based on a distillation of understanding that one was dealing here with the writing up of a case series which did not require ethical approval at that time.
Q And, as I said, that is a reflection of your evidence which you have just been giving a few minutes ago to the Panel.
A Yes. I have referred to sniping. Frankly, at that stage the atmosphere was pretty poisonous, and some things had clearly gone wrong with the paper and its consequences but that did not, as of right, mean that every single thing that had ever been done in relation to this work was wrong, and I was trying, reasonably painstakingly, to distinguish between the two as I went round, and, yes, the management, the senior medical and non-medical management of both places, the Medical School and the hospital, reflected back to me their understanding and I reported this back to Brent because it was just so poisonous.
Q Again, the background to it, the sniping and griping and the atmosphere, of course, I am not concerned with at the moment. I am just concerned with the status of the documentation and what was going on clinically in 1996. That is really the purpose of drawing attention to that.
Q Do we take it, therefore, that when one looks at The Lancet paper, which was published, as we know, in February 1998, submitted, as we now know in its final version in October 1997 – and we were just shown that about an hour ago – it is possible to view the paper itself as a writing up of a case series in respect of these 12 children.
A That is exactly how I viewed it.
Q Thank you very much. Again a case series which, as far as one can analyse it, would not have required Ethics Committee approval in respect of clinical matters.
A Well, we would need someone like Dr Pegg to say whether or not this needed ethical approval at the Royal Free at that time.
Q I understand that.
A But at that time in general my understanding was that for case series you did not need ethical approval, nor did you need the consent of the patient or the family to publicise anonymised clinical data.
MR COONAN: Thank you very much.
Sir, I note the time. Dr Berelowitz has been in the witness box for almost an hour.
THE CHAIRMAN: Yes, indeed. We will adjourn now for our mid-morning break.
(To the witness): Dr Berelowitz, you are still under oath and still continuing to give evidence, so please do not discuss about this case. I am sure someone will look after you for a cup of tea or coffee and we will resume at 11 o'clock.
(The Panel adjourned for a short time)
MR COONAN: Could we just turn to the last topic I would like your assistance on. I am going to ask you some questions about this transfer factor study. I appreciate that you have told the Panel you did not see the pro forma application which runs from 676 onwards to 690, would that be fair? That appears to be the pro forma.
A It is hard for me to know what I did and did not see. I do know that I did not agree to be involved in this project, so I would not have agreed for my name to go forward as part of the project to any panel.
Q I was just asking you, first of all, about whether you had, particularly before the application was made, seen the pro forma as opposed to the content of the study. There are two separate documents, are there not?
A I learned about it, so people must have engaged me in conversation about it and maybe they showed me a document.
Q Again just dealing with the document for a moment, the Clinical Research Protocol appears to begin at page 691.
Q And it runs for many, many pages.
Q Down to 752. That appears to be the bulk of the Clinical Research Protocol.
Q Can I ask you, please, to look with me at a number of features in the document. First of all, if you look at page 677in the pro forma you will see the objective:
“To assess the clinical benefit of measles virus-specific transfer factor (DLE TFmv) in children with developmental disorder and intestinal inflammation (autistic enteropathy).”
Q We see a statement to pretty well the same effect in the protocol itself at page 710.
Q If you look at paragraph 1.1 at the top:
To examine the effect of DLE-TFmv on children with ileo-colonic lymphoid nodular hyperplasia, non-specific colitis and regressive developmental disorder, hereinafter referred to as autistic enteropathy.”
Q If you go back to page 678, we see under paragraph 6, under the question in the pro forma “Who has verified the scientific validity of merit of this study?” and the declaration is Professor Pounder.
Q You obviously must have had some discussion, as you told us yesterday, about the concept underlying this proposal.
Q Did you not understand that the purpose of the study was to assess the efficacy of transfer factor?
A Absolutely. Yes.
Q In other words, it was not intended to be a study to investigate the mechanisms by which transfer factor works.
A But one has to have a hypothesis about how the substance might work before using it.
Q One might do, but this study specifically, being concerned with efficacy, did not need to address the question of input from, as you described it yesterday, a brain biochemist.
A It is not my business if a group of doctors in the hospital, including my paediatric gastroenterology colleagues, wish to try a new treatment to try to change a clinical gastroenterological condition. It would have to be my business, as then the only substantive child psychiatrist in the hospital, to take an interest if they were expecting this to change the clinical presentation of the child’s autism as well. Who else in the hospital could ask questions about this except me? Then, as I said yesterday, one has to ask what sort of change and how it will be measured. The CAPA – we talked about it yesterday – is a diagnostic instrument; it is not an instrument to measure change. So I had a lot of questions about this. One of the questions was: How is it going to work? And that was not the only one.
Q I am not disputing the fact that you had questions to ask about it, I was just dealing with the short point that, in a study of this type of design, one would not need to address the question of a brain biochemist or brain biologist. One might do, of course, if a study was being designed to study possible mechanisms. Then one might need to address that question. But that was not this study, was it?
A I do not know how large a point this is but I am always involved in clinical studies for the treatment of eating disorders and different interventions are tried and we do not say, “We have no interest in why the intervention works; we only want to know whether it works or not.” We do have to postulate why this intervention might work.
Q I am not going to take you to the fine detail of this, but there are documents here which are available to the Panel and they can see how the hypothesis is set out. Perhaps I could just deal with the other dimension in the question of your proposed role in this study and leave the first point to one side. As you say, it is not clear quite how much of a point it is. Let us look at the psychiatric role, which appeared to be an ingredient of the study. Would you turn to page 724. This is in the protocol and you will see in paragraph 3, under the heading of “Neuropsychiatric assessment” that it sets out three main, if you like, rhetorical questions to be addressed within the study:
• “Was there clear evidence of normal development prior to the onset of regressive autism, and what are the behavioural features that characterise the regressive state?
• Do these features improve in response to therapy, and if so to what extent?
• Are any changes sustained from week 26 to week 52?”
Then in paragraph 3.ii:
“Full neuropsychiatric examination will be performed on each patient by the same
Clinical Research Fellow in Child Psychiatry, under the direct supervision of Dr Mark Berelowitz … Confirmation and characterisation of the behavioural disorder will be a structured and validated scoring system (Childhood Autism Raging, CARS). Assessment will be conducted by the same investigator blinded to the child’s treatment at weeks 0, 26 and 52.”
So it was envisaged that there would be a clinical research fellow who would be carrying out the assessment and we can see on page 725 the working document envisaged by what I have just read out. Again, I am not going to take you through it. I am just highlighting the document so we can follow it. The assessments, again according to the protocol, would be done on three specific occasions and we can pick that up at 715. You see the main heading, “Screening Visit” and then, in the fourth bullet point down:
“Behavioural assessment …”
Then you drop down to “Week 0”, the first bullet point:
“Repeat assessments …”
Then drop down to “Week 26 … and 52.” You have to go over the page for this, page 716 right at the top, the bullet point:
And so we see linked to the wording in 724 to what was anticipated would be the structure of this study. Now, Dr Berelowitz, that document we know was submitted to the Ethics Committee and I want to suggest to you that those elements, and in particular the idea that there would be clinical research fellow, was inserted because you did have concerns about your ability to carry out this neuropsychiatric role, and it was to address those legitimate concerns, may I say. What do you say about that?
A Firstly I have to say, I do not remember any conversations about that. I do remember a general spirit at the time, that if we are to do better in this area we should not do research on the fly. It needs to be properly funded with dedicated time for proper research workers. It would have been in the spirit of my thoughts then to say, “If I am to do anything at all, we need research fellows.” Absolutely. But I have never actually seen the CARS before today. I did not know what it looked like. I cannot have put the CARS into this submission. I do not for a living have to rate changes in children with autism. The CARS is not my idea. How could I possibility supervise a research fellow on an instrument that is not of my choosing. It may be the perfect instrument, but I did not know that then, and I do not know that today.
Q You see, eleven years or thereabouts, nine years in respect of the 1999 period, passed and I am going to have to suggest to you there were discussions about this and you have signified a general agreement to take part provided the structure was right?
A That is how some people think I came across. I was quite clear. Why did I talk to Professor Ann Le Couteur. I talked to Professor Ann Le Couteur because I was clear we needed a more senior figure in the autism world than me, and Ann Le Couteur was a contemporary of Dr Wakefield at medical school; she knew who he was; she was prepared to consider being involved. I think we even discussed when she was going to be in London, and could there be a meeting between her and Dr Wakefield. At no stage was I agreeing to be the senior child psychiatrist in the project. It would not have been proper for me to have done that.
Q Do you not remember a discussion whereby the clinical research fellow would in fact be instructed how to use the CARS, and Professor Le Couteur or Professor Rutter and his team would be involved in that element of training of the clinical research fellow?
A I do not know if you need any training to do the CARS. You need a week long training to do the CAPA and the ADI. I do not know what training you need to do the CARS.
Q You see, yesterday you said that you had concerns about the American psychiatrist who featured in this study?
Q If one looks at this documentation, I for one am having difficulty trying to locate the presence of an American psychiatrist.
A At the point at which I was still receiving paperwork on this proposal there was the name of an American biotech company, and there were names of two American child psychiatrists, at least one of whom was female, but I cannot remember the names. I do not know what the document looked like, but I looked them up.
Q You see, yesterday you were addressing this documentation, and I for one had got the clear impression that your comments were directed to these documents. Would you look at page 692. You will see the proposed personnel: Dr Wakefield as the principal scientific investigator, Professor Walker-Smith, the clinical investigator, Dr Murch, and the principal collaborative investigator, Dr Fudenberg?
Q Who is an immunologist. He clearly is not an American psychiatrist, so again, please take your time to look at it, but I think if you look through this you will not find any reference to an American psychiatrist.
A Clearly not.
Q I do not want to take an unfair point.
A No. Clearly not. I remember sitting in front of my computer at home, not in the office, looking people up, talking to Professor Le Couteur. I did not want to dismiss this out of hand but I am clear now, and I was clear then, that it needed to be on a different kind of footing.
Q Absolutely. To a certain extent, and I am not disputing this, there had been discussions about this and things, in order to go forward, had to be put – and I am using this word in a neutral sense – in proper form. Following those suggestions, all I am suggesting to you now is that this document represents an attempt to meet the matters that you had raised but carrying with it an indication, rightly or wrongly, but carrying with it an indication that if the matter had been sorted, as it were, to your satisfaction, that you would be involved in the study. That is how your name appears on the first page of the pro forma on page 676? Where did ten years go, Dr Berelowitz?
A It is nearly ten years ago. For reasons that are partly connected with this whole episode, I do not have much to do with autism any more. But really, if one of my trainees had asked me yesterday, “What is the CARS”, I would not have been able to answer. I would not have known what it was. Maybe I knew then, but I certainly did not know today what it was or what it looked like. I have a research training. I have a research degree. I have done outcome research, although not in the field of autism. If we are trying to find out whether transfer factor has a clinical impact, we would need to have a discussion about how it might impact because we would need to know whether, for example, it has a sustained impact or a fluctuating impact. And if it has a fluctuating impact, there is absolutely no point doing assessments every six months. You might need to do them every ten days. Or if the impact peaks after three months and then declines, that would have been completely missed by this study design. This was not for me nearly a well-formed enough study for me to have participated in.
Q Again, you have agreed this was ten years ago almost?
Q And you tell us that you do not understand the significance or the operation of CARS now, and I would not dream of disputing that if that is what you say, but of course, ten years ago the position may have been this, may it not? That you had had discussions with Dr Wakefield and with others, did you? About the study.
A I am sure I did, yes.
Q Again, looking back you agree in principle that there must have been discussions about this, but it is fair, is it not, now ten years down the line, it would be enormously difficult to remember the precise content of those discussions?
A It is difficult to remember the content of the discussions. I do remember the meeting with Professor Walker-Smith when he asked me to go and see him. If he does remember it too, then perhaps he could say who the emails were from. If he does not remember it, then we are in the dark, but if we knew who the emails were from, perhaps this would shed light on what I am saying now because I was not told they were from Fudenberg. But also --
Q I think you mentioned ---
A Sorry. There are logical inconsistencies. I have not seen the CARS before. I have seen the CAPA and other child psychiatrist diagnostic interviews. On the face of it, it looks to me like anyone can apply the CARS, and you do not need a week’s training to apply the CARS. It is not one of these very fat Maudsley instruments which you are not allowed to use without a training. Nowhere on here does it say, “Only to be used by so-and-so and so-and-so.” Logically it does not add up that Ann Le Couteur was going to train people to do the CARS. Mike Rutter is way too busy to train anybody to do anything. It just does not add up. I also had not agreed to participate in research with Paul Shattock. I mean, I had not. Paul Shattock is one of the investigators buried in the detail here. I had not agreed to participate in research with Paul Shattock.
Q Is there not a point at which, again going back to January 1998, when this application was made – we know that from the first document – and it was not long after that that relationships between you and Dr Wakefield became somewhat strained?
A Yes. Dr Wakefield stopped talking to me. I remember exactly where. I cannot remember when.
Q Again, I do not think I personally need to go to the precise details, but thereafter you and he, your relationship was not the same?
Q And you are perfectly entitled, of course, to change your mind about participating in a study – perfectly entitled – but I have to suggest to you that there was the clear indication given to Dr Wakefield at least that you would take part in this study and that your memory now is not perhaps what it would have been back in 1998?
A I am going to dispute that extremely firmly. I was very troubled by the idea of a study of transfer factor on children with autism, without really knowing what we were doing. One of the joys of being a child psychiatrist in a place like the Royal Free is that you learn about new things. I had not heard of transfer factor before. I was interested to learn about it, but I was not going – I say again – I spoke to Professor Le Couteur. I remember where I was standing when I was speaking, on my mobile phone in another country at my own expense, to Professor Le Couteur about this. I can give an example of another sort of misunderstanding between Dr Wakefield and myself which, perhaps, puts this into perspective. Dr Wakefield and I went to Freiburg for two days to meet with Falk Pharma, I thought to fine tune the design of a study to which they had committed a lot of money. That is what I thought. I arrived at Freiburg the day before Dr Wakefield. He and I had a long dinner the night before the meeting – a pleasant dinner, at which he told me a lot about his ideas. Our conversation then turned to the meeting with Falk the next morning and he explained to me – and this caused me a lot of anxiety – the money was not in the bag at all. We were not going to fine tune. We were going to ask for money from scratch. My heart sank. Actually, I would not have gone. It is all very well going to Freiburg, but I have other things to do. When I came back to London, I went straight to Professor Walker-Smith and said to him, “John, what was your understanding about why Andy and I went to Freiburg,” and he said, “To fine tune the research project to which they have already agreed to commit a lot of money.” I said, “That’s what I thought too, but that was not the case.” These are the sorts of very important misunderstandings that happened between Wakefield and not only myself, but clearly between Wakefield and Professor Walker-Smith in this regard.
