GENERAL MEDICAL COUNCIL
FITNESS TO PRACTISE PANEL (MISCONDUCT)
Thursday 6 September 2007
Regents Place, 350 Euston Road, London NW1 3JN
Chairman: Dr Surendra Kumar, MB BS FRCGP
Panel Members: Mrs Sylvia Dean
Ms Wendy Golding
Dr Parimala Moodley
Dr Stephen Webster
Legal Assessor: Mr Nigel Seed QC
WAKEFIELD, Dr Andrew Jeremy
WALKER-SMITH, Professor John Angus
MURCH, Professor Simon Harry
(Transcript of the shorthand notes of T. A. Reed & Co.
Tel No: 01992 465900)
A P P E A R A N C E S
MS SALLY SMITH QC and MR CHRIS MELLOR and MR OWAIN THOMAS of counsel, instructed by Messrs Field Fisher Waterhouse, solicitors, appeared on behalf of the General Medical Council.
MR KIERAN COONAN QC and MR NEIL SHELDON of counsel, instructed by Messrs RadcliffesLeBrasseur, Solicitors, appeared on behalf of Dr Wakefield, who was present.
MR STEPHEN MILLER QC and MS ANDREA LINDSAY-STRUGO of counsel, instructed by Messrs Eastwoods, Solicitors, appeared on behalf of Professor Walker-Smith, who was present.
MR ADRIAN HOPKINS QC and MR RICHARD PARTRIDGE of counsel, instructed by Messrs Berrymans, Solicitors, appeared on behalf of Professor Murch, who was present.
I N D E X
Transcript of meeting of the Medical Research Council 1
- read in part by MS SMITH
Video played (transcribed by shorthand writers) 4
APPLICATION – MS SMITH 6
ADVICE OF THE LEGAL ASSESSOR 7
THE CHAIRMAN: Good morning, everyone. As some of you may or may not know, the gentleman sitting on the left-hand side of this Panel is a trainee Legal Assessor and he will be sitting in and observing proceedings. Ms Smith?
MS SMITH: Sir, what I am going to do first of all is to read to you the evidence relating to a Medical Research Council meeting which relates to a charge involving Dr Wakefield only. In fact it is head of charge 36. The transcript is an agreed transcript of the evidence at that meeting. It is a very long document and I am certainly not going to take you to all of it, but I am going to take you to those parts which are the background to the actual charge and the representations made by Dr Wakefield.
Sir, when it was photocopied for your bundles, the list of attendees at the meeting and the conclusions of the meeting was inadvertently left off; I am now going to give you those and ask you to put those in. The relevant bundle is FTP7 and the transcript of the entire meeting starts behind divider 7 at page 85. If you would turn to the end of it, sir, which is page 196, you will see that the pages I am about to hand you are paginated with an alphabetical letter and they go from 196A to 196O. (Same distributed)
Sir, if I can take you first of all to page 85, the beginning of the document, so that we can see just what the meeting was about, you will see that there is an introduction by Professor George Radda from the Medical Research Council. He said:
“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.”
He then went on to thank Professor Sir John Pattison, who was actually going to chair the meeting.
If I could then take you on to page 152, sir, you will see, if you look back in the document, there were a series of presentations given by a number of people. If you would go to page 152, you will see that the heading is “Mr Andrew Wakefield” and that he was talking on a new syndrome: ileal lymphoid nodular hyperplasia, non-specific colitis and pervasive developmental disorder in children. This was a talk which he gave with slides and you will see reference to the slides. If you go down to the third paragraph, you will see he said:
“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, 20 male, consistent with the over representation of autism in males, and the selection criteria initially. And these have broadened latterly.”
Then if you would turn on again – I am simply taking you to the references to the referral of the children and the numbers – to page 154, at the bottom of the page, you see:
“We have now some 500 of these children who have been referred, or who are in the process of referral.”
Then if we go on again to page 168, you will see that by this time Dr Wakefield has given his presentation, which in facts ends on page 165, and this was in the open session of questioning by attendees at that meeting. On page 168, we see there is a question asked by Dr Anne Ferguson. She said this:
“I am going to be forthright – since it looks as if nobody else is going to raise the issue of bias in generating this series 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 assume 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 child 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.”
You will then see the answer of Dr Wakefield:
“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 thorough their general practitioners or paediatricians by the standard route.”
Dr Anne Ferguson then said:
“I apologise. I wasn’t suggesting any impropriety. It was really the interest in the subject.”
The questioning then went on to other matters.
