GENERAL MEDICAL COUNCIL
FITNESS TO PRACTISE PANEL (MISCONDUCT)
Monday 6 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
PROFESSOR ARIE JEREMY ZUCKERMAN
Examined by MS SMITH, continued 1
Cross-examined by MR COONAN 2
Cross-examined by MR MILLER 22
Cross-examined by MR HOPKINS 36
Re-examined by MS SMITH 37
Questioned by The Panel 40
Further re-examined by MS SMITH 47
Further cross-examined by MR COONAN 47
Questioned by The Legal Assessor 48
RICHARD CHARLES HORTON, Affirmed
Examined by MS SMITH 49
THE CHAIRMAN: Good morning, everyone. Ms Smith, you had almost completed the examination-in-chief of Professor Zuckerman.
ARIE JEREMY ZUCKERMAN,
Examined by MS SMITH, continued
MS SMITH: I have got a couple of very short questions and then I shall be concluding my questioning of you. Could I ask you to turn back, so you orientate yourself in the evidence you were giving on Friday, in the chronological bundle FPT2, page 405. You recall this is the detailed letter that was ultimately sent to you when you sought advice from the BMA about the Legal Aid Board funding. If we look at the third paragraph, we read through this and we see that the main ethical questions are addressed. The BMA then say the approving committee should have a detailed protocol of what the research will involve, the manner in which participants are recruited if relevant, confidentiality, if litigation is envisaged, the quality of the informed patient consent, and then we see the words and the source and uses of funding. When you gave your evidence on Friday, you told us that it was essential that the Ethics Committee, that the Royal Free Ethics Committee, considered the source of funding and that the Ethics Committee were aware that, to say the least, that source of funding was unusual.
A Yes, indeed.
Q All I wanted to ask you arising out of that was as far as you were concerned whose duty was it to make sure that the Royal Free Ethics Committee were indeed aware of those matters relating to the funding.
A The applicants to the Ethics Committee.
Q Thank you very much. If you stay there you will be asked some further questions.
THE CHAIRMAN: I think I mentioned to you on a Friday morning that after Ms Smith’s questions the representatives of the three practitioners will have the opportunity to
cross-examine you. Mr Coonan, representing Professor Wakefield, will start.
Cross-examined by MR COONAN
MR COONAN: I am going to take you back to some of the ground you covered on Friday but I am going to do it in order to put some of the documents in chronological order because
- and this is not a criticism - some of the documents were taken out of chronological order on Friday and it is done to assist the Panel as to how part of this account emerged. I am talking here particularly about your concerns in relation to the Legal Aid Board funding.
Q Could we begin by looking at volume 1, page 237(b). I hope there is a copy in your bundle?
Q This is a letter which is dated 25 September 1996, a letter from Dr Wakefield to the assistant finance officer. In the body of the document Dr Wakefield says:
“We have recently been awarded a grant from the Legal Aid Board to fund research into measles virus and inflammatory bowel disease. This is a most unusual source of funding but one cannot complain. Please find enclosed a copy of a letter from the Legal Aid Board to the co-ordinating solicitors.”
There are other matters referred to in the letter but can we stand back for a minute. Did you ever see this letter?
Q There is clearly no doubt that certainly that part of the school, in other words the finance section, had been told by Dr Wakefield about the future funding of research into measles virus and IBD funding from the Legal Aid Board.
Q It looks from this that some material from the Legal Aid Board to the co-ordinating solicitors, which we now know to be Dawbarns, was disclosed by Dr Wakefield in September 1996.
A So it appears.
Q Do I take it from your evidence thus far that these matters were not brought to your attention by the finance department at the school?
A Not at the time, no.
Q If we then move on to page 245, keeping this strictly in chronological order, on the 11 October 1996 you write this letter to Dr Armstrong at the BMA which deals with what I am going to call, in global terms, Legal Aid Board matters. That is what you raise with Dr Armstrong you see in the second paragraph.
A Yes, in the broadest terms.
Q We will look at some of the detail in a minute. That was raised there. Can we look at the second paragraph. You there record that you clearly had become aware that Dr Wakefield was engaged in the research which is set out in that paragraph. You clearly were aware of that.
A Obviously, yes.
Q You had become aware by this stage that the Legal Aid Board had provided funding through a firm of solicitors representing Crohn’s disease sufferers. Where did you get that information from?
A As I recall it, I received it from the Department of Health and from Professor Sir David Hull.
Q When you say the Department of Health, any particular person at the Department of Health?
A I think it will be difficult for me to say that because, as you probably know, I have been an adviser to the Department of Health continuously for 38 years and, therefore, I had numerous contacts there. It could well have been either Dr Jeremy Metters or Dr Salisbury,
I am not sure who.
Q At any rate you had come to know, or at least come to know on the basis of what you were told, that the Legal Aid Board had provided funding and that “we” - I presume by that the school, is that fair, the reference to “We have been asked to make an appointment ...”?
A That refers to the Medical School, yes.
Q “... specifically to undertake a pilot study of selected patients.”
Q Who told you that patients were going to be, as you say, selected for the purposes of a pilot study?
A As far as I recall, this was from the documentation that Dr Wakefield sent me with the Legal Aid Board documents stating that ten patients were to be selected by Dawbarns Solicitors.
Q That correspondence comes later.
A I am sorry, it is ten years ago. I could not possibly confirm this or reject it now.
Q I, for my part, fully understand the constraints of looking back over ten years. No doubt it is going to affect everybody. We will look in a minute that the disclosure of documentation by Dr Wakefield comes later in 1997.
A That is quite possible.
Q When one sees you saying here that there was to be a pilot study of patients who were going to be selected, I am trying to understand where the source of that belief taking hold.
A I simply cannot answer this.
Q At any rate, that was your belief: there was to be a study funded by the Legal Aid Board which was going to feature selected patients.
A That was my belief and that was subsequently confirmed by the documentation.
Q We will look at that in a minute. Did you understand from that belief that those patients were going to be selected by the solicitors in question?
A I did not specify solicitors I do not think.
Q Not at that stage but that was your belief.
A No, patients were to be selected either by Dr Wakefield or somebody else or by the solicitors; I do not specify which.
Q The next sentence I want to have your assist about. “Clearly this could lead to a case against the government.” By government that is a reference to the Department of Health?
A Yes, obviously.
Q Was that, therefore, a cause of concern to you as the Dean of the Medical School that the resources of the Medical School might be utilised in an action against the government?
A Not necessarily. The reason this statement was made is because my colleagues have raised this with me and I felt that it was justified to get an opinion on that.
Q That would be, you would think no doubt, a clear conflict of interest in the sense of the Medical School being seen to fund, indirectly or directly, by utilising its resources an action against the government.
A Not necessarily. This was an issue that was raised with me and I was asked by my colleagues to raise this specifically with a body outside the Medical School, somebody that was independent of the Medical School. I do not think it raises a conflict of interest. As I indicated on Friday, and as I now see, even Dr Wakefield agreed this was a most unusual source of funding. It was a matter of concern. I decided to seek the advice of my senior colleagues. I then decided to seek independent advice. This is completely in the context of simply trying to get ethical issues straight.
Q In the second paragraph you say:
“My dilemma is that the Medical School might be seen to utilise its resources which are largely funded from the public purse to take sides in litigation before there has been a finding.”
Q There are two elements there: first of all, before there has been any scientific conclusion one way or the other, is that what you mean?
A No. I think the words I used on Friday in giving evidence this was a fishing exercise to try to see if you can proceed to litigation. I have already indicated, both in the letter and previously, that the research was flawed, was not confirmed elsewhere and fishing exercises is not the way one conducts medical research.
Q Your take on it, if I can use rather loose language, was that this appeared, at that stage, as a result of what your colleagues were telling you in the Department of Health that this was a fishing expedition?
A No, the word “fishing expedition” are my own words.
Q I am many using it back to you.
A No, I do not think I can blame the Department of Health that. You have to ask them that question.
Q At this stage all your belief is based on what you have been told by your colleagues at the Department of Health.
A That is simply distorting the facts. It is for some months that I have been questioning the problem that Dr Wakefield’s research was not confirmed by anyone else independently, indeed I do not think it was confirmed by Dr Wakefield. It has nothing to do with the Department of Health. You are distorting facts I am afraid to say.
Q I am basing my cross-examination thus far on two factors: one, that which you told the Panel this morning about the basis of your information; and, secondly, what is written in this letter where you highlight the role of the Medical School as against the government.
A With the greatest respect, this is your interpretation; it is not my interpretation.
Q At any rate, October 1996 I think we can agree was the first time the Medical School, certainly yourself now as opposed to the finance department at least, knew about the involvement of the Legal Aid Board.
A That is correct.
Q The action that you took, again following the chronology through, was to write to the BMA, as we see in that letter, but at that stage, as I understand it, you did not raise any of these matters with Dr Wakefield?
A I think you have to look at the chronology, if this is what you told me, that is correct.
I did raise the question with Dr Wakefield without question. I would like to stress to you again please - I stress it again - I went to the BMA in order to obtain completely unbiased independent advice from a body which was highly respected and is outside the Medical School and the hospital. That was the reason, to try to establish and obtain an independent opinion.
Q I am not disputing that at all. That was clearly a sensible thing to do. I am not disputing it. My question was whether you could confirm that at that stage you did not raise the matter with Dr Wakefield.
A I will have to be guided by the chronology as you outline it, which is one point. Secondly, I needed to discuss this with my finance officer before approaching Dr Wakefield.
Q Just to remark on this as we go through it, that letter to the BMA, as we can see, was not copied to Dr Wakefield.
A Certainly not.
Q The next stage was that the money, or at least the first amount of the money, was paid into the finance department. If we turn to page 338a, this is a photocopy of a letter of a cheque photocopied together. I do not know if you have seen this before but we can see that the cheque is a cheque made out, cut off at the top, to the Royal Free Hospital School of Medicine and drawn on the account of the solicitors.
Q That, as we will hear in due course, was paid into a suspense account at the school.
A It was paid into an account in the school. I do not know if this is a suspense account or not.
Q It is a description that has been used.
A The suspense account, the term, was used when I first questioned the use of this money which I said was not to be accepted by the school. At that stage it was called a suspense account. Dr Wakefield was consulted. He said return it to the solicitors. Why it was not returned to the solicitors I have no idea but it would have stopped the matter in its track right there and then. Subsequently it was referred to the special trustees of the hospital. If it had been returned to Dawbarns none of this would have materialised.
Q We will look at the steps before we get to the stage at which the money wanted to be returned but it was not at this stage that that happened. We will go through it. I entirely understand that there was a request for it to be returned but we will look at it in the chronology. The money arrived in December and obviously it was paid into, let us call it neutrally, an account of the school.
Q There the matter remained, may I suggest, unresolved until Professor Sir David Hull intervened in February 1997. If you would go now to page 367, in the unfolding chronology – let us just stand back for a moment – the matters raised with you in October with the BMA, no solution, the money has arrived, Professor Hull writes to you in the terms we looked at on Friday – I am not going to go through all that again, save to direct your and the Panel’s attention to the last paragraph on page 368 – and you respond to that letter in a letter dated 18 February 1997, which we see at page 369.
A May I yet again say that I am afraid this is out of context, because I already knew that there was money from the solicitors, because I wrote to the BMA well before I received Professor Hull’s letter.
Q We have looked at that. You wrote to the BMA in October 1996.
A And the reason for the delay of course was that the BMA was extremely slow in responding.
Q I understand. I am simply setting out the milestones. We now come to February and we see in the third paragraph of your letter to Professor Sir David Hull that you there in effect describe the fact that the money was held in a suspense account. So by that stage you have used the adjective “suspense account” for the location of the money.
Q You say again to him that you are seeking advice from the BMA on this unconventional offer of funding. Again, as a matter of fact, that letter was not copied to
Dr Wakefield, was it?
A No, it was not copied for Dr Wakefield.
Q But then on page 372, Mr Blatch attempted, no doubt on your instructions, to deal with this delay which had arisen. Is that fair?
A No, that is not.
Q Tell us the position.
A The reason I asked Mr Blatch to write to the BMA is because this was now an administrative matter on the conditions of appointment of a member of the staff. I do not deal with conditions of appointment; I only deal with actually senior academic appointments, and therefore I asked Mr Blatch to write to Dr Armstrong to explain the employment situation with regard to this offer of money. That is why this letter was sent by Mr Blatch. Otherwise I dealt entirely with the BMA on my own.
Q Whatever the reason, the BMA, we will see, did not respond substantively until some time later in March. We will look at that in a moment. Three days before that letter on page 372, there is a memo I would like you to look at on page 366. This appears to be a memo – it is cut off somewhat on my copy.
A I have never seen this. I need to read it.
Q Of course. It appears to be from the finance officer, Dave, to Mr Tarhan.
Q Do take a minute to read it. (Pause for reading)
Q You said you had not seen that before. If you look at the bottom left-hand corner, the last two lines – it may be cut off in some of our copies – is that your writing in the bottom left-hand corner?
A No, unless it is cut off. I have never seen this before.
Q Do you see some words which appear to read, “BAB will reconsider in view of political overtones”?
A I presume this is Mr Tarhan, not me. It is definitely not my writing. I never referred to Mr Blatch as BAB. In fact, I do not know what BAB stands for.
Q Can you help as to what political overtones might be referred to here?
A I do not see any political overtones. I see ethical issues, not political.
Q Let us deal with the first contact you had with Dr Wakefield. If you would leave bundle 1, please, and turn to bundle 2, page 393, we can see from this document two major points: first of all, it records the fact that you and Dr Wakefield had a telephone conversation during the course of which the subject matter of conflict of interest arose. We can see that from the third paragraph on page 393.
Q It records a telephone conversation. Secondly, it appears to represent the first contact which you had with Dr Wakefield on the question of conflict of interest and legal aid money and so forth, does it not?
Q You will see in the third paragraph that Dr Wakefield says:
“You mentioned a conflict of interest when we spoke. This is something which has exercised my mind greatly in the interim. I feel I must go on record as stating that I do not see how any conflict of interest exists.”
Just pausing there, on the face of it Dr Wakefield is referring to a conflict, a single conflict of interest, is he not?
A That is what he refers to, yes.
Q He is asserting that he rejects any conflict of interest existing.
A He does indeed.
Q In that telephone conversation – and I appreciate it is, as you rightly said, some ten, 11 years ago – I have to put to you that the only conflict of interest which you raised with him at that time in the telephone call was the potential conflict of interest between the role of the Medical School and the potential legal action against the government.
A Absolutely not. The conflict of interest arises because of potential vested interest in the outcome. That is where the conflict of interest arises. It has nothing to do with the Medical School.
Q As I suggest, he had thought about this and wrote to you in the terms of that letter which we see.
A That is Dr Wakefield’s opinion. It is not mine.
Q Then at page 397, you responded to that on 13 March 1997 and in the final paragraph of that, you take the matter, I suggest, to a slightly different level at this stage. You say:
“However, it is a different matter when lawyers fund a particular piece of research where a specific action is contemplated. This surely suggests that some preliminary legal discussions have taken place and that a specific action … ”
Presumably that is legal action –
“ … is contemplated. If so, then the interpretation must surely be that a conflict of interest may well exist.”
It is there, is it not, for the first time that you are raising the question of the involvement of lawyers?
A I am sorry. I know I do not have a legal mind and I do not quite see it this way. You omitted the first sentence in that paragraph, which I think is very important. The disagreement between Dr Wakefield and I relates to a duty of care to patients, which of course is the most important factor in medical practice, and the provision of independent expert medical advice to lawyers. That is entirely a different matter, where one discusses with lawyers a specific action which may lead to litigation and has nothing to do with expert evidence. I think it is extremely important that the Panel understands the difference between these two concepts. Many members of the profession provide expert evidence – I am not so sure that many of us will continue to do so in the light of recent events – but this is entirely different from when you are discussing with lawyers a specific piece of research in order to determine potential compensation, et cetera, et cetera. I just do not see it in the way that Dr Wakefield does. I think I am entitled to differ from his opinion.
Q You are. I am not suggesting otherwise.
Q But there is, as in many things, room for differences of opinion about this.
A Of course.
Q When you wrote the letter, as we see, on 13 March at page 397, the next day or in fact the same day, I think, if you turn the page to page 398, you write again to the BMA, who – and this is a matter of fact, Professor Zuckerman – have still not provided you with the definitive advice.
