Tuesday, January 31, 2012

Day 5 GMC Fitness to Practice hearing for Andrew Wakefield



Friday 20 July 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 1
Cross-examined by MR MILLER 16
Cross-examined by MR HOPKINS 22
Re-examined by MS SMITH 23
Questioned by THE PANEL 23


Examined by MS SMITH 28
Cross-examined by MR MILLER 38
Cross-examined by MR HOPKINS 45
Re-examined by MS SMITH 48
Questioned by THE PANEL 48


Examined by MR THOMAS 51
Cross-examined by MR MILLER 61

THE CHAIRMAN: Good morning to you all. Ms Smith, I think you had completed your opening and you were going to start with your witnesses this morning.

MS SMITH: Yes, but before I do so I want to hand in two documents, one is an anonymisation key so you have it because I propose to ask the general practitioners to look at the list and identify the name of their patient against the number assigned to that patient. I am going to hand round that and the other document is a list of the general practitioner or consultant who is being called in respect of each child so you can easily refer to which GP refers to which child.

THE CHAIRMAN: I think that will be very helpful. (Same handed: anonymisation key marked as C4 and the list of general practitioners/consultants marked as C5).

MS SMITH: My first witness is Dr Hopkins and he is the GP relating to child 10.

Examined by MS SMITH

Q (After introductions by the Chairman) I am sorry I am addressing you from rather a long way so please tell me if you have any difficulty hearing me: would you please first of all give the Panel your full name and address?
A My name is Trevor Hopkins, I am a GP working at the North Road Medical Practice in XXX.

THE CHAIRMAN: Can I ask that you pull the microphone a little bit closer to you, and I think maybe, no matter from where the questions are being asked, try to answer the questions to me to make sure that the Panel can hear everything you say. Sorry to interrupt, Ms Smith.

MS SMITH: Dr Hopkins, we are asking you in particular about a patient of yours, as you are aware, a child patient. The children in this case are being referred to by numbers. You have in front of you a laminated sheet which has got the anonymisation key in it. Would you tell us whether your patient was in fact Child 10 on that list?
A He was indeed, yes.

Q I am going to refer to him as “Child 10” and I would be grateful if you would do the same, but do not worry if you do slip into calling him by his name because the press are aware that confidentiality must be maintained in any event.

I think it is right that, although you were Child 10’s GP, he saw other GPs in the practice as well, is that correct?
A That is right. We work very much as a practice and the patients can see whichever GPs either they want to see or are available at the time they need to see a GP, yes.

Q Have you had an opportunity to review Child 10’s GP records?
A I have indeed.

Q Are those records kept so that whichever person in the practice sees him they can refer back to the history of his time with you through those records?
A That is correct.

Q Has this little boy been treated by the practice since birth?
A He was born into the practice, yes.

Q Was it your experience that in fact you saw him very frequently in his early years?
A Certainly very frequently in his early years, yes.

Q Were you the general practitioner partner who ultimately referred Child 10 to the Royal Free Hospital?
A I made the referral to the Royal Free, yes.

Q Prior to that referral had there been a number of other specialist referrals by you and your partners in relation to him?
A There had indeed, from February 1995 when he presented with loss of skills.

Q I am afraid I did not hear that.
A When he presented with various quite significant symptoms which required investigation by a specialist, yes.

Q I would like to take you to the records which are in the bundle in front of you which has “Child 10 GP records” on the front, and could we go to page 128? That is his immunisation record, and we can see at the top that his date of birth is given as XXX, and then if we look down we see the dates on which he had his various immunisations and we can see from that that he had his MMR on 21 February 1994.
A That is correct, yes.

Q So that is when he was a year old, is that about the standard time as far as you are concerned?
A It is indeed, yes.

Q I think it is right that there were signs of concern expressed as to his development, is that correct?
A Yes, he was presented to one of my partners on, I believe, it was 28 February 1995.

Q If you go to page 119, in October 1994 … Is Dr Thomas one of your partners?
A Dr Thomas was a former senior partner. He is now deceased, unfortunately, but he was the senior partner.

Q That is a letter from Child 10’s mother to Dr Thomas, requesting a referral for speech therapy, and she refers to one of Child 10’s siblings having had that therapy, but we see in the middle of the page:

“However, [Child 10] is now showing signs of some of the same problems, and I am also concerned about his comprehension.”

Do you see that?
A Yes, I do.

Q It would appear that Dr Thomas referred him to a consultant paediatrician, Dr Hodges, and we can see that referral letter, which is on page 113, and if I can take you briefly through that letter:

“Thank you … for seeing this little boy whose mother is very concerned about his detachment, his low responsiveness and his poor eye contact.

It seems that this slowing up has been noted for some time by [Mrs 10] and the grandparents but, only recently did she bring it to my attention.”

Then he refers to the speech therapy for both children and then says that Mrs 10 was very anxious about the child and that he had had two falls in the garden. That was a letter, as you said, which was addressed to Dr Hodges and he is a local consultant paediatrician is that correct?
A That is right, yes. At least he was at the time, I do not know if he still works there.

Q Dr Hodges did indeed see the child, and if you look back at 110 you can see his response to the practice:

“… family were quite happy with [Child 10’s] progress up until June 1994. At that time he developed a pyrexial illness and a rash. He was unwell for about a week and it was following this that Mum describes him as going into a shell. All speech and communication stopped and he seemed to regress as far as play was concerned. The parents also noted that he made little eye to eye contact with adults …”

He sets out the other difficulties:

“… making himself understood by using gestures.”

At the bottom of the page we see Dr Hodges describing how Child 10 seemed to him when he saw him.

At page 11 he said:

“It was difficult to do a full assessment on [Child 10] in such a short period of time, but I thought that his play, although not entirely normal for a child of two, was not that far outside the normal range.”

He then goes on:

“I am always very concerned when children develop what appears to be a simple viral illness and lose acquired skills. I think Mum has been quite right to be worried about [Child 10] although I did give her an optimistic prognosis when I saw her in Clinic. I have told Mum that if she remains concerned about [Child 10’s] lack of progress then I would gladly see him again but I must have a longer period of time with him in order to do a more formal assessment.”

Then we see there was another referral, again by your senor partner to another paediatrician and that was Professor Sibert, apparently because the parents had not been very happy with that referral, and we see that at page 115. Whereabouts is (or was) Professor Sibert, do you know?
A Recently retired, professor of – well, community paediatrics I believe.

Q Is he local, again?
A Yes, sorry, XXX.

Q Dr Thomas said:

“I wonder if you will be able to help with this little boy whose mother is very concerned about his [development].

… outbursts of aggression.

… slowing up of his development has been noted for some time … but only recently brought to my attention.”

Then he sets out the history again and explains at the bottom of the page that there had already been a consultation with Dr Hodges who thought that the problem might be associated with an episode of measles that the child had contracted.

THE CHAIRMAN: What is the date of this letter on page 115? The date is missing.
A It is 3 April 1995.

MS SMITH: There was a referral to an ENT consultant on page 109 to Dr Rivron. He was a consultant ENT surgeon at your local hospital, is that correct?
A Yes. He as seen in the BUPA Hospital in XXXX but he works just up the valley but locally in South Wales.

Q It sets out the history. I shall not go through it at length but simply to say that his mother was concerned about his development in general and felt that poor hearing might be playing a part. Dr Hodges had felt that his ears and throat were normal and that his play was not far outside the normal range, but nonetheless there had been a second opinion. He had been seen by the local audiology clinic who thought that his hearing was satisfactory. The doctor says that he also thought both drums were normal and that he responded to sounds in both ears. Nonetheless, the mother remained very concerned and she was making much of the relationship between intermittent catarrhal hearing loss and possible development delay.

Subsequently I think it is right that Dr Paul Davis became involved, who was a consultant community paediatrician, is that correct?
A That is right. The referral that was sent to Professor Sibert was actually passed on to Dr Paul Davis, who is the consultant community paediatrician in the XXX area, so he was not actually seen by Professor Sibert. Dr Paul Davis took on from that referral to Professor Sibert.

Q That explains why there is no response from Professor Sibert in the records. The letter is on page 106. It is a letter from Dr Davis to Dr Thomas, your senior partner, thanking him for his referral. He discussed the child with a speech therapist, detached from every day life, does not interact well, delayed sounds acquisition and poor retention of learnt communication skills. Then it refers to the ENT surgeon. There had been a previous consultation with Dr Hodges, who linked the developmental problems to measles and then sets out his birth history. It says there were no neonatal problems. At the age of two weeks he had a brief episode of fever and diarrhoea and was admitted overnight but that settled spontaneously, full vaccinated. Despite MMR, he had had an illness in June 1994 and he describes that illness.

Under family history, following his episode of measles Child 10 appeared to lose eye contact, went into his own world, lost interest in toys and books and ceased all interaction with other people. It sets out the problems concerning that – his attempts at communication and the fact that his eye contact was beginning to improve but he rarely responded to commands.

At page 108, Dr Davis’ impression:

“He certainly appears to have had a developmental regression, particularly in communication and social skills which appears coincident with the illness which may or may not have been measles. There is also a history of some trivial head injuries.

I think it is worth investigating him at this stage. I will arrange a hearing assessment in the Welsh Hearing Institute, a vision assessment by the community orthoptist. I have taken blood … will arrange a head scan and EEG and next time he comes we will take some urine to look for organic and amino acids.

His father after some open-ended questioning asked if he could be autistic and I had to spend a considerable time talking them through what autism is. Child 10 certainly has a number of features at the moment which are characteristic of autistic children, but his score on the autism behaviour checklist was certainly not in the autistic range, i.e. some autistic features but not autistic. I told his parents that I could not guarantee that he would not be labelled autistic later in life but I felt it was extremely unlikely. More likely he had a transient developmental regression due to a setback, presumably a viral illness, and is making good progress towards recovery and I hope will continue to do so. His mother was rather shocked because she thought that we could totally rule out autism by virtue of the fact that he had been normal during the first year of life, but this is not the case.”

He planned to review him in six weeks and then, if appropriate, to get an opinion from a paediatric neurologist.

Going to page 102, tracing through the history, a review by Dr Davis saying that he had seen Child 10 in the child centre, a significant regression for two weeks precipitated by a cold and setting out the findings in relation to his ear. Under impression:

“He is still exhibiting a number of autistic features but at this stage I would certainly fall short of labelling him as autistic. All his problems could be explained by a specific speech and language disorder aggravated by transient deafness due to glue ear. The role of the precipitating measles illness in June in causing his current problems is rather unclear, although his measles antibody titre was significantly raised.

Other investigations have been unremarkable. His DNA and chromosomes were normal.

The Home Advisory Service are due to start visiting tomorrow and a paediatric neurologist becoming involved.

I have asked Professor Bill Fraser to see the family to give a clear view on the autistic element and Dr Sheila Wallace to comment on the neurology.”

Do you know what Professor Bill Fraser’s specialism is?
A I never came across Professor Bill Fraser much in XXX. I never referred a patient to him, but reading from that he was involved with behavioural things with children. He is not a professor with whom I am familiar.

Q Dr Sheila Wallace is a paediatric neurologist.
A She most certainly is. She is now retired but she was a senior paediatric neurologist in XXX at the time.

Q We can see that he underwent an MRI scan. Going back to page 100, we can see that this is a discharge notification to the GP surgery from XXXX Hospital, admitted on 12 July and discharged the next day and under “Operations” that he had had an MRI. Is that correct?
A That is what it says, yes.

Q He was indeed seen by Dr Wallace, the senior paediatric neurologist, page 96.

“He came to my clinic on 1 August. Child 10 has many autistic features but he seems to have had a rather more acute loss of social and communication skills than usual. I wonder whether the more appropriate diagnosis would be disintegrative psychosis. I note that you are referring Child 10 to Professor Fraser and I should be very interested to have a copy of his report.”

She sets out the history which by now is clear of an illness starting in June 1994 when he apparently had a viral illness. Going to the last page, the last paragraph:

“Child 10 seems to have become behaviourally disturbed after an illness and this behavioural disturbance seems to have come on rather rapidly and I wonder whether the term disintegrative psychosis would be more appropriate for him. His parents were extremely upset that I did not have the result of his MRI … I explained the result would be sent to you … I was able to get the result and reassured them that the MRI did not show any abnormalities. If sudden episodes of stillness and quietness become a regular feature of his behaviour it would be worth repeating the EEG.”

The last letter that I want to refer you to is on page 83. This is going back to Dr Davis, the community paediatrician, in September 1996, the second paragraph:

“Behaviourally he is making slow progress. He still has no speech. He is very preoccupied with some objects … His parents feel he hears adequately and do not want his hearing retested. They have not yet heard from the education department. They did not want him to be seen by Professor Fraser, who I felt could have shed some useful light, although I do not think he would attract a firm label of autism. They are due to see the dietician later in the week and asking for referral for occupational therapy.”

That takes us on to September 1996. I would like you to help us as to the circumstances in which the referral was made by you at that date. How did it come about, first of all? Who asked you to make that referral?
A This was a parental request. The father of Child 10 visited me in surgery saying that he felt his son had developed some new symptoms which were not mentioned in the letter from Dr Paul Davis of 2 September. He felt that he had developed some new symptoms and that he had heard about a doctor working in London working with children who had similar symptoms to which he identified with is son and he asked for referral.

Q Can you help us as to the nature of those new symptoms?
A They actually sounded quite vague and non-specific. It could well have fitted in with the autistic behavioural pattern that he had exhibited for 18 months but the new symptoms seemed to be that there were times where he would go onto the floor and cry and pick up his knees, apparently in some form of discomfort. That had come on in the previous few weeks, certainly since he had been seen by Dr Paul Davis on 28 August.

Q Were you clear as to the nature of the discomfort that the father thought he was having or where it was?
A Not really to be honest. The father said that the doctor working in London is working with children with symptoms very similar to what he had identified in his son and he wanted referral.

Q Did he name the doctor he was referring to?
A He did, indeed, Professor Walker-Smith.

Q Was he a doctor who you personally heard of or knew anything about at that time?
A No, he was not.

Q Did you have any concerns about making that request?
A My first instinct would have been to have referred back to the local consultant paediatrician but it was quite clear from the parent of Child 10 that he wanted referral.

Q Did you in fact go along with it?
A The consultation took place in early October 1996 and to the best of my recollection I mentioned that I would have to speak to someone in the local health board or the predecessor, which was the FHSA, to get permission from them to refer to Professor Walker-Smith. Again, to the best of my recollection, I was told by the father of Child 10 that Professor Walker-Smith would see the child, so I believe there had been some contact between dad and Professor Walker-Smith before he came in to see me. That, to the best of my recollection, is October 1996.

Q If I can go to the referral letter that you wrote at that time. It is at page 82 in your bundle. You say there:

“Thank you for seeing this unfortunate 3½ year old boy who has been extensively investigated by our local paediatricians.

He was presented by his mother in late February 1995 with a history of loss of acquired skills. This appeared to follow on from a viral-type illness which [he] caught whilst visiting his grand-parents ….. accompanied by a rash and thought to be a measles-type illness”,

but that he had not been seen by any doctor from your practice, and you said “we have no documentation”.

“He had been given the MMR vaccine on 21 [February]. Of all the investigations performed by Dr Paul Davis ….. the only thing of significance was that his ‘measles antibody was significantly raised’.”

You say what medication he was on, low dose penicillin for recurrent ear infections, and you say:

“No actual diagnosis has been given for [10]’s condition but the most recent report states ‘severe speech and language disorder with some autistic features’.”

That of course was the diagnosis of September 96.

“Mr [10] – who holds a PhD – has heard of your work and is keen for [10] to be assessed …..

The situation is obviously much more complex than I am able to outline in a brief introducing letter and [10] has been seen by a Consultant Paediatric Neurologist and a Principal Clinical Psychologist in addition to the Community Paediatrician and ENT surgeon.

However, the situation is so difficult and complex that I’ll be grateful for any help you can give.”

Can I ask you, Dr Hopkins, in terms of length and detail would you regard that as being a relatively standard referral letter from you?
A I mean, referral letters depend on the nature of the problem. I mean, you might have someone who has a hernia and they have a two line referral.