Q And possibly between Dr Wakefield and the company?
A But you see, Wakefield told me before we met with the company, “The money is not in the bag.” Sunday night. I do not think he was communicating with the company on Sunday morning.
Q Dr Berelowitz, one can speculate if one wants to with a particular colour again if one wishes to, but I am glad you brought the subject matter of the trip to Freiburg up because in that proposed study, which was going to involve Salofalk, was it not?
A Yes. Something like that.
Q A preparation.
A A preparation that dissolved in the ileum, I think.
Q Particularly a preparation for inflammation. Is that right?
Q In children?
Q Again, that as before this application for transfer factor was submitted as a policy, was it not?
A I cannot remember when I went to Frieberg. I do know why I was interested in Freiberg and it was again back to the Rutter principle, because this was going to be a trial of a medication within European pharmacological legislation. This is the tightest, most rigorous structure that I had ever encountered as a doctor and I thought, “Great.” To work in this incredibly rigorous structure, where there are log books for everything, their books are designed so you cannot tear a page out or cross anything out, everything is set in stone and checkable and I was interested in that. I had been affected a lot by what was happening with The Lancet paper. I was not going to be involved again unless I knew in advance exactly what we had let ourselves in for.
Q Dr Berelowitz, the question was: when was the agreement for your involvement in the Salo Falk project?
A There was no agreement, because there was no project, as it turned out. As it turned out, all I agreed to do was have a meeting, a nice dinner and a nice lunch.
Q Prior to that, had you not agreed in principle to adopt the same sort of role in that as we see in this document, the transfer factor application? I appreciate it had not got to a formal application by the time you went to Freiberg, but taking it stage by stage, had you not indicated to Dr Wakefield that you would be willing to perform that role?
A That was only an extreme in principle. I had not met with Falk, I did not know where Freiberg was, I did not know the hospital rules about accepting drug company money for clinical trials. I went to a meeting. I was happy to go to the meeting. The substance which I understood Falk to be talking about was a medication already in use, but with a particular technique to get the granules to open up only in a certain part of the bowel, not opening up all over the bowel. So just to make the intervention much more targeted. But it was a known medication. We did not have a project at all until we met with Falk and it turned out that after we met with Falk, we also did not have a project.
Q Do not get me wrong. I am not suggesting that it had reached that formalised stage. All I am suggesting, Dr Berelowitz, is that you had signified agreement to be involved at that early stage. I do not dispute that funding did not appear from the company in Germany.
A Look, all this is meant to be professional and business and not at all personal. If I was the only consultant child psychiatrist at the Royal Free, it is my job to try to be helpful and not use my role as a child psychiatrist just to express a veto. So if people want to do a project involving child psychiatry, frankly, it looks bad for everybody if I say, “I won’t have anything to do with that.” So I was obliged to be receptive to discussions and then say, “Okay. I’ll think about it. I’ll talk to people. I’m a bit out of my depth here. These are my provisional thoughts.”
Q I do not dispute that process, but certainly up to the time you went to Freiberg, you were in effect signifying your agreement to be associated with this embryonic project, having a particular role.
A I agreed to be associated with this embryonic project. I did not agree to commit myself to work in this embryonic project, never mind this fully formed project. I had agreed to be associated with the embryonic project, absolutely.
Q I have suggested to you that your memory is at fault in relation to the discussions.
A Could be, could be.
MR COONAN: In the light of that answer, thank you very much, Dr Berelowitz. That is all I have for you.
THE LEGAL ASSESSOR: Before you finish with the witness, Mr Coonan, I am slightly troubled by how something might read on the transcript from this morning. I now have an advance copy. You were asking questions about the ethics committee approval for the main project with which we are concerned and you asked the question:
“[Q] It was to be therefore a prospective vehicle, was it not?
You then asked:
“[Q] So therefore could only have begun operating at the earliest from 7 January 1994, which was the approval letter.
[Q] 1997. You are quite right.”
There is then a long answer by the doctor:
“[A] I have thought about this, I have agonised over this and especially following the conversations with Dr Pegg, it is not clear to me to this day whether ethical approval was truly needed at a very formal level if these were current patients who were being mostly worked on clinically. I still find it hard to understand.”
You then asked the following question:
“[Q] Whichever way – is this fair – you slice this, you do not get a clear picture from the ethical stand point. Is that fair?
[A] Absolutely not. We are all victims of the fact that the rules were so unclear at that time.”
That clearly does not reflect what the witness meant. Perhaps I could hand this to you and you could have it clarified.
MR COONAN: Thank you very much. I see entirely what you mean.
THE LEGAL ASSESSOR: Several weeks down the line, reading that, it will look very different.
MR COONAN: I think it may be, if I may say so, right if the witness saw the transcript as well. (Same handed) Dr Berelowitz, could you just read the whole series of questions and answers to yourself? Do you see the last question? There is possibly a superfluous “not” in the last answer which you gave. Do you see that?
A I see that.
THE CHAIRMAN: For our benefit, maybe you could ask the same or a similar question again and we can then take the witness’s answer.
THE WITNESS: I answered the first question there, not the second. “You do not get a clear picture from an ethical standpoint” and I said, “Absolutely not”, but there was the second question, “Is that fair?” I see the problem. I am happy to be asked again.
MR COONAN: What I was asking you, Dr Berelowitz, was this. It was an early part of your evidence – and I am summarising – whichever way you slice this, you do not get a clear picture from the ethical standpoint. Is that fair? Can I put the question a different way? Do you agree with that?
A I still do not have a clear picture from an ethical standpoint and I believe I am not the only person who is in that position.
Q Then you went on to say, “We are all victims of the fact that the rules were so unclear at that time.” You still take that view, do you?
A Yes. Can I elaborate on the answer at this stage?
THE CHAIRMAN: You certainly can. You can say whatever you want to say.
A I spoke to Dr Pegg. Why did I speak to Dr Pegg? Because no-one else in the Trust – I was loathe to pick up the phone to Dr Pegg – but no-one else in the Trust could give me an answer, including my own clinical director, about what my own signature conveyed in the mid 1990s. Much more distinguished people than myself still in the medical school who know about these issues and have seen some of the letters say thing to me like, “There but for the grace of God go any of us who were carrying out clinical series in the 1990s.” It is very hard to understand precisely what was required. That is what people say to me, even today.
MR COONAN: Thank you, Dr Berelowitz. That is the last question I need to ask you.
THE CHAIRMAN: Dr Berelowitz, now Mr Hopkins, who represents Professor Murch, will ask you some questions.
Cross-examined by MR HOPKINS
Q Doctor, you will be pleased to know I shall not be detaining you for very long. Can I just go back to the mechanics by which you were being asked to see the 12 patients who ultimately featured in The Lancet? You have told us that back in 1996 and in 1997, there were weekly Thursday meetings on the ward at which you often would be present, or a member of your team.
Q Other people would be present from the paediatric gastroenterology department and I suggest either Professor Walker-Smith or Dr Murch (as he then was) or Dr Thomson, according who was consultant that week. Would that be fair?
A Yes. The gastroenterologists were always very scrupulous about sending senior doctors to this meeting.
Q They would not necessarily all be there for each meeting; it would depend on who was the consultant that week.
A It would be very unusual for them all to be there, but two of them might come together if there were particular concerns about a particular patient.
Q Was it the case that during the course of that meeting a ward sister would give an outline of the patients who were due to be admitted the following week?
A Yes, absolutely. Thank you for reminding me of that. The ward sister often mentioned who was coming in next week and I would look at my diary and try and figure out when I might be able to see the child.
Q Indeed, one of the reasons for mentioning who was coming in next week was to see whether or not you or anyone else there needed to be alerted to that to become involved.
Q With that contextual background, when we turn to Child 2 – you might just want to dig out the Royal Free notes – at page 143, we see a letter which you wrote on 30 September 1996 back to Dr Murch. In the first paragraph we see that you say, “Thank you for asking me to see Child 2 who you saw on 5 September.” Might the invitation for you to have seen Child 2 come at one of those Thursday ward meetings?
Q I think you told us in answer to questions from both Mr Miller and Mr Coonan that at this stage you were being asked to see these children on a clinical basis.
Q Can I move on to a question which you were asked by Ms Smith yesterday and the answer which you gave? She asked you whose responsibility it was whether these children were to be admitted for the study and the answer that you gave was that you thought that all of them had been screened either by Professor Walker-Smith or Dr Murch in outpatients before they were admitted.
Q Would it be right to say that you would not have been present at any of those outpatient assessments of the children?
A I would not have expected to be present and I do not remember being present at any.
Q Therefore would it be fair to say that the answer you gave to that question was based on an assumption rather than actual knowledge?
A You are absolutely right that it is entirely based – well, it is partly based on an assumption and it is partly based on what I had read in some of the correspondence in the files, but it would be wrong of me to say that I know that all patients were screened specifically by one of those two doctors, because I do not know that.
Q The reason I raise it with you is that the Panel is obviously only concerned with the 12 who feature in The Lancet article. This Panel has seen the out patient assessment records for each child and in none of them were the children seen in out patients before admission by Dr Murch, Professor Murch as he now is. Do you disagree?
A No. I am not at all in a position to disagree and I am grateful for the opportunity to clarify that.
Q A separate matter. Going to your contact with Professor Sir Michael Rutter, you were telling us that in 1996, when the suggestion of investigating whether or not there was any link between MMR, bowel problems and autism was raised, you took that matter up with Professor Sir Michael Rutter, who was enthusiastic about this being looked into properly. Would that be fair?
A Yes, absolutely. I do believe that Professor Rutter would have told me in language that I would have understood if he thought it was a bad idea to be involved in that.
THE CHAIRMAN: I am sorry, Dr Berelowitz. Could you keep your voice up a little?
THE WITNESS: Do I need to repeat my last remark?
THE CHAIRMAN: I think if you could, please.
THE WITNESS: Professor Rutter would have told me in language that I would have clearly understood if he had thought it was unwise of me to be involved in this study.
MR HOPKINS: Would it also be fair to say that before any of these autistic children were admitted into hospital for investigation, you informed Professor Murch of the gist of the conversation you had had with Professor Rutter?
A I cannot remember specifically doing that, but I do know that Dr Murch and I spoke a lot and so I would be a little surprised if I had not said to him what senior people in my field felt about this proposed line of work.
Q Moving on to an entirely separate matter, dealing with The Lancet paper. As you know, you are named as co-author on that and, as I understand it, the reason behind that is because you participated in the assessment of some of these children?
A There was no discussion with me about where my name would appear and I said nothing about that.
Q As I understand your evidence, you did not participate in the drafting of that article, other than to suggest the amendments you have told us about.
A Yes. This is common practice. It is not possible for 12 people for write a paper together. One or two have to make a start and then circulate it.
Q Were you aware that in fact the draft was being written by Dr Wakefield?
A Overall, Dr Wakefield came across as the engine behind the project as a whole. He was the one coming round with forms to sign, distributing draft papers and so on.
Q In the context of that, can I go back to a question you were asked by Ms Smith? She asked you who did you rely on to include or exclude children in the paper and you replied that your assumption was that it was Professor Walker-Smith, Dr Wakefield and Professor Murch. At the beginning of your answer you said that was an assumption.
Q Would it be fair to say that you have no actual knowledge of the extent of authorship or the role played by Professor Murch?
A That is absolutely correct, yes.
MR HOPKINS: Thank you very much.
Re-examined by MS SMITH
Q Could I ask you a few questions in clarification of what you have said, Dr Berelowitz, first of all, in answer to some of Mr Miller’s questions, but also generally.
A I am terribly sorry, I do not mean any offence, but I no longer remember who Mr Miller is.
Q Mr Miller was the person who questioned you after me.
A Thank you.
THE CHAIRMAN: Mr Miller is representing Professor Walker-Smith.
A Thank you. I just was not sure who Mr Miller was.
MS SMITH: You were asked about the nature of the study with which you were involved. You have referred throughout your evidence to the study and now and again you have said “our little study”. Could I seek, for clarification, for you to elaborate on this. By “our little study” do you mean the first 12 Lancet children?
Q Could I ask you to turn back very quickly to FTP1, page 200, the ethics application, and to turn to page 201. I just want to ask you about the title. Mr Miller asked you whether this was a study in relation to autism and bowel disorder and you agreed that it was. If we look at the title, “Enteritis and disintegrative disorder following measles/rubella vaccination.”
Q Was that title, as far as you are concerned, a fair summary of what the study was seeking to look at?
A Yes. Although, as I said yesterday, with the benefit of considerable hindsight, we should have said: pervasive developmental disorders, perhaps with a particular focus on disintegrative disorder. But the spirit of it is captured, I think, in that title.
Q Could I ask you to close that up and to go on and look at the Royal Free Hospital records for Child 2. Would you turn to a letter that I asked you about and Mr Coonan asked you about, as well, at page 143. That is the letter that you sent in respect of Child 2.
Q We see what you say in the first paragraph. This is to Dr Murch.
“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.”
Q If we look at the end of the letter, you say,
“I await the next patient with considerable interest.”
Q There appears to be no dispute about this, Dr Berelowitz, Child 2 was the first child to be seen in pursuance of this study. Is that correct?
Q Could you help us in relation to some of the observations you have made about the children, in particular the part that the Legal Assessor has asked you about. You were asked about ethical approval and you said, “I have thought about this. I have agonised over it and, following the conversations with Dr Pegg, it is not clear to me to this day whether ethical approval was truly needed at a formal level, if there were current patients who were being mostly worked on clinically.” Can you explain to us what you mean by that.
A Can I take a step back? Obviously being here for one and a half days, so far, gives me plenty of food for thought, and, although I saw a lot of documents when I met with the GMC solicitors, I certainly did not have at hand 25 ring-binders to refer to, so I have seen things in the last 36 hours that I have not seen before. I think a fairer representation now of what I thought the process I was engaged in was, is that we started with clinical curiosity and then at some stage it became clear that we were going to try to write this up, and so a research application was submitted and ethical approval obtained, and then I felt at that stage, “Well, now things are on a research footing”. Then, at some later point, not very much later actually, the investigations were pared right down and huge numbers of patients were seen for clinical purposes again. It is perfectly legitimate for Dr Murch to say to the mother of Child 2, “Will you meet with one of my colleagues who might understand a little bit more about the child psychiatry side of it?” For example, the girl I referred to as having depression precipitated by glandular fever, it would be very reasonable for me to say, “There is a colleague in the Royal Free who knows much more about immunology than I do. Would you like to meet with him or her to understand a bit more about how these two conditions might be connected with one another?” But if I began doing that with lots of patients and then the colleague and I thought we were going to write this up, then we would go for ethical approval. It would be helpful and not unusual to say to a patient, “This is a bit new, let’s bring in some extra ideas.” Looking back, that is where I think we were in September 1996.