A Yes. Of course you are quite right. You will see from the fact that I had to write two different letters on the same day that an enormous amount of my time was expended with the Dr Wakefield issue.
Q You write on that day and we have looked at the content of that. That document – and this is not a criticism; it is just a fact – again was not copied to Dr Wakefield, was it?
A No, it marked “Private & Confidential” to the BMA. It must not be copied to Dr Wakefield. It was not copied to anybody.
Q I am just establishing in the fact.
A The facts are self-evident.
Q Then we come to Dr Wakefield’s response to your letter on page 401. What I am going to suggest is that the high point in terms of the correspondence between you and him in effect is in this letter, because there is no other letter and what he appears to be saying first of all is, here is documentation relating to this matter involving the Legal Aid Board.
Q Then he goes on to say in the fifth line relating to the conditions for making the award, that is, the Legal Aid Board award:
“These conditions were based upon the enclosed protocol which has been approved by the Ethics Committee of the Royal Free Hospital.”
“I got the impression from Roy …”
That is, Roy Pounder –
“ … that you were concerned that we were being contracted to provide a specific answer – that is, that measles vaccine or the MMR vaccine was the cause of this disease. That is absolutely not the case.”
A I am sorry, may I indicate that this is an impression by a third party. It was not my impression. It is the impression of Professor Pounder.
Q At any rate, I am highlighting what Dr Wakefield’s response is to these matters.
“We are being funded to conduct a piece of scientific research to establish or refute the link between MMR vaccine and the disease. There are absolutely no preconditions concerning the outcome. If this were the case” my emphasis “you may rest assured I would never have been involved in the first instance. The science must lead and everything else follows. As with medical experts opinion elsewhere, I am being asked to provide my opinion, whether that opinion is positive or negative. It is on this basis, and only on this basis, that I have agreed to assist in this matter”.
As I say, that was the high point of his response to the whole of these issues that had been raised by you with him, was it not?
A I am not sure that I would agree that this is a high point. This is a way in which Dr Wakefield was trying to justify something that he knew perfectly well was unconventional and unusual. So, I do not consider it a high point at all.
Q It is probably a rather lawyer’s expression in effect meaning that that was as far as the correspondence and conversations were taken; they stopped at that stage.
A I am sorry, as you say, it is a legal …
Q They stop at that stage, do they not?
A Hardly! It was pursued with the ethics committee of the Royal Free.
Q Professor, it stopped with Dr Wakefield at that stage. There is not a single document from you to him thereafter.
A That is quite possible, I do not know. I am sure that the discussions did not stop there.
Q Having received his letter, in the meantime, as we have seen, you had written to the BMA on page 398 and they did not respond until 26 March 1997 which we can see at page 405.
Q There are two documents, if we can look at it for a minute, which you were not taken to by Ms Smith on Friday and let us look at it together, if we may. It is on page 406 at the top. Perhaps I could pick it up at the bottom of page 405,
“Your letter of 13th March mentions that WHO and the DoH are of the view that there is no confirmed evidence of linkage between immunisation and inflammatory bowel disease and that the epidemiological data purporting to support linkage are flawed. If this view is considered to be totally convincing, then serious ethical issues arise about the possibility of undertaking a futile research project simply because it is funded by an outside body, especially since research would raise expectations for a group of patients who hope that it will assist them obtain redress. Presumably, however, there is sufficient doubt to lead the researcher to be willing to undertake the project and for the Legal Aid Board to fund it. In which case, there is also a strong public interest argument in establishing the truth and, above all, in protecting future patients.
The Legal Aid Board is a publicly funded body which normally pays for eligible individuals to have expert advice as to whether potential litigation has any chance of success. It funds research on relevant issues in law and through the process of judicial review is frequently involved in using public money essentially to sue other government departments. It seems logical that the Board might similarly pay for what is basically expert advice on behalf of a group of patients who all have the same condition. Independently conducted research may establish whether or not they have a case in law and this is no different morally from commissioning a medical expert to provide a view. In this case, arguably a greater drain could be made on the public purse if the Board were separately to fund eligible individuals to have their cases investigated in the absence of any recent or conclusive research findings.”
Pausing there, the BMA were there addressing, if you like, the unconventional source of funding which had exercised you – I am not criticising you for that but it had clearly exercised you – and they are therefore saying that, from their standpoint, there appears to be little, if anything, wrong with it, are they not?
A Yes, except that you read but rather overlooked the fact that the statement, “If there is sufficient doubt to lead the researcher …” There was sufficient doubt in one person only, Dr Wakefield. No one else. Not the WHO, not the Department of Health, not the Centres for Disease Control, not the Institute of Medicine of the United States, not the New York Academy of Medical Sciences, not any of the Royal Colleges. No one except Dr Wakefield had doubts about it. How he managed to convince the Legal Aid Board or the solicitors I know not, but I think the crucial element there is, “if there is doubt in the researcher’s mind”, but the BMA clearly knows that the Department of Health, the World Health Organisation and numerous other international bodies have no doubt about it. The research was flawed.
Q Who is right and who is wrong is not the issue we are debating. We are dealing with whether or not the Legal Aid Board on the basis of a set of facts, whether proved or otherwise, would justify the provision of Legal Aid Board money to the investigation on leading counsel’s advice to fund a particular research project. That is the issue.
A Well, it is and it is not. The fact remains that Dr Wakefield and I and others agree that this was an unconventional/unusual source of funding. There is no question about that. What the Legal Aid Board does in terms of legal requirements is a matter for the Legal Aid Board and I am sure that I need not draw your attention, which is of course in the event subsequent to this, that the Legal Aid Board, on the appeal before the High Court, admitted that this was the first time they had ever funded a piece of research and that, in retrospect, they should not have done so.
Q Professor Zuckerman, are you arguing a case here?
A I am not arguing any case, I am trying to respond to your question.
Q Let me put this to you very seriously: are you arguing a case? You have leapt years down the line to focus on matters which are not relevant to the issue being dealt with in March 1997. I ask you again, are you here to argue a case?
A I am not here to argue any case. I am here to provide evidence before a panel and I should draw your attention to the fact that it is fairly painful for a Dean of a Medical School to be present here to give evidence in a case involving three former senior members of my academic staff. It is not particularly pleasant, I do not particularly enjoy it and I do not particularly like the way in which you are approaching this issue, if I may say so with due respect.
Q Let us move on.
A Thank you.
Q The next stage from page 405 is that you made contact with Dr Pegg.
Q There are four documents and I am going to collect them together. At page 413, there is a letter to him on 2 April 1997; at page 423 is his reply; your reply to him is at page 425; and finally, Dr Pegg to you on page 428.
A Am I to place my fingers in all these documents?
Q Yes. I am sorry, I am taking this arguably too fast. There are four documents.
Q They arise in the month of April 1997.
Q You have been taken to those and I am not going to go into the detail of them but again, just as a matter of fact, can you confirm that you did not copy this correspondence to Dr Wakefield.
A I did not copy to Dr Wakefield.
Q It was only after that in terms of time that Dr Wakefield indicated that he was unhappy with the fact that the School had not formally accepted the funding from the Legal Aid Board. If you would look at page 470 …
A Am I still to keep the other pages …?
Q No, it is all right, you can move on to page 470 and now we are in May 1997 and it is at that stage that we see Dr Wakefield’s unhappiness recorded and [he] asks that the money be returned to solicitors. At the bottom of the page, is that your writing?
A It is my writing, yes.
Q It looks as if therefore that a scheme or arrangement was entered into whereby the money was then to be transferred to the special trustees at the hospital.
A Well, to put this in context, I met with Mr Tarhan to discuss this and he informed me that this was transferred to the special trustees. He told me that they were aware of the situation and I also made a note that although Mr Tarhan was very concerned about the overspend by Dr Wakefield, I noted that but I also made an issue of whether to discuss it with Mr Else. The fact that it was transferred to the special trustee was not known to me until my attention was drawn to this by the finance officer, Mr Tarhan.
Q We will hear in due course that the money was actually transferred in August 1997, I think.
A I do not know when it was transferred.
Q I would like to move on to something wholly separate and I want to deal with this, if I may say to you straightaway, without getting involved into the details of the competing claims for the science. On Friday, you mentioned that Dr Wakefield had refused to send biopsies for independent confirmation
A That is correct.
Q I want to try and understand the context in which you are saying this first of all. Are you saying that that was in 1996 or 1997? When was it?
A It is documented somewhere. I am not sure exactly when it was but I had a discussion with … In fact, I can place it directly to July 1998 because that was a time when I had a very lengthy and productive discussion with Professor Walker-Smith. I told him that I was very, very much concerned that biopsies were not being sent for independent evaluation by an independent expert laboratory. This is a matter that exercised my mind for some time. I am pretty sure that I discussed this with Dr Wakefield and I am pretty sure that I discussed this with Dr Pounder. The reason why I recall this so vividly is because Professor Walker-Smith said to me that he cannot tell Dr Wakefield what to do with the biopsies and I then quoted to him – and I remember this very, very clearly – a legal case where placentas were sold by a hospital to a commercial company in order to extract immunoglobulin which is used for passive immunisation. The legal issue then arose as to whether the hospital could actually sell placentas because to whom did the placentas belong? Did they belong to the patient or did they belong to the hospital? The issue is very important and very relevant because I believe that the judgment was that if you give the placentas to the mothers, the mothers did not want to take them and therefore the actual material belonged not to the hospital but to the clinician and therefore I told Professor Walker-Smith, “I believe that, since these are your patients, it is up to you to instruct Dr Wakefield to send these biopsies”.
I was not the first one to raise this issue because you will recall no doubt that it was an issue that was raised by the MRC expert committee in March 1998, so this was nothing new. In all conventional medical research, one seeks independent confirmation. When the research is of such importance and of such implications to the public health, it is critical that independent confirmation is obtained as soon as possible and I have no doubt in my mind at all, even if it is not recorded in this voluminous correspondence with Dr Wakefield and Dr Pounder, that he was asked repeatedly by me to send this material for independent confirmation either by Dr Bellini or the National Institute for Biological Standards and Control and indeed I had a conversation with Dr Phil Minor of the National Institute for Biological Standards and Control whether he would be willing to examine the material under code and he said that he would. He subsequently wrote to the clinicians asking them for the material but none was forthcoming. I also recall very clearly that I instructed, not asked I instructed, Dr Wakefield to send his material to Dr Bill Bellini of the CDC for independent confirmation. He said that he would do so but he never did because Dr Bellini wrote to me asking why this material was not sent to him.
Q Professor Zuckerman, these matters about which you are talking of course took place after the press conference and after the publication ----
A Oh no, no, no, no, no.
Q You said 1998.
A The events where I described the conversation with Professor Walker-Smith was in 1998, the MRC was in 1998 but that research group was asked to send material for confirmation to Dr Bellini and the National Institute for Biological Standards and Control much earlier than that. As soon as no one was able to confirm the research relating to Crohn’s disease, never mind MMR, I asked them to send it for independent confirmation.
Q Again, I am not going to get involved, deliberately, in the competing claims and counterclaims about the efficacy of the science, but what I do have to suggest to you is that, insofar as there were requests to send samples for confirmation in respect of the Crohn’s disease group, confirmation was sought and was obtained.
A To my knowledge and the knowledge of the World Health Organisation and the knowledge of the Department of Health and the various other international bodies that I mentioned, no such independent confirmation was obtained.
Q It may boil down to an argument about the strength or otherwise of the confirmation but I am going to suggest to you that that was sought and was obtained and is the subject matter of publication.
A I am afraid to disagree with you yet again.
MS SMITH: If Mr Coonan is going that far then he must indicate where the confirmation was from and where it was published so Professor Zuckerman knows what he is trying to answer.
MR COONAN: In respect of the Crohn’s disease, that was published by Miamoto in 1995 in the Journal of Gastroenterology and the epidemiology was the subject matter of a paper by Ekbom in 1996.
A I am afraid that all the international experts found that this was flawed research, was not confirmatory in any way and have stated so; indeed, it is documented that they have stated so. If we are going to go into the technical issues, I would like to see the papers. I would draw your attention that I normally see between 50 and 100 original articles almost every week. Do not expect me to remember Miamoto or any other name from Japan or the United States without having the actual publication in front of me. I consider it is unfair.
Q I did preface it by saying that I was not going to embark on an argument about the competing claims for the science. I am simply dealing with the point you were making that Professor Wakefield had refused.
A Dr Wakefield.
Q Dr Wakefield had refused to have his work the subject of confirmatory exercising. I have to suggest to you that although there may have been delay on dealing with this topic, and delay for reasons which he will explain, the fact is it was put out for confirmation and confirmation came back. You can debate the efficacy or otherwise of that but the point I am suggesting is that it was put out for confirmation?
A I think Dr Wakefield will have to answer that. The fact as known to me was the material was not sent to an expert independent laboratory for confirmation at the time that I instructed this to be done.
Q To complete the picture, I do not dispute that the issue of seeking confirmation was raised in respect of the irritable bowel disease autism group but although there was delay and a reluctance by Dr Wakefield to engage with Dr Minor, eventually the matter was put out for replication and was the subject matter of publication. I am not asking you to look at the detail, I just want this as a matter laid on the table, by Gonzales in 2006 and O’Leary in Dublin.
A Right, I am glad that you raised it. I do not know who Gonzales is and I cannot remember in but I am glad you have raised the question of Professor O’Leary because there lies an extremely, extremely important issue, namely that expert virologists - I recognise that Dr Wakefield does not approve of the term expert virologist - questioned O’Leary’s work. In the United Kingdom, the United States and many European countries, and probably throughout the world, there is a system which is known as quality assurance where laboratories exchange material in order to test and examine the specificity, the reproducibility and the accuracy of the conduct of several tests. Such international groups are common. They are often set up by the World Health Organisation and, in this case, an international collaborative study between laboratories was set up in order to examine the methods used by Professor O’Leary and compare them with other established techniques. Professor O’Leary refused to take part in that evaluation. That does raise a lot of questions. I do not know the reason. The only way I found out is because this was published in the Journal of Medical Virology of which I am editor-in-chief.
Q For my purposes the issue is quite simple.
A I wish it was.
Q I said for my purposes and the question that I am addressing was the fact that you gave the Panel the impression on Friday that Dr Wakefield was implacably opposed to having his material made the subject of confirmatory examination. All I am suggesting to you --
A I am sorry, I did not use implacably opposed. I said I he refused. You are using words which I did not use and it is an entirely different connotation.
Q All I am suggesting to you is that although there may have been delay, although there may have been arguments about where this replication attempt should be made, the fact is that it was made the subject of a replication exercise in Dublin and elsewhere, simple as that.
A It is not as simple as that. I am sorry. It is far from being simple. It is for the Panel to establish the reasons for the delay and to which laboratory these samples were sent. If I interpret what you are saying correctly, the samples were sent in about the year 2000, which is a year after I retired from the school, to Professor O’Leary. As I mentioned, I think that Dr Wakefield and Professor O’Leary have to justify their findings before the Panel. I do not have to do that. I was not involved in this. I really do wish, as I say with the greatest respect, that you do not try to either put words in my mouth or distort what I was saying. During my tenure as Dean to my certain knowledge, and I repeat it, to my certain knowledge, Dr Wakefield did not wish, as late as July 1998 - which I am sure Professor Walker-Smith will testify we had this discussion - to send biopsies for independent confirmation although this was requested as a matter of urgency both by me as Dean of the Medical School and by far more important people than me, the MRC Expert Committee which met in March 1998. What Dr Wakefield did subsequently does not concern me, it concerns the Panel. They will hear the evidence and judge it accordingly. I think it is unfair that you are taking me through a stage where I was no longer involved, although you will appreciate that since my retirement I have been sucked back again into this controversy.
Q Let us move on to ask you some more questions about the press conference or, as you would like to call it, the press briefing.
A It is not necessarily what I would like to call it; it is a press briefing. No doubt you will have noticed just the other day, in the context of the foot and mouth disease, the Chief Veterinary Officer did not refer to her meeting with the press as a press conference but she used the word press briefing. There is a very clear distinction between the two.
Q It may be that others may not share your fine distinction that you seek to make.
Q There had been something of a track record of holding press conferences or press briefings at the Royal Free. There had been one following the publication of the paper by Dr Wakefield in 1995.
A That is correct.
Q That was following the publication of a paper involving Crohn’s disease.
A That is correct.
Q That appeared to be a successful model and obviously was thought to reflect well on the school.