Q Yes.
A That was my attempt to give Professor Walker-Smith as much information as possible. I did not actually mention the knees going up and the crying because they were new developments and might well have changed by the time they had actually seen Professor Walker-Smith. That is why I offered to sort of send any letters to him, or suggest to Professor Walker-Smith that he could liaise directly with any consultants concerned. This was a highly complex case.

Q Yes. Professor Walker-Smith wrote back to you, and we have got two letters from him. One is in the records at page 80, simply saying that he had arranged for an outpatients appointment, and then at 79 a letter dated 11 November.

“Thank you ….. for referring this very difficult problem with [10]’s history of loss of acquired skills, and somewhat autistic features ….. From a gastroenterological point of view it is interesting that he has intermittent episodes of watery diarrhoea and has episodes of screaming when he clutches his abdomen which could be related to abdominal pain. The parents are keen that I should investigate him for possible gastrointestinal disease, it is very interesting that he has a high measles antibody and I think that this needs to be taken into account with the possible relationship of measles immunisation and inflammatory bowel disease. I am therefore arranging for him to come in to have a colonoscopy [in] January”.

Now, Doctor, can I ask you, first of all, as far as you were aware had gastrointestinal disease figured as a significant element of the child’s history?
A Not to the best of my knowledge until that came in, feeling that with the new symptoms that he felt that this might be related to some form of tummy problem, abdominal problem, but I do not recall reading in the notes any significant mention of any bowel problems, no, I do not recall that.

Q I think, if I may, I am going to take you to a couple of references. If you look at page 123, this is very early on of course when this little boy was a month old, we see that here was a reference to an admission with diarrhoea when he was a month old baby in March 1993.
A Yes.

Q Is that correct?
A That is correct, yes.

Q The only other one is at page 130, in September 1994. I do not know if that is your handwriting; is it 4 September or 9 September 94, right in the middle of the left hand column, and there is a reference to diarrhoea, I think, there?
A That is my writing.

Q What does it say?
A It just says “diarrhoea” advised. Diarrhoea is a very common presenting symptom by mums with young children.

Q Of course, that was September 94, so a considerable period of time before.
A Yes.

Q When you got this letter, going back to page 79, the letter from Professor Walker-Smith, were you aware of any other details as to what the plan was in respect of Child 10, save those set out in that letter, namely that he was going to be admitted for a colonoscopy?
A No, I was not.

Q As far as information from then on about whatever was being planned at the Royal Free Hospital, whose responsibility would you regard it as being to keep the parents informed as to what plan was being made?
A I think when any GP makes a referral to a doctor in the secondary sector one does rely on the doctor in the hospital giving full information as to what is to be done to the patient, or the parents of the patient.

Q Yes. Now, you refer in your statement to a letter which is in the records at page 77, and that is a letter in fact again to the senior partner of your practice rather than to you from Dr Davis, saying:

“I saw [10]’s father today without [10]. They feel he is ….. making some quite encouraging progress. There are two new developments in that he has become hypersensitive to sound and is covering his ears and has spontaneously stopped eating milk products which has improved his diarrhoea. He has been to The Royal Free Hospital and I have had a copy of their clinic letter. They are planning to do a Colonoscopy and are also looking to the possible association between measles or measles vaccine and autistic features. This is however a research activity rather than a proven clinical activity. The parents are quite keen to discuss this with Dr Huw Jenkins and I will drop him a line.

From discussion with his father [10] still has quite a lot of autistic features”.

He says he is also going to approach education. Dr Huw Jenkins, Doctor, can you just help us as to his specialism?
A Dr Huw Jenkins is a local paediatrician in XXX who specialises in paediatric gastroenterology.

Q Thank you. Now, as far as you were concerned, is the next information that you had the discharge summary which was sent to you after the child’s admission to the Royal Free Hospital?
A That was the next piece of information we received, yes.

Q We can see that at page 74. That is indeed a letter to you yourself and it sets out the fact that:

“[The child] was admitted for other investigations of his bowel symptoms in association with disintegrative neurological disorder and possible association with measles [vaccine].”

We see above that a diagnosis of learning difficulties, abdominal pain with occasional diarrhoea, an elevated measles titres and microscopic colonic inflammation with lymphoid hyperplasia of the ileum. If we just go through the letter, that sets out the history of his developmental delays, which I am not going to go through again. At the top of the next page it says:

“He has a variable bowel habit. His stool[s] are occasionally watery and he has occasionally to strain at stool. He evacuates his bowel between 2-6 times a day. Further review of systems was unremarkable. He never has any oral ulceration or joint problems.”

Then it refers to the previous investigations, including the fact that he had had an MRI, EEG and blood tests, all at XXX. It sets out the findings at colonoscopy: “prominent lymphoid follicles throughout the colon” and various other findings; biopsies which had demonstrated a normal crypt architecture with mild, increased distribution of chronic inflammatory cells throughout the colon. It says that he was reviewed by a child psychiatrist who will be forwarding a report, and makes a recommendation of sulphasalazine, which is an anti-inflammatory, is that correct?
A That is right, sulphasalazine is an anti-inflammatory.

Q Was that a drug that you were familiar with?
A It was, yes, but not in children of this age.

Q As a result of that, did you telephone to inquire about that prescription?
A Yes, I did. The discharge letter was from Dr David Casson, Senior Registrar in Paediatric Gastroenterology, and I did query that with Dr Casson, yes, on 23 April.

Q Thank you. That was by telephone, was it, Dr Hopkins?
A I telephoned Dr Casson at the Royal Free, yes, and that was the only time I contacted the Royal Free other than by the referral letter.

Q In fact we can see, I think, a note. Is that a note in your handwriting right at the bottom of the letter saying that you had spoken to Dr Casson?
A That is my handwriting, yes.

Q Can you just tell us what it says?
A Certainly. “[23 April 1997] – spoke to Dr Casson [regarding] any monitoring”, and I think the word is “required. Advised no specific monitoring. He will write to confirm”.

Q Did he then write you a letter which we can see on page 68?
A He did.

Q “Dear Dr Hopkins

Thank you for your phone call regarding use of Sulphasalazine in [10]. I should reassure you that it is a medication that we have had very few problems with regarding adverse side effects. Nevertheless side effects are more notable with this 1st generation 5-ASA derivative as apposed to the newer ones e.g. Mesalazine. Unfortunately however the newer ones are not generally available in liquid form and therefore children such as [10] find them difficult to take.

Side effects [are] very occasional idiosyncratic renal dysfunction ….. ongoing liver dysfunction, skin rashes and haematological dyscrasias. There is no recommended protocol for following up these children, nevertheless I would recommend that he should have his renal and liver functions and [full blood count] with white cell differential and amylase checked monthly for 3 months and then at 3 monthly intervals.”

It is signed by Dr Casson, and there is a note beside it which again I think is in your writing, Dr Hopkins, is that right?
A That is my handwriting, yes.

Q Can you just read that one to us?
A “Not what he told me on the telephone. Not what Dr Jenkins (UHW) advised 8.5.97”.

Q Can you just tell us what your concern was, why you made this note, and what you were referring to?
A I think it is a case of clinical responsibility here, because certainly my experience of patients on sulphasalazine are all adults, and we do very regularly perform various blood tests to look out for side effects on them. It would be almost impossible for us to monitor this child doing blood tests and I really did not think it was our clinical responsibility, so if monitoring was required I wanted to make it quite clear to Dr Casson that the responsibility lay with him and his team, or whoever he liaised with to arrange monitoring.

Q He says that he should reassure you in that letter that the medication they had had very few problems with regarding adverse side effects. Was that a reassurance that you had sought when you telephoned him? You have told us that it was not a drug that you were familiar with being used in children.
A That is right, yes, I wanted to clarify things certainly.

Q Now, in fact, you refer to Dr Jenkins there, and if we look at page 72 we will see that a referral – perhaps “referral” is the wrong word – but a request for the child to be monitored locally had been made, page 72 in the GP records. It is a letter to Dr Jenkins, the paediatric gastroenterologist in Wales, Professor Walker-Smith from Dr Casson:

“Professor Walker-Smith would be extremely grateful for your assistance in managing this child.”

Then it sets out why the Royal Free had become involved and explains that he had been started on the anti-inflammatory. You were aware, were you, of an involvement by Dr Jenkins through a request from Professor Walker-Smith?
A The letter is from Dr Casson, yes. I think I was aware of that letter, yes.

Q Was that a usual sequence, doctor? Presumably, normally if you wanted a child to see a specialist in your area, you would refer that child?
A Sorry?

Q I am sorry; I am just asking you was there anything unusual about a request from one specialist centre, ie, the Royal Free, to a local specialist to become involved?
A I do not think so. The child had severe behavioural difficulties and the history in the notes is one of failure to turn up for various outpatients’ appointments where the parents had turned up or telephoned the specialist, and that is happening in XXX so it would be that much more difficult if one is talking of a referral up in London, so I do not think there is anything unreasonable about that at all, no.

Q No, I was not suggesting for a moment there was. I was just trying to make the background clear. You continued in relation to the monitoring issue because if we look at GPR page 69 you said:

“Dear Dr Casson, … I … must confess to being a little disappointed with the last sentence” – that is of the letter that he had sent to you – “which refers to monitoring. There was no mention of [it] …”

And you said that the opinion that he had expressed was that there was no real need for monitoring, and you said:

“You will recall that I informed you that if any monitoring was required then I would not be prepared to accept responsibility for this as … [it was] the responsibility of the recommending Doctor in the secondary sector.”

You say you have discussed the matter with Dr Jenkins and he said he felt no specific monitoring was needed but that you wanted that issue sorted out in effect between Dr Casson and Dr Jenkins. Is that your stance?
A I wanted to make sure that no harm came to my patient and nothing fell between two stools, yes.

Q I think it is right that the child did in fact remain on salazopyrin, that anti-inflammatory, for some period of time and you were not concerned in that prescription but the parents expressed views to you about its success. Is that correct?
A Reading through the notes for the first few years after he was prescribed it, there are still records there coming from doctors in the secondary sector that he was still having abdominal discomfort, but certainly from about 2002 onwards everything seems to have settled completely and yes, the parents are very happy with it.

Q Just for the sake of completeness I am going to refer you to the last annual reviews that we can see in the records, although you may be asked by others about more of the records. If we go to page 41, which is a letter to you in May 1999, that is a letter from Dr Davis again to you saying that there had been some deterioration in behaviour during the warmer months which they had seen in the past three years and which related to the weather. It says:

“He is still on Salazopyrin because his parents find his abdominal pains recur when they cut the dose down, and he is on Movecol … and lactulose … which works well.”

Can you just help us as to what those two last medications are, Movecol and Lactulose?
A Certainly. They are medications that are used to treat constipation.

Q Then he goes on to talk about treatments for allergy. Then if we go on to page 26, this is another letter to you from Dr Davis, this time June 2002. There are references to “overall making reasonable progress although severely autistic”, and then in the second paragraph:

“The other major concern is around his abdominal pain. This occurs on average two or three times a day. He suddenly becomes distressed, clutches his abdomen and writhes on the floor. It stops quite abruptly after 10-15 minutes and he is fine afterwards. There are quite long gaps in between episodes. … They don’t appear to bear any relationship to mealtimes or bowel movements, although his father said that they do sometimes happen after breakfast. He is not constipated at the moment, although he has been in the past. There are no particular associated symptoms.”

Over the page Dr Davis says:

“The abdominal pain has an unusual pattern which does not quite fit for large bowel colic although it could be. We discussed various possibilities. His father was certainly keen to explore the bowel side of things again …”

And then there is a referral to Dr Jenkins and to what is being done in relation to support for his difficult behaviours. The last annual review is on page 24, a letter to you, this time from the Specialist Registrar in Child Health. In the first paragraph it says he had been reviewed at school:

“I am pleased to say that Child 10’s episodes of abdominal pain have significantly reduced since commencing Sulphasalazine at the end of last year.”

So that must mean recommencing it.
A Yes.

Q It says that he still had the occasional episode of abdominal pain:

“but these trouble him far less than previously. Child 10 remains a picky eater, but … his appetite has improved slightly, now that the pain was under control. He continues to have a largely gluten and casein free diet …”

It says Child 10’s bowel habit “is satisfactory on the above dose of Lactulose”. It goes on to say that now he is less agitated as he is no longer experiencing pain, “his concentration has improved, although remains short”, and it then goes on to various other behavioural difficulties that the child has. Were you aware, doctor, that Child 10 was one of the children who was written up in a Lancet paper later?
A No, I was not.

Q And was there any further contact to you from the Royal Free in relation to any findings or conclusions that had been reached?
A No, there was not.

Q Do you have any recollection of discussing any issue in relation to the manufacturers of the MMR vaccine with Child 10’s parents?
A I have no recollection of discussing that with them, no.

Q I can lead on this. There is in Child 10’s records a Vaccine Damage Payment Unit payment form in relation to vaccine damage.
A Yes. In 2001 we had a request from Monmouth for Child 10 asking for details of the dates when the child had attended various hospitals and we thought something might have been happening then, and I think it was January 2003 where we did receive the official request for the notes from the Vaccine Damage Payment Unit and clearly we knew something was happening then.

Q I want to ask you shortly in relation to a separate matter and that arises out of a letter on page 65. That is a letter to Dr Thomas, a senior partner, from Dr Davis, the Community Paediatrician, and the only bit of it that I wanted to ask you about – it is a letter in August 1997 – is in the first paragraph:

“He is on Salazopyrin for bowel inflammation and is awaiting some new treatment with measles transfer factor.”

Have you any knowledge at all of a prescription of measles transfer factor, of a substance called transfer factor being given to this child?
A None whatsoever.

Q And have you in fact reviewed the medical records and tried to see if there is any reference in the GP records to that other than that reference?
A I have indeed, yes. We could find no record. I cannot believe any GP would ever prescribe that.

Q If he was prescribed or given that substance, in view of the lack of reference in his records can you be confident that it was not given by any of the GPs in your practice?
A I have no evidence whatsoever to believe that it was given by myself or any doctor in our practice, and, as I say, it is such a specialised drug that I find it hard to believe that GPs would prescribe it. It should not be prescribed by GPs, certainly.

Q If it had been given to him by someone else – and I mean, of course, a member of the medical profession – would you expect to have been informed of it?
A I think when a GP refers a patient to anyone in the secondary sector that GP expects to be informed of what is going on with the patient, and so any significant treatment or development we should be informed of and I would have thought that was a significant thing, yes.

Q This may be a rather obvious question, in which case forgive me for asking, but why is it important for you as a general practitioner? Why would you expect to be informed of any substance that the child was being given in the secondary sector?
A I think it is important we know what is going on because if something had cropped up in the future and perhaps the parents of the child had come along and mentioned this treatment and then one looks at them and says, “Look, I am sorry, I do not know what you are talking about”, that does nothing whatsoever for a doctor/patient relationship, so we need to be informed what is happening with our patients.

Q Thank you doctor. There is one other matter that I want to ask you about and that relates to the finances. I think you touched on this when you were talking about your referral of this child to the Royal Free. As far as you were concerned who was paying for that admission?
A At no time did I think I was making a referral on anything other than the NHS.

Q If you look at the Royal Free Hospital records, volume 2, and turn to page 10, this is not a document you will have seen before. It is the Royal Free admissions printout and if you look at the bottom you will see “Admission Details”, and under that do you see on the right hand side there is, “Method of adm.”, “Source of adm.” and then “Category”, and it says “NHS”?
A Yes.

Q That would accord with your understanding, would it?
A I felt that I was referring on the NHS, yes.

MS SMITH: Thank you very much indeed, Dr Hopkins.

THE CHAIRMAN: Mr Coonan, I was just going to ask exactly this question – and I will be happy for you to go first – whether Mr Miller would like to go first, but I am happy whatever you want to do.

MR COONAN: I have no questions for Dr Hopkins.

THE CHAIRMAN: Mr Miller is representing Professor Walker-Smith, and he will now ask you some questions.

MR MILLER: Sir, on the last point you made, as between counsel we have discussed that with various witnesses it might be more appropriate for one of the three of us to begin cross-examination. I hope you do not mind if occasionally Mr Hopkins goes on first or I go first or Mr Coonan.

THE CHAIRMAN: I think that is absolutely right. We will have no problem with that at all. Do whatever you think is most appropriate.

