GENERAL MEDICAL COUNCIL
FITNESS TO PRACTISE PANEL (MISCONDUCT)
Thursday 23 August 2007
Regents Place, 350 Euston Road, London NW1 3JN
Chairman: Dr Surendra Kumar, MB BS FRCGP
Panel Members: Mrs Sylvia Dean
Ms Wendy Golding
Dr Parimala Moodley
Dr Stephen Webster
Legal Assessor: Mr Nigel Seed QC
CASE OF:
WAKEFIELD, Dr Andrew Jeremy
WALKER-SMITH, Professor John Angus
MURCH, Professor Simon Harry
(DAY TWENTY-SEVEN)
(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
Page No
DAVID MAXWELL SALISBURY, continued
Examined by MS SMITH continued 1
Questioned by THE PANEL 12
Re-examined by MS SMITH 14
Further questions from THE PANEL 14
MR MILLER introduces Exhibit 3D and reads same 18
Discussion on timetabling 34
THE CHAIRMAN: Good morning everyone. Good morning Professor Salisbury. Ms Smith, you were still examining in chief.
MS SMITH: Yes, thank you very much. Good morning Professor Salisbury.
DAVID MAXWELL SALISBURY,
Examination by MS SMITH, continued
Q I am going to take up from where we were yesterday afternoon but just so I can remind everybody – I am not going to read out things I have already read but if you turn to page 1140A in bundle FTP3, that was the letter I read out yesterday, dated 19 February, to the CMO from Dr Spratt and that was the first letter from Dr Spratt about his concerns in relation to Child 9 who was his patient. Then if we go on to the next letter, which is at page 1141, and that was the second and much more detailed letter in relation to the treatment of Child 9, which I also read out to you, and that is dated 22 March 2002. You explained to us that there had been an intervening telephone call between you and Dr Spratt. We spoke about the protocol and the extracts from the child’s medical records, which were enclosed with that letter. If we then go on to the next letter, which we have not been to before but which is at page 1197. That is a letter from Sir Liam Donaldson to Dr Spratt, and we see in the right-hand corner copied to you, dated 3 May 2002:
“Dear Dr Spratt,
Thank you for your letter of 19 February 2002 about the participation of one of your patients in Dr Wakefield’s research. I apologise for the delay in replying.
I understand you have now spoken in more detail to Dr David Salisbury, Head of the Immunisation Team. The information you have provided is very helpful and I am grateful to you for taking the time to get in touch with the Department of Health on this important issue. David tells me that he is waiting for material that you were going to send him as we are now considering how best to take this matter forward. It is rather important that we receive this but please do not hesitate to contact me again should any further information come to light, which you think might be useful.”
That is a reply to the letter at 1140A letter that I read first of all.
Then if we go on to page 1202: most of this letter has been deleted because it refers to matters which are irrelevant to the charges, but it is simply so that we can see the sequence of the chronology. This is dated 13 May 2002 and it is Dr Spratt’s letter to you saying:
“Many thanks for your letter of 7 May – received today. This has crossed with some rather repetitive correspondence with the CMO – copies of which I will enclose for information.”
That concludes that little section of correspondence from Dr Spratt, and the only thing I wanted to ask you about that is, there is reference to Dr Spratt having taken the trouble to contact the Department of Health, was that entirely, as far as you were concerned, out of the blue?
A Yes, it was entirely unprompted. His action was exactly as described in his first letter.
Q I now want to turn on to a different topic, which I indicated yesterday I would deal with this morning, which is what, if anything, has occurred in relation to the take-up rate with regard to MMR vaccination, and before I take you to the relevant documents, I just want to set the scene a little, if I may. By the end of 1997/the beginning of 1998, in other words, prior to the February 1998 date, which is the date when The Lancet paper was published, what was the position as far as the incidence of measles in this country was concerned?
A Well, we were very much at the low point in the occurrence of measles. We have got extraordinarily sensitive surveillance, probably world-leading surveillance for measles that does not just require a doctor to report that they think they have a case of measles. When they do that the case is then followed up and, using saliva, we are able to show whether the report was correct and the child actually did have measles. At the time, around mid to three-quarters into the 1990s we were seeing about 100 suspected cases of measles for every one. So in other words, measles was extremely rare. We were down to probably something of the order of less than 100 cases of measles per year; most of those were identifiable as importations and there was extraordinarily little secondary onward going spread of measles. Measles was an extremely rare disease.
Q To what did you attribute that happy state of affairs?
A I think there was no doubt that that had come from the achievement of high coverage with MMR, a second dose of MMR and the measles/rubella campaign that had effectively taken away a group of susceptible children amongst whom measles would have been able to circulate.
Q I will ask you about the actual hard percentages shortly, but before I do so I want to ask you about the rather softer subject of public perception. Do the Department of Health have methods for charting public perception with regard to immunisation generally, not just MMR?
A Yes, and I would actually disagree with you that this is soft data. This is extremely valuable data and it is important data. It is also probably data that no-one else in the world has actually got anything like. Since the beginning of the 1990s, I think probably 1990/1991, we have commissioned market research amongst parents, and 1,000 mothers of young children are interviewed twice a year – obviously a different 1,000 – they are randomly selected to represent the differences within our societies; once in every four studies we up-rate the proportion of interviews that are done with people from ethnic groups so that we can look very closely at the services provided to all sections of the community, and about once in every four surveys we do a similar one with health professionals. The purpose of this work is to look at not just public attitudes but the knowledge of parents about vaccines. It covers all of the vaccines. We look at what they know of advertising that we may have done. We look at who they get information from. We ask whether they are satisfied with the service they get from their health providers. It is an extremely extensive interview and lasts about an hour each interview, and it is very sensitive because it forecasts what will happen to immunisation coverage.
Q I should say, when I used the word “soft” I was not suggesting that it was not valuable; I was using it simply to differentiate from what I had previously described as “hard” figures, but it takes me on to the question I wanted to ask you, which is, as far as the Department of Health is concerned how important is that issue of market research into just what the man on the street thinks about immunisation.
A I think it is of great importance. We would not have done 30 of these surveys, and they are not cheap, so we would not have done 30 of these if we did not think these were valuable. We view it as extremely important in the development of our strategy – not necessarily the policy but the strategy – of the implementation of immunisation to actually know what it is that parents know; what they believe; who they get information from; we even break the data down to what newspaper they read.
Q I would like to turn on to look at the first relevant lot of that market research, which is the one which was just post the publication of The Lancet paper, and if you go in FPT3 to page 824, this is prepared, as we see on that page, for the Health Education Authority by a market research firm, is that correct?
A Yes, at that time the arrangement was that the immunisation communication work was done by the Health Education Authority. We funded that work and we funded indirectly these surveys. Subsequently, the group working at the Health Education Authority were incorporated into my team, so the work is commissioned directly by us.
Q We see the date of May 1998 on the front of the document, and if you would turn on to the table of contents, and I am just going to run through them so we understand the variety and the width and breadth of these. There is an introduction section and then there is a profile of mothers for this particular wave, which is wave 14, and we will see in a moment the dates of the field work for this wave, analysing the profile in terms of age and marital status, ethnicity, presence of children, working status, social grade and region. Then knowledge: either spontaneous awareness of immunisations or prompted awareness of immunisations, knowledge of Hib immunisation as a separate subject. Attitudes towards immunisation: seriousness of diseases; safety of immunisations; protection offered by immunisations; intentions to immunise and the likelihood of immunising against further diseases, and then advertising: the awareness of not only advertising but of information about health issues generally and spontaneous awareness of information about immunisation and of leaflets and the department’s TV advertising; prompted awareness of press advertisements and attitudes to advertising. Then recent immunisation experience: prior to the child’s first immunisation from health professionals prior to first immunisations; the most recent immunisation visit they had had and their satisfaction with it, and the issues of choice and consent. Then they are asked about Health Education Authority publications in particular, and there is a particular section as you have already identified on tracking amongst ethnic minority mothers in case there should be differences in relation to information or understanding in that particular category.
If we go on to page 827, the introduction:
“In February/March 1998, the Health Education Authority (HEA) commissioned BMRB International to conduct a fourteenth wave of research examining the impact of their childhood immunisation campaign. The campaign targets mothers with children under the age of three, and aims to promote awareness and use of immunisation services.
The objectives of the research was to provide information for strategic planning on:
• Mothers’ knowledge of immunisation;
• Mothers’ attitudes towards immunisation and
• Mothers’ experience of immunisation services
And also to monitor advertising over time on key indicators.”
It identifies two particular issues, first, that there was a boost of mothers from ethnic minorities and, secondly:
“Shortly after Wave 14 fieldwork began, there was a spate of media attention highlighting new research citing potential links between MMR the vaccine and two conditions: Crohn’s disease and autism. The survey results should thus be viewed in the light of this press coverage.”
If we look at the next page we will see when the fieldwork was and, indeed, how that ties in to the observations that, shortly after the observation began, there was a spate of media attention in relation to this issue.
If we look down at fieldwork dates on page 828, this is Wave 14, the last one, and the fieldwork dates, in other words when these mothers were interviewed, was between 23 February and 14 March?
A That is correct.
Q If we go on to page 829, this confirming what you have told us about, Professor Salisbury, we see the sampling size:
“In Wave 14, a total of 1007 interviews were achieved in England across 175 sampling points.”
with a separate survey in Wales which was reported on separately. If we go on to page 831, we see at the same time that there was a smaller, more specific study, what is called a qualitative follow up.
“A follow up qualitative study, identical to that carried out last year, was undertaken to explore in depth parental views towards immunisation. Fieldwork was conducted in March 1998, after the MMR scare stories had erupted in the national media.
Specifically, the objectives of the qualitative study were to provide information on:
• beliefs and understanding about immunisation;
• perceptions of side effects add risks;
• information sources and needs;
• feelings about the last immunisation visit;
• future immunisations.”
We see that that consisted of twenty five mothers of children aged 0 2 years who had accompanied their child on their last immunisation visit, and then selected from seven geographical locations across England. We see the areas chosen and that they covered a broad range. At the bottom of the page they were also recruited from different socio economic backgrounds and varying age groups.
If we turn on to page 835 – I am being selective about how I go about this, but the document is there for the Panel to read and you may be asked questions by others. This is the section on knowledge on different immunisations. This first chapter covers awareness of the different immunisations available for children, both at the spontaneous and prompted level. We see:
“Spontaneous awareness of immunisations
Wave 14
Spontaneous awareness measures the immunisations which are top of mind for mothers...”
In other words unprompted by the market researchers:
“... and it is often subject to movements relating to advertising campaigns or what has been in the news. The following table shows spontaneous awareness of all immunisations mentioned by more than 10 per cent of mothers at the latest two waves of research.”
We see MMR at the top of the list. August 1997 it was 70 per cent; February/March 1998 it had increased by 6 per cent to 76 per cent. Underneath:
“MMR and Polio have always topped the list in terms of mothers’ spontaneous awareness and this year is no different. However, spontaneous awareness of MMR has increased significantly since the previous wave of tracking research...”
