GENERAL MEDICAL COUNCIL
FITNESS TO PRACTISE PANEL (MISCONDUCT)
Tuesday 28 August 2007
Regents Place, 350 Euston Road, London NW1 3JN
Chairman: Dr Surendra Kumar, MB BS FRCGP
Panel Members: Mrs Sylvia Dean
Ms Wendy Golding
Dr Parimala Moodley
Dr Stephen Webster
Legal Assessor: Mr Nigel Seed QC
WAKEFIELD, Dr Andrew Jeremy
WALKER-SMITH, Professor John Angus
MURCH, Professor Simon Harry
(Transcript of the shorthand notes of T. A. Reed & Co.
Tel No: 01992 465900)
A P P E A R A N C E S
MS SALLY SMITH QC and MR CHRIS MELLOR and MR OWAIN THOMAS of counsel, instructed by Messrs Field Fisher Waterhouse, solicitors, appeared on behalf of the General Medical Council.
MR KIERAN COONAN QC and MR NEIL SHELDON of counsel, instructed by Messrs RadcliffesLeBrasseur, Solicitors, appeared on behalf of Dr Wakefield, who was present.
MR STEPHEN MILLER QC and MS ANDREA LINDSAY-STRUGO of counsel, instructed by Messrs Eastwoods, Solicitors, appeared on behalf of Professor Walker-Smith, who was present.
MR ADRIAN HOPKINS QC and MR RICHARD PARTRIDGE of counsel, instructed by Messrs Berrymans, Solicitors, appeared on behalf of Professor Murch, who was present.
I N D E X
Timetabling discussed 1
MRS A, Affirmed
Examined by MS SMITH 5
Cross-examined by MR MILLER 42
Re-examined by MS SMITH 48
Questioned by THE PANEL 48
THE CHAIRMAN: Good morning, everyone. When we finished last Thursday lunchtime we were talking about some preliminary submissions about the timetabling of the case. I do not know whether this is the appropriate time to take that issue forward, or whether we should carry on with the case and at some convenient time that will all come back to me and you can let me know what you all think about it. Ms Smith, first of all.
MS SMITH: Sir, yes. The position was, if you recall, that Mrs 12, who is the first witness, cannot be here until eleven o’clock anyway for domestic reasons, and so it was anticipated that we would sort out the resumed hearing dates this morning. I mean, we are entirely in the hands of the defence, sir, because it is the defence case and we still have no idea how long each of them are anticipating being, so the best place might be to start with them and asking them how long they anticipate their cases taking. I am entirely in your hands. I mean, you will see on the list you were given the proposed possibilities, which were the week in January, from 14-18, and then between March and 16 May. As I say, I am in your hands really because I cannot predict how long the defence are going to be.
THE CHAIRMAN: Ms Smith, as far as your prosecution case is concerned, is it still the case that your part of the business should finish by 19 October?
MS SMITH: Absolutely, sir.
THE CHAIRMAN: Thank you very much indeed. I think that is helpful. Mr Coonan?
MR COONAN: Sir, could I just say straightaway Dr Wakefield is not present for this part of the session. I gave him leave to attend to other matters. I hope you do not mind.
THE CHAIRMAN: I did see him outside, but obviously I thought that there was something known to you.
MR COONAN: It is not necessary that he is present for this discussion. On the basis that the Council’s case will finish on the 19th, with the last expert witness giving evidence, I make the following suggestion, that if there is available a five day slot in January, and I take my cue from looking at this grid, if there is, then it be the case that the defence consider the position within days after the completion of the Council’s case on the 19th to decide to what extent it will be required for the Panel to receive submissions at half-time, and if the defence (or any one or other of them) take the view that they would require to make submissions, to then have the slot in January used for that and only that, so that if none of the defence wish half-time submissions to be made, for January itself, the five day slot that we see on the grid, to be abandoned and for the defence evidence to begin on 25 March. Now, the reason I suggest that the January slot be abandoned if there is no wish on the part of any of the defence teams to make submissions at half-time is that five days is insufficiently long, and I speak here on behalf of Dr Wakefield, for him to complete his evidence. I really nodded in this direction on Thursday when I observed that it would be, from our standpoint, wholly inappropriate if he were part heard in the middle of his evidence, and then would have to go back to his home 3,000 miles away and to be in that condition for another two months, from January to March. So it is for that reason that I make that suggestion.
There is another observation, and I am not making a concrete suggestion at the moment, but another observation that from discussions amongst the defence there is a preliminary view, considering the position we have got to now, that that eight week slot from 25 March-16 May may, in the result, not be long enough because, and it is very preliminary this, if one factors in the amount of time to allow for witnesses of fact (the three respondent doctors), and any other witnesses of fact, together with expert evidence called by the defence, and speeches and deliberation time, eight weeks is beginning to look tight.
Now, that is another problem and I do not have any particular solution to that at the moment, but the first part was a very firm suggestion to deal with the January and the March periods. It may be that the final point will slot into place when you have heard from my colleagues. I hope you find that helpful at least insofar as it gets the debate moving.
THE CHAIRMAN: Thank you very much indeed. Mr Miller?
MR MILLER: Sir, with respect, I agree with Mr Coonan’s approach. I have some sympathy with Dr Wakefield. It seems to me highly unlikely that he will finish his evidence within five days. We have evidence in-chief over a large number of matters and then three lots of cross-examination, including cross-examination by the prosecution, and the Panel are bound to have questions of him as well, and I think it is unrealistic to think that he would be finished in that time without rushing through, and obviously that would not be appropriate, and obviously there is a serious problem in starting evidence in January and then coming back two months later to finish it.
The position as far as half-time submissions is concerned, again the decision as to those would be probably better left until the prosecution case has finished, and I agree again with Mr Coonan that if we keep that week in January, it ought to be on the basis that it would only be used for submissions, and if there are no submissions to be made, then those dates be vacated and we resume the hearing on the defence cases on 25 March. Sir, again I think there is a risk anyway that the period from 20 March-16 May will not be sufficient. I am, as at present, advised, certainly so far as Professor Walker-Smith is concerned, there will be his evidence, at least one, probably two, experts, and three, possibly four, factual witnesses to be called.
THE CHAIRMAN: Thank you very much indeed. Mr Hopkins?
MR HOPKINS: Sir, I agree with all that you have heard so far from the defence side and do not need to add to that, but from a practical point of view, because I agree there is a risk that an eight week slot may prove insufficient, from a practical point of view can I suggest that another block of four weeks is sought for later in the year. Again, looking at the grid, the Panel’s availability, that means from July onwards, and given the fact that certainly my client has a working career and needs some degree of certainty to know what is happening next year, not least because he has a family that needs to arrange its own holidays as well, I would ask that we can fix the four week slot that I suggest we may need in addition so that we know the parameters within which we are working next year.
THE CHAIRMAN: Can I just give you my preliminary views at this stage. First of all, what I have heard I think does make a lot of sense, and, if I remember it right, what the Legal Assessor actually said the other day was precisely the same, that I think one week in January could actually be left for the half-time submissions if necessary. That is what I remember the Legal Assessor saying the other day. Looking quickly at my diary, I think there is half a day that I am booked somewhere else, so I think that actually reduces that slot to about four and a half days rather than five days.
Now, the other issue, I think again I can actually see that if there are no submissions in January, then I really cannot see in any way, looking at the length and the breadth of the case and the allegations, that the one week is going to be sufficient for Dr Wakefield’s evidence. I am obviously going to speak to the other Panellists as well when we adjourn from here to look at some further days, maybe from July onwards, and I think it is also right that we also want to know exactly where we are going, and there are various commitments that the Panellists have got and they have got to book those things as well in accordance with this particular case, realising that this is actually part heard and this actually takes priority over the other things, but nevertheless there are people involved, there are families involved, and it is important that we all know where we actually stand on this. Does anyone else wish to say anything else? Ms Smith.
MS SMITH: Sir, I only wanted to say that Mr Miller has kindly given us some rough guide as to how many experts and how many witnesses he may be calling. Neither Mr Hopkins nor Mr Coonan have done so. I am not suggesting they should give away anything that they do not wish to, but I cannot see how, for instance, Mr Coonan saying how many factual witnesses it is, whether it is fifty or one, is going to prejudice him in any way at all, and what concerns me very much is we are saying that this time will not be long enough, we are looking in very busy diaries with huge numbers of people for another slot of time, and it is obviously wholly unsatisfactory, it cannot be helped but it is unsatisfactory, that this case is having to be heard in chunks, because it is very difficult for the Panel to keep a continuity in their minds, and I do not know why we are saying another block of four weeks will be enough because the truth is none of us have any idea how many weeks the defence are going to be, as I said, apart from the fact that Mr Miller has given us some indication, which is helpful. So that is a problem. The whole point of today was to be able to fix not only the March-May time, but also what is going to come after it, and it really does need to be done very soon because otherwise we are going to find that the time simply is not there because there are so many diaries to accommodate. So I wonder if we could at least have some sort of pragmatic estimate about how long we are going to be. I mean, Mr Hopkins has put another block of four weeks on, but I do not know whether that is just an informed guess by him or whether that is actually how much longer is going to be needed.
THE CHAIRMAN: I think this is obviously something that you all will have to grapple with and come back with some suggestion to us, and then we can obviously try to do whatever we can under the difficult circumstances. I know that one of my Panellists wishes to come back. I have no idea what he wants to say, but Dr Webster?
DR WEBSTER: It is in fact a very small point. The eight week block which is currently due to end on 16 May, from my point of view it would have to end on 15 May I am afraid, so that is another missing day, but I would rather have it out in the open now than during that time.
THE CHAIRMAN: I can say that from 25 March to 16 May there is going to be more than just one day. There may be one day at a time or two or three days within that period that are booked so those details I will give when we come to the decision that that particular slot is definitely going to be available and then I am going to give those dates to my Panel Secretary and I am sure the other panellists may also have an odd day here and there which is already booked. As we have done in the past, the Panel have given their days and counsel have given their days and we have made those as non-sitting days, so we are obviously going to have to take forward in that particular way. Legal Assessor, you have been very quiet.
THE LEGAL ASSESSOR: I do not think any advice is called for so far.
MS SMITH: Can I just point out, if we are taking days off that period then if Mr Hopkins’ four weeks is realistic it immediately becomes five weeks.
THE CHAIRMAN: I think that is probably right.
MS SMITH: As I say, we have no reason to suppose that it is realistic. We can only go by previous cases with three doctors in and we would have thought 10 to 12 weeks in total would probably see it through but it is a guess. I wonder whether the defence could be pressed to be a little more helpful on whether that is really realistic and how long they expect to be: how many factual witnesses they have got: how many experts they have got. As I say, the identity does not matter it is just having some idea.
THE CHAIRMAN: I am a little reluctant to do that, but I wonder whether the Legal Assessor could actually get involved with this.
THE LEGAL ASSESSOR: Do you want me to put the thumbscrews on Mr Coonan outside or ask him now?
MR COONAN: As matters stand at the moment, and you will appreciate why I use that formulation, there is still a way of evidence to go yet as part of the Council’s case, but as matters stand at the moment Dr Wakefield’s case will probably last between two to three weeks, but beyond that I do not think I am in a position to go any further, even with thumbscrews. That is my best estimate.
THE CHAIRMAN: I think that is quite helpful, and I think Ms Smith will also have found some comfort from that particular comment. I think we cannot go any further at this stage so if it is acceptable to you all we will adjourn to look at your diaries and we will try and give some more concrete dates from our side to you and taking, of course, help from the Panel Secretary because she has to look at the other working arrangements within this particular building to make sure that those all fall into place as well at those times.
Ms Smith, I think your witness is not available until 11.00?
MS SMITH: The witness is not coming until 11.00 because of her domestic arrangements, and perhaps then we can have some time.
THE CHAIRMAN: We will adjourn now and in the meantime the Panel will look at their diaries. Hopefully we will resume between 10.30 and 10.45 to have a little bit of further discussion on this if necessary.
(The Panel adjourned for a short while)
THE CHAIRMAN: Good morning, again. I have been told that you have been passed some dates which the Panel have discussed this morning and have arranged some slots as soon as possible. Having said that, I dare say there may be a slight alteration by one Panel member whose secretary is off sick at the moment and she could not find out the exact situation but if there is any change at all it will only be a minor one and not a major one. I hope that is acceptable to you all.
I will announce the dates so they appear on the transcript and to check they are correct:
• 14 to 18 January 2008, except the morning of 17 January, so we will sit only in the afternoon on that day.