MR MILLER: We will save on cross-examination then.

Cross-examined by MR MILLER

Q Dr Hopkins, I am asking questions on behalf of Professor Walker-Smith. I do not want to go down all the same avenues that Ms Smith has gone down, but I would like you to consider some of the notes in the bundles that we have got, not perhaps in the same detail as you have already done, and you will not be very long in the witness box. It is clear that at least by the middle of 1996 that this boy had serious problems, of whatever cause, but he had serious problems.
A Well yes, before that.

Q By that stage a large number of specialists had been consulted in different disciplines to see whether it was possible to identify what was causing particularly his developmental problems?
A That is right, yes.

Q Those specialists included not only an ENT consultant because it was thought that hearing might have something to do with it, but also a number of paediatricians and a paediatric neurologist?
A Yes.

Q Throughout certainly the period 1996 and 1997 Dr Davis was involved and to some extent he liaised with the other specialists, as well as reporting back in some cases to you and in some cases to your senior partner.
A Yes, I think Dr Davis would be the lead, effectively, in XXX, yes.

Q The lead went over, ultimately, into discussing the case with Dr Jenkins, under whose team eventually Child 10 continued to be treated.
A That is right, yes.

Q As far as the autism, or possible autism, is concerned, we have seen as Ms Smith went through the documents with you, various people speculating as to whether or not this was autism, had autistic features; nobody came to a clearly defined diagnosis before the referral to the Royal Free, but everybody identified features which they said looked to be autistic features although not frank autism.
A That is the general impression.

Q That is what we have seen when we have gone through ---
A Even in the letters up to August 1996, yes.

Q Your principal involvement, apart from seeing the family on a regular GP basis, seems to start – again, apart from fielding some of the correspondence – when you make the referral to Professor Walker-Smith in October 1996, because from the documents you appear to be much more active after that.
A I made the referral in 1996 and up until then the – well, in fact even then … I have not seen the child much since 1996 anyway.

Q Up until then there is consultant involvement at various places; dialogue between them; dialogue coming back to the general practice, and your position is that you had to try to see what is going on, and, if you think it is appropriate, make the referral to a particular specialist: that is your role is it not?
A That is our role as GPs, yes.

Q Would you look at page 82, the referral letter? It is quite a long and informative letter, is it not, as a referral letter? It sets out all that you consider to be relevant for Professor Walker-Smith.
A Hopefully.

Q It is obvious, because we have not seen how this started in the notes or in any of the correspondence, that you must have been asked to refer to somebody with whom you are not familiar but at the specific request either of the father or the mother or both?
A Sorry, yes, that is true.

Q You realised that you had the name of the person, his position, and it was clear that he was a gastroenterologist.
A That is right, yes.

Q There had been no previous gastroenterological referral, had there?
A There had not, no.

Q If you look at your letter, the history comes from your notes and presumably what you were told by the parents. The MMR vaccine is something which, presumably, you considered to be important as part of the background.
A Yes.

Q As well as the measles antibody being significantly raised: again, you thought that was something which was important to tell them about?
A Yes, because that was the one positive finding that had come from the investigation by Dr Davis the local paediatrician.

Q As you say in two places, the last two paragraphs, it is a complex case: I cannot do justice to it in the referral letter, but “over to you; I would like you to see this child and apply your specialist knowledge to whatever may have been going on.”
A I was certainly doing that, yes.

Q It is clear, referring the child to a professor of paediatric gastroenterology presumably in your mind to see if there was any gut pathology that might be affecting him?
A It was partly that and it was also partly to treat the parents because, as I think one can imagine in a situation like this, this was devastating for a family. I had known this family for 20 years. I have known the children all their lives and one does respond – one tries to make sure that no stone is left unturned and when referrals are made it is not always … Well, there is often lateral thinking, and certainly I think had I not made that referral I would have been viewed as being very, very obstructive by the parents.

Q You had established a relationship with the parents, who trusted you and the whole practice, and you have described it as that the parents were desperate to get something done and the referral was your attempt to help desperate parents as well as the child.
A I think certainly I was treating the parents as well as the child, yes.

Q As a general practitioner in these circumstances, this is not meant in any way … There is no spin on this, but you must feel on occasions quite powerless to deal with complex cases in general practice because they are beyond your expertise and all you can do is to refer to somebody with greater experience in a particular problem: that is what happens in general practice, is it not, that all you can do – you cannot be expected to make the diagnosis or give the treatment?
A I do not feel powerless at all, no. I think the important thing for general practitioners is to recognise their limitations, recognise what they can treat and recognise when they need to refer on. I did not feel powerless referring to Professor Walker-Smith for his greater expertise in this area, not at all, no.

Q You misunderstood the question: I said, there was no spin on the question, it is just that you cannot deal with it, as a general practitioner, the only thing you can do, if you think it appropriate, is to refer to somebody who happens to specialise in that particular area?
A As appropriate to all referrals to the secondary sector, yes, I agree with that yes.

Q Exactly so.
A Yes.

Q In this situation you are only too happy, for the sake of the patient and the parents, to refer to a very senior medical colleague in a highly reputable medical institution, as the Royal Free Hospital was?
A I was indeed, yes.

Q Even if you were not sure of what investigations or treatment were being proposed when you made the referral, you would have been relying on the doctors in the secondary sector, in this case the Royal Free, fully to inform the child’s parents of what they intended to do and to let you know what they intended to do, that is your expectation, is it not?
A It is indeed, yes.

Q Obviously particularly the parents because they are going to be in direct contact with the hospital, and you would expect them to be told in this case what investigations they intended to carry out, and, if necessary, what treatment they intended to carry out, and you have got no reason to believe that they did not fully discuss it with the parents in this case.
A I have absolutely no reason to believe that at all, yes, that is correct.

Q As far as you are concerned, you would expect them to let you know what they intended to do; what their findings were and they did that as well, did they not?
A I got the one discharge letter from the Royal Free, which was dated I think March 1996.

Q Yes, you got two things, or three I suppose, firstly you got a two line letter from Professor Walker-Smith in response to your referral letter saying that he would be delighted to see the boy ---
A True.

Q --- and he would make an appointment in the outpatient clinic, and then there was an outpatient appointment, was there not, and you were told about that?
A That is true.

Q If you look at the bundle at page 79, 8 November, I think the letter is dated 11 November.
A Yes.

“Thank you so much for referring this very difficult problem with [his] history of loss of acquired skills, and somewhat autistic features which have improved. From a gastroenterological point of view it is interesting that he has intermittent episodes of watery diarrhoea and has episodes of screaming when he clutches his abdomen which could be related to abdominal pain. The parents are keen that I should investigate him for possible gastrointestinal disease, it is very interesting that he has a high measles antibody and I think this needs to be taken into account with the possibly relationship with measles immunisation and inflammatory bowel disease.”

So he was reporting back what had happened at that outpatient clinic and he was saying, “We intend to do a colonoscopy”.
A Yes, that is down, yes.

Q Is it your experience that patients or parents sometimes tell one doctor something which they do not tell another doctor, not trying to conceal it but simply that you do not necessarily get precisely the same history every time a patient or a parent speaks to a particular doctor?
A I think that probably does happen, yes.

Q Because here, clearly, Mrs 10 was telling this doctor that there were “episodes of screaming when he clutches his abdomen which could be related to abdominal pain”, which is what the father had told you I think about new symptoms, but she had also told him that he had intermittent episodes of watery diarrhoea, which did not appear in the notes that we have seen, except I think in 1994 there was one note, and 1993 I think one note, but in fact if one looks at … Just jumping forward a little, this is just to demonstrate the point, do you have the health visitor’s records there?
A Yes.

Q If you would go to page 32, that has “The Children’s Centre” at the top.
A My page 32 is a letter from Dr Paul Davis.

Q That is right, yes. The point I have just made is, here is Paul Davis, who in fact has been involved quite a lot during the run-up to this and he is writing to the consultant paediatric gastroenterologist, admittedly two months later when he is giving a history to Dr Jenkins about the changes in his personality. In the fourth line he writes:

“He has chronic but intermittent diarrhoea. I don’t think he has symptoms of malabsorption but he has been seen at the Royal Free Hospital fairly recently and they were planning to do a colonoscopy. However, his parents would much prefer to have any necessary treatment in XXX and are very keen to discuss this with you.”

So this is Dr Davis writing to a new consultant, a gastroenterologist in XXX, and this is the Davis whose letters we have seen going back to 1995 I think.
A Yes.

Q He is describing that he has chronic but intermittent diarrhoea, which is not something that we have seen in the earlier letters. Again, going forward, just to make this point, back in the GP records, your records, if you could look at page 65, again it is a letter from Dr Davis to your senior partner, after the treatment had been started: you can see that from the last three lines of the first paragraph:

“He is on Salazopyrin for bowel inflammation is awaiting some new treatment with measles transfer factor. His diarrhoea is much improved.”

As you say, it would not be unusual that when one is concentrating on particular symptoms for a particular purpose, as Professor Walker-Smith obviously was from the gastroenterological point of view, that he gets a rather fuller history than had been given before, that would not be unusual?
A That probably would not be unusual, no.

Q We know that he was admitted to the Royal Free and had the colonoscopy on 17 February 1997, and as you say, you received a discharge letter on 17 March. We can turn that up but I do not want to go through it. This is from Dr Casson, the senior registrar, paediatric gastroenterology ---
A Can you give me the page number, please?

Q Sorry, it is page 74 in the GP records. I think you have expressed the view that this is an extensive summary which could not be criticised in terms of the information that it provided.
A It is a good discharge summary, yes.

Q He reiterates the gastroenterological complaints, the presenting complaints when he was seen there, “abdominal pain with occasional diarrhoea.” He also goes on to deal with the results of the colonoscopy which had identified abnormalities and the histology which had also identified chronic inflammatory changes. At the end, this is after the tests had been done, the last paragraph on page 75:

“In view of the definite inflammatory changes noted in his colonic biopsy we feel that it would be appropriate with anti-inflammatory medication [to treat] and therefore we recommend treatment with sulphasalazine 250 mg qds which we would be grateful if you would prescribe this.”

Having investigated him, identified some bowel pathology from the investigations, they were recommending treatment.
A Yes.

Q There is a bit of to-ing and fro-ing because the ball is being passed back to you. You have a concern about whether or not there are the side-effects of this treatment. You ask for clarification from Dr Casson and he says in his experience there are not that many serious side-effects but you had better monitor the patient on a regular basis which you felt, quite reasonably, was an unreasonable imposition for you in general practice to have to monitor in that way. Is that a fair summary?
A It was an inappropriate request, yes.

Q In fact, as we have seen, there was liaison between the Royal Free and XXXX which resulted in the treatment being taken over by XXXX rather than making you responsible for it.
A That is true, yes.

Q We do not need to follow the paper trail to that but we can see that is what happened. As far as that treatment is concerned, we have seen that letter from Paul Davis in which he says that the diarrhoea had improved. The continuing problem from a gastroenterological point of view was the abdominal pain and in the end the only way in which that was satisfactorily dealt with was by continuing with this anti-inflammatory, was it not?
A Certainly the records would suggest that when attempts were made to stop the medication the problem would appear to have got worse. That appears to be in the notes, yes.

Q There is a period in which it was stopped and then in 2002 it was resumed and the mother said to you when he goes off it the abdominal pain comes back.
A Yes, there is a definite record in 2002 of Dr Jenkins liaising with the family.

Q She says she would like it almost on an as required basis because I do not want to be left in the position where I have to come back when the pain is there. Does that remain the position now? He is still on this?
A He is still on the medication, yes. I have not spoken to the parents about this recently but I think they are very reluctant to stop it, yes.

Q They have said that it has made a dramatic difference to his life, have they not?
A The parents are extremely happy, yes, no doubt about that.

Q You were asked about the letter on page 72, which is the transfer in April 1997. That makes complete sense, does it not, the last paragraph:

“Please find enclosed discharge summary letter which set out the details of the investigations and the treatment. Would it be possible for you to see them in your outpatients department as it is obviously difficult for them to be seen in London.”

That makes complete sense, does it not?
A Absolutely.

Q You referred him to the Royal Free at the parents’ request, you and your practice having made other referrals probably at the parents’ request, but in order to do what was best for the child and the family. The parents were very happy with the way that they were looked after at the Royal Free and with the medication which they believed benefited the child.
A Yes, indeed. I made it in all good faith. I made a referral, the patient was investigated, an apparent problem was found, it as treated and the parents were very happy with that and so from a purely clinical point of view as a GP I have to be happy with that.

MR MILLER: Thank you.

THE CHAIRMAN: It is now 11.30. We will take a short break for twenty minutes.

(The Panel adjourned for a short time)

Cross-examined by MR HOPKINS

Q Dr Hopkins, I ask questions on behalf of Professor Murch. He carried out the colonoscopy procedure that found the abnormalities in this child’s bowel. There is only one area I want to ask you about. You were asked by Ms Smith about this child’s gastrointestinal symptoms prior to the referral to the Royal Free and she asked whether gastrointestinal disease had figured significantly in the history before then and you replied to her “not until the new symptoms that had been mentioned by the father” and you described that as the child falling to the floor, crying, bringing the knees up to the abdomen. Can I ask you to also consider a piece of information that you put in your referral letter? If you go back to the GP bundle and look at page 82, in the third paragraph you report to Professor Walker-Smith a serum ferritin level that had been taken on 31 August 1995 which he described as being low at three.
A That is right, yes.

Q Since that time the child had been placed on iron replacement treatment.
A That is what happened at the time, yes.

Q Turning to page 92 to cross-refer where that result comes from, we see three quarters of the way down the page the serum ferritin at 3 and the normal range starts at 15, so this was a significantly low result, was it not?
A It is certainly below the normal range although I am not sure how that relates to children. There are people who are far more qualified than me to speak on that. I am not sure whether that is an adult range or whether there is a separate range for children but looking at that, that is low, yes.

Q You thought it important enough obviously to draw Professor Walker-Smith’s attention to this result.
A I felt it was important to give Professor Walker-Smith as much relevant information in order for him to carry out the consultation, yes.

Q Can I consider with you what the potentially obvious causes of such a low result might be? First of all, inadequate iron intake in the diet – that would be a possibility, would it not?
A It would certainly be a possibility.

Q Secondly, malabsorption of iron in the gut.
A Certainly.

Q Thirdly, blood loss and potential blood loss from the colon, that is a possibility.
A These are all three possibilities certainly.

Q That low serum ferritin level that you were reporting might have been a pointer towards a gastrointestinal problem.
A It certainly might have been, yes.

MR HOPKINS: Thank you.

THE CHAIRMAN: Ms Smith, do you have any questions arising from counsels’ questioning?

Re-examined by MS SMITH

Q I have one matter arising out of what Mr Hopkins has just asked you, Dr Hopkins. Tell us if you do not remember, but when you referred to the serum ferritin levels in you letter to Professor Walker-Smith, would you have had anything in particular in mind as the reason why you thought it was worth mentioning?
A I did not really to be honest. I certainly felt that with the clinical and social situation being so difficult, when one is returned with a serum ferritin of 3 one treats that, but my vague recollection in the past, I have come across children who have low ferritins for other reasons so I am not quite sure how the serum ferritin level in children equates with an adult one but certainly I felt it was something that was worth treating and as it was treatment I was given and I was referring on to Professor Walker-Smith I thought it was important that he should know about that.

Q Mr Miller asked you previously about the medication that this boy remains on and he said to you does he still remain on the medication and you indicated that he did and that his parents were pleased with that. When you said he was still on the medication, that was a reference to the anti-inflammatories prescribed at the Royal Free.
A That is the salazopyrin, yes.

Q Does he remain on the constipation treatment that had been prescribed by Dr Jenkins, do you know?
A To the best of my knowledge the current medication is salazopyrin as an anti-inflammatory, lactulose for constipation and I believe he is on an antihistamine as well. That is to the best of my knowledge, not having the records in front of me.

MS SMITH: Thank you, Dr Hopkins. I have no further questions but the Panel may have questions to ask you.

THE CHAIRMAN: The Panel may have some questions and, if they do, I will introduce them to you. Dr Webster is a medical member.

