Wednesday, February 1, 2012

Day 20 GMC Fitness to Practice hearing for Andrew Wakefield



Friday 10 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)


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.


Page No


Examined by MS SMITH, continued 1
Cross-examined by MR COONAN 11
Cross-examined by MR MILLER 26
Re-examined by MS SMITH 61
Questioned by THE PANEL 66
Further re-examined by MS SMITH 75
Further cross-examined by MR MILLER 76

THE CHAIRMAN: Good morning, everyone. Wakefield20a1mt

THE CHAIRMAN: Good morning everyone.

Dr Mills, you are in the middle of giving your evidence and Ms Smith was in the middle of actually taking the evidence in chief from you. Miss Smith.

Examined by MS SMITH, continued

MS SMITH: Good morning Dr Mills. If I could ask you to turn back in bundle 1 to page 206.

THE CHAIRMAN: Do you mean the Fitness to Practise bundle?

MS SMITH: No, it is the Local Hospitals volume 1 for Child JS. This is the letter from Professor Walker Smith, which I read out somewhat huskily last night. If you want to remind yourself, this is the letter he sent in response to your inquiries, I think that is right. After you had the document, the proposed treatment document, which we looked at yesterday you wrote to him and said you wanted to know the details of what he said were his successes in treating patients. This is the letter he wrote back to you. I will not read it out again, but I want to ask you, did you discuss that letter with Dr Kirrage?
A I do not recollect precisely, but I know I discussed the whole case with Dr Kirrage in some detail.

Q We have heard from him already, so we know the part he place in relation to this case. What was your view of the position set out by Professor Walker Smith that the investigations were clinically indicated?
A At the time it did not change my opinion that in Child J’s case the investigations they were proposing, the research they were proposing, was not necessarily in his best interests. I was interested to see Professor Walker Smith’s comments regarding the use of salazopyrin and the improvement that some people had reported in children’s behaviour.

Q Professor Walker Smith mentions the position at the end of that letter in relation to the funding of the referrals. He says that:

“... other children that came from distant authorities, the referring authority has agreed to fund these children’s referral as an ECR.”

That was the matter, as we understand it, that you were discussing with Dr Kirrage. Is that correct?
A That is correct.

Q As far as you were concerned, what was your role in relation to Dr Kirrage, what was he seeking information from you about?
A I think my view was I involved Dr Kirrage at two levels. First, there was some correspondence here and people were clearly suggesting it was in the child’s best interests for me to make a referral to them. I wanted to discuss with Dr Kirrage, first of all, the question, simply, if I had made a referral would the health authority accept that and fund that as an appropriate extra contractual referral. Secondly, I wanted Dr Kirrage’s opinion as to how I had been pursuing this and whether the views that I had taken had perhaps been appropriate, and that if he had perhaps taken a different view, then I would have been happy to have gone, or I would have gone, down that route.

Q As far as this issue about whether the tests were clinical or research, why was that relevant to Dr Kirrage’s role?
A I think I was clearly being asked to make a consultant to consultant referral to refer Child J. If I made that referral, the implication would have been that I had wanted Child J to go to London and I had wanted him to have these investigations, because I thought it would in some way help him or be in his best interests. As I said before, I did not think that was the case. I was aware the parents had a different view. I was very aware the parents had a different view and I wanted to make sure I was, perhaps, being fair to everybody in this case, bearing in mind the most important person in the middle of this was Child J, who in fact did not have his own voice, he was not able to express an opinion, so I was trying in some respects to act in his best interest as well.

Q Would you have felt comfortable with telling Dr Kirrage that you were endorsing, if you like, this referral that you were approving it in any way?
A No, I think that is the point. I think if I had made this referral, the implication would have been that I was making a referral because I wanted to make the referral, that I endorsed the referral, that I felt that this was what Child J needed. I did not think that, as I think the evidence here sets out, and I have set out in my evidence, to this point.

Q You say “to this point” and that may be timely because I want you to turn to page 208 in the bundle. This is a letter:

“Dear Andy”.

but in this context that is you, is that right?
A That is correct.

Q It is from Dr Owen, the Community Paediatrician Child and Family Services, dated 2 July 1997:

“I saw this child with his mother at [school]. Mrs S is in touch with ? Professor ? in London re Crohn’s disease associated with Autism following MMR immunisation.

School and parents tell me that [Child J] whimpers prior to passing stools, the stools are mucousy and that there is what XXX referred to as ‘piles’ but what may be rectal prolapse visible for a short time afterwards.

[Child J] was quiet and manageable when seen 4 days after homeopathic treatment.

I will no doubt be in touch about developments as they occur.”

They there is a manuscript note on the right hand side of that, whose note is that?
A That is my handwriting.

Q Can you tell us what it says?
A It says:

“First Evidence for Bowel disease → ? Refer London.”

Q Can you tell us what was the thinking behind that note?
A Up until this point, I had not felt that Child J had exhibited anything what I would have regarded as significant symptoms suggesting that he required detailed gastroenterological investigation. This was the first report that I had had from anyone to suggest that he might have had something that would suggest that we should have taken this further. Mucous in the stools is perhaps suggestive of inflammation within the gut and the question of rectal prolapse is possibly suggestive of pathology within the gut, although it can sometimes be associated with children who have severe constipation or other problems. I suppose by this time I was particularly sensitised as to my view and my opinion and the families views and referral to London, so I felt I had written that note for myself – is this a time when, perhaps, I had been wrong or perhaps this was a sign that he did actually have some symptoms of GI tract disorder which would perhaps indicate tertiary referral. In normal situations I would not be considering referral to London, I would have perhaps done some investigations myself and taken referral closer to home in XXX. I was aware of the view and, in this particular case, I was very aware of the situation and wondered whether this may have been a situation where my view should have been changed.

Q If we look on to page 210, we see a letter from Mum to you:

“Dear Dr Mills.

Enclosed is a copy of a letter I have today sent to Dr Wakefield. I am so sorry you feel you are unable to make a referral for [Child J].

I appreciate it is a difficult decision for you, but I feel sure that when such a totally life destroying occurrence has happened to what was a normal, very happy and communicative little boy, any parent would want to look further.”

There is a note on that letter please copy to David Kirrage?
A That is right.

Q “Asap”.
A As soon as possible.

Q That letter enclosed a letter to Dr Wakefield which is at page 209. This was sent to you, we see at the bottom “Copy to Dr Mills”:

“Dear Dr Wakefield

I am writing to ask if you could please refer my son for tests to see if there is any way he can be helped following the devastating damage caused by his MMR injection in 1992.

As you know he is presently a weekly boarder in an autistic unit at XXX School. His care assistant has noticed he seems to become very agitated before a bowel movement and that he appears to experience some pain or discomfort.

He has a history of diarrhoea – although the stools are more normal now. As he has no communication we cannot tell where his discomfort lies. It is very difficult to know if [Child J] is in pain because he is so active – to the extent of him now scaling a 7ft fence in order to escape.”

It refers to an episode where he was found in a nearby brook some two weeks previously:

“The whole issue if of his security is causing us much worry.

I would very much like to be referred to you as during my last appointment with doctors here it was made very clear that there is nothing they can do to help him medically bar seeing a psychiatrist for drugs and keeping him in an autistic unit.

I feel my doctors do not believe that [Child J] has been damaged by the vaccination – in spite of the fact that he was a perfectly normal baby, and a bright, affectionate and highly verbal toddler. And in spite of the fact that the vaccine he was given was later withdrawn by the government because it carried a high risk of adverse side effects.

My husband and I feel we must explore every possibility to help our son. As it is now [Child J] has no future at all – other than being sedated and confined in an institution.

I look forward to hearing from you soon.”

That is the letter Mum sent to Dr Wakefield. The next thing we see is a letter from Dr Kirrage to you at page 213. We have been through this letter from Dr Kirrage, but if I can refer to it with you. This is his view:

“I drafted a letter to Mrs S which I think sums up the public health views. I would like you to see it before it is sent in case it does more harm than good.

I feel that you are entirely right in the line you have taken. There is no evidence that this will benefit [Child J] and a literature search has not added anything new. I appreciate the pressure on yourself and the GP and will support funding the investigation if you feel that in the end this is appropriate. My letter ‘sits on the fence’ and hopefully will enable you to act either way. If you feel that it is not helpful then please bin it.”

You will see the letter attached to that which is going back to pages 211and 212. I am not going to read the whole of this. This is the letter Dr Kirrage has sent in. Going through it quickly:

“Dr Mills asked me for an opinion on certain aspects of [Child J’s] care and provided me with the clinical background to Child J’s condition together with the correspondence between Professor Walker Smith and himself. As a Public Health Consultant one of my principal duties is to critically appraise the evidence.”

He then sets out the position, as he understood it, from the information he had been given by Dr Elizabeth Miller at the Public Health Laboratory Service in London. Going on to page 212:

“Moving on to whether investigations at the Royal Free Hospital will establish the diagnosis and indicate a means of treating this, I feel that at the present time there is insufficient evidence to support this. I do acknowledge, however, that there could well be benefit from actively addressing symptoms that some children with autism have experienced. My understanding is that Dr Mills has been very exhaustive in his efforts to ensure that [Child J] was not subjected to unnecessary and uncomfortable tests for gastrointestinal symptoms which he was not experiencing. I think this is entirely appropriate in Dr Mills clinical responsibility to [Child J].

I fully understand the desire on the part of all concerned to help [Child J]. I think at the moment there are not strong grounds to indicate referral to the Royal Free. I note from your letter of 5 July that the care assistant has noticed that he may be experiencing discomfort before bowel movements. If this was to persist or increase in severity then I would suggest that the indications for possible referral may strengthen the balance in favour of investigation at the Royal Free. I think this is decision that should be made by those directly involved in his care and that my role is merely to provide an objective evaluation of the indications and benefits of investigation and treatment by the study group under Professor Walker Smith.”

Do you know whether that letter was ever actually sent.
A My understanding is that it was, yes.

Q You think it was. Did you feel that – obviously you can speak for Dr Kirrage – but did you feel that Dr Kirrage had accurately summed up your position of the matter?
A Yes, I thought he had.

Q Was it your understanding that the ultimate decision of the health authority was that they were not going to fund, at that stage, the investigations at the Royal Free?
A It is my understanding that they would. I think they ultimately left it to me and that if I felt it was clinically indicated that they would.

Q If we turn on to the next step at page 214, a letter from Professor Walker Smith to you dated 1 July 1997:

“Dear Dr Mills

I eventually saw Child J privately at the parents’ insistence. You are familiar with the correspondence I have had concerning the child.”

He then sets out his history at birth. He had his first MMR at the age of 18 months when he had a fever and was unwell.

“The parents believe that following the MMR he had frequently running eyes and nose and required antibiotics.”

The grandmother noticed from the age of two that he was looking glazed and losing words.

End of a1 Karen took over

At page 215 we see that he was diagnosed as atypical autism at the age of 3 years by
Dr Betsy Brua. We have looked at that correspondence.

“Later he had a number of investigations by yourself. Deafness was excluded. From about the age of 2 years [Child J] had episodes of diarrhoea. However, his stools are much better now and only occasionally loose. Typically he normally passes 2 large stools per day and currently his episodes of diarrhoea are quite infrequent. He does however sometimes have pain on defaecation. His has never passed blood but at the age of 4 years there was some anal pathology which apparently was diagnosed as ‘piles’ from which he has subsequently settled ...

On examination he is a very active child who is well nourished. Height and weight are both close to the 75th percentile. Clearly this is a child within the autistic spectrum who does have currently some rather minor gastrointestinal symptoms. There is considerable parental concern abut the role of MMR in the initiation of this child’s illness. This is very difficult to be certain about. However, this is a child who would be suitable to have investigation by colonoscopy etc, and I enclose details of our protocol concerning this. I have explained the situation to the parents and I have made no definite arrangements for him to come in but I do believe that this procedure could be of value as I outlined to you in earlier correspondence.”

That was the letter that Professor Walker Smith wrote to you and we see his reference to parental concern about the role of MMR. He describes the child as having atypical autism and he sets out gastrointestinal symptoms himself says that they were rather minor. Overall does that represent in your view, Dr Mills, a fair picture of JS’s position.
A Yes, I think that was a fair representation. I do not think I had recorded the piles previously. I do not have any recollection in any of the notes in front of us about the piles previously. The slightly minor intermittent diarrhoea from time to time was my understanding. His description and mine would have been similar.

Q Would you too have described his gastrointestinal symptoms as rather minor?
A Indeed, yes. I have said that right the way through.

Q Would you too have said that there was very considerable parental concern about the role of MMR?
A Indeed. We have said that right the way through also.

Q The next step was that you wrote to Mr and Mrs S. Before I go on to that, may I ask you to just one more question arising out of that letter, Doctor. Professor Walker Smith says again that he is enclosing a protocol. Do you recall the details of what was enclosed with that letter?
A I do not precisely remember the precise details as to what was enclosed. I think we have seen two protocols in the other parts of the paperwork. Whether they were similar to the ones that had been sent or not, I do not recollect.

Q The next step is that you wrote to Mr and Mrs S. We have that letter, dated 2 September, at page 216.

“Dear Mr and Mrs S,

Following my recent telephone call, I am still not sure whether you wish me to make a formal referral to Professor Walker Smith in London for detailed gastroenterological investigations of [Child J].

I note from Professor Walker Smith’s letter to me that he feels that [Child J’s] gastro intestinal symptoms are ‘minor’ but he would be suitable to have investigations by colonoscopy etc.

How would you like me to proceed?”

There is a note at the bottom – is that your handwriting?

A That is my handwriting, yes.

Q Can you just tell us what it says? It is dated 5 November.
A It is dated 5 November 1997.

“Phone call to mum. They did not receive this letter”.

Then underneath that I have put, “Dad’s business address”. You will notice at the top of the letter I have changed the postcode from ‘XXX’ to ‘XXX’. If I remember correctly, I think mother may have said, “We did not receive the letter, we have been having problems with the post. My husband’s business address may be more reliable” if my memory serves me right on that.

Q They did not receive it, so obviously they did not respond to it. As far as you were concerned, what was your thinking behind that letter? Were you changing your mind about referral? What was the reason for writing in those terms?
A The family had made a decision to take J to London for an opinion and for an assessment themselves. That was their decision and they were entirely entitled to do that. I had had an opinion from Professor Walker Smith regarding what he felt may be appropriate and I felt, considering the whole weight of the case and what the family wanted, that I would be happy for them to go ahead with what Professor Walker Smith was recommending if that is what they wanted.

Q Whose responsibility would you then have regarded it as being to make the final decision if the referral was made to Professor Walker Smith as to whether it was appropriate for J to undergo the investigations, the actual ones he was proposing?
A The family had voted with their feet and had gone privately to see him. That was always their right to do that. I recognise that and I respected what they wanted to do on behalf of their child. I had an opinion from Professor Walker Smith after he had seen J, so he had actually made the clinical assessment having seen him rather than having heard about him. I felt if he was still advising having seen Child J, then it would not have been appropriate for me to say no. I had my own view about it, but after he had actually seen J and had given that opinion, I felt it was inappropriate for me to then say, no. The family were aware of my view right the way through, but they had taken a different view. They had made a decision on their own behalf to go and seek this and I felt that I needed to support what they wanted from that point of view even though I had my own private misgivings regarding it.

Q If we go on to page 219, Doctor, this is a letter from Daniel King, the ECR manager, and you were copied into that letter. I will not read through the whole of it. It was to the Deputy Contract Manager at the Royal Free.

“... You will see that at that time there was no information available that supported the clinical effectiveness of the proposed treatment. We are not aware that this situation has changed from that time and will therefore not be funding this ECR”.

That was a decision, obviously, that was made at the local authority level and was not your decision. Can I ask you, so the Panel are clear, if the parent choose to go and see a doctor privately and pay for it, then that is their right and it does not involve public money and so it is their decision; is that right?
A That would have been their decision, yes.

Q If we can turn briefly – and we are nearing the end of the story as far you are concerned – to the correspondence from the Royal Free Hospital to you. If we go to page 224 we see a discharge summary from the Royal Free dated 27 November 1997 to you:


1. Autism.
2. Intermittent diarrhoea”.


“[Child J] was admitted for a colonoscopy as part of our investigations into inflammatory bowel disease in autistic children.”

Then it sets out his birth history. It says,

“[Child J] has had intermittent diarrhoea with no blood or mucus over the preceding year or so. This is associated with abdominal pain but no vomiting”.

Then under “Immunisation history”

“[Child J] received his 3 triple vaccination and his MMR booster at 15 months.”

Then the investigations which were carried out are set out, blood tests.

Then under “Colonoscopy”

“Increased vascularity in the rectal sigmoid junction from the splenic flexure. Increased granularity around the caecum possibly with increased vascularity. Lymphoid nodular hyperplasia of the terminal ileum”.

Then under “Histology”

“Revealed no active inflammation but the caecum showed lymphoid aggregates, the colon revealed patchy active cryptitis with eosinophils and neutrophils”.

Then under “Plan”

“[Child J] was discharged shortly after colonoscopy prior to his histology results becoming available. We will be following him up in clinic to discuss implications of the results.”

You got that discharge summary, but were you in fact aware of how JS had ultimately fetched up having these investigations and who funded them, Doctor?
A No, I was not aware precisely how that had happened. I assumed that it may have carried on from the parents’ wish for private treatment, but, as the correspondence indicates, I had not actually formally requested those. They had gone ahead anyway. Maybe the GP being involved, I was not aware.

Q Then Professor Walker Smith wrote to you and we have that letter at page 226 dated 6 February 1998.

“Dear Dr Mills.

I thought I would just follow up the previous communications that you had concerning [Child J]. In fact, a colonoscopy did show lymphoid nodular hyperplasia with a non specific colitis as we have shown in other children. What was particularly interesting was that [Child J] did in fact have evidence significant of inflammation histologically. There were crypt abscesses and some patchy evidence of inflammation in his colon. Furthermore, subsequent investigations have shown some abnormalities of T cell subsets. Other investigations are currently being pursed. I have suggested a therapeutic trial of Pentasa 500 mgs twice a day when I saw the child once for follow up. I have not made further arrangements to see the child fro the moment, but I do think that it would be helpful if we were to see him at some time in the future to evaluate any therapeutic success with the Pentasa therapy”.

As far as that information was concerned, we see from the discharge summary, if we turn back a page to page 225 that the histology had revealed,

“No active inflammation, but the caecum showed lymphoid aggregates, the colon revealed patchy active cryptitis ... “

There is a note of the fact that the results had not become available until Child J had been discharged. Then we see on page 226 histologically, there was evidence significant of inflammation and that prescription of pentasa by Professor Walker Smith. Who did you regard as being responsible from then on for the clinical management of any inflammation that Professor Walker Smith felt he had detected?
A At the time, Professor Walker Smith had undertaken the investigations he had started a form of treatment. I felt that he bore some responsibility for monitoring and following that treatment through.

Q Was pentasa a substance with which you were familiar?
A No, I do not recollect having used it in any children previously or subsequently, although I tend not to see children with inflammatory bowel disease as part of my practice anyway.

Q If we turn to page 227, we see a letter from you to Professor Walker Smith dated March 1998.

“[Child J’s] mother contacted me soon after the appointment with you to ask my advice. She was of the view that the Pentasa had resulted in increased frequency of bowel motions and increased discomfort. I suggested that she withheld the medication for several days and then restarted it to see if the symptoms recurred.
I have advised her to contact you, although she indicated that she had not been able to do this previously.

She went on to ask them if it was possible for [Child J] to be referred to a Paediatric Gastroenterologist nearer to her home as she is finding the burden of travel to London quite difficult. I said that I would write to you suggesting that you may wish to refer [Child J] to Birmingham Children’s Hospital.

I have taken the liberty of copying your previous letter to me, to [Child J’s] general practitioner, Dr K Shore...

With regard to my previous correspondence, I am still looking forward to information from you in relation to your successes in treating children with autism”.