That is the 6 per cent:
“... almost certainly attributable to the spate of media attention possible side effects of this vaccine.”
A Could I add that the two asterisks in that table against the change between 70 and 76 mean that this was a statistically significant difference.
Q Thank you. That is knowledge, and if we turn on to 842 we see the analysis of the attitudes towards immunisation. 842 is start of that section and we see the heading “Attitudes”. If you turn to 848, Wave 14:
“Since the first wave of research, mothers have been asked to make an assessment of the safety of a number of immunisations by rating them on a four point scale: ‘completely safe, ‘slight risk, ‘moderate risk’ and ‘high risk’. Table 4e shows the proportion of mothers at the last two waves considering each immunisation to be either completely safe or to involve a slight risk.”
We see again MMR at the bottom of that table. August/September 1997, 80 per cent; February/March 1998, 73 per cent. That is a seven per cent decrease in mothers thinking that MMR is safe. Again, we see the two asterisks against it and you have explained the significance of that.
Underneath:
“Over the past 6 months there have been some movements in the perceptions of the safety of certain immunisations. There has been a significant reduction in the proportion of mothers rating the MMR as representing no more than a slight risk, which is unsurprising given the media attention about this vaccine.”
If we turn to 849, we see more of an account of the reasons for that:
“Most, but not all, of the qualitative study participants were aware of the recent MMR scare. In general this had heightened people’s awareness of the risks associated with immunisation and it increased their concerns about the MMR triple vaccine.
‘There has been a lot of news about these triple vaccines and how they could cause Autism and things like that’.”
Which is plainly a direct quote from one of the participants in the small InDDex study.
“Of the mothers who had heard of the MMR scare, several had heard that it could cause brain damage and bowel disorders in young children. Others recalled press articles indicating that children may become Autistic or suffer with Crohn’s disease as a result of the MMR vaccination.
‘There has been a lot of press about it and linking it with Autism and Crohn’s disease’.
‘It was on the news about a month ago. They were saying that by having three injections together there was a high risk of becoming Autistic or having bowel problems’.”
Then it says:
“Parental reactions to the MMR were varied. Primarily there was concern that children would develop a serious illness as a result of the MMR vaccination.”
It then sets out a number of other examples of the express observations that were made in relation to that issue. If we turn to 853:
“However there have been movements over the past 6 months in the types of immunisations which mothers believe to be risky. Formerly, whooping cough has always been the vaccination which mothers have been most concerned about. However, during this current wave MMR topped the list. Overall 13% of mothers (when prompted) considered the MMR to be riskier than the actual diseases, up from 8% in August 1997, and 3% six months previously. This again is almost certainly a result of the increased media attention on MMR.”
It then says:
“The full figures, based on the total sample, are shown in Table 4i, compared with the equivalent figures in the previous two waves.”
We look to MMR at the top of the page. It is the percentage of mothers believing the proposition which is put by the table:
“Whether any immunisation present greater risk than the disease it protects against.”
It says “prompted”, in other words, that was the question that was asked of these mothers for them to respond to. We see February/March 1997 3%; August/September 1997 8%; and February/March 1998 13%. Again we see your two asterisks by that, the only ones in the list, indicating that that is a significant percentage increase. Is that correct?
A That is correct.
Q Turning on to 860. This is the question mothers were asked about whether there were immunisations that they would not allow a future child to have. It says:
“Mothers were also directly asked whether there are any immunisations they would not allow a future child to receive. As the following chart shows, for the previous eight waves no more than 7% of mothers responded positively. However, at the latest wave, this proportion has risen significantly to 12% of mothers, which once again is likely to be a reflection of the recent MMR publicity.
Those who said that there was at least one immunisation they would not allow a future child to have, were asked to specify which immunisation s they would refuse. Until August/September 1997, whooping cough had always been the immunisation that mothers are most likely not to allow. However, in February/March 1998, of those mothers who object to at least one immunisation, there has been a significant drop in the proportion mentioning whooping cough (from 37% to 14%). Conversely, the proportion mentioning MMR has increased significantly from 33% up to 55%. This ‘displacement effect’ was also observed in section 4.2 where confidence in the safety of whooping cough appeared to rise at the expense of lost confidence in the safety of MMR.
In total, therefore, 7% of all mothers say that they would not have a future child immunised for MMR this figure is much higher amongst the professional subgroup.”
Was that a particularly concerning statistic, as far as you were concerned, that mothers with another child coming on would now be saying that they would not have MMR?
A Yes, it was undoubtedly concerning, as were so many of the messages that this public research revealed to us.
Q I turn on to the last part I want to refer to, page 866. This is the advertising section, which is the chapter that examines mothers’ awareness of advertising and publicity about immunisation and their attitudes towards it. If we go on, most of this is about express advertising, but if you turn to 872, this is about the material which might have had an effect on persuading mothers not to have their children immunised. We see at the bottom of the page:
“When asked to describe the material which could have dissuaded them, many mentioned the side effects of immunisation: unspecified side effects nor risks (43%); television documentary or news items (26%) or general mentions of newspapers or magazine articles (10%). Just over a third (37%) of mothers who recalled negative publicity specifically mentioned the MMR, twice the equivalent proportion in August/September 1997 (18%).”
That was the indication from Wave 14, Professor Salisbury that I wanted to take you to. For the sake of balance and completeness, you have also kindly provided the next survey that was done by the same body, which is Wave 15. As far as Wave 14 was concerned, as the Head of Immunisation, what was your overall concern, in broad terms, about what that revealed, Wave 14 revealed?
A I think that we were all concerned by these indicators of increasing public anxiety over vaccine safety which we felt were not justified, and we were concerned about the likelihood that these concerns would be translated into actions, either for immunisations that were due, because some of these children had not yet had their MMR because they were too young, but also because of actions that, as the mothers themselves said, they may or may not take for subsequent children. This, just as immunisation coverage tells us important information, this was raising really quite a lot of concerns in our minds.
Q If we turn on to Wave 15, page 973. It is in precisely the same format. If we turn to 976, we see at the top of the page:
“A representative sample of 977 mothers of children aged 0 2 was interviewed across 132 locations in England during August/September 1998.”
So this is a little later on into 1998. If we turn on to 978, we see a particular summary reference to MMR.
“The rise in spontaneous awareness of MMR has been concentrated among the lower social grade groups.”
We will remember that the previous wave said there was a higher proportion in the higher socio economic groups:
“This has led to a narrowing in the gap in awareness.
Between Aug/Sep 1997 and Feb/March 1998, the proportion of mothers rating the MMR as representing a ‘moderate’ or ‘high’ risk increased significantly.”
That is Wave 14 which we have looked at:
“This trend has not continued between Feb/March and Aug/ Sep 1998. In fact, among the ABC1s ...”
which is a higher socio economic group,
“...there was a slight recovery in the perceived confidence of the vaccine (25% considering the vaccine to represent at least a moderate risk compared with 31% months earlier).
One in nine mothers (11%) considered that the MMR vaccine represented a greater risk than the disease it protects against. This figure remains unchanged since February/March 1998, although among ABC1 mothers, the proportion who believe this has fallen (17%-11%).
A small minority (6%) say that they would not allow a future child to be given the MMR vaccine (no change since February/March 1998).”
If you would turn on to page 980 to identify the fieldwork dates for Wave 15, which were between September/October 1998. If we turn on to 989, in the middle of the page under the paragraph which starts “Confidence in the safety of whooping cough”, we see:
“The perceived safety of MMR has risen only slightly from the previous wave, although this continues a more steadily inclining trend.”
If you turn on to page 991: the same type of questions were asked about intentions to immunise, and it makes the specific point, and we can go on to look at the statistics which we do have, but:
“The tracking study is not designed to collect accurate information on uptake of individual immunisations. Therefore, softer measures of intentions to immunise are obtained through attitude statements and hypothetical questions regarding ‘future children’.”
If we look at the table the question was “If I had another child I would have them fully immunised against all childhood diseases”, and what was being charted was whether they agreed with that proposition or not, and we see at the bottom of the page:
“The vast majority of mothers across all waves have agreed with this statement, either strongly or slightly. However, since Aug/Sep 1996, this proportion has been on the steady decline, possibly associated with adverse media coverage about MMR. Levels of intention fell to their lowest level since tracking began at Feb/March 1998, with 87% of mothers agreeing overall, and 64% agreeing strongly. However, the halt in decline at the most recent wave would seem to be a reflection of the dilution in media coverage over the previous 6 months.”
Then on, if you would, Professor, to 996, under the title “MMR”:
“In February 1998, a paper was published which highlighted medical evidence purporting possible links between the MMR immunisation and two serious illnesses: Crohn's disease and autism. This was widely reported in the media. Media attention has continued to a lesser extent over the remainder of the tracking survey. In order to help counter against the negative publicity, the [Health Education Authority] has produced an information leaflet specifically about the MMR and the potential risks. Thus there is a special interest in the potential effect this may have had on mothers’ perceptions about the immunisation.”
It then analyses those. We see on page 997, the next page:
“Compared with February/March 1998, confidence in the safety of the MMR immunisation recovered slightly at the current wave, with 75% of mothers saying it was either completely safe or carried only a slight risk. This represented a slight [increase] from 73% in February/March 1998, but confidence has yet to return to the level of a year ago, when this figure was 80%.”
So that was the slightly longer term views that were being expressed towards the end of 1998. I have read out, Professor, that these reports expressly do not deal with the statistics in relation to actual coverage, but I think that those are separately available to the Department of Health to show the figures in relation to who has actually had their child immunised, and if we could go on to page 1220, please. That is the first page of the document and we see the “Measles/Mumps/Rubella” column over to the right hand side. Can you just tell us where these statistics come from, Professor?
A Yes. These are routine annual collections that were undertaken. The methodology changes a little bit over time as to the process by which it was collected, but essentially the process starts with the GP recording that a child has been immunised. That data makes its way effectively through to the local Health Authority. It then makes its way centrally ultimately to the Department of Health and this time to the Public Health Laboratory Service, and the analysis ultimately of the data was done by the Public Health Laboratory Service and then provided to the Department of Health.
Q If we turn on to the second page and run down the page, unfortunately it does not have the actual vaccinations at the top, but we are the third column in on this page but the second row of figures, the point at which I am referring, which is where it says “2nd birthday in 1997/98”, and we see that the coverage for measles, mumps and rubella was 91%, is that correct?
A Yes, that is correct.
Q If we go down to the next year “2nd birthday in 1998/99” it has gone down from 91% to 88%. Is there a continuation of that drop thereafter; we go down to 88%, 87%, 84%, 82%, 80% and then 80% on the next page and a slight increase by 1 per cent in 2004: is that correct?
A That is correct.
Q I want to ask you very specifically, Professor Salisbury, about the drop that I have highlighted, namely the drop from 91% in 1997 to 88% in 1998. Now, that is a drop in coverage of 3 per cent. Can you tell us in your own words is that a significant drop from the point of view of immunisation generally in this country for MMR?