A I am sorry, no. It did not reflect well on the school at all because the result of that press conference was an almost dramatic fall in immunisation against measles because, once again, the measles vaccine was blamed for this. The press, of course, found this a very exciting story. It was not a model of a press briefing and we had cause to regret that it took the turn of event. During that briefing I indicated very, very strongly yet again that immunisation against measles is absolutely vital. It saves lives. Measles is the eighth most common cause of death in children worldwide. 1 million children die from measles every year. It was not a model press briefing; it was a disaster.
Q I am talking about the 1995.
A I am talking about the 1995.
Q If that was so bad in your eyes, why did you allow the one in 1998 to go ahead?
A It is not a question of me allowing. There is a media group which is shared between the hospital and the Medical School. I, as the Dean of the Medical School, simply chaired that committee. What was agreed by the media group was that the changes in the bowels of children with autism, the pathological changes, were important significant new findings. I, with the rest of the media group, agreed that this should be subject to a press briefing for two reasons: we were aware that The Lancet were going to issue a press statement; and, secondly, we felt that it was important that these pathological changes, and no more than those pathological changes, be presented at a press briefing to make sure that they understood the significance of the pathological changes, nothing to do with measles vaccines.
Q I want to suggest to you two things: first of all, that you were keen to have a press briefing in 1998.
Q Because of the history of the previous one.
Q Because you thought it would reflect well, that is to say the findings in the 1998 Lancet would reflect well on the Medical School.
A With the greatest respect, the answer to all these statements are categorically no. My position was to defend the Medical School’s reputation on flawed research. Every time I went to Geneva to the World Health Organisation I was challenged why was the Medical School, and I in particular as the Dean, as the director of the one of the laboratories, did not challenge and stop this particular publicity which was damaging the reputation of the school. It certainly was not enhancing the reputation of the Medical School as you allege, it is the reverse. It was extremely damaging to the Medical School.
Q I am sorry to have to suggest this but your recollection and reconstruction of this is inadequate and inaccurate.
A I absolutely reject this. I resent the statement. I really do resent this. Mr Chairman, I absolutely object and reject this.
THE CHAIRMAN: Can you please let counsel ask the question first before you answer.
A He is not asking me questions; he is making statements on my behalf.
Q You will have the opportunity to answer that in either yes or no and in as many strong words as you wish to but Mr Coonan has to complete the question first before you answer.
A I am sorry, but I am not being asked questions. Mr Coonan is making statements on my behalf and I object to this. If this continues in this vein I have to ask you to release me so I can get my own legal advice to come and represent me. I just find this is not correct.
Q It is not up to me to advise you what you should and should not do but definitely what is within my remit is to ensure that the proceedings go according to the rules. I think the process is that if the counsel actually makes a statement, he is entitled to make a statement, and you can then stay that you do not agree with that statement.
A Which I have done.
Q But I think the only thing is Mr Coonan, as the representative of Dr Wakefield, has to complete his statement before we actually hear your answer.
MS SMITH: I do not think I can add a great deal to the dispute. With the greatest respect, I do not think Mr Coonan is entitled to make statements when he is cross-examining somebody. It might be helpful if rather than prefacing his questions with observations, which is not really part of his job, he could put the question before the observation at least. I see it is quarter to eleven and Professor Zuckerman has been a long time in the witness box and I wonder if we could have a break and a cup of coffee before we proceed.
THE CHAIRMAN: That was certainly my intention at this stage to break for the mid-morning break. Can I say that I do not think it was the statement coming as a statement; it was a suggestion being put. I have seen these suggestions being put to the witness and the witness has an opportunity to answer, whether he agrees with those suggestions or not. I have seen that from the prosecution and the defence on many occasions. We will call it a break here.
Professor Zuckerman, I have to remind you that you are still under oath and still in the middle of giving your evidence so please do not discuss this case with anyone. I am sure someone will look after you for a cup of coffee and hopefully the temperature will cool down after the mid-morning break. We will resume at 11.05 am.
(Short break at 10.50 am until 11.05 am)
THE CHAIRMAN: Yes, Mr Coonan?
MR COONAN: Professor Zuckerman, I want to go back, please, to the preparations for the press briefing. When you were being asked about these matters by Field Fisher Waterhouse in September of last year, you told them that you did not know that Dr Wakefield would suggest the use of monovalent vaccines in place of the MMR vaccine.
A That is correct.
Q That is correct, is it? You did not know that?
A I knew that he held that view. I knew that the press briefing was to be restricted to the pathological changes in the gut. The issue of vaccines was not relevant. I was reassured on this by Professor Pounder, I was reassured on this by Dr Wakefield, I was reassured by the letter that Professor Pounder wrote to the Chief Medical Officer on 15 January, assuring him that the press briefing would be restricted to pathological changes and therefore the issue of monovalent, polyvalent or any other vaccines was not an issue to be discussed at the press briefing, merely the pathological changes.
Q Can we just try and break this down, please, and try and get a clearer understanding of the position? Let us look first of all in volume 2 at page 647.
A I do not have that.
Q I will come back to that document, Professor Zuckerman. You have mentioned Professor Pounder’s letter and it is dated 16 January 1998.
A I think it is either the 15th or 16th. I cannot quite remember.
Q You were the chairman of the media centre committee.
A That is correct.
Q There was prepared, was there not, what was called a video news release?
A I think that the issue of a video was discussed certainly and there is no question that I agreed to it. What did surprise me, when I ultimately saw the video after the press briefing, was that it was not prepared by the Medical School, as is the customary way – in fact, we have an excellent medical illustration unit which always produced our videos – but it was produced by the hospital through a commercial company and I knew nothing about it at all.
Q Are you saying you did not know about the content of the video news release before the press conference?
A No. As I say, I knew that there was going to be one after the press briefing and secondly, I also saw captions that were to be used, but I assumed, quite wrongly, that this was to be produced by the medical illustration unit of the Medical School. Having seen the subheadings – and I amended some of them – the press officer from the hospital wrote to me to say that this did not mean that these were going to be the ultimate subheadings, because the wordings may well be changed. To my horror, in fact the wordings were changed when I saw the video after the press briefing and I instructed Mrs Hutchison not to release the video because it did not reflect either the contents of the press briefing nor did it reflect the contents of The Lancet paper, but she unfortunately told me that the actual video had been released before the press briefing, which surprised me.
Q Let us just take stock. I am not for present purposes concerned with who produced it.
A But I am.
Q I appreciate you might be. With respect, I am just asking the questions. If you need to mention other matters, they can be dealt with in cross-examination. Do you follow? That is the process we have. I am just seeking to establish the extent to which you were aware of the content of the video news release before the press briefing.
A I was aware of the subheadings, not the contents. Also, I was told that these were subject to alteration.
Q Were you sent the script of the video news release before the press briefing?
Q I am going to ask you to look at a document, please. Could this be distributed? It is from the unused material. The prosecution has seen this document already.
THE LEGAL ASSESSOR: There seems to be no problem about this going in and being inserted into the bundle as a defence document from Dr Wakefield.
MR COONAN: It is page 674C and goes into bundle 2. (To the witness) Do you have that?
A Yes. That was precisely the paper I was referring to.
Q This is dated 28 January 1998. I assume the stamp is in your writing.
A It is.
Q I have asked you to look at this because when I asked you whether you had seen a copy of the script of the video news release, you said you had not.
A I still say so. The word “script” is in inverted commas and then the following sentence is “captions”, which I said I saw.
Q Did one of the contents of the material which you were shown have Dr Wakefield, in accordance with the script, saying that the monovalent, the single vaccine, to be safer than the polyvalent vaccine?
A I do not see it here.
Q In the accompanying document.
A Are you asking me to remember what happened ten years ago?
Q Professor Zuckerman, can you just help? If it is the case that you cannot remember, just say so.
A If you produce the document, I will tell you whether I have seen it or not.
Q I just want to ask you this. Can you remember, before the press briefing, being aware of Dr Wakefield’s position on the debate between poly and monovalent?
A Yes, indeed, I was and I have already said so. Let me just qualify this. It was an exchange of correspondence between Dr Wakefield and I where he wrote to me, assuring me that he had confidence in polyvalent vaccines.
Q I am going to ask you to look at that correspondence, since you have raised it. I am going to ask for two documents to be distributed, please.
MS SMITH: Can I just say one thing? These are long letters. It is correct I think in respect of both of them that they have come from the unused material, so that we have seen them before, but Professor Zuckerman needs time to read these letters properly and consider them, not just have them banged in front of him after 11 years and be expected to answer questions on them.
MR COONAN: I have to say, that is a really ill-judged comment. I was going to invite Professor Zuckerman to have as much time as he needs to read the documents. Everybody is having to labour under the burden of 11 years ago. There was going to be no unfairness at all to Professor Zuckerman. He has just raised the point and here are the documents.
THE CHAIRMAN: Indeed. I think it is reasonable for Professor Zuckerman to be given the document and be able to read it before he can respond to any questions on the document.
MS SMITH: I think it is unfair that he be asked to do it under pressure, with the entire room waiting for him while he reads them. It seems to me to be a very odd use of time, if I may respectfully say so, when we have been back from a break for at most ten minutes.
THE CHAIRMAN: Can I suggest that we ask Professor Zuckerman what he would like to do, rather than we making a judgment on that particular issue?
THE LEGAL ASSESSOR: Can I suggest he be given the document first, so he can make a reasoned assessment?
THE CHAIRMAN: At the same time, I think we will need to be circulated with the document as well. (Same distributed) Professor Zuckerman, I do not want you to feel under any kind of pressure. If you wish to have a five or ten minute break, that is fine.
THE WITNESS: I am not trying to impose more time restrictions on the Panel. I am quite happy to have a few minutes to glance at this. I am aware of my reply, but I just need to see this letter, which was not in my file.
THE CHAIRMAN: That is absolutely fine. Take as much time as you need.
MS SMITH: Can I just make the position clear as far as we are concerned, because I said something which is incorrect. In fact, one of these letters, the one date stamped 15 January, has never been seen by us before and Mr Coonnan produced it just now.
MR COONAN: The letter dated 15 January should go into bundle 2, pages 646A to C, the letter dated 22 January, pages 674A-B.
THE WITNESS: I have read the letter now.
THE CHAIRMAN: Are you happy to respond to questions on these documents?
MR COONAN: Professor Zuckerman, can we just establish how they are connected? First of all, the letter of 15 January 1998 is addressed to Professor Walker-Smith and it is signed by Dr Wakefield. If you look at the third page, that letter is copied, amongst other people, to yourself.
A That is correct.
Q The second letter, dated 22 January 1998, is signed by you and is addressed directly to Dr Wakefield and, as we see in the first line:
“You kindly sent me a copy of your letter of 15th January 1998 addressed to your senior colleagues … ”
Clearly this document is a reply to the first document which we have just been looking at.
A That is correct.
Q We can see in that second document that your reply to Dr Wakefield was copied to Professor Pounder, Professor Revell, Professor Walker-Smith and Dr Berelowitz.
Q The correspondence in effect reflects, does it not – these are my words; you may disagree with them and please feel free to do so – the polarisation of view which had emerged by that stage? Is that fair? I am just seeking a form of words to summarise the two positions which we see in these two documents.
A It is stating Dr Wakefield’s position, yes. Absolutely.
Q In relation to the fourth paragraph in the letter to Professor Walker-Smith which was copied to you, you see the beginning of the paragraph. It says this:
“In view of this, if … ”
My emphasis –
“ … my opinion is sought, I cannot support the continued use of the polyvalent MMFR vaccine. I have no doubt of the value of the continued use of the monovalent vaccines, and will continue to support their use until the case has been proven one way or another of the measles link to chronic inflammatory bowel disease.”
In the course of your evidence a few minutes ago, before you took a few minutes to read the correspondence, I think you told the Panel that Dr Wakefield had assured you that he had confidence in the polyvalent vaccine. In fact, he did not, did he?
A So it appears, but from the conversations I had with Dr Wakefield, he assured me on three points: that polyvalent vaccines are useful, that his views on monovalent vaccines, which were well-known and discussed with the press in 1997, never mind 1998, were well-known and he assured me that the issue of vaccines will not be discussed at the press briefing.
Q Professor Zuckerman, I have to suggest to you that that was not an assurance that he gave you in January 1998, because that is the very opposite of what that fourth paragraph is saying, is it not?
“… if my opinion is sought, I cannot support the continued use of the polyvalent vaccine.”
A I think that you should address this question of whether he discussed this with me to Dr Wakefield, who will have to answer it under oath.
Q I am just going to suggest, and content myself with suggesting for present purposes, that your recollection is at fault.
A I have to disagree with your suggestion.
Q At any rate, knowing what was in, at the very least, this letter and knowing what was in the Professor Pounder correspondence which you had referred to, the correspondence with the Chief Medical Officer ---
A No, no. I did not see that letter. The letter I saw was where he was talking about monovalent vaccines. I only saw the internet more recently. I had no knowledge of that letter. I was referring to the letter that he wrote to the Chief Medical Officer, assuring the Chief Medical Officer that nothing would be discussed other than pathological changes. That letter is on file somewhere.
Q This is a letter from Professor Pounder to ---
A The Chief Medical Officer. The second letter I did not see until I saw it on Mr Deer’s internet site.
Q We will leave that to one side, because I am concerned with your state of mind at the time.
A My state of mind?
A Good heavens. I find this quite offensive. What are you implying?
THE CHAIRMAN: This is actually a legal term. “State of mind” means as was within your knowledge at that particular time.
THE WITNESS: I accept that. I am not a lawyer, but I find this rather strange.
THE CHAIRMAN: It is a commonly used legal term.
THE WITNESS: I am grateful to you for that clarification.
MR COONAN: The fact is that knowing what you did from this correspondence, from this exchange of letters between Dr Wakefield to Professor Walker-Smith and your reply, you did not stop the press conference.
A No, I did not. I should have done but I was assured that this would not arise. So, there we are.
Q At the press conference, I am going to suggest to you that, at some stage, a particular journalist raised the question – and this is a summary, not a verbatim account – of what parents should do in relation to MMR and you directed the journalist to Dr Wakefield for an answer.
A I directed the question to Dr Wakefield for an answer, yes.
Q After Dr Wakefield gave his answer, you explained to the journalists gathered there the basis of Dr Wakefield’s theory, namely by which the immune system is challenged by the combination of three vaccines. That was his theory.
A What I recall happened is as follows. The question was asked. I certainly directed the question to Dr Wakefield for an answer. When he gave his answer, which I did not expect … The reason why I directed his question – and let me illustrate to you my state of mind at the time – was as follows. Single measles vaccines were not available in the United Kingdom, were not used in the United Kingdom, and were not used in any of the western countries, the United States or Canada. I knew that Dr Wakefield had a young family. It therefore was inevitable that they were protected with MMR and the expectation was that he would say, “Yes, I used the MMR to vaccinate my children”. When he replied in the way that he did, I immediately directed the question to Dr Simon Murch, who was the paediatrician, who rejected that completely and said that he had full confidence in MMR, which I did as well. That is the position. Unless you show me the video, I really cannot remember word for word what happened, but that was the state of mind, to use your term, behind this.
Q Professor Zuckerman, I am not expecting you to remember exactly word for word what happened during the press conference, but I just wanted to explore with you, when you say that you were wholly surprised to hear Dr Wakefield say what he did, how accurate that is. I am suggesting to you that you knew well in advance that this is what he was going to say.
A I am suggesting to you that you are wrong and that you are once again trying to question my integrity which I resent very much.
Q I am simply questioning your recollection.
A I have given you my answer.
MR COONAN: Thank you very much for your patience, Professor Zuckerman.
THE CHAIRMAN: Professor Zuckerman, Mr Miller will be asking you questions now on behalf of Professor Walker-Smith. Mr Miller?
Cross-examined by MR MILLER
Q Professor, I will come back to the press meeting at the end of dealing with this. Professor Walker-Smith was not at the press meeting, was he?
A No, he was not.
Q I do not think we are going to have any problems about your integrity or questions about your integrity.
A Thank you; I am relieved.
Q I will put one final document to you which I think you also received but, as I say, we will come to that in due course. Again, you may be relieved to know that it is not any part of my case on behalf of Professor Walker-Smith to argue the case of reproducibility of virology results. That is clearly not Professor Walker-Smith’s area of expertise.
A Of course not.
Q However, I can confirm that you did indeed have, as you described it, a lengthy and productive discussion with him in July 1998, I think it was, in which Professor Walker-Smith said that he could tell Dr Wakefield what to do with the biopsies.