Did you ever receive a reply to that letter, Doctor?
A I do not recollect receiving one, no.

Q You sent one to the GP, as you said you were going to. If we look at page 228, we can see that letter. If we go on to page 230, you copied Professor Walker Smith into that letter. We see that you had been asked to see Child J because of increasing episodes of aggressive difficult to manage behaviour and the school had reported that he was becoming increasingly aggressive. We can see further down on page 229,

“Mother and school report that [Child J] likes to wear clothes loose around his waist and I wonder if this may be a sign of abdominal tenderness. Apparently bowel motions are very variable. On occasions he can have loose bowel motions up to four times a day. On other occasions they can be formed occurring twice a day. Sometimes [Child J] has apparent discomfort on having his bowels open but on other occasions there is no particular problem. Slime occurs from time to time but there has never been any blood.

On physical examination [Child J] had a soft non tender abdomen. I could palpate deep into his left and right ileo fossa without any discomfort. His anus was clean and there was evidence of any inflammation. I did not attempt a p.r. Genitals appeared normal.

[Child J] is growing every well and height and weight continue to grow along the 75th centile for his age.

Mrs S reported that Pentasa treatment by Professor walker Smith has resulted in increased frequency of bowel motions and increased discomfort. She stopped the treatment for a fortnight and re started it. After seven days [Child J] developed quite severe nose bleeds and the medication was stopped again and the family are not keen to re start it. In addition they found that [Child J] was very reluctant to take the medication which has always been a longstanding problem with him. The family have asked me to refer [Child J] to a gastroenterologist nearer to home so I have written to Professor Walker Smith in March, but I have not yet received a reply concerning this. I note that investigations at the Royal Free showed no evidence of malabsorption. I find it very difficult to convince myself that [Child J]’s difficult behaviour is in any way related to feelings of discomfort of pain. Despite the investigation findings from the Royal Free Hospital, I do not believe that pursuing treatment of his inflamed bowel will make any difference to managing his behaviour.

I understand his behaviour is particularly bad at present... It is clear that those looking after [Child J] need a lot of support at the moment and I have arranged to see him again in a month’s time”.

It is plain from that letter that the view the family had as far as pentasa was concerned. I have asked you already whether you heard from Professor Walker Smith. Did you hear in fact hear subsequent to that letter, the letter to GP?
A I do not recollect having heard from him subsequently, and I do not think there are any letters in the bundle from him, if I remember rightly.

Q Has Child JS continued under your care?
A He continued under my care until he went into residential care out of the county. It is a manifestation of how severe Child J’s disability and behavioural problems were that his family, and indeed the residential school in XXX, was struggling to meet his needs. In fact, he was one of the small number of children that the local authority and educational authority have to find alternative residential placement for a child somewhere else in the country and he moved to XXXX if I am correct. I have not had any dealings with him since he moved out of the county.

MS SMITH: Thank you very much, doctor. Please remain there.

Cross examined by MR COONAN

Q Dr Mills, good morning. Could you have a look, please, first of all at the local hospital records at page 117? It is a little time since we looked at this document, and I would just like to spend a minute or two with you, please, looking again at it. If we look at the terms written by you to Dr Wakefield, we see that in the first paragraph your understanding is that Dr Wakefield has recently spoken to the mother of Child J and it is clear from that, isn’t it, that the mother must have told you that?
A Yes.

Q And in the second paragraph you set out there that your understanding was that Dr Wakefield had suggested to her on the telephone that a referral to Professor Walker Smith may be appropriate, and that Mrs JS had contacted you asking you if you would make a referral. Do you see that?
A Yes.

Q Now, first, the information in that second paragraph clearly comes from Mrs JS, does it not?
A Yes.

Q And on the assumption that it is an accurate distillation of what she told you, and I am not suggesting it is not but on that assumption, she is in effect relaying a suggestion from Dr Wakefield that a referral to Professor Walker Smith may be appropriate?
A That is what it says here, yes.

Q But she is specifically asking you to make a referral?
A That is the implication of this letter, yes.

Q And she is asking you to make the referral to Professor Walker Smith?
A The letter implies that Dr Wakefield had suggested that that was something that could be done.

Q I do not dispute that, but she is clearly asking you to make the referral to Professor Walker Smith? It is an actual direct request?
A That is what this letter says, yes.

Q To him?
A That is what this letter says, yes.

Q And at that stage, as we see from the last two lines on that page, to take it a stage further, “Mother has asked me to make a referral to your team”. Now, was it the position that you believed at that stage that Dr Wakefield and Professor Walker Smith were part of the same team?
A Certainly the letter implies that, yes.

Q And, of course, the letter may imply that to us now, ten years/11 years down the line, but that surely reflects your understanding in 1996, does it not?
A That is what this letter reflects, yes.

Q Now, I will come back to that but if we just focus for a minute on the first two lines again, I understand you recently have spoken to the mother. If we keep a finger in that, you will need to look at the Royal Free notes, page 80, and you will see what should be a letter from Mrs JS to Dr Wakefield, dated 16 April, “Thank you for your telephone call last week”, so we have clear evidence of a conversation between Dr Wakefield and Mrs JS. All right?
A Yes.

Q And then put that to one side and go back to the local records and turn up, please, page 191. I will come back to this letter in a different context, if I may, but you will see there on the fourth line where it is asserted by Dr Wakefield:

“Secondly, Mrs JS phoned me initially and has continued to request investigation as part of our protocol”.

So we can see, can we not, that we have clear evidence of Dr Wakefield’s position as to the first contact between him and Mrs JS. Do you see that?
A One letter says that she phoned him and the other one says that he phoned her.

Q It says, and let’s be careful, Dr Mills, RF80 says “Thank you for your telephone call last week”. That is all it says. It does not say who phoned who first, does it?

Q It does not deal with the leaving of messages, does it?
A The letter is written as it is, for the Panel to judge.

Q Why did you make an assumption, then?
A I am sorry, which assumption are you saying that I made?

Q That the two were inconsistent?
A I am sorry, I was not aware I was making any assumption talking about any inconsistency.

THE CHAIRMAN: Dr Mills, can you keep your voice up, please?
A I am sorry, I was not aware I was saying there was any inconsistency.

MR COONAN: We have a position by Dr Wakefield at page 191 that it was Mrs JS who made the first contact with him, and that following that there was clearly a telephone call between them, all right?

Now, this Mother, as we have heard, was by all accounts a fairly desperate parent, was she not?
A That is right, yes.

Q And I think we can divine from what you have been saying, therefore, that it would not have been surprising at all if, in her desperation, she had got to know of Dr Wakefield’s work and had contacted him.
A I am sure that is quite possible.

Q Now, we come back to this letter at page 117 in the local records, and it is stating the obvious but I am sorry to take you through these steps, the first contact with Dr Wakefield was by you. It was not Dr Wakefield phoning you or getting in touch with you; it was you to him?
A Yes. That letter implies that, yes.

Q And as we see at the bottom of the letter, on page 117, you say to Dr Wakefield, “Could you let me know what you would be able to offer [Child J] and the family?” and that on any view is a clear invitation to him to respond to you, isn’t it?
A Indeed it is.

Q And on the next page you set out your position, and you say that you are not keen on sanctioning detailed investigations unless there seems to be some logic behind them, and that was the phrase you used, “logic”.
A That is the phrase I used in that letter, yes.

Q The next stage I am going to suggest in this was a telephone call between yourself and Dr Wakefield. Would that be about right? That following that letter, you had a telephone call?
A My recollection is we had a telephone conversation, yes.

Q And that telephone conversation would be, of course, in direct response to the request at the bottom of the letter, would it not?
A I presume that it would have been, yes.

Q Now, you do not have a note of the telephone conversation, do you?
A The records that have been presented here do not contain any of my contemporaneous written notes, no.

Q It is a long time ago. The nearest we can perhaps come to any sort of record is perhaps on page 114 of the local notes, and this is a letter to Dr Shore, the GP, on 3 June. Your letter to Dr Wakefield had been on 29 April on page 117, as we looked at here, and we are now on 3 June, and we look at the last paragraph on that page 114 and you say on the fifth line, “I have discussed the issue with Dr Wakefield myself and his team are undertaking research into measles associated chronic diarrhoea”.

Did you think when you wrote that again that Dr Wakefield and Professor Walker Smith were part of the same team?
A Yes, I think I did.

Q But we see over the page in the last paragraph that you refer on the second line to “gastrological investigation and research”.
A That is right, yes.

Q So you are making a distinction between the two elements?
A That is what this letter implies, yes.

Q And you could only really have got that sort of distinction as a result of having spoken to Dr Wakefield on the telephone.
A I remember speaking to Dr Wakefield on the telephone and I described to the Panel yesterday my memory of that telephone call, his enthusiasm about bowel associated, or colitis, virus measles associated, and that is association with autism, and the research that they were doing looking at those things. The gastroenterological investigation was part of their research.

Q I think you told the Panel that is how you understood it, as a result of what he is saying, that it was all part of research.
A My memory from the telephone conversation I had with Dr Wakefield, and the implication from my letters, was that this was research they were undertaking in his area of interest.

Q You see, you talk about the research “they” are undertaking, and “his” research interest, yet you thought Professor Walker Smith and Dr Wakefield were all part of the same team?
A I had no reason not to think that.

Q You had not at that stage separated out in your mind that Professor Walker Smith was the clinician assessing and investigating children, and that Dr Wakefield was a scientific researcher.
A No. Dr Wakefield had not told me his background. In fact I assumed he was a paediatrician, maybe a gastroenterologist himself.

Q I see. So you thought he was a paediatrician.
A Well, indeed I did, yes.

Q Let’s go back to the content of the conversation you had with him, and I appreciate it is eleven years ago. The picture you came away from that phone call with was this, was it: that here was somebody who had been speaking very enthusiastically about his research interests?
A Correct.

Q Was he animated?
A I remember him saying: “We are really very excited about this, we think it is very important”, or words to that effect.

Q And he gave the impression to you of being very interested indeed at looking at the mechanisms for the cause of gastrointestinal symptomotology and pathology, did he not?
A That is my memory, yes.

Q And did he talk about the possible link between that pathology and symptomotology and those children who had suffered regressive developmental symptoms and signs?
A If I remember rightly he talked through the history of it and said that he and his team were surprised to find that the things they were looking at were often associated with children with autism.

Q Yes. And did he mention the possible mechanisms for the pathology and symptomotology as being potentially viral or due to B12 deficiency?
A He explained his interest in the measles virus and the measles virus being associated with inflammatory bowel disease, and was surprised to find the association between the inflammatory bowel disease and autism, and then began to find that maybe the measles virus was, if you like, a common aetiological factor.

Q And do you remember him mentioning the potential role of vitamin B12 deficiency?
A I have no recollection of that.

Q And did he mention that a number of children had been assessed and investigated at the Royal Free Hospital to date?
A I am sure that he implied that they had been doing research and investigation on such children, yes.

Q And that there had been some good results with treatment on those children in relation to their bowel symptoms?
A I do not remember that precisely. He might have said that: I do not remember it. I think if he had implied to me that they were treating and these children were showing great improvement then I might have actually mentioned that in some of my correspondence, because I would have seen that as quite an important fact.

Q And did he mention to you that there had been, in respect of some of the children, following assessment, investigation of them, either by colonoscopy, EEG and MRI, and occasionally by lumbar puncture?
A I remember from the conversation that I was left with a view that the extensive investigation that they were offering these children as part of the research was very intensive, and probably would not be suitable for someone such as Child J. I remember being left clearly with that impression.

Q Well, you have made your position clear that you did not think it appropriate for this child and that is your view. I am not going to deal with that particular point; you have made that clear. But do you remember that Dr Wakefield said to you that he knew something of this little child as a result of what the mother had told him?
A I do not remember that precisely, but

Q You would not be surprised?
A I would not be surprised. I am sure that would be implied in the conversation. I knew he had spoken or had communication with the family.

Q And do you not remember him saying to you that from what he already knew via the mother of the child, that the child appeared to be suitable for assessment not investigation but assessment from which might lead investigation? Now, I have put it in those words eleven years down the line, but I want you to try and, as it were, take the gist of what I am saying.
A I think the evidence that we have are the letters that I have written subsequently. The letters I have written subsequently do not put that spin on that. The letters that I wrote subsequently do not imply that I was left with the view that this was going to, clearly, lead to treatment.

Q I was not saying that there was any spin at all, nor was I suggesting that it would lead to treatment. I was simply suggesting whether you could remember Dr Wakefield saying to you that from, what he knew, the child was suitable for assessment at the Royal Free?
A Oh yes, he was very enthusiastic. Mrs JS was passionate in her belief that MMR had caused her son’s difficulties and I respected that view. I knew that Child J would have fitted into Dr Wakefield’s model of how autism could be caused by MMR vaccine, or measles virus, so I could understand why he was keen to see him.

Q At that stage, you are talking, as it turns out, to the researcher, although you did not know that at the time?
A No.

Q This person you were talking to was talking about a research interest, clearly, was he not?
A Yes.

Q At the end of the telephone call did you, in effect, think, “I am not closing the door to this, let us see how we go”, or words to that effect. I am putting it in that rather rounded way, but was that not your state of mind?
A I think that is a fair reflection. I remember thinking, “I am not sure this is the right thing”, but I do not think my mind was closed.

Q Because you were asked about this yesterday. You have to look in the Royal Free notes at page 78. We see on that version of the letter that you sent what appears to be Dr Wakefield’s note. Do you see that?
A Yes, I do.

Q “Discussed with Dr Mills, happy to make”. This is a photocopy, we do not have, as far as I am aware, the originals available, but this is a telephone note which was clearly written as a result of a telephone call, was it not?
A I presume so, yes.

Q It could not have been in any other circumstances. It is not as though you had ever met?
A No.

Q Certainly, as a result of that telephone conversation, you appear to have left Dr Wakefield with the view that you were, and I simply quote, “happy to make”, as the note appears to be incomplete. That is the impression you must have given him?
A Well, I do not quite know what “happy to make” means, but that is an interpretation of that, yes.

Q I suggest it is a common sense interpretation of the note, is it not?
A I do not know what “happy to make” means. That is an interpretation and seems a reasonable interpretation, but I do not know precisely what it means.

Q It does not say, for example, “Dr Mills rules this out” or “Dr Mills rejects the idea” or “Dr Mills thinks this is wholly unsuitable”, nothing like that?
A It does not say that, no.

Q It may be that the position was, Dr Mills, if we turn on to page 76 in the Royal Free notes, there is a letter we have not looked at yet. There is a letter from Dr Wakefield to Professor Walker Smith. You see on the second line, and you will not have seen this unless you have seen it recently:

“His community paediatrician, Dr Mills, was initially enthusiastic about referring him. He now seems to have gone cold on this”.

You see the date of that, 6 November. Again, that, on any view, was Dr Wakefield’s take on the initial conversation that he had had with you?
A Yes, that is what he says there.

Q The situation after the first telephone conversation, as you have just told the Panel, was that you had an open mind, you were not going to rule anything out, but in fact nothing happened in the sense that you did not make a referral. That is correct, is it not?
A My first letter to Dr Wakefield was in April 1996 and that letter was November 1996. I am not sure of the date of me receiving the details of the investigation schedule, but I suspect it was between those two dates.

Q When you say “the investigation schedule” from whom?
A I think the initial one I received from Dr Wakefield and the one more subsequently was from Professor Walker Smith.

Q We will look at the correspondence but, so far, on the unfolding correspondence
A I need to check through the notes to see, but there is a six month gap there between those two letters.

Q There was, and the correspondence, if we go back to page 117 of the records, that is you by letter to Wakefield, then we have the telephone call we have been discussing. The next correspondence of any sort that you have with Dr Wakefield is a letter from him in which he deals with the accusation that you made against him in January 1997, if you turn to page 191. As between you and he there are only two letters?
A Indeed.

Q Two telephone calls?
A That is my recollection.

Q I do not want to rush ahead for a minute, but we have dealt with the first phone call following the letter from you to him, the door was left open by you, no referral was made and then, I suggest, the second telephone call occurs and it is simply Dr Wakefield asking you, in effect, what was going on. Those are my words, but just a query to find out what had happened because there was now a five month gap. That makes sense, does it not?
A My recollection of the second telephone call was that he phoned to say, “Why have you not referred?” That is my recollection.

Q Or words to that effect?
A Yes.

Q The phone call is made because a significant amount of time had elapsed and you, having given him the impression that you had an open mind to this, nothing had happened and, so, his inquiry to you was perfectly reasonable, was it not?
A Yes. His second phone call to me was to ask why I had not referred.

Q It is a perfectly reasonable inquiry?
A Yes.

Q Thus far, two telephone calls and that one letter from you to him. That is the only contact you have had with Dr Wakefield?
A That is the only contact I had directly with Dr Wakefield given the information in the bundle we have in front of us, yes.

Q Thus far, if you bear with me, one letter from you to him, one telephone call back in response to a request in the letter by you in which he explains his research interest, and the second telephone call four/five months later to say in effect, “What has happened?” and you have agreed that this is a perfectly proper inquiry. So far there cannot be any basis whatsoever, can there, for thinking that Dr Wakefield has been pressurising you or the patient?
A There is not any evidence here that Dr Wakefield pressurised me. As for Mrs JS, I am sure that each time I met them she had talked to me about it.

Q I do not doubt they did?
A I do not have a record of those conversations, but I know she remained very enthusiastic about it.

Q My question was not about enthusiasm or contact, my question was simply this, so far there is no basis at all, is there, for any suggestion that Dr Wakefield has pressurised the patient or the mother?
A From this correspondence, no.

Q I want to deal with the next step because, having taken ourselves up to November, the next thing that happens is a letter from Professor Walker Smith to you on 7 November at page 183 of the local records. On the face of it, and I stress that, on the face of it, this simply comes out of the blue – you having had these conversations with Dr Wakefield on the telephone?
A Yes.

Q It just comes along on the 7th?
A Yes.

Q On page 185 we see a letter written by you, not to Dr Wakefield but to Professor Walker Smith. It is dated 15 November, eight days later. It is quite clearly, if you look at the first line, in response to the letter on page 183. Would you agree with that?
A Yes.

Q There are two elements in this, or rather three, that I would like your help with. First, at this stage on the 15 November you are clearly still of the view that Professor Walker Smith and Dr Wakefield are part of the same team?
A Yes.

Q Because, if we look in the third paragraph, you say:

“I agree that your research findings are very interesting”,

and on the second line:

“I do not think your research programme....”

A Yes.

Q Again, it is against the same backdrop that you had right at the beginning of this sequence. The second matter I would like to look at with you is the question of pressurising. That is raised by you at the bottom two lines:

“I am beginning to wonder whether you and your department...”

Again, at the risk of labouring the point, you thought that Dr Wakefield and Professor Walker Smith were part of the same department, did you not?
A I had no reason to think otherwise.

Q As you have agreed, thus far no possible basis for believing that Dr Wakefield himself could have been pressurising you or the family or the mother?
A I think my third paragraph in that letter implies my view that correspondence and communication was continuing.

Q Absolutely, I will come to the correspondence in a minute. But, simply on the basis of telephone calls and contact, no possible basis at all, do you agree?
A I think my third paragraph in that letter, which says:

“I understand that Dr Wakefield is continuing to send the family information. In particular, he has been sending them information from a firm of solicitors who seem to specialise in litigation in relation to immunisation.”

The implication in that is that there had been communication.

Q Dr Mills, I know you are eager to deal with that and I have said I will come back and deal with it, but, simply, we have to go through this carefully. On the basis of contact between Dr Wakefield and you, no evidence at all of pressurising. You have agreed that already?
A Directly, no.

Q I will deal with the correspondence in a minute. In relation to the question of pressurising, let us deal with Dr Wakefield’s position. If you look at the local records at page 191 and look at the fourth line, this says:

“[Mrs JS] phoned me initially and has continued to request investigation as part of our protocol. I find the accusation that we are pressurising this family grossly unfair and without any substance whatsoever.”

