GENERAL MEDICAL COUNCIL
FITNESS TO PRACTISE PANEL (MISCONDUCT)
Friday 3 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, Sworn
Examined by MS SMITH 1
Application for an adjournment by MR COONAN 38
Reply by MS SMITH 39
Reply by MR COONAN 41
Legal Advice 41
THE CHAIRMAN: Good morning, everyone. Ms Smith, we finished with the evidence of Dr Cartmel yesterday late afternoon.
MS SMITH: Yes, sir. I am going to call Professor Zuckerman in a moment, sir. There was just one thing I wanted to say to the Panel first arising out of you requesting us to slow down a bit on the GPs yesterday, and that was to proffer some reassurance – and obviously I am only speaking for the GMC but I suspect I could be speaking for the defence as well – which is that we will certainly be, at the appropriate moment in this case, presenting chronologies which set out the relevant medical records that we have been going through with the GPs. I just wanted to reassure you; obviously we will be visiting and revisiting these medical records throughout this trial as various different appropriate witnesses come into the witness box, but I wanted to reassure you of that as well in case it assists you.
THE CHAIRMAN: I am very grateful to you for that suggestion. The Panel will find that exceptionally helpful and I do hope that the defence will co-operate on these issues.
MS SMITH: I am sure they will. I am now going to call Professor Zuckerman, please.
PROFESSOR ARIE JEREMY ZUCKERMAN, Sworn
Examined by MS SMITH
(Following introductions by the Chairman).
MS SMITH: Thank you very much, sir. Professor Zuckerman, we are a long way away from each other, I am afraid, so tell me if you cannot hear me and, equally, can you remember that it is a big room which has to hear you, so if you could keep fairly close to the microphone it helps. Would you first of all give us your full name, please, and your address? You are an emeritus professor at the Royal Free and you may give that address if you prefer to.
A Yes, my name is Arie Jeremy Zuckerman, Emeritus Professor of Microbiology, and my address is the Royal Free at University College Medical School, the Hampstead campus.
Q Thank you. You have been kind enough, Professor Zuckerman, to produce a CV and I would like to have a look at that first of all just briefly with you. You should find that you have a bundle which has got 7 on it. It says FTP7 and if you could turn to page 16 in that.
A Thank you.
Q As you know, we are concerned with events in 1996; is it right that your position then was Professor of Medical Microbiology in the University of London from 1975 until 1999.
Q And you now occupy that as an emeritus post, a retired post.
Q You were Honorary Consultant in Medical Microbiology at the Royal Free and also Principal and Dean of the Royal Free School of Medicine from 1989 to 1998.
Q Then when that became the University College Medical School you continued on from 1998 to 1999.
A That is correct.
Q Thank you. As far as your other appointments are concerned, Professor, just running down that CV, you were Honorary Consultant Virologist to the National Blood Authority, Director of the World Health Organisation Collaborating Centre for Reference and Research on Viral Hepatitis and Viral Diseases and Editor-in-Chief of two journals connected with virology, is that correct?
A That is correct.
Q Thank you. If we look on further into that document, I do not propose to go through it all but we see from page 20 that you are the author of a number of textbooks.
Q And on 21 that you have made over 1000 contributions in the sense of scientific papers to various medical journals.
Q Thank you. I realise it is clear on the face of the documents, Professor, but remembering that there are lay members of the Panel as well as medical members, can you just explain in lay terms what your specialty is, your medical specialty?
A My medical specialty is clinical virology which deals with infections of man by a variety of viruses and, in addition, I have had considerable experience in epidemiology and immunology in the evaluation and development of vaccines. My principal interest over the last 40 years or so has been safety and evaluation of vaccines and viral hepatitis in particular, in all its forms, and the development of chronic liver disease associated with viral hepatitis, including liver cancer. So it is a fairly wide range of medical specialty but the emphasis has been on viral vaccines and viral hepatitis.
Q Thank you. Can you also tell us what responsibilities, just in general terms, did your post as Dean of the Medical School involve?
A I suppose the role of the dean is to be the academic head of the school and also to serve in a way as the chief executive of the medical school, and I was also the budget-holder, so it had wide-ranging responsibilities.
Q Thank you. You have been asked to look by the General Medical Council at a large number of documents and I am going to take you to those and ask you about some of them. Can I just emphasise, both for your purposes and the purposes of the Panel, what is important is what you wrote at the time so if you could try when you are explaining things to put your mindset back to then rather than looking at them retrospectively, I think it would help us all, thank you.
A Of course.
Q First of all I just wanted to ask you some questions about the nature of Dr Wakefield’s post at the Royal Free. Was he first appointed at the Royal Free Hospital School of Medicine as a research fellow?
A Yes, that is my understanding. He was appointed to the Royal Free before I arrived there.
Q Under whose supervision did he work?
A He worked under the supervision of Professor Roy Pounder, at the time Dr Roy Pounder.
Q Did there come a time when he was promoted to a senior lecturer at the Royal Free Hospital Medical School and honorary consultant at the Royal Free Hospital?
Q Then a promotion in 1997 to a reader in experimental gastroenterology.
A That is correct.
Q In broad terms can you explain the nature of an honorary consultant post?
A Well, this is a reciprocal arrangement between the hospital and the medical school whereby senior lecturers and above are offered normally honorary consultant appointments in the hospital, in the same way as the consultants in the hospital are offered honorary senior lectureships in the medical school. It is basically a reciprocal arrangement between the two institutions and I should point out that the relationship between the Royal Free Hospital and its medical school was particularly close, closer than I have encountered in any other institution.
Q Thank you. You can put aside and you will not need again the bundle you have got in front of you, number 7, you can put that away altogether. Would you take bundle FTP1 and turn to page 41.
A Yes, I have it.
Q That was a letter in fact to Mr Cooper who was then the chief executive but it was copied in to you and it approves the honorary consultant contract with no clinical sessions for Mr Wakefield. Full title: consultant in experimental gastroenterology and enclosed his job description.
Q As tabled at the CSC. If we look at the next page, 42, this is a document that we have looked at before but does this just set out that Mr Wakefield was the research director of the IBD Study Group and it sets out his academic activities and, at the bottom of the paragraph, that he was not to be involved either in the clinical management of patients with inflammatory bowel disease or the routine histopathological reporting of tissue from those patients, not involved in the outpatient or inpatient management of patients in the Royal Free NHS Trust and was not to practise as a consultant as part of the appointment, and a daily timetable which consists wholly of research with two Gut Club and Grand Round meetings as well, but other than that research duties mornings and afternoons.
Was that your understanding of the position that Dr Wakefield in fact held, both as a research post and as a clinical post?
A Yes, it was.
Q Thank you. As you know, Professor, I am going to deal with you in relation to a number of different subjects and the first one that I want to ask you about is the documentation relating to some Legal Aid Board funding in relation to Dr Wakefield’s research studies. The first letter I want you to look at in fact is not in your bundle and I am going to hand it to you, and it should go in at page 357A. (Page 357A distributed). This is a document, Professor, sent to Professor Roy Pounder and Dr Wakefield in the Inflammatory Bowel Disease Study Group by a firm who are apparently connected with the raising of funds called Sawyer, Edwards and Butler. Can you assist as to whose handwriting it is on the top of that document?
A It is my handwriting.
Q “Please keep on the file”, is that right?
A That is correct.
Q So we know from that that it was sent to you and if you would look at page 3 this sets out the priorities for 1997. We see, just to put it into context, the first bullet point:
“To continue to make a range of applications for research funding …
To establish an independent medical research charity, to be called the IBD Study Group …”
Then if you go down to the third bullet point:
“To explore community fundraising opportunities. The increasing weight of publicity devoted to the issues addressed by the Inflammatory Bowel Disease Study Group and the attention reflected onto the work by the activities of Messrs Dawbarns, creates an opportunity for the [Group] to attract more general contributions. With your agreement, Mike Butler will formally arrange meetings with JABS, NACC, 3Cs and a few other small organisations with a mutual interest in the activities of the Inflammatory Bowel Disease Study Group to explore collaboration on this issue.”
It then continues with the fact that this company would draft and produce some printed materials and arrange their distribution with the aim of developing a dedicated community fundraising programme.
Do you recall, Professor – and please tell us if you do not – whether you knew who the firm of solicitors Dawbarns was in that letter and whether you picked up on it at the time?
A I certainly picked up on it at the time. The actual timing is very difficult because I heard about this firm of solicitors from at least two different sources, one was the Department of Health and the other one was by letter from Professor Sir David Hull, so it is difficult for me to say chronologically when was the first time that I heard about it unless I see all the documents together, but I was certainly aware of the involvement of a group of solicitors and it did give rise to a lot of concern.
Q Yes. We can see how that concern reflected itself. If you go to page 245, please, in the same bundle.
Q Is this a copy of a letter that you in fact wrote in October 1996 to Dr Armstrong who was the secretary of the British Medical Association?
A Yes, it is.
Q If I can just run through it, Professor:
“Dear Dr Armstrong
I should be grateful for your advice on a potentially difficult situation in which the Royal Free School of Medicine finds itself and on which, therefore, I must take a decision on the position adopted by the Medical School.
A senior member of the School’s Clinical Academic Staff is engaged in research that has become somewhat controversial in that he is suggesting a causal link between the measles virus and in particular vaccination against measles and the onset of Crohn’s disease and inflammatory bowel disorders. Arising from recent widespread publicity given to this research, the Legal Aid board has provided funding through a firm of solicitors representing Crohn’s disease sufferers and we have been asked to make an appointment to the staff of the Medical School, specifically to undertake a pilot study of selected patients. Clearly, this could lead to a case against the Government for damages.
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. It is quite common, of course, for clinical academic staff to be called as expert witnesses in legal cases, both criminal and civil, where they act as individuals although their reputation is clearly based, in large measure, upon their academic and professional appointments. That, however, is somewhat different to this situation and I would find it helpful if you could let me know whether you have come across parallels elsewhere that might provide a precedent and also advise me on the ethical and legal position of the Medical School.”
Could you identify the senior members of the school’s clinical academic staff to whom you were referring?
A Yes, it is Dr Wakefield.
Q As far as you were concerned, the provision of funds for whatever precise purpose by the Legal Aid Board, was that a situation that you had encountered before?
A No, I have never encountered it in my entire academic career, which spanned about 45 years.
Q Did you feel that you understood all the implications that there might or might not be in relation to that source of funding, at the time you wrote this letter?