A That is correct.
Q And you had a discussion about that. What I would like to begin with is history and context and I think that probably you are the best person to deal with this because the Panel as yet has not heard very much about the setup at the Royal Free and you are in, I think, the best position to put the history and context in order that we can see what we are dealing with. What I would like you to look at first is a letter written to you by Professor Fine in 1995 which is in bundle 1 at page 87. Again, let me assure you that I am not asking you to argue the merits of what was being suggested here, but this was a letter which was written by Professor Fine who was the ultimate head of Dr Wakefield’s department of the joined university schools and we can see from the first line that he was wishing to propose the promotion of Dr Wakefield to Reader in Gastroenterology.
A That is correct.
Q After that first line, what he is doing is setting out the case which he says supports that promotion.
Q We can see in the first of the main paragraphs on page 87, Professor Fine says that Dr Wakefield’s work has focused on three main areas and we see at “1. Crohn’s disease” and, on the next page “2. Ulcerative colitis” and “3. Nonsteroidal anti-inflammatory drug enteropathy”; do you see that?
Q Historically, that was true, was it not? For many years, Dr Wakefield had been involved in those areas, some of which involved working with Dr, then Professor, Pounder.
A That is correct.
Q So, well before we get to Professor Walker-Smith’s involvement, there had been research about a suggested link between measles and Crohn’s disease.
A That is correct.
Q I think you touched on this, that that in itself had produced considerable controversy.
Q And the first press briefing which you mentioned related to that research, did it not?
A That is correct.
Q Dr Wakefield had, according to the letter written by Professor Fine, formed – and this is at the top of page 88 and you can see it italicised about six or seven lines down –
“He formed the Inflammatory Bowel Disease Study Group of which he was founder and chairman. The group has worked together extremely effectively over the last five years”
and we are talking about a letter written in October 1995. It is correct that what was called the inflammatory bowel disease study group had been set up?
Q And that quite a lot of the correspondence we have seen shows Dr Wakefield as the director of that group.
Q When we talk about the “research group” and sometimes we see references to “Dr Wakefield’s group”, it is a reference to that entity, is it not, the inflammatory bowel disease study group?
A That is correct.
Q Which had been in existence for four or five years before Professor Walker-Smith came to the hospital or the Medical School.
A That is correct.
Q That group was under the general umbrella of the academic department of medicine.
Q And it was a separate department from what was to become the paediatric gastroenterology department.
A Indeed. They are entirely separate departments. Incidentally, the inflammatory bowel disease group was within the department of medicine, it was not a separate department.
A There was the academic department of medicine and Professor Walker-Smith’s newly established department which was entirely separate.
Q You have made the point ahead of me that the inflammatory bowel disease study group was in existence and had been for a number of years.
Q And a great deal of work had been done within the group before the transfer to the Royal Free of the group that had been working under Professor Walker-Smith at Bart’s and Queen Elizabeth Hospital.
A That is correct.
Q When that transfer took place, which I think was in September 1995, so about a month or so before this letter was written, there was no existing dedicated paediatric gastroenterology unit at the Royal Free, was there?
A No and that is why we invited Professor Walker-Smith to come.
Q I think that you were involved as one of the invitors.
Q And there was some correspondence going back to the beginning I think of 1995 about that.
Q This was a unit which had an extremely high reputation, did it not?
A Yes and let me add that Professor Walker-Smith was welcomed with open arms and very enthusiastically by the Medical School and by the hospital.
Q I am sure he will echo that when he gives his evidence. Part of the reputation that his unit had was in the energetic investigation of childhood bowel problems.
Q And using upper and lower gastro-intestinal endoscopy.
A That is correct.
Q I think you have made it clear from your last answers that you were very pleased that Professor Walker-Smith was coming.
Q And that you looked forward to working with him.
Q You got on well with him during the five years that he was there at the Royal Free, did you not?
Q And you respected him as a clinician and trusted him.
A Absolutely and still do.
Q I am going to do this in topics and the topics that I want to deal with are the ethics committee approval issues that arose as a result of Professor Hull’s intervention in 1998, a suggested drug trial involving Mesalazine and a German company, and then the press briefing. Although that is not chronologically the way in which these events occurred, I would like to deal with it in those separate topics. We have some insight into ethics committee applications because by chance for one day when there was an ethics committee meeting on 13 November 1996, you had six applications yourself for ethics committee approval to that one meeting, some of them may have been ongoing, but that would not be unusual because you were heavily involved in research.
Q And you were familiar then with the way in which the ethics committee worked at your hospital.
Q Dr Pegg gave evidence earlier in this hearing and he told us that, in 1996, local ethics committees were in their infancy. I think he told us that they had only recently begun to sit but certainly they were sitting in full flow at this time, but it was a relatively new concept and it was worked out institution by institution.
A I find this difficult to answer beyond saying that, yes, I was involved with ethics; yes, I was trained in ethics as a medical student; and yes, I was throughout my research career which spanned nearly 45 years involved with many ethics committees. I was deeply involved in ethics and particularly evaluating – and this is not irrelevant but I think that I ought to draw your attention to that - in the Willowbrook State School studies in New York where mentally deficient children were inoculated experimentally with hepatitis A and hepatitis B, so I had cause to look very, very carefully into ethics involving studies on children. To answer specifically whether each hospital had a different arrangement in terms of ethics, I do not know. All I would say is that, for example, as the editor of two medical journals, we would not look at any paper unless there was a clear statement of ethical approval for the studies and also parental consent in the case of children. There is no doubt that ethics was a very, very important topic at the Royal Free and I say this not only as a former student of the Royal Free but, during my tenure as Dean, we even had an ethics prize for undergraduate students. So, ethics was a very important issue at the Royal Free. What the position is in other hospitals I know not.
Q It is good enough that you can tell us about what was happening at the Royal Free because that is after all what we are concerned with, but I think that things have moved on in the ten years or so since that time.
A Oh, yes.
Q Again, we spent some time earlier in this hearing looking at the original application for ethics committee approval for the study which became or was labelled 172-96.
A I would need to see that.
Q I am not asking you to confirm that. That is the name it was given. Presumably it was the 172nd of 1996, I do not know.
Q In any event, we called it the shorthand 172-96. We have seen and noted that, on the face of the application and would you turn it up at page 209 in bundle 1, and I think you are still in bundle 1, it is right at the bottom of the page and I think it is in answer to a proforma question,
“Would the procedure(s) or sample(s) be taken, especially for this investigation, or as part of normal patient care?”
and the answer is,
“Yes: in view of the symptoms and signs manifested by these patients, all of the procedures and the majority of the samples are clinically indicated”
and it goes on to deal with extra biopsies and blood. So, the question is asked and it is answered in that way and the only reason why I take you to that is because of what happened subsequently and what you wrote to Professor Hull.
Q So, it is there on the face. Presumably you could understand that as a concept, that a child might come into a paediatric gastroenterology department to be thoroughly investigated on the basis of clinical need, but that those investigations could also give rise to research activity.
A Yes. I think that I made it absolutely clear on Friday that it was not my role to question clinical needs and clinical investigations; this was the responsibility of the clinician in charge. I have absolute confidence in the clinical decisions that were undertaken by the clinician in charge. I did not question this, nor should I.
Q That will shorten the questioning I hope. We see, just to turn it up, the personal letter you received from Professor Hull. Again, we have seen it a number of times in this hearing already. You passed it on to Professor Walker-Smith to assist you with a reply to him. You were not looking other than to know how to respond authoritatively to Professor Hull.
A Absolutely. My practice throughout as the Dean of the Medical School was where necessary to seek the advice of my senior colleagues. As I stated earlier, I found the letter from Professor Hull extremely disturbing and I was not going to reply in haste to this without getting the information and the advice of my senior colleagues who were involved. I was entirely satisfied with the response which I had from Professor Walker-Smith. Furthermore, Professor Walker-Smith obviously took this extremely seriously because he, as soon as he received the letter, flew into my office to discuss this. As I said earlier, we had a very meaningful, fruitful, helpful, useful discussion. I was left completely satisfied that the children were investigated by clinical need. That, as far as I was concerned, was perfectly satisfactory.
Q Could we turn up the letter he wrote to you? You have a discussion and he writes a letter to you which is his formal response. It is in the third volume, FTP 3, page 937. It is quite a long letter but you have seen it on a number of occasions already. It explains the thinking from the point of view of the clinician, does it not?
Q We have looked at it on a number of occasions, the second paragraph, “subsequently children have been seen on the basis of clinical need”. That is, in fact, what Professor Hull was asking about, was it not? After the publication of the paper, what is the justification for carrying on investigating not the original ones in the paper.
A That is right.
Q He goes on to refer to the proposed Falk study, to which I will return in a moment, and ends up, in the last paragraph on page 937, expressing the hope that it may in future be possible, if blood tests provide a clinical feature, to do away with ileo-colonoscopy this in these children as well.
Q By that stage we know the number of investigations had reduced. As a consequence of that, can I take up one point with you on 937b, the third paragraph:
“As an outcome most of the children have had similar bowel changes and have been commenced on Mesalazine or related drugs with a variable but usually favourable clinical response which we hope to analyse in a controlled manner.”
There is a reference there to Mesalazine, which is the drug he hoped to set up a trial.
Q But he is also saying that they hope to analyse the response in a controlled manner.
Q Was that the point that made you advise Professor Walker-Smith that they ought to apply for Ethical Committee approval in relation to the writing up of the data? Before you answer that, let us have a look at the letter. Let us look at your letter on page 939, the second paragraph:
“I am reassured the children with autism are investigated according to the clinical need and their clinical management. Nevertheless, it would be prudent to obtain ethical approval if, as I understand it, Andy Wakefield is collecting cases for report by publication, which is therefore a research project.”
A Yes, which was carefully worded and is based on the response that I had from Dr Michael Pegg, namely that if this is to be published the collection of data and the analysis of the clinical data constitute a research project and therefore there should be clinical approval for collecting data for that purpose. That is all it says.
Q Whatever may have been the position about the original study, if there was going to be continuing collation of data that needed to be covered by Ethics Committee approval?
Q Taking the thing through to the end, without turning up the letters which you went through on Friday, Dr Pegg wrote a fairly lengthy letter to you so you had two letters: one from Professor Walker-Smith and the other from Dr Pegg and you produced a synthesis of their letters in your response to Professor Hull.
A That is correct.
Q Can I turn to the trial of Mesalazine? All I want to do is put this in context. You were made aware that Professor Walker-Smith wanted to set up a controlled trial for the use of Mesalazine, and anti-inflammatory drug, for children with bowel disease.
Q It is happening about the same time, in 1998.
A That is correct.
Q It was hoped this was going to be financed by a German pharmaceutical company called Dr Falk Pharma GmbH.
A That is correct.
Q Could we insert some documents. The first one is at page 646a, bundle 2. (Document handed out)
THE CHAIRMAN: We already have 446a given to us by Mr Coonan. Does it go before Mr Coonan’s papers or after?
MR MILLER: It better go after.
THE CHAIRMAN: There is a 646b, a continuation of 646a, and 646c, that is one letter, so would it be 646d?
MR MILLER: I apologise, I had prepared these on Friday. It has taken a long time to introduce this but this simply is the protocol for the proposed trial. The principal investigator, J Walker-Smith, randomised, double-blind, placebo-controlled clinical trial on the efficacy of mesalazine pellets in children with ileal lymphoid nodular hyperplasia, non-specific colitis and regressive behavioural disorder. It was hoped that was going to be funded by Falk. We heard a little bit about this by Dr Berelowitz last week but, in the event, Falk decided to pull out, did they not? You are nodding.
A I am nodding because I think the Panel should be aware that Dr Falk has been associated with the Royal Free for many, many, many years in both supporting the work of the liver unit at the Royal Free and supporting international symposia on liver disease and has been regarded as, if you like, a loyal - not friend - collaborator of the Royal Free for many years. In many ways I welcomed the continued association and was somewhat disappointed that he decided to withdraw because I thought the potential there was quite interesting.
Q I was not in any way going to say anything deprecating about Dr Falk.
A I am not even suggesting that but I felt that you should be aware that Dr Falk was not new to the Royal Free. That is all I was trying to imply.
Q I am going to show your letter to him and his letter in response because we see entirely what you are saying and what he was saying about this. He makes the point about the long association with the Royal Free.
A That is right.
Q And gives what, on the face of it, looks like a fairly good reason why he was not going to be involved. We will have a look at those documents as well.
A I do not remember them.
Q I give you 926a and 926b for bundle 3. (Documents handed out) The first is your letter.
A Yes, I recall this letter.
Q We can see the first letter, 19 May 1998, you to Dr Falk, because you had been involved in discussions about this.
“I was very disappointed to hear that Dr Mittman had informed Dr Mark Berelowitz that funds were no longer available to support our proposed treatment trial for children with autism and inflammatory bowel disease.”
Who was Dr Mittman?
A He was a member of the staff of Dr Falk.
Q Somebody from Falk had told Dr Berelowitz.
“As you know, we are increasingly interested in this area, both for scientific reasons and because of the possibility of making a real difference to the quality of life of the children. The study which we had in mind would be of particular value because it does not attempt to tackle the controversial area of the possible causes of autism and inflammatory bowel disease, but instead focuses directly on a new clinical finding and the scientific and therapeutic implications thereof. The trial would have the full support of the Hospital and the Medical School. We have a cohort of patients who wish to enter the study, and we have available immediately all the necessary clinical and research expertise to enable us to carry out the work. The only obstacle is funding. I very much hope therefore that you might be able to reconsider your decision so that we can continue to investigate this important new possibility.”
If you do not agree with what I am suggesting to you, say so. What you were saying is that the finding which had been reported in The Lancet paper, the important finding, the trial was to see whether the condition of the children could be improved by a drug such as Mesalazine and it avoided the problems of what had bedevilled events after January 1998, namely the publicity about MMR.
Q That is why you were giving it your full blessing and trying to persuade Dr Falk to come across.
Q Dr Falk responded to that letter on the 25 May 1998, 926b:
“Thank you very much for your kind letter of May 19, 1998 which I have read with great interest.
You will know very well my little company for a long while and you have often participated at our Falk Symposia. With pleasure we have supported financially the progress of gastroenterology and hepatology for more than 30 years as long as our budget will allow this.”
Which is the point you have just made.
“Now, I am sorry to inform you that we see for this year no way of supporting this important study of Professor Wakefield et al. financially and I cannot say today how the situation will be next year.
Therefore, I deeply regret that I cannot give you and your co-workers a more positive answer.
“In view of the fact that the 1997 sales of Asacol generated by the English company SB in Great Britain were 200 times higher than our product Salofalk of our English partner company Thames Lab. Under these conditions I have absolutely no understanding that the English pharmaceutical giant SB will give you no support for your important study.
I would like to recommend to ask the company SB your urgency of your study.”
Again, if I understood this letter correctly he is saying there is a very large pharmaceutical company in Great Britain with big sales, you perhaps ought to approach them to see if they will support the study because their sales are so much more significant than those generated by Falk in the UK.
Q Was that the way matters were left, that the study did not in the end take place.
A All I can say is that I received the letter on the 28 May. You will notice that I did not sit on it very long. I passed it on to Dr Berelowitz and Professor Walker-Smith the same day. Clearly I was disappointed that the study did not take place because I am sure you will appreciate that all of us - and by that I mean all of the members of the staff of the Royal Free Hospital and the Medical School - felt desperately sorry for these children and we wished to help them in any way we could but the actual mechanism of raising funds is not up to the Dean’s office but the individual researcher. If the Dean can facilitate these, either because I have worked with these particular people before or because of similar reasons, I would try to facilitate it but the actual mechanism of raising funds is up to the individual researcher. The Dean’s office can only support them but no more than that.
Q That is very helpful, Professor. You were giving it your full backing, with the weight of the Medical School behind it, pointing out the advantages of it. If that fell on deaf ears, then it would be up to the researchers to try and find another source of funding.
A That is correct.
Q I think one of the messages from the letter is the fact that even though what had been described as a new syndrome had been discovered, what was more important was to discover whether or not there was any treatment which would make the position of the children better.
A Absolutely correct.
Q The final topic I would like you to help me with is the publication of The Lancet paper. We are not I do not think going to get into any area of controversy on this; I hope not anyway. Did you actually see the draft of the paper before it was released or published by The Lancet?
Q Would that have been in the run up to the press briefing?