• 25 March to 15 May 2008 is available subject to not sitting on the morning of 17 April. On 24, 25 and 28 April we are not sitting; and finally we will not sit on 14 and 15 May.
• The final slot is 14 July to 29 August 2008 except for the morning of 17 July 2008.
I hope everyone has a note of those dates now.
Thank you. Ms Smith?
MS SMITH: May I call Mrs 12?
THE CHAIRMAN: Yes, certainly.
MRS 12, Affirmed
Examined by MS SMITH
(After introductions from the Chairman)
Q I am sorry to address you from such a long way away. Tell me if you cannot hear me. First of all, you should have a piece of paper and a pen in front of you, would you write down your full name and address so we can hand it into the Chairman. (Same done) You should also have a laminated sheet in front of you which has the anonymisation key on it. If you look at that you will see the names of a number of patients: is your son the name opposite the number 12?
Q That is why we are calling you Mrs 12, and if I can just say, I am going to try and stick to that and if you would try and do so as well but you need not worry if you make a slip and call your son by his name because the press have already been warned that they should respect the confidentiality of him and of you. So, first of all, 12 was born on 8 December 1990, is that right?
Q He had an MMR vaccination and I think it is right that was on 6 March 1992?
A (Witness nods)
Q You have to say “yes” or “no” rather than nodding, Mrs 12, because the nod does not show up on the transcript. So, he had his MMR vaccination on 6 March 1992.
Q Prior to that, when he was born, were there some concerns about him having to be monitored as far as his development was concerned because he was born with a low Apgar score?
A That is right. He was on the OCR for the first year of his life but, after that, he was absolutely fine, so there was no need to monitor him anymore.
Q We have the records and I need to trouble to take you through them. After the first year, his developmental progress was thought to be satisfactory and you were pleased with his progress and it was felt not necessary to monitor him.
A That is right.
Q As far as his milestones at that time, had he begun to walk?
A Yes, he was walking at 13 months.
Q Thirteen months unaided?
A Unaided, yes. His brother was aged 10 months.
Q Did there come a time when you began to notice that things were not right and you became less happy with his development?
A By the time he was 18 months.
Q In your own words, Mrs 12, in broad terms, what were the problems that you began to see as worrying?
A He stopped communicating in the way that he had been; he started to scream and shout rather than use the odd words that he had been using; he was just less happy; he was not playing with his toys in the way that he had been; he just seemed to be a much more difficult child, not difficult in the way that normally progressing children become difficult sometimes, it was different; it was a worrying different.
Q When that began to happen, at first, did you think that it was anything in particular?
A No, I did not.
Q What about his toileting? Had be become potty trained before he began to have problems?
A He was starting to potty train normally. He was not potty trained … I cannot remember exactly but it was at about that sort of time up to two years when he was fully potty trained and then he started to soil himself again.
Q Did that soiling become a real problem?
A Yes because he was still doing it when he started school which obviously was a problem.
Q I think that you spoke to the family centre and to your GP about that problem.
Q I would like to take you to those records. You should have some GP records for Child 12 and would you turn to page 132. This is a letter dated 29 March 1996, a letter to your GP at that time, Dr Stuart; is that correct?
Q It is from somebody at the XXX, the family centre worker as we can see on the next page, Ms Hopkins, and I want to look at that with you.
“As you may recall, [Child 12] was referred to XXX in May 1995”
and she says that she has been working with the family since. In the second paragraph,
“When I last met [Mr and Mrs 12] on 28th March 1996, [Mrs 12] was feeling very stressed and low about [Child 12]’s continuing soiling. [She] has to change his underpants up to 4 times before he goes to school in the morning and he often comes home from school heavily soiled.
[Mr and Mrs 12] do not feel that the problem is due to constipation, as [Child 12] passes regular motions once or twice a day. [He] appears unaware that he had soiled and when asked he has to check his underpants before he can say. [Mrs 12] describes [Child 12]’s motions as normal, but the soiling is very loose.
When [his] bowels are open, the smell is often very strong and offensive.
Looking back over [Child 12]’s medical history, given by [Mrs 12], he has had regular bouts of sickness and diarrhoea with a high temperature.
Given time, [Child 12] will hopefully be seen again at the MacKeith Centre, but as we have re-referred him it may be some time before a more comprehensive medical assessment is carried out. I feel it is possible that [Child 12]’s soiling is part of a psychological/behavioural problem that will be further assessed … I wondered if you would be able to assess [his] soiling from the medical point before I pursue my side.
I have therefore suggested to [Mrs 12] that she makes an appointment with you to talk about [Child 12]’s soiling.”
Does that letter accurately reflect the difficulties you were having at that time?
Q If we go backwards to page 131, we see the reply to that.
“Dear Miss Hopkins,
Thank you for your letter about [Child 12].”
This is dated 10 April 1996.
“I saw him this week with his mum. On examination there is no evidence of any abdominal abnormality and rectal examination revealed an empty rectum. It would appear, therefore, that [Child 12] does not have a significant constipation problem and I feel he should be referred back to the MacKeith Centre as outlined in your letter.”
Can you tell us what the MacKeith Centre was. Do you recall?
A It is part of the children’s hospital in XXX and it deals with psychological issues in children.
Q At that stage, was it thought that his soiling might be associated with a psychological problem rather than a medical problem?
A I do not think anybody knew what it was at that point.
Q Did there come a time, Mrs 12, when you first began to think that your son’s problems might be linked with a particular event in his life?
Q First of all, what was that event?
A I went to a mother and toddler group and got chatting to one of the other parents there as you do. I was speaking to her about some of the problems I had with [Child 12] and I think she had the same problems with her son and it was she who told me that there was a possible link between these types of problems and the MMR vaccine.
Q Would you look back at the plastic sheet you have with the names of the children on. Was the name of the lady you met at the parent and toddler group … Was it in XXX?
Q Was her name the name of the children who appear at 6 and 7 on that sheet?
Q She told you that there was a possibility of a link with the MMR vaccination?
Q Did she tell you about a particular doctor who was interested in that particular issue?
A Yes, she did.
Q Can you tell us who that was.
A It was Dr Wakefield.
Q When she told you that, did you think that that might indeed explain what your little boy’s problems were and why they had begun?
A Absolutely. It was like a jigsaw puzzle; it suddenly seemed to fit into place. I had this perfectly normal child who, as I could see, for no apparent reason started to not be normal and, looking back, obviously being clever with hindsight, it was the one thing that I could see that had happened to him that could possibly have caused such a change.
Q After you had had that conversation with the other lady at the parent and toddler group, what did you do? Did you contact Dr Wakefield?
A Yes, I did.
Q Did you do that yourself directly rather than going through your GP?
Q Do you remember how you got hold of his contact details/how you knew where to go?
A I believe that the parent gave me the contact details.
Q Was it your understanding that her own children or child was being seen by Dr Wakefield?
A I cannot remember.
Q I want you to go in the GP records to page 126, so backwards again from where you were. This is a letter dated 19 July 1996 to you from Dr Wakefield. Do you recall receiving that at around that time?
Q If we look at it, it says,
“Dear [Mrs 12],
Thank you for your letter regarding your son. We have recently taken a profound interest in this subject, particularly in view of the link between bowel problems and Asperger’s Syndrome. I would greatly appreciate if you would mind calling me at the Royal Free before 3rd August and in addition I would like you to seek a referral from your GP to Professor John Walker-Smith, Professor of Paediatric Gastroenterology at the Royal Free Hospital, for investigation. It will be necessary for me to discuss the nature of the referral with your GP and I would be very grateful if you could let me have his/her name and telephone number. Also could you please let me have your telephone number so that I can speak to you directly on the subject.”
Do you recall that there was indeed a telephone conversation between you and Dr Wakefield?
Q Can you help us as to when it was. It appears that you wrote to him in order to get this letter in response.
Q Do you think that the phone call was after you received this letter with the suggestion that you phone or do you think that you had phoned before?
A I really cannot remember.
Q In broad terms, Mrs 12, and I know that it is a long time ago, can you tell us what was said during that telephone conversation. First of all, what was your understanding of what Dr Wakefield was doing?
A I understood that there was a research programme going on seeing if there was a link between the vaccine and the problems my son was experiencing.
Q Do you remember anything else about the telephone conversation?
A I think that Dr Wakefield asked what sort of symptoms my son had. I believe that he wanted me to contact my doctor, again reiterating what was in the letter. Apart from that, I cannot really remember.
Q I think it is right that at around the same time, as well as that contact with Dr Wakefield, did you also have some contact with a firm of solicitors called Dawbarns?
A Yes, that is right.
Q Can you tell us how that came about. Why did you get in touch with them?
A The same mother told me about them as well.
Q What was your understanding of what they were doing?
A They were trying to really put a stop to the MMR vaccine being used and obviously to stop any damage that was being done to children.
Q What about any children who had been damaged by the vaccine? What was your understanding of what Dawbarns were going to do about it?
A I think at that time I had not really … It was really a case of trying to find out whether there was this problem with the vaccine and to stop the vaccine.
Q At that stage when you contacted Dawbarns first of all, had you any knowledge of any kind of association or connection of any sort between Dr Wakefield and Dawbarns?
A I do not think that initially, very initially, I realised that there was a link.
Q I would like you to go the first letter that you had from the solicitors, please. Would you put the GP records away for a moment; you may need them again, so put them to one side. You have some bundles which are marked FTP bundles and I would like you to turn to FTP1 and page 129. This is a letter dated 18 July 1996 and, if we look at the next page, page 130, we see that it is on behalf of a Mr Richard Barr from Dawbarns Solicitors in King’s Lynn, Norfolk. Do you recall receiving this letter?
A Not especially because I received an awful lot, but it would have been one.
Q Let us just see what it says,
“Dear [Mrs 12],
Thank you for contacting us regarding the MMR vaccination. We are investigating a number of vaccine damage cases and are also (with Messrs Freeth Cartwright Hunt Dickens of Nottingham) co-ordinating and managing the Mumps Measles and Rubella cases on behalf of the Legal Aid Board for the whole country. Recently the Legal Aid Board has also extended our contract to investigate claims following the Government’s measles/rubella vaccination campaign in the autumn of 1994.
To give you an idea of our work I enclose an information pack which consists of a copy of a fact sheet which we have produced on the MMR vaccine and a fact sheet on ourselves.
We have built up a considerable volume of evidence that vaccines can cause injury to children, and we are hoping to take compensation claims to court. See the fact sheets for more information. Legal Aid is now being granted in vaccine damage cases where we can show a close link up in time between the vaccine being administered and the onset of recognised side effects. In claims being brought on behalf of children the Legal Aid Office does not take into account the finances of the parents, but there are sometimes difficulties in obtaining legal aid …”
and he goes into the reasons relating to that. He says,
“We are not against vaccines in principle, but we do feel that the government has three clear duties:
to show that the benefits of vaccination campaign clearly outweigh the drawbacks;
to give parents adequate information about the risks of vaccines so that each family can make an informed decision;
to accept full responsibility for the consequences in the cases where children have been injured by vaccines; they and their families must be given proper treatment, support and compensation (not just the ‘token’ £30,000 paid by the vaccine damage unit).
We would rather not have to fight cases through the court. We would rather the government set up a proper compensation scheme (like the American one) where fair recompense is paid for the injuries suffered by vaccine damaged children.
Unfortunately the government is showing no sign of discharging these duties, and we therefore have to find ways of making the legal system work for you. To this end we are hoping to use European legislation (the Consumer Protection Act) to obtain for clients what the government is not providing.
If you would like us to help you further the next step is to apply for legal aid on behalf of your son or daughter. To do this we need to prepare a statement of your case.
Included with the information pack is a checklist of the kind of information that we need. What I would like you to do is to go through the checklist item by item and let me have a written account of what happened.
It really is important to get as much detail as possible, especially when considering the immediate and long term effects of the vaccine. By all means make your notes on the checklist, but do also expand the details where you can. We will then turn your information into a legal statement and send it to you for approval with the legal aid forms. This statement will also be useful in defining the case – and building on it later”
and he makes it clear that you were not under any obligation to use that particular firm of solicitors if you did not wish to do so.
In fact, the letter referred to an enclosed information pack, a checklist of information and a fact sheet, but I think it is right, Mrs 12, that you did not in fact keep hold of the enclosures that went with that letter.
A No, if it was not with the other documents.