Q You said in answer to Mr Coonan’s questions that, as far as you were concerned – you could not speak for others, and I entirely understand and accept that – you thought you were doing research. Why did you think you were doing research?
A It is a bit circular, really, but because we went for ethical approval.
Q You have told us about various inquiries you made with Dr Pegg.
Q And you have said in particular what it meant having your signature on the ethics application.
Q Are we to understand from that that these inquiries with Dr Pegg were later than 1996 when you signed the application?
A Earlier this year or late last year, after I had been approached y the GMC.
Q Did you have any conversations at the time of the Ethics Committee application with Dr Pegg about any concerns you had? Did you have any concerns that you discussed with him at the time?
A I did not have concerns at the time. My concerns came later with how things were portrayed.
Q Mr Miller asked you about some of the investigations that these children underwent and he put to you expressly that, as far as you were concerned, you did not see anything odd about the investigations that were being carried out, and you said, “especially if they were not helping, they were dropped”.
Q I wonder whether you could assist as to what you mean by “if they were not helping”.
A If they were not helping to shed light on the clinical condition. I am sure that the doctors in San Francisco who began seeing the first AIDS patients ended up doing very investigations in the beginning from those they were doing a month later and six months later and ten years later. When faced with a possible – possible – new clinical entity, you choose likely investigations, you obtain consent and then you are frank about whether these investigations are taking you anywhere. I saw no reason to question the judgment of my colleagues. These were not my investigations, I did not ask for any of them, but the inherent logic of it, I thought, was not particularly unusual.
Q Were you measuring the logic against the hypothesis I took you to first of all, namely the hypothesis set out in the research application; in other words, whether behavioural disorders and inflammatory bowel disorders and vaccination were linked? When you were thinking about whether these tests were, as you have said, logical or not, was that what you were testing them against?
A Yes, absolutely, as one, in effect, does all the time in clinical practice. Parents say to me all the time in my office, “Might my child’s ADHD be caused by this or made worse by that?” We have a reasonable discussion about it and we decide whether or not there are investigations that we can do and should do that might shed light on this.
Q You were asked particularly about the lumbar punctures. You have made it clear to us that it was not your decision that they should be included, but Mr Miller particularly asked you about a Medline search that you had done as to whether lumbar punctures were done on children with autism and you said that you had, indeed, done that and you have turned up some results. You referred in particular to Gilberg, is that correct?
A And I think I have shared those results with the GMC solicitors.
Q Yes, you did indeed. Those were all research projects, were they not?
A Yes. (Pause) I should not try to defend the lumbar puncture because I was not the person who tried to order it. What I am trying to defend is the logic that might lead a doctor, listening carefully to parental concerns, to conclude that a lumbar puncture is a worthwhile investigation. But it is not for me to say lumbar punctures were indicated. I am thinking more about the inherent logic and whether we use that sort of logic in ordinary practice.
Q And when you thought about that, if you looked up the indications for being used, although you have now said ordinary practice, what you found were the indications for it being used in research ---?
A No, no. I did not meant ordinary practice in autism. I was just talking about the logic of ordinary clinical practitioner when parents come with a specific concern, how one might investigate things. Since you have come back to me on this, it is very very easy to look up on Medline who has published what in research terms. It is also relatively easy to find out who has obtained funding for what, but has not yet published it, because NIH tells you, and the Wellcome tells you. It is very, very hard to find out who is doing what clinically because that is not available on Medline. Individual clinicians will come here and give answers. We do not, in child psychiatry at the Royal Free, do lumbar punctures in our assessment of an ordinary child with autism without any other clinical hypothesis. But I cannot say further than that.
Q I want to just ask you one or two questions about The Lancet article.
Q Can you turn back to page 758, please, which is the version ---
A The draft?
Q The draft version.
MR HOPKINS: I am sorry to interrupt but could Ms Smith speak up, please. We are finding it difficult to hear you.
MS SMITH: I am sorry. Page 758, which is a draft version. The title at that stage – and this was after, of course, your letter expressing concerns ---
Q ---- is “Developmental Disorder”.
Q Can you now go on to page 783, which is the last version – the printed version?
Q We can see from that that the title has become “… pervasive development disorder…”?
Q Do you remember whether you saw any version of The Lancet article between those two?
A No. I cannot remember.
Q We also see that in the final article – and you indeed pointed this out this morning – an addendum has been added as to the number of patients seen?
Q Can you help at all as to whether you would have seen a version which was the same, particularly with regard to the title, as the final printed version? Would you have seen it in its final form?
A I did not see a paper sent back for proof reading, and I did not see any changes suggested at the proof reading stage to The Lancet.
Q Sorry. Were you –
A I was just watching people making notes. That is also a sign of how things have changed. I was a co-author earlier this year on a multi-centre study published in The American Journal of Psychiatric. We all had to sign the fact that we had seen the proofs, and that we had seen the changes in the proofs – all ten or eleven authors had to sign a statement to that effect, and the corresponding author to send all our signatures back to the American journal, saying we had all seen what had gone back. That is how it is today. It was not like that then. Then one relied on trust, and one would have expected the proof-reading author, if he or she was going to do anything more than correct spelling mistakes, to come round and say, “I think we need to modify this paragraph.” That did not happen with me.
Q Do you know who the proof-reading author was?
A No idea. There must be a corresponding author listed – “Correspondence to Dr Wakefield”. That to me means The Lancet correspondence with Dr Wakefield.
Q You were asked about the retraction.
Q And you said in particular that as far as you were concerned, it was important that the paper expressed what the parents had said about what they thought was wrong with their children, in effect?
Q Or what might be a cause. But you also said that you had no known at the time about the funding or the vested interests, were the phrases you use?
Q Did that affect your view as to the need for a retraction in the context of what you say about it being important to know what the parents think?
A Sorry. Can you just say the very last part of that again?
Q In the context of you having told us that it was important to know what the parents thought, I am asking you what part that played, the fact that originally you thought it was important that that should be published, what part that play in your deciding to retract, or to retract the interpretation?
A As I hope I said yesterday in slightly different language, it was the possible vested interests of one of the authors and the parents who were giving the history that was really the trigger for the retraction. It was not the only reason for me, but it was the trigger. So yes, of course, if we were seeking to highlight the concerns in 1998 that parents had, and then we discover that those parents were involved in litigation, then everyone needs to know whose parents concerns – as expressed then – might well have been shaped by their involvement in litigation. They stood to gain from the hypothesis being upheld.
Q And you were asked by Mr Miller about whether you thought that the paper, The Lancet paper, had public health implications. I would just like you to look, if you will, at page 504, which is in your bundle 2. This was a letter you wrote in August 1997.
A I do not have it. Could it be in here?
Q No. It is not the green page. It is in your bundle 2, FTP2, page 504.
A I promise you, it goes from 496 to 506.
Q Are you in FTP2, Doctor, because we did look at it yesterday?
A Yes. I said the same thing yesterday.
Q I am told it was added, so it might be a white sheet that you have separate, but it is not a green one.
THE CHAIRMAN: I hope you can all hear. I think what actually happened was, this was the paper that was given additionally by Ms Smith and inserted into the bundle. It may be that the witness bundle does not actually have it in there.
THE WITNESS: I am sorry – I have not interfered with the bundles at all, so I have not put anything in. If I should have, I am sorry.
THE CHAIRMAN: We will make sure that you get the papers. Just wait a second, please.
THE WITNESS: I have it now. I just did not put it into the bundle – I am sorry.
MS SMITH: It is a letter that is familiar to you?
Q That you wrote yourself. This was in August 1997 which is just prior to the publication. In the letter we talked about the pervasive development disorder, if you remember?
Q Looking at the first paragraph, did that accurately reflect how you were feeling in August 1997?
A Yes. I would not have written this letter lightly. The first time I met Dr Wakefield in the senior common room, I had no inkling then that he had very strong views about the MMR. I had no inkling then. I thought we were just engaged in pure science. It became clear to me over time that he had a very strong view - very very strong views - about the MMR and how toxic it was. Those views were not shared by the rest of our team to the best of my knowledge. I cannot say now what triggered me to write this particular letter, almost exactly ten years ago to the day; but I had become increasingly concerned about – how shall I put it – there is something going wrong with science, that the very fact that a question had been raised, even if it was going now to be dismissed, it was the raising that was going to be given attention, and we had to be thoughtful about that.
Q Thank you. Just so it is clear on the transcript, what I have been asking you about is the first paragraph of the letter:
“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 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 Dr Andrew Wakefield strong conclusions from our preliminary research about the wisdom of vaccinating children.”
Was that it?
A Yes. I do not know if anyone can help me with this or not. I cannot remember what was going on now in the first few days of August 1997. Somehow, someone was going public on work that was in process. Who that person was, or those people were, I do not know now. I must have known then, but I do not know now.
Q I want to ask you about a letter that you wrote later, if you please, which is a green letter.
Q It is 1116a. It is in FTP3, for those of us who have inserted it. This is the letter that Mr Miller put in the bundle and you have told us you wrote to Professor Taylor, who is the Head of Department of Paediatrics, because of what you described as the difficult atmosphere at that time. This is in July 2000. Is that correct?
Q I just wanted to ask you about a couple of aspects of it. You are raising concerns that had been raised by others, and you say in the second paragraph:
“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 ground only, and not on research grounds.”
Q Were you able to have any input into that representation, or was that simply you reporting what the gastroenterology department and Professor Walker-Smith had said?
A It was not for me to say whether the clinical presentation in relation to the bowels merited endoscopy, but if you look at the chronology of the letter, and I would be grateful for the opportunity to put this letter in context. If you look at the chronology of the letter, Dr Sullivan says to Professor Taylor, “I don’t believe there is any thing wrong with their bowls.” So I come back. Professor Walker-Smith was clear that they needed endoscopy. This was a conversation at this stage about bowels, and not about anything else.
Q Then you say further on – it is the bottom of the page:
“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 approach will need to be taken.”
Are you there expressing the lack of clarity, as you saw it, that you told us about this morning? In other words, you were not sure about the ethical permission point and you need to know?
A We had a strange situation at the Royal Free. We had two professors, a professor of community child health (Professor Taylor) and a professor of paediatric gastroenterology (Professor Walker-Smith) and two relative small academic teams. Low and behold, they seemed to be trying to prove one another wrong rather than coming together and working on a joint project. They were submitting conflicting arguments, with good reason, to the scientific press. I, for a number of different reasons was in conversation with everybody except, perhaps Dr Wakefield, at that stage. I always listen sympathetically to Professor Taylor and his concerns, because I was in some ways…. I listened to his concerns and I went around – and I am going from memory now – in effect I was trying to say to senior people like the dean, “Did you think, with hindsight that the ethical application was misleading? Were you hoodwinked?” And no. There was considerable discomfort in the hospital and the medical school about aspects of this business, but not about the ethical approval. People seemed to think it was not an inappropriate way to work in 1996/1997. As I said earlier today, people with much larger research output than me, and very distinguished people, still take that view: that this was not by any stretch of the imagination the most worrying or disappointing aspect of this whole episode. That is what I was trying to come back to Brent on.
I think I should add for clarification, if I may, a context here. I know Professor Taylor well. He calls me. “Dr Sullivan is very concerned.” “Well, I have not heard of Dr Sullivan. Who is he?” “He is engaged by the vaccine companies”. “Well, come on, Brent. It is hardly impartial.” But still we talked. It was at a time when Professor Walker-Smith was going to retire and when Dr Murch was a serious candidate to succeed him, and if Dr Murch did not succeed Professor Walker-Smith, then several of us had concerns about the long term viability of academic gastroenterology at the Royal Free – academic paediatric gastroenterology at the Royal Free – concerns which have been validated over time. So at a personal, at a scientific and at a corporate level I thought that sniping was very, very dangerous, and I went round and I checked with senior people. “Do you have a problem with how this research was conducted in 1996?” No: their problem was not with that. It was with what happened afterwards, and also with what we learned subsequently about funding and other issues. But it was not about the ethics or the test. I took that back to Professor Taylor and said, “There it is. If you know more stuff, or you are still unhappy, please let us have it out in the open.” That did not happen and I do not know why. Obviously the children, and what was done to them, is very very important, that that be on the right footing, but the arguments about that were now being used personally and institutionally, with consequences. And if they are fair arguments, of course they should be used. But if they are not fair arguments it is very bad territory, and that was my concern.
Q Thank you for that, Dr Berelowitz. Can I ask you about just one last matter. That was the questions Mr Coonan asked you about the transfer factor?
Q You said when you were being pressed as to whether you had agreed to have anything to do with this study or not, you expressly said, “I would not have agreed to participate in research which involved Mr Shattock.” Can you tell us what you meant by that?
A I said I did not agree to participate in research with Mr Shattock. If pressed, I think I would say, ‘And I probably would not have agreed to do research with Mr Shattock, because some of his research methodology – I am going from memory now – had been called into question. Given everything that had gone before, we needed to be rock solid in terms of our academic integrity. Whether the questions about Dr Shattock were fair or unfair, it did not really concern me at that point. We just needed to be rock solid. Look, it is easy to see how things can get misunderstood. I have agreed in principle to consider participating in a multi-centre study of adolescents who harm themselves more than once. I have agreed in principle. When I see the final research design, I might withdraw my agreement. I will be pretty disappointed if, when I see the final research design, I withdraw my agreement and then people say to me ten years later, “But you agreed in principle.” I agreed in principle, yes, but when I saw the detail, I was out and my team was out. Something of that logic must apply here. I did not say to my colleagues, “I forbid all discussion of transfer factor with me.” We talked, I listened, I had conditions, I did not like the way my conditions were being considered, I withdrew. End of story.
MR MILLER: It is a small point. Ms Smith took the witness to the document at page 504, which may still be open. It is his letter written to my client on 5 August 1997. She took him to that letter in examination in chief and she took him back to it again in re-examination. She took him to the first paragraph, it may be to make a forensic point, but she left hanging in the air what that first paragraph meant. The witness had said, “I do not know. If somebody could tell me what was going on at the time, it may put that letter in context.” I think in fairness, as he is the only person who can deal with it, I would like to ask him about that context; not the detail, just something which had occurred which led him to write that letter, because otherwise we simply will not know.
MS SMITH: Sir, it was not to make a forensic point. It was making a point, certainly. This witness said that paragraph accurately represented his views. Mr Miller has already asked him in cross-examination about it and he cannot in my respectful submission have two bites at this particular cherry.
MR MILLER: I am not trying to ask him about it. I simply want to ask him if he is able to identify what the first sentence or the first few words are, which otherwise are simply left there with nobody being able to deal with it after he goes. “It seems clear from the events of the last few days that our research has already attracted complex publicity.” I cannot see how that can be objectionable. Indeed, the Panel might be curious anyway as to what happened which led him to write that letter. As I say, he is the only person who can deal with it. It was not a matter which was involved in my cross-examination because I was not making any point about that.