A No, no, no. That would be completely independent. I think out of courtesy some of my staff would send me copies of their papers. They had absolutely no requirement to do so – usually it is the head of the department who approves publication of papers – but I think out of courtesy this was sent to me. It has nothing to do whatsoever with the press briefing.
Q It would be an earlier stage?
A Yes, absolutely.
Q It was because presumably it was coming out of the Medical School of the university?
A Absolutely. I think I may have made a slightly emotional statement about the need to protect the reputation of the Royal Free. That is the function of the Dean. Let me try and put this in perspective, because I know that I was somewhat upset with the way the questioning was carried out. When I became the Dean of the Royal Free, in terms of the research assessment exercise and in terms of the perception of the Royal Free, we were the bottom of the list of all Medical Schools in London. We were in a dire financial state, we were virtually bankrupt, we were about to be ordered to have management accountants imposed on us by the university, but within three years we turned the position completely around. We made new appointments, we raised a substantial amount of money, research money, peer review money. We within a few years became the second best Medical School in the country, with the highest research income from peer review research grants, second only to the University of Oxford. We had the highest number of applications to the Medical School, 20 for each place we had, as compared with the average of four applicants per place in other Medical Schools. So the whole position with the Medical School was turned. The reason I say that is simply to emphasise to you that the poor Dean’s office had more than enough to deal with without all these enormous papers which you have before you and without all the controversies that were generated. Yes, I felt passionately about the Medical School, I felt passionately about the need to protect the reputation of the medial school and I still do.
Q So the dark days, if I may so describe them, would have been at the end of the 1980s?
A They were very dark days indeed.
Q Was this the 1980s?
A That was the late 1980s.
Q I imagine that by the time with which we are concerned in 1996, 1997 and 1998, things had turned round?
A Things had turned round, but we faced an enormous new problem and the enormous new problems were the imposed merger with another Medical School. That required an awful lot of negotiation, I assure you.
Q I do not think we want to go down that route.
A Absolutely not.
Q But certainly as far as what you have described is concerned, by the time we get to 1996, 1997, 1998, you had turned the place round.
A With the help of my colleagues, yes.
Q Can I come back to the paper? On the face of it, it did not establish any link between MMR and bowel disease or pervasive development disorder.
Q But the merit of the paper, and the only merit, was that it appeared at the time and subsequently that they had made an important finding of a link between bowel disease and what was termed pervasive development disorder.
A Exactly so.
Q At the time, this was considered to be a very important and interesting finding.
A Indeed. Even to me, who was not a pathologist.
Q At some time before the publication, it was decided that there should be a press briefing to coincide with the publication, or precede the publication.
A No. The precise sequence of events I find difficult to recall, because so many things were happening at that time. As I recall, the position was that the paper was to be submitted to The Lancet. That is all that I was aware of. When The Lancet accepted the paper, if I recall correctly, I was told that The Lancet considered it a very important observation and they were going to issue their own press release. I felt that this was inappropriate. The findings originated in the Royal Free and if there were to be any public statement or public briefing on those findings, they should be from the Royal Free. There was no cause and effect, so to speak: “Here’s the paper. We have a press conference.” Not at all.
Q I was not suggesting that. I was trying to get it in sequence.
A As I say, it is terribly difficult to recall, without documentation, ten years later. It really is difficult.
Q Presumably the purpose was to inform of the important and interesting findings?
Q Presumably you hoped that was all which would be published?
A To my knowledge, that was precisely all that was to happen. Incidentally, let me try and explain the role of the media group, why the Medical School employed PR consultants initially and subsequently, because I think it might put it into context. When I arrived at the Royal Free in 1998, it was already established that there was firstly a media group and secondly that we were to be advised by an independent public relations company. The public relations company which was chosen – I was not involved in that – was in effect a public relations company that worked for the British Heart Foundation and the British Gastroenterology association, so they had a good track record in dealing with the media. The reason why we did that, which may appear unusual for a Medical School, is because we had numerous visits from distinguished members of the Royal family and others, we had important findings which we wanted to ensure were interpreted correctly by the public. One does not write papers in order to hold press briefings. One undertakes research in order to advance medicine, but when it was important and important observations were made, it was important that we explain the meaning of these observations in a scientific manner. All that that press briefing was meant to do was to describe the findings in The Lancet paper and nothing else. Vaccines did not come into it, virology did not come into it, the measles vaccine did not come into it, monovalent vaccines did not come into it, polyvalent vaccines did not come into it, public health issues did not come into it, immunisation programmes did not come into it. This was entirely unexpected and was very, very difficult to control at the time, I assure you.
Q I am going to come back to the press briefing. You acknowledged that Professor Walker-Smith was not there. You gave an answer a moment ago saying that you came to the Royal Free in 1998. When was the date you came to the Royal Free?
A I am sorry. It was September 1989.
Q It was a slip of the tongue. You said 1998.
A I beg your pardon. We are talking about 1989.
Q Mr Coonan asked you to look at Dr Wakefield’s letter written to Professor Walker-Smith on 15 January 1998.
Q Which you have seen and commented on. You were also copied into Professor Walker-Smith and Dr Murch’s reply. Can I just show you that document and one other at the same time? (Same handed)
A I must say, I do not recall that.
Q It seems to have been done in the same way. The first one is page 673A and is a letter dated 21 January 1998, which has to go in bundle 2. The second is a document which is dated February 1998 and is page 782A of the same bundle. (Same distributed) Can you recall that the letter which you were asked to comment on was in fact a letter from Dr Wakefield to Professor Walker-Smith, copied to you?
A Yes, that is correct.
Q This is the reply, which again is copied to you, although it is a reply from Professor Walker-Smith and Dr Murch.
Q The Panel will bear in mind , as you will, what had been written by Dr Wakefield in the earlier letter. I see you are reaching for that to see what it was he was saying in that.
Q This says:
Thanks very much for your letter to clarify your position before the press conference.
Our position is that the new paper as published does not present direct evidence for any implication of MMR vaccine although such evidence may be forthcoming in the second paper and other work in progress.
For us it seems inappropriate to emphasise the role of MMR vaccine in publicity about this paper. Its main thrust is to describe for the first time bowel inflammation in children with autism and so suggest a pathogenic mechanism for autism.
Even when pressed by journalists we feel no specific information about the role of MMR should be discussed at a press conference. Our position must be to maintain a public agnosticism about the risk of MMR and for the moment support government policy concerning MMR until more firm evidence is available for us to see ourselves.
In private our view is that the government should institute urgently a comparative study of MMR and monovalent vaccine. This is more likely to happen if we refrain from publicly attacking government policy until we have published evidence.
We continue to support our collaborative research with you and we respect very much your passionately held views and your concerns for the children themselves. We value immensely your huge contribution.
Then it is signed by the two of them, copied to you and copied to Professor Pounder, Dr Wakefield’s head of department, Dr Berelowitz and Dr Mike Thomson, who was the other consultant paediatric gastroenterologist.
A I could not have put it better myself.
Q That is what you had hoped was going to happen.
A That is what I was confident was going to happen.
Q In fact, the second document , which I do not think was ever actually put out, which is page 782A, is a press release which was given to Ms Hutchison, who was I think in charge of the press department.
A That is correct.
Q That is again signed on this occasion by Dr Thomson as well. This is before the publication of the paper. It says:
“The Lancet paper of Wakefield et al is important as for the first time it describes significant bowel inflammation in children with autism and related disorders. This opens the possibility of developing improved understanding concerning how autism occurs.
As to the possible risk of MMR, we support present public health policy concerning MMR. However it is important that evidence be collected as soon as possible to establish whether there is any role for MMR as a cause of the bowel inflammation found in children with autism.”
So it echoes what was said in the letter.
A This is precisely what Dr Murch I believe said at the press briefing. I see that actually it is dated February 1998, but you say that it was not issued. I do not remember that it was issued, but if it was not issued, the reason for that was because the Medical School issued the next day a precisely similar statement. Indeed, the Medical School continued to issue statements of this nature repeatedly to the media, but as I said on Friday, the media chose to ignore it, even when very, very strong words were used. When the press release stated clearly that the Medical School wished to disassociate itself completely from the views and work carried out by Dr Wakefield, even that was ignored. The only time that we were in any way quoted that there was no virological evidence whatsoever to link MMR with autism or bowel disease was I think in The Guardian and in that remarkable publication, Private Eye.
Q I think you introduced the press briefing, did you not?
A Yes. And I stressed in my introduction that there was no association with MMR or vaccination.
Q I think there was then a presentation by Professor Pounder.
Q The research findings were introduced by Dr Wakefield.
Q Then a paediatrician’s view was sought from Dr Murch.
A That is correct.
Q Then, as far as the autism findings were concerned, there was a clear exposition by Dr Berelowitz.
A That is correct.
Q That is the sequence of those who were speaking.
Q Then there were questions from the floor.
MR MILLER: Thank you very much.
THE CHAIRMAN: Mr Hopkins represents Professor Murch.
Cross-examined by MR HOPKINS
Q Professor Zuckerman, you will be pleased to know that I will not be detaining you very long and also I do not think that the matters I will be putting to you will be controversial. Can we consider the importance of the histological findings that were reported in The Lancet and the view you took on that and go back to a document that we were shown this morning in FTP2, a letter which started at page 674A, one of the blue papers that were handed up this morning. This is a letter dated 22 January 1998 where you were writing to Dr Wakefield.
Q I am not concerned with the contents on the first page but would you go to the second page and the third bullet point down where you say this,
“Your observations together with your colleagues on ileal lymphoid nodular hyperplasia, non-specific colitis and developmental disorder(s) in children are clearly important and merit considerable further research.”
If I understand your evidence correctly, you saw the importance of The Lancet article in drawing attention to these pathological findings.
A That is correct.
Q Indeed, you saw the importance of the forthcoming press briefing in drawing attention to that finding.
A That is correct.
Q Is it right that, prior to that press briefing, you yourself looked at micrographs of the histological findings?
Q And you satisfied yourself that there were pathological changes of significance?
Q When we turn to the press briefing itself, as you have told us, there were questions from the floor which related to or potentially related to the role of MMR.
Q You have told us how Dr Wakefield dealt with that.
Q And you have also told us that Dr Murch, as he then was, was asked for his opinion.
Q And you have told us that he strongly supported the continued use of MMR; is that right?
A Yes, very strongly; indeed, vigorously.
Q Would it be right to say that you regarded that as the responsible position for him to take as a paediatrician?
Q In the course of your evidence and in answer to Mr Miller, you have drawn a distinction in your answers between the research group within the academic department and the paediatric gastroenterologists as clinicians.
Q We have been taken through quite a number of letters that passed between you and Dr Wakefield and you and Professor Walker-Smith, many of them generated by issues that have been raised by Professor Hull.
Q It is right, is it not, that you at no point correspondence with Dr Murch, as he then was, in 1997 or 1998 on these matters.
A No, I did not.
Q Presumably, that is because you wanted to correspond with his head of department, Professor Walker-Smith.
A Yes. The customary way within Medical Schools or indeed universities is that the Dean corresponds or deals with the head of the department, the head of the department that has a responsibility for the staff and the staff are responsible to the head of the department who is then responsible to the Dean. So, it was perfectly acceptable practice that I write to the head of the department as I did to Professor Walker-Smith.
Q Indeed. I am not suggesting otherwise.
A I am just trying to paint a picture.
MR HOPKINS: That is very helpful. Those are all my questions, Professor. Thank you.
THE CHAIRMAN: Professor Zuckerman, Ms Smith now has the opportunity to re-examine you to clarify some of the points that may have arisen in the cross-examination.
Re-examined by MS SMITH
Q You will be pleased to hear that I only have a couple of matters. The first arises out of the questions that you were asked by Mr Coonan on behalf of Dr Wakefield and he took you to a letter or rather, he did not take you to a letter, he put in a letter which the other advocates have taken you to and that is on page 674A. I want to ask you about its content. You have had the opportunity to read it again and you set out in that letter your concerns to Dr Wakefield generally about these matters but you concluded – and remembering that this is a letter in January 1998 –
“On a more personal note, you know that I supported your work, particularly on vascular supply and endothelial changes. I am now alarmed by the publicity in the popular media and the effect on immunisation programmes and the public health. It is vital, in your own interest and that of children, that you state clearly your support for monovalent vaccination.”
That was a typographical error which I must say escaped me until my attention was drawn to this by the solicitors for the GMC. If you read the entire letter and the context in which it is written, it was of course meant to be polyvalent. It was a typographical error which I overlooked and incidentally all the recipients of the letter overlooked and indeed Dr Wakefield overlooked as well. I think it was understood that this was a typographical error and should clearly state polyvalent.
THE CHAIRMAN: Where exactly is this?
MS SMITH: On page 674B in the penultimate paragraph. (To the witness) Does the rest of that letter set out accurately your position in relation to the concerns that you wanted Dr Wakefield to understand at that time?
A Yes. You drew my attention to the penultimate paragraph about the publicity. I did not use the word “alarmed” without giving it considerable thought. I was alarmed and, not only that, I subsequently, as you no doubt have seen from the file, had written repeatedly to Dr Wakefield asking him very, very firmly to stop discussing this letter with the media and he assured me that this would stop but in fact it did not. Yes, I was alarmed by the publicity.
Q There are two questions that I want to ask you arising out of the questions that Mr Miller put to you. The first is that when he first started questioning you this morning, he asked you about the ethics committee application and he took you to the paragraph setting out the fact that the tests were clinically indicated and you said, “It was not my role to question clinical needs and investigations, it was the responsibility of the clinician in charge. I did not question it nor should I.” Does that apply to an application in respect of any specialism which is outside your own? In other words, would you always rely on the clinician whose specialism it was?
A I think that it would depend on the seniority of the clinician. The answer to that is clear. I am not a clinician; I am not in a position to question clinical decisions or investigations required according to clinical needs.
Q If they are made by a senior doctor, do you feel comfortable about relying on any representation that is made to you about the clinical need for an investigation?
A Yes, I do.
Q One other matter. You were asked about the Mesalazine trial and Messrs Falk who in the end could not finance it. You said, “It is always up to the clinical researcher to find the money”.
Q Forgive me if this seems to you an elementary question but I want the Panel to be clear. If a study is entirely research rather than involving clinically indicated medicine, is it always the case that anyone who wants to do the research has to find the money to fund the research?
Q There is no source within the NHS in broad terms which would enable research to be done rather than clinical medicine?
A I believe that more recently the NHS has set up a fund for clinical research but it is clearly subject to the same criteria as any other research work which is undertaken and would go through the same procedures of application and evaluation as, say, in an application to the MRC or to the Wellcome Trust or the Wallson(?) Foundation and so on. I do not think that there are specific funds either within the Medical School or within hospitals which support research per se.
Q The only other matter is The Lancet paper. Mr Miller asked you about whether the paper on the face of it was a paper that was interesting because of the link between the behavioural disorder and the bowel disease and you agreed with him on that ---
A I am sorry, not quite. What I agreed is that the pathological changes were significant. I did not link it to behavioural changes.
Q At any rate, that finding was an interesting finding.
A Yes, no question about that.
Q The paper, as you know, reported a temporal link with the MMR.
A Well, it alluded to it. It was mentioned as one possible environmental factor but no more than that.
Q Was that a concern to you when it came to decisions about how this paper was to be presented?
A Yes, it was a concern to me because I was very sensitive to any attempt to link immunisation with disease without the virological evidence which is absolutely essential. Let me give you an example. If you look at this weekend’s news, I think you will appreciate the importance of virology. You also will appreciate that virology is really a very specialised science and, when it comes to vaccines and virology, it really has to be left to the expert. Yes, I was sensitive to the MMR but it is not for me to censor papers. Papers that are submitted for publication in peer review journals are subject to peer review and it is up to the referees and finally up to the editor to decide whether it merits publication or not. I certainly allowed MMR to be alluded to because I knew that in any case the whole world was already aware of this link in September 1997 when there was an enormous eruption of publicity about immunisation and autism without any supporting evidence. I allowed it to go through because I assumed that, you know, it is the editor who will decide, it is not for me to decide that. It seemed that, yes, as an environmental factor, it is worthy of investigation if you can provide the virological evidence of which I saw none.
MS SMITH: Thank you very much, Professor. It is now up to the Panel to ask any questions they may have of you.