A Well, there is always going to be some variation in the coverage data, there is always going to be some oscillation, and therefore a percentage change of 1 per cent up or down may not be meaningful, but where we see a 3 per cent drop, and that is 3 per cent for England of 600,000 children – I am sure someone quicker than me at the moment can work out what that is – but that is the number of children who would not be immunised who had been immunised effectively in the previous year, so these are not trivial numbers. The other thing to of course take account of is these are trend data, and you have to look not just at change between one and the next, but change over time, and the trend here is very clear. I can do 10 per cent of the 600,000, which is the drop, and that is 60,000 children who did not get immunised.
Q Absolutely. I am waiting for one of my juniors to come up with the 3 per cent figure. Neither of them look very keen on the prospect. The significance of that, that number of children, what is the impact of that every year? Do you see an increase in the number of unprotected children every year?
A Well, yes, they accumulate. I mean, this is exactly the point that I was making yesterday about why you need a second dose of MMR, or you need to recampaign. As each year cohort of children remains unimmunised, they add to the numbers that you accumulated the year before and the year before and the year before.
Q Yes.
A Ultimately you have to reach a critical mass at which point measles will be transmitted amongst these children.
Q I am sorry if this seems an obvious question, but if that happens and parents do choose not to immunise, what effect is that going to have, in your view, on the health of the children of this country?
A Well, it is undoubted that unless these children do get immunised they are vulnerable and ultimately there will be ongoing transmission amongst them. Critically important will be the ages at which they remain unimmunised or unprotected, because the case fatality rate and the complication rate of measles for instance varies with age. So many of these diseases are very much more serious, for example, at older ages than they might be at some younger ages, but measles is particularly serious if you catch it below the age of one, which is below the age when routine vaccination can be applied. So this is an extremely dangerous situation to be getting into. It is not just measles that we worry about. It rather gets forgotten that throughout a whole lot of what has happened our worry has been about rubella, because if children are not immunised against rubella, if rubella immunisation is delayed, then children can start transmitting rubella again amongst each other, and social networks of children are quite different now, with much more contact between children in day care and so on, and so if rubella starts circulating amongst young children, their pregnant mothers are at risk. These are the risks that we face.
Q You mentioned the fatality rate as far as measles is concerned, and I am only asking you this because I am not myself entirely clear what you said, were you suggesting that that was more of a problem under the age of a year?
A Well, there are several issues here. If children under the age of a year catch measles, then the risk of a fatal and devastating complication of measles, it is called sub-acute sclerosing panencephalitis, it is a brain damaging condition---
Q That is the SSPE.
A It is the only condition that we know where measles virus persists, and if children get measles below the age of one, the risk of SSPE is very, very much higher, and if measles is circulating freely in the community, children under one must be at risk because they have not been routinely vaccinated. As you get older, however, and certainly into adolescence and beyond, then diseases such as measles are very much more unpleasant with higher attendant complications.
Q Thank you very much, Professor Salisbury. If you excuse me for one second. I am told that, stunned by my challenge, I can now tell you that 3 per cent is 18,000.
A Thank you.
THE CHAIRMAN: You mean 1,800, I think.
MS SMITH: No, 18,000. Thank you very much, Professor. You may be asked some questions by others.
THE CHAIRMAN: Professor Salisbury, I am conscious of the fact that you actually started giving evidence this morning at quarter-past nine. Are you happy to continue with the cross-examination or would you like to have a little break?
A I am fine, thank you.
THE CHAIRMAN: Right. Mr Coonan.
MR COONAN: Sir, I have no questions, thank you.
THE CHAIRMAN: Mr Miller.
MR MILLER: I have got no questions.
THE LEGAL ASSESSOR: I thought Mr Miller had some correspondence he wanted to put in.
MR MILLER: Not to put to Professor Salisbury. I am just going to put it in, because it is with Dr Spratt. I have got no questions for the witness.
THE CHAIRMAN: Mr Hopkins.
MR HOPKINS: No, thank you, sir.
THE CHAIRMAN: That is very interesting. Can we in that case actually have about maybe 20 minutes break, because we will need to have a look at our notes just to see whether the Panel members may have some questions. We were not actually prepared to be asked to do questions immediately.
MS SMITH: I have no re-examination, sir.
THE CHAIRMAN: (Laughter) Yes, obviously. I did not think you would.
THE LEGAL ASSESSOR: Ms Smith would not be entitled to ask any questions!
THE CHAIRMAN: It is just about five past ten, so we will now adjourn and resume at half-past ten. Professor Salisbury, my usual reminder once again, you are still under oath and still in the middle of giving of your evidence so please do not discuss this with anyone. We will now adjourn.
(The Panel adjourned for a short time)
THE CHAIRMAN: As I said earlier, the Panel members may have certain questions for you and if they do I will introduce them to you.
Questioned by THE PANEL
THE CHAIRMAN: I only have a couple of small questions of clarification. I do not think the other Panel members have. Can I first of all just ask you to open the FTP2 bundle, page 501. That is the Pulse press release. Now just to give my background, I understand the Pulse because I am a GP and this is actually a medical newspaper for the general practitioner predominantly. I think the first paragraph, it says:
“Pressure on the Government to order a full review of alleged links between MMR immunisation and a range of serious illnesses grew this week”.
Now, this is actually 2 August 1997, so what actually happened during that particular week which increased that pressure?
A I think the answer to that, as best I know, and I can only interpret from the material I have, is that a journalist from Pulse contacted Dr Wakefield and Dr Wakefield gave the journalist the information on which this story was built. My interpretation comes from the letter that was sent by Professor Pounder, which lays out that that was the background.
Q I think Dr Wakefield’s involvement is mentioned at the bottom of the page in the last three paragraphs, but what I was concerned about is did it have anything to do with Mr Llew Smith, Member of Parliament, asking the questions, or raising the issue, which increased the pressure?
A I cannot know if there was any contact, or where the contact came from between Llew Smith and Pulse. Clearly there is correspondence between Dr Wakefield and Mr Smith, which I believe is here.
Q So really there is nothing that you know of that actually gave rise to that increased pressure on the Government during that particular week, apart from the fact that maybe the Pulse got hold of something and they tried to contact the officials?
A I can only imagine that Pulse, based on the interview that the journalist had had with Dr Wakefield, felt that there was a story here, and it took off. Whilst what you have here is the Pulse reporting, there was of course considerable spillover from this Pulse report into all of the public media, so this was picked up and there was a great deal of press coverage in the general media.
Q I know you said in your evidence that you were aware, or at some stage you became aware of the involvement of Dawbarns Solicitors. You would not have any idea whether it was around that particular time that the knowledge of Dawbarns became more open to the Department?
A No. We knew about the interest of Dawbarns, I think, before 1997.
Q Right. My last question: we have seen all of this market research survey, as it was called this morning, and interesting as they are, but I think they only give the figures so far as public perception was concerned. Do we have any figures of the uptake, how it went down? I mean, we all have our own anecdotal figures, particularly for example from my practice, how it went down, but did you have any figures nationally how it went down?
A Yes. The data is collected on a national basis, and what we discussed at the end of my evidence was the national data showing overall at least a 10 per cent decline in coverage on a national basis, and the first fall around the time of the 1998 Lancet article was of the order of 3 per cent. We have the national data here. We also have the data broken down, down to local level, regional level, national level, and we also collect data every three months. So although what you saw here was the annual data, we actually track it quarterly, and we track it not just for children coming up to their second birthday, but we also look at children at 16 months of age, 20 months of age, 24 months of age, 36 months of age and 48 months of age, so we are able to follow all of the cohorts at different times as frequently as quarterly, and we saw this 10 per cent overall drop in coverage, which lasted for far too long and is only just now showing signs that it is moving back up.
THE CHAIRMAN: Yes, indeed. Thank you. I am looking at again the Panel members and they still do not have any questions. I am going to ask the counsel if they have any questions to come back to you on the basis of two or three small questions that I have asked. Ms Smith.
Re-examined by MS SMITH
Q Just so we are all absolutely clear, Professor Salisbury, the chairman said the market research was interesting but did we have any hard figures, and I just want to be clear: the statistics that I put to you at the end of the questions that you asked, which are on page 1220/1221---
A Of which volume?
Q Sorry, of FTP3.
A Yes.
Q I do appreciate that you have explained this, but can you just make sure we are all clear; these statistics are not part of the market research waves that I took you to, they are separate statistics which are obtained in the way that you have just explained to the chairman, is that correct?
A This data is the national coverage data of children by their second birthday against a multiple range of vaccines, but particularly against MMR.
THE CHAIRMAN: Sorry, can I just come back on that. I understood that data. My question was basically about the uptake. I mean, I can see how it affected on the normal children covered. But whether they had the figures, which I know that the Department of Health did have, and they were published at different stages, about the uptake of MMR amongst the children - but I think I got the point actually.
MS SMITH: Thank you, sir. It may be that we are just using slightly different terms, sir, and perhaps I can just be clear on that. (To the witness) “Uptake” and “coverage”---
A Are synonymous.
MS SMITH: Thank you.
THE CHAIRMAN: I think one of the Panel members has a point of clarification. Mrs Dean.
Questioned by THE PANEL
MRS DEAN: It is just a point of clarification on the same matter, Professor. On page 1221, is it right that the uptake percentage for MMR is shown in the column – I cannot best explain it, but the second in from the right hand side, is that the MMR uptake column?
A It is complicated because the second page is not the same as the first page. What has happened is that over this period of time we have introduced additional new vaccines and so on the second page you have got a far right-hand column which is in fact the coverage of meningitis C vaccine down at the bottom of your page.
Q Is that the three figures, 85, 92 and 93?
A Yes, that is the coverage of meningitis C vaccine showing the introduction of the vaccine and then it is stabilising above 90 per cent. The next column in, going in from the right, is the coverage of haemophilus influenza B vaccine, Hib vaccine, so that is the next column that starts at around 75 per cent, and then peaks – and then you can see at the bottom it is 93 per cent. That is showing the introduction of that vaccine. Your next column – so at the top it is your first and at the bottom it is your third – that is the MMR coverage.
MRS DEAN: Thank you.
THE CHAIRMAN: Ms Golding has another question.
MS GOLDING: I was just going over my notes and I just want to be clear about something, it is the difference between the MMR vaccine and the measles vaccine: are they two separate vaccines altogether?
A Measles vaccine contains just the attenuated, the attained (?) virus against measles. We used it in our routine programme from which it was first introduced in the 1960s through to 1988, so that was just measles on its own. In 1988 we introduced MMR and no longer used measles on its own. The actual ingredient of the measles is the same in the two vaccines, but from 1988 onwards we supplied no more single measles; there was actually no demand for it.
Q In the application of the protocol for this study that we have been talking about, it mentions measles: was it your understanding that it is that single measles vaccine that is being talked about there?
A The title of that study is specific. It says “measles and/or measles/rubella”, those are two quite specific vaccines, one is the single measles vaccine, the next is a combined measles rubella product that we only provided for six weeks at the end of 1994, and the third, that is not mentioned anywhere, is actually MMR, which is measles and mumps and rubella as one combined product.