MS SMITH: The witness expressly said that he could not remember the events which led to this letter. If the Panel want to inquire about it, then the Panel have of course reached the point where they can do so.
THE CHAIRMAN: I have just been having a word with the Legal Assessor and it seems a very appropriate way to follow it through. What we are now going to do is to adjourn for our lunch break and also we will be going into camera for about 20 minutes or so to formulate our questions, as we did with the previous witness. If one of the Panel members does not deal with the question which Mr Miller is suggesting, then the Legal Assessor is going to take it up. First of all, is that acceptable?
MR MILLER: Sir, I am very happy with that course. I may renew my application if, after the questions have been followed up by the Legal Assessor, we are no clearer as to the outcome.
THE LEGAL ASSESSOR: Of course, all legal representatives are entitled to ask questions on issues arising out of Panel questions. For the purpose of Panel questions, I assume that means the Legal Assessor’s questions.
THE CHAIRMAN: Thank you very much indeed. In that case, as I said, we will now adjourn for lunch and we will go into camera for about 20 minutes or so during this period and we will resume at two o’clock.
Dr Berelowitz, I have to remind you yet again that you are still under oath and still in the middle of giving evidence. Therefore please do not discuss your evidence with anyone.
THE WITNESS: Of course, sir. Would the Panel have any objection if I pop back to the Royal Free briefly and assisted my colleagues there with ordinary day to day clinical issues, because as of last week I had not anticipated being here, so they are a little thin. If the Panel says no, they want me to stay here, I will, but I would like just to phone them up and check.
THE CHAIRMAN: As long as you do not discuss this case with anyone, that will be fine. You have been in the witness chair since yesterday morning, but it is entirely up to you. Wherever you go, we have no problem with it, provided you do not discuss the case. We will now break and we will resume at two o’clock.
THE CHAIRMAN: Good afternoon, everybody. As you gathered before we adjourned, Dr Berelowitz, now is an opportunity for Panel members to ask you questions. If they have any questions, I will introduce them to you.
Questioned by THE PANEL
THE CHAIRMAN: Dr Moodley is a medical member.
DR MOODLEY: Dr Berelowitz, you mentioned in your evidence that this was a pilot study several times.
Q It does not say that anywhere in the ethics committee application, nor in the paper. Do you know where that came from, pilot study?
A Thank you for asking me about that. I do not think one has to call something a pilot study to the outside world, but one has to know internally conceptually, are we trying to do a piece of definitive work or are we trying to learn more about the field as part of planning a possible next stage of work? In the minds of all of us as far as I was concerned at the time, this was a pilot study to see whether there was any point at all in doing a larger study and, if so, what kind of study. I am not sure there is any rule which says if you think it is a pilot, you have to name it as a pilot. In support of that idea, when Richard Smith was still the editor of the British Medical Journal, he wrote an article about withdrawal of papers and he described The Lancet paper as “A what you see is what you get” paper and he explained what he meant underneath it: a not very good paper which did not pretend to be anything more than a not very good paper. What it aspired to do he felt was laid out. So I did not feel we had to call it a pilot, because it was clear that our aims were modest and our design was a pretty modest design and I believe we made that plain.
Q You felt quite sure that all your fellow researchers were doing a pilot study with you?
A Conceptually it would be a bit difficult to have approached this piece of work in any other kind of way. It is a case series, a new piece of work and the numbers are very small.
Q This morning you very helpfully tried to draw out how a case study evolved into a piece of research. You were saying at some point it evolves and then you get ethical committee approval.
Q Could you say when the ethical committee approval was sought in this study, where you were on that evolutionary pathway?
A I cannot now, except to go back to the dates of letters, I cannot say how long it took us to draw up the ethical approval. How many days or weeks or months we spent on that, I cannot now say.
Q Are you saying that you had already seen a series of cases with autism for reasons other than to confirm the diagnosis and that is how this series of cases was evolving? I am trying to understand this.
A Thank you. I was just trying to think over lunchtime if I could try to be clearer on this and thank you for giving me the opportunity to come back. I thought, if I may, to try to come back using the case of my patient with glandular fever to try to illustrate the point. I had one patient with glandular fever and severe depression. If I had referred her to an immunologist at the Royal Free and the immunologist had said, “Thank you for referring this girl. Actually, two things stand out. One is that her antibody responses are actually a little bit exaggerated. Also I have recently read two papers from John Hopkins University saying that people with exaggerated antibody responses in general may be more at risk of developing depression. Can you see if you can send me a couple more patients to see if there is a pattern?” Then I would be entitled clinically to say to the next patient with glandular fever and depression, “Can I send you to my colleague?” I would not need any ethical approval for that. If we collected 12 and we wanted to publish them, in terms of today’s’ rules, I do not actually know what kind of ethical approval I would need to write up that case series and I would have to go along and talk to Dr Pegg and say, “Who do I need approval from simply to publish this case series?” In terms of today’s rules, I would not be clear and anything that is unclear in today’s rules would be trebly unclear in terms of the 1996 rules. If my immunologist colleague said, “What we now need to do is join up with the John Hopkins’ people and do these three radioactive tests on your patients and ten new patients and pool all the data.” We are doing research then definitely and at that point definitely I need to go for ethical approval. With one’s own patients, when you are trying to understand something new, it is actually ever so hard to work out what is now the cut-off where I stop doing very thorough, tertiary centre clinical investigation and I am now doing that different thing called research. It is much easier with somebody else’s patients who you would have no right to go and see unless the research ethics committee permits you. With your own patients in a tertiary centre, where lots of tests are done, people want you to do lots of tests – that is why they come – even now the cut-off is hard to know.
Q Coming back to the patients that were being seen at that time, were you already seeing patients with autism in the paediatric gastroenterology unit for other reasons?
A Absolutely. Because these patients were new and we were just, as my letter about patient 2, I think it was, makes clear, we were just trying to learn more here and share our knowledge, listen to what the families are saying, pool our knowledge, decide what, if anything, should be done. That is how we started.
Q In that letter you say, “I look forward to seeing the next patient.”
A Because at that stage it must have been clear that the Royal Free was developing an interest in the relationship between gut symptoms and mental disorder symptoms and patients were in the pipeline for a clinical work up. That is why I thought he was not going to be the only patient. I had been led to understand by my colleagues that parents had become interested in taking this further. How the parents got interested, that is other territory. All I knew is that parents were becoming interested and the Royal Free should expect more patients.
Q At that time in 1996, not with the benefit of another 11 years of research in autism and so on, was it fairly simple and straightforward, this cut-off between autism and disintegrative disorder? Rutter had said 30 months. Was that being used as the cut-off point?
A By the 1990s, there was an age cut-off for autism. I cannot remember whether it was 30 months or 36 months. There would have been an age cut-off. The patient had to have developed symptoms before either the 30th month or the 36th month. It fluctuated between the two for complex reasons that only classifications experts know about. If a patient does not fit the core diagnostic criteria, if they miss it on a technical point, like symptoms started at the 39th month, but otherwise everything is spot on, then you would probably say, “Autism not otherwise specified” in the diagnostic report, and you would say to the family, “Just think of it as autism” and the statement of special educational needs. We will not complicate anyone’s lives by calling it “autism not otherwise specified”. We will just call it autism, because that is what it is for all practical purposes. If the difference was not in the cut-off, but something more complex in the clinical presentation, like the patient was unusually verbally skilled, then you have to think, is this core autism or are we tending towards Asperger’s syndrome here? Sometimes that distinction makes a huge difference, sometimes it is really quite a semantic distinction from the child’s point of view. Equally, if the child’s problems are very serious, then there are complex decisions to be made about whether you should say the child has severe autism, severe autism plus severe learning difficulties, or that kind of autism which some people call Heller’s syndrome or disintegrative disorder. One tries to work out the right balance between what is kind of true in a pure sense and what the families need. Families are interested in diagnosis, they are also interested in statements of special educational needs and getting resources and family risk and genetic calculations. So one thinks about all of that when one says, “This is the technical diagnosis” and then one says to the family, “But this is how you might as well think about it and talk about it to the school and so on.” These decisions are sometimes very difficult to make. If it matters that an absolutely right decision is made, then you have to use an additional diagnostic tool.
Q Such as?
A Such as the ADI or something like that, or you refer the patient for a second opinion, which is a legitimate thing to do.
Q That is not what you were being asked to do.
A No. I was asked broadly, autistic spectrum or not? That is what I felt I was being asked to do.
Q Although the study which went to the ethics committee says “disintegrative disorder”.
Q You have explained you felt that should have been more broad, but that is what was written down.
A Yes. That is regrettable. It was written down. I do not believe there was any attempt to deceive and I do not think that fundamentally it changed anything. I do not think it would have led to a different way of working, which I suppose is what really matters from the children’s point of view.
Q The study design says that these children manifested disintegrative disorder and symptoms and signs of intestinal disease. That is page 201, which we are all familiar with. Also page 209, the first line of which says, “All subjects will be under the age of 16 and all will manifest disintegrative symptoms and signs to different extents.” How would you define disintegrative disorder? Would anybody reading this understand that the subjects recruited would have that disorder established before further tests were carried out?
A Reading this, I would have thought that people would have taken it that the children would have symptoms suggestive of that disorder. That is how I would read it, but I do not know how other people would read it. I have read it many times and that is how I would read it. There was fairly detailed discussion about what disintegrative disorder might be on page 202 and the relationship with autism. The study certainly did not say “an outpatient diagnostic screen by someone with my sort of background”. It did not say that. Did we inadvertently imply that? I do not think so.
Q If you are recruiting subjects to a study and the criteria for inclusion in the study are that they have this particular disorder, it is presumed that that disorder is established in some shape or form, in general terms.
A Yes, but as we were reminded this morning, Professor Walker-Smith, Professor Murch, Dr Thomson had all once been paediatricians and so would be familiar with developmental disorders. I took it that at this stage, in this sort of study, it was their job to screen referrals and we should only include referrals where there was a very substantial likelihood that some kind of developmental disorder was going to be diagnosed. And, in practice, we did diagnose either a quite serious developmental disorder or some other kind of pretty serious brain insult, so it did not happen to the best of my knowledge that a child went through all of this and did not merit going through it at all from a child psychiatric diagnostic point of view. The filter, although it was poorly defined – I accept that – did work in practice. That is how I see it. I fully accept it could have been worded a lot better, but in practice it seemed to have worked okay.
Q One last question: given that, in psychiatry, the diagnosis is based on history and some observation, when you learned about the issues of funding and the litigation, and that in your opinion some of the parents at least may have had a vested interest in the outcome, were you concerned at all about how you came to make your diagnosis and whether you needed to revisit any of the diagnoses?
A Obviously I was concerned and that was the trigger to what ultimately led to the retraction. With the benefit of hindsight – and this has only occurred to me now in response to your question – should I have written to every GP saying, “All the diagnoses that I have made should be called into question because of the history of this, so if you have a report from me please take it with a pinch of salt”? Now that you mention it, yes, but that did not occur to me before now and it did not occur to any of the many senior colleagues to whom I have gone and said, “What do we do now?” I am sorry if letters that carry some weight but may be based on an inaccurate history are sitting in patients’ files and I must go off and think about what to do about this.
DR MOODLEY: Thank you.
THE CHAIRMAN: Thank you, Dr Moodley. Mrs Dean, a lay member.
MRS DEAN: Good afternoon.
A Good afternoon.
Q In fact Dr Moodley picked up many of the things that I did want to ask you about, so I do not have very many questions. I wanted to clarify my understanding of your “normal” role, if I might call it that, with your colleagues in the Department of Gastroenterology in or around 1996. My understanding, from what you said yesterday, was that your role was to support parents and children who were coming to terms with a diagnosis of long-term illness and also to support staff, particularly staff on the ward, in managing those children. Is that right?
A Yes, but also to deal sometimes with the direct consequences of long-term illness and the treatment thereof. Coming to terms is important but sometimes there were psychiatric consequences of either the underlying illness or the treatment. For example, a field of study which Dr Murch and I would have pursued if he had stayed was the relationship between inflammation and mood. Our clinical impression is that inflammation causes depression. I would be asked: “This boy seems depressed, can you try to work out whether he has an autonomous depression or whether this is, as it were, a sort of biochemical response to all the inflammatory products circulating around his body?” If it was the latter, then the best thing is to try to reduce the inflammation, but if it was the former, you have to follow a different course. Child psychiatry is like liaison work because it is very variable, keeps you on your toes and you are always learning different things every day and one has to be flexible.
Q Within that, could you tell me how frequently you were called upon to diagnose a child as having autism or some other developmental disorder in the course of that normal work?
A In the course of normal work, that was uncommon.
Q Thank you. I have one other question which is about a clarification. Forgive me, it may be in rather simple terms but I am a lay person. Yesterday my understanding was that you said something to the effect that, if in the course of your work as a doctor you discover something interesting and subsequently decide to write it up then that is not research, it is a record of a case series, and you do not now and you did not in 1996 require Ethics Committee approval for that. Am I right so far?
A Is the question is that what I think or is that what I said yesterday.
Q That is what you said yesterday. Perhaps it would help if I went on to tell you what else you said.
A Okay. Thank you.
Q By my understanding you said that if you decide to go looking for something to prove a hypothesis with the intention to write it up then that is research, and you do need Ethics Committee approval. I have put the emphasis on it, but that is my understanding of what you said. I wonder if you want to let me know whether I have got that right or whether you want to comment on that at all.
A One does not need ethical approval to collect a series of patients and think about them with one’s colleagues. I do not know today what the ethical situation is if, when going through a set of case notes, I find that I have 12 patients whose condition seems a bit unusual and I would like to write them up. I would have to go and ask Dr Pegg: “How do I approach this?” There may be other people who know the answer perfectly well. I mean, I have not written up a case series now for some time: I just do not know the rules and they do not pop into my head intuitively. There are several boundaries for me. One is someone else from another institution coming to look at the patients or me going to another institution to look at a whole series of patients. That is one boundary. Another boundary is a combination of doing a test that you would not usually do in clinical practice and handling the data differently. So, for example, if a mother says to me, “I have been reading about ADHD and dopamine transporter genes. I would like to know if my son has this particular gene or not. Can we take a cheek swab and send it off for analysis and see what we learn?” We will discuss it. I might say, “Madam, you have to understand this is not going to affect the clinical treatment at all. This genetic business is speculative. But if you want to know the answer – and a good laboratory will give us the answer – let’s go off and do it.” If, on the other hand, somebody else wants the cheek swab to put a whole lot of human DNA into a pool of data shared with the Institute of Psychiatry and shared with Manchester to be analysed in another laboratory, untraceable back to the original patient, that is the same test, a very unusual test, being used for a pure research purpose. So it depends partly on the test and also on who the data is for. Is it for this patient now or is it for some other kind of goal or something in between? I am sorry if I was confused before. I hope I have been a little bit clearer now.