THE CHAIRMAN: It is 12.45 and I think that it would probably be appropriate for the Panel to look at the notes we have made ourselves of the evidence we have received so far and, as we have done with one or two previous witnesses, I think we will spend 20 minutes or so doing that. That will take us to 1.05 and then we will have our lunch break and we will then resume at 2.05 when the Panel will be ready with their questions of Professor Zuckerman. I hope the course which I have just suggested is acceptable to you all.
(To the witness) Professor Zuckerman, my usual warning reminder once again. I know that you quite used to listening to it but I have to say it for the purposes of the transcript. You are under oath, you are in the middle of giving your evidence and therefore, please, do not discuss this case with anyone. Someone from the Secretariat will look after you over lunch and provide you with a sandwich or whatever else your requirements are. We will go into camera now for the next 20 minutes or so and then we will break for lunch. Would all parties now withdraw.
(The Panel adjourned for a short while)
MS SMITH: Sir, during the course of his cross-examination, Mr Coonan referred to a document and, you may remember that, when you looked in your bundles, it was not there. It is page 657 in volume 2 and, for the sake of completeness in case anyone needs to refer to it, I ask you to include that, please. (Same handed to the members of the Panel)
Questioned by THE PANEL
HE CHAIRMAN: Professor Zuckerman, as I said before we broke for lunch, if there are any questions from the Panel members at this stage, then I will introduce them individually to you. First of all, Dr Webster is a medical member.
DR WEBSTER: When a project is funded by an organisation like the Welcome Trust, is there still a local middleman that acts as banker or is it a direct transaction between Welcome and the researchers?
A What happens, for example, in a case like the Welcome is the individual researcher is informed of the award of the grant, a letter is then sent to the Dean asking the Dean whether he will accept the grant and will ensure that it is properly managed and executed, and then it goes to the finance office of the Medical School. There are no intermediaries.
Q The Medical School is a sort of intermediary then.
A The Medical School holds the budget, yes.
Q The trustees of the Hospital would have a similar role?
A The role of the special trustees of the hospital remain a mystery to me; I do not know.
Q If the Medical School was being used, when it came to acknowledging funding would you just mention the Medical School or would you mention the Welcome.
Q Would you mention the Medical School at all?
A No. Normally the customary procedure, in effect the accepted procedure, is to acknowledge in a published work the source of the funding only.
MS GOLDING: I keep on the source of funding. Where we have the Legal Aid Board, was it the fact that it was the Legal Aid Board or was it the apparent reason for the funding that you were unhappy about?
A It is not a question of the funding, it was the source of the funding. As I mentioned before in my evidence, it was a remarkably unusual source of funding, one that I have never come across in my entire career. It seemed unusual and unconventional and that is the reason I questioned it.
Q The fact that it was not mentioned when the application was at the Ethics Committee, when you were told that did you not query with the members of the research team as to why the source of funding was not mentioned?
A No, I did not. The reason for that is, first of all, it was now historical and, secondly, on the application form that I saw, in other words actually on the response from Dr Pegg, he says that the source of funding was the Royal Free Hospital. My position was absolutely clear. We were not going to accept that funding. The statement on the records of the Ethics Committee was the Royal Free Hospital and that is why I left it.
Q Given that there were still concerns about the source of funding and also what the study was about, whose role would it have been to probably put a stop to the whole study until everything was clarified?
A You cannot stop the study in an academic setting. Academic freedom is the criterion and researchers are entitled to undertake any research that they wish in their field of interest, to hold any views that they wish and to express these views provided they are within the limits of the law. There is no way that a Dean would even attempt to stop a research project.
Q If there were concerns about a project, what happens if everyone is having so many questions over the years?
A The questions over the years, as I wrote in my letter to a very distinguished professor of oncology from the St George’s Hospital, and that is on file, Professor Dalgleish, he asked me why did the Medical School not act more vigorously to defend the public health. I wrote to him that the Medical School did all it could do to protect the public health but we have no control on publication in peer review journals. If papers are published in peer reviewed scientific journals, that is the expression of academic freedom and there is no way that I could interfere. It is up to the scientific community to judge the validity of published work. They either accept it or reject it.
Q You said on Friday that from about 1966 you became increasing concern about approaches made by the media by the research group.
Q Was there anyone in particular making these approaches and what was being said?
A I was hoping, in a way, that you did not ask me that question, nevertheless I will answer it of course. It became evident to the Dean’s office, and to others, that a number of research workers - I will name them if you wish - were approaching the media, in fact seeking media publicity, despite the fact that they were clearly instructed by the Medical School, both verbally and in writing, that they must stop approaching the media. Furthermore, they agreed to do that both in writing and verbally but within a matter of days they were again talking to the media.
On two occasions I wrote to one member of the staff that before he speaks to the media not only should he not do this because it is unwise, because it has already received such enormous unwelcome publicity, that he must obtain the consent of every member of the research team. A number of members of the research team came to my office complaining about this media attention which was really quite unwelcome.
What was even worse was, if I may say so with due humility, what became apparent was that with some of these contacts with the media there was a pattern emerging of contract with the media before or during public holidays when the Dean was not available to respond, or anybody else was available to respond, nor was anyone in the Department of Health available to respond. That caused considerable upset.
It is not usual for the Dean to write to members of the staff with such instructions but I had to actually draw their attention to a paper that I sent out shortly after my appointment to heads of department and members of the academic staff outlining their responsibilities, namely their responsibility in terms of their commitment to the Medical School, to academic work, to the students, to teaching and to their responsibility in terms of approaches to the media. Furthermore, I spelt it out very clearly that I was not interfering with academic freedom. They were free to express their own views, free to undertake whatever research, free to publish within the limits of the law but if they were expressing their own personal view they were not to use the name of the Medical School, they were not to use the address of the Medical School and not to speak on behalf of the Medical School. Unfortunately some members of the staff did precisely that and on one occasion actually issued a press release in the name of the school without the school knowing it, without my approval and that was totally unacceptable.
Q You said that you asked Mr Wakefield to send biopsies and other material for independent confirmation. You said he refused to do so. How did he refuse? Was this to you or to the head?
A Basically it was through different sources. Professor Pounder and Professor Walker-Smith as I described in some detail previously. If I recall correctly, when I asked him to send material directly to Dr William Bellini at the Centre for Disease Control he said no.
Q He actually said no?
A I believe so. Please remember this took place many years ago.
Q When you had the discussion with Professor Walker-Smith, Dr Murch and the medical director and Mr Else, why was Mr Wakefield not part of that meeting?
A Mr Wakefield was not responsible, as far as I was aware, for clinical investigations.
Q At the press briefing, how did the measles topic actually come up. Did you say it was because of a question from the press or was it part of a general response?
A It was part of the general theme that developed.
MRS DEAN: I want to ask about one letter if I may, the letter from Professor Hull at page 928 in the third volume. I simply wanted to ask you to clarify for me that your understanding was that Professor Hull was concerned about the continuing work on children rather than the initial study.
A Yes, that is correct. You have to ask Professor Hull but my understanding was that he was concerned that following the MRC meeting where 30 experts or more, I cannot remember the exact number, came to the conclusion that there was no association between immunisation and autism he clearly found that this would be unacceptable to continue investigating these children using invasive procedures. That was my understanding. I feel I cannot speak on behalf of Professor Hull.
Q There is one other matter on that letter I wanted to ask you about. At the very last paragraph Professor Hull puts forward an offer that the Ethics Committee of the Royal College of Paediatrics and Child Health might give an independent review of the ethical position. Did you take that offer up at all?
A I consulted the professor of Community Paediatrics, Professor Brent Taylor, who felt that we should do that. If you study Professor Brent Taylor’s response, and in the light of the events at that time, it was far too late to seek yet another independent opinion. Had I not been satisfied with the response that I received from the clinicians, namely Professor Walker-Smith and Dr Simon Murch, had I not been satisfied, I certainly would have taken it further to the Ethics Committee of the College of Paediatrics. It really appeared a little churlish to continue further when both the hospital Ethics Committee, the chief executive, the medical director and others were satisfied that, in fact, Professor Walker-Smith and Dr Simon Murch were operating under full ethical approval.
THE CHAIRMAN: I have a few questions and I hope you will forgive me because I am going to ask you some questions maybe jumping from one place to another as the evidence was given rather than in some chronological order.
Can I, first of all, ask you about your letter to Dr Armstrong at the BMA, page 412 of bundle 2? I think all in that letter, in the penultimate paragraph, you mentioned the suggestion that the detailed protocol is developed at each stage of the research. Can I ask you what stages of the research did you actually have in mind at that stage?
A The research, as I understood it at the time, was a significant finding of the pathological changes in the bowel which I felt something was something merited further investigation. It is not for me to judge but that is what I felt. I considered that if indeed, as the BMA suggested, further research was to be undertaken, in a way new research, then it should be subjected to detailed protocol. That, in fact, is precisely what I discussed, if I recall correctly, with Professor Walker-Smith and it was agreed. Indeed, on the basis of this he immediately wrote both to Dr Michael Pegg, the Chairman of the Ethics Committee, and indeed he went even further and wrote an explanatory letter to the chief executive of the Trust.
Q At the same stage you mentioned, and quite correctly, that that posed another very difficult question: who actually owns the data.
Q That is a very proper ethical question. Did you actually resolve that in one way or the other, the answer to that question?
A Yes, I resolved it to the best of my ability in the discussion with Professor Walker-Smith using the example of the placentas in a teaching hospital in London. I believe that this was tested in law and I have to leave it to the lawyers to actually find a reference. It was clearly established that the ownership of the clinical material is not the patient, is not the hospital but is the clinician in charge. That is why I asked Professor Walker-Smith to instruct Mr Wakefield to send the biopsy for examination.
Q Can you, in the same bundle, open page 606? This was the statement, if I remember correctly, that you said you drafted.
A I did; I wrote it.
Q And circulated it. In the third paragraph I think I can see what you were trying to achieve, to try to dampen the speculation that was going rather than anything else. That was the objective.
Q But the beginning of the third paragraph would that not have achieved just the opposite:
“Until and unless the appropriate national and international authorities decide to review the policies relating to MMR immunisation, the Royal Free will continue to support the current programme.”
I can see where you are coming from but I in a way that is adding fuel to the fire, that something is amiss, something needs to be done, by the national and international authorities. I am trying to see as an outsider.
A To quote this morning, my state of mind at the time was that the Royal Free will respond appropriately to any findings or any decision that is made by the appropriate national or international authorities. I do not think it was opening the school to criticism; it was simply indicating that the school is open-minded and remained open-minded and will undertake whatever is accepted nationally and internationally. The reason why I emphasised “internationally” is two-fold: one is my own personal close association with the World Health Organisation as a consultant and as a director of one of their laboratories. Secondly, that nationally, if we had undertaken the course which was suggested by one researcher, we would have been completely out of sync with the rest of the world. We would have been the only country in the world using monovalent vaccines – the only country in the world – so I was simply protecting the position of the Medical School. We were open-minded, we would follow whatever policy is dictated.
Q Do I understand from that answer that although you knew exactly what the policies were at that particular time and you wanted to support those policies, at the same time you wanted to keep your mind open to future development?
Q That is very helpful. The press briefing which was actually given – I made a note;
I think it may be paraphrasing – that what you wanted to achieve was that there was no connection, no causation with the MMR proved, but perhaps there was some connection with bowel disease, inflammatory bowel disease, and autism. Is that correct?
A No, I do not think I would have gone that far, because I am not an expert in autism or bowel disease.
Q Or the possibility of a connection?
A It is an area which needed further research, is the way I would put it.
Q What I also remember of what you actually said at that press briefing was that you particularly instructed that no mention of vaccination – forget about MMR – no mention of any vaccination was to be made.
A That is correct.
Q How was that information passed on to the participants of that conference?
A They were present at the media committee meeting which considered this matter and also there was a briefing held before the press briefing. We do not usually go into a press briefing without actually agreeing what is to be said beforehand and it was agreed that this would be restricted to the pathological changes.
Q They were all present in that pre briefing session, those who were going to be present?
A I am pretty sure of that, yes.
Q Transfer factor. I think you knew quite a lot about it as one of the authorities on this particular subject.
Q I think what you actually said was that Professor Walker-Smith, to his credit, came to see you and asked you something more about it.
A That is correct.
Q Were you able to give him the details or were you actually only able to tell him to seek the information from somebody else?
A If I recall, what I told Professor Walker-Smith – and I say again, it is a conversation which was held some years ago – I told Professor Walker-Smith that I had worked with transfer factor for about three or four years in the mid 1970s and I think I published three or four papers on the subject. I told him that I believed that most of the work and the results which were published were based on anecdotal reports and not based on controlled studies and that I was obviously out of touch – that was some years ago – and that it would be wise if he sought advice of the two people whom I knew well who knew more about it than I did. As you know, Professor Walker-Smith took this advice and wrote to Professor Dumonde.
Q The next question is on the conflict of interest. Please forgive me, this is not in any way questioning your integrity, but I am asking you this because it is an important question in my mind. I think what you actually said was that you had been an adviser to the Department of Health for many years; I think you might have said 38 years.
Q On the vaccine. Here there was a study that ---
A No, sorry. Not on vaccines. I was an adviser until last month to the Department of Health as a member of the advisory group on hepatitis for about 28 years, as an adviser on the expert committee on AIDS for about five years; an adviser on the microbiology advisory group for about six or seven years and an adviser on the advisory committee on the safety of blood for transfusion or organs for transplantation. I was not an adviser on vaccines; it was specifically on other topics, but I was an adviser to the Department of Health continuously for 38 years.
Q That answers the problem which was in my mind of your conflict of interest at that stage.
A Nothing to do with vaccines whatsoever.
Q Ms Golding has asked you this question about the evaluation of the biopsies. I think you told Professor Walker-Smith that these were his patients and that he cannot instruct Dr Wakefield what to do with the biopsy samples. I think you actually said they were your property, they were your patients.
A Yes, I did tell Professor Walker-Smith precisely that. No doubt he will be questioned about this and he may recall other details, but I do know that I used the placenta example in order to try and emphasise to Professor Walker-Smith that the actual biopsy material came under his jurisdiction, not Mr Wakefield.
Q What was Professor Walker-Smith’s response to you, as far as you can remember? If you do not remember, just say so.
A I do remember. He said that – what did he say? – something along the lines – I cannot remember word for word – something like, “Andy does not wish to do that” or something like that. I do not know. I really must ask you to direct that question to ---
Q This is why I said, if you do not remember, please say so. What we cannot do in these proceedings is speculate. If you cannot remember, I think that is the answer.
A Absolutely. I am trying to avoid speculation at all costs.
Q My last question. The Lancet paper which was published – this is in bundle 2, page 787 – that is the end of the paper, I think you said you saw this paper before it was published.
A A draft.
Q Did you actually see this on page 787, for example, the addendum? Do you have any recollection of whether you saw this?
A I was going to say that my gut feeling is no, because it would have alerted me to something unusual, so I think not. Probably not.
THE CHAIRMAN: I do not have any further questions. Ms Golding has another question for you.
MS GOLDING: At page 293 of FTP1, this is the minutes of the meeting of the ethical practice subcommittee and under “Committee Membership”, it says that it was noted that Dr Jacobs, Professor Wakeling and Professor Zuckerman had all resigned from the committee.
Q That is you resigning, is it?
A That is me.
Q The application for the original study was put in in September of that year and I wondered if you had had a chance to actually give your comments as a member of that committee to the application?
A I think not, but I notice that on the following page my daughter has raised a query, Dr Jane Zuckerman, under 174-96. No, that is her application. Sorry. I do not know.
Q Can I just be clear? There is a Dr J. Zuckerman.
A That is my daughter.
Q You had resigned prior to this meeting, had you?
A I resigned prior to this.
Q Was there any particular reason?
A Yes. I had served as a member of the committee by then for seven years. I was absolutely inundated with work relating to the merger with University College London, the research assessment exercise, the teaching quality assessment exercise, you name it, it was on my desk and I simply could not cope with any more papers, let alone the problem we are considering today. I do not mean to sound silly about this, but I started work at six o’clock in the morning and normally finished at six in the evening every day. There are only so many hours in the day, so I just felt I was sitting on so many committees, I had so many responsibilities, I just had to start shedding some if I was to remain effective.
MS GOLDING: Thank you.
THE CHAIRMAN: Now is the final opportunity for counsel to come back to you with any questions they may have. Ms Smith?
