GENERAL MEDICAL COUNCIL
FITNESS TO PRACTISE PANEL (MISCONDUCT)
Monday, 7 April 2008
Regents Place, 350 Euston Road, London NW1 3JN
Chairman: Dr Surendra Kumar, MB BS FRCGP
Panel Members: Mrs Sylvia Dean
Ms Wendy Golding
Dr Parimala Moodley
Dr Stephen Webster
Legal Assessor: Mr Nigel Seed QC
CASE OF:
WAKEFIELD, Dr Andrew Jeremy
WALKER-SMITH, Professor John Angus
MURCH, Professor Simon Harry
(DAY FIFTY-FIVE)
(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 not present.
MR STEPHEN MILLER QC and MS ANDREA LINDSAY-STRUGO of counsel, instructed by Messrs Eastwoods, Solicitors, appeared on behalf of Professor Walker-Smith, who was present.
MR ADRIAN HOPKINS QC and MR RICHARD PARTRIDGE of counsel, instructed by Messrs Berrymans, Solicitors, appeared on behalf of Professor Murch, who was present.
I N D E X
Page No
ANDREW JEREMY WAKEFIELD
Examined by MR COONAN, Continued 1
THE CHAIRMAN: Good morning, everyone. Mr Coonan, you were still in the middle of your examination in chief.
ANDREW JEREMY WAKEFIELD
Examined by MR COONAN, Continued
MR COONAN: Yes. I am now turning to the next section and all these will be relatively brief compared with the previous sections. (To the witness) Dr Wakefield, can you turn to volume 2 of the Panel bundle, please.
THE CHAIRMAN: This is section 14 now, is it?
MR COONAN: Section 13.
THE CHAIRMAN: It is 13 now? Thank you.
MR COONAN: It is page 464a. Do you have that? (A discussion followed on page numbering. The pages were handed to the witness) Dr Wakefield, I am just going to ask you a few questions about the background to the publication of the paper. This is a letter that the Panel have seen before, a long time ago now, written by you on 15 January 1998 to Professor Walker-Smith. It is of some length and I am going to ask you to read it out; then I shall ask you a couple of question, if you would.
A Shall I read it?
Q Yes.
A
“Dear John
Re: MMR and Autistic Enteropathy: forthcoming publicity
Firstly, the paper has been officially accepted by The Lancet after some minor revisions. They will be sending proofs next week and I will pass one on to each of the authors.
I felt that in view of the imminent publicity regarding our work, it was important to write and clarify my own position. Clearly, pending a press-briefing or other communications with the press, which now seem inevitable, we need to have considered our points of view, well in advance of publication. There may be points upon which we disagree, but I do not think that this is a problem, as long as that is made clear. If we can both recognise and respect each others position, then there should be no ambiguity. I have thought about this issue almost continuously over the last 5 years, firstly in relationship to inflammatory bowel disease, and latterly autistic enteropathy, and I have tried to set this out below, as a template for a more detailed discussion.
In addition to our own work and that of others, my opinion is also based upon a comprehensive review of all safety studies performed on measles, MR and MMR vaccines and re-vaccination policies. This now runs into a report compiled by me of some 250 pages, which I am happy to let you see. In summary, the safety studies are derisory, and appear to reflect sequential assumptions about measles vaccine safety, MMR safety and latterly, two dose vaccine safety, where each assumption has potentially compounded the dangers inherent in the first.
In view of this, if my opinion is sought, I cannot support the continued use of the polyvalent MMR vaccine. I have no doubt of the value of the continued use of the monovalent vaccines and will continue to support their use until the case has been proven one way or another of the measles link to chronic inflammatory bowel disease. I believe that 1998 will see some conclusive data in favour of the measles link from both our own work and the USA. I recommend that measles vaccination is deferred in children with a strong family history of IBD.”
Q Just pause there for a minute. For my current purposes I am going to ask you now to look at the third paragraph on the next page. Can you pick it up on the fourth line from the end of the third paragraph, beginning “Any drug”.
A I am sorry? I am just ---
Q Third paragraph, last four lines.
A
“Any drug, and especially one that involves 3 live viruses, must be considered dangerous until proven otherwise: this has never been proven and, therefore, all claims of adverse events should have been thoroughly investigated. They have failed to honour this obligation.
In an attempt to avert the House-of-Cards collapsing, I will strongly recommend the use of measles vaccines as opposed to the polyvalent vaccines. This will not compromise children by increasing their risk of wild infection, and may reduce the risk of an apparent synergy between the component viruses that has been identified by Dr Scott Montgomery as a risk factor for inflammatory bowel disease, and may well be a risk factor for autism in our children, currently under investigation.
I appreciate that you cannot (or feel that you cannot) support this stance, and I completely respect that. I value you[r] opinion and your friendship.
Kindest regards and best wishes.”
Q At that time, January 1998, was that an accurate expression of your opinion?
A Yes, it was.
Q And were they honestly held?
A Yes, they were.
Q Will you turn now to the reply at 673a. It is dated 21 January 1998, a letter from Professor Walker-Smith and jointly from Dr Simon Murch. Do you have that letter?
A No, I do not. (Same handed to the witness)
Q Can you read out this letter, please.
A Certainly.
“Dear Andy
Thanks very much for your letter to clarify your position before the press conference.
Our position is that the new paper as published does not present direct evidence for any implication of MMR vaccine although such evidence may be forthcoming in the second paper and other work in progress.”
THE CHAIRMAN: I am sorry. Can you just hold on. I think your voice is breaking up. Ms Smith, are you having some difficulty?
MS SMITH: Yes. It is breaking up quite badly, but it may be because Dr Wakefield is a bit too close to his microphone.
MR COONAN: In fact, would you push the microphone slightly towards me. Let us pick it up again.
A
“For us it seems inappropriate to emphasise the role of MMR vaccine in publicity about this paper. Its main thrust is to describe for the first time bowel inflammation in children with autism and so suggest a pathogenic mechanisms for autism.
Even when pressed by journalists we feel no specific information about the role of MMR should be discussed at a press conference. Our position must be to maintain a public agnosticism about the risk of MMR and for the moment support government policy concerning MMR until more firm evidence is available for us to see ourselves.
In private our view is that the government should institute urgently a comparative study of MMR and monovalent vaccines. This is more likely to happen if we refrain from publically attacking government policy until we have published evidence.
We continue to support our collaborative research with you and we respect very much your passionately held views and your concerns for the children themselves. We value immensely your huge contribution.
With Kind Regards
Yours sincerely”.
Q That letter was copied, as we see on 673b to Professor Zuckerman, Professor Pounder, Dr Berelowitz and Dr Thomson. Do you see that?
A Correct.
Q Your letter, if one goes back to page 646c, was copied to Professor Zuckerman, Professor Pounder, Dr Murch, Dr Thomson and Dr Berelowitz.
A Correct.
Q Did you receive a reply from Dr Berelowitz?
A No, I did not. No.
Q Or from Dr Thomson?
A No.
Q If you go to 674a – I hope you have that?
A I do.
Q Is this a reply from Professor Zuckerman to the copy letter that we looked at at 646a?
A Yes, it is.
Q Can you read this, please.
A
“Dear Andy,
You kindly sent me a copy of your letter of 15th January 1998 addressed to your senior colleagues stating your position with regard to MMR and your various studies.”
Q I think it reads “your own position”. I am sorry to be pedantic, but it ---
A “… your own position” – yes.
“I venture to make the following comments in my capacity as a virologist with considerable experience in vaccine development and evaluation.
• You have compiled a comprehensive review of the safety issues on measles, MR and MMR vaccines and the re-vaccination policy. This is helpful and it should be submitted for examination to Dr Geoffrey Schild, the Director of the National Institute for Biological Standards and Control and to the Medicines Control Authority.
• You will know that many millions of doses of these vaccines have been given worldwide with no reports of the adverse effects which you observe, and you are of course aware of the published reports which do not confirm your findings. The Canadian Communicable Disease Report (Vol. 23-1) also noted that ‘the balance of risk and benefit must weigh most heavily toward the side of benefit’, and the examination of your studies was not complimentary.
• The World Health Organisation will publish shortly an Editorial agreeing with the opinion expressed in the Canadian CDR, stating that ‘the hypothesis that measles vaccination in childhood predisposes to the later development of either IBD overall or Crohn’s disease in particular remains just that – an unproven hypothesis. These studies have no implications for immunisation programmes throughout the world which use measles-containing vaccines; measles vaccines are among the safest and most cost-effective vaccines ever invented’.
• You support the continued use of the monovalent vaccines and you write that you have no doubt of their value. To my knowledge this has not been repeated by the media. Had this been made clear then I doubt whether immunisation rates would have fallen by some 20% and continue to fall at an alarming rate.
• I disapprove of the use of the WWW on the Internet through a server in New Zealand on headed paper of the Royal Free Hospital School of Medicine. I am assured that you did not place this on the Web and since your name and address is used you will, no doubt, take the appropriate action to remove the site from the Web.
• Your observations together with your colleagues on ileal lymphoid nodular hyperplasia, non-specific colitis and developmental disorder(s) in children are clearly important and merit considerable further research. But until you have valid, confirmed virological data employing appropriate specific primer sequences, the association with MMR remains tenuous.
On a more personal note, you know that I supported your work, particularly on the vascular supply and endothelial changes. I am now alarmed by the publicity in the popular media and the effect on immunisation programmes and the public health. It is vital, in your own interest and that of children, that you state clearly your support for monovalent vaccination.
Finally, I note in passing your use of the title of Reader in Medicine and Histopathology. This is inaccurate. The correct University title awarded to you is Reader in Experimental Gastroenterology.
Yours Sincerely”
THE LEGAL ASSESSOR: Mr Coonan, did not Professor Zuckerman say that there was a typing error where it says “monovalent vaccination”?
MR COONAN: Yes. I am just about to deal with that.
THE LEGAL ASSESSOR: Thank you.
MR COONAN: That is what he said. When you received that letter, Dr Wakefield, what did you understand Professor Zuckerman to be saying in relation to that penultimate paragraph and in relation to the first bullet point on the top of that page?
A He was responding directly to my statement of support for the monovalent vaccine. He says “you support the continued use of the monovalent vaccines”, which is a direct reference to the statement in my letter, and he reiterates the support for monovalent vaccine in the penultimate paragraph.
Q And how did you read that?
A It was entirely consistent with the position that I had taken and recognised that position, and endorse that I should continue to support the monovalent vaccine.
Q Did you say to Professor Zuckerman at or about this time that you would not discuss vaccine safety at the press briefing?
A No, I did not. The very purpose of my letter to him was to give advanced warning that if asked, if specifically asked, on this point then the response that I would give is as set out in my letter.
Q If you now go back a page to 647, I just ask you this globally. Did the Department of Health know in advance that there was likely to be a different view expressed?
A Yes, they did.
Q Let us look at this letter at 647. It is from Professor Pounder to Sir Kenneth Calman, 16 January 1998. Can you just read out, please, the first two paragraphs?
A Certainly.
“Dear Sir Kenneth,
With this letter I enclose a pre-publication copy of the manuscript ‘Ileal lymphoid nodular hyperplasia, non-specific colitis and development disorder in children: a new syndrome?’ This is provided to you on the express understanding that you will respect our embargo about discussing it in public until the Thursday before publication. We have also provided Sir David Hull with a personal copy, so that he can be fully informed.
We undertake to tell your office of the precise date of publication, together with the arrangements that the Royal Free will make for the press briefing.”
Q And the third paragraph, please.
A
“It seems likely that at least some members of our team will recommend that there is a switch from MMR to monovalent vaccination, to ensure that the measles vaccination programme continues (excluding only those with a family history of inflammatory bowel disease or autism). We believe that there is only a limited amount of monovalent measles vaccine available at the present time, and your department may wish to investigate this potential problem.”