That is the position in January 1997, Dr Wakefield having been passed a copy of your accusing letter, he responds in direct terms to it and denies it, does he not?
A He does, yes.

Q Let us look at the third paragraph that you were keen to draw our attention to. Let us read it out:

“I understand that Dr Wakefield is continuing to send the family information. In particular, he has been sending them information from a firm of solicitors who seem to specialise in litigation in relation to immunisation.”

That was the accusation that you made against Dr Wakefield in particular. Pause there and turn on to his response at page 191. I will start at the beginning of this letter this time. 8 January 1997:

“Professor Walker Smith has passed on a copy of your letter to me dated 15 November 1996. In it, you make several serious allegations. I wish to make it quite clear that I have at no stage sent this family any information from solicitors dealing in litigation in relation to immunisation.”

There it was. He was making his position absolutely clear, was he not?
A Yes.

Q Do you agree that you had made a serious allegation against Dr Wakefield?
A At the time I did not realise it was as serious as he perhaps interpreted it. I was simply stating the fact, and stating information and pinning my view, that the family were being particularly pressurised.

Q The comment that caused, in fairness, that he makes about serious allegations is in the plural, because, arguably, in the body of your letter on page 185 was, I suggest, a serious allegation of pressurising the family. That is really the thrust of it, is it not?
A Indeed, yes it is.

Q You accuse a doctor of pressurising the patient. That is a serious allegation, is it not?
A I felt it was particularly unfair in this case, yes.

Q Part of the underpinning was this correspondence which we will look at. In your response to that letter, which we can find at page 195, directly to Dr Wakefield.

“I am sorry if you feel that the information contained in my letter of the 15th November is inaccurate. [Mrs S] gave me a fact sheet from Dawbarns Solicitors ... She also gave me a study proposal entitled”

and we have seen that document.

“[Mrs S] told me that you had given her both these documents. It is quite possible that [Mrs S] may have been confused about the origin of the documents and failed to admit that they had come from separate sources. However, I certainly was led to believe that you were the source of both documents, particularly, as the Dawbarns document encourages parents to contact yourself” and then there is a quotation.

Then you set out other details in relation to pressurising which we will look at in a minute.
In relation to this question of the documentation from Dawbarns, can we look please at the mother’s letter to you which you will find at page 144. This was on 6 November when Mrs JS writes to you. I read the third paragraph:

“I have, this week, heard from Dr Andy Wakefield who has sent me the enclosed information about Hellers disease. This sounds so much like [Child J’s] history that we find it most alarming”.

The protocol that you referred to in your letter is at page 145. At page 149 we see in this document, a number of times now, there is a significant piece of text on Hellers disease. Do you see that?
A I do, yes.

Q The Dawbarns fact sheet begins at page 162. It is a lengthy document. Dr Mills, I am not here to defend the construction or content of this document. All right?
A Yes.

Q It goes from pages 162 to 182. I will be corrected if I am wrong, but there is no reference to Hellers disease in that document is there?
A I would have to re read it, but I will take your word for that.

Q I just want to explore with you, I appreciate now it is some time ago, even then, when one looks at the letter from the mother, she does not say words to the effect “Here is Dawbarn’s fact sheet”, she just on its face refers to enclosed information specifically referring to Hellers disease.
A Yes.

Q It directly refers, does it not, internally to the protocol?
A Yes.

Q Quite apart from the fact that the mother may have been mistaken, as you concede in your letter.
A Yes.

Q I am not disputing that, she might have been, but, equally, might she have brought to you that fact sheet?
A My understanding was that she gave me that fact sheet, yes.

Q Physically?
A I do not know if she physically gave it to me or whether she sent it to me.

Q I do not mean to be unfair, Doctor, but you are clearly uncertain as to whether or not it was sent or given.
A I cannot recollect how I precisely received that document.

Q Did you know at that stage that Mrs JS was in fact in contact with Dawbarns Solicitors?
A I do not recollect that.

Q It is an obvious point, that if she was in contact with these solicitors with a view to legal action, with a view to obtaining a legal aid certificate for her child, then an obvious route for receipt of the Dawbarns newsletter is from the solicitors themselves is it not? It is common sense, is it not, Dr Mills?

MS SMITH: This witness cannot answer that. It is speculation by Mr Coonan and it appropriate for closing submissions, not in the middle of his cross examination.

MR COONAN: (To the witness) Do you feel ill equipped to answer the question, Doctor?
A The documentation here implies that it was my belief that she received it from Dr Wakefield and she passed it on to me. That is the evidence that is set out here. I do not actually remember where it was given. The documentation that was written at the time implies that I felt that she got it from that source.

MR COONAN: Even in the documentation available at the time, it does not make clear the route by which you got it.
A No. I conceded in one of my letters that I may have been mistaken, but I also said in the documentation that I thought that was the source.

Q Just going back to the letter on pages 195 and 196, in a sense we have covered this, but if we leave aside the question of the documentation, that is the Dawbarn’s, and if we assume that that may have been the result of confusion by somebody, so that, in effect, it is robbed of any significance, what one is left with here is a basis for surmising that there had been pressure. You dealt with this earlier in your evidence. Then on the second page you deal with what you perceive as being the facts. I am just trying to understand with you, please, how you can maintain these elements if, on the one hand, you put to one side the question of the fact sheet as being the product of misunderstanding, what is left to underpin any thoughts of pressurising in the light of your evidence today?
A I think what is left is what we do not actually have in front of us which is a culmination of conversations, meetings, discussions and telephone calls during that time and the clinical opinion that I had at that time which came. Unfortunately, we are left with the vestiges of the written documents, the written typed letters. I know that I would have come to that view through a number of discussions with the family and others.

Q There is no possible complaint here by the mother of pressurising is there?
A No. Mrs JS did not complain to me that Dr Wakefield or anyone else was pressurising her for referral. The pressure was coming on me I felt for referral and that I had made my view known about that.

Q Thus far and I am just here to represent Dr Wakefield’s interests you have agreed that the only contact you have had with him is two telephones calls and you have agreed that both were perfectly proper.
A Do you want me to respond to that?

Q Yes, please.
A My direct contact with Dr Wakefield was those two telephone conversations. My indirect contact with Dr Wakefield was through the family and the information the family were having and the belief that the work at the Royal Free would be the right thing for Child J and helpful for Child J. I was left in no doubt that the family were left to believe that that would be helpful and the right thing for Child J.

Q The family are perfectly entitled to discuss these matters with Dr Wakefield and any person they wish to, are they not?
A The family are indeed entitled to that, yes, and I was entitled to make my opinion and my view regarding it.

Q You have made your position very clear, if I may say so, and very firmly took a view. It may be that you felt at the time that if other people were of seeking interest in an alternative view from a far flung place like London, as you described it in your letters, that here was a body of professionals who were taking an interest from a different standpoint than you.
A That is entirely correct, and they were entirely within their right to do that. I knew Child J and the issues and I took a view regarding that. In terms of far flung, subsequent correspondence has indicated the family found transport difficult and travelling the distance difficult.

Q Let us a look, almost finally, at this letter on page 196 at the top which reads,

“I fully accept the family contacted you in good faith and that you encouraged them to discuss with me the possibility -

I stress that word

“of referral to your department”.

Pausing there, again you were still of the view that Professor Walker Smith and Dr Wakefield are in the same department. Is that right?
A Yes.

Q If we just pause there for a minute and turn back to page 186. That is the letter from Professor Walker Smith to you on 22 November 1996. This was between two and three months before you wrote the letter we have just been looking at. Can I take you please to the last sentence.

“I am sure Dr Wakefield, who is not actually a member of my own department, would also say the same”.

Did you absorb that?

A In truth, I cannot remember what interpretation I put on that comment. I knew that they were working closely together. They copied letters to each other and they appeared to be both involved in the same research.

Q As you believed?
A As I think the research documentation that we have indicates.

Q It can be no more than a belief on your part. That is right is it not; that Professor Walker Smith was involved in research?
A He was named as a co coordinator in one of the research papers.

Q We understand what you mean. At least you believed they were involved closely and letters, which you are quite right, were copied one to the other. I just make the observation for you to comment that despite the letter from Professor Walker Smith to the effect that Dr Wakefield was not member of his department in this letter on page 196, if we go back to it, in February 1997, you continue to describe Dr Wakefield as being a department to which a referral is to be made. Do you see that? You mentioned this in three separate areas: in the first paragraph, in the third paragraph, and I look at the third paragraph:

“In view of all these facts, I was rather surprised to receive a letter from Professor Walker Smith on the 7th November continuing to recommend referral to your department”.

Professor Walker Smith, with respect, was not recommending referral to Dr Wakefield’s department at all was he.
A Maybe I should have used the word ‘hospital’.

Q Perhaps I could come to a close, please. We have looked at Dr Wakefield’s response to your series of allegations and his response if we look at it finally at page 191. Again, the strong message from this letter on page 191 is that Mrs JS had telephoned Dr Wakefield, and was continuing to request investigation “as part of our protocol” as Dr Wakefield puts it. “Mrs JS, perhaps quite justifiably, has sought inclusion of her son in our investigations.”

She makes comments about under investigation. Finally, the position was reached on page 209 that Mrs JS in July 1997 is making a direct plea to Dr Wakefield to see if there is anything that can be done for her child is she not?
A She is, yes.

Q And this parent was quite clearly desperate and wanted to explore any possible avenue that may be open to her. That is fair, isn’t it?
A That is fair, yes.

MR COONAN: Thank you, Dr Mills.

THE CHAIRMAN: Thank you, Mr Coonan.

MR MILLER: Sir, I mentioned yesterday there were some pages missing from the document which we have starting at page 200 in the local health hospital records, particularly because there are references to publications in the body of the document. Can I hand in just one page, in fact, that is relevant, which is a list of publications?

MS SMITH: Mr Miller did very kindly give me this sheet but he did also explain that because of the nature of the photocopying there was a middle sheet. I think in the light of some of the questions that have been asked we perhaps ought to have the middle sheet as well, if we may.

MR MILLER: Fine. I explained to Ms Smith this morning that our copy has been printed slightly differently, the line starts one line further down so that the last line on page 203 I think is reproduced at the top of the next page, and then there are the printed names of Professor Walker Smith and Dr Wakefield. I have a copy of that, and I can photocopy it, as long as we just ignore the last line which is repeated from the page before. We will do that over the break and renumber this, and then I will give it to you when we start again.

THE CHAIRMAN: Thank you very much.

MR MILLER: Also, having start this system I have done it in white because it is basically part of the same document.

THE CHAIRMAN: We will now adjourn. It is very close to twenty past eleven; we will resume at twenty to twelve. Dr Mills, I have yet again to remind you that you are still in the middle of giving evidence and still under oath. Please do not discuss this case with anyone. Thank you.
(Short break)

THE CHAIRMAN: Mr Miller, I think you were going to hand over some documents?

MR MILLER: Yes. Sir, they come in the local hospital records bundle 1, at page 203a and b, so after page 203. Sir, you will appreciate as the document stood it just came to a rather abrupt end and other institutions without anything else to finish it off, and it should have the names, Dr Wakefield, Professor Walker Smith, date February 9, 1997, and then there is a list of the papers referred to in the body of the document.

THE CHAIRMAN: Yes, indeed. Thank you.

On housekeeping, can I check with Mr Coonan that the exercise you were going to do again has been done, to make sure that the heads of charges list was accurate?

MR COONAN: Thank you for reminding me. It is accurate, and the exercise has been done.

THE CHAIRMAN: Thank you. Mr Miller?

Cross examined by MR MILLER

Q Dr Mills, I am asking questions on behalf of Professor Walker Smith. We may have to go over some of the same ground but I hope not too much and not too slowly. You were appointed a consultant paediatrician in 1992?
A That is correct.

Q So by the time that we become involved, as far as the Royal Free is concerned, you had been a consultant for four years, or something over that?
A Correct.

Q Can you tell us something about your career background before that, your position as a community paediatrician? What was your career background before that?
A I qualified in 1978 and undertook pre registration house jobs and then post registration senior house officer posts. I started working in hospital paediatrics in I think it was 1980 or 1981, and I have continued substantially in paediatrics since that time. My initial career was working in paediatrics in a variety of settings, including Nottingham City Hospital, Sheffield Children’s Hospital; I undertook a period as a registrar at Amersham Hospital. I then moved to Westminster Children’s Hospital. I then undertook and passed my membership of the Royal College of Physicians at that stage. I then undertook a post at Whip’s Cross Hospital in East London, which was a combined hospital registrar post, including working on the wards and working on the special care baby unit, but also combined community work as well. I found I enjoyed the community work and working with children with disabilities, and I decided to pursue that as a further career. I then transferred to work in Islington as a senior clinical medical officer, and although that was not a training post I got the training authorities to agree to having that organised as a training senior registrar post. During that time in Islington I worked both in the communities but continued to do hospital on call at the Whittington Hospital, acute hospital paediatrics. What happened then? During that time I also undertook a Master’s degree at the Institute of Child Health at Great Ormond Street in community paediatrics which I passed, I think, in 1989. I then took up my first and only consultant post in Worcestershire in 1992. Since I have been in Worcestershire I have been predominantly a community paediatrician but have continued to do hospital work on call, and I continue to do that to this day where I cover the special care baby unit, the ward; I undertake a hospital outpatients session; and I work carefully in the children’s clinic. I attend hospital and community audit sessions with hospital, if you like, paediatric colleagues, as well as community colleagues. The reason I am emphasising this career is that a lot of community paediatricians have perhaps not done much in the way of hospital work, whereas I would feel that I have continued as a paediatrician covering the widest range of paediatric services, both within the hospital and community.

Q Yes. It is a very general background including, for those who are not familiar with it, the special care baby unit which is the first hours to days of life, perhaps a little longer but certainly problems that may afflict children at or around the time of birth or after birth, and it looks from what you have said that from the mid to late ‘80s anyway you were looking towards the community as the place where you would like to work.
A Indeed. I gained further training in child development, children’s disability, and a whole range of community services.

Q Did you ever work in a specialist paediatric gastroenterology unit?
A Yes. When I was at Westminster Children’s Hospital I worked with Dr Martin Brueton.

Q For how long?
A I was there for a year.

Q And did you have any training or develop any expertise in endoscopy? With children, obviously, because that is your specialty anyway.
A No, I did not do endoscopies, and I do not, in fact, remember anyone doing endoscopies at that stage, even at Westminster Children’s Hospital.

Q I did not ask you to put dates on it, but that was at what time?
A That would have been the mid 1980s.

Q You told the Committee that your special area of work is reviewing and treating children with complex needs and disabilities.
A That is correct.

Q And clearly Child J comes into that category and came into that category in 1996?
A That is correct.

Q And I think the correspondence reveals that you remark with some surprise that you first saw him when he was four years old. In other words he was quite old when you saw him for the first time in January 1995.
A That is correct.

Q And you had been told in the referral letter that he had severe communication problems and was probably in the autistic spectrum.
A That is correct.

Q And what Dr Seyler asked you to do, and we looked at it yesterday when Ms Smith was asking you questions, was local supervision by you?
A That is correct.

Q And you in turn referred him to a clinical psychologist, Betsy Brua?
A That is right.

Q You involved Ms Brua?
A I did, yes.

Q And the referral is at page 16, I think, and also an audiologist, because there was some concern about whether or not his hearing was affected?
A Correct.

Q And that is Dr Ruth Owen.
A Correct, and indeed Mr Cable subsequently became revolved, yes.

Q You said to some extent Mr Cable went down a blind alley because he identified a hearing loss and suggested that that might be dealt with by hearing assistance?
A Yes. I think his comments were made in good faith

Q I am not suggesting otherwise, but it did involve a procedure under general anaesthetic and admission to hospital, did not it, for him to get the diagnosis he made?
A Yes.

Q We have at page 30 a quite detailed report, I think this is a report it is not completely clear the relationship between this and another document, but this is Ms Brua’s report, isn’t it?
A Yes.

Q And it is a long report which ends up with the conclusion that “[Child J] is autistic but it is atypical autism”.
A That was her conclusion, yes.

Q And that I think pretty well has remained the diagnosis as far as the autism is concerned, throughout?
A I think as the documentation has gone on we have probably dropped the “atypical” part, because I think describing him as “autistic” I think does justice to his presentation. The term “atypical” is a specific one regarding the DSM and ICD classification, and that is why she used that. She was trying to be precise.

Q Yes. Whatever. You inherited a situation, it did not change under your supervision, it ends up with autism as being that diagnosis?
A Yes.

Q And there is a letter or a summary of visit at page 40 which follows that report in the bundle which appears to be a discussion between the parents and Ms Brua, is there not? It says “Date of visit, 7 March 1995” and there is just a one page document without any signature on it but it is in your notes.
A I suspect it is incomplete.

Q It does not matter for my purposes because if we look at the last paragraph on that page, presumably this is Ms Brua because she is the only non “S” person present.

“We discussed whether or not it is helpful to pursue the issue of what has caused Child J’s condition. I explained that autism is linked to many different possible causes but most children with autism do not have a known cause. There has been some work done in the States with a possible link between autism and immunisations. I agreed to give [Mrs S] the address of the American research unit that is doing this work and she can pursue it”.

We do not ever see that followed up, but it looks to be the first reference to immunisation as being possibly implicated?
A I cannot remember the precise date of when I first saw Child J.

Q January 1995, I think.
A And I recorded there that his mother was clearly of the view that MMR vaccine had caused it at that stage.

Q Yes. At the bottom of page 19.

“The family believe that Child J’s problems started to develop several weeks after his MMR immunisation but there was certainly no history of any acute neurological episode at that stage.”
A That is right, yes.

Q Just on that point, was that what you would have been looking for, if you were trying to find if you were trying to find some causative link, you would have looked for some acute episode closely linked to the giving of the immunisation? Is that what that sentence appears to be suggesting?
A The history of Child J was that -

Q Sorry, just in general. I do not want to get our wires crossed. I am not interested in what his history was, we are not going to get involved in that. It is just that my reading of that last sentence on page 19 is that although the family said it started to develop several weeks after the MMR immunisation, you may have been looking for an acute neurological episode close to the time of MMR as being necessary, if it was to be a cause.
A Yes, and indeed that would have been part of the vaccine damage payment.

Q And, in fact, just to go forward a little bit, Mrs S wanted to make an application under the Vaccine Damages Scheme, and you assisted her in that by giving her or providing a medical report detailing this child’s history, which went to the Vaccine Damage Unit.
A Yes.

Q And that was in relation to the statutory scheme for compensation which is administered by Department of Health?
A Yes.

Q But the point we were looking at was just that Ms Brua appears to have been going to suggest or going to give information to Mrs S about information in the States, the American research unit doing work on the link between autism and immunisations?
A That is what the report here says, yes, though I am sure it is an incomplete report

Q Again, I am not holding you to everything being correct; you have already pointed out that documents are missing from your file. Certainly, really from the moment you became involved, Child J’s behaviour was in your words from your witness statement very difficult and very challenging?
A Correct.

Q He was also referred, as we have seen, to Dr Mike Cooper, who is, from his correspondence anyway, a consultant psychiatrist?
A Yes.

Q It is not entirely clear how or why he was referred because it was not a referral from you.
A I think in the correspondence there is a letter from Dr Martin Ounsted, the GP, somewhere saying that he had done that.
Q We do not actually see the referral but we see Dr Ounsted’s response, and again Ms Brua says this is as a result of a locum GP referring but, in fact, Dr Ounsted was one of the more senior partners in the general practice, was he not?
A That is right, yes.

Q And just looking at page 45 again, the letter from Dr Cooper, it is a letter to him, and at that stage you are not copied in on it although it has got into your file, but it is because the referrals come from the general practitioner rather than you, and what he is saying to Dr Ounsted in the second paragraph is:

“I would be very grateful if you could arrange for Dr Mills to know that I am involved and ask him if he would be kind enough to send me any further investigation that he is undertaking, or is intending to do”.

So you have not been bypassed but this is a referral from a general practitioner to another consultant and he wants to let you know that he has been involved by that doctor.
A That is right.