Further re-examined by MS SMITH
Q There are two matters, sir, which I would like to raise. The first is that when Ms Golding asked you questions the first time, Professor Zuckerman, you made a number of comments relating to the conduct of what you described as research workers seeking publicity, being told that they must not speak to the media and then it happening and happening in particular at the times of public holidays. You referred throughout to the research workers and in those circumstances I think the first think I have to ask you is, to whom you were referring when you said that.
A I was referring to Dr Wakefield and Dr Montgomery.
Q The second matter is this. I would like to put in a document. You were asked by Mrs Dean whether you had taken up Professor Hull’s suggestion of an independent review, you recall, and you said you consulted Professor Brent Taylor in the Department of Child Health, who felt that the matter should be pursued and he expressly referred to the letter which Professor Taylor sent. In fact that letter is not in the bundle, because it is one of the letters which there were objections to and which was removed. I think in those circumstances, it should go back in. It is page 950, sir, and it will go in bundle 3. (Same distributed) Is that the document you were referring to, Professor, which sets out Professor Taylor’s views on the whole matter?
MS SMITH: Thank you. I have no other matters.
THE CHAIRMAN: Mr Coonan?
Further cross-examined by MR COONAN
Q Professor Zuckerman, there is just one short matter I want to clarify with you. It arises out of the question put to you by Dr Kumar. You were describing a media committee meeting before the press briefing and also a further briefing and you said that you thought that the participants at the press briefing were all there and you appeared to say at both pre conference meetings.
Q Do you have a very clear recollection of both those occasions?
Q If I were to suggest to you on instructions that whereas Dr Wakefield was present at the media committee meeting but not present at the second meeting, would you be in a position to dispute that?
A No, I am not able to do so.
MR COONAN: Thank you very much.
MR MILLER: I have no questions.
MR HOPKINS: I have no questions.
Questioned by THE LEGAL ASSESSOR
Q I have one matter to clarify, Professor Zuckerman, before you go regarding a question that you were asked second time round by Ms Golding. Would you turn to page 293, the minutes of the ethical practice subcommittee. She noted that you had left and she asked whether you had been concerned at all, on the next page, with this research, 172-96. If you turn back in that bundle to page 244, this is when the proposal was first distributed to members for them to look at in anticipation of that meeting and we can see that your name is not on the distribution list.
A That is correct.
Q In fact, it was not distributed to you and you did not see it.
A No, I did not.
Q You had gone from the Committee before it was circulated.
A That is correct.
THE CHAIRMAN: Thank you, Legal Assessor. Professor Zuckerman, I thank you on behalf of the Panel for giving us most of your Friday and today to help this Panel with its inquiry. I thank you and you are now released.
A Thank you, Chairman. I would like to thank all of you for your courtesy. I hope you appreciate that this has been a very trying experience indeed for me to have to give evidence under these circumstances in the case of three members of my staff and my colleagues; it has been very trying indeed but I thank you for your courtesy.
THE CHAIRMAN: We fully appreciate it and we understand it. Thank you again and, as I have said, you are now released.
(The witness withdrew)
THE CHAIRMAN: Ms Smith, I am looking at you to see who your next witness is. I am also looking at the time: it is 2.50. Would you prefer that we have a break now rather than breaking shortly after you start examining the witness?
MS SMITH: I am entirely in your hands as to which you would prefer. There are a number of documents that have to go back into the bundle which I am going to be asking this witness to deal with and it would be quite helpful for me to be able to do that all at once rather than having to keep doing it whilst the witness is in the witness box. Perhaps we could do that first.
First of all in volume 2, page 615. You have this document but it is very difficult to read; it is a document entitled “Writing for The Lancet”. (Same handed to the members of the Panel)
THE CHAIRMAN: This is a better copy than the one we have. Would it be better if we remove the first copy rather than having two copies in the bundle with the same number?
MS SMITH: That is a very good idea. Remove your pages 615 and 616 and put in the fresh copy.
The next documents are pages 1207 to 1209 in volume 3 which is an extract from The Lancet. (Same handed to the members of the Panel)
The last is also in volume 3, it is also an extract from The Lancet entitled “Editor’s reply” and it is on page 1217. (Same handed to the members of the Panel)
Sir, that gets us off hopefully to a nice clean start and I am now in your hands as to whether you would like me to call Dr Horton or whether you would like to have a short break before doing so.
THE CHAIRMAN: I think it would probably be better that we have a break because I never think it right that, within minutes of starting, you have to break. We will now adjourn and resume at 3.15.
(The Panel adjourned for a short while)
MS SMITH: I call Dr Horton.
RICHARD CHARLES HORTON, Affirmed
Examined by MS SMITH
(Following introductions by the Chairman)
Q Dr Horton, would you begin by telling us your full name and your address.
A My name is Richard Charles Horton and I live at XXX.
Q I think it is right that you are presently the editor-in-chief of The Lancet.
Q And you held that post in 1996.
A In 1995.
Q You qualified in medicine from the University of Birmingham in 1986; is that right?
A That is correct.
Q I think that you did your general medical training in Birmingham and you were for a time a clinical research fellow in fact at the Royal Free Hospital.
A Indeed, I was.
Q Can you tell us the nature of the specialism with which you were involved at the Royal Free.
A I went to join the academic department of medicine at the Royal Free in 1988 to be a clinical research fellow in the laboratory of Dr James Owen and that was in the department of hepatology.
Q You joined The Lancet in 1990; is that correct?
A That is correct.
Q As assistant editor and the reason why I went to 1996 is because that is the beginning of the events with which we are concerned but you in fact became editor-in-chief in 1995.
A That is right.
Q Doctor, remembering that there are lay members on the Panel as well as medical members, can you tell us the nature of The Lancet as a journal. What subjects does it cover?
A It is a general medical journal that publishes a mixture of academic medical research covering both clinical and public health specialties, educational reviews and also opinion, analysis and comment.
Q In broad terms, can you tell us what your readership is and who it is aimed at.
A It has a predominantly medical audience, in particular academic specialists, I would say, and about 80 per cent of our readers are outside the United Kingdom.
Q Before we talk about the events which bring you here today, I want to ask you some general questions about the standard procedure for the submission of papers to The Lancet. Are they considered by a group of editors?
A They are. We have about 12 editors, a mix of physicians and scientists, who evaluate papers when they first are submitted to the journal. We receive about 10,000 submissions every year and those are triaged to those editors who read them and make an initial decision about whether they should be pursued or not.
Q In 1995 when you became editor-in-chief, did you in fact implement a new system for some degree of peer reviewing?
A Yes. As you pointed out, I first joined the journal in 1990 and then I worked in the United States for two years prior to 1995 and I was fortunate enough to be able to observe peer review systems at some of our competitor medical journals and I had become anxious that our peer review systems were somewhat falling short of our competitors. So, when I became editor in 1995, I wanted to upgrade the procedure, which meant that we extended the number of editors who read the papers, we instituted a formal weekly meeting to discuss papers, we entered a summary of the decisions about each paper as a minute in a logbook and we were much more careful about the nature in which peer review was conducted, increasing the number of reviewers for each paper in particular.
Q When you considered the decision making which you say you recorded in a log, was that at weekly manuscript meetings?
A That is right. Every Thursday afternoon, we have a weekly manuscript meeting. I guess that we all learn from our experience and, for me, it was a little like a weekly ward round. Editors are assigned manuscripts, they present those manuscripts to the whole editorial review group and then the papers are debated and discussed amongst the review group.
Q Who generally chaired that weekly manuscript meeting?
A When I am in London, I do.
Q If we may go back to the period with which we are concerned which, as you know, is 1997/beginning of 1998, can you take us through the way the procedure goes from the paper arriving on the mat in The Lancet front door, if it arrives like that. It is looked at/triaged to see if it is potentially suitable and who did that at that time?
A The procedures then are somewhat different to what they are now but, at the time in 1997, of course we did not really have electronic submission and so all papers literally did arrive on the mat as you described. The initial triage was conducted either by myself or the deputy editor. The way in which that would work would be that, on a daily basis, the manuscripts, something like 10 to 20 per day, would be read by one of us. We would decide who was most appropriate to take that paper on more formally, that is to say which of the editors. The editor would read the paper, would usually consult one or two of his or her colleagues about the appropriateness of the paper for further peer review. The initial editorial submission was based – and is still based – on a set of criteria for a general medical journal and those relate to whether the paper is suitable for a general medical readership, whether the work is original, has not been reported before, whether it is topical, so discusses a matter that would be of current concern, and also obviously the question of validity enters the debate: is it likely that the results reported in the paper are true? Once the paper is sent to an internal editor, then that person will decide about sending the paper out for external peer review.
Q What dictates that decision? Can he reject it at that stage?
A Most certainly and about 60 per cent of papers are rejected without peer review..
Q If he decides that it is appropriate to send it out for peer review, at that stage, how many reviewers would it go to?
A The paper would be sent to three external reviewers plus a statistician. It is very important to have a statistical adviser take a look at the design of the study.
Q Remembering that we have lay members, would you say briefly why that is the case. Is that to do with whether the number of samples is sufficient?
A I apologise. Yes. One of the critical questions when one is thinking about the validity of any study is, what are the likely sources of error and are the claims being made in the paper strong enough from a statistical point of view? A statistician or what is also sometimes called an epidemiologist, somebody who specialises in the mathematics of studying human diseases, would take a look at the paper to decide whether the claims were sufficiently justified based upon the contents of the manuscript.
Q If the editor who is in charge of it decides that it should go out for peer review and it goes out to your three reviewers, who chooses them?
A Those decisions would be made by the editor sometimes in consultation with colleagues.
Q Will those reviewers be doctors with the relevant specialism who are in ordinary practice and nothing to do with The Lancet?
A Yes, they are certainly nothing to do directly with the journal. Usually, they will be specialists, most often investigators, concerned with different aspects of the research study and often not just in the United Kingdom but researchers from outside the UK.
Q Once that process is complete, they have seen the paper and written reports on it, what happens next?
A Those reports back in 1997 would have been sent in my mail, collated by the editor and, when all the reports were available, then he or she would present the paper plus the peer review comments at the Thursday afternoon editorial meeting and the debate would ensue.
Q Is it customary for people who have reviewed the paper to say critical things as well as positive things?
A Extremely, yes, very much so.
Q How do you handle those as far as the authors of the paper are concerned?
A We have two separate components. They say things that they are happy to be transmitted to the authors and they also provide confidential comments that they say they report to the editors, which often presents us with a tricky situation because they are frequently very polite to authors and somewhat less polite when they are discussing a paper in front of us privately.
Q On those parts that they are happy to have relayed to the authors, do you discuss any criticisms that have been made?
A On the Thursday afternoon meetings?
Q Or at all?
A We certainly debate all the pros and cons of the paper at the manuscript meeting and make a decision then whether we are going to reject the paper, seek further opinion or open negotiations with the authors.
Q Will there be, at that state, any general discussion about other matters which might be relevant to publication?
A Certainly we will be discussing whether the paper has aspects of it that might cause controversy and should be considered in judging a paper, whether there are any conflicts of interest that should be taken into account in considering the paper or any other aspects of the work that might have cause for concern.
Q At the end of that meeting, do you then make a final decision as to whether you are going to reject the paper or admit it for publication?
A Three options: either to reject, to open negotiations or to seek further opinion.
Q Can you tell us what open negotiations means?
A That means that if there are questions raised by one or more of the peer reviewers that we think require explanation or further elucidation in a revised manuscript by the authors, then we will go back to the authors and say please can you take a look at your paper, in the light of these reviewers’ comments, and make the necessary adjustments. They hopefully will take account of those questions, submit a revised version of the paper and then we go back into a Thursday afternoon discussion to decide whether that is acceptable or not.
Q The third option you said was to seek a further opinion. Is that over and above the peer reviews you have already had done?
A Yes, that is right. Particularly I would say now that is quite a common option but back in 1997 it was less common.
Q I want to turn, if I may, to the paper that you know we are concerned with which was submitted to The Lancet by Dr Wakefield, Professor Walker-Smith, Dr Murch, as he then was, and other authors. It is in the bundle which is marked FTP 2, at page 783. Is that the paper as ultimately published in The Lancet.
A I remember it well.
Q Can I ask you, first of all, prior to the submission of this paper did you have any personal contact in respect of this paper with either Dr Wakefield or any of the other authors?
A No, I did not.
Q Had there, to your knowledge, been previous submission of papers to The Lancet by Dr Wakefield?
A Yes, several. In fact, there was quite a long-standing series of papers that Dr Wakefield and different sets of colleagues had submitted to the journal over preceding years. Certainly, when I was at the Royal Free, he had become a very well known investigator in gastroenterology circles at the time because he had published in The Lancet, before I joined the journal, a paper that was much debated and discussed about the possible origins of Crohn’s disease.
Q As far as this paper was concerned, who was the editor was responsible for taking it through the peer review process?
A One of my colleagues then, Dr John Bignall.
Q Do you have any recollection of the peer reviewers who were nominated by Dr Bignall?
A Only one, I am afraid, Professor Candy.
Q Do you have any recollection or are you assuming that it would have been the norm as far as the number of others who were concerned?
A Yes, it would have been the norm to have sent it to three external advisers and a statistical reviewer.
Q Do you have any recollection of the nature of the reviews that were received?
A From what I can recall, there were two aspects that were most important. The first was that all of the reviewers remarked on the original nature of the description of the syndrome and felt that this was something that merited consideration for a general medical journal but there was concern about the reporting of the parents’ testimony relating to a possible temporal link with MMR vaccine.
Q We have the log book for when the paper was first discussed. I think it is right, I should say, so the Panel is clear, the actual reviews are no longer available?
A I am afraid that is so.
Q We do have the log book. If you look in the same volume, page 637, we see, in the middle of the page, the left-hand number is a manuscript number, is that correct?
A Correct. That would have meant it was submitted in November, so the first two digits reflect the month, then the next set of digits the simple sequence with which it was entered up by our office.
Q We are about ten figures down at 11096 “new GI syndrome in children”, is that correct?
A Correct, and JB refers to John Bignall under “Ed”.
Q What is the last column?
A The last column is about the decision about the paper. You can see we received two papers: one describing a new G I syndrome in children, and then a second attempting to define the cause of that syndrome. Both papers were taken through peer review by Dr Bignall. The first one, PP means put points, so a set of manuscript reviewer points were put to the authors, and the second paper was rejected after peer review.
Q As far as the title “A new G I syndrome in children” was that of any legal relevance, the title you have given it there?
A This has been a source of much discussion in the past eight or nine years. Many people have focused on the fact or asked the question was The Lancet in some way supporting the linking of MMR vaccination with this syndrome. From our point of view, when we first received the paper, the parental testimony was actually incidental. The central thrust of the paper was this new syndrome. This is not an uncommon kind of report. If you read any text book of epidemiology, the very first description of any new syndrome often comes with either a case report or a case series. If you go back and look in history at, for example, the first reports of HIV and Aids, the first reports of variant CJD, they all began with a simple case series very much like this one. Then it is quite typical for the investigators to ask, and it is their obligation to ask, the families or the patients “Do you have any thoughts yourself about any behaviours or activities you might have done that might have precipitated this syndrome?” For example, if you go back and look at the first reported series of Aids or variant CJD you see questions like that raised and the answers are very speculative. In this case, again, the answers were very speculative. Eight of the 12 families put potential temporal link with MMR vaccination was made. That was very much supplemental to the major theme of the paper which was this new syndrome.
Q Before I turn you to another page, I just wanted to complete things. As far as the second paper, which you rejected, was concerned, did that come from the same research group?
A It did come from the same research group although I cannot recall, and I do not have a record, of exactly what the authorship of that paper was. I do not recollect.
Q Can you help us as to its nature at all?
A From what I can remember, this was a laboratory study trying to identify what the possible cause of the new syndrome was. From what I can remember, this was an attempt to try to isolate a component of the MMR vaccine with this syndrome.
Q Without that paper, the paper with which we are concerned, the 11096 paper made only the temporal link, is that correct, with the MMR vaccine?
A That is exactly right. Not only did it only make the temporal link but it was made very clear in that paper that such a temporal link was not a proof of association, moreover that there was no published evidence to support any association between the vaccine and the new syndrome.
Q If you turn back to the paper, page 783 and go on to 787, the discussion session, we see, in the left-hand column:
“We did not prove an association between measles, mumps and rubella vaccine and the syndrome described. Virological studies are underway that may help to resolve this issue.