Questions by THE PANEL

DR WEBSTER: Is it a common occurrence that patients come to you and ask to be referred to a distant unit?
A It happens but I would not say it is common.

Q Were you given any explanation for the request at the time?
A The dad’s demeanour. Dad came in saying, as I think I said earlier on, he had heard of a doctor in London doing work with children who he equated with his own child and he wanted referral.

Q Did he say how he had heard?
A He did not although mum and dad are pleasant, intelligent, middle-class for want of a better word, patients. I feel sure they must have surfed the net. We are talking 1996 but, even then, I think they would have been highly computer literate and I think they must have got it from the net although I did not actually asked that question.

THE CHAIRMAN: Ms Wendy Golding is a lay member.

MS GOLDING: When Mr 10 spoke about Professor Walker-Smith and the referral he wanted did you get the idea that there was research going on and that Child 10 would be part of that research or whether it would be part of the normal clinical activity that the child would be embarking on?
A At no time did I think I was referring on other than for normal clinical activity. That was a clinical referral. I had no reason to suspect it was anything other than that.

THE CHAIRMAN: Dr Moodley is a medical member.

DR MOODLEY: In response to a question by Mr Miller were you satisfied with the response that you got from the Royal Free, you said “from a clinical point of view I was satisfied”, suggesting that you were not entirely satisfied.
A In 1996 I made the referral, as I said, in all good faith and with the greatest respect to everyone here today I would rather be sitting in XXX looking after my patients rather than sitting here today. I have been drawn into something which is beyond my control. From a clinical point of view I made that referral. I know that I was making a clinical referral. The patient was seen by Professor Walker-Smith and his team and the parents have told me that they are very happy with the outcome. They are very happy with the way that they and the child were treated at the Royal Free. Again, I am looking at it from the clinical point of view, bearing in mind that I am here before the GMC today and that was why I said from a purely clinical point of view. I do not know what else has gone on with research and funds. I know nothing at all about that, but from a clinical point of view my patient has been investigated, treated and the parents are very happy with that treatment. As a GP I have to be content with that.

THE CHAIRMAN: Dr Hopkins, I have three questions for you. I am a GP like yourself so that will help you as to where I am coming from. I think you said that you made this referral because of the parental request in view of the new symptoms that had developed after 2 September 1996.
A Yes.

Q I think one of the symptoms that you mentioned was actually clutching the abdomen.
A Yes.

Q Were there any other new symptoms that you were made aware of at that stage or were they the only new symptoms?
A That is all I remember going to the floor, clutching his abdomen and apparently in pain and discomfort.

Q Did you try to find out if he was clutching the abdomen are there any abdominal symptoms or gastrointestinal symptoms?
A I cannot remember.

Q If you do not remember please just say rather than trying to speculate.
A I cannot remember. I just remember the demeanour of the dad and dad wanted referral.

Q My understanding from your answer to the question from Ms Smith was about salazopyrin monitoring.
A Yes.

Q I think you said that if you are taking the clinical responsibility then you do the clinical monitoring as well.
A That is right. I certainly felt that if any monitoring was required it was by the recommending doctor.

Q Can you help me, did you in fact issue the prescription yourself?
A As you know, Doctor, as GPs we are often put in a difficult position with regards to this. The guideline is that if you are issuing a prescription you must have sufficient knowledge of that to be able to issue it and take responsibility for that, and that is the party line, which I accept, although from a practical point of view had I said that to my patient, then that would have meant them coming up to London to the Royal Free to get prescriptions, and that would have been very, very obstructive as a GP, so I wanted to clarify that issue with Dr Casson as to what was needed. I clarified it with one of the local consultant paediatric gastroenterologists, Dr Huw Jenkins, and was reassured by Dr Huw Jenkins that no monitoring was necessary, so we issued the prescriptions, and had we not done that, that would have meant them initially either coming up to London to pick up prescriptions, or going to the University Hospital of Wales, which is almost as difficult to get to with the parking these days.

Q I fully appreciate that, and that is precisely the reason I am asking the question, because legally I think the one who signs the prescription carries the legal responsibility.
A Legally, the one who signs that prescription, as I say, as you know---

Q But you were trying to get into the arrangement with Dr Casson.
A ---one has to help the patients and one has to bring a bit of common sense to things every now and again.

Q Thank you. My last question is, I think that was in answer to the question from Mr Miller, he actually asked you a question, and that is when you were making a referral to Professor Walker-Smith you were aware of his clinical expertise, and that is that he was a paediatric gastroenterologist?
A Sorry, did you say “were” or “were not”?

Q Were you aware of Professor Walker-Smith’s special expertise, clinical expertise, and that is in the area of paediatric gastroenterology?
A The information that was presented to me by the father of the child told me that the gentleman’s name was Professor Walker-Smith and he was a Professor of Paediatric Gastroenterology at the Royal Free Hospital, so yes, whilst I did not personally know Professor Walker-Smith, I felt comfortable that I was referring to a professor in one of the country’s leading hospital research institutions, yes.

Q Did it come to you as a surprise, because I think looking at your notes and the knowledge that you had at that particular time about the symptomatology of this particular patient, that there were very few gastrointestinal symptoms, if any, at that stage?
A Again, the referral came about because dad was convinced the child had abdominal symptoms, and dad was convinced that Professor Walker-Smith was dealing with patients who had exactly the same symptoms. The referral was almost inevitable.

Q So do I now understand that I think one of the new symptoms, that was clutching the abdomen, which was brought to your notice at that stage, was that the factor which was in your knowledge in dad’s mind, and then eventually in your mind, to make that referral to Professor Walker-Smith, or was there any other factor, or was that still a surprise issue?
A The main factor, I think, that brought dad along was the new symptom of falling to the floor clutching his abdomen, which dad equated with tummy pain, and that was what pushed me to refer, yes.

Q You still did not think that there was any association - at that stage I am talking about, when you were making this referral - were you actually referring him anything to do with his MMR vaccination that he had had earlier?
A That had not entered my mind at the time I made the referral, certainly not, no.

Q Dr Casson in his letter actually referred to the measles vaccination, not to the MMR vaccination. I think that letter was brought to you – let me just see what page it is on. Yes, it is on page 74. It is addressed to you, Dr Hopkins, by Dr Casson, and in the very first paragraph, the second line, “neurological disorder and possible association with measles vaccination”. Again, I just want to know about your understanding; did you think that this measles vaccination that was being talked about was a separate antigen vaccination, or part of the MMR? What was your understanding at that stage?
A I did not make any association at the time, Doctor, when I looked at the first bit, the investigation of his bowel, and then the rest of it is just a little bit loose, is it not, “with possible disintegrative neurological disorder and possible association with measles vaccination”, that is just not something which struck any alarm bells at the time.

Q Right. So you did not actually put two and two together and try to ask certain questions from yourself, “What is all this that is happening?”
A Not based on that sort of loose wording which is just part of one sentence of a long letter, no.

THE CHAIRMAN: Thank you. I think that is very helpful. I do not have any further questions. I am going to look to the Panel members again to see f they have any, and they do not seem to. I am now going to ask first of all the three counsel representing the doctors, any questions arising from the Panel members questions? Mr Hopkins? Mr Miller has already nodded “No”. Mr Coonan?

MR COONAN: No, thank you.


MS SMITH: No, thank you.

THE CHAIRMAN: Thank you, Dr Hopkins, on behalf of this Panel for sparing this morning. I know your preference would have been to sit in the surgery to look after your patients, but this is an important part of the work that we all have to do at some stage. Thank you again. You are now released.

(The witness withdrew)

MS SMITH: Sir, before I call the next witness, who is the next GP, there is a very short matter that my learned friends have raised with me, and I do not know how they wish to deal with it, whether you would mind if we just popped out for five minutes with the Legal Assessor. None of them seem to be …

THE LEGAL ASSESSOR: This needs to be dealt with before we proceed, does it?

MS SMITH: It relates to the next witness, yes.


THE CHAIRMAN: We will now adjourn shortly and we will come back as soon as we get a call from the Panel Secretary.

(The Panel adjourned for a short time)

THE LEGAL ASSESSOR: Ms Smith, I understand the next witness is going to be Dr Ajjegowda Shantha, is that right?

MS SMITH: Yes, that is correct.

THE LEGAL ASSESSOR: Well, the chairman has something to say before you call that witness.

THE CHAIRMAN: Thank you. It actually only happened at the mid-morning break, I saw a lady outside who I knew as Dr Shantha Jayaram. They live in the same town as myself, she and her husband, but their practice is somewhere outside Widnes, I practise in Widnes itself. We have had no professional dealings of any kind, but I did actually have no idea that she is called Dr Shantha in her professional life, so when we were circulated the names earlier, “Dr Shantha”, I had absolutely no idea this was going to be Dr Shantha Jayaram. So I just want to make that declaration, but, as I have said, I have had no professional dealings at all either with her or with her husband, and I just want to make that declaration and I just want to ask for all counsel’s views on this. First of all, you, Ms Smith.

MS SMITH: Thank you very much, sir, and thank you for indicating that to us. I think I can speak for everyone in saying that there is no problem in relation to that, but thank you for telling us.

THE CHAIRMAN: Thank you very much indeed, and I think I have that nodding from the other three counsel, so I am very grateful to you all. You certainly can call the next witness now.

MS SMITH: Thank you. I call Dr Shantha, sir.

Examined by MS SMITH

(Following introductions by the chairman)

Q Dr Shantha, could you first of all give the Panel your full name, please, and also the address of the practice in which you are a general practitioner.
A Ajjegowda Lakshminarayana Shantha is my full name. My practice I currently am in now is XXX in XXX in XXX.

Q You should find in front of you on the table a laminated plastic sheet with an anonymisation key in it, and if you look at that, is it right that you are the general practitioner of the child whose name is described as Child 3 on there?
A That is right, yes.

Q We are going to refer to him as Child l3, Doctor, but it is sometimes difficult to remember when we are looking at records obviously, and just to say you need not worry if you slip – I slip as well – and say the name of the child, because the press know that they must respect confidentiality.
A Okay.

Q Have you in fact been Child 3’s GP from his birth in 1990 until the early part of 2004?
A That is true.

Q That was when he moved to a new practice, is that correct?
A Yes.

Q Do you operate a system whereby sometimes a patient who is your patient is seen by other partners in the group practice?
A That was when I was in a group practice, and also if I had a locum, and now I am in partnership with somebody, so that …

Q Right. Well, taking you back to the time when you were caring for Child 3, you were in such a group practice, is that correct?
A That is right.

Q Where was that?
A That was in XXX, XXX. It is in XXX again.

Q Are the records of the child kept so that any member of the practice who sees that child can refer to those records if they need to?
A Yes.

Q Have you had the opportunity to look through the records in relation to Child 3?
A Yes.

Q I am going to ask you about some of those records, and just so you know the matters to which I am referring, it is the background as far as his behavioural difficulties and development are concerned in particular, and, where relevant, his gastrointestinal history. You have got some records which are entitled “General Practice Records” in front of you. You will see that page 2 is a printout of his history. If you go to page 1, first of all, you will see at the top his date of birth, which was XXX, and then on to page 2 and down to “Immunisations”, and does that show that he had measles, mumps, rubella vaccine (that is the MMR) on 1 March 1991, in the middle of the immunisations list?
A Yes.

Q Now, in October 1992 there was a referral we know to Dr Rosenbloom, and is he the paediatric neurologist at the Alder Hey Children’s Hospital in Liverpool?
A Yes.

Q Was that made because there were concerns being raised as to the way Child 3 was developing?
A Yes.

Q Before that referral I think the first record of any parental concern in relation to development was when Child 3 was two and a half in June 1992, and if we look at the GP records at page 123, please, and it is a letter to you from the Senior Clinical Medical Officer in Audiology, and we can see that it says in that he was catarrhal and his parents were concerned because at the age of two and a half he was only putting three to four word sentences together, and in fact at that stage there was reassurance given that that was within normal limits, and that his hearing was normal. If I can take you on to the referral to Dr Rosenbloom, and in fact if you go to page 121 this is a letter to Dr Oppenheim – and I think it is right she is a consultant psychiatrist, is that correct?
A Yes.

Q It is a letter to Dr Oppenheim sent by Dr Rosenbloom (sic), Senior Registrar, and if we look on the next page, 122, we see that it was copied in to Dr Verma. Was that one of your partners at the time?
A That is true.

Q If we look at that letter we see he is aged two years and eleven months, seen on behalf of Dr Rosenbloom. The mother’s main concerns are [3]’s lack of speech. Then it goes into his birth history and various behavioural habits that he has. Then in the third paragraph:

“He enjoys rough and tumble play ….. and hugs from his mother but [he] is not interested in other children. He [sometimes] becomes …..annoyed and upset”.

Then on the next page:

“The whole of the consultation time [3] was ….. roaming round the clinic. He is very agile and totally unaware of any dangers.”

Then at the bottom of the page:

“I am very concerned about this little boy’s delayed development and he is really showing very little ability beyond the 12 months stage ….. concerned about his constant flicking through books and eating [at] the carpet and ….. poor eye contact.”

He says that he will review Child 3 in the near future and if his odd behavioural traits were still apparent would refer him to the Language Clinic. Thereafter did this little boy remain under review by the Alder Hey Children’s Hospital in Liverpool?
A Yes.

Q We can see another letter, again addressed to your partner Dr Verma, on page 116. That is a letter to Dr Verma, again from the Consultant Community Paediatrician, saying:

“I reviewed [3] in clinic today …..

I had the opportunity to discuss [his] problems with [the] social worker ….. that [3] continues to have” – I am now in the second paragraph – “very poor social skills, pre-occupations with eating [at] the carpet and flicking through books and ….. flicking his fingers in front of his eyes. [The parents] are aware of [his] developmental delay and I expressed again to them my concerns about his poor social skills ….. and that I considered that [3] may well fit into the category of childhood autism. They had already heard of this condition and did not look unduly surprised when I mentioned it. They have agreed to full assessment ….. in [the] Language Clinic.

I feel it is ….. important to admit [3] as a day case to carry out some investigations and [that] his parents [were] agreeable to that.”

Then if we go on, please, to see the investigations that were carried out, page 115, again to your partner, Dr Verma from Dr Rosenbloom’s Registrar:

“I reviewed this young man with significant developmental delay, social difficulties and obsessional behaviours.”

We then see that he had a CT scan, EEGs and amino acids, calcium and CPK tests and everything was normal, and there was a plan to review him again when there were the appropriate chromosome results. Carrying on with the chronology, doctor, could we look at page 26 of the actual records, please? This is the printout of the records and we see there “14.9.1994 Autism”, and then typed at one side “? Link to MMR Vaccine”. Can you give any assistance as to how that note came about? Can you help at all as to how that “? Link to MMR Vaccine” had arisen?
A Sorry, I cannot really.

Q If we go on, in October 1994, that is a month after that, there is a letter from Dr Rosenbloom, the Paediatric Neurologist, again to your partner, which is at page 110, again to Dr Verma:

“I reviewed Child 3’s progress with his parents … I have told them that Child 3’s acquired autistic problems in my opinion have occurred quite coincidentally to his MMR immunisation rather than that they have been caused by this procedure. I have however, now arranged for him to have an MR brain scan which will require general anaesthetic and will review [his] progress with the result of this investigation probably at the beginning of next year.”

He then says that the Vaccine Damage Payment Unit had asked for sight of Child 3’s notes and that he had forward them. I appreciate, doctor, that this correspondence is with Dr Verma. Do you recall when or if you became aware that the parents were possibly associating the child’s behavioural disorders with MMR?
A I cannot be sure of the dates, but that concern was discussed with me by the mother at some stage. I do not know when exactly.

Q Can you remember whether that was before or after the ultimate referral that you made to the Royal Free Hospital?
A That would be before.

Q That letter also indicates that the child was to have an MR scan under a general anaesthetic, and the results of that were reported to your practice, and we can see that in January 1995 if you would go to page 109 please. This is Dr Rosenbloom and it was to Dr Balachandran, who is the Consultant Community Paediatrician, but it was also copied to you at the GP practice, saying that the child has “a combination of severe learning difficulties and autistic behaviour”. “His mother … is devastated at the change … that occurred at around 14 months of age”, and she says this coincided with MMR immunisation “which she therefore blames”.