MRS DEAN: Thank you.
THE CHAIRMAN: Ms Golding, a lay member.
MS GOLDING: Perhaps I could start with the transfer factor study in FTP2, page 676. Your department is described as “Child & Adolescent Psychiatry”.
Q But the study suggests that a “full neuropsychiatry examination will be performed”. What would be the difference between an ordinary psychiatric examination and this one? Page 724 is the other document.
A It is a difficult area of definition but I can say confidently that I do not call myself a neuropsychiatrist. The people I think of as neuropsychiatrists might be somebody like Professor Eric Taylor at the Institute of Psychiatry who knows a huge amount about brain metabolism or Dr Santosh at Great Ormond Street. They are very, very knowledgeable in a way that I am not about brain structure and function and how this affects human behaviour. They are also more knowledgeable than I am about slightly unusual tests that might examine the functioning of different parts of the brain. I am not that sort of child psychiatrist. I do not know what somebody else meant here by neuropsychiatric evaluation. In an ordinary way we general child psychiatrists look to our neuropsychiatric colleagues to give us a bit more insight into how the condition is affecting the brain or how the brain is affecting the condition. The average child with a tic problem, a repetitive motor movement, would be treated by a paediatrician or an ordinary child psychiatrist. If the motor movements are a little bit strange or if they are associated with epilepsy, then one wants a neuropsychiatrist or a neuro developmental paediatrician. People’s abilities and strengths and weaknesses will fluctuate in different parts of the country. It just would not be me.
Q Did you supervise any other clinician during the time of the study?
A I supervised my trainees, who had nothing to do with the study whatsoever.
Q No neuropsychiatric examination was carried out by anyone supervised by you or by yourself.
A In relation to transfer factor?
Q In relation to any child in the study.
A I did a child psychiatric diagnostic interview of the kind that really any reasonably trained child psychiatrist or general developmental paediatrician could do. No less and no more. I did not do any specific tests, test of gait or tremor. It was a history-taking, clinical interview of the kind that, as I say, every child psychiatrist and every developmental paediatrician should be able to do.
Q If we look at page 785, which is part of the early report to The Lancet, we have table 2. On page 784, it says,
“Table 2 summarises the neuropsychiatric diagnoses …”
Was that anything to do with you at all? Did you put together table 2?
A It is just very, very loose language because at the top of column one, where the diagnosis is made, it says “Behavioural diagnosis” and then it is called “Table 2: Neuropsychiatric diagnosis”. It should not have been called neuropsychiatric diagnosis. Between ourselves and the peer reviewers and The Lancet editors, this should have been picked up. It is confusing.
Q When you saw the children as part of the pilot study, as you felt it was, how many times did you see those children?
A For the diagnostic work, it was once only, but, as you will probably know from questions I was asked and from the files, subsequently I saw some children again.
Q How did you expect your diagnosis to be used as part of this study. I know you said you were clarifying a diagnosis, but how would that have helped the study?
A If, for example, I could see why other people have said that this child has autism but, having listened to the story very carefully, I think that diagnosis is slightly misplaced: “There seems to be something different about all of these children. I can see why people call it autism, but actually if you look at the detail it is a little different.” That would have been a useful contribution in terms of upholding the hypothesis. Equally, if I say, “They seem to have the sort of autism that 20 or 25 per cent of children have” that is normal development and then slipping back, that supports the nul hypothesis; that is to say, there is nothing to this idea. Both are of equal validity scientifically, they just take one in different directions.
Q Do you know then what happened to the children who did not fall into the diagnosis which would be relevant to the study?
A After their week at the Royal Free?
A No, I do not. Clinical management was in the hands of the gastroenterologist.
Q The children that you saw between 5.9.96 and 18.2.97, were you specifically asked to see these children?
A I would never see a child unless I was asked. And we always say, “You want us to see the child, do the parents want us to?” We would need ordinary consent before any member of my team goes to meet with the family. We are asked by a clinician and we check: “You want to see us, do the family members want us to?” and then we go ahead if both answers are yes. To make sure it is one thousand per cent clear, I never go on to any ward uninvited to see any patient – unless it is my own patient, in which case I have invited myself, and still I tell them that I am coming.
Q Do you know whether you saw these children before and after, or before or after the lumbar puncture and the EEG? These are mentioned to be how they would be seen by the psychiatrist.
A No. As I said yesterday, I just used to check whether the family had had enough sleep, and the child was relaxed enough, for me to come then and that question would obviously be shaped by, among other things, what investigation the child had been having or had been prepared for the previous night. But I did not ask, “Have you had this, this and this?”
Q Do you know if it would have made any difference, and whether you had seen them before a particular type of investigation?
A If I had seen all of the 12 children as outpatients before they were admitted to the Royal Free, we would have had to have had a discussion about whether or not the two with “query, post-viral encephalitis” should be included. And we did not have that discussion, but now in my mind one could argue it both ways. If I had seen all 12 children as outpatients before any of them had been admitted, and before any of them had had any further investigations, and we listed the diagnoses, we would probably have had to say to ourselves, “We need to check that the ethics application was clear enough.” And nothing remotely like that happened. And if I had seen them individually I would not be keeping count and knowing how many with autism, how many with disintegrative disorder and so on. We would definitely have included ten, and we would have debated two.
Q I noticed that in the retraction letter Dr Wakefield’s name is not there.
Q Was there a reason for that?
A Dr Murch told me – I believe he may be in print on this as well – that he tried very hard to persuade Dr Wakefield to join the retraction.
THE LEGAL ASSESSOR: Chairman, I have been looking at Mr Coonan to see if he was intending to object. It seems that the answer to that question is not within this witness’s personal knowledge.
MR COONAN: I think that is right. I was a little slow to get to my feet because I did not want to intervene, as it were, too soon, but I think it is verging on the speculative to ask this witness about reasons which may be attributable to somebody else. I think it is permissible to proceed, but to proceed with caution, obviously. I will be guided by the approach of the Legal Assessor for this.
THE LEGAL ASSESSOR: I will ask this question. (To the witness) Was it as a result of any action or advise on your part that Dr Wakefield’s name was not included in the retraction?
A Oh, absolutely not. I would have preferred it if every single author had been asked. Strongly, strongly preferred it.
THE LEGAL ASSESSOR: Thank you.
THE CHAIRMAN: Yes, Ms Golding.
MS GOLDING: Thank you – there is just one more. You said that yesterday that the disintegrative disorder is one of the autism spectrum disorders?
Q So it is nothing new? What is new is the association with the MMR in the terms of this study. Is that correct?
A Disintegrative disorder or Heller’s Syndrome was written about and described before we started this study and surely before the MMR was introduced. That question did not bother me hugely because I thought that it was unlikely in the extreme, in the absolute extreme, that we would establish that the MMR was the cause of every case that had ever been of autism and all its variants. That could not be. The only thing that had any plausibility is that maybe some children who are susceptible might have been affected in a particular way. Maybe, you see, there was something about that susceptibility in joining up the gut and development disorder symptoms. That was the area of interest. By no means all children. So it was legitimate to study an established condition.
MS GOLDING: Thank you.
THE CHAIRMAN: Dr Webster, the medical member.
DR WEBSTER: Hopefully just a couple of brief questions. In reply to Dr Moodley, you said you saw yourself as a sort of filter with regard to the developmental diagnosis for people coming in to project 172/96?
A I did not mean to say that. What I was trying to say that was that with hindsight we could have had a better filter; that is to say, before any tests under sedation are done, complete all the history-taking and check the eligibility of patients to go on to the next stage – have a two stage process. There would have been a good filter with hindsight. In practice, in the absence of such a robust formal filter, nevertheless informally whatever screening was done by whoever did the screening, and it is not clear to me now quite who did, but whatever screening was done by whoever did the screening worked, because only children with severe developmental disorders, or other signs of substantial brain impact got through. We could have had a better filter but the one we had seems to have worked well enough for these cases.
Q So are you saying you were the filter, or other people were the filter?
A I was not the filter at all. The people who accepted the patients for admission were the filter, and I was not that person. I was only told, “This patient is coming in. Can you see them this week?” So I was not the filter.
Q But was it not part of your role to try and clarify the developmental diagnosis?
A Yes, it was. With hindsight many things would have been done very differently. The patients were booked to come in, sometimes from afar, for a series of tests. The tests are to be done in some kind of order. They were endoscopy days booked and endoscopy time, and the endoscopists had access to the theatres only on certain days. So we did not set up a formal filter based on additional outpatient appointments to clear up all the questions save for the tests done under sedation. We did not do that. As I say, the filter sort of worked. Obviously – and I say this with hindsight – if the first child I saw had no developmental disorder of any kind whatever, I would have had to say to my colleagues straight away, “What is going on here?” And if the second one had that as well, we would have all had to say, “Stop”.
Q By Thursday, would that not have been a bit late?
A For that particular child, yes. Medicine is not that good that the diagnosis on everybody is clear by Monday; sometimes it does take till Thursday or Friday, whatever condition one is dealing with. The point I am trying to make is that if it had become evident in any point in the series that there is something dramatically wrong with the outpatient filter, it would have been obvious to all of us. I would have had to say, “You have asked me to see this child. He does not have a developmental disorder again,” or, “What do we know about the next child? Do we know enough before he comes in?”
Q The neuropsychiatric responsibility, whatever that might have been here – did you share that with Dr Harvey?
A Dr Harvey is a neurologist. I am a psychiatrist.
Q That is why I said “neuropsychiatry”.
A I do not think if you put Dr Harvey and me together, we add up to a neuropsychiatrist.
Q That is not what I was implying.
A Nor does our work add up to a neuropsychiatrist.
Q Did you ever liaise with Dr Harvey about these individual patients?
A Dr Harvey and I did talk, certainly about autism and what kind of neurological symptoms, if any, one might expect in children with autism. So we had conversations about the meaning of hand flapping and walking on tip-toes and so on. But we did not progress to any other kind of level in our conversation, and we did not have case conferences including Dr Harvey on individual cases.
Q Did you both attend the weekly ward conference?
A Oh no. Only me.
Q You told us you looked up lumbar puncture and autism research on the internet?
Q Why did you do that?
A Brian Deer asked for a meeting with me on advice from the Royal Free press office. I did not meet with him. I saved my evidence, as it were, for the GMC and this hearing, but I would read what Brian Deer was saying, and he was saying strong things about lumbar punctures and how unethical they were and how very, very unusual it was ever to do a lumbar puncture on a child with autism. My meetings with the GMC gave me food for thought – lots of food for thought – and in between my first meeting and my last meeting with the GMC solicitors, among the many things that I went off and read more about, I decided to read more about who was doing lumbar punctures for research purposes on children with autism today, and why. I stopped after ten minutes because I found so much. So I decided not to take it further. At my next meeting with the GMC solicitors I just gave this to them and said, “This seems to be an acceptable research intervention even now.” That is one reason why I did it. Another reason was, I suppose, this double standards thing, because I do not want to get into the sniping, but certainly lots of other research at the time dealing with the epidemiology of autism does not mention ethical approval in the published articles, and does not mention conflicts of interest. So I was looking all over. A fair criticism we have to take it and unfair criticism we have to say, “This is an unfair criticism,” and the lumbar puncture was in interesting territory.
Q Did you feel better having made your search?
A I think nothing can make me feel better about this whole business. Have I tried personally to be quite scrupulous and even-handed, and have I supported the MMR, and have I criticised people producing bad publicity about it, and criticise them again and try to help. I have done all those things. I retracted. Ought I to regret these individual children ever having had the lumbar puncture? I do not think I am in a position to regret it. They are someone else’s child, and that person, rightly or wrongly, decided their curiosity about their child’s long term condition merited them agreeing to an investigation on offer. I do not know more about what happened with these families. That is the decision that they seem to come to, in conjunction with my colleagues. I just regret the way the whole thing got turned into a paper that everybody in the world thinks, said, that the MMR is dangerous. That started at the press conference. As the press conference broke up, all of the press converted on Dr Wakefield. One of the journalists there, from a prestigious scientific journal, was a friend of a friend of mine. I said to him, “The real story is all the rest of us.” And he said, “No, Mark, it is not.” He turned his back on me, and off to talk to Dr… Dr Wakefield was the only story and so it went, and so it went. I feel ever so sad about that.
Q By the time you saw the families on the ward, it was the end of the week?
Q And they would have gone through all the tests?
A The calendar says it was the end of the week. I think we would have to go back to the original. All the dates that I wrote in – was it the end of the week or not? I do not know.
Q Were some of them at the end of the week, do you remember?
A I did not plan to go at the end of the week. My diary at the end of every week is completely full. At the beginning of the week it has a few gaps. In the middle of the previous weeks it has a few more gaps. I would try to work out where I am going to see the child within those gaps.
Q Whenever you saw the parents, and if they had already had some tests, did you ever ask how the child had reacted to the test, how the child had copied with the tests?
A Yes, partly because my own child had had bowel preparation for colonoscopy and I had had the experience, which I would not wish to repeat, of waiting for one’s child’s MRI scan result, waiting patiently for a colleague to give the answer. So I would have chatted with at least some parents about that.
Q Would that be about the parent’s feelings or what I am more interested in, did they report how the child had reacted?
A Some parents do not want to talk about what the doctor thinks they might want to talk about. For those who seemed open to that subject, we would have some discussion about how everybody had responded to all of this. I do not believe I got a message from anyone saying, “We are very unhappy,” because if I had got such a message, I would have reported it to my clinical director.
DR WEBSTER: Thank you very much.
THE CHAIRMAN: Dr Berelowitz, can I first of all ask you, I also have a few questions. I am the last Panel member, but are you all right to go on, or would you like a break?
A I feel fine. You are all probably better judges of whether I am still fine or not.
Q If you need a break ---
A I am fine, thank you.
Q Thank you. Then I will start. Can I first of all ---
A When I say “fine” under the circumstances.
Q Yes, I fully appreciate that and understand. I think what you told us, first of all in the beginning of your evidence yesterday morning. Then you were introduced to Dr Wakefield in one of the staff meetings ---
Q --- by Dr Harvey.
A I heard about him – did not see him. He was not there, I do not think.
A No, no – sorry. I do not think he was there. No, no; it was an administrative meeting to approve a job description.
Q Right, okay. I see – so there was no personal introduction. It was much more that you were being informed of the appointment?
A Yes. It was not an interval panel. I do not remember any personal introduction, no. It was an administrative process where what level, what grade, what title do we slot this scientist in.
Q I think you also said that you learned at that time that Dr Wakefield was involved in research for multiple sclerosis?