Q Would you turn to page 146. It would appear that you wrote back to Mr Barr because we have a letter dated 30 July 1996 to you saying,
“Thank you very much for your letter of the 25 July and the useful information contained therein”
and saying that Mr Barr was away at that time on holiday and the letter would await his attention on his return. Do you recall that in fact you did write back to Mr Barr setting out as best you could the history of your son’s problems?
Q Then we go on to page 147 which is a letter to you dated 14 August 1996 from Mr Barr and this is a letter that you have produced to the GMC; is that correct?
Q It is dated 14 August 1996 and reads, “Dear [Mrs 12]” and he apologises for the delay and says,
“I have put together a legal aid statement about [Child 12] based very largely on what you have actually said. What you have described to me is very similar to descriptions given by many other parents who have also reported autistic features among children who have been vaccinated with the MMR vaccine.
I noticed in your statement that you have made reference to [Child 12]’s intestinal problems and I enclose a copy of a fact sheet from Dr Andrew Wakefield who is investigating the link between inflammatory bowel disease and the MMR vaccine.
We are also in touch with other experts and together they are hoping to establish a link between the vaccine, inflammatory bowel disease and autism. There is a clear cut biological mechanism for linking the two conditions. I suggest it might be worth your while to contact Dr Wakefield. If you would like me to do so I will be happy to make the introduction for you. May I have permission to send him a copy of the statement that I have prepared for [Child 12]?
The statement will be the basis of the legal aid application and I suggest you check it carefully to make sure I have got everything right”
and he then refers to the numerous documents and, if we go on to the second page, he says,
“I am going to ask Kirsten Limb (our scientific researcher) to contact you separately because there are some tests that we are having carried out in XXX which may help to go some way to relieving [Child 12]’s intestinal problems by a diet change. It will mean sending a urine sample to the expert concerned (Dr Shattock).
The rest of this letter related to legal aid and its various ramifications. …
As arranged I now enclose legal aid forms for you to sign. …”
The rest of the letter, which is indeed long and I do not propose to read out, is all about what would happen as far as legal aid being granted is concerned and the steps you should take thereafter to keep in touch with the litigation; is that correct?
Q As far as the reference to Dr Wakefield was concerned, Mr Barr was offering in that letter to make an introduction to Dr Wakefield but, as we have already seen, you in fact had already contacted Dr Wakefield.
A That is correct.
Q As far as you were concerned, was that apparent association between the two something that you learned from that letter?
Q Do you recall whether you actually told Mr Barr that you did not need that introduction because you had already made contact with Dr Wakefield?
A I do not remember whether I did or not. It is possible that I did.
Q If we go on, there is a fact sheet with this letter at page 152. Before I embark on that, I would like to ask you what I should have asked you at the beginning which is, this bundle of documents which relates to correspondence between you and the solicitors, was that produced by you to the General Medical Council, that is all the documents that you had kept from the litigation?
A Yes; I let them have the box to look through.
Q The next document was a fact sheet, and that apparently comes from the Royal Free Hospital School of Medicine, as you will see at the top of the page. If I can just run through what some of that says, it is headed,
“Inflammatory Bowel Disease, measles virus and measles vaccination.
What is inflammatory Bowel Disease (IBD)?
IBD comprises 2 conditions that have many similarities. Crohn’s disease and ulcerative colitis. Crohn’s disease may affect any part of the bowel, from mouth to anus, whereas ulcerative colitis affects the large bowel only. Many people now believe that these two conditions are part of a single spectrum of intestinal disease. IBD is often difficult to diagnose in children, especially Crohn’s disease, and this may lead to a delay in diagnosis with frustration for parents, doctors and, in particular, the affected children.
What is the link with measles and measles vaccine?
Measles virus was put forward as a possible cause of Crohn’s disease in 1989. The dramatic rise in the incidence of inflammatory bowel disease in developed countries over the last 30 years, in the face of live measles vaccination, also suggested a link between the vaccine and the disease.
Several groups from around the world have now identified measles virus in tissues affected by Crohn’s disease and an immune response to measles virus in the blood of patients with Crohn’s disease and ulcerative colitis. Early exposure to measles virus appears to be a major risk factor for developing Crohn’s disease later in life, and one study recently linked live measles vaccine to both Crohn’s disease and ulcerative colitis. Several new studies are currently underway that are designed to clarify the association between measles vaccination and inflammatory bowel disease. Although no studies have formally examined the issue, we have been aware of a large number of new cases of childhood IBD following the MR revaccination campaign in November 1994”.
Then it sets out what you would look for:
“Crohn’s disease. The symptoms and signs of Crohn’s disease in childhood are often insidious and non-specific and may lead to a delay in diagnosis. Intestinal symptoms include mouth ulcers, cramping abdominal pains, loss of appetite, diarrhoea with or without blood and problems in the anal region, including skin tags, tears or abscess formation. However, children commonly present with weight loss and failure to thrive as the only indications that they may have Crohn’s disease. But be aware, unexplained joint paints, sore eyes and skin rashes can also be the presenting symptoms of Crohn’s disease.
Ulcerative colitis is often more clear-cut, with diarrhoea, urgency and blood and mucus mixed in with the stools. Again, growth failure and symptoms such as joint pain may precede the intestinal problems.
What should we do?
If you suspect that your child has inflammatory bowel disease, prompt referral to a specialist centre is essential. Either the diagnosis will be excluded and your mind put at rest, or it will be confirmed and the appropriate treatment instituted. As a first step you should contact Dr Andrew Wakefield at the Royal Free Hospital”,
and his details are given. This is a fact sheet that was sent to you, as we can see, with the letter I have just read to you, Mrs 12.
A What page is it, sorry?
Q It is on pages 152 and 153.
A Thank you, yes.
Q Can I just ask you, on page 152 the reference to the MR revaccination campaign, you have told us that your son in fact had the MMR vaccination.
A That is right.
Q Did you notice or query that, do you recall?
A No. It was my eldest son who was involved in that campaign, so I was aware of that campaign.
Q It meant something to you.
Q Also enclosed with that letter of 14 August 1996 were the legal aid forms. I think that is right. Did you fill in the legal aid forms in order for an application to be made for your child to be legally aided?
Q If we can go on please to page 188, it appears that you did indeed send those off on 20 August because we see a letter from Mr Barr to you, dated 28 August 1996,
“Dear [Mrs 12],
Thank you for your letter of 20 August 1996 returning the legal aid forms to me. One of the problems about dictating things at the airport is that I don’t have all my records with me. I am afraid to say that I wrongly identified the brand of vaccine as Immravax. In fact from the pattern of the batch number it is MMR2. It makes no difference to the legal aid application and I have simply amended it accordingly. You might be interested to know that the batch number matches with another little boy who is suffering from exactly the same symptoms as [Child 12]”.
If we go back to page 242, or on to 242, is that the legal aid certificate for your son that was ultimately granted?
Q It is dated 9 October 1996, is that right? It shows at the bottom of the page.
Q We see a description of the legal aid, to take proceedings in fact against a drug company pursuant to the Customer Protection Act. Under the conditions and limitations,
“Limited to non-generic work including the obtaining of appropriate medical records, including if necessary an application for pre-action discovery and the preparation of a proof of evidence”.
From that time on, was your son part of the group of litigants whom Dawbarns were representing in relation to the litigation?
Q If you can now turn to page 198 this is another letter from Mr Barr, and you had obviously responded to him because it says,
“Dear [Mrs 12],
Thank you for your letter of 29 August.
From a legal point of view, we do not think it is going to make any difference that [Child 12] was given the MMR2 vaccine. Although Immravax and Pluservix were withdrawn on safety grounds, the particular problem they caused was fairly limited. What we are looking at is the wider issue of serious problems caused by the vaccines with the measles constituent in them. Certainly we have a large number of other cases where the MMR2 vaccine is involved.
You are right that the other child is” –
and then a name –
“I am afraid to say that there are plenty of others who are going through a similar experience. When we next send out a Newsletter we are going to invite parents to say whether or not they would like to be put in touch with others. Obviously we have to have the written permission of parents to be put in touch with one another. Just as a matter of interest, would you like to be put in touch with other parents experiencing vaccine damage in your area”.
You had obviously guessed at the name of a child with similar symptoms to your own boy’s symptoms.
Q How were able to make that association, do you recall?
A I do not, no, I am sorry.
Q Were you in fact ultimately put in touch with other parents through Mr Barr to have some sort of support group?
A I do not think we actually were, no. Again, I cannot remember being put in touch with other parents.
Q If you go on to page 189, this is a newsletter dated September 1996, and I think it is right that this was in the bundle of documents that you retained, having
been sent it by Dawbarns. Is that correct?
Q I would like to just look at it for a moment, if I may. We see it says, “MMR and MR vaccination cases September 1996”:
“This letter is being sent those who have either contacted us over the MMR/MR vaccines or are in the process of applying for legal aid. If you have contacted us but have not yet sent us back the information on your child’s case, we will be happy to help with any queries”.
If we then go down to “Progress Report”,
“Things have been a little quiet with the vaccine cases because we have been waiting for the go ahead from the Legal Aid Board to progress the cases. We put in our request for extended funding back in May. This has just been authorised and a further £135,000 of funding has been recently approved for the generic cases. This will enable us to set up and carry out a pilot study (see below) and will also enable us to carry out much more detailed work researching the vaccine cases.
We can also tell you that we have now had a very positive barrister’s opinion advising that there are indications that this is a strong case and recommending that the MMR/MR cases do indeed merit further investigation”.
It goes on to the fact that,
“He has set out a detailed scheme for investigating the cases and we are working closely with him to gather all the necessary evidence and to carry out the pilot study (mentioned below). It will take time. We are bound to meet with a very strong defence from the pharmaceutical companies who will no doubt oppose us all the way. Our task is therefore to make sure that our case is as strong as possible before we launch court proceedings”.
Under the heading, “Autism and inflammatory bowel disease”,
“A substantial number of children referred to us are suffering from chronic stomach problems and/or have developed autism-like symptoms. Our own researches indicate that these two conditions may well have been caused by the MMR/MR vaccines and that they may well be linked.
We are trying to put together as much information as possible about the apparent link between these two conditions and the vaccines. If you have any information or know of other families with children who have one or other of these conditions (or both) following vaccination we would be very interested to hear from you. If your child has the condition(s) and you have not yet received the fact sheet produced by Dr Andrew Wakefield, do contact us”.
Under the heading, “Pilot study”,
“If we can prove a clear link between the vaccines and autism/inflammatory bowel disease this will be exceedingly useful, not only for cases involving those conditions, but also for other types of damage such as epilepsy.
To obtain the evidence to do this, we will be running a pilot study. Around 10 children with symptoms which are closely linked to the vaccine will be extensively tested by a team of doctors headed by Dr Wakefield at the Royal Free Hospital in London. We will be selecting children to take part in the study from details and medical notes we already have. The investigations will involve a whole battery of tests to be carried out by a number of leading experts in their fields. We will of course be liaising closely with the families concerned and the doctors will be giving very full details of what will be involved”.
Then on the last page, in the right hand column, “Contacting others”, there is again a suggestion that was in the letter from Mr Barr suggesting that parents who were feeling isolated might derive support from being put in touch with other families. I think you already had in your possession a similar newsletter, Mrs 12, although that was a little earlier in time, but I have gone through them in this order deliberately. It is at page 90. I think it is correct you are unsure about when you actually received this, but it was in your documents that you retained from Dawbarns, is that correct?
Q It is a newsletter “MMR and MR Vaccines”, and if you turn to page 91 we see on the left hand side “Other activities” – are you with me?
Q “During the year we have had meetings ….. with a large number of different people and organisations”.
Then if you go down to the bottom column:
“Dr Andrew Wakefield
As you may have read in the Sunday Times of 17 December 1995 Dr Andrew Wakefield has published some very disturbing material which indicates a clear link between the measles element of the vaccine and Crohn's disease (a persistent inflammatory illness of the digestive system). He has deeply depressing views about the effects of vaccines on the nation’s children. He is also anxious to arrange for tests to be carried out on any children vaccinated with the MR or MMR vaccine who are showing symptoms of possible Crohn's disease. The following are signs to look for. If your child has suffered some or all of these symptoms could you please contact us and it may be appropriate to put you in touch with Dr Wakefield.”