Q Was there any reply to that letter?
A I believe there was, although I did not see it at the time.
Q So far as the press briefing is concerned – and for my present purposes I just want you to help the Panel with this – whose idea was it that there should be one?
A It was Professor Zuckerman’s idea.
Q If you turn in the same bundle, please, to page 790 – and this runs through to page 795 – can you identify this document for us?
A This is a press release prepared in collaboration with the Media Committee at the Royal Free Hospital School of Medicine.
Q What constitutes the Media Committee?
A This was a committee chaired by Professor Zuckerman with various members of the Medical School as representatives on that committee, with a lady – I do not remember her name at the moment – who was in charge of coordinating that committee and dealing directly with the media.
Q Can you tell the Panel who drafted this document?
A I will probably have been responsible for the drafting process with input from my various colleagues.
Q I am not going to ask you to read out the whole of this document – the Panel of course can read it at their leisure – but I want to take you to page 793. There is a sub paragraph towards the bottom of the page:
“What recommendations would you make with respect to MMR vaccine?
The majority opinion among the researchers involved in this study support the continuation of MMR vaccination. Dr Wakefield feels that vaccination against the measles, mumps and rubella infections should undoubtedly continue but that until this issue is resolved by further research there is a case for separating the three vaccines into separate measles, mumps and rubella components and giving them individually spaced by at least one year.”
Did that represent your view?
A Yes, it did.
Q How long before the press briefing was that document circulated in the way you have described?
A I do not remember precisely but I think as of the decision to hold a press briefing it will have been put in action; so I would imagine within the last two weeks before publication there would have been circulation of this document.
MR COONAN: Sir, at this moment I am going to invite the Panel to view two short sections from the press briefing on your monitors. There are available for you the transcripts of those sections to which we will be inviting you to pay attention. I say straight away that the sound quality on the DVD is not of the quality that one might get in a cinema, so that is why we have had the transcripts prepared. But I also say that if the Panel or indeed anybody else involved in the case takes the view that there are other matters that should be included in the transcript or there is room for debate about something which we have captured on the transcript then of course that is a matter for discussion. I am perfectly open to that and I do not pretend that this is 99.9 per cent accurate. That said, we are confident that it is a pretty good working document.
THE CHAIRMAN: Is this transcript going to go into your D2?
MR COONAN: Yes, it is. Tab 18, sir. There are two sections. Mr Sheldon is going to operate this and if of course the Panel wish any part to be replayed at any stage then of course Mr Sheldon will do what he can to assist.
Sir, you will see that they are time marked and it might he helpful to mark them A and B or 1 and 2. The first one begins at 00 hours and the second one begins at 12.03. It is a reference to the minutes and if you turn to the last page on the second extract you will see that the entirety of the press briefing lasted some 31 minutes.
Sir, when Mr Sheldon plays this if you take the first of the two and he is going to start it at 00 on that first extract.
(DVD of press conference played to the Panel – transcript set out below)
“0:00
M … three separate vaccines would be better …
AW The er association – the temporal association between MMR and
autism was initially made in the United States and two eminent doctors who’ve published upon this subject making the same temporal link. We have confirmed that temporal link in our small cohort. It is apparent when looking at the data – the epidemiological data, although they’re imperfect, this particular syndrome that we are describing is very new. If one looks at er isolated populations it appears that it may have appea – come er into being beyond nineteen eighty eight when MMR first originated. This is something that requires extensive investigation … but I think that my concern – my concerns are that one more case of this is too many and that we put children at no greater risk if we disassociate those vaccines into three, that we may be averting the possibility of this problem. And vaccination policy in this country depends upon trust between the people and the regulatory (authorities/authority). And I think that trust has to be maintained for the protection of all vaccine strategies. And if we do not acknowledge this and investigate it er to the best of our ability to establish or refute (the claims), then I fear that there may, in future, be a breach of that trust and that that may adversely affect all vaccine policies. And that would be a great shame.
1:44
AZ Can I just actually try and answer the question more precisely. Er
MMR consists of the three live attenuated virus strains. In other words we are administering to children (from) the MMR the attenuated vaccine strains against measles, against mumps and against rubella. It’s a combination of three different viruses. Now, theoretically it is possible that the immune system will be challenged by three separate viruses and that would be the rationale (I think) for giving these vaccines separately. And, of course, before MMR was produced er these preparations were available – they were available as monovalent vaccines. Any other questions?
[Cough]
F …
AZ Well, I think there is – there is vast experience in giving people these
erm er these vaccines er separately and in combination. (Indeed), hundreds of millions of doses of these vaccines have been given worldwide, including the United States, and Scandinavia, and the United Kingdom and Europe. They’ve been shown to be absolutely safe. I’m sure that you will recognise that all vaccines meet er international standards for safety and (efficacy), meet with WHO requirements and all the evidence is that these vaccines are safe individually, or in combination. One possible explanation, which
I think is er Doctor Wakefield’s view, and I think others would share it, that it is possible that at the age of one er the immune system is not (fully developed) and therefore challenged by the three viral er live attenuated strains may er be associated with side effects … need to be … I emphasise again these studies have not demonstrated by a long way the criteria which we, as virologists, would require …
(Andrew, would you agree with that?)
4:20
AW I’d certainly agree that there is vast experience of giving these vaccines
and for the vast majority of children there is clearly no problem at all. We are looking at a small number of children … it is mandatory that we try and identify what Professor Zuckerman has said, whether this is a genuine association, we are working very hard on it. And, indeed, who are the group … case … identify them by some genetic marker or other way and exclude them for …
4:50
[End of section]”
MR COONAN: Sir, the next speaker is Professor Pounder, who is RP on your transcript.
(Further sections of press conference played to the Panel – transcript set out below)
“12:03
RP I think it is very important for two reasons. One is that er the new
syndrome of er b-damaged bowel associated with autism has been identified and that is tremendously important because autism is incredibly (disruptive/destructive) to the individual family if there’s a child who suddenly is falling apart and dominates the whole of that family. And hitherto, there is no – there’s been no clear way ahead and so that this is a – er an opportunity er to find out a great deal more about autism. I take the point also that probably six million children in Britain have received MMR vaccines and we are talking first twelve and then forty-eight … patients and there probably is more, but compared with – compared with six million this is a very small number. But for those individuals it’s very, very important and I think that many of these families have felt isolated, that even the possibility that for these rare children there was a problem. They have been told “No, everything is safe” and I think that one of the things we need to do is to go to those families and support them and er to try and er nurture them and their children er in a positive way. Now, my feeling about vaccination goes more along with Andrew Wakefield, that erm
I think that it appears these rare cases have only appeared since the introduction of MMR and since the publicity that started leaking in the summer there have not been older people turning up and saying, “Aha, we had the same thing before MMR.” So that it does seem that this unique combination of having three viruses in the same injection may be an unnatural and unusual event. That’s not to mention that in the last few years we’ve learnt enormous amounts about viruses, particularly er from HIV, and we now know that when multiple viruses are active at the same time you get (many/funny) responses, you get augmented or deficient responses. So that in hindsight, it may not have been – although administratively it’s a wonderful idea to fix everything in the same vial, in the same vaccine, er it may not be the ideal solution. So that I would argue that it looks as if when they had the vaccine individually er there was no problem and, therefore, I would suggest that that may be a strategy that should be looked at again.”
14:25
[End of section]
[video fast-forwarded]
“AW I just want to say a couple of things and that is to- to reassure you we are not at odds on our er perception of the need for a measles vaccination. We are all agreed on that and that is extremely important. Er I don’t agree with Professor Zuckerman on the extent of the safety trials that have been conducted. I don’t think that the limited safety trails with MMR- MMR in particular with regards to the three to six weeks are sufficient when giving three live attenuated vaccines that may have delayed consequences. Erm in terms of the virological-virological question, the presence of the virus in the gut, there’s supportive evidence from around the world in the context of Crohn’s and colitis as well, erm a- as Professor Pounder said, the positive data were not presented, in two groups from Japan, a group from Italy, a group from Sweden and a group from Argentina have all found evidence of the virus and later this year we believe that data from the United States will emerge showing the same thing as well. We would not have presented this paper to The Lancet, the paper describing the syndrome, had we not conducted extensive virological studies already and those studies have been accepted for presentation at the British Society of Gastroenterology in Harrogate next month and for the American Gastroenterological Association in Louisiana in May and those will be presented. So an answer to the virological questions will be provided at that time.”
MR COONAN: Thank you very much, Mr Sheldon.
MS SMITH: Sir, before you continue, may I just raise one matter because Mr Coonan has invited commented in relation to the video that we have just seen. I have some concerns. I have no idea of course what points he wants to make in relation to that, but it may be that the Panel feels that any point that he wants to make is not going to be fully helpful to them when they have not seen the whole transcript and the whole video.
I do not want to waste everyone’s time and I have to say that it does seem to me that the whole issue is one of very limited relevance, if any, but that is not really my concern. My concern is that if Mr Coonan thinks it is of relevance, then the Panel may feel that they need to see what everybody said. They will have been able to identify some of the other people who were at the press conference. In fairness indeed it may be to Professor Murch, you may wish to hear what he said about it and you may wish to hear what Dr Berelowitz said. As I say, the whole thing is only half an hour perhaps. It seems to me it might be appropriate for you to see the whole thing.
THE CHAIRMAN: Mr Coonan?
MR COONAN: It is entirely a matter for the Panel. I am conducting the case on behalf of Dr Wakefield. I am drawing attention to a number of passages of potential relevance later on. I am content with what I have adduced. If the Panel want to see any more, then equally I am content. The Panel can listen to it now, but I did not want to waste time.
I am sure that if Mr Hopkins wishes passages of Dr Murch’s utterances, if any, on that transcript to be placed before the Panel, he will be the first one to speak. I am not sure it is Ms Smith’s concern, with great respect, at this stage. It is a matter for Mr Hopkins.
THE CHAIRMAN: I am looking at it from a slightly different perspective. The whole video is 31 minutes and we have probably seen about 10 minutes already. That actually means that we are saving only approximately 20 minutes or so.
I have not discussed this with the Panel members. I just wonder whether looking at the whole thing actually would give the proper perspective.
MR COONAN: Certainly; we can play the whole thing again right from the beginning.
THE CHAIRMAN: Can I just look quickly towards my Panel members. If a discussion is required, then obviously we will need to go into camera. Before, that I call on the Legal Assessor.
THE LEGAL ASSESSOR: You will need the transcript of the whole thing.
THE CHAIRMAN: If we are going to see the whole video, then I think we will need the whole transcript just to make sure because, as you said, the quality of the video is not that good. We should make sure that we are hearing the things correctly as we are reading.
MR COONAN: I say “we” but I have no instructions when I say this because there are cost implications. A perfected transcript of the whole thing is not available to us, but it could be obtained. Quite how it would be obtained of course is a matter for inquiry. As I say, there are cost implications. I can take instructions on the point but to assist the Panel, it may well be that instructions can be given to the people who did these two extracts and the person who did it could do a transcript of the whole.
THE CHAIRMAN: In that case, may I make a suggestion that that hopefully will be acceptable to all counsel and to the Legal Assessor? If we keep this thing in abeyance for the time being, you could do some work at the mid-morning break and come back to us. In the meantime, I will consult my Panel members to see how they feel about this particular issue, and then we will take it up after the mid-morning break.
MR COONAN: Certainly, sir. I will make some inquiries.
THE CHAIRMAN: Ms Smith, are you happy with that suggestion?
MS SMITH: I am entirely happy, sir, thank you.
MR COONAN: Dr Wakefield, first of all, did the paper itself have prospectively public health implications?
A Yes, potentially it did.
Q Can you explain to the Panel in what respect potentially it did?