Q And for you to give him any up to date information you may have and also, presumably, any intentions you had to carry out further investigations?
A Yes.

Q And he raises for the first time, I think, and this is the psychiatrist writing in the last paragraph, possibly pursuing further investigations of the dietary aspects of his condition?
A Indeed.

Q Because he is pretty interested in it within the spectrum condition, which is autism spectrum, and he asks the mother to make a list of food which he appears to be sensitive to insofar as his behaviour changes if he has them, or if they are removed from his diet. “This is increasingly seen as important in his condition after a period of being marginalised, but it is certainly not the answer to the entire problem by any means.” So you presumably understood that, doctor, to be a suggestion that particular types of food may affect this child’s behaviour?
A Indeed, yes.

Q And although that had been marginalised it is increasingly seen as being important to his condition?
A That was his opinion, yes.

Q You wrote back to Dr Cooper, page 48, and told him that “Dr Green” -

who was a consultant paediatric neurologist at Birmingham Children’s Hospital, was he not?
A He was, yes.

Q “has not advised any further investigations, although an MRI scan might be useful at some stage in the future. I do not have plans to take any further blood in the future as you can appreciate he is not the easiest child to take blood from”.

So to Mike Cooper anyway you are saying he has been seen by Dr Green, he has not advised any further investigations, although it may be that an MRI scan would be necessary in the future, and you were not intending to take any blood.
A That is what I said, yes.

Q So in response, if you like, to Dr Cooper’s query you, in fact, had no investigations in mind at the time to carry out on this child?
A At that particular stage, no.

Q If you turn to page 50, Miss Brua, the Clinical Psychologist, was somebody who worked within the community of the NHS Trust?
A That is right.

Q Which was the same Trust that employed you?
A That is right, yes.

Q And somebody, presumably, with whom you had worked with on other cases?
A That is right.

“Think you for your letter about Dr Cooper.

I am not sure how the referral to him came about, but I think it may have been due to a locum GP...”

which we know is wrong:

“...who perhaps was unaware of everything that you and I were already doing!”

In the fourth paragraph:

“I am pretty certain he is a clinical psychologist, not a psychiatrist however. (I think the parents had misunderstood this!)”

Unless he is misrepresenting himself in his own correspondence, he says consultant psychiatrist, does he?
A Yes.

“One of his areas of interest is the effect on diet on autistic behaviours, especially gluten free diets. There has been some recent work in Norway on this although I have not read the actual reports. Dr Cooper’s opinion might be useful on this in relation to [Child J] as the child appears to react severely to various foods in terms of very loose stools. His mother also reports that there are many family members who have allergic reactions. I really do not know how effective specific diets are with children whose behaviour is as difficult is [Child J’s]. My feeling however is that [Child J] is an extremely difficult and demanding child who is going to present with major management problems in the future. Although I have not shared this with the parents, but I suspect his prognosis is poor as he has fairly limited abilities and has extremely poor concentration and poor social interaction. I guess that I feel that anything that might produce even a slight change may be worth pursuing.”

Did you agree with those sentiments?
A I certainly agreed that the gloomy prognosis in time has shown that she was very accurate on that. In terms of doing “anything that might produce a slight change”, “anything” is a very big scope. No, I did not agree that “anything”, doing anything was right, but I agree with the sentiment that we should be trying very hard to see what we could do to find treatments that might alleviate Child J’s symptoms.

Q It was a fairly astute her observation, was it not, because life, she predicted was going to be difficult and it turned out that her prediction was entirely accurate, as you said. In terms of what had been on offer up to that point, there is not any particular evidence that his condition had been improved by anything that had been done.
A No, that is fair. At the time we were not pursuing the hearing. If we had found that he did have a significant hearing loss, that would have been very significant. We were pursuing educational placement and making should sure that he had appropriate educational supervision. That is also crucial to ensuring his wellbeing and future progress. We were trying, through people like Betsy, to provide as much support to the family as possible.

Q I am not trying to undermine that or to undervalue that. Here is somebody who remained quite involved in Child J’s case. In a paragraph in which she starts dealing with dietary concerns and ends up saying, “I guess that anything that might produce a slight change may be worth pursuing”, you rightly make the point that, of course, it cannot mean “anything”, but her sentiment was that, anything which might produce even a slight change might be worth while, but you say you did not agree with that?
A I did not agree with the “anything”. I think Betsy was reflecting that parents’ distress, in many respects everyone’s distress. This was a clearly difficult, challenging child who was distressing to see and causing huge distress within the family which was affecting relationships and health all round. She was reflecting the view that we must try to do something to help.

Q One of the things you did – first of all, there was this theme in the background about MMR, and you have dealt with that through the report to the Vaccine Damage Unit. At the end of 1995 I think you discussed with Child J’s mother the possibility of treatment with vitamins and he was started on a dose of vitamin B12.
A B6.

Q Two doses – a dose of B6 in January 1996, but it was reported to you that his behaviour did not really change as a result of that and it was stopped in April, I think?
A I think that is what the record shows, yes.

Q You perhaps trust me at least on the documentation as it seems to be that is the sequence. It started, it does not produce any change and it is stopped in April 1996. Then we get the letter which you wrote to Dr Wakefield on 29 April. At the time that the B6 was stopped you write to Dr Wakefield with copies to Professor Walker Smith, Dr Shore and Mr and Mrs S; that is page 117. However it got there, we have seen or heard – you were not here yesterday when it was read – but there was a statement from one of the general practitioners from the practice about the fact that Professor Walker Smith’s details were in the general practice notes, but he appears to have thought that it was more appropriate that any referral should come from you rather than him. By whatever route, whether it is from the general practitioner or from Mrs S, you end up writing to Dr Wakefield?
A That is right.

Q I am not going through it in detail – you have gone through it twice – but there has been a telephone conversation between Dr Wakefield, to whom you are writing, incidentally, at the Department of Medicine, are you not. That is the address you have?
A I am sorry, can you repeat the question?

Q To whom you are writing at the Department of Medicine, Royal Free Hospital. That is the address you are writing to?
A That is the address on the letter, I do not know why that particular address was used.

Q Presumably somebody gave you that address?
A Presumably, I do not know why that particular address was used.

Q We can come to it when we look at his own documentation where you refer to. This is a letter that must have followed the telephone conversation between Mrs S
A Which letter are we looking at now?

Q Page 117:

“Dear Dr Wakefield

I understand you have recently spoken to the mother of this 4 year old boy who lives in XXXX. You suggested to her on the telephone that a referral to Professor Walker Smith may be appropriate and Mrs S has contacted me asking me if I would make a referral.”

My question was, is it right that your understanding was that there had been a conversation between Dr Wakefield and the mother, and that in that conversation he had suggested that a referral to Professor Walker Smith might be appropriate?
A Yes.

Q You say, although you cannot put any details on it, that you had a conversation with Dr Wakefield, more than one conversation, although you cannot say with certainty who initiated those telephone conversations?
A Yes, that is what I said. I said, I thought on balance, Dr Wakefield had phoned me, but I do not know that for certain.

Q The clue to the fact that there was, certainly one telephone conversation, at about the time of this letter is the Royal Free copy of the letter which you have looked at. I am not going to ask you to open another bundle just for this, which has a handwritten note, “D/W Dr Mills happy to make” and we have assumed “referral”. That must have followed a telephone conversation between you and him?
A Yes.

Q If you look at the letter of 3 June from you to one of the general practitioners, Dr Shore, at page 114, this is now some five weeks later. I say “one of the general practitioners because we have seen involvement from Dr Ounsted and also a Dr Owen whose statement was read yesterday?
A Dr Owen was one of our community paediatrics working in my team. Dr Shore and Dr Ounsted were GPs.

Q I am not sure that is right, but it does not matter?
A For your information, Dr Owen is a paediatrician who worked in my team.

Q Yes, there certainly is a Dr Owen because we come to him or her later. I think there is a Dr Owen who is a general practitioner.
A I apologise in that case.

Q It is all right, I am referring to the evidence that was read yesterday.
A Dr Ruth Owen was a paediatrician with an audiological interest in my team.

Q Excuse me, Dr Mills, I just want to keep to one Owen at a time. The one I am talking about did not matter because he has now dropped out of the picture. Let us go back to Dr Shore who is a general practitioner?
A Correct.

Q The last paragraph on that page. You are, at that stage in June 1996, expressing your reluctance to the general practitioner to send the child to a far flung centre, is that right?
A Yes, I did, that is what I said.

Q The trail of line has gone dead as far as the Royal Free is concerned, because there has been no referral and no subsequent letter. But, effectively, you are saying to the general practitioner that, “It is not my view that it is a good idea to go to London”?
A That was my view.

Q Instead, one assumes you agreed with Mrs S – at the request of Mrs S, but you certainly agreed – that Child JS should have an EEG and blood and urine tests?
A Yes.

A Well, if we are looking at 114 and 115, I do not actually say EEG.

Q No, you do not, but 125 you do which is about the same time?
A Yes, I do.

Q That is why I said that you agreed with Mr and Mrs S. It is happening at exactly the same time. You have not changed in your view about the referral to the Royal Free, but you have decided, on whatever basis, for Child JS to have an EEG and to have blood tests – blood and urine tests?
A Yes, that is right.

Q An EEG was one which would have to be done, in his case, under sedation, would it not?
A Yes.

Q One of the tests, incidentally, which had been proposed originally by the Royal Free. Would you consider it invasive, an EEG, with a child under sedation?
A If I remember rightly, Dr Green had organised the EEG previously. EEG is not a particularly invasive test, although an autistic child might regard it as extremely invasive.

Q Absolutely. In fact, I think in 1995 he had an EEG under Dr Green and this is 1996 where you were referring him to hospital to have another one?
A Yes.

Q Whether or not it is technically invasive for an autistic child, it would require sedation or general anaesthetic?
A General anaesthetic would not be an appropriate means of sedating a child for an EEG, but some form of sedation, carefully organised sedation, may be necessary.

Q It would have been necessary in his case, would it not?
A Yes.

Q What was the purpose of those tests that you decided to do rather than refer?
A The implication from the evidence here is that, after discussion with the family – they continued to be very concerned about Child J, continued to feel that detailed investigation at the Royal Free would be the right thing – was that I felt it would be reasonable for me to look a little further to see whether was any evidence of mal absorption or GI problems, to look further which may have tipped my opinion in the balance of perhaps referring down there. I also obviously added some other investigations in, but I do not have a record as to why I made a decision to add those in at that time.

Q The EEG would not help on the gastrointestinal side of things would it?
A No.

Q If we look at page 292 in the bundle, this is the Neurophysiology Department of Ronkswood Hospital. It is certainly a request by you, or there has been a request by you, although I cannot see a date on the document. Under “History and Relevant Features of Examination” it says:

“Autism. No history of Rits.”

is it not?
A “No history of fits”.

“Symptoms apparently developed after vaccine at 18 months. Recent deterioration in behaviour, self mutilation, aggressive. Does he have an abnormal EEG that may provide a hint to aetiology and possibly guide treatment?”

Is that you or somebody else?
A That is my writing.

Q That is your explanation for the EEG:

“There has been a recent deterioration in his behaviour.”

You are looking for some hint to aetiology of his autism, presumably?
A Actually, I would probably be more likely to be looking at a recent hint as to the deterioration in his behaviour than the autism per se.

Q The aetiology of the recent deterioration is what you were looking at?
A I think that would be the implication. An EEG, in the main, is not a particularly good investigation looking for aetiology of autism.

Q The blood tests, can we have a look at the results of those. They are in the other Local Hospital Record Bundle NHR2, page 524. It is the last document in that bundle. Under “Comments” it says:

“Anisocytosis + Polychromasia +.”

What did you understand to be the relevance of that comment?
A Anisocytosis and Polychromasia are a description of the shape and irregularity in the shape in the red cells.

Q Anisocytosis is odd looking, uneven, odd looking cells and Polychromasia is when the haemoglobin in the individual cells is unevenly distributed?
A Correct, yes.

Q I suggest that, with a history of – first of all, the pattern suggests an iron deficiency, or may suggest an iron deficiency?
A Such a pattern may be seen in iron deficiency, particularly if it is associated with abnormalities in the full count, the red cell indices, such as the mean corpuscle volume, MCV, and the MCH, the mean corpuscle haemoglobin and the MCHC, which I think in his case are probably all normal.

Q What are the causes of potential causes of iron deficiency?
A Dietary.

Q Is it poor diet?
A Or some form of iron loss, blood loss.

Q Blood loss or malabsorption.
A Yes, or absorbing the iron properly.

Q Something has been flagged up here and with it we know a background history of diarrhoea, even mild diarrhoea, was there not?
A There had been a history of intermittent diarrhoea, yes.

Q The culmination of those two features, I suggest, really made it quite a good idea to refer to a gastroenterologist centre?
A No I do not agree with that. Anisocytosis and polychromasia frequently be commented on in the full blood count. He was not anaemic and the red cell indices did not further suggest iron deficiency. The judgments would be clinical ones as to how you could interpret investigations in any particular clinical situation.

Q We do not see the result of the EEG, or at least I have not managed to identify where that is, but, presumably, you must have got a result of something. It may not be in that bundle.
A I do not recollect seeing it.

Q Those two investigations that you instituted did not give you any further information that assisted you?
A No, they did not. I cannot remember how I interpreted this particularly, but I presume that I felt that the full blood count in particular was acceptable and did not make me feel that this was clearly diagnostic of significant intestinal pathology.

Q You also referred Child JS to a psychiatrist, Dr Knowles?
A I cannot remember if I referred. I think I probably did yes, but, yes, he was seen by Dr Knowles.

Q Again I do not think anything came of that, anything that helped the management of this child. Pages 130 and 131 are the response from Dr Knowles. It is a letter to you dated 24 July 1996 from Dr Knowles. Do you see that?
A I have page 130 in front of me.

Q The bottom paragraph,

“I discussed with Mrs S that many of the parents with our children with autism, would in fact be able to make the same claim”.

This was as to the temporal relationship between the MMR and the onset of symptoms?
A That is right.

“The MMR immunisation is routinely given at approximately 13 months of age. Often it is only after this age that symptoms, leading eventually to a diagnosis of autism are noted. I discussed with her the possible benefits to [Child J] of undertaking a brain scan, given that this would require the administration of a general anaesthetic”.

That is an MRI scan is it or a CT?
A A brain scan could imply either a MRI or a CT scan.

“During the ensuing discussion, Mrs S described that if brain damage could be seen on a brain scan, she had read of a process of myelination and that any damaged areas of [Child J’s] brain could therefore be re myelinated and his condition alleviated. Eventually it was agreed that I would look into discovering any literature associating MMR immunisation with autism and would contact other professionals involved in the assessment and care of [Child J] to gather any other data available as to [Child J’s] functioning and development. I suggested to Mrs S that [Child J] might benefit in his behaviour from Tegretol”.

What is Tegretol?

A Tegretol is the trade name for a drug called carbamazepine. It is a medication which is used predominately for epilepsy, but some psychiatrists and others will occasionally use it as a means of reducing anxiety and it has a mild tranquilizing effect.

Q At some stage at around this time, Doctor I am trying if I can just to get the whole pattern, and if I miss things Ms Smith will come back we have looked at some of these things and others we have not. Mrs S must have been in contact with you again in the late summer/early autumn 1996 because you wrote to Dr Shore as we have seen on 24 September, at page 134.

“I saw [Child J] with his mother on 17 September” so a week before this.

“He is an extremely difficult child to manage. He has no spoken language and his comprehension of language is similarly extremely limited. His social interaction and behaviour is considerably impaired and the family find caring for [Child J] an extremely daunting, challenging task. Because of this they are seriously considering some residential placement for him which is a major undertaking for any child so young. One option has been at the XXXXX. The second option is the local XXX School Residential Unit. They are currently considering these options at the moment.
Mother remains desperate to find out why [Child J] has developed the problems. We talked again about referral to London and gastroenterological investigations which again I have advised against. I have arranged to see him again in three months”.

We are to take it that Mrs S remained desperate to find out why Child J had developed the problems he has. You had advised again against gastroenterological investigations and had arranged to see him in three months’ time.
A Correct.

Q At this time his behaviour began to deteriorate further, did it not?
A Yes. Whether his behaviour deteriorated or whether he simply became bigger and more difficult to manage because of his size I do not know, but clearly he was becoming progressively more difficult to manage.

Q He also began what is described as “losing his toileting skills”. Is that right? If you look at page 139, this is in October, but it is within a month of you seeing him and writing to Dr Shore. This is a letter from Betsy Bruar again.

“Mrs S has contacted me recently as [Child J] seems to be losing his toileting skills. He has started to urinate and defecate wherever he is and has also started to wet the bed at night. It does not appear to be due to attention seeking because:

- he will urinate while receiving attention, e.g. when being ‘read’ a story, he got out of bed and urinated on the floor.
- he does not respond particularly well to attention generally.

Obviously Mr and Mrs S are very concerned as being toilet trained is one of [Child J’s] few positive skills”.

She sets out the advice that she had given about that. At the end of the next paragraph on page 140,

“Mr and Mrs S are not particularly keen on seeing Dr Stuart Green” who was the Birmingham paediatric neurologist “and have made some enquiries about going privately to the John Radcliffe Hospital in Oxford”.

There was deterioration there, was there not, in the way in which his life was going?

A There was. Betsy was not sure if it was just a phase, or whether we needed to be concerned about, or whether it was something more significant.

Q In your witness statement at paragraph 31, Doctor, you said that you too were worried about the possibility that the child might have some brain disease at this point.
A I do not have a copy of my witness statement in front of me.

Q If I have misquoted it, I will be put right. My note is that in paragraph 31 you too were worried about the possibility that the child might have some brain disease.

THE CHAIRMAN: I wonder whether the witness could be provided with his witness statement.

MR MILLER: Do you have a copy of your witness statement there? (Same handed) This is November. Just to put it in context, if you look on page 5 of the witness statement, this relates to a letter you had received from Mrs S on 6 November enclosing information which you have dealt with in examination in chief and in cross examination with Mr Coonan.

“I recall reading all the enclosed information with great interest. At that stage, I was very concerned about JS who seemed to be regressing. I was worried about the possibility that he might have brain disease”.

A That is what it says, yes.

Q Is that right?
A Yes. At the stage we had the situation of a very disabled child and people were describing that he had lost his toileting skills. There were a lot of potential causes for such a thing to happen and one of them perhaps would be a further deterioration or further neurological based on a change within his brain, a neurological condition, which may be causing that. In practice with children with autism their behaviour will fluctuate greatly and in practice that often is not the case, but I felt that this was something we needed to be looking at with Child J.

Q This appears to have been a second deterioration within six months because you told us earlier that you had referred him for an EEG in June 1996. In the request for that EEG, you had noted deterioration in his behaviour at that stage as well. There was a change in his behaviour then and a change apparently in November.
A I do not know whether I can say from these records whether they were two acute changes or whether this was a progression of a pattern which we had previously noted.

Q I do not believe we have been shown any document up to now that makes this complaint about loss of toileting skills at an earlier stage?
A No.

Q So that is different from the reason for asking for an EEG in June?
A Not necessarily different. For instance, an autistic child becomes very emotionally distressed for whatever reason and may present with aggressive and difficult behaviour as noted for on the EEG document which then may progress to a loss of toileting skills as part of the pattern of change.

Q We see in point of time that you received at about this time in November 1996 the letter from Professor Walker Smith at page 183. There had not been any communication in the intervening period between you and the Royal Free. Is that right?
A That is correct, although I think my documents indicate the family had talked to me about it.

Q I am talking about you. The letter is dated 7 November. It is from the University Department of Paediatric Gastroenterology at the Royal Free.

“Dr Wakefield has passed on correspondence concerning [Child J] Through Dr Wakefield we have been looking at a group of children with autistic symptoms related to MMR vaccine and has found that a significant number of children had gastrointestinal symptoms. When these had been present we have so far found endoscopic abnormalities in all five children we have investigated. I would be quite happy to see Mr and Mrs S and to discuss the situation with them and to indicate what investigations might be appropriate, and then to get your advice as to the right for us to proceed”.