A Oh yes. I mean, I think, clearly, there was a conflict of interest: that was the first point. Secondly, I was deeply concerned that lawyers were to select patients for investigation. I have never come across that sort of situation before, where research is undertaken by a member of the academic staff and yet the patients are to be selected by lawyers: that seemed to me most unusual, to say the least. Thirdly, I considered very carefully that I have never come across a case where medical facts are actually going to be determined by lawyers, possibly in a court of law: that seemed to me extremely unusual and in fact unacceptable. I also felt that it seemed to me at the time most unusual that lawyers should even attempt to direct medical research. It just seemed to be unprecedented and it did cause me a lot of anxiety and I discussed this with my colleagues, who expressed similar views. None of them have ever come across a situation where the Legal Aid Board was funding a piece of medical research. It more or less appeared as if one was fishing for evidence. That is not the way one carries out clinical research, so I was very concerned, and I felt that since the BMA had a legal department and they would have had a lot of experience on issues relating to this, that it was perfectly reasonable to ask them for advice, because I think the medical school was in a very difficult situation. In any case, I refused to accept that money.
Q I was going to ask you about that, and then just trace through the rest of the correspondence which, as you know, took place between the BMA and the medical school, but as far as the money was concerned, if you just look at page 237, this is not a letter with which you were concerned but it is a letter from Dr Wakefield to the solicitor involved, and we see that it is dated September 1996, and he says there:
“I would be grateful if the initial sum of £25,000 could be transferred to the Royal Free Hospital School of Medicine ..[account details given].. for the purposes of initiating and carrying out the initial phase of this analysis.”
If you would go back to the BMA letter at page 245, which is some three weeks later, at the time were you actually aware, do you recall, whether the medical school had actually received the money or whether it was merely proposed that they should do so?
A I was not aware of this correspondence, nor was I aware that actually money has been paid into a medical school grant at the time.
Q You say that ultimately the medical school did not accept that money.
Q Did you have a part to play in that decision?
A I decided that.
Q As I say, we will go back to the details of the correspondence with the BMA, but in broad terms, why did you make that decision to refuse the money?
A Because there was a clear conflict of interest and it was really unacceptable from the ethical point of view that there should exist this conflict of interest. It also appeared that there may well be a vested interest in the outcome, which would be completely unacceptable ethically, and, thirdly, I felt very strongly that it was not for lawyers to select patients for study at the Royal Free: it seemed to me totally inappropriate.
Q You have told us this source of money was unusual.
Q Is it unusual for the Medical School to turn away money that they have been offered for some form of medical research within the school?
A I would say it is most unusual, yes. Medical schools are generally very short of funds and we would welcome research funds for approved projects.
Q Picking up the correspondence again if we can, Dr Armstrong wrote to you and the letter is at page 265, if you would go to that, please.
A I do not have page 265, I have page 265A.
Q A copy will be handed to you. (Same handed) This is a letter dated 15 October, so a few days after your letter, thanking you:
“I am grateful … for the details you have provided but I wonder if I could possibly press you for some further information on a couple of points.
You say that a group of Crohn’s disease suffers have recently obtained legal aid support for an action in respect of the putative link between measles virus vaccine and inflammatory bowel disorder. If that is the case, it suggests that there has already been some preliminary legal discussion of this case and that a specific action is contemplated. I should be grateful to know, if possible, the nature of this action.
The second point is that [quoting your letter] ‘we have been asked to make an appointment to the staff of the Medical School, specifically to undertake the pilot study of selected patients’. Do I take it that it is the group of Crohn’s disease sufferers who have asked you to make this appointment? I cannot believe that it is the Legal Aid Board. It would be helpful to know the nature of the appointment which is contemplated. Is this for example an entirely new appointment or is it simply a suggestion that the work currently being undertaking by the senior member of the staff to whom you allude is to be further supported?
In the meantime, I shall take some further advice on the basis of the details you have supplied and I shall be in touch with you shortly.”
Then we see a stamp from your office, the Dean’s Office, whose handwriting is that on it?
A That is my handwriting.
Q We see, “Mr Blatch, for your comments”, is that correct?
Q Who was Mr Blatch?
A Mr Blatch was the school secretary and therefore responsible for administration, and I would certainly have valued his comments.
Q Before that issue progressed, because I am trying to take you through it chronologically, I think it is right that you in fact received a letter from Professor Sir David Hull, and that is on page 367.
Q You may recall that letter, and we have looked at it briefly but I will go through it: February 1997, to you, thanking you for your hospitality when he visited the Royal Free Hospital Medical School. He said:
“It was helpful to hear the evidence from Professor Pounder and Mr Wakefield about their work and how they interpret their findings. I have written to them both to thank them.
The JCVI [Joint Committee on Vaccination] have to consider whether the increase in any disease of unknown aetiology might be due to the changing experience of infection or the consequence of the vaccination strategy, so it is important that we listen to Mr Wakefield, Professor Pounder and their colleagues when they raise the possibility that IBD is due to measles virus.”
He then sets out his various views in relation to that issue, and he goes on to the issue I wanted to ask you about:
“I was a little troubled when I heard that Mr Wakefield was investigating many children with autism. I think I must have misunderstood what he was saying. I see from the submission to the House of Commons Select Committee by Dawbarns – solicitors that ‘they are working with Mr Wakefield of the Royal Free Hospital London. He is investigating this condition (Crohn’s)’. It is possible he is also advising Dawbarns about the association of vaccination with autism and is not, in fact, investigating the children or advising about their care, and that this explains his statement that he was looking at hundreds of case notes.”
He then finishes the letter with various courtesies.
You replied to that letter, if we go on to the next page, page 369, thanking Professor Hull for his letter and for visiting the medical school to discuss the observations on Crohn’s disease by Mr Wakefield and Professor Pounder. You say:
“I found, some years ago, that the observations on changes in the vascular supply in patients with IBD were interesting and based on fairly convincing evidence. Some of the changes in the endothelium were also of interest, but I would wish to see independent confirmation of the virological data.”
You say you were troubled by the interpretation of various epidemiological surveys by the potential adverse impact on immunisation against measles and rubella and mumps, and the consequence effect on the health of children.
You went on:
“I am rather alarmed by the extension of the investigation to children with autism, and more so by the involvement of lawyers. The claim in the submission by Dawbarns, Solicitors, to the House of Commons Select Committee that ‘they are working with Mr Wakefield of the Royal Free Hospital’ troubles me. I am also aware that the Legal Aid Board has offered financial support for work on IBD, which the School has not accepted and is held in a ‘suspense’ account. I am seeking advice from the Ethical Committee of the BMA on this unconventional offer of funding.
It would of course be presumptuous of me to marshal the arguments for academic freedom and I am in the difficult position of balancing these against the reputation of the Medical School.
I would welcome the exchange in confidence of any information which may help to prevent a major public relations issue and potentially the impact on the public health.”
That was a letter that was copied in to Professor Leon Fine. Can you tell us who he was?
A Professor Leon Fine was the head of the Joint Academic Department of Medicine, that is to say in anticipation of the merger between the Royal Free and University College, we formed joint departments and Professor Leon Fine was the head of the Department of Medicine.
Q You say at the bottom of the first page that it would be presumptuous of you to marshal the arguments for academic freedom, and you say, “I am in the difficult position of balancing these against the reputation of the Medical School.” Can you explain to us exactly what you meant by that, Professor?
A Yes, I found the position of the Medical School to be very difficult in terms that the work that was initiated by Professor Pounder and Mr Wakefield on the association between measles virus and inflammatory bowel disease was not confirmed independently by any other group to my knowledge. The failure to secure such confirmation was obviously a source of concern. The epidemiology was not confirmed. There was no confirmatory evidence for virological involvement of measles as a virus or measles antigen, and that certainly troubled me very much because there was now an issue of whether publication of numerous papers in peer review journals cannot be replicated elsewhere. The basis of scientific advancement is confirmation independently of findings without specific confirmation by independent research workers, I think the work is not valid and therefore the reputation of the Medical School was clearly at risk because this had been going on for some years. It had been going on since I joined the Medical School, and I should preface this by saying that when I was first appointed as Dean of the Medical School I went round each department and met every member of the staff. I did meet Professor Pounder (Dr Pounder at the time) and Mr Wakefield, and I was certainly impressed by the modelling of the vascular supply to the small intestine. This was clearly very elegant work, meticulously carried out and I certainly was impressed. That led to the second stage of the findings, which were clearly positive that the reason why there was narrowing of the vascular supply to the small intestine which ultimately led to ulceration and so on and so forth was because there were changes in the small cells lining the blood vessels, known as endothelial cells, and it was perfectly reasonable to put forward a hypothesis that measles virus does and can damage the endothelial cells, so this was really a very sound hypothesis. That was followed by a series of papers where they detected, apparently, measles virus, measles RNA, measles antigens in biopsy material, but what troubled me is that no-one who was completely independent of the group was able to replicate these findings.
Q Just taking you back to the terms of the letter, was it issues of that sort which were in your mind when you talk about the arguments for academic freedom?
A Yes, because there is a very fine balance between academic freedom and academic licence, and to define academic freedom – I am sure I do not have to define it for you. Members of the staff are entitled to undertake research work in areas which interest them, they are entitled to express their opinion, they are entitled to publish their findings provided all this is within the limits of the law, and here I had a situation where, yes, they are continuing to carry this sort of work, and publishing extensively, but no-one else can confirm it, so it was a dilemma.
Q Continuing with the chronology of the BMA correspondence, if you go on, please, in the same bundle to page 372, you had asked Mr Blatch to assist in relation to this issue as we saw and this was his letter back to Dr Armstrong at the BMA on the same subject of the Legal Aid Board funding; is that correct?
A Yes, that is correct.
Q We see that he says that you, the Dean, had passed him the letter
“and asked that I follow up the queries that you raise.”
He apologises for not responding before, this is 24 February 1997,
“but we are anxious to receive your further advice on the situation arising from this unusual source of funding for Mr Wakefield’s research.
The situation is indeed that the funding is from the Legal Aid Board and is specifically ‘to facilitate the setting up of the clinical and scientific study proposed by Mr A J Wakefield in respect of ten assisted persons …’: that is to say that ten persons suffering from the symptoms being studied are being assisted by the Legal Aid Board with a view to possible future civil action. The money has been passed through solicitors to Mr Wakefield. It would seem that there has been no legal action taken in the Courts so far, but the authority from the Legal Aid Board to contract the work makes reference to the Opinion of Council [sic]” which should be “counsel” in the legal sense “and the research is to prepare a preliminary report from Mr Wakefield pursuant to this Opinion. The appointment is for two years and the research worker has been employed specifically to undertake this research project. The person appointed is a Molecular Biologist who I understand will, amongst other things, be searching for evidence of the virus from samples obtained from the assisted persons and from controls, etc. in the standard manner. The money awarded by the Legal Aid Board does not cover the full cost of the salary and consumables.
I do hope that this additional information will assist you in considering the dilemma that we face, but please do not hesitate to contact me on the telephone if you require a further explanation of any of the points given above or indeed if you require additional information”
and then he thanks him for this assistance.