A It brought in two respects: firstly, it raised the possibility that this apparent rising tide of autism may be related to a specific environmental exposure in a majority of children in this instance to a vaccine. Therefore, clearly there were public health implications. On the second point, that if this association were picked up on clearly, as was very likely as it was, then there may be concerns, as there were, about the safety and continued use of the MMR vaccine.
Q Did you understand the importance of ensuring that the paper therefore was accurate in its descriptions of the data which had been obtained?
A Yes.
Q As far as you are concerned, was it accurate?
A Yes.
Q If we can just jump ahead, but this point is linked to what we have just been talking about, the Panel have received some evidence through Professor Salisbury when he gave evidence about the monitoring processes following publication of the paper in relation to take-up rates. The Panel received that evidence and that evidence from the agencies who carried it out was not challenged. Do you have any observations to make about your position in relation to the apparent juxtaposition of the paper, the press conference, and a reduction in take-up rates?
A Yes, two observations really: the first is that the uptake of the MMR vaccine in particular had been an issue for some time, indeed after the withdrawal of the Urabe containing MMR – that is Pluserix and Immravax, in 1992 – because of the association between the mumps component and meningitis. So there had been a gradual decline since that time. I have no doubt that that decline was exacerbated by the publication of this paper. My position was taken with an abundance of caution. A drug is dangerous until proven otherwise and the extensive reading that I had done and the consultation that I had undertaken with vaccine safety experts on those trials led me to believe, as I have said, that they were wholly inadequate, they were derisory, and from that position and from a position of wishing to continue to have children protected against these infections, and measles in particular, I endorsed the sue of the single vaccines. That was my position.
Q Two short points: they are not directly related to what we have just been looking at but they relate to two short aspects of the evidence that Professor Zuckerman gave. You may remember that Professor Zuckerman suggested that you had refused to send biopsies for independent evaluation. Do you remember that evidence?
A I do.
Q Again, can you please for my purposes deal with this as shortly as you may. Is he right or wrong about that?
A He is wrong.
Q Why is he wrong?
A Because I had undertaken exactly that process and I had arranged for the biopsies to go to an entirely independent laboratory for scrutiny using the most modern and sensitive and specific molecular technology, which was not available in my lab, and indeed was not being used in the laboratory of the National Institute for Biological Standards and Control that Professor Zuckerman suggested. They were using a measles virus detection technique that was similar to our own; in fact, it probably had an inferior sensitivity. We could detect 10,000 copies of a virus in a reaction. Professor O’Leary, the independent laboratory to which the samples were sent, could detect down to 1 copy of a virus in a reaction. The advantages are clear.
Q The second point is this: it was suggested that the question of research into the link between inflammatory bowel disease and measles vaccination had not been independently verified. Is that contention right or wrong?
A It is wrong.
Q In a word or two, please, why is it wrong?
A It is wrong because in fact we were not even the first, as I mentioned earlier in my evidence, to identify evidence of measles virus in Crohn’s disease. This was achieved some years earlier by Professor Miomoto at the Wakayama Institute in Japan. This paper was not ultimately published until 1995, but the data had been presented before that time.
Q Dr Wakefield, that is all I am gong to ask you about this section. We will move on now, please, to the Medical Research Council meeting, section 14 for the Panel, on 23 March 1998. There is a transcript of that meeting, which you will find in Panel bundle 7, tab 7. I am going to take you to page 85 of page 7. That should be the beginning of the transcript. I want to pick it up with the introductory words of Professor George Radda from the Medical Research Council. I am going to read out that first part.
“Good morning and welcome to this meeting. I would like to thank all of you for attending, many of you coming at very short notice, which reflects the seriousness and the importance of the business and the topic today.
The MRC was asked by the Chief Medical Officer to hold this meeting to examine evidence relating to measles and measles vaccine to chronic gastrointestinal disease. As you are all aware, the MRC, while receiving public funds, is independent in its choice of research, as it is independent in the way that it organises meetings on a topic, so the decision to hold this meeting was entirely that of the MRC in consultation with Mr Wakefield and his colleagues.
Recently the chief scientific adviser to the government called for greater scientific advice in policy formation – a very difficult issue. I hope that in line with this thinking the output of this meeting will assist the Chief Medical Officer in his task.
Finally, I should like to thank Sir John Pattison for taking on the difficult task of running this meeting, no doubt on time and efficiently, and at the end trying to bring it to some sort of conclusion.”
Dr Wakefield, did you understand the seriousness and importance of the business and the topic that the meeting was called to deal with?
A Yes, indeed; in fact, I called for the meeting.
Q If we now just, before looking at the text of the meeting, look at page 196a, and I hope you have that; it was put in at a later point.
A No, I do not. (Same handed to witness)
Q We see on page 196a a list of attendees and, running down the list, the Panel may remember but it may be timely to remind ourselves of it, in the left-hand column, Dr Berelowitz, Professor Sir David Hull, and in the right-hand column, Dr Murch, Professor Pounder, Professor Sir Michael Rutter, yourself, and then as observers, Dr Salisbury and Professor Zuckerman. Over the page, there are apologies from a number of people, including Professor Walker-Smith. I want to go to the text, please. Can you start by looking at page 152? As the Chairman indicated, at the top of page 152, you were invited to make a presentation headed “A new syndrome: ileal lymphoid nodular hyperplasia, non-specific colitis and pervasive develp0mental disorder in children”. Again, it may be timely just to emphasise it for the transcript at least: had The Lancet paper been published by this stage?
A Yes.
Q I want you to pick it up where you start talking and look at the second paragraph which has not been read into the transcript as part of the prosecution case. Can you now rectify that, please?
A Certainly.
“[slide] This came about when it was clear that we had an interest in measles and the gut – measles vaccine in the gut – and started getting calls from a series of parents who said that ‘my child was developing perfectly normally until they had the MMR vaccine’. In a short space of time they had started exhibiting behavioural features consistent with autism and one, two or three years later they ended up with a diagnosis of autism. I put the phone down and I got five calls in two days telling exactly the same story and I felt that we really needed to look at this. That there was a consistent story here that really merited investigation. And I asked a group of my colleagues, including Simon Murch who is here today, and Mark Berelowitz our child psychiatrist who is also here, to help us look at this.”
Q Would you read the next paragraph, please.
A
“We originally reported, in a paper that came out recently, 12 children. We have now the results of a paper that was presented at the British Society of Gastroenterology, two weeks ago and we have now looked at 51 of these children to date. So I report here on the 30 consecutively referred children, with a mean age of 6 years (3-10), 28 males, consistent with the over representation of autism in males, and the selection criteria initially. And these have broadened latterly. We are not testing an a priori hypothesis. We felt we should not be constraining this. A period of normal development, followed by developmental regression and gastrointestinal symptoms. And it was the gastrointestinal symptoms that really the parents complained had never been taken seriously and never been investigated. The children were having their bowels open 4, 5, 6 or 10 times a day or had severe constipation or alternating constipation and diarrhoea, food intolerance and bloating. And this had always been put down to their behavioural abnormality.”
Q Then go to page 154. Would you go to the last paragraph, and read that, please.
A
“[slide] So what about the aetiology? Well, historically early viral exposures have been linked to the development of autism, although in the vast majority of cases no cause is ever identified. There is certainly a genetic predisposition. Measles and rubella have been linked to both disintegrative disorder (Heller’s disease) and autism. And measles encephalitis can lead to Heller’s disease. So there is a biological basis perhaps for suspecting that these may be involved. The vaccines have been linked. Fortunately for us we were not the first to raise this spectre. We may yet be the last and Harry Fudenberg has published on this, and Professor Gupta from University California Irvine [?] has also published on this. They did not, again, test an a priori hypothesis. They merely noted that regressive autism had this striking temporal relationship in normal children with exposure to MMR. And again it was the component vaccine. This has never been described. We have now some 500 of these children who have been referred, or who are in the process of referral. We do not know what their guts will show yet. But none of them – not one – is associated with monovalent vaccine. They have all been associated with MMR.”
Q Then go to page 167, please. I am sorry. I am going to pick it up at the bottom of 166, where Professor Anderson set out, I think, two questions. Can you read those, please?
A Yes.
“Two questions about association. I have not read in detail the analysis so I may be widely at error here, but if you look at the distribution of the average age of immunisation, particularly with MMR – I think the average is about 2 years. So if you chose children at random of that age, then in essence most of them would have been in a very close proximity to the point of their immunisation. So I am just wondering in the analysis there of an association, whether you corrected for age and the average age of vaccination? Second opinion that is the first question. The second one is related to the longitudinal studies in instance ---“
Q It is “longitudinal trends”.
A I am sorry. “… longitudinal trends in instance of the condition”. I think that should read “incidence of the condition”.
“… in incidence of the condition, which on the face of it, not knowing anything about diagnosis which Michael commented upon – there did not at first sight appear to be close association with the total volume of MMR vaccination? I mean you’d only say that the vaccination was somewhat loose, wouldn’t you?”
Q Sorry. “…the association…”. I am sorry. Can you just read that last sentence?
A
“I mean you’d only say that the association was somewhat loose, wouldn’t you?”
Q Yes. And then your answer, please.
A
“What we are reporting is merely the story as it was reported to us. We have not corrected for anything. I have merely told you the story as it was told to us by the parents. And the parents had made the association with MMR. XXX has a population for this and it may be a place in which one can get some kind of epidemiological handle because children in XXX have been looked after by the same paediatrician for the last 15-30 years and he sees all children with developmental disorders in XXX. And until the end of 1988 he had none of these children at all. At the end of 1988 with a period of three years, he had eight such children, born XXX and two born XXX. And it took them by such surprise and it put such a strain on their resources that they had to build a new school for them and I would strongly recommend that if money were going to be put anywhere it would be to investigate in that sort of XXX cluster of this kind of phenomenon. But at the end of 1988 three vaccines were combined into MMR and that is when our cases started.”
Q Then turn to page 168. I am going to read myself the question put by Dr Anne Ferguson:
“DR ANNE FERGUSON: I am going to be forthright – since it looks as if nobody else in going to raise the issue of bias in generating this serious of cases. Maybe that the timescale I have got and the facts I have got are not correct, but at least my perception is as follows. That about 1994 your group became concerned about measles vaccine as a hazard and that coincided with the organisation JABS [?] being either created or supported or sponsored or some interest in the idea. And I recall hearing a year or two ago and seeing an abstract of autism, Crohn's disease and bowel symptoms in two children – whom I assumed were the first one or two that were mentioned in this series. And then I have to say that I understood that there was a lot of publicity on the telly and newspapers on the Internet suggesting that if someone had a chi ld with autism and bowel symptoms that this was the centre in the world to find out about it. I mean I think – is that not correct? Is that not how these 500 cases have come along? But I mean I am surprised that among even 50 children with disturbed guts, disturbed immunity, that there have not been some with duodenal ulcers, with gallstones, with other problems as well as the condition you are talking about. And anyway – to hear what the clinical immunologists feel – the immunological features which are, after all, described in the peripheral blood mainly, would entirely go along with what we were told about with sore ears, sore noses, sore throats, swollen glands and so on.”
And your answer, please?
A
“Thank you for being forthright. I imagine you are suggesting we are a sort of dumping ground for disaffected parents? No – we are not. And indeed these parents came to us de nouveau without any connection through any other organisation. Latterly, parents have heard about our work – through the media or through other organisations – and have come to us. Whether that is linked to MMR or not we will find out hopefully in time. All patients that we have reviewed so far have come to us through their general practitioners or paediatricians by the standard route.”
Q
“DR ANNE FERGUSON: I apologise. I wasn’t suggesting any impropriety. It was really the interest in the subject.”