MS GOLDING: Once you realised that these differences were not mentioned in the protocol, did you or anyone in your department try to make it clear that there was a difference?
THE CHAIRMAN: Mr Miller wishes to say something.
MR MILLER: Sir, I simply do not see how this witness can deal with that question. He said he fielded late in the day (I think in 2002) a copy of the protocol which was sent to him by Dr Spratt, and he cannot answer the question. In any event, I would respectfully submit that it has no relevance to the issues which you have to deal with on the charges.
MS SMITH: Sir, I have made this point before but I think with respect defence counsel do sometimes forget that there is an inquiry element to these proceedings and if a member of the Panel wants to ask a question of this kind, I do not think Professor Salisbury needs to be protected in any way by Mr Miller in the way that he answers it. It seems to me perfectly appropriate: we know this protocol – it is not a question of him being asked to comment on something that has arisen just as a result of these proceedings. As Mr Miller said, this protocol was sent to him years ago by Dr Spratt and if a Panel member wants to ask what his views on that when he got it in relation to the particular vaccine that is mentioned in it were I see no earthly reason why she should not ask that question and Professor Salisbury should not answer it.
THE LEGAL ASSESSOR: Despite the fact that these are to some extent inquisitorial proceedings, my advice is that it is wide of issues you are contemplating, and it does not seem relevant to any issue that has been raised, and it seems like opening up new territory which in one way the Panel are entitled to but it has not been raised by either the GMC or defence counsel. My advice is that exploratory questions of this nature on an issue which at best is tangential or inappropriate.
MS SMITH: I am sorry but I wonder if I could just come back on that, with the greatest respect to the Legal Assessor, but this whole issue of the distinction between the description of the measles and the MR vaccine and the MMR vaccine is indeed a central issue that is being investigated in these proceedings, and it is one that I expressly asked Professor Salisbury about, and it forms one of the charges.
MR MILLER: He has given his answer about this already in response to Ms Smith. She knows the confines of this witness’s evidence. The question was: did anybody in your department, or did you or anyone in your department consider the difference between these two MMR and measles, or measles/rubella. He has been asked about it. We have been given no evidence that he was tasked to go back to anybody to deal with it. It really is nothing to do with the charges which any of these doctors face.
THE CHAIRMAN: Legal Assessor, have you anything further to say?
THE LEGAL ASSESSOR: I have nothing to add. He has dealt with the issue so far as he can. I understood the question to be going into a new area and my advice is that Mr Miller’s intervention was a proper one. The professor can speak for himself, but he was being asked to take it wider than that.
MS SMITH: I wonder if I could respectfully ask whether we could hear what the question was again because it may be that I misunderstood it, but I understood Ms Golding’s question to be whether Professor Salisbury, having seen this, felt that he had to do anything about going back to anybody in relation to any distinction that he saw. I wonder if, with respect, we could just hear what Ms Golding’s question was.
MS GOLDING: I have forgotten it now.
MS SMITH: Can we ask the shorthand writer to find that.
THE SHORTHAND WRITER: May I have a moment to look through my notes?
MS GOLDING: Perhaps I could ask the question again: I was asking whether, having looked through the protocol and seen the measles and measles/rubella rather than MMR, did anyone, either yourself or anyone within the department raise this at any stage, perhaps with the doctors or anyone else?
THE CHAIRMAN: Would you hold on before you answer? Ms Smith?
MS SMITH: That was my recollection of the question and I wondered whether I had mis-recollected or misheard because of the objections that were being raised, but now I have heard it I renew my position, which is that that is a perfectly appropriate question for Professor Salisbury to answer since he is the head of the department; he can answer both off his own bat whether he felt it was appropriate to raise it with anyone, and he can answer on behalf of the department whether it was felt appropriate.
THE CHAIRMAN: For the last time, Mr Miller, have you anything further to add?
MR MILLER: No, sir.
THE CHAIRMAN: Mr Coonan?
MR COONAN: Can I just enter the fray? There are two points. First of all, I agree with Mr Miller’s intervention. Secondly, with great respect, the learned Legal Assessor has expressed a view on this matter already and I have not heard anything myself which would be sufficient in my submission to make him change his mind, and with great respect to his opinion, that opinion should stand.
THE CHAIRMAN: I am going to ask the Legal Assessor to give his final view on this.
THE LEGAL ASSESSOR: Having heard the question again – it is now slightly more specific – if the department had a view one would have expected it to have been in the papers before you, it would not have been something unrecorded by all parties, and it would be wrong now at this time to ask him to recollect without any basis, whether he could either be referred to a document or not, and my advice is that in the absence of any documentary material to which, if she relied upon it, one would have expected Ms Smith to have taken you during this witness’s evidence in chief, or if any of the doctors thought this matter had been raised they would have cross-examined him about it and taken him to the relevant documentation. In the absence of documentation my advice is this issue should not be explored.
THE CHAIRMAN: Right, that is the final advice we have got. So, Ms Golding, have you got any other question apart from that?
MS GOLDING: No, nothing.
THE CHAIRMAN: Thank you. In view of the further questions asked by the other Panel members, first of all, Ms Smith, have you got anything else to ask?
MS SMITH: No, thank you very much.
THE CHAIRMAN: Mr Coonan?
MR COONAN: No thank you.
THE CHAIRMAN: Mr Miller?
MR MILLER: No thank you, sir.
THE CHAIRMAN: Mr Hopkins?
MR HOPKINS: No thank you.
THE CHAIRMAN: In that case, can I thank you, Professor Salisbury, for giving your evidence yesterday and the first half of today. You are now released. Thank you.
(The witness withdrew)
MS SMITH: As I have already indicated to you, Mr Miller has some correspondence that he wants to draw your attention to in this context in relation to the Dr Spratt correspondence with the Department of Health, and we have agreed that he will deal with that now.
MR MILLER: Sir, you may recollect that last Friday you were asked to admit the evidence of Dr Spratt. Medical evidence was produced to show that he was unfit to give evidence in person to the Panel and having heard the evidence put before you you admitted that evidence. I made the point at the time that the defence, certainly in my case, were deprived of the opportunity of cross-examining Dr Spratt about his witness evidence which is contained in his statement but also other correspondence which is not before you. I said that the only way in which that imbalance could be dealt with was to admit the other correspondence and place that before the Panel so you could see all relevant correspondence about which this doctor would have been cross-examined had he been in the witness box giving evidence under oath, and that is what I propose to do now, to give you a clip of correspondence and to take you to that correspondence.
In addition, sir, you heard from his evidence about the fact that Child 9, who is the child with whom he was concerned, had been seen and investigated at the Chelsea & Westminster Hospital. I also wish to place before you three documents from the Chelsea & Westminster Hospital, which were sent to the general practitioner and Dr Spratt and Dr Spratt would have been cross-examined about the contents of those letters. Sir, you actually have those documents in a separate bundle of Chelsea & Westminster records, and I can do it in one of two ways, either to refer you to that bundle, because no other witness is going to deal with the Chelsea & Westminster records. I have in fact reproduced them in this clip of correspondence anyway so it may be, because they are all of a piece, sensible just simply to leave them in that clip of correspondence. I can give you the page references in the Chelsea & Westminster notes so if necessary you can find them. I do not propose to comment in any way on these documents but if I do say anything it will be just to put them into context with other documents that you have got. I will give you the references to those other documents because you will recollect that Ms Smith read correspondence which was exhibited to or referred to by Dr Spratt in his witness statement, so if we have a particular document I can just give you the reference to where that ties in with the documents that I am giving you now. (Documents handed and marked as D3)
The first page is a discharge letter from Chelsea & Westminster Hospital. It is in fact in the Chelsea & Westminster Hospital records at page 3 and it was sent to the general practitioner and the parents. I think it in fact goes to the general practitioner. It is headed “Discharge letter”:
“Dear Doctor,
I am sending you the following details concerning your patient:
Date admitted: 11/10/95
Date discharged: 24/10/95
Diagnosis: Deficient in vitamin B12 absorption with food.
Autism.
Operations/treatment:
Schilling test. Food hydroxycobalamin absorption studies.
Recommendations for future management:
• Referred to Professor Walker-Smith at Royal Free Hospital.
• Hydroxycobalamin 1mg [intramuscularly] alternate days for two weeks.
• Then hydroxycobalamin 1mg [intramuscularly] twice a week for two weeks.
• Then hydroxycobalamin 1 mg [intramuscularly] every fortnight.”
The drugs are reproduced again at the bottom and then there are the signatures and the dates.
The second document is a discharge summary, again from the Chelsea & Westminster Hospital, sent to the general practitioner and copied to Dr Spratt. I cannot see a date on it but I think it was produced at the same time. Again, it comes from the Chelsea & Westminster Hospital and it is page 4 in that bundle:
“This is a 4½ year old boy who has been diagnosed as having speech delay and [able to] autistic after it was noticed that he was unable to say words at the age of 3 years. At the age of 12 months be said ‘mamma’ and ‘dadda’, but no further words since then. He is generally silent and screams. His comprehension is very poor. Most of the development is entirely normal, gross motor is normal, fine motor – is able to scribble, is clumsy, can use a knife and fork, cannot learn to do up buttons or laces. Is unable to dress himself. Socially he screams. His screaming episodes lasting at least 30 minutes. He has some eye contact to his mother. Not to other children, or other people. He does not play with other children. Has no ability to concentrate. He is not aggressive or hyperactive. Normal pregnancy from 10-41 weeks. Both weighed 12lbs 3½ozs. His vaccinations are up-to-date.
Diet – He is only on bread and potatoes at this time.
DRUGS: He takes vitamin drops, which he has not taken for the last week prior to admission. No known allergies.
EXAMINATION: Was entirely normal. Head circumference on the 52nd centile was 50cm.
INVESTIGATIONS: He had an EEG which was normal. He had urine sent for mucopolysaccarides which was normal. He had a lactate of 1.6. His serum and urine amino acids normal. His urine organic acids showed increased excretion of MMA. His urea and electrolytes were normal. Urate was 0.21. His CK was 180. Thyroid function was normal. Full blood count – his haemoglobin was 10.7, slightly hyerchromic texture. He had iron studies performed which were also normal.
From the ward he had a valine load, the results of which are not available at the time of dictation. He will be seen in outpatients to discuss the results, and any follow-up studies that Dr Batt would like.”
That is from the Paediatric neurology senior registrar Dr Maltby, copied to Dr Spratt.
The final document in this series, the Chelsea & Westminster Hospital records page 53, is a letter from Dr Cavanagh to Dr Fulerton, the general practitioner, copied to Dr Spratt, dated 20 November 1995:
“[Child 9] was in the ward recently for further investigations.
The upshot of these is that [Child 9] appears unable to absorb food cobalamin.
He has been advised to continue with the hydroxycobalamin treatment 1mg IM, alternate days for two weeks then, twice a week for two weeks, then every fortnight thereafter.