Can you assist us – and it may be that you cannot, Professor Zuckerman, in which case do say so – because he quotes in the middle of that letter on page 372 what the funding specifically was for, “to facilitate the setting up of the clinical and scientific study proposed by Mr A J Wakefield in respect of ten assisted persons …”. Do you happen to know where that quotation comes from?
A I am not absolutely certain without looking at a document but I believe that these are the wordings that were used by the Legal Aid Board in awarding the contracts to the solicitors but I am not sure, I would really have to look at the papers.
Q The other matter that I wanted to ask you about that letter is that it refers to a research worker, specifically to a molecular biologist. Do you happen to know the identity of that research worker?
A I am afraid that I cannot really recall. It is 11 years ago and I really cannot remember.
Q We then go on to Dr Armstrong from the BMA’s response in fact to Mr Blatch and that is at page 374. He just indicates that he is going to be taking some advice on the matter. The next letter is the substantive advice, Professor, and would you put away that bundle and go on to FPT2 at page 398. This is not Dr Armstrong’s advice, this is a further letter from you – and now we are in March 1997 – and you thank Dr Armstrong for his letter and you say,
“I have spent much time attempting to clarify the position, as you will note from the copy of my letter to Mr Andrew Wakefield, …
My Finance Officer advises me that the funding for the research appears to have been obtained by a firm of Solicitors from the Legal Aid Board of possible litigation. The Board can only make payments to lawyers.
The research funds from Dawbarns, a group of Solicitors, is being used to meet the costs of a new appointment i.e. a research assistant to Mr Wakefield, who is a member of the Medical School staff.
To turn to the possible nature of a legal claim, I suspect that this will be on the basis that measles vaccine and the combined MMR vaccine may cause Crohn’s disease and inflammatory bowel disease and that the safety of these preparations had not been established. Expert opinion and the advice and views of the World Health Organisation and the Department of Health’s Joint Committee on Vaccination and Immunisation (…) are that there is no confirmed evidence of an association between immunisation against measles (and rubella and mumps) and inflammatory bowel disease, and that the epidemiological data are flawed.
While I would not wish to attempt to balance the arguments for academic freedom and the public interest with respect to the protection of children against infection, the position of the Medical School is difficult. Further, I am deeply concerned by the unconventional funding of research work by interested lawyers acting on behalf of children with inflammatory bowel disease”
and you ask again for the advice from the BMA.
Q It would appear that you had had some communications with Mr Wakefield at that stage and I am going to take you back to those, doctor, but, if I may, just to complete the BMA role, if we could go on to page 400, we will see Dr Armstrong replying to you saying that he has passed the matter on for legal and ethical advice to the head of the professional resources and research group which includes both their legal department and their medical ethics committee.
If you would turn to page 405, we come on to their long letter in response from the head of that department from Dr Armstrong but quoting the advice that he has himself been given. I am not going to read the whole of that letter; I am going to read from it selectively and, sir, this is a letter that the Panel may wish to look at carefully themselves at some point. He says,
“… I have placed the main points of your dilemma before the BMA’s Ethics Department and Legal Department. I am now in a position to forward their comments and hope that these will be helpful.
In the BMA’s view, all research projects involving patients or their records should have approval from a local research ethics committee (LREC) or its hospital equivalent … Through ethical review of the details by an appropriately constituted committee in advance of the research being undertaken is essential in cases where the findings are likely to be controversial or produce potentially psychologically harmful results for the families involved. Presumably this research, whatever its findings will produce potentially distressing information and will also involve minors (or their medical records) for whom decisions have to be made about their best interests”
and then it refers to the BMA’s own medical ethics committee which could not assist on an individual basis. Going to the next paragraph,
“From the Ethics Department’s perspective, the main ethical question is whether the research project is scientifically sound and has been approved by an appropriately constituted research ethics committee as a valid and potentially scientifically useful project. The approving committee should have a detailed protocol of what the research will involve, the manner in which participants are recruited (if relevant), whether their [confidentiality] will be adequately protected if litigation is envisaged, the quality of informed patient consent and the source and uses of funding. Ownership of the findings of the research is also important and whether any constraints are envisaged on its use by the funders or by the patients involved. The question of whether health professionals, individually or collectively, may be involved in litigation as a result of the research is a matter to be borne in mind with regard to the potential uses or publication of the data obtained but should not determine whether the research is in itself a valid project.”
It then looks at the issues relating to the science and it defines the nature of the Legal Aid Board and it concludes,
“Two issues arise from the previous correspondence:
1. Whether a publicly-funded health facility, such as the Royal Free, should be closely involved in a research project which may result in the Department of Health being sued. The view of the Ethics Department is that it is important that the research, if considered a scientifically valid project, is carried out by a reputable and independent body. Also arguably the expenditure of the DoH could be significantly greater if the research is not done now but proceeds later and finds a linkage when there may be many more victims. The interests of justice also require that if harm has been unintentionally caused to patients through immunisation, this should be compensated although presumably the courts will consider the matter in the light of the information available at the time when the immunisation programme was instituted. To delay or decline to conduct research, which appears to be in the public interest, on the grounds that it may embarrass the government or a particular health facility does not appear to be a sound moral argument.
2. Whether a research project on the causes of Crohn’s disease should be funded by a group with a clear financial interest in discovering a linkage between immunisation and the onset of the disease.”
So that is the second issue.
“Funding of research by special interest groups is commonplace and as long as the findings or the uses to which the data may be put are not influenced by the wishes of the funders, this should not be problematic.
Whereas I do not imagine that these comments solve your problems, I hope that we can at least indicate that a detailed protocol needs to be developed, outlining the main ethical and practical issues at each stage of the research, the involvement of patients, their consent and confidentiality, the foreseeable uses of the data obtained and the potential impact of that data, not only on this group of patients but for many others who come forward later.
In our view, it would be desirable that the Department of Health be informed of the project in good time and thus be able to issue public assurances about the current state of knowledge and the WHO advice if the need should arise. An inadvertent leakage of information about the research project via the media could obviously have profound public health repercussions especially if health officials were not forewarned or prepared to respond.”
That was the obviously generalised ethical advice that was given by the BMA and, if we go on to page 412, we are now at 2 April 1997 and this is your reply to Dr Armstrong thanking him for his letter “and the helpful comments of both the Ethics Department and Legal Department of the Association” and you say,
“There are certainly some points made by the Ethics Department which I must now explore with our local Research Ethics Committee, particularly the issues of patient selection, of adequate patient confidentiality in the event of possible litigation, the source and uses of funding and of course ownership of the research findings and the potential uses of publication.
The suggestion that a detailed protocol is developed at each stage of the research and the involvement of patients is excellent.
Thank you for your help.”
You make it clear in that letter that there were points which you plainly needed to raise with your own local research ethics committee, Professor.
Q Is that in fact what you subsequently did?
A Yes, indeed; I wrote formally to the Chairman of the Ethics Committee of the Royal Free.
Q That is Dr Pegg?
Q If we go on, we will see your correspondence with him at page 413.
Q You said,
“I am writing following the advice of the Ethics Department and the Legal Department of the British Medical Association, concerning research into Crohn’s Disease which I am assured has been approved by the Ethics Committee of the Royal Free Hospital and the School of Medicine”
and you then quote the letter that you had also received from Professor Sir David Hull and you said,
“The difficulty is that the Solicitors provided a grant to Mr Wakefield to facilitate clinical and scientific studies at a maximum cost of £55,000 and the continued maintenance of a computer database and ongoing worldwide literature searches at a maximum cost of £15,000. These funds have been authorised by the Legal Aid Board, but it is not clear whether the sum of £15,000 for the database was provided to Mr Wakefield or to the Solicitors. The School has placed this money is a suspense account until the following issue is resolved.”
You have told us that ultimately you refused this money, but at that stage you put it in a suspense account pending your inquiries; is that correct?
“The dilemma which the School faces is whether it is ethical for lawyers to fund a particular piece of research where a specific action in law is contemplated, rather than a scientifically-based research project. It has been suggested that I explore with you whether the Committee considered these issues and whether the Committee will continue to monitor patient selection (particularly of children), adequate patient confidentiality in the event of possible litigation, the sources and uses of funding and of course ownership of the research findings and the potential uses of publication.
I should stress that the Medical School does not question the scientific validity of the project, the independence of research, the academic freedom of the staff and publication in learned scientific and medical journals.”
Were you there again concerned, at least to some degree, with striking a balance between the academic freedom of members of your staff and any ethical dilemma that might arise as a result?
A Yes, I was concerned about academic freedom but that was a separate issue from the ethical considerations. The ethical considerations gave me a lot of concern and essentially I needed the information in order to reach some sort of a decision. I did speak to – if I recall correctly and I think it is certainly implied in my letter – the researchers and I was assured that there was approval by the ethics committee of the Royal Free. What I was not clear about is whether the ethics committee considered the source of funding which is absolutely essential in consideration by the ethics committee and whether the ethics committee was aware that this source was, to say the least, unusual and whether the ethics committee appreciated that there was an issue concerning the selection of patients and, as I said before, my main worry about this was that it seemed astonishing that a solicitor should select patients for investigation and I felt that this had to be clarified. That also led to the next stop of who actually owns the findings. Is it the research worker, is it the Medical School or is it the solicitor? Frankly, I have never come across a situation like this and that is why I actually wrote to Dr Pegg.
Q Dr Pegg replied to you and we have his reply at page 423, a letter dated 15 April.
“Dear Dr Zuckerman,
Thank you for your letter … You did not mention which of Mr Wakefield’s studies had received funding from the legal aid board so I have reviewed all submissions made by Mr Wakefield to the ethics committee in the last two years.
I have discovered four applications”
and he sets them out and, in respect of each, he gives the source of funding. So, the first application, 127-96, the “Stated source of funding: Wellcome Trust”.
Q We then get 172-96 which was enteritis and disintegrative disorder following measles/rubella vaccination, with, “Stated source of funding: Royal Free Hospital”. Then 203-96, “Stated source of funding: Royal Free Hospital School of Medicine” and the last one, 77-96, “Stated source of funding: Royal Free Hospital School of Medicine and the Royal Free Hospital”.
“As you can see, none of the stated sources of funding include the legal aid board. Thus as far as the ethics committee is concerned these are ordinary scientifically based research projects, and did not raise the particular ethical questions noted in the third paragraph of your letter.
If you have evidence that Mr Wakefield has made a false statement to the ethics committee then I would be obliged if you could formally lay that evidence before this committee.”
You reply to that at page 425 and you said:
“You misunderstood my letter of 2 April [writing on 17 April]. There is absolutely no suggestion of any misconduct by Dr Andrew Wakefield.
The issue which I brought to your attention is an ethical matter on a possible conflict of interest and data protection in the case of litigation as raised by the Ethics Committee and the Legal Department of the BMA. The School’s concerns and dilemma are outlined in paragraph 3 of my letter.”
