GENERAL MEDICAL COUNCIL
FITNESS TO PRACTISE PANEL (MISCONDUCT)
Monday 23 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
CASE OF:
WAKEFIELD, Dr Andrew Jeremy
WALKER-SMITH, Professor John Angus
MURCH, Professor Simon Harry
(DAY SIX)
(Transcript of the shorthand notes of T. A. Reed & Co.
Tel No: 01992 465900)
A P P E A R A N C E S
MS SALLY SMITH QC and MR CHRIS MELLOR and MR OWAIN THOMAS of counsel, instructed by Messrs Field Fisher Waterhouse, solicitors, appeared on behalf of the General Medical Council.
MR KIERAN COONAN QC and MR NEIL SHELDON of counsel, instructed by Messrs RadcliffesLeBrasseur, Solicitors, appeared on behalf of Dr Wakefield who was present.
MR STEPHEN MILLER QC and MS ANDREA LINDSAY-STRUGO of counsel, instructed by Messrs Eastwoods, Solicitors, appeared on behalf of Professor Walker-Smith who was present.
MR ADRIAN HOPKINS QC and MR RICHARD PARTRIDGE of counsel, instructed by Messrs Berrymans, Solicitors, appeared on behalf of Professor Murch who was present.
I N D E X
Page No
DR N, Sworn
Examined by MS SMITH 1
Cross-examined by MR MILLER 26
Cross-examined by MR HOPKINS 43
Re-examined by MS SMITH 44
Questioned by THE PANEL 48
Further cross-examined by MR HOPKINS 49
BRUCE BAIRD LETHAM, Sworn
Examined by MR THOMAS 50
Cross-examined by MR COONAN 52
Re-examined by MR THOMAS 54
Questioned by THE PANEL 55
WILLIAM TAPSFIELD, Affirmed
Examined by MR THOMAS 56
THE CHAIRMAN: Good morning.
MS SMITH: First of all, thank you for allowing us a few moments and I think you require an explanation as to that. The reason is quite shortly there are often minor issues arising in relation to the admissibility of evidence in parts of statements and the easiest and most economic way, as far as time is concerned, is for all sides to get together and discuss those issues. We are grateful for the time we have discussed them and we are able now to go ahead without wasting the Panel’s time.
I will call the next general practitioner witness. For reasons which will become apparent we are anonymising him simply by referring to him by the initial of his name. I will call him Dr N.
THE LEGAL ASSESSOR: Is that statement 8 in my bundle?
MS SMITH: Yes.
THE CHAIRMAN: Can you give us the child number?
MS SMITH: He is the GP for Child 6 and Child 7.
Dr N, sworn
THE CHAIRMAN: Good morning Dr N. I hope you do not mind calling us that but that is to protect the anonymity. I thank you on behalf of this panel for coming this morning and giving us the benefit of your evidence. (Following introduction by Chairman)
Examined by MS SMITH
Q You have in front of you a sheet of paper which is heeded list of GPs consultants relating to each child and has the initials C5 at the top of it. Can you see that? Would you look down to Child 6 and Child 7? Is that your full name?
A Yes.
Q Would you look at another sheet that you have in front of you which is a laminated sheet which is headed “Lancet Children Anonymisation Key”. If you look down that to Child 6 and Child 7, are the names of those two children your two patients?
A Yes, they are.
Q I am going to refer to them as Child 6 and Child 7. If you can try to remember to do the same that would be helpful. If you do slip, as it very easy, do not worry about it because the press are aware that they must preserve the anonymity even if the name is mentioned.
I think it is right you are a general practitioner working at XXX.
A Yes.
Q Did the mother of Child 6 and Child 7 join your practice in around May 1995?
A She did.
Q Was there any particular reason that you understood as to why she had come to your practice?
A Yes, she had had a disagreement with her previous practice and she had heard that I had an interest in children with autism.
Q Do you have other patients who suffer from that disorder?
A Yes, I do.
Q So it is clear why we are referring to you as we are, I hope you do not mind my asking but it is correct your own son suffers from that condition.
A Yes, he does.
Q When Child 6 and Child 7 joined the practice, did you know any details either as to their neurological or their bowel conditions?
A No.
Q What was the first information that you had from their mother as to the nature of their condition?
A She told me that they had autism and that they had bowel problems. She specifically referred to Child 6.
Q Later on were you able to review all the children’s records when you obtained their full GP records?