It is advised that he be referred to Professor Walker-Smith for further investigation of his impaired B12 absorption abilities. As you know, [Child 9]’s parents’ observation of him is that on the more frequent B12 supplementation his appetite is good and he does not appear to suffer pain. I have suggested that if on the reduction of the B12 supplementation his symptoms return, that he be tried on Nalcom 1 capsule, 100mg four times a day before meals and I would be grateful if you could prescribe that, if need be.
Yours sincerely,
Dr N Cavanagh, consultant paediatrician.”
THE CHAIRMAN: The number on your green sheet is 53 but it is page 54 in the bundle of papers.
MR MILLER: As you have observed already in this hearing, we have a rogue bundle because that number comes from the original, but I am content to call it 54. I doubt we will coming back to this.
That deals with the Chelsea & Westminster Hospital documentation.
The next letter is a letter dated 25 September 1996, from Dr Spratt to Professor Walker-Smith, and may I say that when Ms Smith read the correspondence last week she read a short letter of the same date from Dr Spratt to Professor Walker-Smith, sent to his professional address, and that is effectively the referral to which reference has been made. This is a letter sent to his private address, on the same date. As I say, l recollect that the short formal letter was read out to you last Friday when Ms Smith dealt with this correspondence, and that short formal letter is in the Royal Free Hospital records for Child 9 at page 38.
“Dear John,
Thank you for your considerate letter of 11 September” – and that was read out to you – “I have sent a formal reply to your office address. Of its nature this note is intended to be personal and not for inclusion in the child’s hospital record.
‘Oh dear!’ – [child 9] has been a vexed case for me since the time in September 1992 when for lack of cooperation he ‘failed’ an ostensibly routine health visitor’s examination and was suspected of being hard of hearing. He almost certainly wasn’t – and I was asked to see him a few weeks later.
I had already met his parents during the unhappily blighted life of their first child …”
In the next paragraph he deals entirely with that child. Taking up the last paragraph on that page:
“[The mother] in particular, is a complexly unhappy lady who (I believe) is still very largely estranged from her family in XXX – who may have disowned her anyway when she married out of her faith in XXX. Her husband … is an intensely committed non-believer – with an incidental and apparently amazing flair for mental arithmetic. He is in a line of very ‘difficult’ male members of the local pedigree. Shades of the Bobby Fischer or Asperger’s syndrome – perhaps?
Although I was at first disinclined to accept the indications of organic abnormality in [child 9]’s presentation four years ago I fairly readily revised my view in July 1993, and agreed that the boy showed the signs of severe ‘secondary’ autism at approximately three years of age.
I persuaded his parents to take him over to see Chris Rolles and his team in Southampton. To their later modest discomfort they agreed. At the time, and from the point of view of medical diagnosis, that seemed to be the correct and indeed inescapable opinion.
But not so for Child 9’s by now distraught mother, who set out to prove us wrong about her son with evangelical zeal and, in her view, signal early success through contact with another very unhappy parent (?near XXX) who, by coincidence, had also had a ‘bad experience’ with the staff in Southampton. She had found her salvation through the offices of Dr Ray Bhatt and his laboratory colleagues associated with the Chelsea and Westminster Hospital in London.
Dr Bhatt had diagnosed Vitamin B12 deficiency in this other child’s case, by technical means owned by his laboratory alone, and was holding out the prospect of remedial therapy. Subsequently he saw Child 9 privately, without a professional referral around July/August 1994, and promised his mother the likelihood of a similar diagnosis and treatment – if only her son could be referred to him from XXX.
The mother duly laid siege to my office and reputation with all and sundry locally, and I tried desperately to convince myself that Dr Bhatt was sound.
I was told Child 9’s maternal grandmother had must been found to have Vitamin B12 deficiency by her family doctor in XXX. Apparently a sympathetic cousin had passed the information to the mother secretly. Through the good offices of the GP here I checked on this new family history: only to be told the old lady had sought medical advice and whilst awaiting laboratory results her doctor had given her a couple of injections of Cytamen as semi-placebo therapy. Subsequently, on learning that her B12 and folate studies were normal, he had stopped the treatment – but crucially, was unwilling to explain his decisions to his patient, or her family and insisted nothing more be said about the matter here or there. We have respected his wish.
I took refuge for a while in the fact that my health authority does not allow me to refer patients outside the NHS at public expense. However the mother came back with the information that Nick Cavanagh would act as Dr Bhatt’s agent, and I got on to my old friend. Yes indeed he would be willing to admit Child 9 to his public ward provided I was happy for him to follow Dr Bhatt’s advice in due course.
He said he had confidence in the man and referred me to experts in the field of metabolic medicine who could vouch for him. Perhaps foolishly I made the enquiries he suggested – with unsettling effect. The experts elsewhere in London, Southampton and Bristol, were highly critical, not to say suspicious of the doctor and seriously doubted all he and the Children’s Medical Charity stood for.
They held a kinder personal view of John Linnell – who was thought to be honest and might have been duped by an all but professionally destitute clinical colleague at the time.
I got back to the mother with an offer to make arrangements to repeat some of Child 9’s tests locally, and by mail in GOS and Bristol – in particular urinary assay for methylmalonic acid – but she refused. Indeed she now believed the other child had had the same undiagnosed disease in 1987/1988, and was clearly in a state of torment.”
That is her daughter:
“I got back to Nick, who was now kindly prepared to give Dr Bhatt the benefit of everybody else’s doubts and to agree to Child 9’s mother’s plan. And so it happened – the boy saw Nick; tests were done by Dr Bhatt with, as predicted, semi-positive results; more investigations were said to be required if I would agree (ie sanction the expense); I demurred and have not had any more contact for nearly a year.
Throughout all the fuss and upset Nick seemed reluctant to say whether or not he thought Child 9 had [has] autism – his parents are of course adamant he has not – and I could not find anyone (other than Dr Bhatt) who would associate the diagnosis with any known abnormality of Vitamin B12 metabolism.
Perhaps Dr Wakefield would be able to do so now – or I suppose just as hopefully change the diagnosis and even partially pin the blame for the child’s very distressing symptoms on his ordinary second year immunisations. If so, especially the latter, I know of at least two other very unhappy families who would be keen to beat a path to his door. Please advise.
Could I make two additional points?
Firstly, although I know about Child 9’s very restricted diet in his toddler and later pre-school and early school years, I am not aware of any convincing bowel symptoms in his history and doubt that he even inhabits the borderland of clinical gastroenterology. But I would of course be very happy to prefer your advice on that account.
Secondly, the negative views I received about Dr Bhatt were voiced by careful, cautious and conservative colleagues, and yet were very damning indeed. It would seem to me his professional stock amongst fellow specialists was virtually bankrupt two years ago, and I doubt anyone could survive let along prosper by an association with his work. And yet I see Dr Linnell is one of your collaborators. Are you really happy about the reliability of the science of what is being proposed.
On a lighter note all is well with us and notwithstanding Tim Malpas’s fatal eleventh hour vacillation I am looking to Julian Eason’s arrival at the end of the year. I think he will be a less comfortable colleague personally; but was, I must say, the more popular choice with my colleagues and will fit in well.
Please convey Phyllis’s and my own very best wishes to Liz and your family.”
That is signed by Dr Spratt.
The next letter is dated – the hole punch has gone through the date but the second page shows it is – 23 February 2004:
“Dear John
Thank you for your call on Friday.
I enclose copies of our exchange of letters at the time of Child 9’s referral to your clinic @ seven years ago.”
These are all the letters you have:
“As discussed I can recall clearly that I welcomed your particular and expert association with his case, as I had been very uncertain about aspects of his earlier referral to colleagues in another hospital in London and was medically unconvinced of the ten prevailing diagnosis of cobalamin deficiency.
In my mind although I was aware that Child 9 preferred a decidedly limited range, but I did not harbour any clinical suspicions that he might have a covert form of malnutrition, or indeed intestinal malabsorption; and amongst other doubts and uncertainties could not understand why ordinary Vitamin B12 laboratory (blood) assay tests had been deemed unacceptable, in pursuit of that detail of his general assessment, by other significant doctors, in 1994/1995.
For my part I was uncomfortable with the conclusion that in all substance this boy had any condition other than severe autism, of unknown causation, and was also ill at ease with the realisation that Child 9’s parents had become resolutely rejecting of my understanding of their son’s case. Moreover I was unhappy that their preferred specialists and I did not seem to be in one another’s complete confidence, and that (in my view) arrangements for his consultant care were in relatively poor order at that stage.
I do not believe that any of these personal worries were known to you; but I remember very well that I felt at a professional loss and that the prospect of a new collaboration with your good self was entirely to my liking in September 1996
I do not recall any more enlightening conversations with Mr and Mrs 9 before your introductory note, and I am not aware that there had been any mention of his MMR history preceding his referral to the Royal Free Hospital. Nor indeed until quite a long time later.
I do not know how or when the idea of vaccine-related injury may have arisen in Child 9’s parents’ conscious awareness of his lengthy medical history, but do not think it had received any prior attention in his case.
That is my best recollection. I hope its confirmation is helpful.”
Those are letters to Professor Walker Smith. The remaining letters, with the exception of the last page, are from Dr Spratt to Ms Emmerson, at Field Fisher Waterhouse, in relation to the evidence he was going to give and which was in due course reduced into the witness statements which you have before you. There is comment about that evidence in the course of this correspondence, and it is correspondence to which I would have taken Dr Spratt because of matters he raised in that but which he does not raise in his witness statement. There are a series of letters that start on 6 April 2005. I think that pre dates any witness statement which has been placed before you:
“Dear Ms Emmerson
Thank you for your letters of 17 and 29 March 2005.
My full name is Henry Clifford Spratt, and I hold the medical qualifications MD, FRCP, FRCPCH. I am 61 years of age and have held the post of Consultant Paediatrician at this hospital since 16 September 1978.
I have known Professor John Walker-Smith, first by reputation in the mid-70s and later, personally, from about 1980, as a trusted senior colleague and friend, and have a very high opinion of his integrity and medical ability in the sub-speciality of Paediatric Gastroenterology. In that capacity I have referred several patients to him for expert clinical advice over the years, with excellent outcome; and I would say that although we meet infrequently nowadays, especially since his retirement five years ago, we know one another well.
I confirm that I received from him, in September 1966, a letter which I considered was an invitation to refer a child, named Child 9 (b: 1990), to his clinic in London, and accepted the opportunity to do so. My patient had severe autism – which, in my view, was, of unknown causation.
From his letter it was my understanding that Professor Walker-Smith had been informed of Child 9’s case by Dr Wakefield who was one of his colleagues, and that the child’s parents had already expressed a willingness to attend with their son for medical investigations at the Royal Free Hospital. Professor Walker-Smith’s correspondence was accompanied by a copy of a protocol for related research which he and Dr Wakefield, and others, were contemplating at the time.
In due course I received follow-up reports about Child 9 from Professor Walker-Smith and one of his junior staff in London, and probably later than February 1998 (my wife was seriously ill) became aware that my patient’s history had featured in an article in The Lancet 351 : 637-641. In that paper, to the best of my reading, the particulars of Child 9’s form of autism, and reported indeterminate colitis, and that of eleven other similarly affected children, had been linked – by way of an interpretation - to the administration of MMR immunisation in infancy.