He replied to you on 25 April at page 428:
“To my knowledge the ethics committee has not considered any applications in which the stated source of funding was from the legal aid board, neither has it considered any applications where the stated aim of the research was a specific action in law.
We have therefore not considered the issues stated in paragraph three of your letter … and I am unable to assist you with your dilemma.”
Does that have your handwriting on it again?
A Yes, it is my handwriting.
Q “Please keep on file Mr Andy Wakefield”, is that correct?
A That is correct.
Q Can you help us as to that little exchange, Professor Zuckerman? You said there was no question of misconduct by Dr Wakefield at that stage; what exactly did you mean by that?
A I am asked by Dr Michael Pegg whether Mr Wakefield has made a false statement. I had no evidence that Mr Wakefield has made a false statement. Looking at the response from Dr Pegg, if you look at item 2, the grant reference is 17296. It is stated that the source of funding was the Royal Free Hospital and in essence it is true because the funds from the Legal Aid Board were placed in the account of the special trustees of the Royal Free Hospital, so it was a perfectly legitimate answer.
MR COONAN: I am sorry, I must interrupt. I have not been given any notice of any of this evidence and what the witness is being led to do is to comment on matters and almost to argue a case. That is not the reason he is here. I have been very patient so far and it has happened so many times this morning, but on this point I do rise and I seek the protection of the Legal Assessor.
THE CHAIRMAN: Ms Smith, any observations on the objection that has been raised by Mr Coonan?
MS SMITH: Sir, Mr Coonan says he has been given no notice but the fact is that Professor Zuckerman is here to produce a whole series of correspondence which inevitably involves asking him what he meant, and I made it very clear to him that what we were interested in was what he meant at the time and not what he meant since. I am certainly not inviting him to argue the case; I cannot help of course the way a witness feels it is appropriate to answer a question, but to leave a letter in the air which says something which necessarily asks the question “What did you mean by this?” – and as Mr Coonan says I have asked that on a number of occasions in relation to a number of letters. I am in the hands of the Legal Assessor, the letters are there, they speak for themselves, I was simply seeking clarification because I thought it was helpful for the Panel, but I will not pursue it if nobody wishes me to.
MR COONAN: Sir, the underlying principle which I am focusing on is that the evidence that in due course will be laid before you, potentially evidence in the case being relied on by the Council against, for example, Dr Wakefield, consists of the documents which were available at the time. What was in this witness’s mind or any other witness’s mind and the rationale for making comments at the time cannot be evidence against this doctor. The risk is that one is straying into an area which is potentially very misleading for the Panel, and I shall have submissions to make about this in due course. So it seemed to me timely to rise now at this point because I can see that if this is not nipped in the bud one is going to have this problem being faced again later.
THE CHAIRMAN: Legal Assessor?
THE LEGAL ASSESSOR: As I understand it Mr Coonan was taking objection at the point where the witness was giving an answer, directly related to page 424, item 2, in the letter to him, Professor Zuckerman, from Dr Pegg. He was explaining a matter within his knowledge, as I understood it, namely that whilst the stated source of funding was the Royal Free Hospital, he Professor Zuckerman, because of other correspondence about which he has already given evidence, happened to know that the Royal Free Hospital held those funds because they came from the Legal Aid Board, that was how I understood his answer. To that I can see no objection.
THE CHAIRMAN: Mr Coonan?
MR COONAN: I have made my point; there were in effect two layers: the first part, what matter Professor Zuckerman was addressing at that time, I can see is perfectly acceptable, but to go on and explain underlying thinking behind a comment on page 425, which Ms Smith was embarking on and which was the main reason for me getting to my feet is – and I repeat my objection – fraught with danger.
THE LEGAL ASSESSOR: As I understand it Ms Smith has said she will not pursue that line.
MS SMITH: Sir, I think in fairness to myself actually I was not embarking on anything. I had asked a question which you have indicated was a perfectly proper question to ask, I have had an answer and I was now going on to the next letter.
THE CHAIRMAN: It seems the matter is now resolved, so thank you.
MS SMITH: Would you excuse me for a moment because I cannot now remember where the next letter is.
THE CHAIRMAN: Do you think it is probably an appropriate time to have a little break?
MS SMITH: Now that we have anyway I am sure Professor Zuckerman will be grateful for a cup of coffee and we can go on shortly.
THE CHAIRMAN: Sure. We will adjourn now, it is ten to eleven so we will resume at ten minutes past eleven. Professor Zuckerman, I have to remind you that you are under oath and are in the middle of giving evidence. Someone will look after you for a drink and refresh yourself, but please make sure that you do not discuss this case with anyone.
A Of course not.
THE CHAIRMAN: Thank you. We will now rise and resume at ten minutes past eleven.
(The Panel adjourned for a short time).
THE CHAIRMAN: Good morning again; Ms Smith.
MS SMITH: Good morning, sir, thank you. I had just concluded taking you to the correspondence which you had with Dr Pegg, Professor. Can you assist us, did you discuss this matter with anyone else at the medical school at the time?
A I am sorry, could you repeat that?
Q I took you through the correspondence that you had with Dr Pegg, Professor, and I just wanted to ask you, did matters rest there in relation to the correspondence with Dr Pegg, first of all?
A As far as Dr Pegg is concerned I think I pursued it a little bit further and then I wrote to each member of the staff individually, if I recall correctly, and then I formulated a reply to Professor Sir David Hull.
Q Can I just ask you to turn on in your bundle 2 to page 469?
Q In fact there is a second copy of this document with different notes on it, page 470, the next page on. This is a memorandum to you from Mr Tarhan, the finance officer, is that correct?
A That is correct.
Q Does this have your handwriting on it?
A It does.
Q Is it all your handwriting, the manuscript?
Q We see there:
“Mr Wakefield is unhappy with the fact that the School has not formally accepted the research funding and has asked that the funds be returned to the solicitors.
I will be arranging for this however there is likely to be …”
Then he deals with a matter in relation to overspend which I do not think is relevant to the matters we are considering, and you have put a note on there: “Transferred to special trustees”, is that correct?
A That is correct.
Q “They are aware of the situation and overspend. [Query] discuss with Martin Else.”
Q Is Martin Else the chief executive at the hospital?
Q Did you communicate to him that the medical school would not be accepting this money?
A Yes, I did.
Q Can you remember how you communicated it with him? We do not have a letter from you in relation to it.
A Mr Else and I used to meet once a week to discuss matters involving both the hospital and the medical school, so this was during a weekly meeting that I had regularly with Mr Else.
Q Thank you. I want to ask you about the dealings which you actually expressly had in the documents with Dr Wakefield on this issue. He wrote to you and we have a letter from him at page 393, if you go back in bundle 2. It would appear from the first sentence that this followed on from a telephone conversation that you had had, and the letter says:
“Following our telephone conversation the other day, I agreed that I would look into the question of whether there was a Parliamentary Select Committee being convened on the subject of measles vaccine and Crohn’s disease, and specifically my link with the solicitors, Dawbarns, in this matter. Dawbarns are not aware of any such developments and claim not to have misquoted me at any stage during the correspondence that they have had with the press and others.
I can confirm that I have been unable to establish that any Parliamentary Select Committee or other committee has been set up to examine this, as far as I can ascertain.”
He then goes on to the matter which is relevant to the finances:
“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. It is, as I am sure you would agree, our joint and several responsibility as members of the medical profession to use our training and expertise appropriately. In the context of the current measles vaccine safety/consequences debate, I am providing independent expert guidance based on facts available to me. I do this in common with colleagues worldwide. The fair legal assessment of potential claims relies on high-calibre expert advice. The GMC and the Royal Colleges have long accepted this premise.
In the particular circumstances with which I am dealing, there is, I believe, an even higher moral obligation to act as an expert adviser. We are faced with a situation where the most vulnerable category of patients, i.e. children, may be put at risk. It is right and proper therefore to review the facts, assess them, and offer guidance.
I hope these comments are helpful. Please do feel free to contact me if you wish to discuss my role further.”
Do you happen to recall, Professor, and again say if you do not, it is a long time ago, who had initiated the telephone conversation between you that preceded this letter?
A I do not think I could really recall that.
Q You wrote back to Dr Wakefield and that letter is at 397.
Q Thanking him for his letter and saying:
“There appear to be two misunderstandings.
I am informed that Dawbarns, Solicitors, have made a submission to the House of Commons Select Committee and I quote ‘… (we) are working with Mr Wakefield of the Royal Free Hospital London. He is investigating this condition (Crohn’s) …” Will you ask Dawbarns to clarify this submission.
There is no Select Committee looking into an association between Crohn’s and measles.
I do not think that there is any conflict between duty of care to patients or the provision of independent expert advice to lawyers. 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 is contemplated. If so, then the interpretation must surely be that a conflict of interest may well exist. The School must, therefore, seek expert advice, but in the meantime you should know of my concern.”
Did that reflect your view as to the distinction, Professor, between the provision of independent expert advice and the situation which you at least thought you were dealing with, the situation you were concerned about?
A That is correct. I thought there were entirely different issues involved there, as the paragraph indicates.
Q If we go on to page 401 we can see Dr Wakefield’s response.
Q This is a letter dated 24 March 1997:
“Further to our exchanges regarding the investigation of children with enterocolitis and autism, and especially the involvement of Dawbarns Solicitors and the Legal Aid Board, please find enclosed all documentation relating to this matter. This includes a letter to Dawbarns from the Legal Aid Board specifying the conditions for making the 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 …”
Is that Professor Pounder?
A That is so.
…”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. 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, 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. I hope that this issue can be resolved as quickly as possible and my group are working to achieve this end.”
Enclosed with that letter, we can see if we go on to the next page, a letter from Legal Aid Board to Messrs. Dawbarns, and in the middle of it:
“When the 10 children have been chosen for Dr Wakefield’s study please let me know so that their individual certificates can be properly amended.
In all the circumstances, now that the authority to do contract work has been amended in the terms it has, I will now just wait to hear from you as to what progress is made.”
Attached to that at page 403 is the Legal Aid Board authority to do contract work, and we see at paragraph 2:
“To facilitate the setting up of the clinical and scientific study proposed by Dr A.J. Wakefield in respect of 10 assisted persons at a maximum cost of £55,000 and to cover the work necessary by the solicitors in doing so …”
If we go back to the letter at page 401, we see again your Dean’s Office stamp. Is that your handwriting in the text?
A It is.
Q It says:
“Please copy to Mr Blatch. This does confirm my worst fears.”
Can you tell us, your worst fears in relation to what?
A That there was a clear conflict of interest and selection of patients by lawyers.
Q Going on to the raising of this issue with Professor Walker-Smith, which was at a rather later stage, in 1998, can I ask you to turn on to page 939, which is in FTP3. This is a letter apparently in response to Professor Walker-Smith’s letter, raising Professor Sir David Hull’s concerns.
Q You say to him:
“Thank you for your letter of 14 July 1998 in response to David Hull’s letter.