Then there is a list of what you should be looking for:
“Failure to thrive
Loss of weight
Intermittent bouts of diarrhoea and/or stomach pain
Blood in faeces
Anal polyps and skin tags
Unexplained low level fever
Then there is also reference to another doctor who was looking in particular at autism. Then if we go on to the next letter which you received, Mrs 12, that is at page 246, this is a letter to you from Mr Barr at Dawbarns:
“Dear Mrs 
As requested, I am enclosing a copy of the Proposed Clinical and Scientific Study, as requested by you recently.
I am sure you will be aware that this information is confidential and should not be disclosed to anyone else.”
If you turn over on to the next page, 247, Mrs 12, you can see the study that was with that letter, “Proposed clinical and scientific study” with the coordinating investigator Dr Wakefield. I am just going to go briefly through this because we may at a later stage have to compare it with other documents, and then I am going to ask you a question or two about it. At 248 we see the “Investigators” at the top of the page, “Department of Paediatric Gastroenterology”, “Professor Walker-Smith, Dr Murch”, and then at the bottom of the page “Department of Histopathology ….. Dr Andrew Wakefield”, and on to page 249 “Department of Child Psychiatry Dr Mark Berelowitz” and 250 “Department of Neurology Dr P Harvey”. At 251:
There are indications of the emergence of a new syndrome comprising” – I am sure that it meant to be – “disintegrative disorder and a possible enteritis associated with vitamin B12 deficiency. The syndrome has been linked – anecdotally but consistently – with either measles or measles/rubella vaccination.”
Then we see a heading of “Disintegrative disorder [or] (Hellers’s disease)” and a description of it. Then on to page 253, another heading “Complement, measles and disintegrative disorder” and a description of the science in relation to that. On 254, “B12 metabolism, enteritis and disintegrative disorder”. Then on to 256:
“The proposed studies will involve …..
• full clinical examination
• [full blood count] …..
• Measles and rubella ….. immunoreactivity …..
• Colonoscopy/ileoscopy and biopsy …..
• Histology and immunohistochemistry for measles virus …..
• ….. analysis of mucosal biopsies for more subtle changes
• [virology studies] RNA extraction from frozen biopsies ….. ([at] appendix 1)”.
Then on to the next page, 257, the neuropsychiatric studies with Dr Berelowitz and the neurological studies from Dr Harvey. At 259:
“Referrals will be coordinated by [Dr Wakefield, Professor Walker-Smith and Dr Murch], such that they will be admitted for colonoscopy preparation on a Sunday afternoon. Patients and their parent(s) will remain in hospital for one week.”
Then the days on which the various tests are to be carried out. Now, as far as that document is concerned, Mrs 12, that was sent to you by Mr Barr, is that correct?
Q It appears to be in answer to a query by you. Can you tell us how it came about that you were asking for that proposal?
A No, I do not remember, I am sorry.
Q It was a proposed clinical and scientific study, as we have said. You were asking Mr Barr for it rather than the Royal Free, but it has got the Royal Free’s address on it. Can you help at all as to why you might have been asking Mr Barr for it?
A I do not remember, I am sorry.
MS SMITH: You do not recall.
THE CHAIRMAN: Mrs 12, can you just pull the microphone a little bit closer to you. The sound is not coming out very clearly, so speak a little bit louder, please.
MS SMITH: The tests that are referred to in that document, Mrs 12, the tests and investigations on pages 256 and 257, and the plan on 259 for admission for those investigations, do you recognise those as something that ultimately bear any resemblance to what your son was treated for at the Royal Free?
Q We have heard from the Dawbarns newsletter that I read to you previously that as far as the solicitors were concerned there was a pilot study being arranged. Did you have any understanding or awareness whether your little boy was a part of that pilot study at all?
A He was referred to Dr Wakefield by my GP for investigations, which I understood to be research investigations, but that was the route he was referred.
Q Now, just finishing off the correspondence that we have between you and Mr Barr at this stage, if we go on to page 264, that is a letter to you dated 15 October 1996 and that carries on the suggestion about the contact:
“Dear Mrs 
Many thanks for your letter of 10 September 1996. I will contact some other parents in your area and if they agree then you can all swap names and addresses. It is interesting how isolated people feel (and sometimes are!).
I would like to see the records. These may well be helpful if we have any difficulties over legal aid. At the moment I am still waiting to hear from them.”
So that was the end of the correspondence, and I now want to ask you about the actual referral, which you have explained to us was through your GP to the Royal Free Hospital in respect of your boy. We have been through this already, but just to remind you, if you go back to the GP records, please, page 126, this is a letter that I asked you about when I first began to question you, Mrs 12, the letter from Dr Wakefield, and we see in that the suggestion that you in fact you should go to your GP for a referral. Did you do that?
Q Is it your recollection that there was some time lapse between that request and the actual referral? (After a pause) Perhaps I can ask you, do you remember when your son was actually seen as an outpatient at the Royal Free Hospital?
A I think it was around the October time.
Q Yes, it was. I can, I am sure, tell you the date, which was 18 October 1996. If you put away those records and find the Royal Free Hospital records for Child 12, please, and go to page 69 in those records. This is the letter that your GP wrote on your behalf, Mrs 12, and it is dated 23 September 1996. It has “Professor John Walker-Smith” and his address at the top of the page, and then “For the Attention of Mr A J Wakefield” and it is addressed “Dear Mr Wakefield”:
“Thank you for seeing [Child 12] who we have discussed on the phone recently. [Child 12] initially presented at his eighteen month check with delay in talking and communication skills. He was seen locally at the Speech Therapy department and has been under the care of our local community paediatrician since that time with behavioural difficulties. He has been rather hyperactive and difficult to control and became easily distressed when his routine was changed. His early years were unremarkable apart from the usual upper respiratory [tract] infections. He had chicken pox in January 1992 and his routine MMR vaccine in March 1992. He has for sometime had bowel problems, but did not present to my surgery until March this year when Mrs  came along to discuss his soiling habit.
On examination at that time his abdomen was normal with an empty rectum. He has seen Dr ….. Ing our local Consultant Child and Adolescent Psychiatrist who has expressed the opinion that [Child 12] may well have Asbergers Syndrome. He has two siblings, both of whom are well.
I look forward to hearing your opinion regarding [Child 12’s] further investigation and outlook.”
Now, I do not expect you actually saw that letter at the time, Mrs 12, but in broad terms does that fairly sum up the position at that stage as far as his condition was concerned?
Q As you have said, you went and had an outpatient appointment with Professor Walker-Smith in October 1996, and we have got the notes for that at page 12 in the same Royal Free bundle. Can I just ask you about that appointment. Did you and your husband attend?
Q Do you remember it, first of all, the appointment?
Q Can you tell us who was present at it?
A Professor Walker-Smith.
Q On his own?
Q Did you take [Child 12] with you?
Q So there was you, your husband, [Child12] and Professor Walker-Smith?
Q If I can just ask you, and tell me what you do and do not remember, what were you asked about?
A Family history, I think, what the family consisted of, obviously the problems we experienced with [Child 12], and I think he had some blood taken, but I am not sure.
Q If we just look at his notes, I am not going to ask you about all of them, the bottom half of the page on page 12, do you see where it says “? Aspergers syndrome”?
Q Just the part under there where it deals with the gastrointestinal symptoms, it says: “Appeared to be toilet trained”, do you see where I am, “aged 3 [years]”?
Q “Soils – not had diarrhoea. Has variable abdominal pain”, and then I cannot read the rest of that sentence. Mr Miller is trying to assist me – “occurring every week”. Thank you. “Mother had not associated vaccination with his problems until met a parents support group”. Does that set out the problem as far as his gastrointestinal symptoms were concerned, I mean obviously in brief terms?
Q Mr Miller is pointing out it also says “Stops him eating”, so it reads: “Has variable abdominal pain – occurring every week. Stops him eating”, and it says, “Soil – not had diarrhoea”, is that correct?
Q If we go on over to the next page we see the details in relation to MMR in March 1992, and the note that there was a red rash which lasted for two days and “Had fever”, and there is a note at the side in the margin which says, “Had ‘measles’ diagnosed by GP at 2 years”. Do you recall Professor Walker-Smith asking you about the vaccination history, the details as to when Child 12 had his MMR and whether he had any reaction to it, matters of that kind?
A Not specifically.
Q We see at the bottom of the page that there was a plan for blood tests. Do you remember whether blood was taken then?
A I cannot remember if it was taken then, no.
Q After that consultation did you in fact write to Professor Walker-Smith, Mrs 12?
Q We have the letter that you wrote, which is at page 267 of bundle FTP1. Mr Miller is kindly pointing out that it is in the medical records as well. I am aware of that but there is another letter as well and as I have got the references here I prefer to use them. Page 267, this is the letter you wrote:
“Dear Professor Walker-Smith,
I am writing following [Child 12’s] visit to the Royal Free Hospital last Friday 18 October 1996. My husband and I have thought long and hard about this situation since the appointment. We have also re-read Dr Wakefield’s proposed clinical and scientific study notes.
We do feel that [Child 12] does have a problem in that most children of his age do not soil themselves a number of times a day. As well as being pale in colour and foul smelling (as are his motions in general), this soiling is always very loose, which might explain why he is not always aware that he has done anything. Although I would not say it was diarrhoea exactly.
Obviously I do not wish to put my son through any procedures unnecessarily but there must be a reason why he has these problems. Also, as I mentioned to you at our meeting, [Child 12] is not growing or putting on weight like my other two children.
I keenly await the results of the blood tests and if you feel they warrant further investigations my husband and I are happy for him to be referred on to Dr Wakefield’s study project. As you pointed out, it might not help [Child 12] but if not hopefully it will be of benefit to others. There is also the chance that [Child 12] has a problem that can be detected and helped.
I do hope to hear from you in due course.”
I will ask you about these letters in a moment, Mrs 12, but the same day, I think it is right, you also wrote directly to Dr Wakefield, is that correct? If we turn back to page 266, do you remember that letter:
“Dear Dr Wakefield,
Following our first communication in the middle of July this year, [Child 12] has at last been seen by Professor John Walker-Smith. His appointment was last Friday the 18 October 1996. Professor Walker-Smith took some blood from [Child 12] for analysis but did not feel sure that [Child 12] would need referring to yourself for further investigations. His main reasons were the absence of blood in the faeces and the lack of diarrhoea.
Both my husband and I found the lead-up to the appointment quite stressful as we were not sure what to expect. At the time we did tell Professor Walker-Smith that [Child 12] soils himself every day, sometimes three or four times a day. However, on reflection, this motion is always extremely loose, which is perhaps why he doesn’t always realise he has done anything. It is always of a pale colour and is always foul smelling as are his motions in general. Although I would not say it was true diarrhoea it certainly is not of a solid consistency. I do not feel that this was stressed to Professor Walker-Smith.
I do feel that things are not right with [Child 12’s] ‘insides’. Neither of my two other children have these problems. Also, as I mentioned to you before, [Child 12] is not growing as well as the others, neither is he putting as much weight on as they are.
The appointment with Professor Walker-Smith was left such that I should call the hospital in two weeks time and see what the blood test results showed. If there are any positive indicators then I think [Child 12] will be referred to you for further tests – have I understood the situation correctly? Both my husband and I are happy for [Child 12] to undergo these tests as we feel there is a problem somewhere in this area. I am sure children of his age do not usually soil themselves every day as he does. I know you are very busy, but if you are able to telephone me at some point to discuss this further I would greatly appreciate it.
Finally, I would like to say how nice it was to meet you at the JABS open meeting on 4 October in London. I found your short discourse both informative and interesting. I wish you all the best with your research.
So as far as those two letters are concerned, why was it that you wrote to Dr Wakefield as well as Professor Walker-Smith?
A Because we had seen Professor Walker-Smith at the Royal Free for the appointment and I had already had dealings with Dr Wakefield beforehand. It was just really a courtesy letter I think.
Q In your letter to Dr Wakefield you say that your understanding was that it was left that you would call the hospital to see what the blood test results showed, and you say, “If there are any positive indicators then I think [Child 12] will be referred to you for further tests – have I understood the situation correctly?” What did you understand to be the significance of the blood tests?
A That they would show that there was an inflammation in the intestines which was causing the diarrhoea.
Q What did you understand as being the significance of the fact that there was a lack of diarrhoea or blood? You refer to the fact that the main reasons, you say to Dr Wakefield, why Professor Walker-Smith was thinking he would not refer on was the absence of blood in the faeces and the lack of diarrhoea: what was your understanding of why that would mean that Professor Walker-Smith would not be asking Dr Wakefield to be involved?