I am now going to take you to the end of the transcript, page 196A, which is a list of attendees at the meeting. I am not going to read them all out, but you can run your eye down them and see the number of people there and if you wish to look at what any of their particular specialisms are, they are easily found in the transcript. I am just going to take you now to what are the by now familiar names in the context of this case. You will see that among those present were Dr Berilowitz, Professor Sir David Hull, Dr Murch, Professor Pounder, Professor Sir Michael Rutter, Dr Wakefield. Among the observers, you will see that one was Professor Sir Kenneth Calman, who was at that time Chief Medical Officer, and you will also see Dr Salisbury and Professor Zuckerman, in his capacity for the World Health Organisation. Then the MRC officers and on the next page, you will see the heading “Apologies” and amongst those apologies, you will see Professor Walker-Smith’s name.
Following on from that, at page 196E are the conclusions relating to that meeting, in other words, the document which was produced at the end of this day’s meeting to examine the science. It sets out the background to the matter at page 196C, the structure of the meeting, all the papers which were submitted and then on page 196D the programme and the presentations that were made.
You will see under “General Discussion”, “Mr Andrew Wakefield”, and that is the presentation to which I have already taken you. It is then consists of a series of conclusions that the Committee had reached. If you turn to page 196L, you see section c) which poses the question that was discussed amongst many at the meeting and the conclusions that were reached. “How were the patients selected” and the recording of the conclusions:
“Members were interested in hearing how the children had come to be referred to the [Royal Free Hospital School of Medicine] team, as this had a bearing on the issue of bias in the generation of the case series. Mr Wakefield explained that originally the parents of the children had come to the Group without any connection through any other organisation. Latterly, following media attention, parents had heard of the RFHSM Group’s work either directly or through other organisations. All patients who had been reviewed to date had been referred by their general practitioner or paediatrician by the standard route.”
Just for completion, you will see at the end 196n and 196o are the conclusions and recommendations from that meeting. Those are the matters to which I want to draw to your attention in relation to this charge.
That concludes what I have to say at the moment about the Medical Research Council meeting. As you know, the other matter that has been arranged for this morning is that you should hear short excerpts from a video. I hope we are in a position to go ahead with that.
MR COONAN: Before my learned friend proceeds with the next stage, could I correct one inaccuracy. My learned friend said Dr Wakefield’s presentation finished on page 165. It did not, it finished on page 159 and the presentation that finished on page 165, which you may have to look at later, is that of Professor, Sir Michael Rutter.
MS SMITH: Thank you, I entirely accept that.
THE CHAIRMAN: So, next we are going to see the video.
(Video prepared) Can I make sure that the members of the Panel are able to see?
MS SMITH: One alternative may be that the members of the Panel move closer for the purposes of listening.
(The Chairman checked with the Panel that they could hear the video)
THE CHAIRMAN: Are we going to be provided with a transcript of the video?
MS SMITH: A transcript is being taken.
“[DR WAKEFIELD]: What is the next part of the equation? The virus is there, it seems to be instrumental of these things in producing this lymphoid reaction. Does that make it the cause? No, it does not; no, it does not. All we are doing is putting together pieces of a jigsaw. The next piece of jigsaw is, is that virus causing an immune response? Is there an exaggerated immune response to that virus in these children? So we take the sera from the blood and we look at measles antibodies, rubella is controlled, mumps and cytomegavirus, a common virus, antigens, 22 affected children, two of them with autistic enterocolitis, 32 healthy controls.
Again, for those who have heard the story, you can put your hands over and you can take time out here, but this is again my son’s birthday party, 32 healthy controls. You line them up, with informed parental consent of course, they all get paid £5 – which does not translate into many dollars, I am afraid – but when they put their arms out, they have a cup on to have the blood taken, all entirely voluntary. (Laughter). When we did this at that party, two children fainted, one threw up over his mother (laughter), one child, who is my son’s best friend, [name], put his arm out – very bold – had the tourniquet put on, then went pale and sort of ‘wait until next year’. (Laughter). He was nine at the time, and his four year old sister came up, stuck her arm out, had the blood taken, took her £5 and walked off. (Laughter) He then burst into tears, ruined his birthday party. People said to me, ‘Andrew, you know, you can’t do this, people, children, won’t come back to your birthday parties’. (Laughter) I said, “You are wrong’, I said, ‘Listen, we live in a market economy, next year they will want £10’. (Laughter) We have a birthday party coming up as well when I get back so we will be going. They charge me a fortune. Urine – I mean, come on, they charge me a fortune. (Laughter). But, they were all less than ten years of age and none had been revaccinated against measles and none were within 18 months of vaccination. So, these were the two comparable groups.
We also had cerebrospinal fluid samples from six children, because at the beginning of this study we were not sure whether the problem was sera or (inaudible) so we were looking fairly broadly. Here are the results and you can see the measles, mumps, rubella and the cytomegavirus levels. These are really titres of antibody in the area of (inaudible) and cases against controls, and the only one which distinguishes the cases, the autistic children from the controls, is this one here, it is measles. The rest there is no difference. The cerebrospinal fluid was normal in all children.