Now, Dr Wakefield, it is the last answer, taken as a whole, that I want to ask you about. When you said, as you did, in answer to that question by Dr Ferguson that “All patients that we have reviewed so far have come to us through their general practitioners or paediatricians by the standard route”, what issue were you addressing when you said that?
A What I was addressing is that the referrals to Professor Walker-Smith for clinical investigation based upon clinical indication had come from their general practitioners or from the paediatricians as extra contractual referrals or otherwise.
Q Was the use of that term “standard route” an accurate description of how you explained at length with each of these children what happened?
A Absolutely, and it should be taken in the context of what I had said earlier in my presentation about the initiation of this process by the parents spontaneously making contact with me.
Q Turn back to page 152. What is the passage that you have in mind?
A If you go to the second paragraph of my presentation, I say there, “and started getting calls from a series of parents who said that ‘my child was developing perfectly normally,” etc. And then, “In a short space of time they had started exhibiting behavioural features”, carrying on with, “I put the phone down and I got five calls in two days telling exactly the same story…”. What that conveys to the Medical Council meeting, it was the Medical Research Council, was that this was a self-referred group based upon an initial contact from the parents looked for children for their children.
Q In the next paragraph, on the third line, you say:
“So I report here on the 30 consecutively referred children…”.
That is a phrase which has an echo – an exact echo – in The Lancet paper itself?
A Correct.
Q Were you using that in the same sense in which you use in The Lancet paper?
A In exactly the same context. These were the first 30 children to come through the doors at the Royal Free and to undergo investigation.
Q And when you used in fact both expressions, on page 152 “consecutively referred” and on page 168 “standard route”, were those terms used – and you have explained the context and the issue you were addressing – were they used honestly?
A Yes, they were.
Q The Panel will have in mind in the light of that evidence heads of charge 36. Thank you very much. I am to ask you to put that to one side, Dr Wakefield.
Sir, I am now going on to the next section which is concerned with head of charge 35. You will need to turn up volume 3 of the Panel bundles and go to page 924. (To the witness) I just want to use this to set the scene, Dr Wakefield. You will see on page 924 in the left-hand column a letter from a Dr Rouse. Do you have that?
A I do.
Q And immediately below it the beginning of a reply to that letter, continued in the next column from yourself?
A Correct.
Q And the edition of The Lancet is May 2, 1998, the paper itself having been published on 28 February 1998.
A Correct.
Q Before looking at the content of these two letters, as we must, I am going to ask you, please, to look at two documents. You will be given them. (Same handed to the witness) Then I shall just ask you, please, to deal with their provenance. There is a purpose for doing this, Dr Wakefield. First of all, you have been handed two documents. Have you seen those before?
A Yes, I have.
Q When did you first see them?
A These were sent to me in a bundle of letters which constituted responses to the paper that was published in The Lancet at the end of February 1998.
Q Have those two documents been available to you for the purposes of the first part of this hearing?
A No, they have not.
Q How did they now emerge and come to light?
A The Panel will know by now that I enjoy professional exile in Texas, and I have been there for some time. My family, who was still in England, moved over some two years later. When the contents of our house were packed up and sent to Texas, certain things failed to arrive, including two filing cabinets which were held in the back of our garage at home in England, along with a number of other things. As it turned out, my wife tried to track these down and they said that they were missing. She decided to pursue a claim against the removals company, and then they took the trouble to actually look, and they were found in a warehouse in England. They were subsequently shipped to the United States a few months ago. Just prior to returning to this hearing, my wife decided to just go through those to make absolutely certain there was nothing in there that might be materially relevant to these proceedings, and this is when she found the original letter from Dr Rouse to The Lancet.
Q Having laid the ground in that way, I am going to ask you now to formally produce to the Panel copies of those letters. The other parties have had copies already. (Documents circulated) Could we refrain for a few minutes from given them a number or letter. The reason for that will become clear in a moment. Do you have your copies there, Dr Wakefield?
A I do, yes.
Q Now that the Panel have the photocopies in front of them can we go back, please, to what it was you were dealing with? There are two documents: the first is a document in bold lettering, headed “Letter to the Editor Lancet” and a second document which is headed, “Vaccine adverse events: Litigation bias might exist”. Again, since the photocopy reproduction may or may not be as good for some compared with others, the date on the covering letter to The Lancet, alongside the lettering, “LETTLANC.DOC” is that 4 March 1998?
A Yes, it is.
Q I hope the Panel can see that on their copy. On the top of the page there is a fax date and time; what is the date?
A 2 April 1998.
Q Does that say, “From: Lancet”?
A Correct.
Q On the second page also with the fax time and date the same is there a date stamp on the top of 9 March 1998?
A Yes, there is.
Q Was it both of these documents you received?
A Yes.
Q Tell us again, from whom did you receive them?
A I received this from the office of The Lancet.
Q Can you remember exactly when it was you received them?
A I am afraid I cannot.
Q As far as you are able to say what does the fax date on the top mean?
A That will be the date that it was sent to me.
Q I will come back to this but for immediate purposes on the top of the second page the heading of the letter from Dr Rouse is, “Vaccine adverse events: Litigation bias might exist”.
A Correct.
Q I just point out in the box the first bullet point:
“Inflammatory Bowel Disease. We are working with Dr Andrew Wakefield of the Royal Free Hospital London. He is investigating this condition.”
And there is a reference to a page number. That is an extract from a 48-page fact sheet obtained, according to the box, from a website.
A Correct.
Q Can we then go to The Lancet correspondence column and I am going to read the published letter.
“After reading Andrew Wakefield and colleagues’ article I did a simple Internet search and quickly found the Society for Autistically Handicapped.”
He sets out the website:
“I downloaded a 48-page fact sheet produced for the society by Dawbarns, a firm of solicitors in King’s Lynn.
It seems likely then that some of the children investigated by Wakefield et al came to attention because of the activities of this society; and information from parents referred in this way would suffer from recall bias. It is a pity that
Wakefield et al do not identify the manner in which the 12 children investigated were referred (e.g. from local general practitioners, self-referral via parents, or secondary/tertiary or international referral). Furthermore, if some children were referred, directly or indirectly, because of the activities of the Society for the Autistically Handicapped, Wakefield should have declared his cooperation with that organisation.”
If we just pause for a minute and go back to the version you received, when you were responding to what I am calling the Rouse letter, did you respond to the two-page document that you have identified now or were you responding to the article as published?
A I was responding to the two-page document as it is clear from the reference to litigation bias in my response, which did not appear in Dr Rouse’s published response.
Q If we can pick up that point on page 924 in the middle column, you say in the second paragraph:
“A Rouse suggests that litigation bias might exist by virtue of information …”
et cetera.
A Correct.
Q Is that a reference to the two-page document that the Panel now have?
A It is.
Q I am going to ask you, Dr Wakefield, to read that part of your letter beginning “A Rouse suggests” on page 924.
A
“A Rouse suggests that litigation bias might exist by virtue of information
that he has downloaded from the Internet from the Society for the Autistically Handicapped. Only one author (AJW) has agreed to help evaluate a number of these children on behalf of the Legal Aid Board. These children have all been seen expressly on the basis that they were referred through the normal channels (e.g., from general practitioner, child psychiatrist, or community paediatrician) on the merits of their symptoms. AJW has never heard of the Society for the Autistically Handicapped and no fact sheet has been provided for them to distribute to interested parties. The only fact sheet that we have produced is for general practitioners, which describes the background and protocol for investigation of children with autism and gastrointestinal symptoms. Finally all those children referred to us (including the 53 who have been investigated already and those on a waiting list that extends into 1999) have come through the formal channels described above. No conflict of interest exists.
The authors stand by their findings. We recommend that paediatric gastroenterologists investigate this problem further, since it is our belief that there is both a large unmet need in the community and a possible window-of opportunity for some children with autism.”
Q Taking that as a whole, first of all, I need to break it down. When you were expressing those views and making those observations were you telling the truth?
A Absolutely.
Q Going back to the letter from Dr Rouse, the published version, in the first part of his letter he says:
“I downloaded a 48-page fact sheet produced for the society by Dawbarns, a firm of solicitors in King’s Lynn.”
The Panel have seen some fact sheets in their bundles with the name Dawbarns on top – and you have given evidence about this in another context but can I have your evidence in this context. Were you involved in the production of any fact sheet which has the Dawbarns’ logo on top of it?
A No, I was not.
Q In respect of any of the children that you dealt with in The Lancet paper did you understand – yes or no – as to whether any of them came to your attention as a result of the activities of The Society for the Autistically Handicapped?
A No.
Q Dr Rouse goes on – and I am now looking at the second paragraph:
“It is a pity that Wakefield et al do not identify the manner in which the 12 children investigated were referred (e.g. from local general practitioners, self-referral via parents, or secondary/tertiary or international referral).”
Pausing there, did you address that very question in The Lancet paper?
A Yes. It makes me wonder whether Dr Rouse actually read The Lancet paper; we were explicit about this matter.
Q If you turn to page 785, right hand column under the heading of “Discussion”, did you deal with that topic in any part of the paper?
A Yes, we did.
Q Go to the reply by you, please, volume 3, page 924. In the middle column that you have read out I have taken you to the passage six lines down where the paragraph begins, “A Rouse”:
“Only one author has agreed to evaluate a small number of these children on behalf of the Legal Aid Board.”
Pause there. This is 2 May 1998. Remind us, please, Dr Wakefield, when had you agreed to help evaluate a small number of children on behalf of the Legal Aid Board?
A In the first quarter of 1996.
Q What were you intending to convey when you said:
“Only one author has agreed to evaluate a small number of these children on behalf of the Legal Aid Board.”
A The tense that was used was both specific and factually accurate. It is the present perfect tense and the meaning that it is intended to convey is an event or state that started in the past and continues in the present.
Q Then you go on:
“These children have all been seen expressly on the basis that they were referred through the normal channels (e.g., from general practitioner, child psychiatrist, or community paediatrician) on the merits of their symptoms.”
What issue were you addressing when you used the expression “normal channels”?
A I meant that the parents having initiated the contact required by information from me, a referral from one of these individuals – the general practitioner, the paediatrician or another professional looking after the child – a referral to Professor Walker-Smith through the formal channels that are established practice for the evaluation of their symptoms.
Q When you used that expression was that an accurate description against the background of the facts that you have explained to the Panel?
A Yes, it was.
Q Was it an honest description?
A Yes, it was.
MR COONAN: I am going to ask you, please, to look at a small bundle of further documents. I understand that there is no objection to this and so I do not why they cannot be distributed to the Panel straightaway.
THE CHAIRMAN: We are also coming close to the time when we will require a short break.
MR COONAN: I am happy to break now, if you wish.
THE CHAIRMAN: Then that is what we will do. You still need to give us the position of this two-page document, where it goes.
MR COONAN: That is what I am going to do immediately after the break.
THE CHAIRMAN: Then we will keep it on the side for the time being. On the second issue that I have marked you are going to discuss with the other counsel about whether the whole DVD is going to be played to us and a transcript provided at that point.
We will now break. It is five minutes past 11 and we shall resume at 11.25.
Dr Wakefield, you are still under oath and in the middle of giving your evidence; please do not discuss this case with anyone.
(The Panel adjourned for a short time)
THE CHAIRMAN: Mr Coonan, there is the issue about the video first of all.
MR COONAN: The position is that we have managed to locate the transcript of the DVD which was prepared by or on behalf of Field Fisher Waterhouse. I am not going to suggest for a minute that you rely on that document because in so far as you look at it – and I have obviously no objection to you looking at it now – you will see, even by reference to the two documents that have gone in before you this morning, that the transcript that Field Fisher Waterhouse had prepared is inadequate, and I think others in this room agree; and there may be dangers in relying on a inadequate transcript. So what you have available are the two extracts which we have put in; you have the DVD itself which you can listen to; then you may have an imperfect transcript, and that appears to be really the limit of it. Obviously if you wish to have a proper transcript prepared of the whole DVD then you can give instructions in the appropriate quarters and no doubt it will be done.