You have made great play, Dr Mills, of your concern about invasive and intensive investigations which were being proposed if this child was to be referred to the Royal Free. Here was a letter from somebody who you knew to be an eminent professor of gastroenterology inviting you suggesting that he see the parents to discuss the situation with them to indicate what investigations might be appropriate and then to get your advice as to the right for them to proceed. What was wrong with that approach from a professor of gastroenterology asking whether it would be appropriate to see the parents to discuss, to give them advice and then to ask your advice?
A On the surface that letter is fine. What we do not have, as I said before, is the trail of discussion and conversation that I had with the family regarding this, the knowledge that I had about the investigations that had been proposed by Dr Wakefield and also my feeling about his symptoms, and indeed my knowledge of the way that many children with autism present with a fluctuating condition, and many of them present with bowel problems as well. The judgment that I had made that detailed investigations in London were not necessarily appropriate for Child J.

Q That is not what Professor Walker Smith is saying is it? He is saying that he will be happy to see them to discuss the situation with them, indicate what investigations might be appropriate and then to seek your advice as to how to proceed. That is what he is saying is it not?
A That is what his letter says.

Q This is the first letter you have from Professor Walker Smith. It is a perfectly reasonable sensible letter which is asking only for the child, if it is appropriate, to come up to be seen for discussions to take place with the family and with you. That is what it says is it not?
A That is what the letter says.

Q There is nothing else before this from Professor Walker Smith is there?
A The thing that is before this is the discussions that the family and I had had regarding the whole issue.

Q I do not know how I can get this through to you Dr Mills; he is not asking for you to refer the child for investigation. He is asking you to refer the child so they can discuss what investigations might be appropriate. This is not Dr Wakefield from the Academic Department of Medicine; this is the professor of paediatric of gastroenterology.
A I had seen Child J. I had assessed him clinically; I knew him and his family. I had also known the family wants and what the family desired. I felt that the approach and the way that it had come was unusual and I did not feel that it was appropriate. If I felt that Child J had needed gastroenterology investigation, then I would have happily have referred him somewhere closer to home or taken further advice more locally.

Q From your evidence, Doctor, and what you said yesterday in examination in chief and just now, it appears to be that you are saying that your experience was that children with autism often have gastrointestinal problems and that goes with autism?
A Children with autism and children with severe learning difficulties will often have problems presenting as gut problems.

Q That is just a statement, is it not? Surely the next question is do we know why that is?
A No, I think the next question is what is appropriate for any particular child in any particular clinical situation.

Q That jumps over the question. If you are just simply saying “That is my experience, these children have these problems and that is the end of it”, that does not leave open any question of investigation to see whether there is a link between gastrointestinal symptoms and autism?
A The question is an interesting one. It continues to be researched and continues to be discussed. What was clear in my view was that the things that I had known that had been proposed for Child J were not appropriate for him.

Q That was your professional judgment at the time?
A That was my professional judgment - and my professional judgment was not just based on the bowel symptoms he presented, it was based on the whole package of care and the whole way he was presenting, the strain the family was under. I was perhaps concerned that the family were focusing their distress, their determination for something for Child J, focusing on intensive investigation I did not think was in Child J’s best interests.

Q You reply to that letter a week later but in the meantime you requested an MRI, did you not, if we look at page 184? This again is your request for an MRI, isn’t it?
A It is, yes.

Q “Has this child any significant intracerebral abnormalities, autistic plus recent loss of skills, degenerative process, CT normal three years ago”?
A Correct.

Q And, again, it is admission and sedation so it involves admission to the hospital and sedation for the purposes of MRI?
A As a day case, yes.

Q Can we look at your reply to Professor Walker Smith, please, at page 185? We have looked in detail at Professor Walker Smith’s letter to you described by Ms Smith as a ”stern” letter. It was an offensive letter to a senior professional colleague, wasn’t it?
A No, I do not agree it was offensive.

Q “I am beginning to wonder whether you and your department are rather pressurising this family and I would request this to stop.”

A perfectly courteous reasonable letter written by Professor Walker Smith gets that response. It was an offensive letter.
A It was not intended to be offensive, and if it was I apologise. It was not intended to be offensive. It was intended to set out the view that this was a vulnerable child and a vulnerable family. The family had had a great deal of contact with the Department and felt that they wanted Child J to undergo a series of detailed investigations. Those investigations, I felt -- there was no evidence that they were going to help Child J, there was no evidence that they were going to be therapeutic for Child J in any way at all, and I was worried that perhaps this vulnerable family were being brought into a thing which at the end of the day was not going to help him or them.

Q Given the tone of the letter that you got from Professor Walker Smith would it not have been better to say: “Well, I am worried about whether you are putting too much pressure”, or “Do you think these parents are being put under too much pressure?”, instead of which it is effectively ticking him off for the letter he had written to you, somebody whom you knew to be an extremely senior professional colleague?
A My letter is a matter of record and I think describes how I felt at the time.

Q So on the one hand you have your clinical judgment about whether or not it would be appropriate for this to be managed in this way; on the other you had the parents repeatedly asking for a referral, and, in between, you had the investigations which you yourself were commissioning which we have seen as being MRI, admission day case. So that was the way that you wanted to manage his then current symptoms.
A That was the way I felt I needed to behave and respond at that particular time to the range of clinical circumstances that were being presented to me.

Q So no question of saying: “I do not think that your suggestion that you should see this child in an outpatient clinic to discuss with the parents, and then to discuss with me”, was a reasonable approach?
A My response was clearly the culmination of the range of information, the conversations I had with Dr Wakefield, the conversations I had with the family, my belief of their feelings and my understanding of the investigations that Child J was likely to be put through if referred to the Royal Free.

Q Did you ask Mrs S whether or not, before writing that last sentence on page 185, she felt that she was being pressurised by the Royal Free?
A I have no recollection of asking her that. Not that precise question.

Q That is quite important, isn’t it, because you were about to write to Professor Walker Smith saying “Your Department are rather pressurising this family”. Did you ask her whether she felt she was under pressure?
A I do not recollect. I recollect talking to her about it in some detail, listening carefully to what she felt was going to be done, bringing in the information I had already had on the telephone from Dr Wakefield and from perhaps other sources.

Q Other sources?
A Well, we have already said that the telephone conversations and the Dawbarns and research protocol, et cetera, had been sent through to me; we have agreed that perhaps we do not know precisely when some of those things were sent across but I suspect, by that particular time, I had had all that information; I had spoken to the family, I knew that they passionately wanted this to go ahead, but I have to say that I felt Child J was a vulnerable child and this was a vulnerable family. I got the feeling that they were being led to believe that Child J would be helped, he would in some way find some treatment from the investigations that were being proposed, and I did not believe that to be the case.

Q Right. Well, let’s have a look, then, can we, at Professor Walker Smith’s reply, which is by any standards a courteous and measured response to your abrupt communication. 22 November, page 186.

“Many thanks for your letter. I can quite understand you feeling it may not be appropriate for us to see Child J at the moment. However, I would be happy to hear from you again should the position change.

In relation to your last comments, I am certainly doing nothing to pressure the family to see us. In fact my department is somewhat overwhelmed by the response of parents who believe that their children have autistic and gastrointestinal symptoms following MMR. I personally had no idea that there were such large numbers of patients in the community across the country where the parents have made this association. I am sure Dr Wakefield, who is not actually a member of my own department, would also say the same”.

So he is saying: “Well, that is the view you take: I can entirely understand it”. It was a courteous and measured that is a reasonable description, isn’t it - a courteous and measured response to your letter?
A It was his response, yes, and it was courteous. I would object to my letter being regarded as objectionable. I think my letter was entirely

Q We will hear the evidence from Professor Walker Smith about it when he gives it. You will accept it is courteous and measured; it does not argue any case; it simply says “This is the position. It is up to you”?
A Indeed.

Q And we have seen that Dr Wakefield wrote to remonstrate on page 191, just for one purpose, if we look at that. Just taking up the point you made earlier, this letter is from the Academic Department of Medicine and at the bottom it says: “Senior Lecturer in Histopathology & Medicine, Hon Consultant in Experimental Gastroenterology, Director of the Inflammatory Bowel Disease Group”, so you asked the question of yourself, “I do not know why that was the address I used” but that, in fact, was his address, was it not? All correspondence came to you from him from that address?
A I am sorry, are you asking me a question about the address?

Q Yes, because you say “I do not understand why I wrote to him at the Academic Department of Medicine”.
A You highlighted the address and I said I did not know why I had used that particular address.

Q Would you accept that all correspondence in this case from him comes from that department?
A Indeed. Academic Department of Medicine at the Royal Free Hospital.

Q And then your response to him, which Mr Coonan has gone over, and then his short two line letter: “I now consider this matter closed”. So a line was drawn under the matter at that stage and you referred the child, instead, to Dr Green, the paediatric neurologist in Birmingham. What was the purpose of that referral?
A I wanted to be sure that well, I wanted a neurological opinion. Was the change or was Child J’s presentation part of a degenerative condition? Had I missed something? Were there neurological investigations or others that he would recommend? Dr Green, in fact, did a clinic in Worcester so we had close clinical links; we knew we would be able to see the patient and the family together, generally, and I wanted his opinion.

Q And what was his opinion?
A Could you direct me towards the letter?

Q Well, this is the letter which he did not respond to or did not provide a report for quite some months, I think. It does not look as though it was received until August because the date stamp is 6 August, and that would be your date stamp, would it?
A That would have been my office date stamp. Whether that was precisely when we received it or whether I asked for a further copy of it I do not know, but that is clearly when this particular copy was received.

Q And what was he offering? “He might be suitable for Ritalin” at the bottom. What is that?
A Ritalin is the manufacturer’s name for methylphenidate. It is a drug which is used for children who have short concentration span and impulsive behaviour, classically children with attention deficit hyperactivity disorder. It can be very useful in children with severe learning difficulties and those other behavioural symptoms as well.

Q He says.

“I don’t actually like using this in hyperactive children with autistic symptoms. You might ask your local child psychiatrist whether he is suitable”.

So that was passing it on to somebody else to make that decision, is that right?
A That is right, yes.

Q Did anything else come out of the consultation with Stuart Green?
A Well, he discusses an EEG ---

Q But he had had an EEG, he had had two already in the previous eight months, hadn’t he?
A EG sometimes has specific changes in the condition of Landau Kleffner syndrome.

Q Did he have another EG?
A He had already had two by this stage.

Q Exactly. So effectively nothing came out of that consultation?
A Well, I think that Dr Green had seen Child J, made a clinical assessment, felt that the appropriate investigations had been undertaken, and he did not feel that anything additional needed to be added at that stage. It is not true to say that nothing came out of it: he actually gave a detailed expert neurological opinion.

Q What was the detailed expert neurological opinion?
A The letter sets it out.

Q Yes, but what was the detailed expert neurological opinion that you did not already have?
A If you would like to wait a moment and let me read the letter through in some detail. (Pause for reading.) Dr Green, who at that stage was an eminent paediatric neurologist and had worked at Birmingham Children’s Hospital for some time, said in the third paragraph before the end:

“Unfortunately I don’t think there is much more abnormality here”.

Q That is the detailed neurological
A I know from Dr Green and the way he functions and the way he wrote his letters that would be the combination of taking into account a whole variety of factors, and that was the way he expressed that opinion.

Q I ask the question again: that is the detailed neurological assessment?
A That is a summary of the fact that he saw Child J and that he did not feel that any further particular investigation or anything else needed to be done at the time.

MR MILLER: Sir, I am not going to finish in the next quarter of an hour or so.

THE CHAIRMAN: Yes. This is a perfect time to adjourn for lunch. It is one o’clock; we will resume at two o’clock. Dr Mills, yet again I have to remind you that you are still under oath and still in the middle of giving evidence, so please do not discuss this case with anyone.

(Luncheon adjournment)


MR MILLER: Dr Mills, we had finished before the adjournment with the letter of Dr Stuart Green which you told the committee provided you with a detailed neurological report, but, as we have seen, not much in the way of a difference in future management. It is clear, is it not, that around this time, or between the visit to Birmingham and some time in April, Mrs S must have contacted Dr Wakefield at the Royal Free again because on 23 April, which is at page 199, Professor Walker Smith wrote to you again a short letter:

“I am writing to you again as I understand from Dr Wakefield that the family are considerably distressed concerning [Child J]. We have begun to have some quite remarkable success in treating children with autism and the evidence of bowel inflammation with Sulphaslazine and related drugs. I do believe it really would be helpful for us to do these investigations in [Child J] or for me at least to see the child and assess the situation. I enclose a copy of our protocol and would be grateful if you would reconsider this once more.”

The protocol is the document that follows it, is it not? It is called the “Introduction to the rationale, aims and potential therapeutic implications of the investigation of children with classical autism or the autistic spectrum disorder who have gastro intestinal symptoms”. It is that document, is it not?
A I presume so.

Q This document is obviously not the same as the document which had been supplied by Mrs S earlier on to you – that is a question? It is not the same as the one we looked at earlier given to you by Mrs S?
A This is a different document, yes.

Q The question on page 200, “What is the background to this study?”:

“Following publications of data demonstrating a possible link between measles virus, measles vaccination and inflammatory bowel disease, we have been contacted by an increasing number of parents who have described in their children features both of autistic spectrum disorder (especially ‘late onset’) and also symptoms suggestive of intestinal dysfunction, including pain, diarrhoea, bloating and food intolerance.”

Pausing there, up to this point there had been reference to diarrhoea in this child’s past history and a question about food intolerance?
A Diarrhoea had been mentioned, food intolerance had been proposed, I think, by Dr Cooper, but there had been no evidence that that was the case.

Q I think the mother was telling him that there were certain things he reacted badly to.
A I do not recollect seeing that in this.

Q It is not an important point, but if necessary we can turn up the documents. At the time Dr Cooper was trying to conclude. We have been through this document as a whole. Turn over to page 202.

“Question: What does this study hope to achieve? The purpose for this preliminary clinical study.”

Do you understand what is meant by “clinical study”?
A It means research.

Q That is what you think, is it?
A Yes.

Q What is the “clinical” aspect, does it have no meaning?
A I thought that it was actually referring to the research study that I had had previous information about.

Q Can I ask the question again. Do you think the word “clinical” has no meaning?
A Clinical refers to the total assessment of presenting features, both signs, symptoms and historical features.

“The purpose of this preliminary clinical study is, firstly, to adequately and appropriately investigate the gastrointestinal signs and symptoms manifested by these children: investigation is merited on clinical grounds. It is our experience that these clinical features often have been ascribed to the inevitable consequence of behavioural abnormalities upon bowel function.”

Is that what you were discussing before the short adjournment?
A Yes.

“...and as a consequence the children have not necessarily been investigated adequately. It should be stressed, therefore, that the investigations are clinically indicated in all cases that are admitted for evaluation. The validity of this approach is borne out by the fact that most children investigated so far have significant and consistent intestinal pathology (lymphoid nodular hyperplasia and microscopic colitis). Secondly, the purpose of the study is to seek the presence, and to characterise the nature, of any cerebral and intestinal pathologies in affected in children.

In view of the coincident changes in both behaviour and intestinal symptoms we believe that this form of regressive autism, and perhaps other behavioural problems within the autistic spectrum, may be linked to chronic intestinal inflammation.

It is our aim to investigate and institute appropriate therapeutic measures aimed at controlling the intestinal inflammation and correcting any nutritional deficiencies that may be present. The impact of these measures on behaviour will be monitored. Preliminary experience has shown that mesalazine or enteral nutrition may have significant benefit in some cases.”

I that is a part of this document, an adjunct to what has been written by Professor Walker Smith, which clearly raises the question of treatment, does it not?
A This one does, yes.

Q You say “this one”, it is right, because you were asked questions by Mr Coonan, and my note of your evidence on the subject was, if Dr Wakefield in his conversations or correspondence with you had implied to you that they were treating and getting good results, “I would have mentioned that in my documentation as a matter of some importance and I would have considered that a matter of importance”. Is that a fair reflection of your evidence this morning?
A It is a fair reflection, yes.

Q We have moved on from discussion about investigations. We have a letter from Professor Walker Smith which tells you about remarkable success in treating children with autism and the document which talks about treatment. So it is not just investigation, it is investigation and treatment with a view to alleviating the child’s condition.
A The letter claims “remarkable success”, it does not give any detail of it.

Q Wait a minute, Doctor. You are the person who, on the face of it, is looking after this child. Up to now, as we have gone through the various measures that you have suggested, we do not look as though we are finding any real improvement in his behaviour or his quality of life. None of the investigations which you have instituted have achieved any measurable success.
A The investigations would not have been designed to achieve treatment, they would have been designed to look for other features which, perhaps, would have given us other avenues to either investigate and perhaps lead to treatment.

Q Your two EEGs under sedation and your MRI under sedation had given you no new information which would have led to any form of treatment?
A Yes, that is right.

Q You are being told by an eminent professor of gastroenterology that their experience in an academic unit at a London teaching hospital had had experience of children with a combination of features, not major gastrointestinal features necessarily but, nonetheless, gastrointestinal symptoms and autism who had benefited from treatment with mesalazine or similar drugs. Here was somebody who was offering the possibility anyway of that, and was inviting you to refer the child for discussion, outpatient appointment if not investigation.
A I am sorry, what is the question?

Q This is a fair summary. Things had changed as a result of what you got here and we have been through the track record up to this point. I just want to know why it was, when there was the possibility anyway of treatment, that you felt that it had to be proved to you with documentary evidence from this unit, before you would recommend a referral. Had you done that with the other doctors to whom you referred?
A No, but I had never been in a situation where I had had frequent letters and communication from another unit asking me to make referral to them.

Q Yes, but they were not coming out of the blue, were they, were coming, clearly, because the mother was at her wits end as to how to deal with the situation?
A I agree that [Child J’s] mother was at her wits end. I agree that [Child J] and her, the family, were very vulnerable. I recognised that and they were desperate to find something. I think, as I said to the Panel before, I was under the impression that the investigations that were being proposed were very extensive, required a prolonged hospital inpatient period and were really quite invasive. I had taken the view then, and I had taken the view up until Professor Walker Smith’s letter there, that they were probably not going to benefit [Child J] and I was not the only person. I had a colleague in the paediatric unit in Worcester who agreed with that view and, indeed, Dr Kirrage also agreed with that view.

Q Tell us about Dr Kirrage, tell us about his expertise in the area at the time?
A Dr Kirrage was a public health doctor.

Q What was his background in medicine before he became a public health doctor?
A He was a general practitioner.

Q For how long, do you know?
A I do not know.

Q Somebody else within the Community paediatric service was the other person you spoke to, was it?
A No, it was Dr Marie Hanlon one of our consultant paediatricians on the acute unit at Worcester.

Q The acute unit?
A Yes, I work closely with them and I work in the unit as well, as I said at the beginning of my evidence.

Q You told us about that and the Special Care Baby Unit as well. The letter from the Professor for paediatric gastroenterology, was not coming from the scientologists or the Harry Krishna, or some out of the way obscure cult, it was coming from the academic department, the University Department of Paediatric Gastroenterology.
A It came as a combination of a series of correspondence.

Q In April 1997 what treatment were you currently offering this child?
A Child J had been placed in a special school, special unit. With him were teachers and other people who had experience in dealing with children with severe learning difficulties and autism. I cannot remember whether he was in the residential unit at this stage or not, but I know it was close to that. He had had involvement with the clinical psychologist, Betsy Brua, who made advice both to the school and to the family in terms of behaviour and behaviour management. We had undertaken a trial of B6 therapy which had not been successful. We had undertaken a range of investigations, including brain scan, EEG and some blood tests to see if we could identify any other underlying disorder which might lead me to want to look for a tertiary investigation. I had seen Child J on a regular basis and I had got to know him and his family.