I am reassured that the children with autism are investigated according to the clinical need and their clinical management. Nevertheless, it would be prudent to obtain ethnical approval if, as I understand it, Andy Wakefield is collecting cases for report by publication, which is therefore a research project.”
Then the paragraph I want to go to for these purposes:
“A source of some of the funding has been highly controversial …”
You then quote a letter that had by then been written to The Lancet:
“You will know that the Medical school questioned the funding through Dawbarns, Solicitors, and we sought the advice of the Ethics Committee here and subsequently advice from the Ethical Committee of the BMA. This issue must also be resolved without delay.”
This was after the publication of the data in The Lancet journal, is that correct?
A That is correct.
Q And you said:
“Please discuss these two matters with the Chairman of the Ethics Committee”.
You copy the letter to Professor Pounder, Dr Berelowitz and Dr Pegg, as well as to Mr Else, is that correct?
Q So even at that stage you were concerned, is that correct, about this issue, the issue of the finances and the role of the Ethics Committee?
A Yes, it seemed to me that the whole matter was becoming even more complex than in 1997. I did write formally to Professor Walker-Smith. He did reassure me that the children were investigated according to clinical need and their clinical management, and I was quite content with that. What worried me was the issue of whether ethical approval was actually available for a research project. There was not – there seemed to be a very clear answer to that.
Q I am going to take you back to that letter and to those issues when I ask you about the ethics situation, but, as I say, that was the last reference in 1998 to the issue of what you described as the controversial Legal Aid Board funding.
Q I now want to turn issues which you deal with in your statement, Professor, in relation to public health and the press briefing and press statements at the time of The Lancet publication. Can I ask you first of all to go back to bundle FTP1, page 363. This page has to be handed out because it is missing from the bundle at the moment. (Same handed) This is a letter that you wrote in January 1997.
Q So that was prior to the publication of the research in The Lancet by a considerable period, I am going back in time. It is a letter to Sir Kenneth Calman, who was the Chief Medical Officer at the Department of Health:
“My colleagues and I remain very concerned about the unwelcome publicity and controversy surrounding the work on Crohn’s disease which is carried out at this School by Dr Andrew Wakefield and his group.
Every effort has been made to introduce a greater critical element and considerable care into statements which are made to the media and to the public (but unfortunately with little success). You know, of course, of the fine balance between academic freedom and views which are expressed by academic staff, and on which I provided guidance to my staff …”
You attach a paper and I will go to the relevant item in a moment:
“The response of the Medical School in the case of enquiries to the School following the article in Pulse is enclosed.
I am assured by Dr Wakefield that he will not discuss the controversial issue of autism with the media in the immediate future.”
You say you are a copy of the letter to Jeremy Metters and to David Salisbury with whom, you said, “I will continue to maintain close contact.”
If we turn over, we will see attached to that the guidance that you gave to the staff.
Q If we look at No. 8: “The safeguarding of the reputation of the department and the school as a whole” is one of the responsibilities that heads of department are responsible for discharging:
“The school recognises the right of its staff to hold and express any views within the limits of the law and the distinction between licence and freedom of speech, but … ‘in the exercise of free speech the academic has a special responsibility to avoid having his personal views represented as being those of the University of which he is a member, unless he is specifically authorised to do so’.”
Was that the general principle that was laid down by you in relation to your protecting of the reputation of the Medical School?
A Yes, it was.
Q I want to look on at two of the press statements which were issued by the Medical School in relation to this issue: one was on 12 September 1997 and it is in your bundle 2 at page 606.
Q This was the statement by the Medical School on MMR research, I September 1997.
“As in all universities, academic staff at the Royal Free Hospital School of Medicine undertake lines of research in accordance with their interests and areas of expertise. The school encourages this. Work on vaccination and immunisation procedures is an area of inquiry in several departments.
From time to time, staff may conduct research which has surprising or controversial findings. Staff are encouraged to submit the results of research for publication in the established medical journals, which subject them to a rigorous review by external experts.
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. Immunisation has eradicated smallpox; it is likely to eradicate poliomyelitis in the near future; and it has prevent diphtheria, tetanus, pertussis, measles, rubella, hepatitis A and B, rabies, some forms of meningitis and other infections.
Vaccines meet the most rigorous national and international safety and efficacy requirements before being licensed and millions of doses of MMR have been given in many different countries.”
Was that a press release which was formulated by your public relations department?
A No, it was written by me.
Q It was actually written by you personally?
Q We know that this was published in advance of the publication of The Lancet article, which was in February 1998, what in particular prompted you to issue that statement at this time?
A From about I suppose the beginning of 1996, I became increasingly concerned by approaches made to the media by the research group, providing them with information on ongoing research. That was a source of considerable concern because approaches to the media were not really required. The event that, if I recall correctly, led to this press release was the provision of information, two particular reporters, concerning the safety of MMR, the relationship with, the possible relationship, or the alleged relationship if you like, their alleged relationship with chronic bowel disease and autism, and in particular questioning the safety of vaccines. Now, that really puzzled me because vaccines are not issued just like that. They undergo a very rigorous testing, safety testing, evaluation, Phase 1, Phase 2, Phase 3 clinical trials and so on, and to suggest to the media, to the popular media that vaccines have not undergone safety testing was I suppose to my mind at the time absolutely bizarre, and I therefore decided, after discussing this issue with the media group which I chaired, that we must issue a statement to the press in order to stop the enormous amount of publicity and speculation which was taking place, which resulted in a significant fall in the number of children who had been immunised, which then became a public health issue, and I should add that nobody from the press took the slightest interest in that; not the slightest interest.
Q That was in September 1997, so that, as I say, foreshadowed The Lancet paper. Then at the time of the publication of The Lancet paper there is a further press statement that I wanted you to look at, which is in the same bundle, at page 757.
A I do not have that.
MS SMITH: In that case I will ask that you are handed a copy. (Pause) I am sorry, I am told that hitherto producing I do not think we have copies, so if the Panel will just bear with us for a few moments whilst that page is copied. (Pause while page 757 was photocopied and then distributed)
(To the witness) Professor, this is a statement which is dated 27 February and the paper, I can tell you as there is no dispute about it, was published in The Lancet on 28 February.
Q Was this statement produced by you or was this from your press officer?
A I wrote it.
“The Dean of the Royal Free Hospital School of Medicine, Professor Arie Zuckerman, said today the research team had discovered an important new syndrome which provided the opportunity to investigate inflammatory bowel disease and autism.
Professor Zuckerman, who is also Director of the World Health Organisation Reference Centre on Viral Diseases, said the study did not provide a proven association with MMR vaccine. ‘It is essential that the immunisation programme continues to protect children against these three serious infections. If immunisation rates fall, measles will return and children will die’, he said.”
That is the statement that was issued the day before the publication of The Lancet. Was it in fact issued the day after there had been a press briefing?
A That is correct.
Q That was on 26 February 1998. Can you tell us in relation to that briefing, first of all was the subject of it the subsequent Lancet paper?
Q Where was it held?
A It was held at the Royal Free Hospital at the facility which is known as “The Atrium”.
Q Who decided to organise it?
A That was decided by the media group which I chaired and I approved the briefing as it was considered that there was an important finding in relation to changes in the bowel in children with autism. I should qualify this I think now, because it was absolutely vital at the time, by saying that that briefing was to be only on the intestinal changes in the bowel. It had nothing to do with MMR or MMR vaccination and that was confirmed by a letter from Professor Pounder to the Chief Medical Officer on 15 January. So, it was absolutely clear that that press briefing was to be restricted to pathological changes in the gut and nothing else.
Q It has been rather loosely referred to by everybody including myself as a press conference when we have alluded to it before this hearing.
A No, no.
Q You used the term “press briefing”; did you see a distinction?
A There is a very clear distinction between the two. The press briefing is designed to inform the media about specific findings in relation to published material. It is completely different from a press conference which is a rather more loosely arranged sort of discussion between the press and the persons organising the press conference. This was a press briefing simply to outline methodological changes in the intestine, a new finding at the time, in relation to children who was suffering from serious behavioural disorders and no more than that. It was a briefing. It was not going to be an open discussion.
Q Then the statement that I have already read followed on after that and as a consequence of it; is that correct?
A That is correct.
Q I am going to turn on, Professor, to a different topic which is the ethics behind the research. Sir, I should preface this by saying that I am sorry that there is some jumping around chronologically but that is because it was felt that it would be clearer to the Committee if the various subjects were dealt with. I want to take you back, Professor Zuckerman, to a letter that you received from Professor Hull in July 1998 which is in your FTP 3 bundle at page 928. This is the letter that you alluded to before. This is a letter that was written to you from Professor Hull and this of course postdates The Lancet article by some months. He says,
“I would welcome your help on a matter of personal concern. In February 1998, Mr Wakefield and his colleagues reported the findings of their search for the cause of bowel disorder in children with autism. At the MRC meeting on MMR they said that many more children had been similarly investigated and still more were on the waiting list.”
Is the MRC the Medical Research Council?
“The studies include: admission to hospital, sedation, lumbar puncture, biopsies of the bowel, MRI imagine and radiography.
In the light of the initial findings and the evidence that as a group the children do not suffer long-term bowel disorder, it would seem difficult to justify such invasive studies on clinical grounds. It may be that there are arguments to perform further investigations to elucidate the nature of the brain disorder and the bowel findings. As I cannot see what those might be, the thought of autistic children being subject to such investigations continues to trouble me, and thus my request to you.
I see that the investigations were approved by the Ethical Practices Committee of the Royal Free Hospital NHS Trust. If the studies are continuing I would be grateful if I could see the Ethics Committee position on the investigations, especially if they have reviewed their position in the light of the reported findings. If you thought it helpful the Ethics Committee of the Royal College of Paediatrics and Child Health could give an independent view.”
This is a letter that postdates The Lancet article and refers to the fact that the investigations had been recorded as approved by the ethics committee in relation to those children and asks you about the continuing of the study; is that correct?
A That is correct.
Q You sent that letter to Dr Pegg asking for his urgent comments.
A Yes. I was needless to say extremely disturbed to receive this letter.
Q If you look over on to the next page, you see the letter that you wrote to Dr Pegg,
“I would welcome your urgent comments and that of the Ethics Committee on the concerns expressed by Professor Sir David Hull, Emeritus Professor of Child Health at the University of Nottingham, about the investigation at the Royal Free of children with pervasive developmental disorder for bowel disorder. A copy of the letter from Professor Hull is attached.”
Did you also respond to Professor Hull and, if you go on to page 931, the next letter, do we see that response?
“Thank you for your timely letter of 6 July, 1998 concerning the investigations at the Royal Free of children with pervasive developmental disorder for bowel disorder. I have sought the comments of the Chairman of our Ethics Committee, a joint Committee between the Hospital and the Medical School, and the comments of the members of the Committee. I have also written to Professor John Walker-Smith, who is the clinician in charge of these patients.