THE CHAIRMAN: Ms Smith, have you any observations to make on what has just been said?
MS SMITH: Sir, as I understand it there is a transcript which was indeed prepared by somebody on behalf of Field Fisher Waterhouse and it is true to say that it is not particularly satisfactory because, as you will have gathered, the video is not very easy to hear.
I understand that Mr Sheldon has listened to that and has felt able to fill in a few bits which were missing and he has discussed it with Mr Mellor and Mr Mellor is going to listen to that when we have a break and listen to the video, and provided we are happy with the amendments that Mr Sheldon is suggesting then we are going to end up with the best that we can do, which is by far from being a perfect transcript. But it will enable you to have a transcript that you can look at and obviously you will be listening to the whole press conference at the same time and if you hear things slightly differently no doubt you will rely on your own ears rather than the transcript, if I can put it like that. But it seems to me the most pragmatic way of going forward is for us to do our best to agree an imperfect transcript, which we all agree is imperfect, and for you to have it and for you to see the whole video and to make what you will of it.
THE CHAIRMAN: The difficulty with us using our own ears and relying on them is that the quality of the video is not the ideal quality. Mr Hopkins.
MR HOPKINS: Sir, I have been rather kept out of the loop but I make no criticism of that. I do have concerns if an imperfect transcript is placed before you. I had the advantage of watching the whole or most of the DVD when we broke at the end of last week with the imperfect transcript and it is of poor quality in a number of sections. The advantage of the process that Mr Coonan and those instructing him went through in getting professional people to take a good transcript from part of the tape is that it came out as much better quality and therefore a fair representation of what was said. So I am afraid I would object to an imperfect transcript being put before you as evidence and the observation that you yourself made, sir, that it is not possible just to supplement that by listening to the bad quality of the tape. So if you do wish to have the full DVD played to you then I would respectfully suggest that the proper thing to do is to get a proper transcript of the whole thing. It is the only fair way for this evidence to be introduced.
THE CHAIRMAN: Mr Miller? I do not want to be accused that you have been left out of the loop!
MR MILLER: My client was not there!
THE CHAIRMAN: Thank you. Legal Assessor.
THE LEGAL ASSESSOR: Sir, I hope you do not mind my revealing the in-camera discussions that the Panel were quite clear that they do think it is only fair they should hear the whole thing. I have advised them – and I have probably more experience than they do through the criminal courts of videos and transcripts – that this is inadequate, you cannot hear it properly and so they do need a full transcript. So it is the view that between you, the parties involved, you have to produce a transcript upon which you all agree for the Panel and the Panel want that and they want to view the whole video, as I say.
THE CHAIRMAN: I was going to say after the Legal Assessor that the Panel is of the view that they would wish to see the whole DVD and also as far as possible to have a perfect as possible transcript of the proceedings. The only question now remains who actually does it and I do not believe that the Panel should go into that. I am quite sure that the four of you, along with the Legal Assessor, are more than capable to decide on that issue.
MS SMITH: Certainly, sir, we will do our best. Perhaps I could just say in that context, since I anticipate what is going to be said, that Mr Coonan already in effect said that it was not my business whether the whole transcript was put in and whether references to other people should be before the Panel. I should make it quite clear that it is my business because one of my roles is to ensure that these doctors are treated fairly in so far as I am able to do so. It seemed to me that the Panel might wish to see it. You have indicated to me that you do wish to see it. That is as far as my role takes the matter. So, yes, we will discuss it. You have said you need a full transcript and we will do our best to make sure you are provided with one.
THE CHAIRMAN: I would prefer not to make a direction from here but that it comes from all counsel. We will leave this matter in abeyance for the time being. I am sure you will discuss it during the lunch break and come forward with a solution that will satisfy the Panel’s requirements.
THE LEGAL ASSESSOR: In terms of timing, one way out of this may be the following. It is anticipated, Mr Coonan, that you are going to finish your examination in chief today.
MR COONAN: Yes, that is correct.
THE LEGAL ASSESSOR: As I believe you know, it was indicated by the Panel that they would wish to take some time, possibly a day or more, to review matters before any cross-examination begins. It may well be that tomorrow will be taken as a reading day in preparation for that. Wednesday we are not sitting. It could be that although you may have reached the end of evidence in chief, you could perhaps reserve the question of the video until, say, Thursday morning as a final act before cross-examination begins, if there is a transcript available by then. That is a possible way of dealing with it practically.
MR COONAN: If the Panel are content with that, I am too.
THE CHAIRMAN: This is a practical way out of it. Hopefully, that will be acceptable to all of you.
Mr Coonan?
MR COONAN: Dr Wakefield, I was poised to invite you to produce some documents. I do not know what may have reached you as part of that process. Might the rest of the files be distributed?
(Volume D9 marked and circulated)
MR COONAN: I am just going to lay the ground and I will come back to the other two documents that are at the moment unanotated.
Dr Wakefield, again can we deal with the provenance of these documents. In the file in front of you, which I think should begin at tab 2, there is a fax header or transmission report and a letter with accompanying documents. Then in tab 3 there is further correspondence and in tab 4 a Dawbarns fact sheet.
A Correct.
Q If you go to the beginning of tab 2, to the date on the fax transmission header sheet, you will see the date, 3 April 1997, and the message, “Correspondence with Dr Wood and this letter by fax. Fact sheet and other originals by post.” On the third page is the letter that you will see is addressed to Dr Horton, the Editor of The Lancet, dated 3 April 1997. It is signed on page 5 by Richard Barr.
A Correct.
Q I am going to ask you this: did these documents – that is tabs 2, 3 and 4 – ever come into your possession?
A Yes.
Q When was that?
A That was, I believe, about two days before the resumption of this hearing.
Q Where did they come from?
A They came from contact that I had with Kirsten Limb, who then identified them and provided them to me.
Q Did you have these documents at the time when Dr Horton gave evidence?
A No, I did not.
Q Did they emerge as result of inquires made by you?
A Yes, they did.
Q I want now to go to the letter. I shall go back to the fax transmission sheet, 3 April 1997, to Richard Horton, Dr Horton, and then on the letter, page 3: “Dear Dr Horton”, and I am just going to read out two short passages from this:
“Your assistant Sarah Quick has been having discussions with our medical and scientific researcher Kirsten Limb over our fact sheet which we have produced on the MMR/MR vaccines. She has a copy but for easy reference I enclose a further copy with this letter.”
Then there is the issue which has sparked the correspondence off, a matter in relation to the question of copyright. I move on to the third paragraph:
“If we have got the position wrong then I do apologise. I would like to apply retrospectively for permission to reproduce the references contained in the fact sheet to the Lancet.
These are referred to in the following footnotes of the fact sheet: 8, 36, 44 and 50. Footnote 50 refers to the article by Dr Wakefield and others. We have Dr Wakefield’s specific permission to make references to it.”
Then, if you go to tab 4, which is the fact sheet, and to page 21 of the tab, there is a footnote 50. That is the paper we have looked at already. Is that not right?
A Correct.
Q In the left-hand margin under “Crohn’s Disease” the newsletter says, towards the end of that paragraph:
“There is convincing evidence of a connection between the vaccination and inflammatory bowel disease (including Crohn’s disease)¬50. It is a serious lifelong illness which has affected a large number of the children we are helping. We are working with Dr Andrew Wakefield of the Royal Free Hospital London. He is investigating this condition.”
As a matter of fact, in March of 1997, which is, if you go back to page 1, the date of this newsletter (bottom left-hand corner), was that assertion accurate?
A Yes, it was.
Q Just in a word, please, what was it, and just deal with this factually, that sparked off your inquiry leading to these documents being revealed?
A In framing my answer, I want to make it absolutely clear that I am not in any way impugning the honesty of Dr Horton but I was reading his Day 17 evidence and in that he made several assertions. He asserted – that is prior to the publication of that – that he was not aware of Richard Barr, he was not aware of Richard Barr’s relationship with Dawbarns, that he was not aware of MMR litigation and he was not aware of my working relationship with Richard Barr. I remembered that there had been an interaction between Richard Barr and Richard Horton in the matter of copyright. I did not have the documents but clearly the timing of that interaction was crucial, and so I made contact with Kirsten Limb and obtained these documents, which confirmed that certainly at the time of publication of The Lancet, and indeed up to a year before that, in my opinion beyond a shadow of a doubt he was aware of all those factors.
Q Could you go back to The Lancet publication and first to page 924, again in volume 3, and I am concerned with your reply to Dr Rouse’s letter, in the middle column of 924, beginning “A Rouse suggests”. We have looked at this before in another context. Can we go back to it now, the sentence beginning:
“Only one author …. has agreed to help evaluate a small number of these children on behalf of the Legal Aid Board.”
You gave your evidence about that this morning to the effect that it was accurate and honest. Then if I take you in the same bundle to page 1217, there is a letter from the Editor, Dr Horton, in the right-hand column:
“We do not accept Andrew Wakefield and colleagues’ interpretation of the letter published in The Lancet on May 2, 1998….”
Pausing there, that is page 924.
“….which was, in any event, only published 3 months after the original 1998 Lancet paper. This letter was written in response to a letter from Dr A Rouse, published in the same issue. Dr Rouse’s letter raised concerns about whether children investigated in the 1998 paper had been referred to the authors by the Society for the Autistically Handicapped, and simply mentioned that his concerns arose out of a fact sheet produced by a firm of solicitors.
Although the letter made it clear that Dr Wakefield [a quote from the letter] ‘has agreed to help evaluate’ some children for the Legal Aid Board, it does not indicate that in fact such work had been commissioned and was being undertaken well before the 1998 paper was published. The natural and ordinary meaning to be drawn from Dr Wakefield’s letter at the time was that following the publication of the 1998 paper he had agreed to complete evaluations of children reported in the 1998 paper for the Legal Aid Board. We understood the letter to mean that, although Dr Wakefield agreed to undertake an evaluation for the Legal Aid Board, the evaluation had not taken place before the 1998 paper’s publication.
In the light of this, and Dr Wakefield’s express statement that no conflict of interest existed, we had no reason to investigate the position further, until the editors were notified for the first time that Dr Wakefield’s relationship with the Legal Aid Board predated the publication of the 1998 paper by some considerable time.”
Dr Wakefield, when do you say that the Editors of the Lancet were notified of your relationship with Dawbarns ---
A They were notified on at least two occasions. The first by virtue of the correspondence between Richard Barr and Dr Horton in April 1997, a correspondence that continued right up on till June or July of that year, certainly during the time that the paper had been submitted for consideration for publication, and then Dr Horton was reminded of this relationship in a letter from Dr Rouse one working day after the publication of our paper. It seems therefore – again I am not impugning the honesty of Dr Horton in any way – unlikely that the events, my relationship with Richard Barr, could have post-dated the publication of The Lancet.
Q Just so that the Panel understand it, were you aware of the existence in your possession of the original Rouse letter at the time Dr Horton gave his evidence?
A No, I was not.
Q Did you have available to you the Horton-Barr correspondence that you have just produced?
A No, I did not.
Q When you published the letter --- I will rephrase that slightly. When you submitted your letter, which we see at page 924, your response to the Rouse letter, to The Lancet, did anybody, including Dr Horton, raise with you any issue about conflict of interest?
A No, they did not.
MR COONAN: Thank you, Dr Wakefield.
Sir, the two documents which were put in earlier might now conveniently slot in at tab 1 of D9.
THE CHAIRMAN: Yes. (Documents inserted as Tab 1 of D9)
MR COONAN: Dr Wakefield, we have been dealing with the events up to 1998. I now want to move on six years to 2004 and for this you will need volume 3 of the Panel’s bundles. There are a number of issues arising out of events in 2004 that I need your help with. Did you come to leave the Royal Free in or about 2001?