Again, this singular response suggests that this is not a non specific response that you would see for any virus.”
(End of video)
MS SMITH: Can I check that you were able to hear that?
THE CHAIRMAN: Yes, I think just about, but, as has been pointed out, we are going to have the transcript anyway so we will be able to read what was said.
MS SMITH: In relation to that transcript, when I opened the case to you I read it out and so you will have that in my opening. I wanted to say if that is different, which it may well be in respect of a word here or there, to the one that you get when it is transcribed this morning, you should go by the formal transcription and not my version.
MR COONAN: I have not yet seen a document that I can agree in relation to a transcript. I am sure I can when I see it, but can I suggest that the transcript as we get, for example in the Hansard transcript, also indicates where laughter is recorded.
THE CHAIRMAN: I am sure the shorthand writer has taken a note of what you have had to say.
THE CHAIRMAN: Could this be replayed, so we can have a look at it again. Some Panel members would like to move closer, as was advised by Ms Smith earlier.
(Video replayed, transcription as above)
THE CHAIRMAN: Right, Ms Smith.
MS SMITH: Thank you, sir. That is all the evidence that I am going to be dealing with this morning. As you know, the Panel were not proposing to sit in any event tomorrow, and thereafter there will be a gap until we start with the experts, which it is anticipated is going to be the 27th.
There are a couple of matters that I wanted to deal with. The first of them relates to what we were proposing to give to you, to assist you in any deliberations that you may have during that time prior to hearing the experts. The first thing I would say is that with regard to the background to these children, there is in the transcript of my opening of the case what I freely admit is a potted version of their backgrounds but you may, though, find helpful as a preliminary reminder, and of course the detail is contained to a large degree in the general practitioners’ evidence.
In addition to that, sir, we propose to provide you, and I hope you will bear with us for a few days whilst we produce it, simply a list of the relevant records which we will be dealing with in our evidence from the expert. In other words, just a list of the page numbers in respect of each child.
I do make it clear that I am not for a moment saying that is an exhaustive list. Of course the defence may be referring to lots and lots of other medical records and we may indeed ourselves when I take the experts through their evidence, but it will be most of the documents to which we will be referring, and certainly the most central to the views that they are going to express. It seemed to us – obviously we will be going through them with the expert - that if you had them in advance, then you would have the opportunity to look at them and read round them to any extent that you wished to do so. I hope that will be helpful.
We have arranged that my juniors will ensure that the Secretary gets those, as I say, within the next few days. I hope you will bear with us as far as those few days are concerned. You will appreciate, it is quite a detailed job and we wanted to be as comprehensive as we can, so it is helpful to you.
THE CHAIRMAN: I am sure that is going to be very helpful. We have already discussed amongst the panellists. What we are going to do is this. I do not think every one of us is going to come here every day, but some of us are going to come on a few days and do some work here, do some reading here, and take a few tasks and some documents with us, and then come back again and replace them, change them and take different documents. We are going to use this time reading either in this chamber or outside this chamber. Most of this time will be used as reading time. We will be making sure that we do proper justice do the documents that you are referring to now, and hopefully we will be provided a list in due course.
MS SMITH: Certainly, sir – as soon as we can produce it. That is the first thing.
The other is just a matter that I want to raise which relates to disclosure of the defence experts’ reports. If the defendants are relying on experts, then they have an obligation, which I think they would all acknowledge, to provide those reports within a sensibly practicable time to the GMC so that the experts who are being called by the GMC are not taken by surprise by them. A reasonably practicable time in this case, sir, I would say, was a rather lengthier one than might usually be the case because you will appreciate, having seen the complexity of the medical records, there are twelve children to be considered. All the experts in this case are extremely busy people and they need time to consider how they will be answering any question that is put to them.
In addition to experts’ reports, of course, there is any medical literature that the defence wish to put to the experts. They need, again, time to consider what their expert view is in relation to what they are going to be asked about on that literature.
We have this gap of two weeks. We have not had any experts’ reports as yet. Mr Miller has kindly indicated to me that his expert, in fact, has been unwell and so there have been some delays. All three have said to me that if they are relying on expert evidence, they will be producing it for us. As I say, two weeks may sound a time, but it is no time at all if we have to add on to that time time for my experts to consider anything that is produced.
THE CHAIRMAN: Three.
MS SMITH: Three weeks. Nearly three. Two and a half, in fact.
THE LEGAL ASSESSOR: It is exactly three weeks today when we resume.