I was unsure of these diagnostic associations and discussed my concerns with Dr Salisbury some time ago. More recently I have come to consider the retraction published by Professor Walker-Smith and most of his colleagues, in the issue of The Lancet of 6 March 2004, has put the matter to rest and I do not wish to make any further comment about this child’s case.
I have not had any association with Dr Wakefield or Dr Murch or Mr Brian Deer.”
The next letter is 29 April 2005:
“Dear Ms Emmerson
Thank you for your further letter of 27 April, and enclosure.
I am grateful for your acknowledgement that I may inform Professor Walker-Smith that I have been contacted by your firm, on behalf of the GMC.
I am happy with the text of the witness statement you have kindly prepared for me, and return this script with a few alterations – and the following clarifications:
10a) …”
This is in relation back to the first witness statement that was read to you and a copy was given to you last week.
“ …After my initial exchange of notes with Professor Walker-Smith in September 1996, I heard from him again about six weeks later (letter from his clinic 8 November 1996) and on 31 December 1996; and from Dr Malik (Registrar) on 14 January 1997.
10b) Dr Malik’s letter contained the information that my patient had been admitted to the Royal Free Hospital for investigations on 17 November 1996. To the best of my knowledge he did not attend again in London after the end of that year.
10c) I enclose copies of these reports, for information.
11a) I identified my patient as likely to be Child 9 in The Lancet paper of 28 February, as I was aware that Child 9 had been entered into a research study of this kind, by this group, and there was only one other child of the same age in the series. Also Child 9 had been stated to have erythema of the mucosa of the hepatic flexure of his colon. That endoscopic description matched the anatomical findings in my patient’s case, and the observation had not been reproduced in the reports of any of the other children.
12a) I do not think that I have met Dr David Salisbury; but I remember with clarity that we shared the details of the care of one or more complex cases, when he was Professor June Lloyd’s Senior Registrar at Great Ormond Street Children’s Hospital, about fifteen years ago, and I have a lasting regard for his abilities as a perceptive and well informed paediatrician.
12b) More recently we have spoken to one another, on the telephone, two or three times – probably over about eighteen months in 2002-03.
12c) I contacted him to discuss Child 9’s case in his public health roll, as although lacking in any sub-specialist expertise of my own I was unconvinced of the clinical scientific weight which had been placed on the medical evidence of my patient’s history in The Lancet paper of February 1998.
In my view Child 9 had had minimally symptomatic colitis; and for local logistical reasons I was sure that this child’s MMR inoculation, reportedly @ 16 months of age, could not have caused any significant concern at the time. In a small island community, with only paediatrician (until December 1996) I would have been almost bound to have been informed.
I was and am very reluctant to believe that Child 9 could have been a vaccine-damaged child.
14a) I am not aware that Child 9’s parents have engaged in any legal dealings in respect of their child’s case helpful.
I hope these additional notes are helpful.”
16 June 2005:
“Dear Ms Emmerson
Whilst grateful for your further letter of 13th June, I have two concerns arising from this new correspondence – and a third inadvertently.
Firstly, I have been struck forcefully by your information that Dr Wakefield has obtained Child 9’s parents’ permission for the release of their son’s medical records held at the Royal Free Hospital. With a stab of regret, and some anxiety, I have to say that I have not done so here. What do you think I should do, at this stage? I would appreciate your direct advice, please.
Secondly, I am worried by a temptation to ascribe a degree of expertise to my opinions – which is demonstrably lacking in my understanding of Child 9’s case. In responding to your questions I can of course confirm facts known to me, and am very willing to try to explain myself completely, but with due diffidence I am not in a position to offer you any form of expert evidence.
Thirdly, your new questions have sent me back to Child 9’s local hospital notes, and hiding there is a photocopy of a letter from a firm of London solicitors – addressed to our Medical Records Department and dated 15th April 1999. It is of course a request for copies of Child 9’s medical records, referring back to an original enquiry by another firm of lawyers of 14th August 1997, and clearly has been dealt with by our general management – without my knowledge. There is no other trace, and I have to believe this paper has been misfiled and that I was not supposed to know. Maybe you do already? If not I am sorry that I was not better informed earlier.
Bearing in mind my non-expert status I will try to answer your questions in order:
a) I have not seen Child 9’s notes from any other hospital – but it crosses my mind that my reply to Professor Walker-Smith’s letter to me of 11th September 1996 may have been the effective ‘referral’ which led to the setting up of medical records for Child 9 at the Royal Free Hospital. That sort of office short-cut happens here, and perhaps elsewhere.
b) As a local child, born in XXX, Child 9 is likely to have received MMR (not single measles or MR) vaccine in the way that Dr Wakefield described – but without, as far as I was informed, any reaction at the time.
The story of his reaction, and developmental set-back, is presumably as remembered by his parents, and to the best of my knowledge was not raised in association with his condition before the end of 1996.
I do not think the medical documentation of Child 9’s receipt of MMR in XXX (? October 1991) has been checked.
c) Child 9’s referral to Dr Nicholas Cavanagh at the Chelsea and Westminster Hospital in 1994/95 was separate from his visits to the Royal Free Hospital the following year. Dr Cavanagh did indeed make a diagnosis of ‘adenosylcobalamin (vitamin B12) deficiency’ – but did not apply any clinical description to Child 9’s case.
As a paediatric neurologist he must have completed his own neurodevelopmental assessment of the child’s case, or arranged for someone else to do that for him. At earlier times Child 9 had a complete developmental assessment here in 1993, and two more in Southampton later in 1993, and in 1994.
The latter information was probably not available to the staff at the Royal Free Hospital. Stripped of its circumlocution our report, and those in Southampton, concluded that Child 9 had severe autism. Since when, I am very sorry to say, he has become socially and clinically reclusive, and has developed generalised epilepsy. The poor lad is a severe or possibly better described ‘profound’ case nowadays, and lives a withdrawn life at home.
d) I cannot offer a reliable opinion about the correctness of Child 9’s investigations at the Royal Free Hospital in November 1996. Paediatric gastroenterology is a very difficult specialty as the functional spare capacity of the bowel is notorious for its ability to mask clinical symptoms. For that and other reasons which inform medical judgement the election of patients for endoscopy is best left to experts; and at the end of the day, whether I expected it or not, Child 9 had positive histopathology in his terminal ileum.
I am sure that my decision to refer Child 9 to Professor Walker-Smith’s NHS clinic, in September 1996, was the right response at the time.
e) I do not know anything about informed consent arrangements for the parents of children at other hospitals.
f) I wrote to Professor Walker-Smith several more times in 1997, and up to mid-1998, almost exclusively about Child 9’s gastroenterology – as that is his area of expertise. I also wrote him a personal letter, to his home after a call @ March 2004”,
and, sir, I have read that letter to you,
“and have written twice more in the last few weeks. I have told him about my contacts with you, and we have exchanged family stories and sympathies as friends.
As you know I am strongly influenced by Professor Walker-Smith’s retraction of the interpretation placed on the original paper in the Lancet, in February 1998; and by his forceful disapproval of any dealings with lawyers that could have influenced research to which he put his name at that time. I believe that he, and most of his colleagues, have acted entirely properly to put all medical disagreements about the safety of MMR vaccine to rest.
I hope these comments are helpful. I remain conscientiously anxious about the need for me to make a unsolicited medicolegal approach to 9’s parents, to seek permission for disclosure of local medical notes. They are very private people. Please let me know.”
Then a letter of 1 November 2006:
“Dear Miss Emmerson,
Thank you for your letter of 27th October. Having retired a few months ago I am more easily available at home nowadays.
I have also, partly for health reasons, retired from the Medical Register and have chosen to be free of further professional responsibilities.
Concerning the GMC, and my exchanges with Professor Walker-Smith, about the case of Child 9, several years ago, I am happy with my witness statement to you last year and the record of hospital correspondence in the past. However for reasons of my more recent history of myocardial infarction my family doctor has advised that I should not undertake to attend a hearing in London, in up to a year’s time, at this stage.”
12 December 2006:
“Dear Miss Emmerson
Thank you for your further letter of 20th November, and enclosures.
There is no doubt that in the course of my work as a general (hospital) paediatrician in XXX (1978-2006) I had difficulties with a few cases of severe autism among local children and their families, including Child 9 and his parents from time to time.
However in so far as differences of opinion with some individual parents related to their fears about the relevant safety of MMR vaccine, which I did not share, and stemmed from the findings and views of the Royal Free Hospital research group, I was strongly reassured that the retraction published by Professor Walker-Smith and most of his colleagues in 2004 had put the remaining medical controversy to rest at that time.
For that reason I do not wish to comment further on my correspondence with the Department of Health in 2002.
In response to your additional questions of confirmation:
1. It is correct that Professor Walker-Smith’s letter to me of 11th September 2006 was our first contact with one another about Child 9’s case.
It may be noted that Dr Cavanagh of the Chelsea and Westminster Hospital had mooted Child 9’s referral to Professor Walker-Smith about a year earlier. However I had not taken up his suggestion as I was unconvinced that Child 9 had Vitamin B12 deficiency (which was Dr Cavanagh’s understanding) – or in fact any gastrointestinal disorder at that stage.
The approximate year between Child 9’s referral to the Chelsea and Westminster Hospital, and Professor Walker-Smith’s letter to me in September 1996, represented a relative interruption in my association with Child 9’s parents and I do not recall any significant exchanges with them, or anyone else, about Child 9’s case over that time.
Apart from Dr Cavanagh’s mention of an interest in Child 9’s type of case history at the Royal Free Hospital I was not aware of any related work being carried out there, prior to Professor Walker-Smith’s letter, and do not know how Child 9’s parents and Dr Wakefield came to know of one another in 1996.
As observed, I was relatively out of favour with Child 9’s parents (or felt that that was the case as I was not invited to take part in his Vitamin B12 treatment) for about a year before Professor Walker-Smith’s interest in Child 9’s history effectively restored me to the loop. I recall that I was grateful at the time, and nursed hope of a medically more circumspect reassessment of Child 9’s case at six years of age.
2. I have always believed that the cause of Child 9’s severe autism is unknown – and probably, in my view, unknowable in the present state of medical knowledge generally.
I have also been keenly aware that the almost entirely clinical nature of the diagnosis of autism in Child 9’s case, and the lack of any prospect of an explanation on my part have been wholly unacceptable aspects of Child 9’s history to his parents and the source of enormous distress to their family – from the outset.
To turn to gastroenterology: although I was medically unsighted for much of Child 9’s progress in 1995/96, I remained in touch with school staff and others in XXX and was aware that Child 9 was on a self-preferred but unvaried diet of sandwiches and potatoes at that time. However I was informed that he remained generally physically well and did not receive any reports of abdominal symptoms whilst Child 9 was at school.
3. This statement is also correct. The discovery of a legal letter of 15th April 1999, in Child 9’s hospital notes, was a complete surprise to me.