A Yes, I did.
Q And the Panel have your CV we looked at all those days ago, at the beginning of your evidence?
A Correct.
Q Did you go to Texas?
A Yes.
Q And were you employed, as you have described, from that date in Texas?
A My employment in Texas started some years later, but beyond that date, yes.
Q At any rate, how long were you out of the country? Did you leave the country in about 2001?
A Yes, I did.
Q Did your family remain behind for a time?
A Yes, they did.
Q Then in March 2004 were you alerted to something?
A Yes, I was. I was in Texas and I received a call from a Mr Abel Hadden who was at that time working pro bono as a public relations officer from the charity “Visceral”.
Q As a result of what we said to you, what did you understand to be the nature of the problem?
A There was an extensive article to be published in the Sunday Times the following Sunday – the next Sunday – and that I had 48 hours to respond to the various allegations that had been made.
Q What was your response to that?
A I did not sleep very much that night. Then I booked a flight and came home. I think I arrived home on the Tuesday for a meeting arranged with the deputy editors of the Sunday Times in Mr Hadden’s office on Wednesday morning.
Q Who else was present at that meeting?
A I think there was Paul Nuki who was at that time – I forget his precise title – but he was in charge of features, or some feature, in the Sunday Times magazine; three deputy editors and Mr Hadden and myself.
Q How long did the meeting last?
A It lasted probably about two and a half hours.
Q Were the allegations which were being made laid out before you?
A Yes, they were.
Q And were you in a position to respond in any way, lengthy or not so lengthy, at that stage? You tell us?
A I made my best efforts. I had absolutely no documentation whatsoever relating to the matter to hand. I had literally got off the plane and got some sleep and then gone into the meeting, so I was relying entirely on memory.
Q Following that meeting, did you have any other meeting involving the editor of The Lancet?
A Yes, I did. That afternoon I went with Professor Walker-Smith and Dr Simon Murch (as he was at the time) and Dr Peter Harvey joined us. We went and met in the office of Dr Richard Horton.
Q Was anybody else there apart from Dr Horton from The Lancet?
A I think there were two junior editors, sub-editors, ladies.
Q Did Dr Horton appear to know what the allegations were already by this stage?
A Yes, he did.
Q And was there a discussion of the allegations?
A Yes. What Dr Horton presented to me off the bat was that he had been told by Sunday Times journalists, a free-lance journalist, that I had been paid £55,000 for The Lancet paper, the published Lancet paper. Was that true, or was that not true?
Q What was your response?
A That it most certainly was not true.
Q Were there any other issues which were identified and responded to during that meeting?
A The predominant issue as far as I was concerned was the allegation of a conflict of interest, which was to my mind, at least at first, entirely straightforward: was funding from the Legal Aid Board spent on The Lancet paper? No, it was not, and the Panel have now have now seen that funding was not even available to be spent until the paper had been submitted. I explained to Dr Horton that the funding had been used for a separate study and that at that point the issue of a possible perception of conflict of interest arose for the first time in my mind. I confess to being somewhat confused because it did not concord with my understanding of The Lancet’s requirements as published in The Lancet.
Q Was there a discussion between you and Dr Horton about the concept of a perceived conflict of interest?
A Yes, there was. He referred back to published conflict statement in The Lancet. As we know, that now says “This is a simple one,” et cetera, et cetera. I could not understand how that statement, presented in the active mood, that is, “What would you consider a conflict that needs to be declared that might embarrass you at a later date if it were to be disclosed,” compared with a perceived conflict of interest which is in the passive mood. In other words, you have to put yourself in the third person, or the person of a third person, to think what someone else might perceive as a conflict of interest. That is an entirely – entirely – different matter, and raises almost infinite possibilities. It is not one with which I was familiar or aware. I think Dr Horton and I went backward and forward on this for about half hour and it remained unresolved at the end.
Q Was that discussion in the presence and hearing of other people at the meeting?
A Yes, it was.
Q Was that the first time that anybody had raised the question of a perceived conflict of interest in relation to these matters?
A Yes.
Q What was the end result of the meeting that day?
A I think we were all in something of a state of shock. Again, we had no documentation. We were given instructions to go away with various allegations in our charge to write a response which was to be published on line for The Lancet that Friday. So we are now on Wednesday afternoon. Presuming I have the timing right – I may be corrected if I am wrong – that it was to be submitted to the Lancet for publication on line on the Friday.
Q And did you do that? Did you go away and compose something?
A Yes, I did.
Q Did you do that on your own, or with anybody else?
A I did that on my own.
Q What about the others. What happened to them?
A I believe, as we have heard in evidence, that they went to the Royal Free and went through the records of the relevant children, and responded according to the questions or the charges that have been put to them.
Q When you say “put to them,” were the allegations or charges are put to you all collectively?
A I think there were certainly specific allegations put to me, and then there were charges that were put collectively in respect of, for example, ethical approval, yes.
Q But mechanically were these in effect set out and revealed during the course of the meeting with Richard Horton that afternoon?
A Yes, they were.
Q Where did you go to compose your response?
A I went back home.
Q If we look at volume 3 and if you turn to page 1214, in the left-hand margin do we see it headed “A statement by Dr Andrew Wakefield”?
A Correct.
Q Is this the document that you composed that day?
A Yes, it is.
Q Did you provide it to the editors of the Lancet?
A Yes.
Q Dr Wakefield, I am going to ask you – take your time over this please – to read this and in so far as we need to there are references in the body of the document to allegation by number. There is something of a key to the numbering system on page 1211, so the Panel can cross-reference. I am not going to ask you to cross-reference it as you go through it. Did you have the allegations written down?
A Yes, I believe we did.
Q Were you told specifically to deal with specific allegations or did you just decide yourself to deal with those? How did it come about?
A I was told to deal with specific allegations.
Q Can you start the narrative, please?
A Certainly.
“Allegation 4 completely misrepresents the facts. These were two quite distinct issues; the first a clinical report of 12 cases and the second, a hypothesis-testing laboratory study to examine for the presence or absence of measles virus in autistic children when compared with appropriate controls.
A minor of the children described in the 1998 Lancet report were part of the second study that was funded in part by the Legal Aid Board (later to become the Legal Services Commission). The relationship of these two distinct studies to the legal status of the relevant children is set out below. Professor Walker-Smith has already described the basis for the referral of these children according to clinical need.
At the time that the children reported in the 1998u Lancet paper were referred to Professor Walker-Smith for investigation of the gastrointestinal symptoms – the time material to their sequential investigation and subsequent inclusion in the report – none of the 12 reported children was in fact legally aided, ie, in receipt of legal aid certificates and therefore legal aid funding.
Whether parents perceived an association with MMR vaccine or not, whether parents had approached lawyers with the intent to seek legal redress, or whether children were in receipt of legal aid funding or not, had no bearing whatsoever on their selection for clinical investigation or inclusion in the Lancet report. Since these allegations were made I have returned to parents (and where appropriate their current lawyers) to determine these facts. At the time the children underwent ileo-colonoscopy (ie, the time at which their pathology, as reported in the Lancet in 1998, was detected and reported by endoscopists and histopathologists), one child had been granted a legal aid certificate. The authors had no knowledge of this fact until now.
In support of this and in view of these allegations, parents of children in the 1998 Lancet report have provided a written signed statement that (i) they contacted me for help given their child’s gastrointestinal symptoms, (ii) their referral to the department of paediatric gastroenterology at the Royal Free was through their child’s doctor, (iii) that at no time did I encourage them to seek legal redress through the courts in the MMR class action, and (iv) that their child formed part of the initial study of 12 children reported in the Lancet in 1998.
Independently, I was commissioned through a solicitor, Richard Barr, to undertake quite separate virological studies on ten children. This is entirely in line with other university-based studies that have been similarly funded by the Legal Services Commission, and reported, for example, in the BMJ. The list of children provided to me by Richard Barr was based on his knowledge of an overlap between patients referred to the Royal Free and those whose parents had made contact with Richard Barr. I could not have constructed such a list since I had no knowledge of the litigation cohort or the legal status of children within this cohort. I was specifically concerned with addressing the scientific question in relation to measles virus – a perfectly legitimate question in view of the nature of the intestinal disease and the sequence of events in the children. Measles virus infection of the intestine is a specific interest of mine.
Once again, it is important to emphasise that I had no specific knowledge of the legal status of the ten children on the list other than as described above. Investigations, in light of the current allegations, indicate that four of these children (exact number to be confirmed by Richard Barr) were among those reported in the 1988 Lancet paper. The virological studies on these children have been submitted for publication. If and when these studies are finally published, due acknowledgement will be made of all sources of funding, including that from the Legal Services Commission.
Allegation 5 is an inaccurate misrepresentation of the facts. The results eventually reported in the 1988 Lancet paper were in the public domain long before their publication in February, 1998, having been presented at several national and international scientific meetings. They were readily available for interested parties to scrutinise and interpret as they saw fit. The findings were not actively made available to the media until after publication but, other than this, there was no attempt to conceal these data.
Such was the level of concern from the clinical and scientific team at the findings in this group of children with a similar history and an apparently novel bowel pathology, that I and Professor Walker-Smith reported them to a meeting in October, 1998, convened by the Hon Tessa Jowell MP, then Minister of Health, attended by the Chief Medical Officer Sir Kenneth Calman and other officials from the Department of Health in the presence of Richard Barr of Dawnbarns solicitors, and representatives of interested parent groups. Barr, for his part, was in attendance as a lawyer, responsibly concerned by the sheer numbers of parents reporting, to him, developmental regression and gastrointestinal symptoms in their children following MMR vaccination.
It is important to emphasise that the only aspect of the 1998 Lancet paper that could have been used to justify a multi-party action, as in the foregoing accusation, is the parents’ perception of a temporal relationship between MMR vaccine exposure and onset of symptoms. This perception was well known to the lawyers before we were even aware of the role of the lawyers, or the proposed multi-party action, and certainly long before our publication in The Lancet in 1998. This publication alone added nothing further to the issue of causation than that which was already well known to the lawyers. The accusation is therefore specious. My own report to the Legal Services Commission on this matter was served in 1999.”
Q Just pausing there, is that a reference to the interim report ---
A It is
Q --- that you gave evidence about earlier in these proceedings?
A Correct.
Q Carry on.
A
“With respect to allegation 6, as has been indicated above, these were two separate matters. One, a report of clinical investigations, and the other, a study commissioned quite independently through Richard Barr. The latter study was designed in order to explore the issue of possible causation. These studies were concerned with viral detection in the diseased intestinal tissues of ten potentially affected children. This approach is entirely in line with other university-based studies that have been similarly funded by the Legal Services Commission, and reported in the BMJ. Funds received from the Legal Aid Board were paid into, and properly administered through, a research account with the special trustees of the Royal Free Hampstead NHS Trust.
I have stated above that the origin of the list of children was provided to me by Richard Barr. My involvement was limited to the legitimate concern: was measles virus present in the intestinal tissue of these children?
As outlined above, I can confirm that publication of the relevant virological studies is still awaited. An interim submission of a report of this study (rejected) contained an explicit acknowledgement of the Legal Aid funding; this will be made available as necessary.
If and when the relevant virological studies are finally published, due acknowledgement will be made of all sources of funding, including that from the Legal Services Commission.
For none of these or any subsequent children has legal status influenced the need for investigation or the interpretation of the findings. Where it is known that children are in receipt of legal aid certificates or where studies receive funding from the Legal Services Commission, this will be included in any relevant publication.
The clinical and pathological findings in these children stand as reported. They have now been confirmed independently by reputable physicians and pathologists. On the basis of the molecular detection of measles virus in the diseased intestine of these children this issue, too, merits further study.