A Yes.
Q Do you have your witness statement in front of you? I am not asking you to have it in front of you but we are checking whether you do or not.
A I do not think I do.
Q It was just because you were looking down and Mr Miller thought you were referring to a document. I think you said you were able to review the GP records when they became available to you.
A Yes.
Q At that time in May 1995 were you aware of any work that was being done at the Royal Free Hospital in relation to autism?
A As far as I recall I had some inkling of it but I do not remember exactly what. There was some talk.
Q Do you remember why you had that knowledge?
A That is my point, I think probably just social knowledge from other parents of children who might have mentioned it.
Q Do you recall reading about any particular work relating to measles virus and bowel disorders at that time?
A Not at that time.
Q I am going to look at both of these children separately and chronologically. If I may I will turn to Child 6 first of all. When you reviewed the GP records, as far as his behavioural symptoms were concerned I think it is right he had been seen by Dr Bennett, a consultant community paediatrician. We can see what she had to say in the GP records at page 59, a letter to the previous doctor, Dr Mills. Are you with me?
A A letter from South Downs Health.
Q Typed 13 December 1995. Are you with me?
A Yes.
Q Not received until April 1996. If I can run through that with you, looking at the second paragraph Child 6 had had a Griffiths Assessment which demonstrated that he has a rather uneven developmental profile. He had particular skills with remembering sequences and sentences. Then if we go down to the bottom of the page:
“At home it is clear that [Child 6]’s behaviour is very difficult. His parents find it
difficult to reason with him and he does not respond to the usual discipline measures.
His mother was particularly concerned that he is not developing good peer relationships. All these features confirm that [Child 6]’s difficulties lie within the
Autistic spectrum and he probably has Asperger’s Syndrome, although this will
become clearer as he becomes older. I explained to his parents that it is difficult at
this early stage to predict how [Child 6] will be in the future.”
She referred him to the clinical psychologist for further advice. Turning over the page, he will be undergoing a statement of his educational needs in the new year and Dr Bennett planned to review him in three months. It appears at that time that it was thought that he might be suffering from some form of difficulty within the autistic spectrum, probably Asperger’s Syndrome, is that correct?
A Yes.
Q I would like to look at the preceding records with you, still in this bundle. He was born in XXX and there are early references when he was a month old to some diarrhoea when he was a baby, if we look at page 4. The date at the top is 14 May 1992 and there is a reference to bowels being loose.
A The entry is dated 20 May.
Q Going down to the 27 May, “bowels loose”, that is the entry you are referring to. Then down further down the page it says “diarrhoea two days. Vomiting frequently”.
A Yes.
Q If we go on to page 10 we see an entry on the 18 March 1993 “Admitted overnight. Febrile convulsion.” Then underneath “rash raw - florid measles.”
A Yes.
Q If we go backwards to page 1, that is his immunisation record card, we see that he had his MMR vaccination on the 15 June 1993.
A Yes.
Q Then back to the GP records, on page 11, in the middle of the page, 10 December 1993, there is a reference to behavioural symptoms “Falling over and very aggressive. Self-hitting. Unhappy” and then there is a reference to pellety stools, is that correct?
A That is correct.
Q On to page 14, 14 July 1994, some diarrhoea, one stool contained mucus and a little blood.
A Yes.
Q Then if I take you to page 29 leading up to the admission to the Royal Free, is this your handwriting of the 25 March 1996?
A No, it is not.
Q Do you know whose it is? Was it another GP in the practice?
A It is not.
Q You cannot help us as to that.
“Dr Wakefield - Royal Free. To discuss association measles + Autism + inflammatory bowel disease. Discussed general concerns re family. If we feel relevant can refer for treatment to Professor Walker at the Royal Free for investigation.”
A I do not recognise that handwriting or the signature. I think it might have been one of the registrars in the practice.
Q In fact you did indeed refer to the Royal Free and the letter is dated 9 August 1996, that is in page 125. Can you help us, first of all, as to how that referral came about? Do you remember why you wrote that referral letter to Dr Wakefield?
A Yes, I would have written that referral based on Child 6’s mother’s request, and based on this letter I must have had a phone conversation with her, but I do not recall it, discussing with one of the team. It must have been Andrew Wakefield.
Q First of all, you say it was at the mother’s request. Was there anything unusual to your mind in a request from a mother or this mother in particular?