Q Can I ask you again, what treatment were you currently offering this child?
A I was not offering any medical treatment myself. However, I was involved in a team of people trying to do their best to actually manage this boy’s symptoms. The symptoms were predominantly behavioural and were part of his autism and severe learning difficulty.

Q You wrote back to Professor Walker Smith on 12 May 1997 on page 204. In the second sentence you say:

“Please send me details of your remarkable successes in dealing with children with autism.

Please send me details of all children you have treated and the results of the successes in these children.”

Was that a mocking request?
A No, it was asking – he had written to me saying, “We have begun to have some remarkable successes in treating children with autism”.

Q That is why I asked you whether it was mocking, you used “remarkable” successes?
A No, I was simply using the phrase that he had used.

Q “Please send me details of all children you have treated”.
A That is what I have written in my letter.

Q Professor Walker Smith wrote back to you on 206:

“Many thanks for your letter. The successes that we have had with treating autistic children is an unexpected secondary aspect of our study, we had expected improvement with the gastro intestinal symptoms with use of 5 ASA derivatives and Salazopyrin, but we had not expected the parents to tell us thee has been such an improvement in behaviour. We are in fact with the help of Dr Marc Berelowitz, planning a further study to analyse the successes but our work at the moment has been to provide a diagnostic service to determine the gastro enterological manifestations of these children. Dr Wakefield has written a paper with submission to The Lancet, which discusses the links between MMR and autism, it is under review at the moment and we are awaiting that decision.

I am afraid it is not true that my department was energetic in requesting me to refer [Child J] to you, the pressure is coming from his parents who have heard about the success with other children. My own position in this work is entirely responsive, when I transferred from Barts to the Royal Free I was quite sceptical about the research work of Dr Andy Wakefield, but since I came here it is absolutely obvious to me that there is a large unmet need of children with autism who have a variety of gastrointestinal symptom s ranging from quite mild symptoms to quite major ones. The unexpected outcome of this research has led to us being very interested in the treatment of these drugs.”

He goes on to the deal with the BBC and reiterates the point about pressure or reaction to parent pressure. If, as you say, your primary concern was any way in which Child J’s autism could be made more bearable, or his autistic behaviour could be made more bearable, here was Professor Walker Smith saying that the by product of treatment had been that the autistic features appeared to have improved as well as the gastrointestinal. What was then wrong with referral, a referral which the parents were still, after many months, asking you to make?
A What was wrong with it, was my original view, and nothing in this has changed that, of the nature of the extensive these children would be put through.

Q Did you write back and say that “Look I am a bit worried about the fact that this child is going to have invasive procedures carried out. I appreciate I have had two EEGs under sedation and one MRI, but this looks a bit too intensive for me, can you help me as to whether or not this is necessary?” Did you write back in that vein?
A I believe I enclosed that in a previous correspondence, yes.

Q When you were asked for there to be an outpatient appointment at the request of the parents and a suggestion that he would seek your advice as to how to proceed, you had rebuffed him, had you not, and effectively treated this as being an intrusive entry into this family’s life. That is the way in which you were looking at it?
A Yes, that is right.

Q Was there a little bit of pique on your part, Dr Mills, because Mrs S appeared to have by passed you and gone straight to the Royal Free without asking you first and they were offering you something which you had not yourself considered?
A None, whatsoever, none whatsoever. My primary concern was the best interest of Child J. The information that I had let led me to believe that he would be admitted to the Royal Free for a prolonged period for extensive investigation, which I did not believe was clinically indicated. I made that view known. I was fully aware that the family had wanted this and I believed that they felt they were going to get something that would actually help Child J out of that. I had seen nothing that made me feel that was the case. When Professor Walker Smith wrote to me saying that he had had remarkable success with treatment, and that was the first time they had made any contact with me regarding treatment, I wrote back to him asking details of that.

Q When he gives you in general terms what has happened, you were asking him, you say, “I insist on seeing the details of all the children”.
A Because I knew they were undertaking research and I felt it was reasonable for me to ask for information before I made the referral.

Q You did not think to correspond with somebody, again I repeat you yourself volunteered was an eminent professor of gastroenterology “I am a bit worried about the intensive nature of the investigations which I have been told might be necessary. Are they all going to be necessary?” In other words, exactly what he had come to you first asking about?
A I think I had said that in a previous letter.

Q In those terms. “Are you sure that all this intensive investigation is necessary” let us find that shall we?

MS SMITH: With respect to Mr Miller, he should take this witness back to every letter he has written, and not just expect him to flip through the bundle.

MR MILLER: I cannot find it. I do not know where it is.

MS SMITH: That is what I said; he will have to be taken back to every letter he has written and the point he has made about it. The witness cannot be expected to find it himself with a large bundle with which he is unfamiliar.

MR MILLER: You can help us perhaps as to when it was that you said that, that rather conciliatory approach to Professor Walker Smith, “I am really worried about whether or not all of this is going to be quite necessary.” Your first letter to Professor Walker Smith is on page 185 which you conclude by saying “I am beginning to wonder whether you and your department are rather pressurising this family and request this to stop”. It is obviously not that letter is it?

MS SMITH: Page 195 to page 196.

MR MILLER: I am not talking about Dr Wakefield. I am talking about Professor Walker Smith.

MS SMITH: It was copied to Professor Walker Smith.

THE WITNESS: I did feel that the two doctors were working together on this.

MR MILLER: (To the witness) You have made that point. Is this the letter of 12 February 1997 to Dr Wakefield?
A If you look on page 196 in the third paragraph from the end,

“[Child J] is an extremely difficult child to deal with clinically. He is extremely difficult to restrain in the home and school environment. Like [Child J’s] parents and yourselves, were desperate to find something that will alleviate both [Child J’s] symptoms and the family’s distress. However, on reviewing your research, myself and my paediatric colleagues have felt that this is not what [Child J] needs at the moment”.

Q That is just saying “I have looked at the protocol and I do not think it is what he needs.” It is not saying “Can you explain why these are all necessary?” That is what I was asking you about.
A The research protocol set out what it was intending to do.

MS SMITH: The top of the page.

MR MILLER: You can come back to this in re examination.

THE LEGAL ASSESSOR: That is not really fair, Mr Miller. If you look at the top paragraph the last sentence of the top paragraph on page 196 says,

“I have always been interested in your research, but have always been of the view that, given [Child J’s] current clinical state, his lack of any gastroenterological symptoms of any significance and the extensive nature of the investigations that you are recommending”.

He actually refers there to the extensive nature.

MR MILLER: That is not the same point. The point I was putting to the witness was did you not think to go back to speak to the clinician and say, “Can you explain to me why these investigations are necessary?” Here you are saying, “I do not think they are going to be for his benefit”.
A Professor Walker Smith and Dr Wakefield sent me two research protocols which I looked through. They gave me information regarding that.

Q As far as I understand the evidence, you were given the research protocol by Mrs S and Professor Walker Smith sent you the other document which we have been going through.
A Yes.

Q That is correct, is it not?
A I believe so, yes.

Q The second document has nothing to do with the bits that we were looking at. It has investigation and treatment does it not?
A The second document does not detail the investigations and I have to say that I thought at the time the second document was an adjunct to the first document and the investigations and the clinical study that they were talking about were one and the same thing.

Q In your letter of 12 May, which we have looked at, you suggested that Child JS had a minimum of gastroenterological symptoms, but in July, the position appeared to have changed did it not? If you look at page 208 on 25 July.
A Yes indeed. Shall we say had other people caring for Child JS had commented on those symptoms.

Q Including the other Dr Owen who was a community paediatrician?
A Correct, yes.

“School and parents tell me that [Child J] whimpers prior to passing stools, the stools re mucousy and that there is what XXXX referred to as ‘piles’ but what be rectal prolapse visible for a short time afterwards”.

We have seen handwritten, “Evidence of bowel disease →? refer to London”. You say that you wrote that?
A Yes, that is my handwriting.

Q That then was a situation where before you believed that there were not any significant gastrointestinal symptoms the position had changed?
A I had a report then from another source that I felt was of some importance.

Q What steps did you take in response to that letter?
A Do you want me to read through my paperwork just to remind myself of that?

Q No. Did you make a referral as you said “? refer to London”?
A I did not make a referral to London at that time, no.

Q Because on 5 July 1997, Mrs S wrote to Dr Wakefield.
A Can I just butt in there, if I remember correctly, by the time anything had happened actually, he had already been seen in London.

Q The letter from Dr Owen is Wednesday 2 July is it not?
A Yes.

Q Then 5 July on page 210, we get a letter from Mrs S to you enclosing a copy of a letter which it sent to Dr Wakefield, which we will look at in a minute. That is right is it not?
A Can you just remind me which letter you are looking at again?

Q Yes. Page 201, 5 July and it says,

“Enclosed is a copy of a letter I have today sent to Dr Wakefield”.

If you look back to page 209, 5 July, “Dear Dr Wakefield.”
A Yes, there is a letter from Child J’s parents.

Q It is a reasonable inference that the letter she refers to on page 210 is the letter we have at page 209. Is that fair?
A Page 209 is a letter from Child J’s mother to Dr Wakefield. Page 210 is a covering letter that she sent to me to say that she was sorry that I was not able to make a referral. She appreciated it was a difficult decision, but then she emphasised the thing that we were aware of and very sensitive to was that a totally life destroying occurrence had happened. They felt that they were doing the right thing. Obviously at that point based on that letter I needed to explore further the possibility of referral and I asked Dr Kirrage for his advice.

Q Let us take it stage by stage. She sends you a letter in which she ends by saying, “Any parent would want to look further” and she also encloses the copy of the letter which she sent to Dr Wakefield. We have been through this before. Reading the third paragraph,

“He has a history of diarrhoea although his stools are more normal now. As he has no communication we cannot tell where his discomfort lies. It is very difficult to know if [Child J] is in pain because he is so active”.

She then gives a resume of the examples.

“I would very much like to be referred to as during my last appointment with doctors here, it was made very clear that there is nothing they can do to help him medically bar seeing a psychiatrist for drugs and keeping him in an autistic unit”.

Who were the doctors here whom she had been seeing in Worcestershire or extended to the West Midlands?
A She says, “... during my last appointment with doctors here” - again I would have to flick through here, but again I think it was her last appointment with Dr Owen.

Q She is part of your department, is she not?
A Yes.

Q That is her perception that she is being told by the doctors here:

“... that there is nothing they can do to help him medically bar seeing a psychiatrist for drugs and keeping him in an autistic unit”.

A I was not party to that and had not read Dr Owen’s notes. I would be surprised if that is precisely what she said, but it may well have been the family’s interpretation.

Q It is ‘doctors’ plural, is it not? It is not just ‘doctor’.

The last paragraph reads,

“My husband and I feel we must explore every possibility to help our son. As it is now [Child J] has no future at all other than being sedated and confined in an institution”.

This is a poignant reminder, it is not, Dr Mills, of how difficult things must have been for the family and how bleak the prospects were?
A I think that is fair, yes.

Q She told you in the letter that she wrote specifically to you that any parent would want to look further and that she and her husband feel that they must explore every possibility to help their son.
A That was her view, yes.

Q Within a couple of days of the letter from Dr Owen with a reference to different symptoms, you get the mother’s letter, asking again for a referral to Dr Wakefield. You say you passed that on to Dr Kirrage. Is that right? It says “Please copy to David Kirrage.”

What medical input would Dr Kirrage have been able to give as to whether or not it was appropriate to make a referral?

A I think I said in my evidence yesterday, my understanding of Dr Kirrage’s involvement and my
involvement was two fold: firstly, to look at the question of the ECR funding and whether the health authority was happy to go down that route. Secondly, to have another doctor’s opinion of the correspondence and the issues as to whether the way I was handling it was appropriate and reasonable.

Q We know the Committee have heard more about it than you have told us what Dr Kirrage’s background was and we know, because you have heard evidence from him already, that he gave advice to Mrs S and on his authority or his advice a referral was not sanctioned. That is right is it? That is historically what happened?
A I believe so, yes.

Q What he did was to write a letter to Mrs S, which we have at page 211 and following. He wrote you a little note saying that you were entirely right. Let us look at that. It is at page 213.

“I drafted a letter to Mrs S which I think sums up the public health view. I would like you to see it before it is sent in case it does more harm than good. You are entirely right in the line you have taken. There is no evidence that this will benefit [Child J] and a literature search has not added anything new. I appreciate the pressure on yourself and the GP and will support funding the investigation of you feel that in the end this is appropriate. My letter ‘sits in the fence’ and hopefully will enable you to act either way. If you feel that it is not helpful, then please bin it.”

In that Dr Kirrage is saying “I am sitting on the fence. If you think it is appropriate, make the referral”. In fact you have written on the letter from Dr Owen two or three days earlier before you got Mrs S’s letter “? referral”. So why, when you were told by the public health doctor that he was sitting on the fence and that they would support the referral did you not say “I will refer”?
A I think I wrote to the family in September. I had received Professor Walker Smith’s letter by the beginning of August and I wrote to the family in September.

Q By that stage there had been a private out patient clinic appointment not paid for by the authority. The date shows that Dr Kirrage was saying no in a letter dated 21 July 1997 and there was an out patient clinic appointment, a private appointment on 30 July, so a week or so after the date of that letter. Did you actually every say to Dr Kirrage, “I was thinking about recommending a referral anyway once I got the details of the different symptoms from my colleague Dr Owen”?
A I do not recollect details of my conversation specifically with Dr Kirrage and precisely the things that we discussed. I probably would have said, “Look, I have taken this view. I do not believe these investigations are clinically indicated and I feel as though I am being put under quite considerable pressure to make a clinical referral into a research programme that I feel very uneasy about that I do not think will be in the best interests of Child J”. I then probably said “Look, it may be there is just beginning perhaps to be some suggestion of some bowel symptomology and I will need to re assess the situation”. My letter from 2 September (216) indicates that I had contacted Mrs S on the telephone to discuss it.

Q The difficulty about that is that it happens all rather later. I am talking about the beginning of July. Your note on Dr Owen’s letter is “First evidence of bowel disease→ ? refer to London.” This is before there had been any outpatient clinic.
A That is correct.

Q I am asking you about why you did not do anything at that time rather than after there had already been an out patient clinic appointment.
A I did. I first of all clarified the ECR situation. I took further advice from a colleague regarding the clinical situation and from I think my evidence is from my letter on page 216 that I tried to contact the family.

Q Again, looking at the dates, Dr Mills, you receive a letter from Dr Owen, “First evidence for bowel disease → ? refer to London” is written on that. Shortly after 5 July 1997 you received Mrs S’s letter. Then on 21 July you receive a letter from Dr Kirrage effectively saying, “We are not going to support an ECR referral”. This is before any out patient clinic appointment.
A Then I received a letter from Professor Walker Smith at the beginning of August.

Q I am asking you about between those dates. Did you ever write and say “I have changed my mind, Dr Kirrage”, in fact when you got the notes saying “I will bin this is if you want” and then, “I think perhaps it would be appropriate to have a referral”.
A All I can say is from the documentation here that when I got the information from Dr Owen about that, several things happened. I discussed it with Dr Kirrage. He gave me a reply. I then received a letter from Dr Walker Smith. They had obviously tried to contact the family on the telephone during that time. I do not know my precise holiday dates during July and August of that year, so I cannot attribute the exact timescale underpinning that.

Q Dates, Dr Mills, can I try one more time. Dr Owen’s letter is 2 July, Mrs S’s letter is 5 July, there is a letter from Dr Kirrage dated 21 July in which he makes it clear that he is not going to recommend an ECR to the Royal Free, but you have told us that you have been impressed by the new symptoms. Do we find anywhere any indication that you said to Dr Kirrage: “Wait a moment, there has been a slight change because of my colleague’s findings about change in bowel symptoms”?
A These documents are the documents we have. I cannot remember the exact timescale that between July and September. All I can say is what these documents indicate. I recollect talking with Dr Kirrage maybe on more than one occasion about it. The evidence is that I tried to telephone family

Q That is much later.
A Well, I wrote on 2 September so clearly I was trying to contact the family during August.

Q You received the outpatient clinic appointment, or the letter dated 31 July 1997, page 214, and I think you have agreed that your understanding of this boy’s case, and Professor Walker Smith’s understanding, were the same?
A Yes. I think he and I agreed the symptoms were fairly minor.

Q Well, it is all the other aspects as well, is it not? It is everything that he has described. You went through this with Mr Coonan this morning, and you wrote, although it was not received by Mrs S, according to your own note, on 2 September:

“Following my recent telephone call, I am still not sure whether you wish me to make a formal referral to Professor Walker Smith in London for detailed gastroenterological investigation of Child J”,

and this clearly follows receipt of the account of the outpatient appointment, does it not, because what you are talking about is referral for investigation rather than simply an outpatient appointment?
A Yes.

Q “I note from Professor Walker Smith’s letter to me that he feels that Child J’s gastrointestinal symptoms are ‘minor’ but he would be suitable to have investigations by colonoscopy, et cetera. How would you like me to proceed?”

and you did not get any reply to that, did you?
A That is what the documentation says.

Q Because two months later there is a note saying: “Phone call to Mum, they did not receive this letter”, and you say “this letter”. That is your handwriting?
A That is my handwriting, yes.

Q And the letter on the face of it appears to suggest a change of heart about referral for investigations, because you are asking Mrs S whether or not she wants you to make a formal referral for investigations?
A The change was fairly fundamental, because Professor Walker Smith by which time had actually met Child J and his parents and had taken a clinical assessment, and had then made his view based on the clinical assessment of Child J and hearing the story first hand for himself as to what investigations he felt were appropriate.

Q So at that point you were prepared to accept what he told you as a result of the outpatient clinic appointment, that it was appropriate he should be going to London for investigation?
A He had seen Child J and his family and that was his advice at that stage. Prior to that I had been the one who had made the clinical assessment, had known Child J and examined him. After that point Professor Walker Smith himself had done that and had still formed the view, and if that is his advise based on his clinical assessment then I felt I had no choice but to go along with that.

Q Again, you were content, he having seen and examined the child, to accept his recommendation that the child should be investigated and that you should make a referral accordingly?
A I was pretty, although this documentation does not say, but I suspect I was still pretty concerned about the level and extent of the investigation that was going to be involved. However, the family had voted with their feet; they had gone to see Professor Walker Smith, and he had given an opinion.

Q But if Mrs S had received the letter and had written back to you on 5 September, say, telling you, “Yes, I would like you to make a formal referral to Professor Walker Smith”, you would have said “Yes”?
A Yes.

Q Can I ask you about a letter written on 30 October 1997, page 219? This is from the Worcestershire Health Authority, who would be the purchasers of care and therefore those that would have to pay for any extra contractual referral, and although it is written to Ms Lewis at the Royal Free it is copied to you.

“Further to my fax I have had the opportunity to discuss this ECR with Dr Kirrage ... I enclose a copy of a letter that was sent to [Child J]’s parents from Dr Kirrage back in July 1997” - which we have seen - “You will see that at that time there was no information available that supported the clinical effectiveness of the proposed treatment. We are not aware that this situation has changed from that time and will therefore not be funding this ECR”.

Now, they have sent a copy of that letter to you and if, as you say, you were willing to make a referral after the outpatient visit that had taken place in July, why did you not write to the health authority and say: “Well, things have changed because he is now being seen in the outpatient clinic and I would be willing to support such a referral”?
A I think my answer is on page 216 that I phoned the mother on 5 November, which was presumably the day or fairly soon after I received this ECR letter.

Q What, 5 November?
A Yes.

Q Yes, but when you received the letter, 30 October, you would have known that in your own mind your position had changed as a result of the outpatient clinic and therefore the situation had changed from the time Dr Kirrage had written his letter. Did you write to the health authority to say that, in fact, there had been a change and that you were now supporting a referral?
A No. I obviously phoned the family after I received that letter - or I presume I did. I do not know. There is not a date stamp on the 219 letter, so I do not know precisely when I received it, but I do know that I phoned the family on 5 November and I would guess that the two were related.