MS SMITH: All right, then. Three weeks today. It still is not a long time for it to be produced and, as I say, with twelve patients for these defendants to consider it. I am aware, as I say, it has been accepted that these reports do have to be produced in time for my experts not to be taken by surprise by them. Although I am not asking for a specific date when these reports are going to be produced – because quite frankly I do not think I am going to be given one – I am going to ask you, sir, to make it clear that the Panel do not expect to come back and hear that my experts have not been provided with that information. I want the doctors to hear, sir, that sympathetic though I am to the stresses that this case causes, the fact is, if I do not have that information I shall – hugely reluctantly – be forced to ask for another adjournment so that they can take in anything that has been produced depending, of course, on how complex it is and how much there is of it.
As I say, I would ask you, in your capacity as Chairman, to make clear to the defence that no one is going to welcome a position arising where I do not have that information in time to provide it to my experts and time means a sensible time, given the complexity of the case.
THE CHAIRMAN: Thank you. Mr Coonan?
MR COONAN: I have heard what Ms Smith had to say. She told us yesterday and a previous time. I have nothing to add. I hear what she says.
THE CHAIRMAN: Mr Miller?
MR MILLER: Sir, I have made my position clear to Ms Smith. My principal expert has been ill, has been injured, and is recovering from that, and I told her that I am sympathetic to the point that she has made. I intend to make my principal expert’s report available in good time before the resumption of this hearing.
THE CHAIRMAN: Thank you. Mr Hopkins?
MR HOPKINS: I note Ms Smith’s observations.
THE CHAIRMAN: Legal Assessor?
THE LEGAL ASSESSOR: If, when the experts for the General Medical Council are cross-examined, indicate that they are taken by surprise or have not had any adequate notice of any material put to them, the Panel will be duty bound to grant them such reasonable time to deal with the material as an act of fairness, and as equality of arms – as we have come to call it –in our application of conventional law. The doctors will just have to suffer the consequent adjournment, if that is the course it has to take, because of inadequate disclosure.
I have heard the studied legal phrases used from across there. I understand the codes as much as they do. I have been less studied, and that will be my advice to you if any witness says that he or she is taken by surprise, or has not had adequate notice for any proposition put.
THE CHAIRMAN: Thank you, Legal Assessor. Any observations, Ms Smith, that on the advice we have just heard from the Legal Assessor?
MS SMITH: No, sir. I am grateful for the indication that he has given and, as I say, as the Chairman I would be grateful if you would convey that in those terms to the defence.
THE CHAIRMAN: I am looking at counsel. You may not have any comments to make, Mr Coonan, on the advice we have just heard?
MR COONAN: Not really. It is really a matter of language the learned Legal Assessor used, in terms of the phrase “any proposition”. Of course, propositions can be put to an expert without being based on an expert report. It may well be that my learned friend might wish to consider the breadth, or the intended breadth, of that observation.
THE LEGAL ASSESSOR: I do not think in my capacity today I am “his learned friend”, although I normally am, of course. But yes, I was meaning, of course, if it is based on any written material upon which the defence subsequently proposed to rely. If it is merely a proposition put in cross-examination that is not based in literature or research, then obviously what I said does not apply to it.
THE CHAIRMAN: Mr Miller?
MR MILLER: I have nothing.
THE CHAIRMAN: Mr Hopkins?
MR HOPKINS: No.
THE CHAIRMAN: Legal Assessor?
THE LEGAL ASSESSOR: I have something that is very trivial, but it is amazing how things can come back to haunt one. In the list of people of those present at that meeting in the new material produced this morning at page 196a, in FTP 7, I notice Professor A. Tompkins. Do you know who she is? Or does somebody know?
MS SMITH: I am sorry; I am just finding the page.
MR HOPKINS: We think it might be Andrew Tompkins.
THE LEGAL ASSESSOR: In that case, the matter does not arise. Thank you.
THE CHAIRMAN: We have heard submissions from Ms Smith about the disclosure of evidence, particularly the experts’ reports from the defence. We have heard submissions from the three defence counsel and, of course, advice from the Legal Assessor. We only hope that before we resume the hearing that these difficulties will be resolved satisfactorily by all concerned. I do not really think I can say any more at this stage, apart from saying that from Monday onward we will actually be using these two and a half weeks, just short of three weeks, as appropriately as we can in reading the documents and the transcripts, et cetera. Legal Assessor?
THE LEGAL ASSESSOR: I should make it clear, when the Chairman refers to people coming here and reading and doing preparatory work, they will not be deliberating, and I will not be present giving advice. They will not be conducting deliberations during this period.
THE CHAIRMAN: I think that is absolutely right, and we have no intention of having any in camera discussion sessions going on, particularly in the absence of the Legal Assessor. Even if he was, I think it was never the intention to use this time for that particular purpose.
Can I thank you, and we shall see you on 27 September.
(The Panel adjourned until Thursday, 27 September 2007 at 9.30 a.m.)