However there is a little uncertainty in my mind. The Medical Director has told me that the managerial file about Child 9’s case goes back to 1994, and my memory of so long ago is not perfect. Also I do recall that there was a legal enquiry about another XXX-linked autistic child about that time, and given the parochial nature of small hospital life I might have been informed of non-medical matters in Child 9’s case and have forgotten now. If you think so please let me know.
In conclusion: I have tried to answer your further questions about Child 9’s case as fully and yet succinctly as possible. His history is complex and I do not know how relevant such detail as I have provided may be, or the point of your concern. I hope the information is helpful.”
20 February of this year, the next letter:
“Thank you for your further letter of 7th February, and the enclosure of a supplemental statement – with which I am entirely happy, and return a signed copy for your use and the Council’s information in London. (We have had a death in the family and I have been away for a while.)
My only remaining and very small quibble with this new statement is the inclusion of the word ‘original’ in paragraph 13. It might be better removed, or just blacked out – as you decide.”
Sir, you were given a copy of this statement, I think it is called a supplemental statement, and you may recollect or may not recollect that the word “original” has been crossed out and has been initialled by Dr Spratt in the margin.
“It was not the usual practice of our hospital managers to keep a completely separate file in 1994, and I do not know when or from whom they might have received a first legal enquiry. No doubt they will have told you, but the information is not clear to me.
I understand your final paragraph ….. and that in the case of any controversial evidence it is the examination and cross-examination of witnesses that may count most in the legal process, on the day. However, as explained, and with due regret, it is the avoidance of personal examination that so strongly informs my family doctor’s advice on this occasion.
It is my natural hope that the GMC will be able to consider my very carefully prepared witness statements on their simple and relevant merits. They are factual, with substantiation as called for, and in lifting a relatively brief episode out of a lengthy narrative tell the story of Child 9’s referral to Professor Walker-Smith at the end of 1996.
My own modest view and viewpoint have been made clear in our correspondence. It is that the controversy about the safety of mass immunization of children with the MMR vaccine, which troubled the medical profession in UK, after the publication of the Lancet paper in 1998, ended with the retraction in 2004. The matter is no longer a concern for ordinary doctors in this country – and the modern tragedy of children and families afflicted by autism remains unexplained.
I shall continue to hope that the Council will find a happy outcome to reassure itself and others later this year.”
10 April of this year:
“Dear Miss Emmerson
Thank you for your further letter of 3rd April.
I am sorry that my note of 31st January might not have been completely clear.
I have checked my information and there is no question that Child 9’s referral, by me, by letter to Professor Walker-Smith in September 1996, was as a public patient – under the ordinary day-to-day terms of the Health Services Convention (1976).
He attended at the Royal Free Hospital, or travelled from XXX to attend there, as an out-patient on 8th November 1996; and as an in-patient on 17th November and 16th December 1996.
These consultations, in London, are logged in our local hospital records, as a continuation of my referral to my colleague, and were most definitely on the NHS side.
That has been my recollection of circumstances throughout, and is unchanged, and was absolutely the understanding of our hospital staff, in XXX, at the time.
The note that private payments might have been made is far beyond my knowledge of events, and I would be astonished if any such arrangement had applied in Child 9’s case.
I am also sure that the fact of Child 9’s referral to the Royal Free Hospital, and attendance there on three occasions in November/December 1996, will have been notified to the NHS (UK), traditionally at their offices at Elephant and Castle, by our hospital’s central administration; and will have been included in the calculation of our respective Health Service financial accounts for that year. The costs to NHS (UK) will have been settled, at civil service level, in that way.
I hope this additional clarification is helpful.”
16 April 2007, the penultimate letter:
“Thank you for your letter of 12th April, and enclosure.
I have been surprised that this new information merits another witness statement and have had a word with a hospital administrator locally. He thinks that I should be more considerate of UK officialdom, and amend paragraph 5 accordingly. Also omit paragraph 7 of your draft text completely.”
This is the third witness statement.
“In a nutshell he has observed that whilst I referred Child 9 to Professor Walker-Smith as an NHS patient no one in XXX would have been in a position to have influenced his status at the Royal Free Hospital, once he and his parents had arrived in London.
Moreover he has corrected me to say that back in 1996 the onus to claim NHS costs for XXX referrals, under the terms of the Health Services Convention (1976), still rested with the UK government. He recalls that the details of its calculations of expenses were not usually disclosed to public servants in XXX, and that in individual cases there will never have been any relevant records here. If that financial information exists it will be in England.
I am sorry that I was mistaken about the focus of accounting procedures applied ten years ago.
I hope that my alterations to the draft witness statement are clear and helpful.”
Then 20 May 2007:
“Dear Miss Emmerson
Thank you for your letter of 20th April, and enclosures, received in XXX on 11th May 2007.
I am concerned that we might not have understood one another completely – in particular with regard to my position as a thoroughly general paediatrician, in a small district hospital in XXX (1978-2006); and to the many difficulties that I encountered in Child 9’s case several years ago.
With proper awareness I can only be a witness to aspects of Child 9’s local story; and I cannot, nor would wish to, aspire to hold any special or expert opinion about his medical care in England. If required that would be a job for others much more qualified than me. I am sorry if that has not been clear before.
I recall that when I was in contact with Dr Salisbury it was my view that gastro-intestinal disease had not played a substantial part in Child 9’s history of severe autism. That was my ordinary medical opinion and I remember being troubled about it, in my mind, at the time.
However, as I have said throughout our correspondence, and included in my first statement a year ago, I was subsequently greatly reassured by the retraction published by Professor Walker-Smith, and most of his colleagues, in the Lancet in March 2004. For my small part I am happy that this action, by these authors, put the MMR controversy to rest three years ago.
I consider that Professor Walker-Smith’s withdrawal was very significant, medically and (to the best of my understanding) scientifically, and I do not have any lingering doubts about Child 9’s case.
For the reasons given I am unable to agree that my correspondence with colleagues at the Department of Health should be exhibited, and I do not wish to sign the further statement that you have sent to me.
Please note that I will be away from home for about a month, from the middle of the coming week, and will not be available to reply to any further letters until the end of June.”
So the last document is a draft statement relating to that correspondence with the Department of Health, which incidentally you have seen, which Dr Spratt refers to in this last letter and which he did not sign. Sir, that completes that rather laborious exercise, but the documentation is before the Panel.
THE CHAIRMAN: Thank you. I think that is helpful and I think we will obviously file it with our other bundles. We are back in your court, Ms Smith.
MS SMITH: Yes. I do not have any further witnesses for today, sir, but what I do want to do is to give you some information about the rest of the timetable, and in order to do that I need to have some further discussions, which I did not quite conclude during the coffee break. I wonder if I could ask you to rise for say 20 minutes and then reconvene then so that I can, as I say, give you some more information.
THE CHAIRMAN: Yes, I think that information will be helpful to everyone.
MS SMITH: Absolutely, sir, yes.
THE CHAIRMAN: So we will now adjourn. It is 10 to 12 and we will resume at 10 past 12.
(The Panel adjourned for a short time)
THE CHAIRMAN: Ms Smith, you were going to tell us something about the timetabling.
MS SMITH: Yes, sir, and I am going to deal in some detail with the timetable until October and then rather more shortly with the position thereafter. Sir, as you are aware, the timetabling slot for this case this time is until 19 October. It has never been envisaged that the case would be completed altogether, the whole case, within that slot. How much longer a slot would be needed in the future has, of course, been difficult as we are concerned to predict because that entails the defence cases, all three defence cases, not ours.
As far as this slot is concerned, in other words, until 19 October, the same difficulty has applied to some degree. You will appreciate that this is an unusual case in a number of respects, partly because many, many of the factual witnesses are busy professionals and partly because there are three doctors and therefore three teams of defence lawyers involved. We cannot know how long the defence are going to be with each of the witnesses.
Nonetheless, we have done the best we can but one of the difficulties about the lack of predictability as far as how long the GMC witnesses are going to be when they are cross-examined has been, as you know, that some of them have taken rather longer than we could have anticipated. The consequence of that has been that the factual witnesses have run into the experts’ slots, for when it was anticipated that the experts would give evidence. The experts, who are internationally busy, have reorganised their timetables to anticipate the original time at which it was thought they would be called and they cannot now reorganise them again. So, sir, I can tell you that the inevitable consequence of that is a gap when the experts are not available. The position therefore is that we will be calling factual witnesses and other factual evidence that we will be putting before you, such as the playing of a video and the reading of various documents, for the next two weeks, until Thursday 6 September. Friday 7 September is a non-sitting day, for reasons I understand relating to the Panel.
If by any chance there are difficulties with the factual witnesses – in other words, they last longer than we are anticipating – they can tip over into the week commencing Monday 10 September, but our anticipation is that we will probably finish them by Thursday, 6 September.
I hope you will understand why I put it in those rather guarded terms. This morning – and I am not trying to attribute blame, I am simply stating a fact – was a very good example of a witness who was giving very important evidence. He might have taken a long time in cross-examination; as it happens he took no time in cross-examination, so I am allowing for those sorts of problems arising again, but, as I say, our anticipation is that we will finish the factual witnesses by Thursday, 6 September
For the two weeks between 10 and 26 September we are not in a position to start our expert evidence, and so there will be a gap there, subject to tipping over a little bit, there will be a gap between 10 and 26 September, which is two working weeks.
Professor Rutter is beginning his evidence on 27 September, and he has a slot between 27 September (at the moment) and 3 October. 4 October is a clear day.
Professor Booth starts his evidence on 5 October (if he is needed); until as late as 17 October he is available.
Professor Lackman, who is the last short expert, can give evidence on 18 or 19 October – we are not anticipating him taking more than a day (probably significantly less than that).
That, as I say, is the end of the slot that has been allotted until 19 October.
Sir, the clear two weeks – it is of course a matter for the Panel how they deal with those two clear weeks between 10 and 26 September, but all I would underline is that there was no question, obviously, that this case would be finished, whether or not there was that two week gap, and so in those circumstances that this has arisen but that does not have a great deal of pragmatic significance.
Plainly, the case, if it is coming back, that issue has to be addressed now (now or within the very near future given the number of people who are involved), and, sir, in relation to that I make only two points, and I am well aware that both of them are somewhat obvious: this is a case where there has been a significant degree of public interest and it is obviously important that it is resolved as soon as possible. It is also a case where I have no doubt at all it is having a significant degree of stress as far as the doctors are concerned, and we are alive to that. Again, it is a matter which should be resolved as soon as it possibly can.
When it is re-listed is, of course, not a matter for me and so all I say is this: I understand that there was a meeting last week between defence and prosecution solicitors where availability of counsel was discussed at some length. I also understand that the Panel have had a meeting in relation to their own diaries and I also understand that you have been given a form, which I also have been given and I understand the defence have all been given, showing the availability that has been canvassed for the three slots, or for two slots that are indicated on that form. As far as the third slot is concerned, that is a somewhat open-ended issue and all I have to say about that is if you have a tick in relation to that third period in the right-hand column it should not be there.
So, that is the position. I hope that is helpful as far as timetabling until 19 October is concerned, in so far as it is possible for me to predict, and, of course, it is possible for me to predict from the point of view of my own case, and I have done so.