A Not from this mother in particular. She was very determined to try and “resolve” the autism, or the problems as she perceived them. She felt there was a cure.
Q You say in your letter:
“Dear Dr Wakefield
Following our discussion over the ‘phone the other day [Child 6] is a little boy with autism syndrome who does also suffer from bowel disorder. His mother is interested in entering him into your trial and I would be grateful if you could see her for discussion.”
As you have already identified, there had apparently been some discussion over the telephone. Can you help us at all as to who would have initiated that telephone conversation?
A I really do not recall. I suspect I may have done. If she would have given me the number I would have rung to find out more on her behalf; but I do not recall.
Q At that stage you refer to a trial. Did you have any understanding as to what the trial was, or involved?
A No.
Q You received a letter back in fact from Professor Walker-Smith, and that is one page back at page 124?
A Yes
Q Saying:
“I have been asked by Dr Wakefield to see [Child 6] as I am the Paediatric Gastroenterologist associated with Dr Wakefield in our study on autism and bowel disorder. I have taken the liberty therefore of sending [Mr and Mrs 6] an appointment for [Child 6] I would be grateful if you could explain the situation to them.”
A Yes.
Q What did you understand by that as to Professor Walker-Smith’s reason for seeing the child?
A What I understood by that was that Professor Walker-Smith was the clinician involved, and obviously I can only refer to a clinician, and really to explain why it was not perhaps Dr Wakefield that they were being referred to.
Q Professor Walker-Smith in turn has referred to a study on autism and bowel disorder. What was your understanding, if any, as to what was being planned at the Royal Free?
A I had no understanding of it.
Q If we look on to page 123, that is the next letter to you from Professor Walker-Smith:
“Many thanks for referring this boy, he certainly fits into the spectrum of a child diagnosed as autistic who also has bowel symptoms, as there is a history of recurrent abdominal pain and diarrhoea with passage of blood and mucous over several years. I am arranging for him to come in to have a colonoscopy and entering our programme of investigation of children with autistic problems. He will be admitted on Sunday 27th October 1996. In the meantime I have arranged for him to have simple screening for inflammatory markers. I will let you know the results in due course.”
A Yes.
Q Again, that refers to a colonoscopy, and presumably that was an investigation that you were familiar with?
A Yes.
Q But, again, it refers to a “programme of investigations.” Did you at that stage know anything about the programme of investigations that was apparently planned?
A No.
Q Did you gain any information as to that from the mother?
A I can only answer “probably” to that, in that she would have been likely to have told me, but I do not recall. If she knew then she would have told me.
Q We know the child was in fact admitted to the Royal Free for a colonoscopy and for some other investigations, and the next thing we learn from the GP records is page 119. That is a leaflet with “XXX” at the top. Is that the out-of-hours GP service?
A Yes, it is.
Q We can see from it the problem:
“Had a lumbar puncture last Thurs in London. c/o pain ++”,
and under “Clinical information” it says:
“Headache - LP [lumbar puncture] 3 days ago.
Now as above.”
Was there a referral to the hospital as a result of that? That would have been to the out-of-hours GP surgery, would it?
A Yes. That would be a colleague working out of hours. There is more clinical entry there. Under “Observations”:
“alert though prefers to lie down”
and in “Diagnosis”:
“Partly LP effect and no …”
something. I cannot read that.
THE CHAIRMAN: No meningism.
A No meningism, yes.
MS SMITH: Thank you.
A Then:
“Drugs Prescribed …
Analgesics
Ibuprofen …”,
So he was sent home.
Q And he was sent home?
A Yes.
Q As far as you understood, Doctor, did this child’s mother have beliefs as to the reason why Child 6 was autistic?
A Yes.
Q Can you tell us what they were and, if you can remember, when she first made them clear to you?
A I am not sure when she first made them clear, probably from an early stage. She was convinced that it was to do with the MMR vaccination. She said he was fine before then.
Q Was that something, can you recall, that she told you prior to her requesting a referral to the Royal Free?
A I do not know. I do not recall.
Q Did she discuss with you her expectations of that referral, what she hoped to achieve by it?
A She probably did. She was always on a quest for a “cure” and I think she felt that by finding the cause a cure would be found. It was that sort of a discussion really. I do not think she expected him to come back better necessarily.
Q Did you discuss that with her? You say “at sort of a discussion.” Was there more than one discussion between you?
A She was a frequent attender and we had many long discussions.