Q So we have no way of knowing whether or not the health authority were told by anybody that the position had changed since July, because in this letter that they wrote, copied to you, they were saying ECR is not going to be made?
A I do not recollect detailed discussion with the health authority regarding this.

Q Child J was admitted to the Royal Free on 12 November 1997 and by a letter of 27 November 1997, page 224, you received a discharge summary, I think, from a registrar in paediatric gastroenterology, which described various investigations. You have stressed on I do not know how many occasions the invasive nature of the investigations that this child is going to undergo but, in fact, it looks from this as though there were blood tests and colonoscopy. Is that a fair reading of pages 224 and 225?
A Yes. I saw no evidence of a brain scan, lumbar puncture, assessment by child psychiatrist or child psychologist.

Q Yes. No lumbar puncture, no EEG, no MRI. Certainly two of those he had already had quite recently. This is blood and colonoscopy, isn’t it?
A Just I do not know if I could help the Panel. Given the date he was admitted it is quite possible that I was told when I phoned the family on 5 November that they had made their decision to go to London a week or so hence, which is maybe why there is no further correspondence regarding that.

Q Just come back to the document, would you? It looks as though it is blood and colonoscopy?
A Yes.

Q And for what it is worth, under investigations, under “iron”, it is “6 (normal range 11 36)”, so it is an abnormal finding?
A The serum iron is slightly low, yes.

Q And it is clear from what the registrar says that he was discharged shortly after colonoscopy prior to the histology results becoming available, and they will be following him up in clinic to discuss the implications. And it looks as though he was seen in the outpatient clinic on 28 January 1998 following which Professor Walker Smith wrote to you on 6 February, page 226, in which he suggested or recommended a therapeutic trial of Pentasa, and ends the letter by saying:

“I have not made further arrangements to see the child for the moment, but I do think that it would be helpful if we were to see him at some time in the future to evaluate any therapeutic success with the Pentasa therapy”.

So the position at discharge did not involve treatment but at the first outpatient follow up he was recommending treatment with anti inflammatory?
A Yes.

Q And you wrote, I think on 3 March, suggesting a referral to Birmingham and explaining that the child’s reaction to that particular drug had not been beneficial.
A That was my assessment.

Q And you wrote to the general practitioner on 27 May, which we have looked at and, again, I only want to look at one part of it. It is quite a long letter and starts on page 228, I think, and you copy that to Professor Walker Smith on page 229, penultimate paragraph.

“I find it very difficult to convince myself that [Child J]’s difficult behaviour is in any way related to feelings of discomfort or pain. Despite the investigation findings from the Royal Free Hospital I do not believe that pursuing treatment of his inflamed bowel will make any difference to managing his behaviour.”

Did you make those views clear to Mrs S as well?
A Yes, I think we both agreed on that.

Q So, as far as you were concerned, the door had closed on gastroenterological treatment?
A He had had some investigations; he had been seen by outpatient, by Professor Walker Smith and been started on some treatment. Mrs S had told me that the treatment had not suited Child J and I suggest she stopped it and restarted it again as another trial. When she saw me she said she had done that and he developed nose bleeds and she did not want to restart it again as she did not feel it had helped him. She also told me that she had tried to contact Professor Walker Smith without success, and asked me if I could perhaps refer him to a paediatric gastroenterologist nearer to home.

Q Did you do that?
A No. I wrote to Professor Walker Smith regard that issue.

Q Did you do it?
A I did not. I wrote to Professor Walker Smith regarding that issue.

Q The answer is you never did it. You made the point and with considerable satisfaction that you never received a response to that letter, but did you of your own volition make any further gastroenterological referral?
A It was a statement of fact that I did not receive any correspondence and he had had detailed gastroenterological investigations, as detailed in the paper here. He had had treatment which the family did not feel suited him, and at the stage, if you read in the context of all this, in fact I felt that further pursuing his gastroenterological signs and symptoms was not necessary. We were having to deal with other difficulties.

Q So the answer to my question is no?
A No, I did not make a further referral. I think Mrs S said to me: “We are finding travel to London very difficult. Maybe he should be seeing somebody closer to home”, and I felt, as Professor Walker Smith himself had requested the referral and then the family had indeed chosen to go to see him, that if he felt that he wanted to refer to a gastroenterologist in Birmingham, that would be something that I felt he should have done.

Q The travel is irrelevant doctor -
A I do not agree in this case. Travel is very relevant -

Q Please wait for the end of what I am going to say. The travel is irrelevant because presumably if you had felt it was appropriate there would have been somebody in Birmingham who could have seen this child for the purpose of treatment for gastroenterological symptoms.
A There would have been a gastroenterological service in Birmingham, yes.

Q So that if you had wished yourself to refer for gastroenterological symptoms, you could have done so?
A If I had wanted a further specialist gastroenterological tertiary opinion I could have done that.

Q Yes. But you did not?
A No, I did not.

MR MILLER: Thank you.

MR HOPKINS: I have no questions.


Re examined by MS SMITH

MS SMITH: Dr Mills, I am sure you must be getting tired but I have a few matters arising out of the answers you have given. Only, I promise, about ten minutes.

First of all, the chronology I know is rather mind boggling but can I just ask you about this short period of time that Mr Miller has asked you about just prior to the referral? If we go to the local hospital records on page 208, please, that was the letter that you told us about indicating that there was possible, as you have described, first evidence for bowel disease, possible relevant gastroenterological symptoms, and then, if you go on to 213 you have contacted Dr Kirrage and Dr Kirrage responds with the letter, again that we have read, sending you a draft of a letter he proposes to send, and if we go on to 214 we see a letter to you from Professor Walker Smith, and that indicates that he has seen Child J, and in fact that was on 30 July and he writes to you on the 31st. So within a couple of weeks of the response from Dr Kirrage were you, in fact, aware that Professor Walker Smith had seen this little boy?
A Well, yes, I am. There is on 214 a date stamp, which is illegible, halfway up the centre of the first page. I think that says something “Aug”, I cannot be sure, but my guess is I have seen that some time in August.

Q In general terms, doctor, Mr Miller has asked you whether, at the time of this discussion about this referral, you were giving this child any treatment, and he seemed to be suggesting that you were not. I want to ask you this. Was anything that was done at the Royal Free Hospital for this little boy, did anything make you think that your initial reluctance to refer him had been wrong?
A No, it did not.

Q I am sorry to labour the point, but on page 206, this is a letter from Professor Walker Smith that Mr Miller took you to purporting to set out the successes that had been achieved. He says:

“Successes were an unexpected secondary aspect of our study, we had expected improvement with the gastro intestinal symptoms with use of 5 ASA derivatives and Salazopyrin.”

Pausing there, this reference you were expecting improvement of GI symptoms, did you in fact think that Child JS had any that required that type of treatment when you were being asked to refer?
A No, I did not. Perhaps that is the whole point. I was being ask to refer to a gastroenterological service for a child whose main symptoms were ones of behaviour and severe learning difficulty.

Q That brings me on to the next matter I want to pick up on. Mr Miller asked you, he put to you a part of your witness statement when you said you did have concerns that this little boy might have some sort of brain disease. Would you ever have contemplated a referral to the Paediatric Gastroenterology Unit of the Royal Free in relation to those concerns?
A No, I would not.

Q If we look at the referral to Dr Green, Mr Miller took you to page 193 just to refresh your memory. That was the letter, if you remember that he asked you about that Dr Green wrote to you, but if we turn back to page 19, this is the letter that I took you to, the very first letter if you can remember that far back in your evidence, to Dr Seyler, but if we look down at it we see there had already been an involvement by Dr Green in the third paragraph down:

“In view of the history of regression he was seen by Dr Stuart Green at the age of 3½ who organised an EEG and made a referral to the child psychiatrist.”

A That is right.

Q The later time when he was seen by Dr Green was not the first time?
A That is right.

Q As far as tests, such as MRIs and EEGs, would you expect those to be investigations that a Department of Gastroenterology would normally be involved in?
A Not normally, although I could appreciate, if a detailed research study was undertaking them, that that may well be something that they would want to carry forward.

Q There has been a certain difference between you when Mr Miller was questioning you because he suggested this was something by nature of a clinical study and you used the term “research”. You said that you had assumed that the first protocol and the second document sent to you by Professor Walker Smith were referring to one and the same study. I would like to look back at that at page 203, which is the document that Professor Walker Smith sent to you. It starts at page 200. If you turn on to page 200, Mr Miller read out the second paragraph down, which starts:

“It is our aim to investigate and institute appropriate therapeutic measures.”

MR MILLER: It is page 203.

MS SMITH: I am sorry, yes, 203. I said 200 so that Dr Mills, that is where the document starts, so he knew the document I was in. If you then turn to page 203.
A Yes.

Q The second paragraph down, do you see where I am:

“It is our aim to investigate....”

Mr Miller read you that paragraph. Can I just read the next one:

“Finally, we hope that the possible role of MMR will be elucidated and further insights into the pathogenesis of regressive and classical autism will be provided.”

Was that, in your view, consistent with a clinical aim?
A I cannot remember exactly how I felt about it at the time. I presume that I would assume that this reinforced the view that this was just a further description of the research protocol and the research programme that I had already seen.

Q Just turning on to a short number of questions in relation to the matters that Mr Coonan asked you about. If you could turn to page 80 in the Royal Free bundle. This is the letter from Mrs S to Dr Wakefield. You were asked, if you recall, about the original of the telephone calls. That letter starts:

“Dear Dr Wakefield

Thank you for your telephone call last week.”

What is your natural reading as to who made that contact, who initiated it?
A I think the natural implication of “your telephone call” is that you telephoned me. If it had been the other way round it may have said our telephone call.

Q You were asked a number of questions, you will recall, on behalf of Mr Wakefield by Mr Coonan, in relation to your understanding of the various departments at the Royal Free Hospital. In the end you said, “Perhaps I should have used the word ‘hospital’ rather than ‘department’.” As far as you were concerned, was it the nature of the referral or the precise destination in the Royal Free Hospital?
A I had been contacted by two clinicians based at the Royal Free Hospital who were both dealing with an identical research programme, who were both named as researchers in the research programme. I assumed that they were working closely together on it.

Q If we look at two documents in the Local Hospital records on page 183:

“Dear Dr Mills

Dr Wakefield has passed on correspondence concerning [Child J] through Dr Wakefield. We have been looking at a group of children with autistic symptoms related to MMR and have found a significant number had gastrointestinal symptoms.”

That is one question. I will go on, before I ask you about the other one. On page 203a, that is the end of the document Professor Walker Smith sent to you and you see “Andrew Wakefield, John Walker Smith February 1997”. Was there anything in the documentation that you saw which would have caused you to doubt what you are telling us, which is that you saw these two as being involved jointly in a research program?
A No, I think the documentation is plain, that they were both working together in the same institution doing the same work.

Q You said that you had made an assumption that Dr Wakefield was paediatrically qualified and that he was a clinician with Professor Walker Smith when you first spoke to him. If it is in fact the case that he is a research scientist with no responsibility for patients at all, did he give you that impression when he spoke to you about this boy?
A No, he did not.

Q Two more matters, then I have finished. Both related to this issue of your impression of parental pressure. Could you look in the Royal Free Hospital records at page 76. If we look at the first line of that letter, this is November 1996, to Professor Walker Smith and Dr Wakefield:

“This is a child that I would like to be included in our study if you consider him suitable.”

That was followed on by a letter on page 74 from Professor Walker Smith to Dr Wakefield:

“Thank you for your letter. If Dr Mills and Mr and Mrs S are keen for me to see [Child J], I would be happy to do so. I will write to Dr Mills.”

At 75 the letter dated 7 November 1996.

“Dr Wakefield has passed on correspondence concerning [Child J].”

The rest of the letter I looked at for another reason. Were you aware of the background of Professor Walker Smith’s letter to you, this letter on page 75. Did you know how it had come about?
A No, I knew nothing about it other than the letter itself. Also I knew the fact that the family were very interested in pursuing this route.

Q On the same day that Dr Wakefield wrote to Professor Walker Smith, Mrs S wrote to you. If we look at the Local Hospital record on page 144 we can see it. It is dated 6 November 1996 is the letter to you saying:

“I have [this] week heard from Dr Wakefield who has sent me the enclosed information.”

Is that correct?
A That is right.

Q The enclosed information is at least the protocol that we see on page 145. Is it your understanding, Doctor, that Dr Wakefield had sent the document on page 145 to Mrs S?
A Yes, that was my understanding.

Q Lastly, this is a letter you will not have seen but, in the light of one of the last questions Mr Coonan asked you, I want you to look at it. You were asked about a letter much later on in 1997 at page 209. That was a letter from Mum to Dr Wakefield which we see copied in to you. Mr Coonan said to you, “Here is the mother making a direct plea to Dr Wakefield “. Is that correct, do you recall?
A Yes.

Q Would you look at the Royal Free records on page 65. This is a letter which is dated 11 June, so it is three weeks before Mum’s direct plea to Dr Wakefield. It is from Dawbarns, solicitors and says:

“Dear Andy

Have you been able to fix up an appointment for [Child J] to be tested? Things are getting worse regarding his stomach pains, ‘piles’ and peri anal irritation and he now seems to be developing joint pains.

His mum is very keen to bring [Child J] to the Royal Free if you can manage it.”

I was making the assumption, but I may not be right, I assume you have not seen that letter before?
A No, I have never seen that letter.

MS SMITH: Does that confirm your impression of the involvement between Mum and the solicitors?

MR COONAN: I do not think it is legitimate to ask
A Yes, it does.

MR COONAN: Thank you, Dr Mills, eager to have the last word despite my objection.
A I apologise to the Panel, I did not intend to be rude, I was answering the question.

MS SMITH: If I may say so, that is a little rich from Mr Coonan who ignores every interruption that is ever made from me and I would have repeated the question. Dr Mills has given the answer, which is that it does confirm his impression. The only other question I have to ask Dr Mills, is arising out of the questions that you have answered in relation to pressure on this family. You were asked whether the mother had complained about pressure and you have immediately accepted that she did not. Is that the point in your view, whether the family feel pressured?
A Yes. Mrs S certainly did not complain to me that she was being pressurised by the Royal Free, that is certainly true. She was very keen to be involved with what the Royal Free was doing because I think she genuinely believed it was going to help her son, for which I have the greatest of sympathy. It was my view that what was being proposed and what I had seen was not going to help him, and was beyond what was reasonably expected in terms of investigation for a child who was presenting with the minimum of gastroenterological symptoms but extremely severe behavioural autistic difficulties.

Q Sorry, there are two matters we need to clear up. That is in relation to results of the EEG, which Mr Miller asked you about. If we look at the local hospital records at page 130. This is July 1996, the letter from the child psychiatrist, but it is the only evidence we have in relation to why there is not actually an EEG result in the records. If you look at the middle of the page, she, that is Mum, described that:

“A recent attempt to obtain an EEG under sedation had failed when administration of two doses of the sedative failed to sedate [Child J]. Despite this, she raised the possibility that [Child J] might benefit from a brain scan. She described that she did not feel that [Child J] could be autistic because he remains affectionate…”

That seems to explain the EEG. Then if we go to the bottom of the page,

“During the ensuing discussion, [Mrs S] described that if brain damage could be seen on a brain scan, she had read of a process of myelination and that any damaged areas of [Child J’s] brain could therefore be re myelinated and his condition alleviated”.

Does that reflect some of the concerns that you had in relation to her expectations?

A Yes. We have heard before about Mrs S in particular and I think I have may have mentioned parents like this in general. Some parents will focus their energies and their distress into trying to help their child through further investigation or trying to find magic treatment. Sadly, in many cases, such things are not in existence, although we clearly must continue to look. That manifests her desperation to try and find something to help her son of which I fully understand. Child J will never be independent. He will be severely disabled for the rest of his life and the family’s distress has been terrible.

MS SMITH: Thank you very much, Dr Mills. You will be relieved to hear that I have no questions, but the Panel may have some questions.

THE CHAIRMAN: Dr Mills, the last stage is that Panel members will now need to ask you questions. I am going to ask you first of all a question and that is much more on housekeeping lines. Are you willing to continue to give your evidence? I appreciate that you have been here for a while. You can continue and then you will finish sooner or we can have a break now.

THE WITNESS: I am happy to continue to give evidence if that is what the Panel wishes.

THE CHAIRMAN: The Panel would be quite happy to continue now, but we are quite happy to also comply with your request.

THE WITNESS: I am more than happy to continue if the Panel are happy to do so.

THE CHAIRMAN: In that case, I am going to turn to Panel members now. Dr Webster is a medical member.

Questioned by THE PANEL

DR WEBSTER: When JS was admitted and the investigations, including the bloods, the only blood that was abnormal, and I assume it is the normal range we are given here, is one for a child of his age, was the serum iron. Your attention was drawn to the blood result you organised in June 1996 and the possibility of the changes seen there being due to iron deficiency?
A Yes.

Q Did you have any advice about trying to correct this one abnormality?
A No. I noticed that the two investigations beneath that were a ferritin and a serum total iron capacity, both of which I think were within the normal range.

Q Can teams cross departmental boundaries?
A Of course they can. That is the nature of working within the Health Service and working together.

Q It is being suggested that there were two separate teams and Dr Wakefield was in one and the other was the clinical one, yet the letters from the mother, the on page 209 to Dr Wakefield, is saying, “Can you arrange for the tests?” If you are in a department and you are being persistently asked to do things which you do not have to access being asked by patients’ relatives, what would you do?
A You would find someone who could do it for you.

Q So you would refer them to somebody else rather than continuing to take these calls?
A If you felt that it was necessary and you could not do it yourself, you would ask someone else who could.

DR WEBSTER: Thank you.

THE CHAIRMAN: I was going to continue, but I have been passed a note that a short break is required. It will be only ten minutes, if that is acceptable to you all. We will adjourn now for ten minutes and resume at twenty to four.

(The Panel adjourned for a short while)

THE CHAIRMAN: Mr Mills, Ms Golding is a lay member of the Panel.

MS GOLDING: Dr Mills, on page 145 in the local hospital records, we have the proposed clinical and scientific study which Mrs S received from Dr Wakefield. Did you read through this study?
A Yes I did.

Q Did you understand that the tests listed were the ones that the child would go through?
A That was my understanding, yes.

Q From the information that you have and the discussions you had with the two doctors, what do you think the referral of the child was to be? Was it because he was clinically indicated or because he would have been useful for the study?
A I thought it was the latter.

Q Why do you say that?
A This paper does not talk about any treatment. It simply talks about investigation of children who have an apparent regressive disease. It was my view that the detailed investigations were aimed at researching the theories that they felt underpinned the causation for this particular condition.

Q This you have answered, but did you think that there would be any benefit to the child if he went to the Royal Free for these tests?
A No, I did not.

Q There was a mention of the iron deficiency after some blood tests. I just wanted to know, given that the child was not anaemic and there was no iron deficiency I am not sure what that means generally but for a boy to be deficient in the way that is necessary for the study, what would have had to be happening?
A There was just one parameter on the Royal Free study which implied iron deficiency. The first thing they said was full blood count was normal, so clearly they did not feel that he was anaemic or had any abnormality of his red blood cells. They did not comment on any anisocytosis or polychromasia that had been commented on in the Worcestershire. The other two measures of iron were both normal. It would be a judgment as to whether that slightly low serum iron was of clinical significance or not. If it was clinically significant, then I would ask myself was this either dietary or possibly had he been losing blood or malabsorping blood. Those would have been the things I would have thought about. I would have expected to have found on investigation other things that would have backed up those views, other things that would have implied that he was bleeding or malabsorping. I do not think there is a detailed dietary history set out here, although that is something that we would have looked at as well.

THE CHAIRMAN: On the same question, I want to ask something along the same lines which may be helpful to clarify. This serum ferritin level that was actually low.
A It was the serum iron level that was low.

Q You were asked a question on page 524 of the local hospital records bundle volume 2.
A Yes.