As far as the re-listing is concerned, that is a matter which I must leave in the hands of the Panel.
THE CHAIRMAN: Ms Smith, can I actually just make a couple of comments of what you have said, and I am going to ask defence counsel as well.
MS SMITH: Thank you.
THE CHAIRMAN: First of all, it is not absolutely correct that it was never envisaged that the case was not going to finish until 19 October, because on the emails we were sent we were originally asked to keep some of the January dates available, and then we were sent a further email which actually asked us to release those dates because the case was going to finish on 19 October, or something along those lines, so those dates were actually then vacated in our diaries.
The second point is the gap in September, unfortunate as it may be, we can understand the practical difficulties of that and under those circumstances the Panel will try to make use of those days as best they can in trying to read the transcripts and our own notes, which are often multiplying by the day, and will be even more substantial by that time, so I think most of that time the Panel will try to use in that way.
I think it is important for all of us to try and agree dates as soon as possible: the reason being that the longer we leave it more and more days get booked to do other things, and there are various things that we are all involved in – that you are all involved in – and you cannot possibly keep, none of us can, the dates open indefinitely, not knowing what is going to happen.
Those are the three brief points that I would like to make. Do you want to say something about that, and then I will ask defence counsel for their views.
MS SMITH: I do not think I can say very much. Obviously, I have no knowledge of what was communicated in relation to this time slot, save to say that from the point of view of both the defence teams and the prosecution team I do not think that it was envisaged that this case would finish by 19 October, but, as I say, you will appreciate that it is nothing to do with us, so to speak, what information was given in relation to that.
As far as the second point is concerned: obviously I appreciate the importance of people consulting their diaries, and, again, it is not a matter for me except to underline – and I will be very surprised if I do not get support from everybody in this room – the importance of the case coming back as soon as it possibly can, not least because of the complexity of the evidence that you are going to have to consider.
THE CHAIRMAN: Thank you. Legal Assessor?
THE LEGAL ASSESSOR: Ms Smith, can we just clarify certain things before we proceed any further? You are saying that you anticipate that the Council’s case will finish on or before 19 October?
MS SMITH: Yes, sir.
THE LEGAL ASSESSOR: The next stage would then be whether or not any or all of the practitioners wish to make one or other or both of the submissions available to them at the close of the prosecution case.
MS SMITH: Yes, sir.
THE LEGAL ASSESSOR: So the next working day, whenever that would be, after 19 October would be to deal with whether that is happening or not happening.
MS SMITH: Yes.
THE LEGAL ASSESSOR: And if it is not happening then to proceed in the ordinary course of events with Dr Wakefield’s case and the others following on thereafter.
MS SMITH: That would be my understanding, yes.
THE LEGAL ASSESSOR: So what people need to apply their minds to is how best – and nobody will know whether or not they wish to make either or both of the submissions until the conclusion of the case on 19 October. So, really, anything that is done is keeping time open rather than saying it is definitely going to be required.
If submissions are made and are unsuccessful or are not made because it is accepted it is inappropriate to make them then time is going to be needed and an indication will be needed from each practitioner as to how many further days they each require in that situation?
MS SMITH: Yes.
THE LEGAL ASSESSOR: And at the end of it all, obviously considerable time will have to be given to the Panel for drafting after their deliberations, but that is the timescale and the activities once your case has closed that have to be fitted into the timetable: are we all agreed on that?
MS SMITH: Yes.
MR COONAN: Yes.
MR MILLER: Yes.
MR HOPKINS: Yes.
MS SMITH: As far as those applications are concerned, they are multiplied by three because one or other may or may not be making such an application, or one or both of the applications available to them.
THE LEGAL ASSESSOR: And, for example, I just mention that because whilst looking at the piece of paper we have of when people are not available, it is not necessary for the whole of one doctor’s team to be present if another doctor’s counsel is making a submission of no case. That is the point I am making.
MS SMITH: I am in their hands on that.
THE CHAIRMAN: Of course there is one more stage in-between before coming to the drafting and that is our determination on the findings of fact, and I can see that that will itself take a considerable time to go through that exercise knowing the number of allegations there are on the heads of charge.
Do you want to say something, Mr Coonan?
MR COONAN: Sir, I do not think I need say anything at all about the position that we have reached now. The understanding is clear, that the Council’s case would finish on or before 19 October and we work on that basis.
So far as the future is concerned, we respectfully agree with what the learned Legal Assessor has said about the next first step, which may be the question of submissions at the end of the prosecution case. Therefore, an assessment of how much time, if any, will be required for that. I see looking at this document which has been circulated, we saw it some 20 minutes ago, that in January there was a possibility of five days being isolated which might – and I do stress that word, might – be appropriate for dealing with that particular issue, the question of submissions at the end of the Council’s case.
Whether that would be sufficient for that exercise, again requires a degree of assessment which – and again I agree with what has been said by the learned Legal Assessor – one is only in a position to make that sort of assessment at the end of the Council’s case. What has certainly been going through my mind as I have been listening to the debate, is that one may need some sort of administrative mechanism to deal with that sort of assessment, as to whether and to what extent time will be required for legal submissions of no case, putting it colloquially, at the end of the Council’s case. It seems to me that that is a practical way of dealing with it. Again, it is really a question of mechanism of choice for the Panel to consider building that mechanism in between the end of October and some time shortly thereafter, and I do stress the word shortly thereafter for assessing the extent of time which will be required for that sort of exercise. That is the first observation I make.
The second one is, looking at the possibilities of further blocks of time, one particular concern I have – and I take myself as an example because I am likely to go, or my client is likely to give evidence first – is the idea that my client would give his evidence and that his case be adjourned part heard halfway through his evidence. I would be extremely concerned about that, as I am sure you would be.
I do not think I need elaborate for the reasons for that, I think they are self evident. I do not want to complicate matters now or put problems in the way of the Panel addressing this question.
Ultimately the question of diarising time, I think I speak for everybody, is not something we can decide today, but should clearly be dealt with as soon as possible. It may be obvious that I do not run my diary and I would, therefore, have to take instructions from elsewhere in order to properly inform the Panel so that we can slot in with the Panel’s availability.
I am not sure I can be much more help, other than making those preliminary observations at this stage.
THE CHAIRMAN: Can I actually suggest that I think this is absolutely right. What I am hoping is that these are, in your words, the preliminary submissions this afternoon. I do not think we will be in a position to take a final decision on this afternoon. What I would be hoping is that over this weekend we would all be able to consult our own diaries and we will have final submissions on it, maybe on Tuesday morning, and the, hopefully, we can take some decision on this aspect. I think your word is absolutely right, it is a preliminary submission at this stage I am looking for and thank you for that. Mr Miller.
MR MILLER: Two preliminary points. I hear what Ms Smith says about the time taken up to this point. I hope she can confirm this, that I have at every stage I have indicated, to the best of my ability, how long I require to cross examine the witnesses already gone because I recognise that she has no idea what the defence approach to the prosecution witnesses is. I recognise that this morning was a situation where it might have been anticipated that there would be some cross examination of this witness, although I had informed her that I did not have any questions to ask him.
The second point is that, certainly from the GMC’s point of view, we were told that it was anticipated that the full hearing would conclude on 19 October. You mentioned the point about e mails that you had seen. Certainly in the e mails that had passed before we commenced this hearing, it was anticipated that the hearing would finish about that time, although provisional dates were originally booked. Clearly, as the hearing has developed, it has been more and more likely that we would go over and that we would go over for a substantial period of time.
On that point, I can say at this stage, recognising this is my preliminary position, that we do envisage that we will be making submissions to the Panel at the conclusion of the Council’s case on the charges and those submissions will not depend upon the factual evidence that has yet to come or the expert evidence. Over the weekend, thinking about what dates may be available in the near future, I would like it to be pencilled in anyway that, on Professor Walker Smith’s part, we will be making submissions to the Panel at half time. Therefore, any date for the resumption of the hearing will have to bear that aspect in mind.
So far as the long term future is concerned, I do not know – and I do not know whether you will be assisted by hearing anything from Mr Coonan on this point – how long it is likely we are going to need for the conclusion of the case, if it is possible to give any sort of estimate as to the length of the defence case. We do not want to get in the position where we take a block of weeks next year which then prove insufficient because the defence case has overrun. I think we must deal with that over the weekend as well to provide the Panel with some estimate as to how long it is likely the defence case, and your deliberations and anything that comes afterwards, will take because it does need some thought before we just simply say we will take these weeks.
The final point is that you have, in any event, been provided with my available dates so far as my diary is concerned because my clerk has made those dates available. They are there in the table that you have been given. All I can say about those dates is that they are longstanding professional commitments in other cases. Having said that, I do recognise it is not up to me when we resume, it is a matter which the Panel has to decide in due course.
THE CHAIRMAN: Thank you. Mr Hopkins.
MR HOPKINS: I have very little to add to what you have heard already. Can I make this observation? You will see on the chart under Professor Murch’s name that we have made ourselves available in January and in the period March to May. We were not in fact asked about July to December: that is why there is a question mark there.
We have made ourselves available, although we do, in fact, have other professional commitments, but recognise the pressure and stress that is on all those involved, not least my client, Professor Murch, and his desire that is over and done with as soon as possible. We have taken the view that our other professional commitments, because they are not part heard ones, must take second place and this case be given priority. We do, therefore, need to check what the position is from July onwards next year, but that will be the approach we will be taking to it as well.
THE CHAIRMAN: We have heard preliminary submissions at this stage and I think it is probably not appropriate for the Legal Assessor to give any advice on a preliminary basis. I think we will all consider these issues over the weekend and consult our diaries and revisit this issue on Tuesday morning. I think you have something to say, Ms Smith?
MS SMITH: I was going to say that, in relation to Tuesday morning, I am proposing to call Mrs 12, the mother of child 12. She is going to arrive at 11 am. I think that is as a result of domestic commitments. In those circumstances, that might provide us, if we were to reconvene as usual, with a perfect slot to discuss these matters further on Tuesday.
THE CHAIRMAN: That has worked out just right. I think we intend to start at 9:30 am on Tuesday morning. By any chance, Ms Smith, can you possibly give us the batting order for the whole of the next week?
MS SMITH: It is Mrs 12 on Tuesday. She may take a little while. There are a number of documents so she could possibly go into Wednesday. Then it is Dr Jelley, who is the GP to Child 8.
THE CHAIRMAN: That will be on Wednesday.
MS SMITH: Yes. On Thursday we will hear from Miss Debbie Davies, a short witness, who is dealing with some personnel documents. Thursday and tipping over into Friday, Miss Sarah Alwyn, who is the other witness from the Legal Services Commission. You have heard one of them, you will recall, and this is the other one.
THE CHAIRMAN: I think that is very helpful, thank you very much indeed. Obviously there is no further business to be conducted for the rest of today and tomorrow, so have an enjoyable, longer than expected bank holiday weekend. We will start at 9:30 am on Tuesday morning.
(The Panel adjourned until Tuesday 28 August 2007 at 9.30 am)
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