Q Did you try to give her any explanation as to what, if any, assistance that referral could be?
A I was not really aware of what the trial was trying to achieve, I did not have that sort of information, so it was really for her that I had referred him for discussion with a specialist at the Royal Free.
Q I am awfully sorry, Doctor, but I did not actually hear the end of that last answer.
A I referred her for discussion about the trial to the Royal Free. I was not expecting any outcome from a trial in terms of the health of the child.
Q As far as you were concerned, when you made the referral to the Royal Free did you have an assumption as to the reason that the tests were being done?
A No, not really, no.
Q Did you have any concerns as to what their nature was or whether they were justified, and why?
A Yes. As with any trial I had concerns that any investigations should be justified, but I presumed that they were and that the proper procedures would have been followed. The Royal Free is a well-regarded teaching hospital and I would expect those standards and that the child’s interests would come first.
Q Absolutely. When you say “the proper procedures would be followed”, what do you mean particularly as far as that is concerned?
A I mean things like ethical approval. Just the whole design of a study would have to be – there are proper processes, I assume. Obviously, I am not involved myself, but I would expect proper processes to ensure the well being of the child and that is why I referred in good faith.
Q When you say “the trial”, Doctor – tell me if you cannot answer this – can you help us as to exactly what you mean by that?
A My understanding was probably mostly from Mrs 6 and that it was about understanding the condition more and what might be causing it, so that seemed a good thing.
Q You were sent a discharge summary in relation to the child after his admission and that is on page 117. I say “a discharge summary”, but in this case in fact it is in the form of a letter, and that is a letter dated 2 December 1996. Have you found it?
A I have.
Q It says:
“Dear Dr N
…
I am sorry we have not had the full discharge summary to send to you, but it is in the process of being prepared. Basically the recent investigation did reveal some endoscopic abnormalities. The rectum showed minor abnormalities of vascular pattern with no ulceration or friability. The caecum showed prominent lymph nodes around the appendiceal orifice and rather patulous ileal-caecal valve. In the ileum there was marked lymphoid nodular hyperplasia. Histologically there was in the ileum and ileo-caecum some prominent reactive lymphoid follicles and mild focal cryptitis. In the colon there was a mild patchy increase in inflammatory cells in the laminar propria with a focal cryptitis but not abscess formation. There was mild architectural distortion with focal irregularity of the surface epithelium. It is not possible to make a firm diagnosis, but clearly there is an indeterminate colitis present which may be relevant to his Crohn’s disease or ulcerative colitis abdominal pain. We therefore commenced him on Olsalazine in a dose of 250 mg 3 times a day. The other investigations are in the process of being analysed and will be part of the discharge summary, however there was no gross evidence of anaemia or other biochemical disturbance or evidence of iron folate or B12 deficiency.
When I reviewed him in the clinic on 27th November, he had recently had an episode of mouth ulceration which had also affected his brother, but in general he was making excellent progress on Olsalazine 250mg tds. His mother said these episodes of abdominal pain did seem to be significantly less and his behaviour had also improved, apparently friends had noted a quieter behaviour. It is tempting to relate this to Olsalazine therapy, although it is difficult to be certain of this. However we do have definite evidence of bowel inflammation and there seems to be some response to anti-inflammatory treatment. I recommend continuing him indefinitely on Olsalazine and I have not made another definite appointment to see [Child 6] again, but I would like to see him again at some point after the preliminary analysis of the results of the children with similar problems to [Child 6]”,
That is a letter signed on behalf of Professor Walker-Smith. As far as the olsalazine was concerned – the child had been prescribed it – did it at first seem to be making a difference?
A It certainly did as far as his mother was concerned, yes.
Q Did he remain on it?
A He did for some time but, without referring to the notes, I am not sure.
Q And you in fact prescribed it?
A Yes, I did.
Q Were you content to do that?
A I was content to do that under the aegis of Professor Walker-Smith. I would not have done it without that.
Q Was it a prescription that you have any knowledge or experience of?
A Not at that time, no.
Q Were you aware of it as a prescription that was given to children at that time?
A No.
Q As far as you were concerned, reading the discharge summary as a general practitioner, what was your understanding of what Professor Walker-Smith had said about any bowel disorder?
A From the letter, he has clearly found some abnormality in the bowel which he has proposed to treat to see if that will improve Child 6’s symptoms and that is really all it says.