If there is a causal link between measles, mumps and rubella vaccine and this syndrome, a rising incidence might be anticipated after the introduction of this vaccine in the UK in 1988. Published evidence is inadequate to show whether there is a change in incidence or a link with measles, mumps and rubella vaccine.”
Then it goes on to the possibilities of a pre-disposition. Do you recall if that paper was, so far as you can remember, in the original submission, the paper originally submitted?
A Those sentences? I certainly remember that “we did not prove an association”, that sentence, was in the final accepted manuscript, yes.
Q When the paper was submitted to you and considered at the manuscript meeting and logged as we have seen with PP beside it, were various amendments then made to the paper in agreement with the authors?
A Yes, that is absolutely routine practice in peer review. Often quite substantial change to papers are made.
Q Then ultimately a decision has to be taken as to whether to publish with those amendments in place, is that correct?
Q If we go back to page 645 we see, the fourth entry down on that page, 11096, now called “new syndrome in children”, is that correct?
Q We see the editor initials JB and then “accepted as ER”, although it is cut off, is that right?
A Yes. ER stands for early report.
Q Rather than asking you to explain that, I would like to go back to look at a description which is given in a editorial which deals with writing for The Lancet, page 615, on the left-hand side, half-way down the page:
“Early reports may simply be preliminary, the first results from a study, whereas subsequent analysis is planned, for example, of an incidental interesting observation from a study set up with another purpose or they may be early in the sense of being well short of changing clinical practice. These papers will tend to be shorter than articles.”
Does that broadly sum up what is meant by early report?
A Yes. What we were trying to do then - and I should say we have dropped the section Early Reports in more recent years - was to offer the opportunity for researchers to identify something at a very early stage before we were absolutely cast solid certain that what was being reported was totally factual. It gave the opportunity for new ideas, for innovation, to be included in the medical literature which we thought was an extremely important function of a medical journal.
Q This report was categorised as an early report and indeed it appears at the top of the actual paper. Can you help us as to which category it fell into? We see here two categories: the first results from a study where a subsequent analysis is planned, or an incidental interesting observation from a study set up with another purpose. Did you have any need to analyse?
A You are very generous in crediting our categorisation in precise terms. The way we felt about early reports was: is this a preliminary observation; is this raising something that is completely original that requires more in-depth investigation to confirm whether it is absolutely true or not. What we were trying to do in instructions to authors, because you can never cover every eventuality in written guidelines, the closest it would come to would be may be early in the sense of being well short of changing clinical practice.
Q I think it is right that when it was actually published it was published with a commentary.
A Yes. There were several mechanisms that we tried to focus on for making sure that when this paper was published it would not cause an adverse public health impact: one was obviously the statement that was obvious already in the paper about no proof of causation or association; a second was making sure that this paper was identified as an early report; but third, and possibly most importantly, we wanted to have external respected experts in measles eradication and control to offer their view. For us the comments that we published was vital in trying to set the context, which was essentially look at this paper with an open mind but please remember that measles vaccination has saved many hundreds of thousands of children’s lives and in considering this first report do not let it have an adverse effect on measles vaccination.
Q Can I ask you, first of all, how common was it at that the time for you to commission this commentary? You commissioned this commentary, is that correct?
Q How common was it for you to commission a commentary to go with a paper that was being published?
A Not uncommon if we were concerned about the interpretation of a paper but much less common than it is today. I would say today in almost every case a research paper will have a comment running with it.
Q Is the comment sought from somebody wholly independent from The Lancet and the researchers?
A Independent of The Lancet certainly. It is very hard sometimes to have people who are completely independent of the investigators. They are often experts in the field and fields, even globally, are often quite small. They will almost certainly be aware of the research or be aware of the investigators. They may even know the investigators very well professionally but we hope they will give an independent judgment about the quality and meaning of the paper, yes.
Q Your commissioning of it in the context of this paper. You have told us that as far as you were concerned, the reference to the link with MMR was relatively tentatively expressed. Did you nonetheless have concerns about the impact it might have?
A We did have concerns. These concerns were raised by the reviewers of the paper and they were also raised by my colleagues and myself in discussion of the paper on a Thursday afternoon. It was clear that if we were going to move ahead and publish this paper, we had two options: either we erased or asked the authors to erase the parental testimony about the possible temporal association with MMR vaccine or, if we were going to publish, we keep that in, but we give as much context as we possibly can.
Q If we could look at the commentary at page 788, it was commissioned from Robert Chen and Frank DeStefano, who work at the Vaccine Safety and Development Activity National Immunisation Program in Atlanta, Georgia. Is that correct?
A Correct. I think just to clarify, the Centre for Disease Control and Prevention is an internationally recognised centre for public health, based, as it is, in the United States, but with very strong global recognition.
Q If you do not mind bearing with me for a moment, just so the Panel can see what this is about – I am not going to read the whole of this, but if we can just run through it – we can see it says:
“Although immunisations rank among the most important public health measures, no vaccine is perfectly safe. Because vaccines are given to millions of healthy people, usually infants, extremely high standards for vaccine safety are demanded. It is therefore important to examine, critically and with an open mind, the report by Andrew Wakefield and colleagues of several children whose chronic bowel and behavioural abnormalities were linked by their parents and physicians to measles, mumps and rubella (MMR) vaccination.”
Then it sets out the various ways that adverse events of a vaccine can be said to be caused:
“ .. if it is associated with a specific laboratory finding and a specific clinical syndrome or both. Alternatively, a clinical or epidemiological study is needed to find out whether the rate of a given syndrome in vaccinated individuals exceeds that expected among unvaccinated controls. Such studies require acquisition of data in an unbiased way. Because of the inherent methodological limitations of epidemiological studies, biological plausibility, consistency, strength and specificity of association must also be considered in inferring causation. How well then do the features of the association reported by Wakefield and colleagues fit with causality?”
Then they point out:
“First, hundreds of millions of people worldwide … have received measles-containing vaccine without developing either chronic bowel or behavioural problems sine the mid-1960s. This finding provides important negative evidence as well as an appropriate framework for the assessment of [the paper].”
It goes on:
“Is the syndrome reported today clinically unique? Ileal lymphoid hyperplasia is non-specific. Autism was known well before MMR vaccine became available. Are there unique laboratory features, including detection of vaccine viruses in clinical specimens where they would not be expected? Although Wakefield has reported the detection of these viruses in patients with inflammatory bowel disease (IBD), other investigators, using more sensitive and specific assays, have not been able to reproduce these findings.”
Then it refers to a negative report which was actually in the same copy of The Lancet. It goes on:
“There is no report of detection of vaccine viruses in the bowel, brain or other tissue of the patients … ”
Then they look at the epidemiological questions:
“Is there selection bias? The Wakefield report is based on cases referred to a group known to be specially interested in studying the relation of MMR vaccine with IBD, rather than a population-based study. A first dose of MMR is given to about 600,000 children every year in the UK, most during the second year of life, the time when autism first becomes manifest. Not surprisingly, therefore, some cases will follow MMR vaccination. Biased case-ascertainment, as in this study, will exaggerate the association.”
Then it says:
“Was there recall bias. It is usually difficult to date precisely the onset of a syndrome such as autism. Parents and others may attempt to relate its onset to an unusual event such as coincidental postvaccinal reaction. The clearest example of such an association was the link between infantile spasms and pertussis vaccine;”
That is, the whooping cough vaccine –
“ … the vaccine tends to unmask rather than cause the syndrome.
There are other reasons for doubt about the association reported by Wakefield and colleagues. They suggest that MMR immunisation may lead to IBD, which results in malabsorption, consequent neurological damage, and ‘autism’. However, behavioural changes preceded bowel symptoms in almost all their reported cases.”
They go on to say:
“Vaccine-safety concerns gain prominence whenever the incidence of vaccine-preventable diseases falls to negligible levels and when the number of vaccine adverse events, whether true reactions or those coincidental to the vaccination but falsely attributed to it … rises as a consequence of high vaccine coverage. False attribution usually occurs because many developmental abnormalities first manifest in the early years of life, which is also when several vaccines – which can cause crying, fever, and, occasionally, febrile seizures – are given.”
Then it underlines the need for effective and credible systems for the detection of vaccine associated adverse events and it ends, you may think, rather prophetically, by saying:
“Without such a system, vaccine-safety concerns such as that reported by Wakefield and colleagues may snowball into societal tragedies when the media and the public confuse association with causality and shun immunisation. This painful history was shared by the UK (among others) over pertussis in the 1970s after another similar case series was widely publicised, and it is likely to be repeated all too easily over MMR. This would be tragic because passion would then conquer reason and the facts again in the UK.”
You published that commentary in those terms, Dr Horton. Did you feel that that was a responsible way forward, given the concerns which you have expressed?
A At the time, most certainly we did.
Q As far as you were concerned, did it highlight the criticisms which could be made in relation to the paper which you were publishing?
A It highlighted the criticisms that, as I recall, were made at the peer review stage, the concerns about possible bias. It highlighted what we were most anxious about, which was any adverse effect which might follow on MMR vaccination, but it also, fairly, we thought at the time, said, “Treat this study with an open mind.”
Q Did the paper in fact result in a very significant amount of correspondence to The Lancet?
A I think you might say that!
Q You say it in that tone of voice. Tones of voice do not always come over in the transcript. Are you suggesting that it was exceptional?
A Well, remember the context. The context was that when the paper was published, it was not published in a medical journal; it was launched, I think would be an appropriate word, at a press conference where other statements were made which were radically different from the statements made in the paper.
Q As far as the press conference is concerned, I think it is right that you did not attend. Is that correct?
A That is correct.
Q But Dr Bignall, the editor directly involved, did attend.
A That is correct.
Q You obviously cannot tell us anything about the press conference, because you were not present, but what I would like you to deal with is this. Did The Lancet have anything to do with the arranging of that?
A No, it did not, sadly.
Q How usual is it as an occurrence for there to be a press briefing or conference prior to the publication of a scientific paper?
A It is not common, but it is increasingly so, because often institutions, funding bodies and authors themselves want to make a splash of their paper to get more publicity for it, especially if it has something important to say. That can be for wholly good reasons. If there is a concern about the efficacy of a treatment or the adverse effect of a treatment, then it is very important that that gets wide publicity.
Q We have in the bundle an example of some of the correspondence which was generated. If you go to page 818, please – I am not going to take you through all that correspondence, Dr Horton, because I am going to invite the Panel to take some time at the end of your evidence to read the documents which we are producing – but just dealing with it very briefly, from page 818, this is the March edition of The Lancet, the paper having been published in February, we see the first letter, for instance, from the Programme on Immunisation of the World Health Organisation, the second one is from the Department of Public Health at Barnsley Health Authority. Then we have a letter which seems to come from a personal address and then at page 819 one from the Scottish Centre for Infection and Environmental Health. Going over to page 820, one from the Institute of Child Health. Would it be fair for me to summarise it by saying that those letters were mainly concerned with concerns as to the public health implications of the paper?
A Oh, absolutely.
Q We see underneath that on page 821 a reply by Dr Wakefield. Again, would it be the norm for you to give publication room to the author of a paper, if that paper has been the subject of significant criticism?
A Yes, indeed. We would consider it a fair way to conduct the debate that there would be responses, but in the same issue allow the original author to respond or in this case, as you can see, the authors divided in their responses.
Q We see, as you say, one from Dr Wakefield and then one from Professor Murch,
Dr Thomson and Professor Walker-Smith. At the end, we see also your own reply:
“The Lancet has been quick to criticise scientific and journalistic exuberance about the release of data that might unduly aggravate public concern. By contrast with these past episodes and with the implied criticism in the letters we publish this week, the paper by Andrew Wakefield and colleagues is an example of how researchers, editors and those concerned with the public’s health can work together to present new evidence in a scientifically balanced and careful way. Wakefield et al informed the UK Department of Health of their findings in 1997 and supplied them with a final copy of their Lancet paper in advance of publication.”
You then say, “(Wakefield A.J, personal communication)” So this arose as a result of information which Dr Wakefield gave to you. Is that right?
A That is right, yes.
Q You say, “There are at least four parts to this story.”
A I should just say, I do not have the second page of that. It goes on.
Q I think that is the end of your reply in relation to the correspondence.
A I think I probably would have gone on to explain what the four parts of the story were. Otherwise it would have been an extremely negligent reply on my part.
Q I had assumed you had done it in the later part of your editorial. In that case, we must find the remainder of it. Mr Coonan is looking as if he might be able to assist.
MR COONAN: It is not in the papers, any papers that I have seen. I have had to hunt it down. I have a copy, obtained very recently.
MS SMITH: Then perhaps Mr Coonan would be kind enough to share it with us.
MR COONAN: I am afraid it has scrawling on it. We can perhaps find it and provide it to Dr Horton in an appropriate state tonight.
MS SMITH: Sir, I see it is four o’clock. I do not know whether you were thinking of rising at 4.30. I will tell you why I am asking that now. I was going to invite you to read some of these documents to yourselves as we went along, rather than me reading them all out to you. It seems to me that it might be a helpful use of the next 20 minutes for you to read this correspondence. That would give us time to get hold of the last page.
THE CHAIRMAN: I think that is quite appropriate. We will now go into camera for the next 20 minutes or so to review these documents which have been given to us and advised by Ms Smith to go through. Maybe that document can be found for Dr Horton for tomorrow morning, the complete document, so he can be fully informed of the evidence at that stage.
MS SMITH: Sir, as I say, if you were to read the correspondence between pages 818 and 821, namely, the letters which were sent and the replies of the authors, that would get us up to where we are now. I should warn you that I may ask you to do it later on in respect of other long passages.
THE CHAIRMAN: I think that is absolutely fine. I do not see any difficulty with that. We will now do some reading in camera and we will resume at 9.30 tomorrow morning. Can I advise you, Dr Horton, that you are under oath and in the middle of giving evidence. Please make sure – it is never a right thing to do to leave a witness under oath overnight, but I am sure you will be able to observe this – that you do not discuss this case with anyone.
A Of course.
MS SMITH: Sir, apropos of that, firstly, I would like Dr Horton obviously to have the last page of his reply when we can find it. Secondly, there are a number of other documents which Mr Coonan has provided me with in advance which I would also like him to have the opportunity to look through overnight. So perhaps we might be permitted to give him those before he leaves, but obviously we will not discuss any other matters.
THE CHAIRMAN: Yes. Again, I do not see any difficulty with that. Mr Coonan, have you any objection to that?
MR COONAN: Absolutely none. It would be an excellent idea. I can also say that I have managed to lay my hands on this missing page and this version is unmarked. Would you like to receive it now?
THE CHAIRMAN: We can receive it, yes. Obviously Dr Horton has to read it before he is asked any questions on it. Yes, it can be circulated now.
MR COONAN: Can I just clarify one thing? You have been invited to read a certain number of documents, as I understand it from page 818 to page 821, with this new page being page 821A. There are of course many other pages and, as I understand it, you are not being invited to read those at this stage. Is that right?
THE CHAIRMAN: I think at the moment, we only have about 20 minutes, so probably that will be enough, but we will be doing further reading and will continue to do further reading. If you think at any stage that there are page numbers which you would wish us to refer to and read at our quieter times, then we will be very happy to receive those.
MS SMITH: I think I did convey that. It is obviously not appropriate for you to read ahead of Dr Horton’s evidence, because you need to hear what he has to say about it. When we get on to a topic, if there seems to me to be too much paper for it to be sensible to read it into the transcript, then I will suggest we have a 20-minute break while you read up.
THE CHAIRMAN: At this stage, we will only receive document 821A, we will read pages 818 to 821, but we will not do any further reading, as Ms Smith has suggested. We will wait to hear Dr Horton first of all on that.
THE WITNESS: Just to clarify, do you want me to do anything apart from turn up tomorrow at 9.30?
THE CHAIRMAN: Unless either Ms Smith or Mr Coonan has any objection, I think it would be right and proper for Dr Horton to have a look at page 821A and maybe if he wishes to take a copy of it, he may take a copy of it with him to read and then give evidence on it tomorrow morning.
MS SMITH: All I would like Dr Horton to do is not to shoot off too quickly because we are going to give him a copy of that page and we are also going to give him a small file of papers which Mr Coonan has produced which he may be wanting to question him about in order that he has the opportunity to read it overnight, but it is a very small file.
THE CHAIRMAN: You have your answer, Dr Horton.
A Perfect! Thank you.
THE CHAIRMAN: We will have the page circulated. (Same handed to the members of the Panel)
(The Panel adjourned until Tuesday 7 August 2007 at 9.30 a.m.)