“We have investigated [him] exhaustively including an MR brain scan which is normal. I have told Mrs 3 that Child 3 does have brain problems but that time rather than further tests will determine how he progresses. She is very sad and is looking both for somebody or something to blame and also for specific treatments for Child 3 and I am afraid I have not been able to help her on either count.”

It then asks for her to be supervised, which probably means the child, and to have contact with the Child Guidance Service. We come on then, as you know, to your referral to Professor Walker-Smith. Were you aware at the time of referral, doctor, as to the nature of Professor Walker-Smith’s specialism?
A No.

Q As far as Child 3’s gastrointestinal problems are concerned, what was your understanding of the principal problem from which he suffered?
A Constipation.

Q If we look at the GP records, at page 47, there are two entries at the bottom of the page, one on 4 November 1994 and one on 2 December 1994, obviously by the same person. Are they your writing?
A Yes.

Q For 4 November can you just read us what it says?
A “School nurse telephoned. Bowels not opened for four days. Faecal impacted”.

Q And there is reference to – is that to an enema?
A Yes, Micalaxam(?) enema.

Q Then on 2 December 1994 we see a reference to Lactulose. Is that a treatment for constipation?
A Yes.

Q The other page where we can see problems a little later in 1995 is in the printout on GPR 1. We see at December 1995 there is a reference to constipation.
A Yes.

Q And indeed, if we go on down it to August 2005 still chronic constipation with overflow; is that correct?
A Yes.

Q I want to take you to the letter of referral, doctor, which is not in the general practice records but is in the Royal Free Hospital records, which you have also got in a separate file in front of you that says “Child 3 Royal Free Hospital Records”. It is on page 38. This is a letter to Professor Walker-Smith saying:

“Thank you for asking to see this young boy who developed behavioural problems of autistic nature, severe constipation and learning difficulties after MMR vaccination.”

You gave the incriminating batch number, D1433, and you pointed out that that was a discontinued batch following adverse reactions.

“He has seen Dr Oppenheim at Alder Hey Hospital and Dr Rosenbloom at the same hospital. …. His severe constipation is requiring frequent enemas and oral medication. The parents are very convinced that the difficulties in his behaviour etc. started only after the vaccination. I am extremely grateful for you to have taken on Child 3 for case study.”

Can I ask you first of all, doctor, do you remember why it is that you start the letter to Professor Walker-Smith, “Thank you for asking to see this young boy …”?
A I cannot remember how exactly I wrote that letter. I must have received some information from somebody asking for it.

Q Do you have any recollection of how you obtained Professor Walker-Smith’s contact details?
A I am sorry. I cannot really remember.

Q If we look back in the GP records we can see a reference in the notes to this letter, which is at page 43 in the GP records, which simply records the fact of it. The date in the middle of the page, do you see that, 19 February 1996?
A Yes.

Q Is that your handwriting?
A Yes, it is.

Q Perhaps you could read out to us what it says.
A “Ref to Prof John Walker-Smith Professor Paed Gastroenterology Royal Free Hosp London”.

Q That is obviously a reference to the letter that you did in fact write.
A That is right.

Q Would you have made that entry because you had seen the child or would that simply be a reference to the fact that you had written a letter? How would that come about?
A It is just a reference to the letter.

Q I see. It is clear from that letter that by that time there was a conviction by the parents that the difficulties in the child’s behaviour had started after the MMR vaccination. Do you remember any discussion taking place between you and the parents? Do you remember anything about how you were able to write that in the letter to Professor Walker-Smith?
A Just that concern was raised and they were really looking for the answers from whichever ---

Q I am sorry, doctor. You said the concern was raised?
A By the mother. Mostly I was seeing the mother.

Q Was this child’s mother in fact a patient of yours also?
A Yes.

Q So were there numerous occasions on which to discuss the issue of the child’s difficulties?
A Yes. Mostly she did not really bring Child 3 to the surgery because most of the time it was weekdays and he was away in school, and he was pretty disruptive so she used to come on her own.

Q Professor Walker-Smith responded to you and we have got his letter at page 57, still in the Royal Free records, thanking you for your letter and saying that he would be delighted to see Child 3 and was arranging for an outpatient appointment. Then on 4 April there was another letter form Professor Walker-Smith, having seen the child, and that is in the GP records again – sorry to keep taking you backwards and forward – at page 104:

“Many thanks for referring this child. As you say there is a clear history of the child being completely well until the age of 14 months when he had MMR. On the second day after the injection he developed a fever and a rash and since then his mother noticed dramatic change in his behaviour. He has also been investigated in Alder Hey Hospital. Recently his mother has been told by Social Services that it is likely that the MMR might have caused the problem, had been in touch with the organisation JABS who had mentioned the research that Dr Andy Wakefield has done at this hospital into the role of MMR vaccination and Crohn’s disease, hence my interest. We have now seen a number of children who have had features of both Crohn’s disease and autistic behaviour following MMR. Whether this is causally related I simply don’t know at present. Mrs 3 is keen that we pursue this avenue. In the first instance I have screened Child 3 with routine blood tests etc., and we will consider in due course whether it is appropriate to go ahead and perform a colonoscopy. A colonoscopy offers the opportunity to demonstrate if there is any ongoing infection in the gastrointestinal tract which could be in some way cause related to his present problems. Many thanks for referring this interesting child.”

Dr Shantha, as far as the reference to “As you say there is a clear history of the child being completely well until … he had MMR”, was that in fact an observation that you had intended personally to convey to Professor Walker-Smith?
A No. It was really the parents’ concern that had occurred.

Q Did you know anything about the rest of the information that is given in that letter? There is a mention of the organisation JABS which we know is a group set up to investigate vaccine damage. Did you know anything about that organisation at the time?
A No.

Q Or anything about Dr Wakefield’s role in all this?
A No.

MR COONAN: Role in all what?

MS SMITH: I am so sorry. That was not meant at all critically. I mean Dr Wakefield’s role as set out in the letter which says that Dr Wakefield was doing research into the role of MMR vaccination and Crohn’s disease. Were you aware of that?
A I do not remember the details. I feel that the child’s mother must have really given me some information.

Q Did you understand the nature of the investigations that it was intended to carry out in relation to Child 3? You are told there that a colonoscopy was going to be performed.
A Yes, just the information that was given to me. That is all. I do not think I would have really ---

Q Given to you? You mean in this letter?
A That is right.

Q On what basis, Dr Shantha, were you referring this child?
A As far as I know it was just a straightforward NHS referral. I did not think of anything else.

Q If we go on in the GP records to page 103 please:

“Initial screening tests for Child 3 for inflammatory bowel disease were negative. However we are arranging for [him] to be admitted … for colonoscopy followed by a period of investigation in the ward. We will let you know the results of these investigations in due course.”

Did you then know what other investigations were being carried out?
A No.

Q As far as the information that tests for inflammatory bowel disease were negative, what were your views in relation to that?
A I really did not give much thought to it because it was just referred to a specialist and they were going to look after that one, I was not really sure.

THE CHAIRMAN: Doctor, would you speak a little louder to make sure everybody is able to hear. Pull the microphone nearer to you.
A I was not going to be questioning what way the investigations were done and what was done. It was not really my place to talk about that when a specialist was looking after …

Q As far as you were concerned, you were told that the tests for inflammatory bowel disease were negative. Had inflammatory bowel disease been something that you had given any thought to in relation to this child?
A No.

Q You were sent two discharge summaries, one is dated 4 October 1996, and that is at page 100. We can see it sets out that he was admitted for investigation of inflammatory bowel disease and a possible association with autism. It sets out his history; when he had his MMR injection and his mother’s views that his developmental regression had progressed since that time, and then on the next page:

“As regards bowel symptoms, he intermittently suffers from quite marked constipation. He has had occasional rectal bleeding although this does seem to accompany passage of a hard stool.”

Then it says a colonoscopy was performed, and it gives the histology of that, and if we go on to page 102 it records that he had had a barium meal and follow through. It is apparent that he was also given a lumbar puncture because we have the cerebrospinal fluid results; that he had an MRI, an EEG and then it says in the penultimate paragraph:

“Therefore he does not appear to have significant bowel disease. There are several mildly aberrant blood results specifically an elevated blood lead and an elevated lactate. No other metabolic abnormalities were detected. The significance of the MRI findings are uncertain.”

Then did you get another discharge summary, a revised one on this occasion, which was on 31 December 1996. An explanatory letter was sent in relation to that to you from Professor Walker-Smith, and if you look at page 99, that reads:

“You remember you kindly referred [Child 3] to me and we sent a discharge summary to you ... Further critical analysis of histology results has led to an amendment to the discharge summary which I now am enclosing. Our final diagnosis is of indeterminate ileo-colitis with lymphoidnodular hyperplasia and we have no adequate explanation for his elevated blood lead or elevated lactate level. We sent him home on liquid paraffin. Since then I have not heard anything … concerning him although I have had a query from Dr Mahmood … I have not seen [him] since discharge, I would be interested to hear concerning his progress. In the light of these histological findings and if gastrointestinal symptoms persist, treatment with a drug such as Asacol (Mesalazine) might be of some therapeutic value.”

And he looked forward to hearing your comments.

Did that diagnosis of indeterminate ileo-colitis with lymphoidnodular hyperplasia convey anything to you at the time, doctor?
A Not much, no.

Q Was it a diagnosis that you had come across in any patient before?
A No.

Q There was some follow-up by the Royal Free and just to finish the story, there was some communication between you and Professor Walker-Smith with regards the anti-inflammatories. If you would look at the Royal Free records at page 23, it would appear that there was a telephone call from you in relation to the dose because there is an apology from Professor Walker-Smith for not having mentioned the dose, and then he says he has spoken to you on the telephone and he gives you the dosage which was appropriate for anti-inflammatories. If you to back to page 86 of the GP records, that is a letter from Professor Walker-Smith:

“I understand that [Child 3] is having a deterioration in his general behaviour. I wonder if it might be helpful to substitute the Sulphasalazine elixir for a therapeutic trial of the 5-ASA derivative Pentasa. I believe that this might be worthwhile although it may be practically difficult to administer Pentasa …”

Did you understand why that suggestion was being made to you in light of what Professor Walker-Smith said was a deterioration in the child’s behaviour?
A No, it was not – bad condition and this one were not really related, but generally the constipation could really cause behavioural deterioration. I was not really sure as to what exactly was said.

Q Ultimately, this child reverted to local care. We see a letter to you at page 74, in 2001. We see that is a letter from the associate specialist in community paediatrics at the Alder Hey to you, and in the second paragraph is says:

“[Child 3] is a young man with autism. He was previously under review by Dr Wakefield ---
A I am sorry, page 74 in the …

MS SMITH: Page 74 in the GP records.

Sir, can I just say, I am conscious of the time but I only have two short matters and I think I can comfortably finish.

THE CHAIRMAN: Yes, if possible complete your examination in chief, and cross-examination can be after the lunch break.

MS SMITH: (To the witness) Have you found page 74, a letter from S Roberts, to you:

“[Child 3] is a young man with autism ---
A It is not from Alder Hey, yes. It is not from Alder Hey Hospital.

Q No, I am so sorry, that was my mistake, it was copied to Professor Rosenbloom:

“… a young man with autism. He was previously under review by Dr Wakefield and [the mother] has been told that [Child 3’s] autism is MMR-related. [Child 3] has also been diagnosed as having a ‘leaky gut’ and was placed on Sulphasalazine by Dr Wakefield in 1996. [Child 3] has not seen Dr Wakefield for over 12 months hence there is no real monitoring of his bowel condition. [The mother] has been advised to continue the Sulphasalazine until such time as a possible new medication was available.”

Then concerns about his diet were expressed, and it concludes:

“[Child 3] was very difficult to examine but I did manage to palpate his abdomen which was non-tender with no obvious masses. My concern is that [Child 3] is no longer followed up in his local authority area with regard to autism and ‘bowel’ problems.”

He says he is going to refer him back to the Alder Hey.

If we go back to page 69, this is a letter from Dr Casson, but has now moved to the Alder Hey Hospital and is a consultant there, to you, saying that he had reviewed Child 3:

“The main concern is constipation. He has been seen at the Royal Free Hospital several years ago and a diagnosis of MMR associated colitis was made. Subsequently he had been treated with Sulphasalazine but has been no follow up and there did not appear to be any useful outcome from this medication.

Presently he opens his bowels once a week. He strains and passes a large hard stool. In himself he is otherwise well and there are no signs of note. I could not examine him today.

I had a long discussion and have advised stopping the Sulphasalazine as it has obviously not been providing any relief. I started him on an aggressive anti-constipation regime. This involves the use of liquid paraffin … with very, very gradual reduction. They should not stop the treatment as I suspect he will need it lifelong and need to achieve a dose that provides best results.”

There is then mention of an arrangement to review him.

That is a reference to the constipation, doctor. Was it any surprise to you to know that constipation was a problem with this boy?
A No, that was the main problem, always.

Q Were you aware in fact that Child 3 was one of the children who was subsequently written up in a paper in The Lancet relating to gastrointestinal damage and behavioural disorders?
A I was not aware of that.

Q There is one matter which I had forgotten to put, and that is the funding issue, doctor. Can you help us as to your understanding as to who was funding Child 3’s admission to the Royal Free?
A As far as I know it was the NHS that was funding it.

Q If we look at the Royal Free records at page 34. This is not a letter to you, this is a letter which was written to Professor Murch (at the time) saying:

“According to our records, ECR approval was given on the understanding that the patient was to have 2 out-patient appointments and one admission for investigations.”

It is signed by a gentleman called Zaf Mahmood, who was the assistant contracts director. Do you remember any communications yourself with Mr Mahmood and the extra contractual referral arrangements?
A Yes, I did receive a letter advising me to – if I could possibly consider referring him to the local hospital, and that is when I have referred him to Alder Hey Hospital again regarding the constipation problem.

Q So when you say it was your understanding that he was referred under the NHS, were there any other arrangements in relation to any other sort of funding that you were aware of for the child of at that time?
A No.

MS SMITH: Thank you doctor. Sir, those are all the questions I have for Dr Shantha.

THE CHAIRMAN: Thank you very much. Dr Shantha, unfortunately it is now 1.10 and we are going to take the lunch break. You are still to be cross-examined by the three counsel if they have any questions from you, and then Panel members may have questions for you. In that case we will adjourn for lunch until 2.10. Can I remind you, you are under oath. Someone will look after you for lunch but please make sure you do not discuss this case with anyone, including the lawyers, during this break.

(Luncheon adjournment)

THE CHAIRMAN: Ms Smith, you had completed your examination in chief I believe?

MS SMITH: Yes, sir.

THE CHAIRMAN: Mr Miller will now ask questions on behalf of Professor Walker-Smith.

Cross-examined by MR MILLER

Q Dr Shantha, there are three of us here at this table. I am only going to ask you questions on behalf of Professor Walker-Smith, who was the doctor to whom you referred this child when you made the referral to the Royal Free Hospital. Can I just ask you this before I go into any of the records: do you have any independent memory of the events of 1995 and 1996 with this patient?
A The chronology is completely confusing. I cannot really remember.

Q Realistically, you have a memory of the child, some of the gaps may be filled in by seeing the correspondence or the notes but you do not have a picture of what occurred at that time?
A I do not understand.

Q You have obviously got the notes and you can say “that is my handwriting” and “it looks as though I wrote to the doctor” and “this doctor wrote to me” but it is not as though you have got a clear picture from your memory of the ins and outs of what happened in that time?
A No, not all the details.

Q I am not going to go through all these notes again because we have done it with Ms Smith, but as we have gone through it is apparent that this was a very complicated case, and trying to find the right solutions for you as a general practitioner, with the assistance of other specialists, took quite a lot of time, did it not, over quite a number of years?
A Yes.

Q There were two features which appear to come together at some time: there was the developmental problem, which I think was diagnosed initially at the Alder Hey Hospital, and we have seen Dr Grey, the community paediatrician, saying that this child had autism, which seemed to be the accepted diagnosis at the time, that is right, is it not?
A Yes.

Q Secondly, the bowel symptoms which were identified I think probably around 1993/1994 as being severe constipation.
A Yes.