I regret the difficulties that this issue has caused my colleagues over the last week and I am grateful to them for their advice and support. I am enormously grateful for the timely manner in which Richard Horton has dealt with this issue and for his clarification of the issues surrounding perception and reality where conflict of interest may be concerned.
My colleagues and I have acted at all times in the best medical interests of these children and will continue to do so.”
Q Thank you very much. Dr Wakefield, that was a lengthy document which you supplied to the editor of the Lancet. Do you stand by the content of that article, that letter?
A Yes, I do.
Q In the Lancet at this time the question of what was termed the retraction of an interpretation emerged and you will find the reference to this in volume 3 again, page 1210. This short series of observations are signed by some of the authors of the Lancet paper – not signed by yourself or Dr Harvey and, as we can see there, nor
Dr Linnell.
A Correct.
Q Let us stand back a moment. How did the issue of a retraction of an interpretation come about?
A It was Dr Horton’s idea and I think it was based upon a precedent of a partial retraction in a paper that he was either dealing with or had been aware of under different circumstances.
Q Was that a matter that was discussed between you and your colleagues on the paper?
A I cannot remember; I certainly discussed it with Dr Horton but I do not remember specifically discussing it at that time with other colleagues.
Q What about written contact, email contact and so forth – any of that?
A Again, there may well have been and I am certain I spoke about it at least with Dr Harvey.
Q What was the idea, as you understood it?
A In light of the fact that the issue of a possible causal relationship had been raised and in light of the fact that that had had consequences for public health, as anticipated, the retraction was offered by way of removing that possibility.
Q The possibility of what?
A That there was a causal association between MMR vaccine and autism and
I was struck by the fact that you cannot deny a possibility – it is illogical.
Q Did the paper claim a causal relationship?
A No, it did not; in fact, it was very specific in this matter, it said that this paper does not prove a causal association.
Q Could you understand on the basis of logic why it might be that this was being proposed, given the two elements: first of all, the content of the paper and secondly the reaction to the paper or press conference, or both?
A I think that there was a great deal of anxiety at the time and I perfectly understand the position taken by my colleagues. There was a state of relatively disorganised chaos and people were very, very concerned with the fallout from this whole matter. So some decided that it was appropriate to go along with Dr Horton’s suggestion. I did not and Dr Harvey did not and ultimately Dr Linnell did not – we just wanted to stand back and determine precisely what it was suggested should be retracted in light of the fact that this causal association had not been confirmed.
Q I am going to read the content of the retraction on page 1210:
“This statement refers to the Early Report ‘Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children’, published in The Lancet in 1998. It is made by 10 of the 12 original authors who could be contacted. It should be noted that this statement does not necessarily reflect the views of the other co-authors.
The main thrust of this paper was the first description of an unexpected intestinal lesion in the children reported. Further evidence has been forthcoming in studies from the Royal Free Centre for Paediatric Gastroenterology and other groups to support and extend these findings.”
Footnoted.
“While much uncertainty remains about the nature of these changes, we believe it important that such work continues, as autistic children can potentially be helped by recognition of treatment of gastrointestinal problems.
We wish to make it clears that in this paper no causal link was established between MMR vaccine and autism as the data were insufficient.”
Pausing there, was that correct?
A Absolutely correct.
Q The statement goes on:
“However, the possibility of such a link was raised and the consequent events have had major implications for public health. In view of this, we consider now is the appropriate time that we should together formally retract the interpretation placed upon these findings in the paper, according to precedent.”
And it is footnoted. It is therefore that sentence beginning:
“However, the possibility of such a link was raised …”
Pausing there, by whom?
A In the paper itself, in the discussion.
Q “…and the consequent events have had major implications for public health.”
So, again, the basic principle why you did not join in with the others in their approach to this?
A You cannot retract a possibility and the interpretation of a causal association had not come from the authors – we had been explicit about our position – but rather perhaps the interpretation of others by the events.
Q Did you eventually address this matter in the columns of The Lancet?
A Yes, we did. We were invited to offer our perception in a written form, which we did very soon after publication of this letter. However, it was some months before it was actually published in The Lancet.
Q Would you now go to volume 3, page 1216, and it goes on to 1217 and this letter, as far as I recall it, was not addressed earlier in the case and so I am going to invite you, please, to revisit your words here. A letter signed by you, Peter Harvey and John Linnell, is that right?
A Correct.
Q Published in The Lancet on April 17 2004. Why did you write this letter?
A We felt that our position needed to be clarified on this matter.
Q Can you adopt the same approach and read this into the record, please?
A Certainly.
“Sir, almost six years have passed since AJW disclosed in a letter published in The Lancet that he was undertaking a pilot study on behalf of the Legal Aid Board (later to become the Legal Services Commission), a study that sought to examine the merits of parental claims of an association between their children’s exposure to the measles, mumps and rubella vaccine and subsequent autistic regression and intestinal symptoms. He wrote on May 2, 1998, three months after the original paper: ‘Only one author (AJW) has agreed to help evaluate a small number of these children on behalf of the Legal Aid Board.’
There was no attempt at any stage to conceal the fact that the viral study was ongoing before the publication of the paper in The Lancet in 1998. Almost six years have passed during which The Lancet and our co-authors have had the opportunity to seek further details and consider their position with respect to perceived conflicts of interest. We read the absence of any comment as implying tacit acknowledgement of lack of such conflict, as stated by AJW at the time. The Lancet requires that the funding source for a study be declared; our report conformed to this requirement since there was no external funding for the work relevant to this report. The Lancet disclosure policy also required that the authors declare anything that would embarrass an author if it were to emerge after publication. This is, of course, a subjective definition and we can confirm that this was not an issue which causes us embarrassment; we are, however, dismayed by the way in which events have been misrepresented.
Conflict of interest is created when involvement in one project potentially could, or actively does, interfere with the objective and dispassionate assessment of the process or outcomes of another project. We cannot accept that the knowledge that affected children were later to pursue litigation, following their clinical referral and investigation, influenced the content or tone of the 1998 paper, which was a description of a possible new syndrome in the classical mode. We emphasise that this was not a scientific paper but a clinical report. The laboratory support funded by Legal Aid for a separate viral detection study had no bearing on the original paper. No Legal Aid money was used in the preparation of the 1998 paper and the viral study could not then and indeed, does not now, influence the ‘objective and dispassionate assessment’ of the veracity of the original paper, which we reiterate simply reported a novel clinical syndrome. There was no conflict of interest. When the viral study is published, the Legal Aid Board (now Legal Services Commission) funding will be duly acknowledged.
Various claims were made by agents of the Sunday Times on February 22, 2004, against those of us involved in The Lancet 1998 report. These claims included inappropriate patient referral, inappropriate use of Legal Aid funding, lack of ethics approval, unmerited clinical investigation, and keeping secret for six years the involvement of the Legal Aid Board in a separate study. All of these claims have now been investigated and we know they are unfounded and vigorously deny them.
It is worth reiterating that all of the first 12 children reported in The Lancet study were referred to the Royal Free Hospital exclusively for the investigation of their intestinal symptoms at a time when none was involved in Legal Aid litigation. Their pathological findings were interpreted and reported by clinicians who could have had no knowledge of any future legal claim. The report itself was a description of the history as reported to us, and the relevant clinical findings. No claim of a causal association with MMR was ever made. The opinion on choice of single vaccines pending scientific resolution of any possible association, expressed by AJW at the press briefing, was based not on the findings in these children alone, but on a detailed investigation of the history of MMR vaccine and its safety. AJW’s opinion, then and now, has been restated in Jefferson and colleagues’ subsequent 2003 Cochrane Review, i.e. that ‘the design and reporting of safety outcomes in MMR vaccine safety studies, both pre and post-marketing are largely inadequate’, and furthermore, that Jefferson and colleagues ‘found limited evidence of safety of MMR compared to its single-component vaccines from low risk of bias studies’. Nonetheless, we regret the furore and polarisation of opinion that ensued form the press briefing, for which AJW bears some responsibility.
Richard Horton is reported to have stated that he would not have published the paper, had he known about the MMR litigation. As reported, this clearly has major implications for the valid scientific investigation reporting of possible iatrogenic injury in patients who may be seeking legal redress. It is notable that subsequent to the aforementioned Legal Aid pilot study, other university-based studies have been funded by the Legal Services Commission and reported in the British Medical Journal.
On March 6, 2004, some of our ex-colleagues issued a ‘retraction of interpretation’, not a retraction of the factual content of the paper, as widely inferred. Since no interpretation of the possible MMR/autism link was offered in the original 1998 Lancet report, other than to state that the data did not constitute evidence of an association and suggest that further research was required, it is difficult to know quite what has been retracted, particularly in light of Richard Horton’s current plea for further research funding for autism, a plea that we welcome wholeheartedly.
Let us be clear that parents reported gastrointestinal symptoms in their children that many medical professionals denied and refused to investigate. Some parents were referred to social services and false claims of Munchausen’s Syndrome by proxy were levied. The parents were right; their children have an inflammatory intestinal disease. The medical profession was wrong, in some cases shamefully so. In the light of this lesson it is imperative that rather than relying on endless reviews of epidemiological data which failed to even address the original hypothesis, parental claims should be taken seriously and their children should be investigated on an individual basis.
More than six years on, the original Lancet report should be viewed in the context of an emerging laboratory and clinical evidence of intestinal pathology, measles virus persistence in diseased tissues, and abnormal measles immunity in this specific subset of children with autistic spectrum disorder. It would be inappropriate to interpret the events of the past month as exonerating MMR vaccine as a possible cause of autism.”
Q Was that your response to the issue of retraction which had emerged in the month of March of 2004?
A Yes, it was.
Q When you said, looking at page 1217, left hand column, about 15 lines down:
“Nonetheless, we regret the furore and polarisation of opinion that ensued form the press briefing, for which AJW bears some responsibility.”
Can you help the Panel about that, please? In what sense did you mean that?
A I had written to my colleagues, including Professor Zuckerman in advance of the press hearing in an effort to convey at least to Professor Zuckerman that if asked the question then I would respond in the way that I have illustrated in my letter; that
I would support the monovalent but could not support the continued use of the polyvalent vaccine, and set out my reasons for that. This gave him the opportunity clearly of deflecting the question from me – that did not happen. Nonetheless
I answered the question in the way that I proposed and clearly there was a public health consequence to that. It had been anticipated, but nonetheless there it was.
I had taken what could be considered at the time to be a polarised position and it was based upon an assimilation of the facts available to me at the time. My colleagues had taken a different position and so that is what I mean when I refer to a polarisation. I regret clearly that they were drawn into the furore afterwards but I do believe that acting with concerns of the children first and foremost and with at heart the issue of a possible adverse vaccine reaction which was going unobserved, undetected and un-investigated, that I had a duty to raise this issue.
MR COONAN: That is all I am going to ask you about that sector.
Sir, I am in your hands. I will not finish the next section by one o’clock. I am anxious to deal with this really all of apiece without any interruption.
THE CHAIRMAN: In that case, we will adjourn now at 12.35 and resume at 1.35. Dr Wakefield, you are still under oath.
(Luncheon adjournment)
THE CHAIRMAN: Good afternoon. Mr Coonan?
MR COONAN: Sir, we now turn to heads of charge 42 and 43.
I am going to ask Dr Wakefield about the circumstances surrounding the birthday party. (To the witness) First of all, Dr Wakefield, was there a birthday party at which at least one of your children was present?
A Yes, there was.
Q The charge indicates that the circumstances of the party were prior to 20 March 1999. Do you have a date you can provide to the Panel, which deals with at least some of these events?
A My eldest son’s birthday is on 9 August and it was his 10th birthday party, but I do not know whether it was precisely on the day of his birthday.
Q Prior to March of 1999?
A Correct.