A That is what I believed Dr Harvey said. Dr Harvey has the gift of the gab, and sometimes – particularly with me – he would tease me without me knowing it. But still in this meeting as a whole, he would not have teased anybody. I thought he mentioned multiple sclerosis.
Q At what stage did you actually learn of Dr Wakefield’s interest in MMR?
A I cannot say. It was not a sort of one day not and the next day – it was an accumulating process. There is a video of the press conference I think in a television programme made by Brian Deer. Dr Wakefield starts to speak and actually the camera is on me. I have a facial expression which people who know me are familiar with. I am taken aback by this.
Q I am going to come to the press conference later on. I am just getting the introduction bit.
A What I am trying to say is that it became clearer then and then clearer again at the MRC meeting and clearer again with what I have read was his evidence to Congress some years later. So it accumulated.
Q To Mr Hopkins this morning, you said that you learned later on – and that was your impression – that Dr Wakefield was the engine for this study and he believed MMR could be very toxic.
A Throughout he seemed to be the engine. I learned later on, increasingly so, how toxic he believed the MMR to be.
Q Dr Andrew Lloyd Evans, the neurologist, is it?
A Yes. I have to be careful about this. Andrew would say of himself he cannot be called a paediatric neurologist because of his training time; he has to be called a neuro developmental paediatrician.
Q That was the gentleman who you would have actually preferred to be involved in this study, but he refused?
Q I think you tried to persuade him, I think you said, but you could not.
Q Did he give you any reasons why he did not want to be part of this study?
A No, he never did. He certainly did not express scientific or clinical scepticism. He just declined to be involved.
Q Did he say anything about the quality of the study, for example, or the methodology, or the patient recruitment?
A No, he did not. I knew Dr Lloyd Evans well. He has left the Royal Free now to go and work elsewhere.
Q Or was it the workload factor?
A I was going to say that Dr Lloyd Evans, more successfully than me I think, would manage his workload and think, “Can I fit this in?” That is the most economical reason I can think of for him saying no.
Q But he did not actually say?
A He did not say, no. But once Dr Lloyd Evans says no, there tends to be little point in having further discussion with him.
Q I do not want you to speculate what was in his mind, but if he had said anything to you.
A He definitely did not say anything scientific or clinical. It would have given me food for thought if he had.
Q I know my colleagues have gone over some of the ground about your role in this study, but I am coming at it from a slightly different angle, just to make sure I am quite clear about these issues. I think your role as I understood it was mainly the diagnosis of the children, either to confirm the diagnosis or make the diagnosis?
A We were in the business of confirming the diagnosis, because it should not have been the case in this country that a child has these sorts of symptoms and has never been assessed by anyone else and never had any kind of provisional diagnosis. So it was to confirm a diagnosis.
Q Most of the time, that was from the paperwork that you got most of the details, from the history, the papers from the Royal Free?
A And the story from the parents and observation of those children who were alert at the time.
Q Part of that was the examination factor, which was actually basically the observation of the child’s behaviour pattern, how he was behaving, giving attention to yourself and various other things?
A Yes, absolutely.
Q Were you then able to advise with what investigations the child should have?
A I think I advised, from memory, on three cases, how shall I put it, in a very, very advisory way. I was not the treating clinician who could order investigations. At least once, I said, “Let’s ask Dr Lloyd Evans for an opinion” and once I said, “Somebody needs to check the chromosomes.” I did not need to do more, I do not think, with these patients.
Q That is clear enough. I just want to try to understand as precisely as I can your role within this study.
A As I say, definitely twice, possibly three times, I gave advice. Definitely once, Dr Lloyd Evans, possibly a second time Dr Lloyd Evans and definitely once the chromosomes.
Q We have talked about the role of the lumbar puncture. I think your Medline research did actually say that most of the projects, most of the research projects, included a lumbar puncture.
Q You were very careful to try to say that clinically you have no idea what the other people are doing.
A Yes. I should flesh that out and say clinically, it would be unusual as part of a routine work up in the UK to do a lumbar puncture on a child with autism. As part of the routine work up through the child development centre, it would be unusual.
Q Does lumbar puncture have any role in the diagnosis of autism?
A It could have a role in the differential diagnosis. For example, if you are worried that the child looks like they have autism, but might have a biochemical disorder affecting their brain function or might have some viral brain condition, then you would think about a lumbar puncture. For me, I would not order the lumbar puncture. I would say to Dr Lloyd Evans, “What do you think?”
Q You have pre-empted my next question. I was going to ask you that.
A I am a child psychiatrist surrounded by physical medicine doctors and I have not done a lumbar puncture for a long time. Another child psychiatrist in another setting a long way from a developmental paediatrician might be doing lumbar punctures and child psychiatrists working in residential epilepsy units might be doing lumbar punctures. For me in the Royal Free, the obvious thing to do would be to talk to Dr Lloyd Evans.
Q To be absolutely sure – and I think I know the answer, but I just want to be absolutely sure – it is not that you are not doing lumbar punctures because you are a senior physician in your department and it is your juniors who undertake this kind of role, because if they do, you would know anyway, would you not, or they would do it under your instruction?
A No junior doctor of mine has ever done a lumbar puncture in my department since I have been at the Royal Free. Junior doctors of mine will have discussed with paediatricians, “Does this patient need a lumbar puncture and let’s ask Dr Lloyd Evans.”
Q It will then come to your knowledge because you will review those patients either on the ward rounds or in the outpatients clinic at some stage.
A Yes and no. Let me try to explain. Before gastroenterology at the Royal Free, we had a nephrology service for children with chronic renal failure. Once, after a boy had had a transplant, the nephrologists called me and said, “I think he’s depressed. See him and put him on Prozac.” I saw him and it did not seem right clinically. I have not put my hand on a child’s abdomen for a long time, but I said, “I’m not sure he’s depressed. Can one of the surgeons come back and see him?” The surgeon came back and in fact he had intra-abdominal sepsis and they treated this and his mood picked up. How they treated it, I do not know, or what time they treated it. I just gave a piece of advice: “I am not sure this is psychiatry actually. Will you please think again and deal with it within physical medicine?” and so they did. Why I am telling you this story is because we might say, “Thank you for involving us. We do not really think, having met the patient and read the paperwork, that this is within our area of competence and actually you need to talk to somebody else.” Then we would be, “Next patient.” So with all the children who have come through A&E in delirious states and we are not sure whether they have taken a drug overdose or they have had an infection, I do not have a track record of what my SpR said to the paediatric SpR about how to investigate the patient, but there will have been talk of lumbar punctures diagnostically.
Q I understand.
A But they will never have been done by a child psychiatrist.
Q You would make a provisional diagnosis and we have discussed that you would at least advise on the investigations if you considered it necessary. Would you then give your clinical opinion, which I think in most cases was Asperger’s or autistic spectrum disorder?
A I would give my opinion usually in writing to one of the gastroenterology colleagues. With the families, I would, as in all liaison work, take pains to convey to them, sometimes very explicitly, sometimes there was no need to do it explicitly, that I am in their child’s life very temporarily and this is a provisional diagnosis that I have made, that I do not wish in any way to challenge their ongoing professional relationships with anyone else. I encourage my trainees in this regard in liaison work and we have to be very, very careful to keep that particular clinical consultation in perspective. So I would have said, as I wrote down in relation to one of the mothers, “This is how it looks to you, this is how it looks to me. I am not saying it is. I am only saying how it looks”, because I was cautious with the families. I think I have digressed away from what you were asking me. I am sorry.
Q I think I have the point.
A I was not a treating doctor for all practical purposes.
Q Most of these patients were being called Wakefield patients.
A That is what memory says.
Q What about the patients who were already under the care of different departments within the hospital?
A They certainly were not referred to as Wakefield patients. We have tried, unsuccessfully, for good clinical governance reasons, to make sure that every consultation request comes in writing with the name of the consultant at the bottom. In practice, we live in a fast moving environment, it is acceptable to us to work across disciplines and so a staff nurse might ring me up or a professor and we work out what to do next on any individual patient. We get called from all over the hospital really.
Q I think you admitted, at least in Child 2, that your letter actually went much further – this is page 139 – than just giving your advice for the study; that that was actually going into the clinical domain.
A Which page is that?
Q Page 139. While you are getting that, if you want to get Child 8’s file as well, please.
A It was not part of the study to carry out a clinical intervention and then review the children. This is pre-study chronologically and we were in the fortuitous position that the child had been seen by me and then had had a bowel intervention and was available to be seen by me again and the mother was reporting clinical change in the developmental disorder symptoms. So it was perfectly sensible at a clinical level for the gastroenterologist to say to me, “Can you review the child?” I have written a rather terse letter really. Perhaps it is in a way kind of doctor’s code. “The mother and I are seeing different things. Please take that into account. I cannot say she is wrong, but we see different things.”
Q I gathered something like that from the tone of the letter, but I wanted you to confirm that.
A I think, knowing myself, the particular choice of words, that I would want Dr Murch just to notice it, nothing more.
Q Child 8, page 20. If you look right at the bottom of the page, “Opinion only”. That is a referral to yourself by a house physician.
Q This is a referral dated 21 January 1997 to yourself from a house physician.
Q If you go down to the bottom, it is tick marked “Opinion only”.
Q Can I first of all ask you, what was your understanding from that? Opinion about what? About the diagnosis or about the management or what?
A I would not have given that tick so much weight. Let me try to explain. In practice, all children admitted to the Royal Free to one of the paediatric wards are admitted under the care of a paediatrician. There are some exceptions in the field of eating disorders, but I do not think we need to bother with that, because it would just be a distraction. All children admitted to one of the paediatric wards at the Royal Free are admitted under the care of a paediatrician. If the child’s clinical cause turned out to be such that they clearly did not have a paediatric problem at all and they clearly had a child psychiatric problem and they still needed to be in hospital, then we took pains to ensure that a clear transfer of clinical responsibility took place from the paediatricians to me. That is all I would have noted about that little tick and nothing stronger than that. We are not seeking to change the fundamentals of responsibility for this patient’s care in any way. That is all. This form is a bit rare in making it that concrete. Normally we would just have a quick telephone conversation about that.
Q But in this particular case, we have a document.
A Yes, I do not want too much to be read into the document. It really confirms, in a way, what I would assume unless the consultant rings me up and says, “Mark, we have had this patient with us for two weeks. He does not have any paediatric illness at all, his main problems are psychiatric. Can we now transfer care from this afternoon.”
Q Is it not unusual for a house physician to refer a patient to a senior consultant, the head of the department? Usually we see SHOs to the registrars, registrars to the consultants maybe, or consultants to the consultants. Could it be because the SHO knew your interest and your involvement in that study? Because that is what it says for “disintegrative disorder/syndrome” and it says “post MMR” I just wonder whether that is the reason.
A It would be assumed within the hospital that when an SHO or someone relatively junior makes a written consultation request that the request rarely comes from the senior doctor. It would be assumed. I mean, an SHO should not make an autonomous request to anyone in my department of whatever seniority. His or her consultant ----
Q That is the point I am trying to make.
A I absolutely assume that, and I think I am justified in assuming that, when we get a written consultation request like this. Sometimes it happens that somebody rings us up in a little bit of a panic – and people do, understandably, get in panics about children with psychological difficulties – and when someone is in a bit of a panic, we do say, “Does your consultant know about this?” And if the consultant does not, “Please go off and talk to our consultant.” But a written consult within the Royal Free, I think everybody would assume it comes form the consultant.
Q Mr Coonan took you this morning to four patients: Children 2, 5, 4 and 6.
Q Who were seen by you pre approval date.
Q What was your understanding at that time? I would imagine that you would have known that the approval application has gone in, even though approval had not been granted until that stage. (Pause) I appreciate it is 11 years ago, so …
A It is 11 years ago and it is in this territory of when does joint thinking about a complex clinical problem cease and when does research begin. As I said this morning, when I look at all the paperwork the story, as it unfolds, seems clearly to be: we start off with clinical work – from my point of view, not knowing about the Legal Aid Board or anything like that. The clinical work takes us to some hypotheses. We think, rightly or wrongly, we should tell the Ethics Committee about this and organise it into a proposal, and then we carry on our work. But now we have made sure that the hospital as a whole knows the nature of the work that we are pursuing. So, at this stage, prior to the end of January 1997, I was rather like my putative immunologist, helping my colleagues think what is going on with these patients, coupled with, obviously – and I think I said this right at the beginning yesterday – trying to think in advance how the ward might cope should the behaviour of a child with autism deteriorate and become agitated. What advice do we give to the nurses? What medications? It is worth thinking about this before the problem arises, so one is accumulating knowledge and can anticipate knowledge.
Let me try again to explain it from a different way. If on some adventure cruise for children with ADHD (attention hyperactivity deficit disorder) there was contamination of the kitchen and 15 children had developed serious bowel problems and were coming to the Royal Free for treatment of their bowel problems, they would say to me, “Mark, help with the ADHD in so far as that impacts on their life on the ward and how we give them explanations” and so on and so forth. That was a big part of it at the very beginning: how does the ward cope with more than the usual number of children with developmental disorders should their behaviour deteriorate, should difficulties arise. That was a big part of it and then there was also the development of a hypothesis: is there a link between autism and gut problems? And then the MMR, for better or for worse. So I do not mind being called to any ward about the admission of any child where the admission of a child with that particular condition is a little bit statistically unusual for that ward. That is an appropriate use of a liaison team.
Q The indication at that stage seemed to be already trying to include them in this study, if I may put it in that way.
A I did not know then how patients were being recruited. To this day, do I understand how patients were being recruited? No. But it does not look like they were coming randomly.
Q With respect, I think you would have actually known because at least you had seen the draft of the proposal.
A I knew that these were parents ----
Q You would have known that these children would or could fall into that category.
A Could fall into, yes. Absolutely. Yes. But they fell into other categories as well, like: what if their behaviour deteriorates? Or, as I said, yesterday, a senior surgeon asked me to go with him when he was going to talk about a particular therapeutic surgical procedure with a family. So my work at that stage fell into more than one category, but, absolutely, I knew there was interest in the MMR.
Q Do I take it from that answer that I think you felt it was appropriate to advise in that way, as you did, for these four children before the approval and that was quite appropriate?
A Advise the gastro team about what I thought the developmental diagnosis was.
Q Yes, in the terms of the requirements of the proposal.
A Absolutely. I am not sure what would not be appropriate about it.
Q I am not criticising you for it, I am just asking for your views on that.
A Yes, I did think it was appropriate. Yes.
Q Then you would have seen when the paper was published, in the attendance, 40 more children.
Q What was your view then?
A Did you think that those 40 might also fall into the same category and therefore it was fine if there was no approval granted for those?
A Well, my feeling then was of discomfort, that we were on difficult territory and I was not sure then who thought they were doing what, who was putting what sort of words into what sorts of publications. I felt we were all in very difficult territory. But I also knew that the dean and the chief executive and the medical director were very actively involved.