I have voiced ethical concerns in the past on aspects of these studies, and I will write to you again as soon as I have additional information.”
Were the ethical concerns that you had expressed in the past on aspects different aspects?
A Yes. There are a set of concerns which can be, I suppose, considered under two separate headings. One was the Legal Aid Board funding to which I have already alluded and which concerned, in particular, Mr Wakefield. The second one which also concerned me and you will find was also a concern expressed by the MRC Committee, is as follows. As I mentioned earlier, I was deeply concerned that none of the epidemiological findings or the virological findings were confirmed independently by any other research group. I was equally concerned by the fact that the researchers at the Royal Free themselves could not reproduce the virological findings. This was known before the press briefing. I was very concerned that I asked Mr Wakefield repeatedly through his head of department to send biopsies and other material under code for independent confirmation by another recognised laboratory. He refused to do so.
Q Professor, can I stop you there. Obviously whether the results can be confirmed independently is a matter of scientific importance to you.
A Oh no, no, it is not. I am sorry, it is a matter of ethics.
Q That is what I was going on to ask you and you have made the distinction and I would like you, if you would, to make the distinction to the Committee. Not worrying for a moment about the science, why do you say it is a matter of the ethics as well?
A If you cannot confirm the science, you cannot justify continuing with invasive procedures when the aim of the procedures, as far as I understood it, the lumbar puncture, was to confirm whether measles or measles antibody was present in the CSF. Ethically, if you cannot confirm the findings, I could find no justification for continuing to do that. However, I did qualify this by discussing the matter with both Professor John Walker-Smith and Dr Simon Murch and the Medical Director and Mr Martin Else at a meeting in my office and I was assured that these investigations were undertaken as indicated by clinical need. I was not in a position to judge what the clinical needs were, I am not a paediatrician, but there was an ethical issue there.
Q I am going to ask you about that meeting in a moment, but just in order that we can see what you did about this. If we go on to page 932 ---
A I do not have page 932.
MS SMITH: This is another letter that has to be inserted. It is page 932. (Same distributed) Did you write to Professor Taylor who was in the department of community child health seeking his views?
A Yes, I did.
Q Also, if we go on to page 933, to Dr Berelowitz asking for his views?
A That is correct.
Q And also to Professor Pounder and that letter is on page 934?
Q You said to Professor Pounder,
I am troubled by the attached letter from Professor Sir David Hull about invasive studies for bowel dysfunction in children with pervasive developmental disorder, and I would welcome your own comments as a matter of urgency. John Walker-Smith is, of course, the clinician-in-charge and I have copied to him David Hull’s letter and my letter to Michael Pegg, Chairman of the Ethics Committee.
You know that I have raised, in the past, concerns on some aspects of these studies, and I must do so again.”
If we go over on to page 935, we see Professor Pounder’s response to that letter to you thanking you for your letter. He says,
“As you know, I am not directly involved with the studies into children with autism, although I have a considerable interest in this work and appreciation of the various protocols involved.
The original study published in The Lancet earlier this year, was a research protocol investigating the possible link between autism and abnormal bowel function. That was a research study involving a number of invasive and non-invasive techniques, and it received both approval by the Ethical Committee and also parental consent. At the end of that study, an association was identified between autism and a new form of inflammatory bowel disease. From then on, the patients have not been subject to research protocol investigation, but have been investigated according to agreed clinical guidelines. Essentially, they are being investigated like any other person presenting with inflammatory bowel disease – a range of blood tests and a colonoscopy with appropriate biopsies.
I think you were one of the first to recognise the importance of the association between autism and an atypical form of inflammatory bowel disease, and it is this association that is now being confirmed time and again by the present investigations. I have absolutely no doubt that the present approach is ethical and that it does not need investigation or approval by our Ethical Practices Committee.”
That letter from Professor Pounder, Professor, he was not directly involved with the work. You have told us that he was the head of the department in which Dr Wakefield worked, is that correct?
A That is correct. He was basically acting head actually.
Q Did you find the contents of that letter reassuring as to the explanation as to the original study in the Lancet and to the continuing investigations?
A It was reassuring, yes.
Q If we turn to page 936 we see the response also from Professor Walker-Smith.
Q First of all a handwritten note to you. I think it says:
I attach my formal letter to you and a possible draft of a personal letter from me to David Hull. I would appreciate your advice as to whether I should send this or not.”
Q I will come back to your notes on that letter in a moment. If we can just turn on to the formal letter to you, which is the next page, 937,
Thank you for sending me a copy of Sir David Hull’s letter.
In relation to his specific points. The original sturdy covered by the Ethical Committee is now complete. He is quite incorrect to state that the initial findings showed that the children do not suffer long term bowel disorder. Most had non-specific colitis and lymphoid nodular hyperplasia. Whilst there has been discussion about the latter being a normal variant, I have answered this point in a letter to the Lancet as attached.
Subsequently children have been seen on a basis of clinical need referred by doctors (GPs, child psychiatrists and paediatricians) often on the initiative of parents. In this latter group of children a reduced number of tests are dome normally ileo-colonoscopy, blood testing, plain x-ray of the abdomen and child psychiatric review. 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.
This, as you know, was to be funded by Falk but for the moment remains unfunded. These subsequent children are being seen by clinical need to decide upon a treatment and help these children. Analysis of our blood tests may give us a clinical feature which may enable us to avoid ileo-colonoscopy in [the future].
Why the ethical committee should want to review their findings in the light of the published data surprises me very much. The published data has established for the first time, bowel changes in autistic children. This work has been described in a letter shortly to be published in the Lancet as ‘identifying a new relationship between gastrointestinal disease and developmental disorders in children’. The authors are distinguished academics in paediatric gastroenterology and immunology.
In summary the ongoing children are being seen by clinical need.”
If we turn back to the handwritten letter on page 936.
Q We see your Dean’s Office stamp and then is the note by you?
A That is my handwriting, yes.
Q Can you tell me what it says, please, under “Action”?
A Yes, I am sorry, my writing deteriorates with time. It says “Discussed 15/7” – that is 15 July – “not to reply to David Hull directly but to seek Michael Pegg’s views and to seek advice from Ivan Roitt and Dudley Dumonde re TF” which standards for Transfer Factor.
Q That appears to be another matter and I will return to that when I am dealing with the issue of Transfer Factor, but can you just help us, who was Ivan Roitt?
A Ivan Roitt was Professor of Immunology at University College London.
Q And Dudley Dumonde?
A Professor of Immunology at the Institute of Rheumatology.
Q You wrote to Professor Walker-Smith about this issue, obviously, and you attached the letter from Professor Hull. Why did you write to Professor Walker-Smith?
A I wrote to each person who was involved in doing studies because, as I said earlier on, I was deeply troubled by the letter from Professor Hull and, as you can see, Professor Walker-Smith not only replied to me but he came to see me and we had a fairly extensive discussion on the subject.
Q Yes. Professor Walker-Smith also wrote to Dr Pegg and we have that letter at page 940, making the same point, that he was continuing to see the children post the Lancet children by clinical need and asking for permission to write up the results.
Q Then if we look at 939, this is a letter that we looked at before in relation to the funding, Professor, and you say:
“I am reassured that the children with autism are investigated according to 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.”
Is that correct?
Q As I say, I have taken you to the letter of the same date that was written at page 940 to Dr Pegg, implementing that and asking for continuing approval.
Q “As Dr Wakefield is carefully analysing our results and some of the biopsies taken are being used for research …”, is that correct?
A That is correct.
Q You had been reassured, as you say, by Professor Pounder and indeed by Professor Walker-Smith in relation to the information to the effect that these children were being investigated because of clinical need. Were you in any position to question that information, Professor?
A No, I was not. The clinical decisions regarding the management of patients is the responsibility of the clinician in charge. Professor John Walker-Smith is a very distinguished paediatrician and I would certainly abide by his decisions. I had no reason to question his decisions whatsoever, nor was I qualified to do so.
Q A couple of days after those letters on 15 July in fact you had a meeting, and you have already briefly mentioned this, and we see the only note of it which is on page 948.
A Yes, that is correct. The reason for that meeting reflects the concern of Professor Walker-Smith and Dr Murch and it was decided that we should discuss this further in my office. The meeting was attended, as you see from the note, by Professor Walker-Smith, Dr Murch, Mr Lewis who was the medical director and Mr Else and you will see that I note that I was sure that all the necessary steps with the ethical committee and related matters had been taken.
Q Whose responsibility was it, as far as you were concerned, to ensure that the proper ethical approval, the correct ethical approval, had been obtained?
A It is the responsibility of the lead clinician together with all the named research workers.
Q If we go to page 949 we see an indication from Dr Pegg that the matter was going to be discussed further at the Ethics Committee on 22 July, is that correct?
Q Was it your expectation that if any regularisation of the situation was required it would take place at that Ethics Committee meeting.
A Yes, absolutely.
Q The outcome was relayed to you by Dr Pegg in a letter at page 951.
Q This is a letter which we have been to before and I am only going to read it briefly.
“The above application was first considered … in November 1996. The committee was very conscious of the requirement to avoid non-therapeutic research of more than minimal risk in young children. We … asked for reassurance that the investigations that were to be carried out … were clinically indicated and were not being carried out just for research. Professor Walker-Smith gave me that written reassurance …”
and he quotes it.
“Thus at the ethics meeting in December there was no real ethical issue to address. The children were having the investigations as part of normal clinical [care] and the ethics committee was involved purely because the cases were being collected for report by publication. The study was therefore approved.”
Then in July 1998 the study was reviewed again, and this was of course as a result of Professor Walker-Smith’s letter that I have just been to.
“The study was now entitled ‘Autism and Non-Specific Colitis and Lymphoid Nodular Hyperplasia’. Again Professor Walker-Smith gave us assurance that only clinically indicated investigations would be carried out”
and he quotes him again:
“‘I would formally like to request Ethical Committee approval for our clinical research analysis of these children who we are continuing to see by clinical need.’
Again the ethics committee approved the study on the understanding that all that was being approved was data collection.
On 9 July you wrote to me for my comment on the letter of Professor David Hull. In his letter Professor Hull states:
‘I see the investigations were approved by the Ethical Practices Committee of the Royal Free NHS Trust.’
This is of course incorrect. We did not approve the investigations. We approved the data collection from clinically indicated investigations and he points out that it is not at present the role of an Ethics Committee to question clinicians’ judgment as to what are and what are not clinically indicated investigations. However we do not just take the word of the investigator, we ask for independent expert review of all applications. In this case Dr Owen Epstein provided a review of the project and I have a letter from him ‘strongly supporting’ the study.
I hope I have answered all your questions regarding the ethical approval.”
Q The next piece of correspondence is a letter which was copied to you to the chief executive, Mr Else, and that is at page 953, the next page.