Q Where was the birthday party held?
A It was held at the Bank of England Sports Club in Roehampton.
Q What facilities are there at that venue?
A There is the facility to hire courts (these are basketball courts) and they have side rooms and table tennis, that sort of thing.
Q How many children attended the party?
A That is a very good question. We have been trying to reconstruct it with photographs of that party. It was not a large party. I think there were probably something of the order of 12 to 15 children.
Q How many of your children attended?
A At least two.
Q What time of the day was the party?
A It was in the afternoon.
Q Did any parents of the children who attended also attend?
A Yes, they did. I think four or five parents were at the party as well.
Q How long did the party last from start to finish?
A Probably about two and a half hours, I think.
Q Was there a stage at which some blood was taken?
A Yes.
Q Was that prior to the party proper beginning or during it or at the end of it?
A Yes, it was arranged in advance and it was done prior to the onset of the main party.
Q You say it was arranged in advance. Who with?
A The original story starts with we needed some control blood samples from developmentally normal health children, which is very difficult to come by. I asked my two sons if they would be prepared to help out.
Q By giving blood?
A By giving blood, and they said they would. One was 10 and one will have been 8. My wife said that we had a birthday party coming up, maybe she would ask a couple of the others who are very well known to her, some of whom are doctors, whether their children would similarly be willing to give blood. So she had contacted them well in advance of the party to ask the parents if they would be prepared and for them to ask, if they were, whether their children would be prepared.
Q What was the response back from the parents of those children?
A The parents were all happy and when they asked their children, their children were all happy.
Q Was that indication of contentment communicated to you before the party?
A Yes, indeed.
Q Was there any question of payment being raised prior to the party?
A No, there was not. My wife and I talked about it some time just before the party. I suggested that we might give them £5, and that happened at the end of the party.
Q I just need to have this from you. Was there any indication to the parents of these children that the children, their sons or daughters, would or might receive payment before the party?
A No, that was something that was agreed between my wife and I. It was something that was then settled at the end of the party for those children who had agreed to give blood.
Q How many children did in fact end up giving blood?
A Again, we have been trying to work it out. I think it must have been between six and nine children.
Q I am going to come back to the circumstances of the giving of blood in a moment, but, at that stage, was the question of ethical committee approval for the taking of bloods a matter that you had considered?
A It had not crossed my mind that it was something that would fall under the remit of an ethical committee.
Q Is there any reason for that?
A Yes. My understanding – and I appreciate that this may well have been imperfect – was that ethical committees were there for the purpose, or existed for the purpose, of protecting NHS patients when they were involved in medical research, and therefore I did not believe at the time that this extended to children who clearly were not National Health Service patients; they were healthy children, friends of my son.
Q So, back to the circumstances of the party, whereabouts in the venue was the blood taken?
A It was taken in one of the side rooms off the main hall; in fact, the children were all outside playing a game of mini rugby but at the beginning of the party the children who had agreed to give blood were individually in that room having the blood taken.
Q What, if any, facilities were in that room?
A Somewhere for them to sit and the sterile blood-taking equipment that is standard in any doctor’s surgery.
Q Any local anaesthesia?
A No. I should just add that I had worked for a period in paediatric renal surgery and I had a good deal of experience of taking blood from children. I had found during that time that the application of the local anaesthetic cream really did not make any difference. If the procedure was done properly by an expert person, then the cream really did not help and in some ways increased the anticipation of pain. So that was not included.
Q Dr Wakefield, did you take the bloods?
A No, I did not.
Q Were you present when the bloods were taken?
A No.
Q Do you know who took the bloods?
A Yes, I do.
Q Are you willing to say who did it?
A No.
Q Was the person who did it a doctor?
A Yes, they were both medically qualified and highly experienced in taking blood from children.
Q When the bloods were being taken, whereabouts were you?
A I was outside in control of the game of rugby.
Q From what you could see of the position after the bloods were taken, were any of the children in any way in any distress?
A Not at all; they came out and joined in the game.
Q Did any of your children have blood taken in fact on that day?
A Yes, they did, two of them.
Q As far as you were aware, when the bloods were taken, was there a parent present with their child or not?
A Some of the parents were present; some were not, but all had given fully informed consent well in advance of the party.
Q In respect of the question of money and your reference to the £5, did any one or other of these children receive £5?
A Yes, they did. As a reward at the end of the party, the children who had given blood all received £5.
Q When did that happen?
A Right at the end when they collected their party bags.
Q At the end of the party?
A At the end of the party, yes.
Q Dr Wakefield, can we just revisit this again? The overriding purpose of this was what?
A We were looking, in the children with autism, at measles antibody or viral antibody levels in the blood. We had been provided with some samples from the Department of Immunology, which had been taken for another study, but we needed a larger number, and so that was when I had the idea of asking my sons, and then it flowed from there.
Q It is suggested or alleged that the fact that blood was taken in these circumstances in a side room here off this venue where the children’s party was held was inappropriate – an inappropriate setting. First of all, did you consider at the time that the setting was inappropriate?
A Not at all. In fact, in that particular setting the anxiety level was minimal. If it had been done in the clinical setting of a hospital with everything that goes with it and the anticipation, I think that would have been far more or potentially far more distressing to a child having blood taken. These children were extremely relaxed.
Q To an extent you have covered this. Did you offer any financial inducement to any one or other of these children?
A No, nothing was offered in advance at all.
Q Did you behave callously towards these children?
A No, I did not. They all came forward entirely of their own free will and I think, as one of the prosecution witnesses has said, children are or can be by their nature very altruistic. My children were certainly very happy. The parents of my wife’s friends were very happy, and there again were I think quite proud to have been involved and to have helped out in this way.
Q That is all I am going to ask you about the party. I want now to turn to the MIND Institute presentation on 20 March 1999. Mr Sheldon is going to operate the DVD of this but before we start playing it, I just want to ask you a couple of preliminary matters. What was the purpose of this presentation?
A It was an invited seminar – I was invited to speak to parents and professionals at the MIND Institute, which is part of the University of California Davis. These are largely parents and interested professionals – speech therapists, occupational therapists, some doctors, some psychologists.
MR COONAN: This, as we see, was on 20 March 1999. We are going to play a small proportion of the entire DVD. Sir, so that you understand the position, this DVD lasts for two hours and the prosecution played a short section on Day 34. What I am going to propose now, with Mr Sheldon’s help, is to play a slightly longer period than the prosecution played. I am told it is about 20 minutes from the 25 minute mark. Of course that is not to shut out the Panel looking at the rest of it but for my purposes I am not proposing to invite you to sit through two hours at this stage. Others may have different views; you may have different views yourself. That is what we intend to do.
Dr Wakefield, so that you know where it all starts, it is about 20 minutes’ worth from the 25 minute mark, all right, and then it will stop, and I shall ask you some questions about it at that stage.
(Portion of DVD of seminar held at MIND Institute on 20 March 1999 played)
Dr Wakefield, were you recounting to the audience what in fact happened at the birthday party?
A No, I was not.
Q Did anybody faint?
A No.
Q Did anybody throw up?
A No.
Q Anybody burst into tears?
A No.
Q What led you to describe the event in the way you did?
A Humour is in the moment. I do not think it was particularly funny then, and it certainly is not very funny now; but you can see it was the end of a long and rather exacting talk for these parents, and it was an attempt to introduce a little bit of levity. There were two other elements to it. One was to let these parents know I was actually quite proud of my children and their friends for helping out in what was clearly for the parents there a very perplexing situation. The other was to not let the children off too lightly by ending up with the denouement, the punch line, if you like, that it reflected on the mercenary nature of children and the fact that next time they wanted £10. No one ever said that; it was just a quip from me. The way in which these stories are told, if the audience responds, you tend to respond back to the audience, and so the story was told. It had no bearing on the truth at all. It was a story and clearly if it has caused any distress, then I am extremely sorry for that. That was not my intention.
Q Do you regret it now?
A Yes, I do.
Q As you know, you are charged with describing the same incident, in effect, as actually occurred but in humorous terms of indicating in the course of the remarks that you made in the presentation an intention to obtain samples in similar circumstances in the future, and that because of those two facts your conduct has brought the medical profession into disrepute. In fairness to you, you must have an opportunity of dealing with that?
A There was absolutely no intention to bring the medical community into disrepute at all. It was, in the moment, an attempt to produce a little bit of levity at the end of a very exacting talk and it appeared, at least for some members of the audience, to achieve that.
Q Was there --- So sorry. Did I interrupt?
A I was only going to say that had I considered it to be inappropriate at the time, and had I considered at the time the blood was taken that it was in contravention of ethics approval, clearly it seems unlikely that I would have actually mentioned it at all. I think that was a reflection of my naivety as to the fact that ethics committees go beyond National Health Service patients. I was not aware of that, and I should have known it. Other than that, it is something, as I have said, I regret. If it has caused anyone offence, particularly the defence experts, the prosecution experts, then had it been true I would feel exactly the same way as they do, but it was not true, and I hope that it will be accepted that it was simply a story – an opportune one, but nonetheless just that.
MR COONAN: That is all I am going to ask you about that, and in fact Dr Wakefield that, in effect, comes to the end of your evidence in chief.
Sir, you will see that there is a reference to another section but in the circumstances
I have absorbed the matters I was going to deal with and there is no need for me to deal with any other section. That does complete Dr Wakefield’s evidence in chief.
There are two housekeeping matters that I want to raise. The first is head of charge 16 (f). This is a matter you may remember that you raised with us on a couple of occasions, and I think that Mr Mellor and Mr Sheldon had discussions about this. There was some doubt, I think raised by the learned Legal Assessor, about the date of 16 (f). In the light of those discussions we do not seek an amendment to that charge and, as I understand it, nor does the prosecution, but maybe they should speak for themselves.
MS SMITH: That is correct.
MR COONAN: Sir, you have Dr Wakefield’s evidence on the point at Day 52, page 4, and the relevant document in relation to Dr Berelowitz is volume 2 page 605 E.
Finally, Mr Sheldon tells me that he is going to provide an index overnight or as and when the Panel sit again in respect of bundle D2, so that you know exactly what you have.
I should just add, whilst I am on my feet, the question of the transcript of this morning is being actively looked at and I am doing my part in order to try – irrespective of cost considerations, because that fact inhibited me earlier – to get this done professionally so that you have the best possible service and not just attempts by counsel.
Sir, subject to any other matter that completes my part at this stage.
MS SMITH: Sir, I would like to raise one matter in relation to the video that we have just heard. I am not going to suggest to you that you should hear the entire two-hour lecture, you will be relieved to hear, unless of course you have some wish to do so. But I think that I should make it clear that Mr Coonan stopped it after the relevant extract – the anecdote which is the subject of the charge – and Dr Wakefield has referred on two occasions to that being the end of the lecture. In fact that was 45 minutes into a two-hour lecture and I think that should be made clear.
MR COONAN: I thought I had made it clear in introducing the clip before it was played, but whatever Dr Wakefield actually said perhaps ought to be viewed in the context of my opening remarks. I do not think the Panel were under any misapprehension as to where the clip started – the 25 minute mark – and that it was two hours long. I made that perfectly clear.
THE CHAIRMAN: Yes, I remember that and have made a note of that. Thank you.
Are there any other issues from the housekeeping point of view that we need to raise today before we adjourn for the rest of the day today and then tomorrow for doing some of this reading work that we need to do before Dr Wakefield starts with his cross-examination? I do not see any inclination coming from any side of this room and so we will now adjourn and resume officially in a public session on Thursday morning, the reason being, as I have said, that tomorrow we are going to do the reading work and on Wednesday we are not sitting. But we shall be in camera from now until the end of today and tomorrow late afternoon. We will see you on Thursday morning.
(The Panel adjourned until 9.30 am on Thursday, 10 April 2008)
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