A I do not know. I mean, I think with the diarrhoea, you imagine … I mean, [Child 12]’s stools were not normal, they were very loose but it was not … When you are ill and you have diarrhoea, it was not that loose, so I was not sure what was considered technically to be diarrhoea and what was not, so I just wanted to stress the fact that his stools were, in my opinion, very abnormal, but I had not seen blood in the faeces.
Q So that was from your point of view, but you say in your letter to Dr Wakefield, Professor Walker-Smith’s main reasons for not referring [Child 12] on to Dr Wakefield was the absence of blood in the faeces and the lack of diarrhoea, you were saying that is what Professor Walker-Smith’s view was, is that correct?
Q Was that your understanding of the consultation with him?
A I am assuming so, yes.
Q But you have said the blood tests might have shown inflammation.
A That is right.
Q Was it your understanding that if they did show inflammation that would dictate the course of events after that?
Q In what way?
A In that [Child 12] would then be referred on because there would be a problem, that there obviously was a problem with him.
Q You say that you and your husband after the consultation with Professor Walker-Smith had re-read Dr Wakefield’s proposed clinical and scientific study notes, what study notes were you referring to?
A I think the sheet that we had previously read showing what investigations would be carried out.
Q The one you received from whom?
A Dawbarns I think.
Q You said in your letter to Professor Walker-Smith, “Obviously I do not wish to put my son through any procedures unnecessarily but there must be a reason why he has these problems.” What were the procedures that you had in mind then?
A I think it was things like the colonoscopy; obviously further blood tests.
Q Did Professor Walker-Smith discuss with you colonoscopy and what it would entail?
A I do not remember.
Q Would you have known prior to that what a colonoscopy was?
Q And in broad terms what it would involve?
Q You say:
“As you pointed out, it might not help [Child 12] but if not hopefully it would be of benefit to others. There is also the chance that [Child 12] has a problem that can be detected and helped”.
When you say “as you pointed out”, was that when you had your outpatient consultation with him?
A I do not remember the conversation but from reading that it would seem that Professor Walker-Smith had said that the examinations might not help [Child 12].
Q What was your understanding, if it was decided ultimately that [Child 12] was to be part of this study, what was your understanding as to the purpose of it?
A I think pretty well what is stated in the letter. As with all research, it is there to help people. It does not necessarily help individuals but it can be used to help in the long term, so although obviously ultimately I would like something that would help my son, if that was not to be maybe the research would later on be used to help others.
Q If we could go back into the Royal Free Hospital records, please, at page 38, this is the letter that Professor Walker-Smith sent back to you:
“Dear [Mrs 12],
Many thanks for your letter of 20 October. I have now got back the blood tests. One was slightly abnormal. As I see that you are keen for us to proceed with investigation I think it would be appropriate for us to arrange for [Child 12] to come in for a colonoscopy. I explained in the outpatients what this involved. Basically he is sedated and the colonoscope is passed through the lower bowel and pieces of tissue are taken. The children are usually admitted for the course of a week and various other aspects of the protocol are undertaken. If you would like us to proceed with this, please let my secretary know and we will arrange a date for [Child 12] to come in in the New Year.”
That is dated 25 November 1996.
Did you understand what “various other aspects of the protocol” meant at that stage, Mrs 12? What were you anticipating?
A Yes, the sheet that listed what investigations were going to be carried out.
Q I am sorry, just so we can identify that, the sheet that you were sent by whom?
A I think the one that we read earlier, that came with Dawbarns.
Q The scientific study?
Q So at that stage, when you get this letter from Professor Walker-Smith, the various other aspects of the protocol meant something to you did it not?
Q It was your understanding that that was all going to be done?
THE CHAIRMAN: Mrs 12, I have been passed a message by other Panel members that they are having difficulty hearing you clearly. Would you pull the microphone a little closer, or bring the chair in further and try and speak a little louder so everybody in this chamber can hear what you have to say.
MS SMITH: (To the witness) If you go back a page, to page 37, we have got your response to Professor Walker-Smith’s letter, and this is dated 28 November 1996:
“Dear Professor Walker-Smith,
Thank you for your letter dated 25 November 1996.
I would like to confirm my agreement to the investigations going ahead.
Would it be possible for you to let me know what the slight abnormality was with the blood test and what the implications are? I would be most grateful for this information.
I look forward to hearing from you soon with an admission date for [Child 12].”
Is that correct?
Q So you were asking for the detail in relation to the slight abnormality, why was that?
A I like to be informed.
Q If we go to page 35 we will see the response to that, dated 27 December 1996:
“Dear [Mrs 12],
I do apologise for the delay in replying to your letter of 28 November. The slight abnormality that you referred to in your letter was that one of the markers of inflammation was just slightly above the normal range, it just means that we should go ahead. I understand that [Child 12] is coming in in the New Year to have a colonoscopy.”
It think it is right that that is indeed what happened.
If you go back in the Royal Free Hospital records to page 3, that is a printout, and if you go to the bottom of it, do you see where it says “Patients episode summary”, the second heading up from the bottom?
Q If you go to the third one, “IP”, which I can tell you is inpatient, from 5 January 1997 to 10 January 1997, is that correct?
Q He was admitted to Malcolm Ward was he?
Q We see the name, “Professor J Walker-Smith”, who did you understand was the responsible doctor during that inpatient stay?
A I thought it was a combined thing with Professor Walker-Smith and Dr Wakefield.
Q Did you in fact stay in hospital with him for that stint?
Q Were you given any sort of information at all about how that was being funded?
Q I think the investigations, if I can take you first of all to page 34, we can see there the discharge notification and we see on the right-hand side, under “Procedure undertaken” “colonoscopy, MRI and LP” is that correct?
Q If we go to page 32, this is the full discharge and it sets out all the details. I am not going to read it all out but he had a colonoscopy and on page 33 we see blood tests, a barium meal and follow through: does that accord with your understanding that he had a colonoscopy, a barium meal and follow through, an MRI scan, a lumbar puncture and various blood tests?
Q You were there throughout the week when those procedures were undertaken were you?
Q Did [Child 12] also, so far as you can recall, see Dr Berelowitz a psychiatrist?
A No, he did not, not whilst we were there, as far as I can remember.
Q I am going to take you to the record relating to that but did he see a series of doctors? Would you have known the identity of all of them?
A I should have done because mostly they introduced themselves.
Q If you to go page 18 in the medical records, we have a note dated 10 January, and in fact we have heard some evidence from Dr Berelowitz and he has given evidence in relation to all the children, including your son, and it was his evidence that this was his note, and we see at the bottom a diagnosis of “language delay ? [attention deficit disorder]” and then “? Asperger’s”: do you have any recollection of that?
A I do not remember that.
Q If we go to page 22 at the top of the page we see that on 9 January, the day before, “Harvey” and this is in fact Dr Harvey the neurologist: do you recall him coming along and finding [Child 12] fast asleep?
Q He has put “Fast asleep! I’ll call on him at home, I’m often in …” and then the name of your home town. Do you remember, did Dr Harvey ever actually see [Child 12] after that, that you recall?
A I cannot remember.
Q When you said that you cannot remember, would you have a recollection of a doctor visiting him at home, that is a consultant from the Royal Free?
A We had quite a few people coming, taking blood tests and what-have-you over the years. I cannot remember if it was anyone specific.
Q I want to look at some of the consent forms you signed during that week when your son was in hospital. Would you to turn to page 76, please. This is a consent form for research biopsies and it says,
Your child has been referred for diagnostic colonoscopy … Several small pieces of tissue (biopsies) are taken during the procedure for diagnostic purposes. Clinic inflammatory bowel diseases are still little understood and their cause is unknown. It is therefore of great value for laboratory research to have such biopsies available to study how inflammation in the bowel develops and is influenced by treatment. Your permission is asked to agree for two extra biopsies …”
You signed that form on 5 January; is that correct? Is that your signature?
Q On page 77, we see a Royal Free Hampstead NHS Trust consent form in a different format.
“Type of Operation …
Colonoscopy & biopsies.”
Is that also signed by you?
Q The other one – and I am sorry to take you into yet another bundle but I am afraid that it is in a different place – is in FTP7 and behind tab 27, so right at the back of the bundle. This is a consent form again on the NHS Trust consent form for an MRI under sedation on 9 January and is that also signed by you?
Q The reason why this one is in a different place, Mrs 12, is because I think you yourself produced this one, the MRI consent form, rather than it being in the rest of the patient records. Do you happen to remember whether you signed a consent form for a lumbar puncture?
A I do not remember if I did or not.
Q Do you have a clear recollection of Child 12 having a lumbar puncture?
Q If we go back to the Royal Free records – you can put FTP7 away, you will not need it again – at page 21 – it is on 6 January, so the day after the admission – at the bottom of the page it says, “[Ward round] Professor Walker-Smith” and it is a note signed by presumably a junior doctor, “colonoscopy” and then it gives, “prominent lymphoid follicles …” and “? some minor inflammatory changes” and then it says, “not to have MRI or L.P.” In other words, not to have an MRI scan and not to have a lumbar puncture. Then, Wednesday to have a barium meal. Were you aware at all of that note, Mrs 12? Were you aware at the time that that instruction had been given?
Q You say that you recall your son having a lumbar puncture and an MR scan; were you there for those?
Q You have obviously given consent for the MR but were you actually there when they were carried out?
Q Both of them?
Q As far as the consenting was concerned, do you recall ever signing any other consent forms which set out the details of the whole week of investigations and had an information sheet attached to it, a much more detailed longer document?
A Not specifically, no. I signed lots of things and I do not specifically remember that, no.
Q You have told us that you thought that your son was part of a research investigation. Did you have any understanding as to which of those investigations, all of them or any of them, were part of the research investigations?
A As far as I understood, it was all part of the research into this possible link between the problems that [Child 12] had and the vaccine.
MS SMITH: We know that you were familiar with the protocol because you have told us that, that is the one that was sent to you by the solicitors about the research. I want you to look very quickly, just to see if it jogs your memory at all, in FTP1 at page 234. That is a blank consent form, Mrs 12, which says,
“I have read and understood the nature and aims of this study and have discussed in detail the implications of the study with the doctors concerned. I agree to my child taking part and I understand that I can withdraw my child from the study at any stage without prejudicing their management or treatment in any way”.
If you have looked at that, could you also look at page 232, which is the handout to the parents and guardian which went with it. If you would not mind just running your eye down that, you will see it sets out the nature of the investigations at the start and then the request to carry out a series of tests, in the second paragraph, to clarify the problem for the future.
MR MILLER: Excuse me, Mrs 12, but before we go any further, this witness has identified another document which was a fact sheet with which she was supplied. Ms Smith has not asked her whether or not she ever saw this document, which is not the same thing as the fact sheet. But rather than introduce it first, the appropriate way to deal with this might be to ask her whether she has ever seen this document before, because she cannot comment about it. The wrong way is to go through the document first and then say, “Have you ever seen this document?” The right way is to say, “Did you see this document at the time?” and then she can make whatever points she wants about it.
MS SMITH: I am not sure how this witness can say whether this document rings any bells with her – which was the only question I was going to ask her; i.e. whether she had seen it before – without looking at it to see what it is. That was the reason I was just giving her an opportunity to read it, otherwise the question is not one that Mrs 12 can sensibly answer. As I say, I am sorry if my learned friend thinks it is the wrong way, but it seems to me to be the right way. As I say, how can she identify a document if she is not given an opportunity to read it and say whether or not she has seen it before.
MR MILLER: She has been asked to identify the fact sheet, earlier, which did not include this document. So I still submit that the right way is to say, “Did you see this document at any stage, either when you received the material from Dawbarns or at any other stage after that?”
THE CHAIRMAN: As I understood Ms Smith’s version of events, it is only after looking at the document that she can say whether she recognised it or not, but I take the point. First of all, Mrs 12, have a quick look at this document. Do you remember seeing this document before?
A Not specifically, no.
MS SMITH: Sir, I should say also – I think Mr Miller has slightly misunderstood – that I am not suggesting this document was attached to the protocol, and I am not suggesting it was sent by Dawbarns. Quite the contrary. Having been through the consent forms that Mrs 12 signed at the time when the child was an inpatient at the hospital, I was simply going to ask her whether she had any recollection of signing these documents or any other consent forms at that time. That is all.
THE CHAIRMAN: Mr Miller, are you content with that line?
MR MILLER: We have had the evidence from the witness that she cannot remember seeing this document before.
MS SMITH: That is two of the documents. I am going to ask you about one other which is on page 211, Mrs 12.