Q This is again post the Lancet article of course and saying:
I am just writing to you personally in relationship to the letter the Dean sent to me from Sir David Hull concerning the ethical nature of the studies we are undertaking on children with autism. These children with autism who have gastrointestinal symptoms from the very beginning, have been investigated according to clinical need. This has been approved by the ethical committee. Also it is routine for us to have ethical approval to take endoscopic biopsies for research purposes with parental consent for all children who were endoscoped. We have never moved outside any frame that has not been approved by the Ethical Committee or indeed that is outside the bounds of ethical behaviour in the widest range. We have the clearest evidence both published and unpublished that these children have a form of chronic inflammatory bowel disease. The only investigations they now have apart from blood tests is ileo-colonoscopy.
The letter in the Lancet which was published this week independently from the US bears testimony to the importance of the relations that we have made. The children that we are seeing with autism and gastrointestinal symptoms deserve the kind of investigation that we are performing.
I am just writing to you in order that you are fully informed of the situation.”
That is a letter, as I say, from Professor Walker-Smith and that was to the chief executive but copied in to you, is that correct?
A That is correct.
Q Thank you. We then have a letter which you wrote replying to Dr Pegg’s letter and that is on page 954, thanking him for his letter and saying that you had replied to Professor Sir David Hull.
Q Then on the next page, 955, you responded and you write out in that letter all the matters that Dr Pegg had conveyed to you, is that correct?
A That is correct.
Q The basis of the original protocol, under which assurances were given that they were clinically indicated, subsequently seen and investigated on basis of clinical need and the steps that you had taken referring Sir David’s letter to the Ethics Committee and the senior clinician responsible for the care of the children.
Q Also you wrote out the chairman of the Ethics Committee’s observations. We then have a letter from a Professor Revell and that is at page 957. Can you help us as to Professor Revell; he is a professor of histopathology is that correct?
A Yes, he is professor of histopathology and head of the department of histopathology.
Q Did you make enquiries with him about the biopsies that had been taken in the process?
A No, I did not. This letter was written to me by Professor Revell without me approaching him at all.
Q It starts off “Following our conversation …” Is that inaccurate?
A We had a conversation; he was concerned about the biopsies.
Q I see. It says:
“Following our conversation … about any small intestinal biopsy study of children with autism, I have spoken to my colleagues in this department who were co-authors of the paper which appeared in the Lancet reporting nodular lymphoid hyperplasia.”
His colleagues, is it right, are Dr Dhillon and Dr Davies, the histopathologists in his department. He says:
“Both Dr Dhillon and Dr Davies are unaware of any ongoing trial or formal study and Dr McLaughlin, who as Head of Service looks after the biopsy service is also unaware of any study. There are some biopsies being sent from children by clinical colleagues; some may have autism, but they are being examined within the routine diagnostic service within this department. We have to provide this service to colleagues on the basis of their clinical assessment of the patient and need to biopsy.
Where clinical trials or research studies are taking place, we are normally involved with the process of ethical committee approval and have a system of identifying such work both from the reporting and costing points of view. I am assured that no such formal study has been agreed through this department and that any reports are produced on the basis of a clinical request.”
Q We have one of your notes: “Please keep with Sir David Hull’s correspondence”, is that correct?
Q Was that simply for your records that you made that note?
Q Then we have a final letter from Professor Hull at page 958, “Thank you for your letter”. This dated 16 September 1998:
“I see that many in authority know what is happening and presumably do not share my unease.
In the February Lancet article it is stated that ‘the investigations were approved by the Ethical Practices Committee of the Royal Free Hospital NHS Trust’ and yet the Chairman of that committee wrote to tell you that that was not so. He told you that the committee had sought the view of a senior gastroenterologist, not perhaps the best person to advise on the ethics of the intrusive investigation of children with autism.
As you gather, I am still troubled but obviously others are not, so I accept that there I must let it rest.
Thank you for exploring the issues for me.”
Q In fact I think you did not let it rest because we see your action was to hand this on to the Chairman of the Ethics Committee, is that correct?
A That is correct.
Q I want to turn on to a different issue altogether. You will be relieved to here it is the last issue that I want you to deal with, and that relates to the issue of the Transfer Factor patterns. You have mentioned this issue of Transfer Factor in passing when I took you to previous correspondence. Could I ask you to turn back to page 936?
A Yes, I have it.
Q In addition to discussing your concerns arising out of Sir David Hull’s letter, there was discussion between you in relation to Transfer Factor, is that correct?
A That is correct.
Q You have suggested the seeking of advice from two people you have identified as professors of immunology.
Q Can you recall and tell us what the nature of that discussion you had with them?
A The background to this is, as you will see from the correspondence, the meetings that I had both with Professor John Walker-Smith and Dr Simon Murch is that they were as equally troubled by the letter from Professor Hull as I was, and we had a wide-ranging discussion and towards the end of the discussion I was asked for my views about Transfer Factor, which incidentally I did work with between 1974 and 1977 so I had quite a lot of experience of Transfer Factor. Nevertheless, the whole issue had become extremely contentious by then. It was the subject of many meetings with very many senior people.
Q When you say “the whole issue” are you now talking about the issue of the use of Transfer Factor?
A I am talking about the whole research project. It became a subject of common gossip in the Medical School, and I think quite rightly, and entirely to his credit, Professor Walker-Smith kept me fully informed and he asked my advice about Transfer Factor, knowing that I was a virologist and possibly knew something about it. Well, it was nearly 20 years previously that I worked with Transfer Factor, with Dudley Dumonde, and I therefore suggested that he should seek his advice about this, which he did.
Q You have told us you worked with this particular substance yourself: was there a reason why you were suggesting that he went outside rather than asking for your advice, that he went outside to other professors of immunology?
A Yes, because Transfer Factor was a highly controversial substance. Most of the work that has been done with Transfer Factor was purely anecdotal. There were never, to my knowledge, any controlled studies, and, worse, the subject was fairly topical in the 1960s and 1970s, but most people lost interest in Transfer Factor. I felt that the most knowledgeable people on Transfer Factor, and I was obviously a little bit out of date as far as Transfer Factor is concerned, were Professor Roitt and Professor Dumonde and I suggested to Professor Walker-Smith that he should have a word with Professor Dumonde, who really was the country’s leading expert on Transfer Factor.
Q We see that Professor Walker-Smith wrote to you after that meeting, and the letter is at page 941.
Q That is dated 17 July and reads:
“Thanks for your advice. I shall not write to David Hull.”
So that is an allusion to your advice that you would deal with the matter through ---
A Yes, it was clear that I should deal with the matter as it was referred directly to me.
“I have now written to Dudley Dumonde who I have known for many years concerning the safety aspects of ‘transfer factor proposal’. I attach copies of these.”
I will go to those in a minute:
“If it is regarded as safe I do feel in duty bound to the parents of these unfortunate children (where there are 3 pieces of evidence in favour of measles; lymphocyte PCR, serology and tissue immunohistochemistry) to proceed with initially an open trial evaluated by a psychologist or psychiatrist. Andy has promised me this would not be published as such but would be a vital preliminary to a placebo controlled trial. Such a trial would not proceed if the study were entirely without effect. I understand that Roy and Andy are planning a trial in adults with Crohn’s disease.
As to Mike Thomson, in strict confidence, I must tell you that he has made an unreserved apology to me and will continue for the moment to do ileo-colonoscopy for the remaining children where we have already promised the parents on a clinical need basis that this be done. Andy and I had previously decided on the encouraging basis of the analysis of the pattern of perturbation of T-lymphocyte function etc. in our initial analysis of the patients already studied will enable us to do such studies first and postpone ileo-colonoscopy while we are awaiting funding for our definitive controlled study of Mesalazine therapy.
Finally, I have written to Michael Pegg asking him to approve ongoing analysis of these children, copy attached.”
Can you help us as to the third paragraph on page 941, professor: what is the reference to Dr Thomson making an unreserved apology in relation to ileo-colonoscopy?
A As I understood it, it was the fact that it was no longer necessary to continue with ileo-colonoscopy but I think this is a question that should be addressed to Professor Walker-Smith.
Q He attached correspondence.
Q And that is on page 943, and this is his letter to Professor Dumonde at St Thomas’s Hospital:
“You doubtless will have heard about the controversial findings Wakefield et al have reported concerning the possible role of measles in children with autism. A study is proposed to give a group of such children who have evidence of measles antigen in tissue, positive measles serology and PCR positivity in circulating lymphocytes, dialyzable lymphocyte extract – transfer factor. These will be patients under my care and I will be responsible for safety aspects.
As I have known you so long and always valued your advice, I would much appreciate your confidential opinion of the safety of this extract as will be supplied to us by Dr Charles Kirkpatrick, Professor of Medicine & Immunology, University of Colorado, USA.
I have discussed this matter confidentially with our Dean, Professor Arie Zuckerman, and we both would value very much your advice, which I could pass on in confidence to Dr Michael Pegg, Chairman of our Ethical Committee if you were willing for me to do that. Or else you could give me your own opinion in confidence.
I would be happy to discuss this with you if appropriate on the telephone.”
Attached, at page 944, is a letter from the Medical Controls Agency in relation to the granting of a DDX licence, and we see at the bottom:
“It is assumed that the Transfer Factor is produced in accordance with the principle contained in …
The particular provisions regarding the safety in the European Community, is that correct?
Q The next involvement with Transfer Factor, if I can put it in that way, professor, is a memo at page 607, FTP 2. It is a memo from you to Mr Tarhan, a Finance Officer, is that right?
A That is correct.
“I note that the meeting of the Freemedic Board on 8 August 1997 considered a proposal from Mr Wakefield for funding in the order of £200,000 over two years for work on Transfer Factor.
I have considerable research experience with Transfer Factor and viral infection. I would not support the investment of Freemedic funds in this project. The case for an association between measles and Crohn’s disease is highly controversial, and is yet to be confirmed independently.”
Who were Freemedic?
A Freemedic was a company set up by the Medical School to safeguard intellectual property rights of the Royal Free Hospital School of Medicine. They had a certain amount, a limited amount of research funding available for projects for which we felt there should be pilot studies and supported by the Medical School, with respect to retaining intellectual property rights. I was one of the directors of Freemedic.
Q I need not ask you about the merits as to the conclusion that you had reached, but as far as you were concerned, you did not want to support the expenditure of amounts in that direction?
A No, I was not.
Q Were you aware of the fact that patents existed file by Dr Wakefield in relation to the use of Transfer Factor, both on a therapeutic basis and as a possible vaccine?
A My reply to this is, during my 10 years as Dean I had many surprises but none as great as this, when patents were taken in the name of the Medical School without the knowledge of the Medical School, so I was not aware of this until I received a letter from our external relations officer, Miss Ruth Bishop. I was absolutely shocked.
Q If I could ask you, the reason for your shock was your lack of knowledge rather than the particular substance involved?