Q Apart from the finding of anisocytosis polychromasia, the laboratory has highlighted five more squares.
A I am afraid I would have to look at our laboratory reports to know whether they have been highlighted or whether that is actually the way that the report has been printed.

Q Can I explain it to you? I am a GP and I am used to receiving these kinds of reports from the hospital. Usually when there is a highlighting it actually means that you really need to look it. We may decide to do nothing about it, but it is just attracting your attention. If you look at it, ESR is not written there. Haemoglobin is 11.8. What is the normal range in a child?
A That is debateable, but many people would take a lower limit of 11.

Q So it is on the lower end of the scale, the lower end of normal?
A Yes.

Q “WBC 6.1”?
A I think that is within the normal range.

Q “MCV 79.5”.
A I would accept that within the normal range.

Q That is on the lower end of the normal range?
A Yes.

Q Platelets, again at the lower end of the normal range.
A I think 150,000 is regarded as the lowest.

THE CHAIRMAN: Thank you. I just wanted to clarify that. Ms Golding?

MS GOLDING: Dr Mills, if we look at the Royal Free Hospital records and if we go to page 29, did you receive this at all?
A I do not think I did, no.

Q If you look at the bottom half of the page where it says “Macroscopic description” would you be able to decipher what I, II and III mean?
A It says, “I Terminal Ileum” do you want me to read it and give you a clinical interpretation? The bottom three paragraphs describe terminal ileum, caecum and III and IV describe “transverse and sigmoid colon”. What would you like me to comment on?

Q If you keep that page open and then go to pages 224, 225 and 226 in the GP local hospital records, what are these tests show, is that correctly described on these three pages, 224, 225 and 226?
A On page 225 the histology, which is the relevant paragraph there, it says,

“Revealed no active inflammation but the caecum showed lymphoid aggregates, the colon revealed patchy active cryptitis with eosinophils and neurtophils.”

On page 29 it says,

“Caecum unremarkable now. Large bowel mucosa”

whereas on page 225 it says

“Caecum showed lymphoid aggregates.”

Q Does one seem more I do not know if serious is the right word serious than the other?
A In the Royal Hospital report on page 29 it says under “Caecum” “Unremarkable” whereas on page 225 it says that it showed lymphoid aggregates. The role of lymphoid tissue, which is the tissue which we all have, the tissue where the cells that fight infection are based, are quite variable, particularly in childhood. We get these in our tonsils and our adenoids and other parts of the body and they can become variously inflamed or notable. I know that these kinds of findings have been debated by doctors as to their significance. That is the best that I can say on that. Perhaps there are two schools of thought: one school of thought feels that these are of great significance and maybe a clue to follow through in terms of children with autism and other difficulties. Another school of thought feels that they these are incidental findings of no particular relevance. I have to say I do not know myself which of those is a correct interpretation.

MS GOLDING: If it is unremarkable on the test there, how does it

MR MILLER: With respect, in effect this witness is being asked for expert opinion about a document which he has not seen. He is not a person whose area of expertise this is. To ask a factual witness about how he interprets the differences, if there may be, between documents, one of which he did see and one of which he did not see, is a little hard and then to ask him to express an opinion on it in terms of what doctors in that area would think about what the findings were. He would struggle to get to what his own interpretation is, but his own interpretation is irrelevant to the evidence which he has given today because he is not been asked about what he felt about the findings.

THE CHAIRMAN: With respect to Ms Golding, Mr Miller is right. These are not really questions for this witness.

MS GOLDING: On page 203b of the local hospital records you said these references were obscure, what did you mean?
A I said some of them were obscure. I think what I meant was some of them were published in papers that would not be easily obtainable.

Q And did you know that Child J was legally aided?
A No, I did not.

Q And the investigations which were described in the study that you received, were those available locally?
A I am sorry, could you repeat the question? The investigations?

Q The ones that were described on page 145.
A Page 145 of the local hospital records?

Q The clinical study. The tests that were described in here, were those available locally?
A I would need to go through them one by one. In the main, most of these investigations could have been undertaken either in Worcester or in Birmingham. To be fair this was a package of investigations which had been put together as part of the research study, and sometimes the power of the investigations is the totality and their interpretation so yes, I think all of them could have been done. It would have been a question as to whether people locally would have been motivated or wanted to have done them.

Q Lastly, on page 216, I cannot remember if you answered this question except to say that the parents did not receive your letter, but did they answer you as to how to proceed?
A My guess what happened is that I sent this letter, I did not receive a reply. One of the previous letters we talked about stimulated me to telephone the family. They probably told me they were already booked in for investigation and they were going ahead anyway.

MS GOLDING: Thank you very much.

DR MOODLEY: On the local hospital notes, pages 224 and 225, the discharge summary, there are actually no comments on the findings and no guidance as to treatment, is that correct?
A That is correct, yes.

Q And no comment on the low levels of iron?
A It is certainly not commented on, no.

Q And just to confirm that, on page 226, in Professor Walker Smith’s letter to you, there is no comment on possibly low iron?
A I cannot see any comment there, no.

Q Could we go to page 199, where Professor Walker Smith refers to the remarkable successes in treating children with autism and evidence of bowel information. Did you understand that to be treatment of the bowel inflammation or treatment of the autism, or both?
A I suppose in truth I did not fully understand. I think the reason for my response was that I was worried that a department of gastroenterology was perhaps focusing their claim of success on the child’s bowel symptoms and that it was my view that the child’s behavioural and developmental and autistic symptoms were the most important ones, and my, I suppose, concern from that letter was that the claim of success may have been dealing with bowel symptomotology rather than what I would have regarded as the core behavioural problems that Child J was presenting with.

Q And on page 204 in your letter to Professor Walker Smith you asked for clarification and details?
A Yes.

Q And the response is on page 206. Did you feel that that clarified the situation for you? Were your questions satisfactorily answered?
A It gave me some information as to answering my questions. Clearly it did not answer them all in detail but it did give me some feel that his opinion was that treating children with substances such as Salazopyrine who had been identified as having bowel disorder, they would find an associated improvement in behaviour once those children were treated. That was my understanding of that.

DR MOODLEY: Thank you.

MRS DEAN: I have just one question. Did you think this family thought that their child’s autism was going to be treated and perhaps improved by the Royal Free, or his bowel syndrome?
A I think they were overwhelmed by his disability and they were desperate for something. They wanted hope, and they wanted any hope that things may be improved for him. I am not sure they had actually completely thought the whole thing through as to what they wanted different. I think Mother said in one of her letters: “I wanted my [Child J] back”, that is what they wanted, and I suspect when she said they wanted him back they did not want his diarrhoea to go away, although that would have been nice; they wanted him to become communicative, his behaviour to be improved so they could actually enjoy normal family life, rather than the hell that they were going through. That is what they wanted. I suppose one of the thrusts of my worries and concerns was they were being led to believe possibly, or they were not being disabused of the view that things probably would not be any better after he had had all these extensive investigations.

THE CHAIRMAN: I have got two or three questions for you, Dr Mills. I am a GP and I think you will understand why I am asking you these questions, merely to understand your mindset, how the process was working.

First, I think you said yesterday afternoon that you had never received a request for a referral from any other source before. Is that correct?
A Yes, I said that.

Q Is that still your evidence?
A Yes. I think since I was appointed as a consultant I cannot remember anything like this at all.

Q I am again asking for your view on this: does the relationship between the secondary and tertiary referrals work in the same way as between primary and secondary referrals? In other words, the relationship between the two tiers, between primary and secondary, and then secondary to tertiary, does it work on similar grounds?
A I have never worked in primary care so it is possible that I do not have a subtle understanding of those relationships anyway. My understanding and the practice that I generally have been involved in is that as a consultant, particularly a consultant involved with a child with complex on going special needs which are complex and unusual, the consultant, often along with the GP, though the interests maybe that is the wrong word, the involvement of primary care would vary considerably in such a case, would often take a leading role along with the specialist team, and they would then decide with the family what appropriate tertiary or specialist involvement they felt was necessary.

Q Maybe your experience is slightly different because yours was not even a proper secondary care kind of a specialist job, you were doing a very specified kind of a job as a community paediatrician, especially dealing mainly with disabled children or mentally subnormal, with learning difficulties, I think you said.
A Yes.

Q I am asking you this particularly because I know very occasionally, and it is very occasionally, we do have this kind of conversation with our consultants, “This has come to my knowledge, do you think it would be appropriate for me to see this particular patient of yours?” As I have said, this does not happen every day or week but it does happen occasionally, and I just wondered about it in view of your previous answer that you have never received any referral request before.
A I certainly received communication from other specialist areas. For instance, a family may identify and choose to go down a specialist area or they may ask my advice or opinion about going to see another specialist, and in the main I am generally very happy to refer and work with them, to work out what it is they are actually hoping to achieve through that, and whether the things that are being offered are likely to help and be helpful in the whole situation, so I would be in that situation. What is unique about this is that, having gone through this and given an opinion, I had what I regarded as persistent and very regular contact from the tertiary centre requesting me to make a referral, although they had not met the child or the family; that they simply wanted a referral to be made because that is what the family wanted.

Q You eventually did refer this child to Dr Green. Where was he based?
A Dr Green was based at Birmingham Children’s Hospital.

Q Did your Trust have the contract, a block contract, with Birmingham Children’s Hospital?
A Yes.

Q Or was it also a extra contractual referral?
A No. Our Trust worked very closely with Birmingham Children’s Hospital. In addition, Dr Green did outreach clinics in Worcester, so we knew him well.

Q I think you said about the EEG that you eventually ordered for this child to go through it or for it to be undertaken under sedation, and I think you said that by “under sedation” you meant not necessarily - you did not actually use the word “necessarily” - not GA but under medical sedation. For a child who is so disruptive, who cannot be seen in the surgery, who is difficult to be seen in the clinic, do you think ordinary medical sedation would have been enough, or would a GA been appropriate?
A Well, we have now and had then a very experienced neurophysiology department with technicians who are particularly good with some of our very difficult children ---

Q Was this EEG done under medical sedation eventually?
A I think we have pointed out from Dr Knowles’ letter she records that in fact it could not be done. I think he was given two lots of sedation and it could not have been done. It was not in fact completed. I cannot remember what sedation we were using in those days ---

Q I was just asking on the point of principle, basically, on what basis was it considered that medical sedation would be adequate, because I would have thought that with this kind of a child it would be very difficult to undertake an EEG under medical sedation.
A Yes, he would have been very difficult, but a general anaesthetic usually flattens the EEG anyway so you do not get much useful information from it. We have had a very helpful neurophysiology department in the past and have had very often useful results, which is why I thought it was worth trying.

Q Regarding toileting skills I think you mentioned that that could have been because of did you use the words “emotional deterioration” or ---
A Yes, I could well have used that phrase.

Q Something of that kind, I think. but if you look at page 139, this is a letter from Betsy Brua, clinical psychologist, who would be a specialist in her own field, in her own right, in psychological issues, and she has said in the second paragraph: “It does not appear to be due to attention seeking”. Does that not give the indication that this has nothing to do with emotional or attention seeking behaviour, and there is something more happening, and likely to be happening?
A Not completely. Attention seeking would be one behavioural thing but a child who may be distressed for reasons, an autistic child in an environment they did not feel comfortable with, with people they did not feel comfortable with, or a child who was overwhelmed with anxiety for sometimes obscure reasons - these are all things that can sometimes cause symptoms like this, and my experience would be that usually children like Child J who lose skills may regain them, and sometimes it is very different to know why ---

Q I am going to ask you about that just in a second but first, is not Betsy Brua the type of person who would be a lot more experienced in identifying these issues than doctors, either myself or yourself?
A Yes, I would agree that Betsy ---

Q These are people who are really very specialist in their own fields in these kinds of issues?
A I would agree with that, yes.

Q I think you also said that many of these patients come with fluctuating symptoms?
A Yes.

Q Again, would it not be Betsy Brua who would be a lot more appropriate to identify those issues, if those were the issues which were on play in this particular case?
A Betsy was very closely linked with the family and Child J for quite some time, and she worked very hard to identify and help ameliorate his symptoms.

Q I think you also said that your impression is that most autistic children have gut problems, gut symptoms?
A They will present with ---

Q I think that is what you said this morning?
A Yes.

Q Is that your impression? Is that based on any particular experience or expertise that you have in this field?
A I am probably involved in the diagnosis of five, six or seven new autistic children each year and have been so throughout my consultant career. Probably once a year I might find somebody, have a new case as severely disabled as Child J, and I will be following a lot of those children through, so I have quite a lot of children, both newly presenting children and children with on going problems, that I would have regular contact with.

Q So that was anecdotal experience?
A That is my clinical experience.

Q Anecdotal, because you have not actually done any work ---
A No, I have not done research.

Q This is just anecdotal?
A It is my clinical impression based on my clinical work, yes.

Q Lastly, and this is based on much more the kind of ethics, and I am not asking you as an expert but only asking you the way your mind was working at that particular time, was it not the principle of the NHS that - and I remember I think Kenneth Clarke making this statement in 1990, first of all - money follows the patient, when NHS reforms were brought into operation.
A I think so.

Q Who is the best person to make a judgment where is the patient treated in your view. I am just asking about according to your mind set rather than as an expert?
A In the vast majority of cases, talking as a paediatrician, the parents are the people who have best knowledge and understanding of their child and their child’s needs. In the vast majority of cases we will respond and work very closely with the family in order to respond because they have the best understanding of their child’s needs.

THE CHAIRMAN: If the patient decides – sorry, is that appropriate?

MS SMITH: No, I just did not think Dr Mills had finished what he was saying.
A I was going to say, in a smaller proportion of cases, people like myself have to make judgments as to whether the family are necessarily acting in their child’s best interests. The most obvious case of that would be a case of child abuse where it is very clear that families may not be acting in the child’s best interests. In some situations where families are vulnerable, distraught and distressed, I think it is a matter of clinical judgment for those people who are working with them to help them work through their distress and their difficulties to come to a sensible and reasonable approach which is, at the end of the day, in the best interests of their child.

THE CHAIRMAN: I fully accept that answer. I put it as an extreme example?
A I am not suggesting that this was

Q If the patient, and this happens normally in our kind of cases as well, and we advise the patient and the patient says “Sorry doctor I think I would rather see somebody else for a second opinion”, or in your particular case, it will be a third opinion. Do you not believe that, under those circumstances, the patient wishes to exercise his or her right having understood your advice but deciding against that advice. Do you not believe that is the patient’s right to do it?
A Yes, up to a point. I think I made it clear that the family wanted to be involved in a research study and in my view the research study was an arduous research study which would involve extensive investigations which I thought were neither in his best interests or would actually help, at the end of the day, help his symptoms. If I made a referral I felt I would actually be treating the family and the parents’ anxiety rather than addressing the child’s needs. It was an issue I thought through very carefully and struggled with and talked to other colleagues about. But the view that I took was that, in this particular case, although the family wanted it, that actually it would not help their son and actually was not in his best interests to do that.

I was distressed and upset that the family did not agree with that, but that is okay. It was quite clear the Royal Free wanted me to make a referral to them because they said that they felt he needed these things. I knew him, I had assessed him, I had done some investigations and I had a different view. Unfortunately, the family did not agree with that. Just because the family did not agree with that, did not mean that I felt that it would be right for me to say, “I think [Child J] should have these investigations”.

Q My question was nothing to do with the Royal Free, but between Mrs S and yourself, the interaction between yourself that was taking place at that particular time, you were in a position to take an action and you advised Mrs S, she is not happy with your advice, she would wish to go on a different route, but you still felt to stick to your advice rather than consider the patient’s wishes?
A That is what happened.

THE CHAIRMAN: Thank you. I certainly do not have any more questions, but counsel may have further questions, so I will ask them to come back to you again.

Further re examined by MS SMITH

Q Arising out of the Chairman’s last question, he referred on occasions to Mrs JS interchangeably with “the patient”. He said to you, “If the patient wishes to do it” and then he said, “If Mrs JS wishes to do it”. This is an area we have gone into before, but was Mrs JS your patient?
A No, she was not.

Q When you are thinking about whether it is in the best interests of the patient, whether he should or should not be referred, in this instance whose best interests were you thinking about.
A The child.

Q Very quickly, the blood results that you were asked about on page 524 of volume 2 of the local hospital records. It was suggested to you that the highlighted boxes, the boxes that had a thick black line round them, may have been done in that way to draw your attention to them. You said you thought it might just be the way the boxes were done. If it were to draw your attention to them in some way, would you have expected to see a result in the ESR box?
A Not necessarily. The ESR would be an investigation that would be asked for separately and would not done as a routine as part of a full blood count.

Q Would there be any reason in that case to highlight it?
A No.

Q Apart from the ESR results, did you regard the serum iron results in the normal range?
A I thought they were, yes, I thought they were normal.

MS SMITH: Thank you.

THE CHAIRMAN: I am sorry, I was asking the Legal Assessor whether I could flag this particular issue with you maybe. I think you have asked a question about ESR being blank. Could this not be the reason – and I know that while the witness is still here he can probably answer this question, because once he goes we will not get this answer – could it be possible that this part has been highlighted because the ESR has not been done and that might have been an important investigation that might have been needed in this particular case. Again, drawing your attention, in other words that that particular part, is that something you need to look at that it is blank?
A I think that is unlikely. If you look at the form on 524 the clinical details at the top are put as “? autistic”. For instance the laboratory might have chosen to highlight the ESR if I put “? idiopathic arthritis”, but I do not think “? autistic” would have led the laboratory to have flagged that up.

THE CHAIRMAN: That is your understanding and I hope you did not mind my interruption. Mr Coonan?

MR COONAN: No questions, thank you.


Further cross-examined by MR MILLER

Q Would you go back to Local Hospitals Records 1. You were asked about the letter of 23 April 1997, which is at page 189. You were asked whether or not what they were saying, what Professor Walker Smith was saying, in that letter was that the remarkable success they had had was in dealing with bowel inflammation rather than the autism. It is not clear from that letter what is being said is it?
A No, it is does not say whether it is bowel ...

Q Once we get to page 206, which is a direct response to your questions, the second sentence on that letter,

“The successes that we have had with treating autistic children is an unexpected secondary aspect of our study, we had expected improvement with the gastrointestinal symptoms with use of 5 ASA derivatives and Salazopyrine, but we had not expected the parents to tell us that there had been such an improvement in behaviour”.

Clearly in that letter anyway, Professor Walker Smith is saying that the behavioural aspects had been addressed by the treatment in those cases?

A Yes, that is what the letter says.

Q Page 225, please. This is the second page of the discharge summary. Again you were asked by Dr Moodley were you given any explanation about these results or any advice as to treatment and you said no. This is a letter from the registrar is it not rather than from Professor Walker Smith?
A Yes.

Q She says,

“We will following him up in clinic to discuss implication of the results.” In due course you get the letter following that clinic appointment with Professor Walker Smith at page 226. Is that right?

A Yes.

Q In which he explains the interesting features of the histology and makes a recommendation for treatment?
A Yes.

Q Which is in fact what had been flagged up in the discharge summary that was going to be an out patient clinic visit when it would be discussed?
A Yes.

MR MILLER: Thank you.


MR HOPKINS: No, thank you.

THE CHAIRMAN: Dr Mills, can I thank you on behalf of this Panel for spending most of these last two days with us. I am sure the Panel have found your evidence to be helpful. You are now released. Thank you.

(The witness withdrew)

THE CHAIRMAN: Ms Smith, we will now adjourn. It is getting very close to half past four. We will resume the case on Monday morning. Can I ask you what is the plan for Monday?

MS SMITH: Sir, we are planning on two things. The first is to call Dr Lloyd Evans who is a paediatric neurologist at the Royal Free. The second is we are hoping also to have time to read to you a witness statements from a Mr Phipps, who you will remember I was telling you about yesterday, who is the assistant finance director at the Royal Free. That is what we are aiming for.

THE CHAIRMAN: Thank you. We will now adjourn and resume at nine thirty on Monday morning.

(The Panel adjourned until Monday 13 August 2007 at 09.30 am)

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