THE LEGAL ASSESSOR: I am not sure we have had a clear answer to page 234, whether it is being suggested that pages 232, 233 and 234 go together. She was referred to page 234 and she has not said whether she has seen that before.
MS SMITH: Could we go back to 234, please, Mrs 12? Is that a document that you recall seeing at any time?
A I cannot say if I have or have not, to be honest. It is 10 years ago and there were lots of pieces of paper.
Q Just to complete it, can we go to page 211? This is a document also relating to information to be given to parents. Do you recall seeing that one before?
A Again, not specifically. Saying that, I mean I wrote letters saying I agreed to Child 12 being part of the research, so I had given my consent without having necessarily seen a form like that.
Q Those are the letters we have referred to and your understanding was that you were consenting to take part in the research.
A That is right.
THE CHAIRMAN: Mrs 12 has been giving evidence for close to one and three quarter hours now. I wonder whether you would find it appropriate to give her a break.
MS SMITH: Yes, I shall be a little while longer yet because there are a few more documents. If it is a convenient moment I will be happy to stop at that point.
THE CHAIRMAN: I think it is a convenient moment because I was starting to see her concentration waiver a little. As it is quarter to one, we will adjourn for the lunch break. Mrs 12, you are under oath and in the middle of giving evidence, so please make sure you do not discuss this case with anyone, including the lawyers. Someone from the secretariat will look after you for your lunch provision. We will now adjourn and resume at quarter to two.
THE CHAIRMAN: Ms Smith?
MS SMITH: Thank you. Mrs 12, I wanted to come on now to the period after your son’s time as an inpatient at the Royal Free. I think it is right that you did ultimately receive some sort of notification of the results of the tests that he had been involved in and there were some outpatient appointments that you attended. Is that correct?
A That is right.
Q If you go back to the Royal Free records, please, at page 22 there appears to be a further outpatient appointment at Professor Walker-Smith’s clinic on 31 January 1997. Do you remember that outpatient appointment?
A I remember going back to the Royal Free, yes.
Q Do you remember who you saw in fact on that occasion?
A Not on that occasion, no.
Q Do you remember having a prescription for liquid paraffin?
Q It appears there was a plan to do further blood tests on that occasion. What was it you understood the liquid paraffin was being supplied for?
A Constipation, I think.
Q If we go to page 30 we see another letter from Dr Wakefield. That is a letter dated 3 May to Dr Wakefield, and you say,
I am writing with reference to your telephone call three weeks ago. You asked me to contact you again if I had not received an appointment for [Child 12] to be seen again at the Royal Free within a couple of weeks. I haven’t received an appointment as yet.
You also said you would be able to write a report for me outlining the bowel inflammation [Child 12] has. I haven’t received this either yet. I understand how terribly busy you are and so please forgive me if I seem impatient. After so many years of ‘not knowing’ it is a real relief to have something concrete even though it might not be what one would hope for.
I also sent a urine sample to Dr Linnell a couple of weeks ago for analysis of B12. Do you know what the results of that test showed?
I very much look forward to hearing from you soon”.
There had obviously been a telephone call between you, Mrs 12. Do you remember that?
Q This is the first time you have addressed Dr Wakefield as “Dear Andy”, rather than as “Dear Dr Wakefield”. Had there been some circumstances in which you had got to know him any better?
A I do recall asking him once how I should address him and he said, “Andy is fine”.
Q Was that on the telephone or at a meeting?
A I cannot remember.
Q Do you remember whether you saw him at all during the inpatient stay?
A Yes, during the inpatient stay I did, yes.
Q I am sure you cannot remember exactly how many times, but often, a few times?
A Definitely once, around the time of the colonoscopy and possibly again but I am not sure.
Q This is a letter after the inpatient stay and it appears that he telephoned you direct to ask you to contact them again if you had not had an appointment for Child 12. Do you remember how that arose?
A No, I do not.
Q You asked for a report outlining the bowel inflammation. You said,
“After so many years of ‘not knowing’ it is a real relief to have something concrete”.
Can you tell us what that was related to?
A I think the fact that when the colonoscopy was done there were irregularities seen.
Q So when you say “a report”, you were asking for details, were you, rather than a formal report?
Q If you go to page 14, you will see that that was another outpatient appointment on 30 May. It would appear that on that occasion there was going to be an abdominal x-ray. Do you recall that outpatient appointment?
A Not specifically, no.
Q Do you recall there being some discussion as to whether 12 might be constipated and the fact that an abdominal x-ray might help with that?
A Yes. I remember – I am not sure if it was the barium meal – that there was certainly one x-ray that showed he was constipated, yes.
Q But it also seems that on that occasion a decision was made to give 12 anti-inflammatories. Is that correct?
Q What was your understanding of the reason for that?
A To help with the inflammation which would hopefully help with the bowel problems that he had.
Q If we go on to page 29, please, this is a letter to your GP from Dr Casson. Do you remember Dr Casson?
Q It says that he reviewed 12 in Professor Walker-Smith’s clinic:
“Basically he remains as previously. Unfortunately he has not persisted in taking the liquid paraffin as mum was concerned that it made his soiling worse. He still experiences occasional abdominal pain. He is otherwise well. Abdominal examination was unremarkable.
An abdominal x-ray was performed today which demonstrated marked faecal loading. I have discussed the situation with Professor Walker-Smith and we feel that we should initially start treatment with Olsalazine”.
Is that the inflammatory that you referred to?
“To assess whether this makes an effect. We should hold fire on treating his
We will review [Child 12] in a month’s time”.
Do you recall that plan being carried into effect?
Q How long did 12 actually remain on anti-inflammatories?
A I think at least a year, possibly two.
Q On page 75, please we see, “Mrs 12 left a message”, and discussion of the various results.
“I have explained that we do have some immunology results but I am unable to interpret them and Dr Wakefield will see [Mrs 12] in clinic on 4 July. I have also explained that we need more blood for immunology”,
and then setting out the details in relation to that.
“Dr Wakefield is aware of the need for a report on bowel inflammation”,
which is the explanation that you had asked for. Do you recall whether you did in fact see Dr Wakefield at any of these outpatient appointments?
A I certainly saw him at one.
Q Can you remember whether that was just him or whether he had other doctors with him?
A No, I cannot.
Q If you go to page 28, this is a letter from Dr Malik. Do you remember him?
A I remember the name, yes.
Q He was one of the other registrars with Dr Casson, and it is addressed to your GP and dated 7 July 1997:
“I reviewed [Child 12] in Professor Walker-Smith’s clinic today. He has been on Oltalazine for almost 4 weeks. According to mother this has not made a remarkable difference in his behaviour although he has been opening his bowels more regularly. I have not made any further appointments to see him but I have taken a plain x-ray to ensure his abdomen is better. He needs to continue with liquid paraffin. It is advisable that he should continue on Oltalazine for at least one year. I would be obliged if you could keep prescribing. In our experience most of the children improved on anti-inflammatory medicines”.
Did that sum up your feelings about the treatment that was being given, that it was not making a difference that you could see in his behaviour, but it was helping his bowels to be open more regularly?
A I think “more regularly” meant at more appropriate times.
Q In other words the soiling?
Q If you would go to page 74, please. That is simply a telephone message from you in relation to the inflammation results on 18 July 1997. Then at page 26, this is a letter from Ms Thomas, who is a research nurse. Do you remember her?
A I do, yes.
Q It is to you saying, on 25 February 1998,
“Dear [Mr and Mrs 12],
I am writing to confirm the results from [Child 12]’s visit in the New Year. All were normal, including test for Fragile X, except the immune test. This shows evidence of persistent viral infection; i.e. [Child 12]’s immune system is activated in such a way that indicates it is trying to deal with some sort of ongoing viral infection. If you need to discuss these further please contact Dr Wakefield. I have passed on your query about gluten free diets to Dr Wakefield. I hope that [Child 12] is well and that his aching knees are settling”.
Then she gives some results at the bottom of the page. It shows,
“Full blood count and inflammatory markers – normal (i.e. no evidence of anaemia or inflammation”,
and various other negative tests. You had obviously made some inquiries about whether a gluten free diet would help.
Q Can you remember whether you made that inquiry to Ms Thomas?
A I do not remember who it was to, but I know [Child 12] did go on a gluten free diet for about six months because I spoke to my GP about it as well.
Q Did you have any ongoing contact with Dr Wakefield at this time? This was at the beginning of 1998.
A I do not think so.
Q I want to come away from the medical records and return in the chronology to your dealings with the solicitors, Mrs 12, so could you go to Bundle FTP2, please? This is the next bundle in the chronology. Turn please to page 473. This is a letter from Mr Barr to you of 3 June 1997:
“Thank you for your letters of 3 and 10 May 1997. I am sorry about the delay in coming back to you. I inevitably seem to be behind with my correspondence.
I haven’t heard anything more from the Vaccine damage Tribunal”.
Then he says,
“I haven’t had a copy of the Meridian TV item”,
so obviously you had made some reference to it, because he says,
“I would be very interested to see a copy if you can organise it some time.
We are all waiting for Andy Wakefield to deliver the goods and I really think that if he can provide the proof he thinks he can it is going to be much easier to win the cases.
I am interested in your comments about the rise in the incidence of mumps. What you say, of course, is absolutely correct.
I don’t think you have been updated on our fact sheet recently and in case it is of interest I enclose a further updated version. You will see that once again the section on autism has been extended. Don’t be deceived by the fact that it may not look quite as long as before. We have reduced the print size”.
What did you understand him to mean by,
“We are all waiting for Andy Wakefield to deliver the goods”,
as far as the litigation was concerned?
A I think it was the results of the research that Child 12 had been involved in.
Q That letter obviously included a fact sheet, and I think it is right that you did not retain that one with the letter. But you did retain a Dawbarns fact sheet dated May 1997 which may have been the one attached to that letter. We cannot obviously be certain about that, but the one that you retained is at page 460. As I say, it says at the bottom, “Client newsletter number 4 May 1997”. It just sets out the background of the two vaccines,
“The MMR is the vaccine which has, since the autumn of 1988” –
third paragraph on page 460 –
“been given to children at about 12 and 24 months. In September 1992 two of the three brands were withdrawn on safety grounds. The remaining version of the vaccine is still on the market and is being administered and new claims are being notified every week. The MR vaccine was administered to 7 million school children in November 1994 when the government took the view that there was about to be a measles epidemic”.
Then it sets out details in relation to the two brands. If we go to page 461:
Proving vaccine injury is difficult. Children are often vaccinated at a young age, before they have had a chance to establish a health track record. In addition, problems with development caused by other factors are often not apparent until 15-24 months or even later. This can coincide with the age at which the MMR vaccine is administered.
Until recently the only available course appeared to be to call upon experts to give their opinions as to whether or not a particular vaccine caused injury, and support their views by fairly vague criteria.
The studies of Dr Wakefield and his team (see below) could well prove (at least so far as inflammatory bowel disease is concerned), that it is the vaccine which is causing the injury. We are hoping to develop other tests which will establish the link – either by direct proof or by elimination of all other possible causes. In any event, many of the autistic children also have serious bowel conditions. If the vaccine is implicated with one condition (and found to be present in the body) then it will be easier to establish on balance that it is causing other problems.
Another important factor is that our group of cases includes the children who were vaccinated in the November 1994 schools vaccination campaign. Those children (many of whom were in their teens) have a clear record of childhood health. Most of them had no significant health problems until they were vaccinated. The two groups complement each other. The fact of vaccine damage to older children helps to support the view that the same mechanisms of damage are present to cause injury to younger children.”
Then going on to page 463:
The pilot study (being coordinated by Dr Andrew Wakefield of the Royal Free Hospital) has already started and a number of children have already been tested. Preliminary indications are that there is a strong link between the vaccine and inflammatory bowel disease.
We are now awaiting the results of a more detailed analysis. This includes the use of a technique called polymerase chain reaction which may give us some very significant information.
The aim of the pilot study is to pave the way for a wider investigation of the problems associated with these vaccines.”
Then if we could go on to 465 we will see the details of various campaigns.
“Meeting with the Shadow Health Minister
Unfortunately we have found that the present government does not seem to be receptive to the possibility that vaccines can cause damage. We therefore felt it was appropriate to see the Shadow Health Minister Tessa Jowell MP.
Dr, Kirsten Limb, [the] (parent of a vaccine damaged child) and Richard Barr had an extremely helpful meeting with her in January. Afterwards she wrote to express her concern and gave assurances that she would work towards safer vaccines.”