Q As I say, it is mentioned in the general practice notes which we saw this morning, in 1994, and that was treated with Lactulose and again we have seen the prescriptions for Lactulose in the GP notes. I think with micro-enemas. Was this child away at school during the week?
A Yes.

Q So on a day-to-day basis was he being looked after by the school nurse?
A Yes.

Q So in terms of treating the bowel problem, that would have been in the hands of the school nurse?
A Initially it was the parents, before the child was sent to the school, and after that, yes.

Q Certainly by the time we get to, I think, the end of 1995 and 1996 when the referral took place, there was correspondence, as we have seen in the notes, with the school nurse about how she was managing the constipation.
A Yes.

Q To that extent, although in your general practice notes there are prescriptions for Lactulose, the management of the problem was being looked after at school?
A Yes, the child was coming home during the weekends, so at that time they needed the prescriptions.

Q We have got the referral letter from you to Professor Walker-Smith, which is in the Royal Free Hospital notes at page 38, and, again, I do not ask you for the moment to turn it up but as Ms Smith pointed out to you this morning, there is also a record in the GP record for that day with the details of Professor Walker-Smith and his address in your general practice records at page 43, but we will just look at the letter for the moment. There is slightly curious phraseology at the start of the letter:

“Thank you for asking to see this young boy who developed behavioural problems of autistic nature, severe constipation and learning difficulties …”

Clearly, there had been some contact by somebody with the Royal Free Hospital because there is no reference to them anywhere else in the notes before this letter and the note for that day, is there?
A Yes.

Q So somebody must have given you the details in order for you to send this referral letter to Professor Walker-Smith.
A Yes. I think it must be from the mother.

Q Yes, I am not suggesting anything else, but it is not something that you have thought of, it is something that arrived for you to deal with. Somebody said, “This is a person to whom I would like you to refer my child” probably.
A That is true.

Q It is clear, you may not have understood the question the way in which it was phrased, but you obviously knew when you made the referral that Professor Walker-Smith was a paediatric gastroenterologist because the address on that letter, if you just look at it is “Professor of paediatric gastroenterology”.
A Yes, the information was really given to me. By whom I cannot really remember about the details because I do not think I had any contact with the hospital.

Q It is not as though it is one that you have initiated or somebody has recommended from the correspondence that we have seen. It looks very likely as though it was the mother who asked you to refer and this was your referral letter.
A That is true.

Q It may be that the question was not clear. I think you were asked did you know what his specialism was and you said no, but clearly you did because it is written in the address itself and it is in the notes so you obviously knew you were referring to a professor paediatric gastroenterology.
A Okay.

Q We know from the notes in the correspondence that there was this fairly long-standing history of constipation as well as the other developmental problems at the time.
A Yes.

Q Looking at the remainder of that first paragraph:

“Thank you for asking to see this young boy who developed behavioural problems of an autistic nature, severe constipation and learning difficulties after MMR vaccination. The batch incriminated was D1433 incidentally which was the discontinued batch following adverse reactions.”

You were certainly drawing to Professor Walker-Smith’s attention the fact that there was a suggestion anyway that these problems had arisen after the MMR and that particular batch of MMR.
A Yes. I vaguely remember that some information about the vaccination history was asked and at that time I think I was informed that that is a particular batch that was discontinued. I think that information was coming from the mother and I think I rang the chemist to find out if that was the batch.

Q There is no doubt that the mother had made this apparent link and had explained that to you quite some time before this letter. This was the mother’s view and you say you are just putting forward the mother’s view in this letter.
A That is true.

Q There is no doubt that you had gone to the trouble to find out which batch it was and which type of immunisation was, in your words, incriminated.
A Yes.

Q You tell him about two of the other doctors that he had seen at Alder Hey.

“He is attending special school. His severe constipation is requiring frequent enemas and oral medication.”

That is the lactulose and the micro enemas I was talking about. Again you make the point:

“The parents are very convinced that the difficulties in his behaviour started only after the vaccination.”

A Yes, that is what the parents’ concern was.

Q The likelihood is that mother has discussed it with you, she says she wants the referral, there are gastrointestinal problems which you set out there and you were content to make the referral in this difficult case.
A That is true.

Q Dr Shantha, this child’s mother was anxious and had been anxious about him for some time before this referral, had she not?
A Yes.

Q Because however many people had been seen, the diagnosis was not completely clear, was it, as to what was wrong with him?
A Yes, the patient was having some concerns about it and just looking for where I can get any further help that she was looking for and when she found some information from somebody and she brought that to me and if she wanted some help for her satisfaction I had to really do something about it.

Q This was a different avenue from those that had been explored before.
A That is true.

Q You saw no difficulty in the referral and presumably felt that it was in the best interests of mother and child that the referral should take place.
A That is true.

Q On 22 February – two or three days afterwards – there was a letter from Professor Walker-Smith saying that he would be delighted to see Child 3 and providing an outpatient clinic appointment. That is just a courtesy letter back to you saying he would be glad to see him and arranging the appointment.
A Yes.

Q Three or four days after that in the sequence of events you received a letter from Dr Balachandran dated 27 February. It is a letter which relates to all three of the children in the family and it is from the community paediatrician. On page 106 here he is talking about Child 3 in particular:

“He has a history of constipation and blood in the stools. His parents have used lactulose and micro-enemas on the advice of a specialist nurse. I now understand that he is waiting to be seen by the Specialist at the Royal Free Hospital London about his bowel problem.”

In one way or another there had been communication to the community paediatric consultant that he was going to be referred about his bowel problem.
A Yes.

Q The letter which you looked at earlier from Professor Walker-Smith which has been after his outpatient clinic appointment, 4 April 1996, which is in the GP records at page 104, you take issue with the emphasis in the first sentence:

“Many thanks for referring this child. As you say there is a clear history of the child being completely well until the age of 14 months when he had MMR.”

There has clearly been a discussion with Mrs 3, has there not?
A Yes, that is the history from the case.

Q Although we have seen the terms in which you wrote your letter, he has obviously discussed the history with Mrs 3.
A Yes, that was their opinion.

Q There is obviously more in this than was in your referral note because he is talking about the actual events after the giving of the immunisation. In the second part of this letter he tells you a bit about the background and about what was happening at the Royal Free. Three quarters of the way down he says:

“Whether this is causally connected [that is the MMR] related I simply do not know at present.”

He went on to say that he was being screened and they will consider in due course whether it is appropriate to go ahead for a colonoscopy.
A Yes.

Q Presumably you had referred him on to a specialist unit for investigation and you expected that they would do investigations related to his bowel condition.
A Yes. I have not really referred the patient regarding his constipation to the Royal Free. It was more of a concern from the patient’s mother that she wanted it because of the special interest that the Royal Free was supposed to be taking.

Q It is a reasonable distinction for you to make. This is not something you have thought up yourself “I think it is appropriate to send him because of the symptoms”. The mother in this case has said I would like you to have him referred to this unit and that is what you have done.
A Yes. That was never for the constipation.

Q It was for investigation ---
A Yes, to find out the link.

Q Although clearly because you were sending him to a gastroenterology department you had pointed out to the professor what his bowel symptoms were.
A Yes. When I am sending the patient I had to give him the background to the patient’s history which includes what other places he was being treated, what opinions were given and just general information about the patient.

Q As you would expect, presumably at the end of the letter which you get back on 4 April what the gastroenterologist is saying is we may consider doing a colonoscopy and then the last sentence:

“A colonoscopy offers the opportunity to demonstrate if there is any ongoing infection in the gastrointestinal tract which could be in some way causally related to his present problems.”

A Yes, this was not something of an established fact but it was being investigated. They were trying to find out according to the information that was given to me. That is something to really substantiate that this is what exactly was going to be done – this was to be done and I was not really going to be considering doing anything specific.

Q They were going to investigate.
A Yes, when the patient has been referred. It will be done, yes.

Q You were sending him to be investigated at the request of the parents.
A Yes.

Q I think you learned with another short letter that he was going to be admitted for a colonoscopy – a two-line letter in the notes – on 18 July 1996 and you learned subsequent to that that he had had a colonoscopy and a number of other examinations because you were sent a discharge summary by the lecturer from the gastroenterology department.
A Yes.

Q Could you look at page 100 in the GP records dated 4 October sent by Dr Casson, a lecturer in paediatric gastroenterology, which contains quite a lot of detail, does it not?
A Yes.

Q I do not know how much of that detail you absorbed at the time.
A I have underlined the bits that were possibly of some importance or cautionary – elevated blood lead and an elevated lactate.

Q That is on page 102 in the bundle. At the end of that letter, Dr Casson says:

“Therefore he does not appear to have significant bowel disease. There are several mildly aberrant blood results specifically an elevated blood lead and an elevated lactate. No other metabolic abnormalities were detected. The significance of the MRI findings are uncertain.

We will have to reconsider these findings when we review him again in clinic. As regards the protocol that patients who are being investigated as Child 3 is concerned, we have been unable to perform a Schilling test and the evoked potentials.”

What you were being told then was that they had to reconsider what the position was.
A Yes.

Q I think he was discharged on liquid paraffin as a result of that visit. On 31 December you got the second letter, a letter from Professor Walker-Smith, page 99, with a revised discharge summary following what is said is critical analysis of the histology results. In the middle of that letter on page 99:

“We sent him home on liquid paraffin. Since then I have not heard anything further concerning him, although I have had a query from Dr Mahmood from the Contracts Directorate at St Helens & Knowsley Health about another outpatient appointment. I have not seen him since discharge. I would be interested to hear concerning his progress in the light of these histological findings and if gastrointestinal symptoms persist, treatment with a drug such as Asacol (mesalazine) might be of some therapeutic value. I look forward to hearing any comments you may have.”

Professor Walker-Smith was inviting you to let him know about the child’s progress and also suggesting that he could be treated with Asacol. There is not a letter, is there, in the GP notes responding to that, although there was obviously a telephone call that you had subsequent to that. Did you write back in response to that letter?
A I cannot really remember.

Q What we can see is that you must have telephoned him some time after that because there is a letter at page 23 some four months after the last letter:

“I apologise for not having mentioned that the dose of Asacol in my letter to you on 31 December. As I said to you on the telephone, the dose for this drug is 400mg twice a day. If the child is unable to take the capsule, as is quite possible, an alternative would be suspension at 250mg tds.”

Do you know what you corresponded or spoke to Professor Walker-Smith between 31 December and 30 April?
A I would assume I definitely would have done that because the dosage has not really been mentioned with the previous letter.

Q It looks as though you rang him up and asked what the dosage should be.
A It is a possibility, yes.

Q We can see from the GP notes that he was prescribed salazopyrin from the end of 1996, beginning of 1997 through until sometime in 1998 when there was a concern about whether that was the appropriate drug and you corresponded again and it was changed to another drug.
A I am not sure whether it was really done because I do not think he would have been able to take capsules.

Q He appears to have remained on anti-inflammatories from this time until sometime later in 2002 when he was taken off them by Dr Casson?
A That is right.

Q This had been, as it might have had to have been, an extra contractual referral and limited in scope, as Professor Walker-Smith has said in that letter, because he was transferred back, was he not, to Alder Hey, which was your local Trust?
A Yes.

Q It was there that sometime later he was seen by Dr Casson.
A Yes, I do not know the chronology of when exactly it was done, I do not know. It is from when I had received the letter from Zaf Mahmood that at that time I would have referred him to Dr Casson at the local hospital.

Q So the Health Authority would have to tell you that he is now under the care of a particular doctor at Alder Hey; Mr Mahmood would have to tell you that?
A Yes, if it was possible for the local consultant to take over the care of the patient he should be referred to the local hospital.

Q Did you link the Dr Casson who subsequently saw the child with the Dr Casson who had written you the discharge summary? Did you know it was the same person?
A Sorry?

Q Did you know that the Dr Casson who the child subsequently saw at Alder Hey was the same Dr Casson who had sent the discharge summary from the Royal Free?
A No, I did not link. It is the same name, but I was not sure.

Q This is the position, Doctor, is it not, that it is likely that you were asked by Mrs 3 for the referral to be made to a specific person at a specific department, and you were happy to do so because she wanted it done and it was a difficult case? He was, from the documents sent back to you, thoroughly investigated on a large number of parameters which are set out in the discharge summary, and a diagnosis was made and he was treated thereafter with anti-inflammatories until 2002, and that is the summary of it, is it not?
A Yes.

MR MILLER: Yes. Thank you.

Cross-examined by MR HOPKINS

Q Dr Shantha, I ask questions on behalf of Professor Murch. I just want to take you back to an investigation that was carried out on Child 3 two or three weeks before you referred Child 3 to the Royal Free Hospital. Could we have a look, please, first of all in the GP bundle at page 43. I think we see these are the handwritten GP notes for 95 and 96, and if we look about halfway down the page do we see that on 31 January 96 “FBC” is written against the date?
A Yes.

Q Is that a reference to a blood test for a full blood count?
A That is right.

Q If we then move on, please, to page 53, do we there see the test result for that request, if we turn the page on its side? If you look in the bottom right hand corner you will see the date 31January 1996.
A Yes.

Q So would this be the blood test that had been requested?

THE CHAIRMAN: Dr Shantha, I think you will have to speak just a little louder, and also you will need to speak because the answers are noted and recorded in the transcript. I did not quite hear. Did you say “Yes”?
A I am checking the dates.

THE CHAIRMAN: Right. Okay.
A Yes.

MR HOPKINS: Can we just have a look at the information on page 53. Towards the top left-hand corner do we see “Clinical Details: Anaemia”?
A Yes.

Q So the reason for this blood test was because the child was thought, on a clinical assessment, to be anaemic?
A That is right.

Q Then we see the test results, and if we look towards the bottom right hand corner do we see “MCV” and the result under that?
A That is right.

Q Does “MCV” stand for “mean cell volume”?
A “Mean corpuscular volume”.

Q Sorry, “mean corpuscular volume”. We see that that reading was below the normal range at 74 with an “L” next to it.
A That is correct, yes.

Q Could that therefore indicate iron deficiency?
A A slight iron deficiency was there.

Q We also see on this that the platelet count towards the left hand side of the bottom of the page was high, was it not?
A It was just marginally high, yes.

Q If we then go back to see what action was taken on this result, can we go back to page 43, the next entry halfway down the page below 31 January, it appears to say 5 January; might that be a mistake for 5 February?
A Yes.

Q We see next to that reference to a prescription, is that right?
A That is right.

Q Is that Sytron?
A It is iron medication, yes.

Q So is it fair to deduce from this that in the light of those blood test results it was thought that iron replacement therapy was required?
A Yes.

Q Can I just explore with you the possibilities for the anaemia in this child, or the consideration of there being a deficiency of iron. One possibility would be inadequate iron intake in the diet, would that be right?
A Yes.

Q Another possibility would be malabsorption of iron in the gut?
A Yes, could be.

Q Another possibility would be blood loss, for example bleeding from the bowel?
A Could be.

Q If we then consider, and going back to a page that Mr Miller drew to your attention, that is page 105, please, we see that within a matter of days, on 27 February 96, this letter that is being written to you, and your attention was drawn to page 106, when the Consultant Community Paediatrician was telling you, at the top of the page, that the child had not only a history of constipation but also a history of blood in the stools. Have you got that, page 106, top of the page – yes?
A Did you say there is mention about blood---

Q Are you on page 106?
A 107. (Pause) Yes.

Q At the top of the page this doctor is referring to the history of constipation, which you obviously already knew, but also there being a history of blood in the stools.
A Yes.

Q Now, this information clearly was a matter of two days after your referral, but your referral on 19 February was simply a matter of two or three weeks after getting back that blood test result showing anaemia, as a result of which this child was then placed on iron replacement therapy.
A Yes.

Q Do you think that that would have been a consideration for you at the time you were making this referral to the paediatric gastroenterologist at the Royal Free?
A That was not really mentioned, but there was a possibility of this bleeding per rectum, it is elsewhere that it is mentioned, that he had been chronically constipated, passing hard stools, could really give rise to the bleeding.

Q If we look at the history that is recorded on page 106, it actually says the blood is in the stools.
A Yes, it says that.

MR HOPKINS: All right, Doctor. Thank you. I have no more questions.

THE CHAIRMAN: Mr Coonan, any questions from you?

MR COONAN: No, sir, thank you.