Q Actively involved in support -----
A In talking to one another about what is going on here. I did not have to flag up new concerns because, as I say, the dean and the chief executive and the medical director were talking to one another about things.
Q No, what were your views?
A As I say, I was aghast at the press conference, at the way things were turning out, and I had this aghast look on my face.
MR COONAN: Sir, I am not sure that the witness is quite focusing on the question you have put to him.
THE CHAIRMAN: I am not getting the answer.
A I am sorry.
THE CHAIRMAN: It is all right. It may be that Dr Berelowitz does need a break.
MR COONAN: I was thinking that.
THE CHAIRMAN: Dr Berelowitz, I only have about three more questions. I think we will now adjourn. It is 20 to four and we will resume at four o'clock.
MS SMITH: Sir, before you do that, I am anxious that we should not forget the inquiry nature of these proceedings and if the Panel wants to ask this witness questions obviously if anyone has any objections to them then they are permitted to voice them but I do not want the Panel to feel inhibited by Mr Coonan’s interventions as to what this witness may or may not wish to tell the Panel. That is all.
THE CHAIRMAN: I am quite sure the Panel is fully aware of that. I did not take Mr Coonan’s ----
MR COONAN: I was very concerned about the fact that the witness has been in the witness box for now an hour and a half.
THE CHAIRMAN: I took it in that way, that I was not getting the answer, that the witness was digressing a bit.
Thank you. We will now adjourn. Dr Berelowitz, you are still under oath and you are still in the middle of giving the evidence - hopefully for not too long. Do please refresh yourself and have a drink but do not discuss about this case with anyone. We will resume at four o'clock.
(The Panel adjourned for a short time)
THE CHAIRMAN: Good afternoon, Dr Berelowitz. I asked you a question about these 40 patients.
Q Who, it came to your knowledge, were added during the addendum of The Lancet paper.
A Yes. And I apologise, I clearly gave an incoherent answer and I am grateful that the Panel realised I needed a break.
Q We fully appreciate that.
A Thank you. But still I apologise. The 40 patients.
Q Yes. What was your understanding at that stage? Did you feel that they were again the children who were admitted into this study for whom the approval was not required or were they part of the formal study?
A In a way there was some coherence to my answer but I clearly did not put it very well. I was not sure who these 40 patients were, but, also, it did not seem to me to fit because the study said, “We’ve got to where we’ve got to. We did not identify a link. Other kinds of work now need to be done. So why mention 40 more of the same kind of patients. It did not add up to me. It was one of the things that was disconcerting me.
Q Was it the first time that it came to your knowledge in the press conference? Did you actually see that beforehand?
A I do not think I saw that until I saw the paper. I knew that there were more patients but the idea of linking the more patients with the original Lancet paper seemed to me to convey the implication that we know that there is something worth pursuing here in the same way that we have been going on about it before. I did not sign up to putting that in the paper, and I did not think it was at all justified by the paper – so it disconcerted me.
Q Then I think you said that at some stage later on you started having some differences with Dr Wakefield?
A My letter to Professor Walker-Smith in the summer of 1997, “The events of the last few days” letter – I do not have it in front of me.
Q I think I have it.
A I have it now. It is 5 August. It is my birthday – I ought to remember the date. Something must have troubled me a lot. When I say “complex publicity”, I meant an understatement. Something was troubling me a lot then. I do not know what it was, but clearly I had an anxiety then that people would draw a premature and wrong conclusion from our very small study. Something had sparked a concern and that concern was heightened by subsequent events, particularly the press conference, because I was terribly concerned that if someone at the press conference, which was about the paper, said anything negative about the MMR, people would assume that that person has special knowledge, and is deliberately linking the paper in the MMR. So my concerns grew, and they continued to grow at the MRC meeting, and they just grew.
Q Coming to this letter, this 5 August letter – and I know this particularly question has been raised and I only want to just clear my own head about it and, I think, your understanding from this. You actually said that the research has already attracted complex publicity?
A From the events of the last few days, yes.
Q When was the conference held, by the way?
A I do not know.
Q You do not know the date?
A (The witness shook his head) I know The Lancet paper was embargoed at the time of the conference, so it must have been very close to the date of the publication but I do not know the date. Somebody must know the date.
Q I think The Lancet paper was published. We know that was February 28, 1998. The draft that you had, I do not think there is a date on it.
Q That is page 758 onwards. That was February 1998 when the paper was published. Was the press conference called after the paper was published? That must have coincided with the publication of the paper?
A It coincided with the publication but exactly how it coincided… I was simply asked to turn up. Somebody checked with me what I was going to say, and “Oh good, please come to the press conference.”
Q This actual letter you wrote was on 5 August 1997?
Q Which is very close to about six months before the publication?
A Yes, yes. And almost exactly two months before 8 October 1997 with this covering letter, “Please find enclosed…”.
Q So there was something of complex publicity, as you have referred to --?
Q --- that was going on at that stage?
Q Does it actually mean the results were already declared of the study?
A I do not know what it meant. I do not know what was on my mind then specifically, but the few letters that I wrote in this episode all expressed a substantial concern. I was not firing off letters all the time. Each time I wrote a letter I had something on my mind. I cannot remember what was going on there in those few days.
Q But despite that, you were expecting more publicity when the publication of The Lancet was almost imminent, I think?
A Yes, because the press always trawl for interesting stuff, and it gets on the front pages sometimes.
Q I think, quite correctly at that stage, you were starting to get worried about public health?
Q Did you have any views how you were going to handle it, and particularly as a child psychiatrist? Somebody who sees children all the time.
A We are going back a long way in time. There were lots and lots of conversations that were going on about the research. I am not a public relations expert. I am not a vaccine expert either. All I was trying to do at that stage is to say to the person who is the head of the team, “Something is afoot here and we need to be careful.” I flagged that up pretty clearly, and wanted to make sure that the paper downplayed the link – made clear the link had been raised and was now being dropped.
Q I know that your retraction came a few years later?
Q But because of your concern at that stage – that was before the publication of the paper, did you feel you needed to do something about it at that stage?
A I did do some things at that stage. I supported the MMR. I was critical to Dr Wakefield’s face about his conduct. I expressed concerns to Professor Walker-Smith. I appeared on national television supporting the MMR. I kept in close consultation with the dean, Professor Zuckerman, and with Professor Taylor. Also, I was trying in my own way to do what I could, bearing in mind that I was just another doctor at the Royal Free – no greater status than that. I did discuss matters with the Royal Free’s press officer. She said to me more than once that any publicity about the MMR, as it were, turns out to be bad publicity. If people say the MMR is bad, it lowers immunisation rates. If people say the MMR is good, it also lowers immunisation rates. The best thing, their professional advice was, was to try to keep the controversy out of the public eye. That was the official advice from the Royal Free because raising it, even in a way that was intended to be helpful, seemed to have a paradoxical effect. As the press conference showed, eight, nine, ten to one in favour of the MMR – one beats nine. You know – eight, nine, ten in terms of publicity. So I followed Miss Hutchinson’s advice. I knew that the medical school was engaged in complex negotiations with Dr Wakefield about who would appraise him. I was told by the dean that Dr Wakefield had undertaken not to give public lectures to lay audiences about vaccination. That is what the dean told me. Then I was told later on that disciplinary proceedings were in process and that Dr Wakefield was going to leave. I thought more and more, “This is increasingly going to go away,” plus there was an accumulation of scientific evidence being published in journals, saying “There is nothing to support a link.” I thought, “It is best to try and let this matter go away.”
Then it came into the public eye once again, and the paper became more powerful once again. New information came to light. Then the time had come to retract the paper. But Dr Murch, Dr Thomson and I used to talk about what is the best thing to do. “Now that we are here, what is the best thing to do?” None of us thought that we should act unilaterally. So, as I say, we were take advice from the dean, from the press office and, rightly or wrongly, we got to where we are today, although of course that in 2000 I suggested that the Royal Free check that its own house was in order.
Q That was in 1997?
A In 1997 I wrote to Professor Walker-Smith, “Let’s be careful about the paper.” In 2000 I wrote to Professor Taylor, saying, “Let’s do our own internal check.”
Q Getting back to 1997, and this letter – you copied it to two of your fellow researchers, Dr Wakefield and Dr Murch?
Q And it was written to Professor Walker-Smith, so that is three?
Q And including you, four.
A I beg your pardon?
Q Was there any contact with the others, because I know Professor Taylor and Professor Pounder were not the co-authors of that paper?
Q But you copied this letter to them. They were in an influential position, so you felt that you really needed to inform them of your views?
A Dr Wakefield was a reader, or senior lecturer/reader in the department of adult gastroenterology, and Professor Pounder was the head of that department. So in effect, I was writing to Dr Wakefield’s line manager, flagging up my concerns. I do not have authority over Dr Wakefield.
Q No, no. I was only making a point, and asking you a question, was there any conversation with your other co-authors of the paper because there are only four of these that were involved – yourself writing to Professor Walker-Smith, and copying to Andy Wakefield and Simon Murch.
A These were the people who I, rightly or wrongly, perceived to have the largest influence.
Q Right. I think that is –
A I may well have been wrong, but that is what I perceived.
Q I think I am asking for your understanding, if that is your understanding of that?
Q That is fine. Now the press conference: I think you said that you only got notice that the press conference has been organised?
A Yes. I was not asked whether we should have one or not. I was told that there was going to be one.
Q And inviting you to be ---
Q --- present at that one?
Q Can you recall who were the people who were present in that conference?
A Professor Pounder. I am not sure about Professor Pounder. Let me backtrack. Professor Zuckerman. Dr Murch.
Q Sorry. Just slowly so that I can ---
A Sorry. Professor Zuckerman, the Dean.
A Dr Murch.
A Dr Wakefield.
A Myself. I cannot remember who else was there on the Panel. I do remember Professor Pounder giving a talk at that time on the rising incidence of inflammatory bowel disease and my memory tells me it must have been an introduction to the press conference – a kind of medical explanation. But I am not completely sure.
Q Do you know, for example, whether Dr Murch was there?
A Dr Murch, definitely. Professor Zuckerman.
Q Dr Anthony?
A I do not know about Dr Anthony. Dr Murch was definitely there.
A I do not know about Dr Casson. Dr Casson was not then a consultant. I would have been a bit surprised if he had been there.
Q I think you said the press concentrated on Dr Wakefield. Were there any contributions from yourself?
A We all contributed and questions were asked from the floor. When the meeting broke up, absolutely everybody went to Dr Wakefield. Obviously I was naïve at the time, but I was taken aback that no-one wanted to talk to the rest of us. As I say, I went to speak to somebody who I knew indirectly and I said, “Please”. We were not the story.
Q Just moving on to the transfer factor, I think you said in your evidence that it was Professor Walker-Smith who actually told you about your adverse views on that and there were transatlantic adverse emails which were flying around about you?
Q Could you just give me a little more detail on that? Was it your adverse views about transfer factor or your adverse views about participation in this study?
A At some point I said – there was a real falling out over this – at some point I said to somebody that I would go to the ethics committee myself, because I was not happy with what I understood them to be saying about, how can I put it, the child psychiatric legitimacy of the study and I was going to go to the ethics committee about it. Do I regret that? No, I do not. But then Professor Walker-Smith, who has always behaved to me in a courteous and gentlemanly way, called me to his office and, in his courteous and gentlemanly way, apologetically said, “This is what is now going on.” But he said he would not show me the contents of the emails and I did not argue with him about it.
Q You were not copied into those emails?
A Absolutely not, no. I have never received them.
Q You only knew that they were flying around?
A Yes. I can only fantasise about what is in them.
Q I do not want you to do that. My last question to you. I think you said somewhere around the end of last year or the beginning of this year you saw Dr Pegg and made some inquiries about the situation about the ethics committee in 1996 and the situation about it now. Is that correct?
Q Did you at that stage know whether Dr Pegg had made a statement to the GMC solicitors?
A No, absolutely not.
Q Did he give you an indication that he was also expected to be called as a witness?
A No, no.
Q Did you at that stage know that you were going to be called as a witness in this case?
A Yes, I did. I had met with the GMC. I was approached through the MPS to assist the GMC. I discussed this with the MPS and I accepted the invitation. Rather grandiosely, but I hope appropriately, I thought what I am really here about is the truth as I understand it. I am not on any particular side. It became clear that there were lots of things to think about. The more I met with the GMC, in a way the more questions were raised in my mind and the one question for Dr Pegg, as I said, was, “What does this mean?” So I rang him up and we had this interesting conversation. He and I were not cross-examining one another. We were just talking on the telephone one afternoon when we could grab a few minutes to speak to each other. Other than that, I did not know that Dr Pegg was going to be called. I believed that Professor Hodgson was going to be called. Apart from that, I tried not to know who was going to be called and not really think about that.
THE CHAIRMAN: Can I thank you, Dr Berelowitz, for your very clear answers? I am going to look to the Panel members. I think Dr Moodley has one more question for you.
DR MOODLEY: I just have one question about the lumbar punctures. We know that was not part of your diagnostic determination, but, for whatever reason, they were being done. In your opinion, if they were necessary to do on young children of the kind of age these patients were, who would be the best people to do them?
A To do the lumbar punctures?
A The paediatrician.
Q A general paediatrician, a specialist paediatrician?
A I do not know what the test of competency is for doing a lumbar puncture, but the right person to do a procedure is always the one who does quite a lot of those procedures and is comfortable with them.
Q Yesterday you told us that you would confidently send your child to the paediatric gastroenterologist to have a colonoscopy. Would you send your child to a gastroenterologist to do an LP?
A I would not send my child to the gastroenterologist to do an LP. On the face of it, you would send a child to a neurologist to do an LP, a paediatric neurologist, but as with any procedure, if you know that the doctors do it a lot, you do not need to ask them. If you do not know whether they do it a lot, as an informed consumer, you would say, “Are you the right person to do this?”
THE CHAIRMAN: Thank you. I know there was one question which was floating around. I wonder whether that has been cleared up. I am looking at the Legal Assessor.
THE LEGAL ASSESSOR: As far as I am concerned, it has been. It relates to page 504, the letter of 5 August, and I understand this witness to have said more than once now that he cannot remember what it was in his mind which constituted the events of the last few days referred to in that letter. Therefore I do not regard it as necessary for my part to open that up, because he said he cannot remember.
MS SMITH: There is a document, sir, a document which immediately preceded the letter which Dr Berelowitz wrote to Professor Walker-Smith. It is not in your documents at the moment. It was removed because there was an objection to it. It was being produced by Dr Salisbury from whom you have not heard yet, but there was an objection to it by Mr Coonan, which I understand he is not pursuing. It casts light on the very issue which we have been asking this witness about and I would like to put it back into the bundle and put it to this witness to see if it assists.