One of our jobs is to deal with media enquiries. There has been a significant increase in media interest in the issues relating to these vaccines over the past few months, which has resulted in articles being written in: the Sunday Telegraph, the Independent, the People, the Mail on Sunday, the Sunday Mirror, the Observer, the Evening Standard and several magazines.
Several television programs have expressed a keen interest in covering the issues including: Dispatches, Here and Now World in Action and Panorama.
News at Ten filmed a very detailed report, but we understand that they have yielded to pressure from the Department of Health to postpone the showing of the item until after the election. We are now informed that his will be shown soon.”
Then if we can go on to 466, please:
“Plans to Progress the Cases
What we will do
We hope that the pilot study will be completed during the summer.”
Then it says that they will be going back to the QC involved and will continue with their evidence to track down evidence approving the links. So that is in May of 1997, Mrs 12. If we could now go to the next letter to you, which is page 624, please. This is a letter to you from Mr Barr dated 10 November 1997, thanking you for your letter of 22 October, and he says:
“We will be getting out a new Newsletter in the next few days.
This will bring you up to date on what is happening but the key thing is that we are still waiting to hear from Andy Wakefield with his full report.
I enclose a draft of our latest Newsletter ….. not for dissemination. It hasn’t been revised and we may still [need to] add to it or change it.”
He then gives some details about the Vaccine Damage Tribunal. That letter refers to enclosing a draft newsletter, and if we go on to page 610 is this a draft newsletter for September/October 1997 which you produced in your box of documents, and you see it says “Draft” at the bottom, is that correct?
Q “As this newsletter is being prepared we are still waiting for the result of Dr Andrew Wakefield’s pilot study at the Royal Free Hospital. He is hoping ….. to publish the results of his findings and for that reason information about those findings must remain secret until publication takes place. As you will know from previous newsletters he is investigating links with Crohn's disease and with autism. This does not cover the entire spectrum of the damage caused by the MMR vaccines and once his results are known we are hoping to gather together leading experts in the field to determine the evidence that will be needed to bring cases to Court.”
Then there are the details of the meeting with the Health Minister Tessa Jowell, which I have referred to before, but it says on this:
“Kirsten Limb, Richard Barr, Jackie Fletcher and the parents of a vaccine damaged child met Tessa Jowell on ….. 13 October ….. with the Chief Medical Officer ….. and Dr David Salisbury. Dr Andrew Wakefield and Professor Walker-Smith from the Royal Free Hospital also came to the meeting and addressed the Minister on their concerns about the safety of the vaccines.”
Going on to 613, at the bottom of the page:
“Plans to take the cases further
As mentioned earlier, we are waiting for the results of Dr Andrew Wakefield’s pilot study. After that we hope to pull together a meeting of experts to review the evidence”.
I think you then received a further newsletter which may be a finalised version of that draft because it is in very similar terms, and that is at page 630, Mrs 12. That is dated December 1997 and it gave you information, at the top:
“As this newsletter is being prepared we are ….. waiting for the result of Dr Andrew Wakefield’s pilot study ….. He is hoping shortly to publish the results”,
and then reference to the fact that the information could not be released until publication takes place. As I say, it is in the same terms of the draft that I have already read to you so I shall not go through all of it again. We see in the left hand column “Meeting with Tessa Jowell, the Health Minister”. If we go on to the next page there is some information given in the left hand column:
“In our previous newsletter we gave details of the various batch numbers and how to identify the different manufacturers. That information is reproduced again below.”
We see “MMR Vaccines”, the names of the batches and the numbers, and then, underneath those, “MR Vaccines” and the same information. So that, as I say, is December 1997. After that I think it is right, and I think you were aware, that there was an article published in The Lancet which gave the results of various investigations on twelve children with this postulated syndrome between behavioural disorders and inflammatory bowel disease, is that correct?
Q I am sorry, I am just reminded, before I come on to that, Mrs 12, do you recall seeing this December newsletter that I just referred you to?
Q Turning to The Lancet article, were you aware that your son was one of the children in The Lancet paper?
A I think before it came out, yes.
Q If we look at page 790 in this same bundle, this is an embargoed copy of a statement, a press release, in relation to The Lancet paper. Do you recognise that document?
Q This is one of the documents that you produced, is that correct?
Q Do you know where it came from?
A I think Dawbarns.
Q If we can just have a look at its contents, if we go to page 493 (sic) there is a press release by the Royal Free School of Medicine and the Royal Free Hampstead NHS Trust, “What is the relationship with MMR to this condition?” 793, sorry, I gave the wrong number. I do apologise. If we start at 790, just to orientate you, it says “What has the Royal Free Study found?” and it sets out the findings of The Lancet paper:
“Our Lancet paper reports a clinical study that investigated the possible links between bowel disease and childhood developmental disorders, including autism ….. 12 children were referred through ….. Gps, at the request of their parents, because of co-existent behavioural and intestinal symptoms.”
Then it sets out the investigations they underwent. If you turn on to 793, please:
“What is the relationship with MMR to this condition?
Parents reported the onset of behavioural symptoms in their children following either MMR vaccination (8 cases) or a likely measles infection (1 child previously vaccinated with MMR). Behavioural changes included repetitive behaviour, disinterest in play or head banging. This same temporal association with MMR has been observed by workers in the United States. It is important to note that the first symptoms of autism usually appear in the second year of life when MMR is given, leading to the possibility of a false association. Nonetheless, given our own observations and the American findings, we are concerned that MMR may give rise to this complication in a small number of children. This possibility is currently under investigation at the Royal Free Hospital School of Medicine and elsewhere.”
Then going on to 794:
“Having diagnosed this syndrome, is any treatment possible?
At present, there is no specific treatment or cure for autism. However, much more is known about our ability to treat inflammation of the bowel. There are a range of standard therapies including aspirin-like anti-inflammatory drugs that are used to treat inflammatory bowel diseases such as Crohn's disease and ulcerative colitis. Interestingly, when we have treated children affected by this new syndrome with anti-inflammatory treatment, both intestinal and behavioural symptoms have shown improvement in some cases. We intend to conduct a controlled trial of this therapy in affected children, starting in the near future, in this syndrome.
Can I bring my child to be treated at the Royal Free Hospital?
We have been inundated with referrals or requests for investigation of similarly affected children. We are trying to process these as quickly as possible … if you consider that your child fits the criteria for this syndrome, we would be happy to receive a referral from your [GP]”.
There is an enclosed covering letter describing the method of obtaining that referral. You say you received this, you think, from the solicitors rather than from the Royal Free?
A I think so, but obviously I cannot be sure.
Q I have touched on this before, Mrs 12, but did you have any understanding, and please say if you did not, of the pilot study that we have been looking at, that has been referred to in the Dawbarns’ newsletters, how, if at all, that connected with the children who were written up in The Lancet paper, of whom your son was one?
A I had not really taken much note of the---
Q You mean at the time?
A Yes, at the time.
Q I think it is right to say that as far as you were concerned you did not have any complaints about the way that your child was treated at the Royal Free Hospital?
A No, no complaints.
Q Or indeed about the two doctors, Professor Walker-Smith and Dr Wakefield?
Q You have to answer rather than just shaking your head because we do not get it on the transcript.
A Sorry, no complaints.
MS SMITH: Would you excuse me for a moment, please. Yes, thank you very much. Thank you for your patience. Now you will be asked some questions from the other barristers.
THE CHAIRMAN: Mrs 12, as I indicated earlier, this is now the opportunity for representative counsel of the three doctors to cross-question you if they feel it appropriate. Are you happy to continue?
A Yes, that is fine.
THE CHAIRMAN: At any stage if you think that you need a little break, just give me a little hint and I am sure that the Panel will be quite sympathetic. Mr Coonan.
MR COONAN: Sir, I have no questions, thank you.
THE CHAIRMAN: Mr Miller.
Cross-examined by MR MILLER
Q Mrs 12, I am going to ask you just a few questions on behalf of Professor Walker-Smith, and I will try not to go over the same ground we have been over this morning. Your son had developmental problems which appeared to you to commence after he had reached certain milestones ---
A That is right.
Q --- when you compared his progress with that of his siblings?
A I also had the Health Visitor’s record, they have little charts, and he had been progressing on those and then they started to go backwards, so it was not that he just stopped progressing, the charts show that he was going backwards.
Q So it looked as though he had actually got there and then he was receding from that position?
A That is right.
Q Not just simply that he was a slow developer?
A That is right.
Q It was going back. As far as that aspect of his development was concerned, I think a diagnosis, or a tentative diagnosis, was put on it by a local psychiatrist Dr Ing?
A That is right.
Q It was said that he thought anyway that he had Asperger's syndrome?
A Initially he thought he had Asperger's syndrome, but because [Child 12] also had other difficulties he decided it was autistic spectrum as opposed to Asperger's.
Q That diagnosis in whatever form was made before the referral to the Royal Free because it is referred to in the referral letter from the general practitioner?
Q He also had bowel symptoms which included constant soiling or repetitive soiling, loose stools, which you said were not classic diarrhoea but were nonetheless a problem.
Q And abdominal pain which affected his eating, and you were keen to have those symptoms investigated?
Q Presumably, uppermost in your mind, looking back it may have been a slightly forlorn hope, but uppermost in your mind is that some diagnosis might be made and treatment might be decided upon by a specialist unit which would make his life a bit better than it was at the time of the referral.
Q That is why you were interested in him going to the Royal Free, not just simply to be involved in some research but also with a view to making him better, if it was possible to make him better?
A That is right, because I had previously gone to my GP.
Q In your witness statement you say that this was a referral by your GP on matters of clinical need and the referral was on a clinical basis.
Q Do you mean by that that it was for his benefit that you were asking for him to be referred to the Royal Free?
A Obviously primarily for [Child 12]’s benefit.
Q I will come to what you wrote in your letter in a minute because there are two aspects to it which we went through this morning, but anyway, primarily for his benefit. By a slightly roundabout route, Dr Stuart, who was your GP at the time, referred him to the Royal Free and the first contact I think in a hospital setting that you had was with Professor Walker-Smith at his outpatient clinic in October 1996.
Q That involved you and your husband, I think, and your son, telling your history to Professor Walker-Smith, discussing what the symptoms were as far as Child 12’s bowel problems were concerned, and the history, your views about what might have triggered it, and some blood taken for testing about which you were told that the results would be forthcoming within a short time.
Q You appear to have got the impression at that outpatient clinic that Professor Walker-Smith did not initially take the view that your son merited further investigation.
A We wondered whether we put our thoughts across clearly enough.
Q Yes, but one reading of your letters is that you felt you had not argued the case strongly for the bowel problems.
Q Because you wrote the letter to him – I am going to ask you to stay with the Royal Free bundle, although you and the Panel I think were asked to look at this letter in one of the other bundles, but if you would look at the Royal Free Hospital notes at page 68, is that your letter of 20 October 1996?
Q It is addressed to Professor Walker-Smith and in the second paragraph you point out that from your experience of it this is not a problem that children usually have, the soiling problem which was obviously uppermost in your mind, and then you describe in greater detail the nature of his stools, and that was because you did not feel that you had got that point across strongly enough before.
A That is right. At the clinic, our son was obviously with us, and his behaviour is quite challenging when we are out and because you are half trying to control him and half trying to speak to a doctor, sometimes you feel that you have not said all that you wanted to or explained it as well as you would like to if you could have sat quietly.
Q Why were you writing this letter? What was the purpose of the letter?
A I think just to reiterate our desire to have the problems that [Child 12] was suffering investigated, looked into.
Q You were quite keen, if he fitted into the group, if his symptoms did merit investigation you were quite keen that those investigations should take place.
Q Obviously as a parent you make the point that you do not want to put your child through any procedure that is unnecessary but up to that point there was no explanation for these problems.
A That is right, yes.
Q In the third paragraph in that letter, and again it may not have come across quite as forcibly as it does in the letter, you say that you were concerned that he was not growing like your other two children and he was not putting on weight.
A That is right.
Q Did you feel that that was something again which had not come across sufficiently strongly before, or if it had not it needed to be emphasised?
A Yes, just to reiterate it.
Q In the final paragraph you say that you keenly await the results of the blood tests, and if Professor Walker-Smith feels that they warrant further investigations “we are happy for him to be referred to Dr Wakefield’s study project”, so you felt that the blood tests might themselves provide a clue as to whether or not it was appropriate to have further investigations?