THE CHAIRMAN: Ms Smith, any questions in re-examination?

Re-examined by MS SMITH

Q Just one matter, Dr Shantha, arising out of the questions you have just been asked. If you go on in the GP records to the discharge summary that was sent to you, which starts on page 100, this is a discharge summary sent to you from the Royal Free Hospital, and if you look at the top of page 101:

“As regards bowel symptoms, he intermittently suffers from quite marked constipation. He has had occasional rectal bleeding although this does seem to accompany passage of a hard stool.”

Is that the reference that you were just referring to?
A Yes, that is true.

Q Is that in your experience an unusual situation, if a child has bad constipation, that there is---
A No, that is almost expected.

Q Sorry, I did not hear you?
A Yes, indeed, it is not uncommon; it is chronic constipation.

MS SMITH: Thank you very much. I have no other questions.

THE CHAIRMAN: Dr Shantha, if there are any questions from any of the Panel members, then I will introduce them to you. Ms Golding is a lay member.

Questioned by THE PANEL

MS GOLDING: Dr Shantha, on page 38 in the Royal Free Hospital records, I am just curious, because the last sentence, where you say, “I am extremely grateful for you to have taken on [Child 3] for case study”, suggests to me that either Professor Walker-Smith knew of the child already and you were really referring that child because he has asked to see him. Is this what it means?
A I would not have had any information about the case study unless of course it was informed to me through some source. I cannot remember where I got the information from.

Q Who most likely would you have got the information from?
A I do not think it would be the patient’s mother. Most of the information I would be getting from her, but it has to be from some professional sources I would have really got it from.

Q Most of the referral letters that I have seen generally, I do not think I have seen many or any that says “Thank you for asking to see [someone]”, and this suggests as well that you have not decided to refer because you felt that this was the right thing to do, but because somebody has asked you.
A Yes. I can only assume that the initial information from the patient’s mother, but there is supposed to have been some work being done regarding a link between MMR and this autism, et cetera, and at that stage I would have really asked her to really give – I cannot really remember hundred per cent; this is probably what would have really happened – I asked her to really bring the details about it, and I would have contacted the hospital to find out, and I must have really been informed about as to whom exactly I should really be sending the letter to.

MS GOLDING: Thank you.

THE CHAIRMAN: I just ask on the same line, before I ask my other colleague on my right hand side, Dr Shantha, the first sentence, which says “Thank you for asking to see this young boy”, and this letter is addressed to Professor Walker-Smith, does that not give the impression that the contact was between yourself and somebody at Professor Walker-Smith’s department, because you are saying “Thank you” to Professor Walker-Smith, and I am just trying to put two and two together and see what it could mean?
A Yes, that is how I understand it as well.

Q That is how you understand it as well.
A That is right.

Q So there was some contact – initiation could well have been from the mother, through the mother of the child – and there was some contact between yourself and the department at Royal Free, Professor Walker-Smith’s department at Royal Free?
A With the information that was given to me, I would have really tried to find out exactly who I should really be referring to, and that information must have really been given to me.

Q At that stage during that conversation was there any mention about this study?
A Sorry, I just cannot really remember.

Q You cannot remember.
A Because I have mentioned it, there must have been something.

THE CHAIRMAN: Thank you. I think you can only answer what you can remember, so that is fine. Thank you. Mrs Dean is a lay member.

MRS DEAN: Good afternoon. I wanted to ask you about the letter at page 99 in the GP notes. This is, as it were, the revised discharge findings, and I particularly wanted to ask you about the penultimate sentence there, where it says, “In the light of these ….. findings and if gastrointestinal symptoms persist”, it then goes on to recommend the treatment. I just wanted to ask what did you understand by those words “if gastrointestinal symptoms persist”; what was your view of what you should be looking for in this patient?
A Well, the main problem that the patient was suffering from, constipation, so the symptom that the patient would have come with is what I would be considering.

Q So you thought that you were being asked to provide this treatment in relation to his constipation?
A Yes. Gastrointestinal symptoms, there are a few, and the one that we are concerned with with this patient was constipation.

MRS DEAN: Thank you very much.

THE CHAIRMAN: It seems the Panel do not have any more questions. Mr Hopkins, Mr Miller?

Further cross-examined by MR MILLER

Q Back to the referral letter, and do not bother to look at it because you know what it says, but you have no memory of the circumstances of the referral; you have already said that, I think?
A Yes.

Q So either this information came from the mother or it came from the hospital? Those are the only two sources likely, are they not?
A Yes, likely, yes.

Q You cannot say which?
A I think it should be the mother.

MR MILLER: Thank you.


MS SMITH: No, thank you, sir.

THE CHAIRMAN: Well, Dr Shantha, you will be pleased to know that you are now released. Thank you once again for coming and helping this Panel with this inquiry. You are now released.

(The witness withdrew)

MS SMITH: Sir, I am going to call the next general practitioner witness, who is Dr Barrow, and I am going to give you a rest from my voice for a little while, and Mr Thomas is going to take this witness.

Examined by MR THOMAS

(Following introductions by the Chairman)

Q Dr Barrow, could you please state your full name and your professional address?
A It is Dr Andrea Susan Barrow, and the address is St Mary’s Medical Centre, Wharf Road, Stamford.

Q Dr Barrow, you are being asked to give evidence in relation to one particular patient and we are referring to that child by number. Could you please look at the sheet in front of you, which contains a whole list of names and numbers, and confirm that the patient with whom you had some dealings was Child 1?
A Yes, that is correct.

Q Could you therefore in the rest of your evidence describe that patient as Child 1? We have in place a restriction to the effect that the press will not report the name in case it slips out, but if you could try that we would all be grateful. I think it is right, Dr Barrow, that you were Child 1’s GP during the period 1994 to 1996. Is that right?
A That is right.

Q And at that stage you were working as a GP.
A Yes.

Q Have you at some stage had an opportunity to review the GP records of Child 1?
A I have, yes.

Q I am going to take you now to a selected number of entries in those notes. Could you please take up the GP Records volume, which should be there to your right, and turn to page 6? I just want you to have a look at an entry on the left hand side of the page “4.11.93”, which records that Child 1 is:

“New patient – recently posted from XXXX. Mum worried re hearing/wax in ears/? Discharge left ear … Reassured.” Then “(NB – older brother … ? behaviour probs and ? family dynamics ?)”.

Then if you could turn on in the GP records to page 149, we have there at the top of the page the entries, including entries in relation to immunisation, and you see at 19 January 1994 the MMR vaccination, yes?
A Yes.

Q Back to page 7 for the next entry in relation to Child 1’s development. This records on the right hand side of the page on 26 October 1994 the 21-month check, and it says:

“Little co-operation with psychomotor assessment. Will not obey. Tantrums when denied. Does not seem to understand or express speech very much. (cf probs with older brother). Discuss with health visitor for check audio. Re-assess in early 95. Long chat with mum - ? over protecting. ‘Little stimulus for child to develop language etc if its every wish is being instantly met!’. Physical exam & development – normal.”

The next developmental record that I would like to take you to, again at the back of the bundle, is at page 116. This is a letter from the Clinical Medical Officer and it just begins, “Dear Doctor”. It is dated 27 February 1995. Are you able to tell us whether “Dear Doctor” was you on this occasion?
A Not specifically, but it was normal for letters coming back to the Air Force base at XXX to be addressed to the Senior Medical Officer because staff changed quite frequently, so they would quite often come back as “Senior Medical Officer, Dear Doctor”.

Q And they would simply have been placed in the appropriate patient’s notes?
A Yes.

Q What this letter records is that Child 1 attended XXX Audiology Clinic, and we have just been looking at some of the records in relation to hearing problems, for a review of his hearing:

“On this occasion he was more composed and cooperative than on the previous one. Mrs 1 reported that Child 1 has around three meaningful words but his comprehension appears to be delayed. Child 1 was tested by distraction technique using a variety of high and low frequency signals, namely to Voice, High Frequency Rattle, Low frequency Signal and the G Chime Bar. He responded at minimal levels to all these Msignals bilaterally. We are satisfied that Child 1’s hearing is adequate for normal development of speech and have discharged him from this clinic.”

The next entry in relation to his development, if you could turn to page 122, is a letter to Dr Woolliscroft. Was that another GP in the practice at the time?
A Yes. He was the SMO there, that is, the Senior Medical Officer. Whether he was still there at that time I am not sure because often you would get letters addressed to them after they had left. I cannot say whether he was there at that time but it was addressed to the SMO.

Q So this letter may be an example of someone following the practice of writing simply to the SMO?
A Yes.

Q It is from Dr Hauck, who is a Consultant Psychiatrist in Learning Disability, and it says:

“On 7.3.96 I met Mrs 1, at some length, at XXX in XXX. Initially, the concerns reported to me were that Child 1’s sleep caused many problems. As on previous occasions, the conversation ranged widely. It gradually emerged that Mrs 1 is much exercised about Child 1’s eating; he is a choosy and slow eater and she feels he is not adequately nourished. He suffers from loose stools on most days, she tells me. From the Autistic Society she has received information about the benefits for some children of a casein-free and gluten-free diet. She feels she would like to try a diet, before considering any other interventions. I suggested that I would contact the dietetic service and ask for help, but also advised that a period of observation and recording of symptoms she hopes will improve with the diet would be useful, before beginning the diet. By July, she informs me, they hope to move … The help received from their home care assistant is greatly valued by Mrs 1. I plan to meet her again in late April.”

Can I next take you to one further record in the GP records on this question of his behaviour, and it is at page 160? If you look at the top left of the page, at 1 November 1995 it says “Autism”. Are you able to help with where that information came from?
A No.

Q Do you have the entry I am looking at? It is under the column “All Entries”.
A It is under the summary, is it not, “All Entries (except Values)”, “1.11.95”?

MR THOMAS: “1.11.95 Autism”. Mr Coonan is indicating to me, sir, that he does not have page 160.

MR COONAN: Sir, I think amongst the bar there is a document missing. Ours goes up to 159.

THE CHAIRMAN: We have got 160 in our bundle.

MR COONAN: This time you are better off than we are.

THE CHAIRMAN: We will have copies made (pause for photocopying).

MR THOMAS: Dr Barrow, the last two entries I have taken you two are first a letter from Dr Hauck, who had apparently seen Child 1 and who planned to meet him again in late April, and another entry in the GP records suggesting a diagnosis of autism. I was asking you whether you could help as to where that information had come from.
A I do not know. There does not seem to be anything specifically in the notes.

Q You are not aware of any other communication from Dr Hauck or another consultant psychiatrist anywhere providing a formal diagnosis of autism?
A No.

Q During the time when you were at the surgery was Child 1 a regular attender?
A No, because he was very difficult. He did not like coming to see doctors, so sometimes if mother had problems she would come without him to discuss his problems because his behaviour was much worse when he was in the surgery.

Q And was his mother a regular attender on his behalf?
A She was not in very frequently because it was quite difficult for her to get there, having the children to look after. It is difficult to remember exactly how often we saw her, but where she might not attend directly with us I think she probably had a lot of contact with health visitors with us or just general telephone advice.

Q Can I now take you on to page 125 of the GP notes please? This is a letter which appears to be undated from Mrs 1, is that right?
A Yes.

Q It is addressed to Dr Haughton. Was he then the SMO?
A Yes. He was Deputy SMO for some time, yes.

Q What this letter from Mrs 1 says is: “I would like you to refer my son, Child 1, … to the below address immediately”, and then it says “a severe metabolic disorder”, “needs tests done”, and the name and contact details are John Walker-Smith, Paediatric Gastroenterologist, The Royal Free Hospital. Do you know what or who prompted the use of the phrase “severe metabolic disorder”?
A No. I think that has come from the other of the child.

Q As far as you are aware had that been an issue that had been addressed previously?
A No.

Q Was this type of communication from Mrs 1, in other words, a communication seeking a referral to an outside hospital, normal or not?
A This mother had not asked for a previous referral, so we had not had a previous communication like this. The other thing is, it may have been that because we were on an Air Force base she may have spoken to Dr Haughton informally and said, “I will write you a note with the address of where I want the child to be referred to”. I cannot say that that is definitely what has happened because in that instance I would not have been there.

Q I understand. Can I next take you then to the letter that you wrote on page 12 of the bundle? It is dated 17 May 1996, and is headed “Patient Referral Letter”. On page 124 you will see a practice stamp in your name. Is that your signature?
A It is, yes.

Q The first page, page 123 gives the family’s name and it gives your name as the GP and it says: “Please give my patient an appointment to: Dr John Walker-Smith, Paediatric Gastroenterologist”, repeating the contact details.

On the next page, under the bold phrase “Reason for referral” it says:

“I understand [Mr & Mrs 1] have contacted you regarding their youngest son [Child 1] who has been diagnosed as autistic.

[Child 1] initially developed normally, reaching the normal milestones until he was about 15 months old. He then regressed and has now been diagnosed as autistic; his elder brother … is also autistic.

[Mr and Mrs 1’s] most recent concern is that the MMR vaccination given to their son may be responsible for the autism.

We do not have very much correspondence regarding [Child 1] but I have photocopied any relevant information that is available.

I would value your opinion regarding this challenging family.”

Could you say how you came to write that letter?
A We wrote the letter because the mother of the child wanted to be referred to Dr Walker-Smith.

Q Had you anything else to go on other than that undated letter or had you perhaps seen her in the interim?
A I cannot remember.

Q There is a reference in the penultimate short paragraph which says:

“We do not have very much correspondence … but I have photocopied any relevant information …”

Can you remember what information that might have been?
A It would just have been copies of the letters from the consultants who he had seen previously.

Q It says in the first lien that you understood that Mr & Mrs 1 had contacted “you”, that is to say Professor Walker-Smith, regarding their youngest son, Child 1. How did you know that? How do you think you would have known that?
A I would guess from that she had been in or she had contacted us and said, “Have you done the letter because I’ve contacted them?”

Q What did you understand Mrs 1 to want from the referral?
A Mrs 1 was very concerned that the MMR vaccine had caused all the problems with both her children, and I think she was seeking support, reassurance that that is what the problem was, and I think we were saying, “Well we don’t think the MMR does cause it” and she said, “Well these people in London do, can I go and see them?”

Q What view did Mrs 1 have at that stage as to the development of Child 1? Was she accepting that there was developmental delay or autism or not?
A She felt that the child developed completely normally until he had his MMR and that he did have a few words but then he subsequently lost them.

Q Were you aware of Mrs 1 belonging to or being in touch with parents’ groups or support groups?
A Not that I was aware of, not groups of particular … but I think she would have followed any information in the press quite closely, although I do not think she physically would have attended any.

Q Did you know at that stage how she had come to know about the name of Professor Walker-Smith?
A I do not know.

Q Did you at that stage have any independent knowledge of Professor Walker-Smith and his work?
A No.

Q Were you aware of any particular interest that the gastroenterologists at the Royal Free had at that time?
A No.

Q If a parent such as Mrs 1 comes to you and asks for a referral like this, would it be your practice to go ahead and make that referral?
A If the parents were sufficiently concerned, then yes.

Q In this case, does it follow that you were content to make that referral?
A Yes.

Q Was there any particular reason why you thought it was appropriate to refer Child 1 to the Royal Free?
A Not specifically but I think we would probably have assumed that if it was the Royal Free it was a tertiary referral centre and that is where the research was likely to be and therefore it was most likely to be an appropriate referral.

Q What was your understanding of the nature of the programme at the Royal Free?
A I am not sure really. I think we were a little bit confused because the mother was convinced that this was a link between autism and MMR, and then later on things with bowels started creeping in as well. I think we were a little bit confused, to be perfectly fair.

Q Were you aware of any particular investigations that were planned?
A Not at that time, no.

Q What was the state of your understanding as to what was going to happen at the Royal Free was going to fit in with an investigation into MMR?
A I do not think we were really sure. I think we were just – I think the parents were worried and they wanted to go and discuss it at another centre which they felt was going to address some of their concerns.

Q Dr Burrow, I do not mean this remotely critically but did you ask any more questions before you referred or did you simply make the referral?
A I cannot remember.

Q Can we turn on to page 126 of the GP records, which is the next event following your referral letter, and it is a letter from Professor Walker-Smith on 23 May addressed to you and he says:

“Many thanks for your letter. I would be delighted to see [Child 1] and I have arranged for an outpatient appointment to be sent.”