A No, a patent was taken in the name of the Medical School without the knowledge of the Medical School, without the approval of the Medical School, in the name of the institution.
MS SMITH: Would you excuse me one moment? (PAUSE) Thank you. Sir, those are the questions I have for Professor Zuckerman save for one matter which I think Mr Coonan and I need to discuss further. Would it be appropriate if I ask the Panel to rise for a few moments and we can speak to the Legal Assessor.
THE CHAIRMAN: There are two options, either we rise for a short break now or we have an early lunch. The Legal Assessor is suggesting it would probably be a better idea to have a short break, so we will rise and wait for a call from you in five or 10 minutes, whenever you are ready.
Professor Zuckerman, once again, I have got to give you the usual reminder that you are still under oath and still in the middle of giving evidence, so please do not discuss this case with anyone.
THE LEGAL ASSESSOR: I have spoken to the legal representatives and it may that there is going to be an application from Mr Coonan in any event which it might be better for you to hear and determine first. It is an opposed application.
MR COONAN: Sir, by way of preliminaries, the matter outstanding between myself and Ms Smith has not yet finally been resolved, but it may well be that, with a further discussion, we might be able to achieve that. The second matter is this. Should it be resolved one way or the other, then what may flow from it will not take terribly long by way of evidence, if there is to be any further evidence called by her. That being so, the matter that I need to address now is whether or not I am in a position to cross-examine Professor Zuckerman this afternoon at, I do not know, 2.30 or thereabouts. The position is that I would ask the Panel to grant me the indulgence of not having to start this afternoon largely because we have received evidence this morning, of which I had no notice, and you will have to accept that from me because you do not of course have the witness statements. This is an extremely important witness in an extremely complex and serious case and, in fairness to Dr Wakefield, I must be in a position to be fully briefed and fully instructed on the matters which have emerged this morning in order that I can properly cross-examine Professor Zuckerman.
Furthermore, I would wish to be able to conduct the cross-examination all in one piece and I have a doubt as to whether or not that would be achieved this afternoon, bearing in mind the hour at which the Panel might wish to rise anyway on a Friday. So, taking those two particular factors together, it is my application that I be not required to start cross-examining this afternoon at, as I say, approximately, looking at the time now, towards 2.30 because I do not think that I would finish.
THE CHAIRMAN: Thank you, Mr Coonan. Ms Smith?
MS SMITH: Sir, I am not happy with that course and the reason why I am not happy with it is the following. Firstly, as far as the issue that is outstanding between Mr Coonan and I, it seems to me to be clear that it is a matter that will have to be resolved by the Committee and so any amount of time is not going to make any difference to that issue. The second is that Mr Coonan has asked for the indulgence, as he puts it, of not cross-examining Professor Zuckerman until Monday. I should say that, although you do not have Professor Zuckerman’s statement, you should be aware that every attendance notice that Professor Zuckerman has given and his statement have been available to the defence throughout. Every single document to which Professor Zuckerman has been taken this morning the defence have had for a considerable period of time and most of them, as you know, have been in the bundle or have been inserted.
THE LEGAL ASSESSOR: I wonder if I could interrupt at this stage, Ms Smith. Professor Zuckerman is sitting here. It might be slightly embarrassing to discuss what he has and has not said in the past or may or may not have said. In the ordinary course of events in a Crown Court or a Civil Court, a witness would withdraw while his evidence was being discussed.
MS SMITH: I am quite happy with that.
THE LEGAL ASSESSOR: (To the witness) Without any disrespect, Professor Zuckerman, would you mind waiting outside while we discuss your evidence.
THE CHAIRMAN: I believe that is normally the routine here as well. (To the witness) Professor, I do apologise but I think that you will have to ---
A Chairman, I would merely say that I really do hope to conclude my evidence as soon as possible. This has been dragging on now for 18 years. I would prefer to finish this as soon as possible.
THE CHAIRMAN: We do appreciate that but there are various legal procedures that we have to follow. We have made a note of what you have had to say. Would you withdraw and then a message will be sent out to you.
(The witness withdrew)
MS SMITH: Sir, I should have noted that he was present. Sir, every single document to which I have referred this morning Mr Coonan has been well aware of. I am uncomfortable with establishing any sort of a precedent that Mr Coonan would like to cross-examine all in one piece, as he puts it, because we simply cannot have that kind of indulgence given in a case this long and this complicated. We all of us like to be able to examine in chief or cross-examine in one piece and it just cannot happen if you happen to be in the middle of a witness at the end of a day. I have to say that if I had made an application in similar terms, I would be very surprised if I had had any sympathy at all from the defence in relation to it. The reason why I sound, if I do, rather firm on this issue is that I well understand that the Committee has had a very long and tiring week and I do understand how concentrating is difficult and I do not for a moment suggest that we should sit very late this afternoon, but it does seem to me that we could get some further evidence in relation to this witness and in relation to the objection that still exists and that has to be sorted out and could be done this afternoon. As I say, the reason why I sound rather strong on this is that I cannot over-emphasise the pragmatic problems which knock on for days and days in relation to all the witnesses who are lined up for next week. Sir, you will appreciate that this is the holiday period and we have to get our witnesses heard in accordance with the arrangements that have been made as far as possible. There is always slippage – there is always slippage – but next week is a week which contains a lot of witnesses who have very busy professional lives and I am very anxious that, if we do not even start on the cross-examination of Professor Zuckerman until Monday morning, we are going to have, as I say, a knock-on effect with regard to the other witnesses for the rest of the week.
So, although, as I say, I am entirely sympathetic to the idea that we should not sit too late this afternoon, I would submit that we could hear rather more of Professor Zuckerman’s evidence and if that means that it has to be broken in the middle, so be it, that is one of the consequences of a case of this length with this many witnesses.
THE LEGAL ASSESSOR: Ms Smith, there is one matter which you know concerns me and I was greatly assisted by your second junior, Mr Mellor. I am referring to the redacted version or the summary statement of Professor Zuckerman at page 2 and the last bullet point under paragraph 2 which of course has been crossed out. It struck me – and you know that I was concerned about it – that that evidence has in fact been given and the very last clause – and I may as well repeat it since the Panel members are going to be able to read it on the transcript, that Mr Wakefield refused to send, that is the results of their research, for independent analysis. It seems that it was not anticipated that that evidence was going to be given; I assume that is why it has been crossed out in the statement. That evidence has been given and that is a matter that did trouble me and I could certainly understand that that might be of some concern to Mr Coonan. I do not know if you would like to deal with that single issue before Mr Coonan replies.
MS SMITH: As far as that single issue is concerned, you will be aware – and indeed I expressly dealt with this with this witness – that there are two issues as far as the reproduction of results is concerned: one goes to the science and one goes to the ethics. I expressly asked this witness to confine himself to the ethical implications of possible lack of replication independently of results. That is not deleted from his statement; it is at paragraph 44 of his statement in those very terms.
THE LEGAL ASSESSOR: I see that. It was the fact that I did not think it was going to be in evidence that Dr Wakefield, as he is, had refused to do that. That is now in evidence. That is the only point I make.
MS SMITH: There is an inquiring nature to these proceedings and it is not up to me to tell a witness what he can or cannot say. It seems to me that that is a long way down the line and if Mr Coonan needs to take instructions to deal with that, that is one issue and he does not have to deal with that this afternoon.
THE CHAIRMAN: Mr Coonan?
MR COONAN: I think, if I may say so, it is a little unhappy to listen to counsel on behalf of this statutory body addressing you in this manner in a case which is of supreme importance on many levels not least for Dr Wakefield. We are dealing with one of the most important witnesses in the case so far. Professor Zuckerman is not on trial; Dr Wakefield is. One has to have in mind the interests of justice and I know that you will. Questions of witness availability arise in every single case that one hears and one has to do one’s best to deal with them. That must play very much second best, if I may put it that way, to the overarching interests of justice. I have told you that, in my professional judgment, there are matters which have emerged today of which I have no notice and I repeat that. The learned Legal Assessor has pointed out one matter in particular and I respectfully agreed with that. That has troubled me because I did not know that that matter would be adduced in evidence and I have to deal with it, I have to take instructions. Whether it is a subject matter of a charge or not … As it happens it is not but it certainly may have evidential significance or relevance in the case as a whole and I in due course will have to be in a position to make submissions about it, but, more importantly equally, Dr Wakefield will have to deal with it in due course. Before we even get to that stage, I have to be able to deal with it with Professor Zuckerman. It is unsatisfactory for me to embark on a cross-examination of some importance and, as it were, park one issue to be dealt with later on because it can, speaking as an advocate, affect the whole way in which one cross-examines a witness and, in part, the aim of a good cross-examination is ultimately to assist the Panel. That is really also not to be lost sight of. So, in effect, I say that it is right and probably ultimately will result, I venture to suggest, in a saving of time if the matter can be properly dealt with by me taking instructions on these matters this afternoon and resuming on Monday morning when the Panel is fresh.
Sir, that is the way I put it.
THE CHAIRMAN: Thank you very much, indeed. Legal Assessor, do you have any advice for the Panel?
THE LEGAL ASSESSOR: My advice is that you have to act in the interests of justice and fairness to all parties when considering whether or not you should adjourn early today for cross-examination to be postponed. Fairness includes of course the General Medical Council and its witnesses as well as the doctor’s but of course you have to be proportionate bearing in mind the issues at stake.
THE CHAIRMAN: The Panel will obviously have to go into camera to adjudicate on this issue. I thank you all for making your submissions on this particular point and we will consider it and get back to you as soon as we can.
MS SMITH: I will raise one matter in order that defence counsel can hear me: I hope that no one will have any objection to Miss Emerson, my instructing solicitor, conveying to Professor Zuckerman what is happening in order that he knows.
THE CHAIRMAN: Absolutely, yes.
MR COONAN: Sir, are you going into camera now or are you having your lunch first?
THE CHAIRMAN: We will go into camera now because it will be in everybody’s interest to know what is going to happen. We will go into camera now and get back to you as soon as we can.
STRANGERS THEN, BY DIRECTION FROM THE CHAIR, WITHDREW
AND THE PANEL DELIBERATED IN CAMERA
STRANGERS HAVING BEEN READMITTED
D E C I S I O N
THE CHAIRMAN: The Panel has given very careful consideration to the submissions made by Mr Coonan and Ms Smith and of course has taken advice from the Legal Assessor in open session. The Panel has determined in the interest of justice to accede to Mr Coonan’s application for an adjournment until Monday 6 August at 9.30 in the morning. The Panel Secretary will remind Professor Zuckerman that he is under oath and will remain under oath over the weekend, that he is not to discuss this case with anyone and that he is expected to be here at 9.30 on Monday morning. Thank you and have a good afternoon.
(The Panel adjourned until Monday 6 August 2007 at 9.30 a.m.)