MR COONAN: Can I just make the position clear? It is not that I do not have any objection; it is just that I understood Mr Miller may be dealing with this point following the learned Legal Assessor’s himself dealing with it. I do not want it to be thought that I am simply accepting the position. To that extent, I need to correct Ms Smith. The correct way, if I may say so, is for Mr Miller to deal with it if he wishes to.
THE CHAIRMAN: I am looking to the Legal Assessor at this stage to advise us.
THE LEGAL ASSESSOR: It is not clear to me what this document is from looking at it. I have seen it before, but I do not know what it is.
MS SMITH: What it is is a report of a article which was put in a medical magazine called Pulse on 2 August 1997. I do not think, with respect to Mr Coonan, it is a matter for Mr Miller. The Panel have asked a number of questions of this witness about why he wrote a letter on 5 August 1997 in which he said, “It is clear from the events of the last few days that our research has already attracted complex publicity.” In those circumstances, he has himself been casting around for an answer to that question. This is one of our documents, not Mr Miller’s document, and it was, as I say, originally in this bundle and I can see absolutely no reason why the Panel should not have this matter clarified.
THE LEGAL ASSESSOR: My advice to the Panel is that they may receive this if they choose to, for Ms Smith to ask such questions as she thinks appropriate and then for Mr Miller to cross-examine the doctor on it if he wishes to do so.
THE CHAIRMAN: Mr Coonan, it was pointed out to us that originally it was your objection. Are you content with that advice?
MR COONAN: Sir, in the light of what has been said, I have nothing further to say about it. If you wish to receive it, you are entitled to receive it of course.
THE CHAIRMAN: Thank you. Can we have that document circulated?
MS SMITH: Sir, this is pages 501 to 503 of bundle FTP2. (Same circulated)
THE CHAIRMAN: Dr Berelowitz, you have been given pages 501 to 503. Do you want to have a quick look at it before you are asked any questions?
MS SMITH: Sir, what I was going to suggest, I have been reading out documents so they are in the transcript, but this is quite a long article in two parts, so I wonder whether it would be appropriate if everyone was given ten minutes to read it?
THE CHAIRMAN: My only concern is that I do not wish to keep Dr Berelowitz on oath again overnight. I do not think it would be fair on Dr Berelowitz to have to ask him to come back tomorrow morning.
MS SMITH: Then shall I simply read it?
MR MILLER: Sir, perhaps the simplest way of dealing with it would be to ask him, looking at that document, does that help him to decide what it was which was going on in the background before that letter.
MS SMITH: I have no objection to that, but Dr Berelowitz must be given time to read the letter before he can be asked questions.
THE WITNESS: I have read it while the conversation was going on.
THE CHAIRMAN: That is very helpful. Ms Smith?
Further re-examined by MS SMITH
Q Dr Berelowitz, does that assist you as to why you wrote the letter to Professor Walker-Smith on 5 August 1997?
A It assists me very much indeed, yes.
Q Does it ring bells with you? Do you recall it?
A Yes. It rings bells, slightly unpleasant bells, if I can put it that way.
Q Can you explain what you mean by that?
A “New evidence … is contained in five, as yet, unpublished”. This is not a good way to talk about anything to do with public health policy. Sorry, that is the top of page 502, the beginning of the second article, third paragraph down.
Q Are you talking about:
“New evidence of a link between MMR immunisation and Crohn’s disease and autism is contained in five, as yet unpublished, studies examining different aspects of the topic.
Dr Andrew Wakefield, reader in medicine at the Royal Free Hospital in London, said the studies were designed to enable evidence to be looked at from several angles – ‘a bit like fitting together the pieces of a jigsaw’.”
Q You are saying that rang unpleasant alarm bells, are you? Perhaps you would explain how it led to the letter of 5 August.
A I thought we were doing a modest piece of work, quite a discreet, in both senses of the word, piece of work. I find through this that there is a whole lot of activity going on: five studies and Dr Wakefield is jumping the gun, saying to people about papers that they cannot yet read and critically analyse. There is something in there that should make everyone afraid. That troubled me, as I am sure it troubled other people.
MS SMITH: Thank you very much.
THE CHAIRMAN: Do you have any cross-examination on that? First of all, Mr Coonan?
MR COONAN: No, thank you, sir, not on that, but I do have one matter. Perhaps Mr Miller could go first.
THE CHAIRMAN: All right.
Further cross-examined by MR MILLER*
Q Would you turn to your own letter, 5 August, our page 504. That first paragraph, as we see now, is a clear reference to what had happened in the days before.
Q The second paragraph involves your attempt at a remedy to deal with it when the paper actually comes out.
Q I think you told us yesterday that in the draft that was sent a couple of months later, the paragraph that made the point you wanted made was in fact in the draft that you saw.
Q So your concerns as to the fact that it should be spelt out, certainly in the draft that you saw, was there but, as we have seen, it is not in the paper itself.
Q Do you have Child 8’s file.
A Is this a different topic?
Q Yes. I am going to leave that now. I wanted to put it in context, that is all, because it was not clear from the letter. Child 8. The Chairman asked you about a reference on page 20 of Child 8’s Royal Free Hospital notes. The author of that note has ringed “House-Physician” and it is asking you for your opinion with a little bit of history there.
Q It has a tick for “Opinion Only”. Would you turn two pages back in that bundle. You have made the point that if you get a note from a junior doctor, behind that doctor there is a senior doctor under whose guidance he presumably is working.
Q Page 18 is a letter of 28 January directed towards Professor Walker-Smith.
Q It is dealing with this patient. Is it your opinion on trying to get to an opinion on an appropriate diagnosis.
Q Is that the response to what you are being asked to do on page 20?
A Yes. Firstly, as a standard safeguard, although I assume the request came from the consultant I write to the consultant anyhow, so the consultant should know both about the request and that I did the piece of work. That is a pretty standard risk management safeguard. Secondly, I commented on where we stood diagnostically and thought we should involve Andrew Lloyd Evans and, as I said, that I would see what Professor le Couteur had to say as well.
Q Because this was one of the two oddities that involved the possibility of encephalitis rather than developmental disorder.
A Absolutely. Yes.
Q So to a different area.
A Yes, outside my usual range of experience.
Q Dr Moodley, when she started asking you questions – and I may have misunderstood the questions – seemed to be suggesting that it was implicit in the design of the study that there should be a diagnosis of disintegrative disorder before the gastroenterological investigations and other investigations took place. Was that ever envisaged as the timetable?
A A prior diagnosis of disintegrative disorder by me?
Q Yes, by you.
A No. Absolutely not, no. I do not think that the Ethics Committee application implied that.
Q No. Was it any part of your role as a psychiatrist to advise the gastroenterologist as to what physical medicine investigations they should carry out?
A Yes, but only from a very psychiatric perspective; that is to say, if we had met with the parents and one of the parents seemed to have from our point of view a misplaced or irrational preoccupation with a particular symptom or an overvalued idea about how conclusive a particular investigation might be, we would say, “Well, when you are deciding whether or not to do this investigation, just bear this in mind from what we have picked up from the mum.” But the formal clinical indication is not my business.
Q If there was a possible psychiatric element, then you would apply the benefit of your expertise.
A Yes, just a very faint shading of the decision but on the formal decision it would be quite improper for me to start saying this one should and this one should not have a colonoscopy.
Q You have said that there could have been a better filter. Looking back at it, there could have been a two-stage process.
Q With somebody else starting off by looking at that aspect. Did you say that, even if there had been, ten would have been included anyway and there could have been debate about the other two.
Q And the two being the two query encephalitis.
Q I have two other points. You were asked to consider a hypothesis. The child had come to be assessed by you, having already been investigated by the gastroenterologist, and you find there is nothing that could be said to be pervasive developmental disorder or any other disorder, so there is no psychiatric element at all. Would it necessarily follow that the child would have got no benefit at all from the gastroenterological investigation?
A No. Thank you for allowing me to clarify that because clearly I need to. If a child was referred to me and they clearly did not have a developmental disorder, then my job would have been to go to my colleagues and say, “The child does not have a developmental disorder, so please be clear that whatever investigations you are doing are not predicated on the idea that the child does have a developmental disorder.” But I could not say: “Because the child does not have a developmental disorder therefore you must not do anything else clinically sensible with the patient.” I would just say, “Don’t allow the idea of a developmental disintegrative disorder order (positive diagnosis) to inform your judgment. You have to decide what investigations to do.” It never arose, but that is what one would have done.
Q Finally, in the postscript to The Lancet paper there is that short reference that is not in the draft. Leaving aside the status of those patients, patients have continued to be seen, after the first 12, and investigated in the gastroenterological department but also by you providing the development disorder diagnosis, have they not, since the initial 12?
Q Had MMR by that stage got anything to do with it?
A Not particularly in my mind. I remember thinking rather sadly that even in the late 1990s, people had been not paying sufficient attention to quite serious uncomfortable bowel problems that children with autism had that must have been causing them considerable distress and agitation. Thank goodness, this was where the work was now focused, helping the children with their bowel problems while continuing to think, “Is there something about the bowels and developmental disorders in some children”. It is the equivalent of this otitis media thing in a child with autism. I thought now, just standard, good thorough clinical care was being provided.
MR MILLER: Thank you very much.
THE CHAIRMAN: Mr Coonan.
Further cross-examined by MR COONAN
Q Dr Berelowitz, I have just one matter I would like your clarification of. It is not about any clinical matter at all. During the course of evidence in the latter part of this afternoon, you mentioned that at some stage, probably round about 2000 when you wrote that letter that we have looked at, or possibly later, you mentioned that you had considered the question of double standards in relation to a conflict of interest. You referred in the course of your evidence to the area of epidemiology in autism. Did you make some inquiries? Did you look at any material of that nature to see whether or not conflicts of interest had been declared? I am just trying to understand what steps you took, as opposed to your thinking. That is what I am after.
A Absolutely. To put it mildly, I took being asked by the GMC to assist very seriously, and I did my homework. I carried on trying to do homework, learning more and more and more about this situation, and I was reading two of the epidemiological papers, one published in The Lancet. One was in the The Lancet and one is an Archive of Diseases in Childhood. One is 1999 and the other one is 2003? I was just sort of reading, and I thought ---
MS SMITH: I am sorry to interrupt, sir, because it does seem to me to be quite inappropriate for Mr Coonan firstly to treat Dr Berelowitz as an expert in conflicts of interest, but then to invite him to tell us about papers in 1999 and 2003, none of which we have seen and, it seems to me, assist nobody at all. I really do object to this line of questioning of this particular witness. As I say, particularly as we have not seen the papers and they are all years after the events which you have to consider.
MR COONAN: Sir, I take the view, and my submission is, that the Panel should hear this evidence in the light of evidence that you are going to receive at the beginning of next week on the topic of conflict of interest in 1996. I am interested to find out what Dr Berelowitz, who is the General Medical Council’s own witness, has to say about his factual researches, about the declarations of conflicts of interest, or lack of them, in 1999 and even in 2003. Dr Berelowitz in my submission has a valuable role to play in assisting this Panel, in making a judgment ultimately as to whether or not there was, and if so to what extent, a duty to make declarations of interest of one sort or another. Having some evidence from him – I do not know what it is – but having that evidence from him may assist the Panel in making that judgment later. He can identify the papers, if he has them, and we can look at them.
THE CHAIRMAN: Legal Assessor, is this evidence admissible considering the point of view that Ms Smith has made?
THE LEGAL ASSESSOR: I am very troubled about this witness going into detail on this topic. He is not being called as an expert on medical ethics. He is entitled to say what he might have done in a situation. As I understood it, his earlier answer, on which Mr Coonan justifies this line of questioning, is that he referred to looking up something on medical ethics. Whether he should have given that evidence is the first point. I remain in doubt, but nobody objected at the time. My advice is that at this stage it certainly should not be pursued, and if he is going to give detailed evidence, then there ought to have been a statement which all parties had seen, and myself should have seen, identifying any documentation on which he relied. Essentially this is now evidence in chief on a topic of which I had no notice, and other parties – including the General Medical Council itself – had no notice. My advice is, it should not be received in this way. Whether this witness is recalled, if you wish to pursue this, is another matter.
MR COONAN: Of course equally, nor did I have any notice of it. It emerged during the course of the evidence this afternoon. It having emerged, of course it now becomes a matter of some interest. Could I say that I am not seeking to ask the witness for an opinion. I am simply seeking evidence of the material that he looked at. Then I might be better informed of the matter when the topic is looked at next week. That is all I seek. If it can be provided to me, as it were, in the usual channels, I am content with that.
THE LEGAL ASSESSOR: Perhaps when this witness is released from his oath, which I imagine is going to happen, and I hope for his sake is going to happen fairly soon, and the rest of us for that matter, but he could then be asked what the material is, it could be obtained and the Secretariat can make it available then to all parties, I would hope, or those instructing Ms Smith.
MR COONAN: I would be very grateful if that could happen.
THE LEGAL ASSESSOR: Perhaps that could be done before the witness leaves.
THE CHAIRMAN: Ms Smith?
MS SMITH: Sir, the only thing I would add to that is, I am content with that course provided it is provided to us to have a look at before the Secretariat start handing it out to the Panel, because we may have objections to its relevance in any event.
THE LEGAL ASSESSOR: I did not mean the Panel to get it at this stage; I meant the parties.
THE CHAIRMAN: Thank you very much indeed for resolving that issue. Mr Coonan, anything further?
MR COONAN: Sir, no thank you very much. That is all I ask.
THE CHAIRMAN: Thank you. Mr Hopkins?
MR HOPKINS: No, thank you.
THE CHAIRMAN: Ms Smith, I think at that particular stage I just want to be absolutely sure whether you understood that that was only because of that page 504 when you introduced these three new pages. Is there anything else that you wish to take up in response to the Panel’s questioning?
MS SMITH: No, thank you very much, sir.
THE CHAIRMAN: Can I thank you most sincerely, Dr Berelowitz, for putting up with us over the course of the last two days. I can fully understand that it was not easy, and it could not have been easy, but nevertheless it is an important part of the work that we all have to do. On behalf of this Panel, I do thank you for coming and giving us the benefit of your evidence.
THE WITNESS: Thank you.
THE CHAIRMAN: Can I also now say that you are now released. As you have already heard, before you disappear from the building, do please see the Panel Secretary at the end, just in case there is something else needed at some future date.
THE WITNESS: Can I ask if we can do that quickly, please, because I have patients back in the hospital. They are from this morning.
THE CHAIRMAN: As far as I am concerned, I think we have nothing else to do, apart from saying that we will now adjourn and resume at 9.30 tomorrow morning. We are now adjourned and the Panel Secretary can see you straight away now.
(The witness withdrew)
(The Panel adjourned until Thursday 2 August 2007 at 9.30 a.m.)