A Yes. Obviously if [Child 12] clinically did not warrant any tests then it would be pointless doing it but if there was any indication that he did warrant it …
Q I think there may be two aspects to that, first as to the bowel symptoms that he had, which at least you could describe because you lived with them, but as to the medical aspect, the blood sample, that would have to await whatever the results of the blood tests were?
Q You conclude the letter by saying:
“As you pointed out, it might not help [Child 12], but if not hopefully it will be of benefit to others. There is also the chance that [Child 12] has a problem that can be detected and helped.”
That is what Professor Walker-Smith was saying, “We might discover something which will be susceptible to treatment?
Q The Panel has seen the correspondence about the admission. I think that you wanted to know, when you were told about the slightly elevated blood level, what there was about that that was of interest to the doctors and he gave you the explanation about that.
Q If you look at page 38 in the same bundle, this is a response to your letter where you query the question about the blood tests:
“I have now got back the blood tests. One was slightly abnormal. As I see that you are keen for us to proceed with investigation I think it would be appropriate for us to arrange for [Child 12] to come in for a colonoscopy. I explained in the outpatients what this involved.”
Then he explains it again.
It was right that you were by that stage keen that your son should be investigated as described?
Q Could you help us about what the set-up was: up to this point we have been talking about the outpatient clinic at the Royal Free but when it came to the admission to the ward this was a facility which allowed you to stay with your son for the whole of the time you were there. Was your husband there as well?
A No, just me.
Q Any child in there with his parent or parents had facilities for the parents to sleep in the same room or in the same area with their child, did it not?
A I cannot remember, I am sorry.
Q Can you help about the atmosphere of the place?
A It was fine. It was a hospital. I had a small bed next to [Child 12]’s bed.
Q Did you have a bathroom or anything like that?
A There was a bath … yes.
Q I think there is a bathroom for each little bit and it is quite cheerily decorated.
A I cannot remember.
Q But from what you say, you were with your son for quite a lot of the time, and that included the time when he had the lumbar puncture?
A Yes. I do not think there was any time really that I was not with him.
Q So you were with him when he had the colonoscopy?
Q And just help us about that, would you: the lumbar puncture was done and you can remember that being done?
Q Was that done at the same time as the colonoscopy or around the same time?
A I know he was still under sedation from one of the … If the colonoscopy was the only thing he was sedated for then it must have been straight afterwards but he was still under sedation and they felt that it would be a good time to do that.
Q I think he was under sedation for an MRI as well.
Q But in the sequence of events it looks as though the colonoscopy was on the Monday and at some stage after that, or around that time or afterwards, there was a lumbar puncture and an MRI because you have given consent for the MRI, which we had a look at a moment ago.
Q But certainly it was at a time when he was sedated for another procedure.
Q You were there for just under a week I think.
Q Then there were follow-up visits to outpatient, which go quite a long way forward and which we will come to in a moment, but you were asked about your knowledge of what had been discovered as far as the bowel was concerned, from the colonoscopy: do you remember, I think Ms Smith said eventually you heard about that.
Q Did you see Dr Casson’s discharge summary? Would you turn to page 32, please? This is a letter which was not addressed to you but was addressed to Dr Stuart who was the GP who had referred your son to the Royal Free, and it is dated 22 January, so a couple of weeks after he would have been discharged. On the second page there is a description about the findings at colonoscopy and the findings from the histology, the samples that had been taken. Did your general practitioner give you a copy of that?
A No, I do not think so.
Q Did you ever discuss it with her do you know?
A Not in depth. I know later on she prescribed the olsalazine but I do not recall specifically discussing at length with her.
Q The upshot of the discharge I think was that your son would be started on liquid paraffin, I think that was the outcome of the visit, and you started on that but I think you found that if anything that made the soiling worse, or less controllable.
Q So you went back, I think, to the Royal Free to a couple of clinics, in which it was decided to try an anti-inflammatory, do you remember that?
A Vaguely, yes. I know we went back a few times.
Q We can see the letters which were written by the junior doctors, Dr Casson and Dr Malik to your general practitioner reporting on what had happened at the outpatient clinics: you think you went a couple of times in 1997?
Q Perhaps you would look at page 29? This was a letter dated 2 June to the general practitioner from Dr Casson, explaining your views about the liquid paraffin, the X-ray which showed a degree of what he describes as “faecal loading” and then the starting of olsalazine the anti-inflammatory, that was in June, and I think he came back a month later, on 2 July, which is the page before. This time it was Dr Malik who saw your son in Professor Walker-Smith’s outpatient clinic, and the position was then that he remained on that and it was prescribed by Dr Stuart in XXX, I think you say for at least a year or maybe a couple of years.
Q I think in 1998 there was an admission for a different reason, was there not, in January 1998 there was concern about the fact that [Child 12] was having unexplained pains in both of his knees, and we can see that he was admitted (page 15 of the bundle) on 13 January. He came in and was admitted, was he not?
A I do not think he was admitted, it was just a day visit.
Q That does not look as though it was an outpatient clinic because it talks about the ward.
A We went up to the ward but it was only a day visit.
Q But you went to the ward and I think “Thomas” is the nurse, is it not, whose name appears at the bottom?
Q It looks as though a Dr Vaidya, on the next page, came and examined your son. Can you remember whether it was just a routine outpatient clinic or was it something that you went up specifically because of your concern about the pains in his legs?
A I cannot remember, I am sorry.
Q The original referral, as you told the Panel, was from your general practitioner so as a result of you asking your general practitioner to send the child up, which you said was for clinical need, this was a straightforward referral, it had nothing to do with any pilot study, it was in order for him to be investigated at the hospital?
A In the sense that I had heard that Dr Wakefield was looking into these problems.
Q But it was nothing to do with being referred by Dawbarns.
Q This was the general practitioner. You were asked by Ms Smith that while you had no complaints about the way in which your son was looked after, but in fact it was very well looked after, was he not, at the Royal Free?
Q All Professor Walker-Smith’s team, the doctors who saw him from time to time, Professor Walker-Smith initially at other times and Dr Casson and Dr Malik who worked with him, were kind and they were obviously concerned to look after him, were they not?
MR MILLER: Thank you very much.
THE CHAIRMAN: Mr Hopkins?
MR HOPKINS: I have no questions, thank you.
THE CHAIRMAN: Ms Smith?
Re-examined by MS SMITH
Q I just want to ask you, so we can clear up the dates of the procedures, if you look at the Royal Free Hospital notes on page 119, that was the report that was prepared, a colonoscopy was carried out by Dr Murch, and we see the examination date was 6 January 1997, is that correct?
Q If you go to page 104, this is the report referring to the CSF results, which is the cerebrospinal fluid which you get from the lumbar puncture, and it would appear that that was obtained on 9 January, and we know from the MRI consent form that I took you too that you signed a consent form for the MRI scan on 9 January, so do you think it is probably the case that the lumbar puncture was performed on the say day as the MRI scan, he had a sedation for both?
A It is possible. I know that he was still sedated from one of the procedures, which one, as I say, I cannot remember.
MS SMITH: Thank you sir, I have no other questions.
THE CHAIRMAN: Mrs 12, you have been in the witness chair for around a hour so I think that we should give you a little break. We will now adjourn for 20 minutes and resume at 3.05. At that stage, it will be the time for the Panel members to ask you any questions and, if there are any questions from any of the Panel members, I will introduce them to you. Once again, my usual reminder that you are still under oath and still in the middle of giving evidence. Therefore, please, do not discuss this matter with anyone. I am sure that someone will provide you with a cup of tea or coffee. We will resume at 3.05.
(The Panel adjourned for a short while)
Questioned by THE PANEL
DR WEBSTER: I think you said you were present throughout your son’s stay on Malcolm Ward.
Q Does that mean that you were present at the time of the ward round on 6 January, which was I think almost immediately after the colonoscopy looking at the note?
A I would imagine that I was, yes.
Q That is when it is recorded in the notes that he was not to have an MRI or a lumbar puncture. Do you remember that being said?
A He did not say it. I was not privy to that. I was not told that.
Q Generally, it happens around the bed. I do not know, perhaps the system is different and we can perhaps pursue that later. Nothing was said around the bed when you were listening that these things were not to occur?
A Not that I heard or recall, no.
MS GOLDING: After you met with the parent at the toddler group, did you contact your GP at all to find out anything about any kind of research or issues?
Q Who did you contact first? Was it Dr Wakefield or the solicitors?
A Dr Wakefield.
Q Before you had the first hospital appointment, had you made an application to the solicitors for legal aid at all?
A Before I actually went to the Royal ---?
Q Yes, for your appointment.
A I think that it was all around the same time. I think the legal aid was [granted] in the October.
Q At what stage would you say that your child was off the research study?
A There was no point where he was off the research study as such.
Q There is a point when you had not heard anything for a long time.
A We have not had any contact with the Royal Free for many years, so it was just a gradual ending, if you like.
Q The two words investigation and research has been mentioned. How sure were you that your child was being investigated or was part of a research [study] and how sure were you as to what that research meant or that investigation meant?
A I knew that it was research to see whether there was a link between vaccines and the damage that had happened to [Child 12]. Also, he was being investigated to see why he was as he was, so the two were running alongside each other.
Q Were you expecting any kind of medication which would help him? Was that part of the expectation?
A If what was wrong with him was discovered and if there was something that was available that would help, then, yes, but obviously because it was research as well, it might have meant that there was nothing that could be done to help him.
Q In the Royal Free hospital records on page 42, this is dated the day after the outpatient appointment, was the outpatient appointment the first time you had gone to the hospital?
Q This is asking for all the records, notes and so on to be sent to the solicitors. What records would the Royal Free have had?
A I think I signed a few of these and they were to go to all different hospitals and medical organisations.
THE CHAIRMAN: I have one question along the same lines as Ms Golding asked you. You said on two occasions in your examination-in-chief that your understanding was that your child was being admitted for research investigations. Was that research subject to certain findings or had the decision been taken that this child was to be admitted for investigations for research purposes?
A I am sorry, I do not understand.
Q I will try to repeat the question. Had the decision been taken at an earlier stage that Child 12 would be admitted for research investigations?
A The first appointment we ever had was the one with Professor Walker-Smith in October and no decision was then made. When we had the results of the blood tests which showed that there was a slight abnormality was the first time it was decided whether [Child 12] would be investigated or get involved in the research.
Q Did you also understand that the child would also be treated if necessary?
Q So, it was not purely for research purposes in that case. In that case, it was actually the treatment and research; is that correct?
Q Look at page 38 in the same bundle, the Royal Free Hospital records, looking at the last sentence in this letter, does that give you the impression that this child was to be admitted for research investigations, that is, “If you would like to proceed with this …”? What do you understand from that particular sentence?
A That there were reasons for [Child 12] to be investigated and that if we were happy to go along with that, which obviously we would be because there was a need, then, yes, we would like him to be admitted.
Q As I understand it from this letter – and, please, correct me if I am wrong – certain markers had been found but it was your choice whether you wanted to proceed with the further work on that particular child; is that your understanding as well?
A Now that you have put it like that, yes, we did decide.
Q I do not want to put it like anything.
A I had not thought of it.
THE CHAIRMAN: If there any difficulties, I am sure that one of the counsel will clear up that aspect of it. That is all, I do not have any further questions but counsel can come back and ask you any further questions of clarification. Ms Smith?
MS SMITH: I have no questions but do have one piece of information in the light of what Ms Golding asked. The legal aid certificate was granted on 9 October 1996 and the first outpatient appointment was on 18 October 1996.
THE CHAIRMAN: Again, I am going to ask defence counsel now.
MR COONAN: I have no questions.
MR MILLER: I have no questions.
MR HOPKINS: I have no questions.
THE CHAIRMAN: (To the witness) Mrs 12, I thank you for coming and giving us the benefit of your evidence during most of the day today. You now released, your evidence has finished, and thank you again on behalf of the Panel.
(The witness withdrew)
MS SMITH: Sir, that is the end of the witnesses for today and I apologise for the slight time lapse but you will appreciate that it is very difficult for us to predict exactly how long the defence are going to be. We would not in any event I think have been able to finish the next witness even if we had started this afternoon. The next witness we propose to call tomorrow morning is Dr Jelley who is the GP for Child 8.
THE CHAIRMAN: That is what I have on my list which you gave to us. In that case, we will now rise and resume at 9.30 tomorrow morning.
(The Panel adjourned until Wednesday 29 August 2007 at 9.30 a.m.)