If you then turn on to page 127 about a month later there is another letter from Professor Walker-Smith, again to you, and he says:

Many thanks for referring [Child 1] with autism. It is difficult to associate a clear historical link with the MMR and the answer to autism although [Mrs 1] does believe that [Child 1] had an illness 7-10 days after MMR when he was pale, ? fever, ? delirious, but wasn’t actually seen by a doctor. Between the age of 1 year and 18 months his development slowed and then deteriorated. It is very interesting that he has a 5 year old brother who also has been diagnosed as part of the autistic continuum. As part of Dr Wakefield’s and mine interest in the relationship between immunisation and chronic inflammatory bowel disease, I have arranged for routine blood tests to be done for screening for C-reactive protein, etc. The diarrhoea which [Child 1] currently has does have the features of toddler’s diarrhoea. His mother is concerned by the diarrhoea. Loperamide in a dose of 2mgs twice a day could be tried therapeutically. She was concerned that this could have had an adverse effect on his neurological development, I am not aware of Loperamide ever having such effects, its only side effects that I am aware of is some abdominal pain and skin rashes occasionally and in children with intestinal obstruction with overdosage you can get paralytic ileus. However, I think it is an option to be kept available is the diarrhoea causes concern.

My plan would be to see him again in 3 months time and then if [Mrs 1] feels that it is appropriate we could consider performing endoscopy and further assessments neurologically and psychologically of his autism to explore the possible link between measles immunisation, bowel inflammation and autism.”

Did you have any particular reaction to that reported outcome of the outpatient consultation?
A Not specifically.

Q Can we then turn on to the discharge summary, which is on the very next page, at page 128, dated 9 August:

“[Child 1] was admitted for further investigation of his autism and specifically to look into a possible association between his neurological condition and any gastro-intestinal disorders. The main problems are a ‘classical’ autism diagnosed 1 year ago, and of diarrhoea.”

Then he goes on:

“[Child 1]’s developmental problems were first noted when he was 18 months. At this time his brother was being investigated for autism. Mum noted that until 1 year of age, [Child 1] appeared very bright and apparently had 5 full words. He also walked at 14 months of age. Subsequently he had apparently lost his vocabulary. According to mum he has not progressed normally since then, especially with speech and comprehension. There was no recall of his various social milestones.”

Then an account is given of his diarrhoea symptoms:

“His diarrhoea started approximately 18 months ago. He passes 5 watery stools a day which contain no blood or mucous. They do contain some undigested food. He appears to have no control over his bowel motions and frequency is increasing. His appetite has always been poor and there has been no obvious change in this. He has only very occasional episodes of vomiting.

He is up to date with his immunisations … There is obvious parental concern that this has some bearing on his subsequent condition. He is at present on no medication.”

Then it records an attempt at an initial colonoscopy on 22 July which had to be abandoned:

“He was subsequently cleared out and the procedure was repeated … On this occasion, the caecum was reached although it was impossible to pass further due once again to accumulated faecal matter. Macroscopically there was no abnormality noted. During the same time period an upper endoscopy was also performed. There was no obvious lesion to the 2nd part of the duodenum. A small amount of altered blood was noted.

Histological examination of the biopsies taken demonstrated a small degree of focal active and chronic inflammation within the caecum. Biopsies of the ascending colon, sigmoid and rectum were all normal. The small bowel series demonstrated occasional foci of chronic inflammatory cells within the lamina propria of the gastric body. No active inflammation was seen. No helicobacter were seen. Further biopsies from the oesophagus were reported as normal. Samples also sent for disacharridase estimation in view of the chronic diarrhoea. We are awaiting these results.”

Brain MRI normal.

“We would like to review [Child 1] in clinic to discuss the implication of the mild degree of inflammation seen in his biopsies. It is also not entirely clear whether his neurological condition in fact represents a neurological deterioration in view of lost milestones, or whether it is a classical autistic picture.

We will consider these features when we see him again.”

Did you have any particular reaction to that or did you embark upon any particular treatment?
A I certainly do not remember giving him any treatment at all. I think it is difficult sometimes as GPs because you are aware very much that hospital medicine may be slightly different. I think we were surprised that he had so many investigations done but we did not – we would not necessarily question that.

Q No, no.
A But that was all really.

Q When you made this referral to the Royal Free, as far as you were concerned, how was that referral to be funded?
A I do not know how this referral was funded, to be honest.

Q If you look at page 3 of the Royal Free Hospital bundle, that appears to be a form at least partially filled in by those at the Royal Free, for an extra-contractual referral. Does that assist you with how the referral was funded?
A Presumably then the referral would have been funded by the Leicestershire Health Authority.

Q Can you recall having any other expectation at the time?
A Regarding how it would be funded?

Q Yes.
A No.

Q Can I now take you back to the GP notes to the next communication from the Royal Free at page 132? It was a little while after the discharge summary and Professor Walker-Smith writes to you:

“Further to the discharge summary sent to you concerning [Child 1], [Mrs 1] was unable to keep her outpatient appointment yesterday, but I have spoken to her on the telephone as there was some evidence of inflammation in the caecum. I suggest a therapeutic trial of sulphasalazine as Salopyrin syrup [giving a dose] I should be grateful if you could prescribe this … This should have some symptomatic benefit. However, his CRP(3) and ESR (10) were normal.

I have not planned to see him again but Dr Wakefield will be assessing the research aspects of this problem and I would be happy to give further advice.”

In light of this letter did you in fact prescribe the drug that was recommended?
A Not as far as I am aware but there are two comments on the top, “Sue, please see EMIS 41” and “Appointment with MO, please”. I think that was an appointment with the doctor, but, to be honest, I think the mother of the child was so sceptical about anything we were going to give to the child anyway I would be very doubtful that we would have prescribed it.

Q Would you turn to page 36 in the GP records? This is the second discharge summary from the Royal Free. This time, however, it is dated 5 November 1996. It is addressed to Dr Luckens. Is it right that by this time Dr Luckens had become Child 1’s GP?
A As far as I know, yes.

Q It says:

“Further to [Child 1’s] last admission, he was re-admitted in order to perform the various tests which were not performed.

Faecal loading throughout.

Difficult study to perform, stomach and proximal small bowel appear normal. The mucosal folds within the terminal ileum appear normal.

No oligoclonal bands detected.”

Blood lead being 100 with the normal range of less then 100.

“EEG & Visually Evoked Responses
No EEG signs of major cerebral dysfunction.

The flash VEP has a simple wave form which is probably normal.

We will need to arrange a further admission for [Child 1] in order to repeat the colonoscopy. Previously we have not visualised terminal ileum due to marked constipation.

I have advised that treatment for the constipation should initially be 10-15mls of liquid paraffin [twice a day].”

Then just to complete the story in relation to this can I ask you to turn to the GP records at page 40. Professor Walker-Smith writes again to Dr Luckens on 22 January:

“I reviewed [Child 1] again in the outpatients. There has been some improvement with Salazopyrin however, her mother has not really given it very long she was concerned at one stage that Salazopyrin might have produced a rash. I think it is most unlikely that the rash she demonstrated is anything to do with Salazopyrin. At present he is taking with paraffin 10ml a day and Salazopyrin, I recommend continuing this for the moment.”

It looks on the basis of that at least as if Salazopyrin was commenced at some stage comparatively recently from January 22 1997, is that right?
A That is what it looks like from the letter.

Q Then he says this:

“I have made no definite appointment to see him again. I would recommend continuing on this medication as we found other children who have had this kind of colitis have responded well to this therapeutic approach. Mrs 1 also raised the question of whether we should investigate the brother. I think it might be appropriate to do this in due course, although his gastrointestinal symptoms do not appear to be very severe.”

In the GP notes, page 7, on the left-hand side of the page that does appear to show prescriptions not only of liquid paraffin, but prescriptions and repeat prescriptions of salazopyrin. Is that correct?
A That is correct there.

Q Lastly, page 53, a letter from Professor Walker-Smith in July 1998, again to Dr Luckens:

“I saw Child 1 again at mother’s request. She was keen to see how well his constipation had responded to treatment of copper and sulphur granules prescribed by a Scottish doctor, Dr Flint …”

Is that anything that you knew anything about?
A It is not anything I know about but by then he is not in that practice either.

“… who apparently has been involved with the care of both Child 1 and his brother. Mrs 1 was very keen that I should see the child in order that I should be able to pursue some of the research activities suggested by Dr Flint. In particular, the role of aluminium, trace metals, etc. This is certainly not in our area of expertise and I have told Mrs 1 that really we are not able to help her further with the care of Child 1 and accordingly I have not arranged another outpatient appointment to see him.”

Dr Barrow, do you recall Mrs 1 ever raising the issue of aluminium or trace metals in relation to the causation of her child’s problems with you?
A Not as far as I can remember.

MR THOMAS: Thank you very much.

Cross-examined by MR MILLER

Q Dr Barrow, I am asking a few questions on behalf of Professor Walker-Smith. You may have some other questions from my colleagues in due course. You were Child 1’s GP between November 1994, I think when you arrived at XXX and the end of 1996 when Child 1’s father ceased to be stationed there and the family moved away.
A Yes.

Q I am not able to find any of your entries, although there were very few entries in the GP notes during that time. Was that because Child 1 was quite difficult to have in the surgery?
A Child 1’s problems were ongoing but they were not GP problems.

Q I think his condition meant that he was quite difficult to deal with in the surgery anyway.
A Yes.

Q You were asked about the diagnosis for autism. Who made it we do not know, but certainly a diagnosis was made before you came to deal with him.
A Yes.

Q It is nothing to do with you or any referral that you made.
A No.

Q Could you look in the GP records at page 122. Dr Wolliscroft was at some stage the senior medical officer. This is a letter from Dr Hauck in March 1996 and it would have gone to him. He may or may not have been still there at that time. Right in the middle of the first paragraph there is a reference there to the fact that he suffers from loose stools on most days. There are a couple of entries in the GP notes earlier than this about this, but this seems to have been a complaint that was being made by the mother to Dr Hauck to the extent that he chose to write to Dr Woolliscroft. That would have been presumably amongst the general practice notes from that date onwards as we have got it now.
A Yes.

Q The next thing in the sequence that is relevant to this case is, in circumstances which are unclear, Mrs 1 dropped off that handwritten letter identifying Professor Walker-Smith and his address as a place where she wanted the child to be referred immediately I think is what she says, but no explanation apart from severe metabolic disorder and needs test done.
A Yes.

Q We can all speculate about the circumstances but you have no knowledge of what happened and how it got there?
A No.

Q It is certainly nothing about which you can give direct evidence. You did not make any diagnosis and had not seen it anywhere else.
A No.

Q You took the responsibility to make the referral again in circumstances about which you are not clear. You were the doctor who made the referral to the Royal Free.
A Yes. It may have been that Dr Haughton was away or he said could you do this, I am doing something else.

Q Either way, it was you who did it.
A Yes.

Q Turn over to the GP records. The first page of what looks like a pro forma it says: “Type MOD/DHSS no cost agreement March 1998”. Does that mean anything?
A I am not a practice manager so I am not entirely sure but it was something to do with the way that the Ministry of Defence referrals were funded for all secondary care.

Q It is not going outside an area. It is the way in which the MoD dealt with referrals for hospital medicine.
A Yes.

Q You are not clear of the circumstances but the first line on the next page,

“I understand that Mr and Mrs 1 have contacted you regarding their youngest son who has been diagnosed as autistic.”

Then you have set out the history as you understood it presumably from the parents and in the third paragraph:

“Mr and Mrs 1’s most recent concern is that the MMR vaccination given to their son may be responsible for the autism.”

Was that something that she had told you or something that was in the notes?
A No, that is what she had told all of us.

“We do not have very much correspondence regarding Child 1, but I have photocopied any relevant information that is available.”

Bearing in mind you are referring to a professor of gastroenterology, are we to take it that the letter of 12 March which we just looked at from Dr Hauck, which referred to loose stools about which mother was concerned, would have been included.
A Yes.

Q You receive a letter on 23 May, page 126, from Professor Walker-Smith simply telling you that he would be delighted to see the child and arrange for an outpatient appointment. This is not something which you have thought of yourself but it is something which a parent has asked you to consider and to do. Your approach at that stage would be if a parent, particularly with a difficult situation like this, has an idea for a referral, then you would usually go ahead with that referral if it seemed reasonable for the child to be seen in that particular centre.
A Yes, it if seemed reasonable.

Q To the extent that this child had, on the face of it, both gastrointestinal symptoms and autistic symptoms, this seemed a pretty good place to go where you were being told that there was an interest in the link between the two.
A Yes.

Q Was that the way in which you thought of it at the time?
A Yes.

Q The letter from Professor Walker-Smith to you, page 127 – autism appears to have been a given at this stage, so whether that is right or not we do not have to worry about, but he makes the point at the outset:

“It is difficult to associate a clear historical link with the MMR and the answer to autism, although Mother does believe that Child 1 had an illness …”

Even on the account given apparently to him, he is saying it is difficult to associate that purely in terms of the history and not from any other basis. He goes on to describe the physical history as told to him and the mother’s concern with diarrhoea and a suggestion about dosage of Loperamide which she could try therapeutically if you considered it appropriate. This is a straightforward letter, is it not, from a consultant referral centre giving you advice, if you want to use it, about a way in which you might be able to treat the symptoms about which the child was complaining.
A Yes.

Q The plan was that he was to see her again in three months time and if the mother was worried then they would do a colonoscopy and their reasons for that are set out there.

I think the next that you heard from the gastroenterology department was a letter from Dr Casson, the lecturer, with a discharge summary addressed to you, which is at page 128. This is a perfectly straightforward clinical letter, is it not, from somebody reporting the results of such examinations that they have been able to carry out at that stage.
A Yes.

Q Saying we are not sure what the position is at the moment right at the end. At the bottom of page 129:

“We would like to review Child 1 in clinic to discuss the implication of the mild degree of inflammation in his biopsies. It is also not entirely clear whether his neurological condition in fact represents a neurological deterioration in view of lost milestones or whether it is a classical autistic picture.

We will consider these features when we see him again.”

Again, the response that you would have expected from a referral centre.
A Yes.

Q There was supposed to be an outpatient clinic appointment on 29 August but Mrs 1 was unable to keep the appointment, although we can see that she spoke to Professor Walker-Smith on the telephone. On page 132 you have a letter from the Professor:

“Further to the discharge summary sent to you concerning Child 1, mother was unable to keep her appointment yesterday. I have spoken to her on the telephone as there was some evidence of inflammation in the caecum. I suggest a therapeutic trial of sulphasalazine as salazopyrin syrup. I would be grateful if you could prescribe this dose. This should have some symptomatic benefit.

I have not planned to see him again but Dr Wakefield will be assessing the research aspects of this problem and I would be happy to give further advice.”

As far as Professor Walker-Smith is concerned, he is signing off to you and saying you might like, in view of the mother’s concerns, to try this treatment for his bowel condition.
A Yes.

Q Again, that was acceptable to you as a bit of advice from a senior colleague.
A Yes.

Q As far as your involvement is concerned, it ceases at that point and they moved away from XXX and joined another practice in XXXX.
A Yes.

Q You know nothing about what happened there.
A No.

Q Can I ask you about your perception at the time in 1996. The Royal Free Hospital was a well-known, highly reputable teaching hospital and medical school.
A Yes.

Q You were corresponding with a professor of paediatric gastroenterology and your patient had ongoing gastroenterological symptoms, the diarrhoea.
A Yes.

Q It seemed to you that this was a perfect fit that he should go to be assessed and investigated by a professor of paediatric gastroenterology.
A Yes.

MR MILLER: Thank you.

MR HOPKINS: I have no questions.

MR THOMAS: No re-examination.

THE CHAIRMAN: We have no questions. Dr Barrow, thank you for coming and helping this Panel this afternoon.

(The witness withdrew)

MR THOMAS: That is the end of the witnesses that we have available in court today.

THE CHAIRMAN: We will adjourn now for the weekend and resume at 9.30 on Monday morning.

(The Panel adjourned to 9.30 on Monday, 23 July 2007 at 9.30 am)

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