Q Were the nature of the symptoms something with which you were familiar as indicating any particular disorder?
A His mother often referred to his bowel disorder. Obviously, I only had that from the history as far as she gave it to me and she did say that he had a lot of abdominal pains and discomfort and that this had improved it.
Q As far as the biopsies that were taken at colonoscopy were concerned, did you ever in fact see the results of that?
A I do not recall and, if they are not in here, then I did not.
Q Was it your understanding that the mother had gained any particular impression as to what these investigations at the Royal Free Hospital had led to, any conclusions that they had led to?
A She certainly had lots of conclusions that she drew but I think that they were her own views as far as I could tell because I had not been led to believe anything else by the Royal Free.
Q You have told us that she had had a conviction that the vaccine was what had caused her child’s autism.
A Yes.
Q Did that conviction become any weaker or stronger as a result of this referral to the Royal Free?
A She connected the two things, the bowel problem with the MMR and somehow the autism but, as far as I could tell, that was her connection.
Q Would you turn on to page 371 in the GP records. This was a letter that was sent to you by Professor Walker-Smith dated 12 January 1998 after he had seen the boy in outpatients and he says,
“Dear [Dr N],
I reviewed [Child 6] again in the Outpatients. He does continue on olsalazine 250 mg three times a day. Generally, his parents feel that this has had a good effect on his behaviour and he is overall more calm although recently there may be some deterioration in his behaviour. At the moment his mother’s main concern is that he is incontinent and appears to have no control over his stools and this is obviously a considerable burden for her.
On examination, the abdomen is soft and there are no palpable faeces but plain
X-ray of the abdomen does in fact show quite severe generalised faecal loading with distension of the rectum.
From a practical point of view the most difficult problem with this child is trying to achieve control over his constipation”
and then he makes a recommendation of senna liquid and Picolax in an attempt to get the colon empty. He says,
“… as a single dose as we used to clear his bowel for endoscopy. This will obviously lead to worsening of the diarrhoea but may empty the bowel and thereafter continued on lactulose 10 ml twice a day.”
What is lactulose a prescription for?
A Lactulose is a stool softener.
Q
“If this regime does not improve the situation, I think he will subsequently need a further plan X-ray of the abdomen and if the faecal loading persists a period in hospital with medication such as Golickly would be best. I do not believe that this should be done at the Royal Free Hospital as it is so far away. I understand that there have been some problems with the family concerning the [hospital] in XXX and it might be more appropriate to be seen in the Paediatric Service in XXX. However, I do think in fact that further follow-up should be done locally rather than here as basically we have nothing further to offer diagnostically.”
A repeat of a urine test showed some unusual aminoacids in the urine.
“Dr Wakefield will be in touch in due course about the results of research and if there are any new problems emerging I would be happy to see the child again or give further advice about constipation. For the moment I have not given a further Outpatient appointment to be seen in this Clinic.”
Do you recall whether in fact there was any further contact between you and Dr Wakefield about the results of Child 6’s research?
A I do not recall.
Q There is a continuing involvement of the Royal Free Hospital as far as the child’s constipation is concerned. If we look at page 368, this is a letter to you from a research fellow at the hospital.
“We have had repeated ‘phone calls from [Mrs 6] about [Child 6]. It seems that he is having increasing amounts of pain, while he continues to soil and not open his bowel regularly.
As you know he has significant constipation, which his current medication is apparently unable to treat”
and then making a suggestion of an increase in dose of lactulose and senna.
“It does sound as though he will need a hospital admission to clear his bowel with Klean-prep. We would not be doing this at the Royal Free and I have therefore suggested to [Mrs 6] that she tries a local paediatrician …”
Then in fact, if you go back to page 362, that suggestion seems to have changed because we see a letter in August 1998 to you from Dr Casson,
“[Child 6] was admitted to the ward at the Royal Free Hospital on the 11th July 1998 for Klean-prep treatment to clear his constipation. This was administered successfully over the course of 2 days by which stage his bowel was effectively cleared.”
He was discharged on lactulose and was to be reviewed in due course. That would appear to be the end of the involvement with the Royal Free Hospital. Can you assist at all as to the constipation problem? Had that been a part of the bowel disorder prior to the referral to the Royal Free Hospital or had that become apparent later?
A No, I think that had been a longstanding problem.
Q Did he remain thereafter on the treatment for constipation?
A I do not know; I cannot recall; he probably did.
Q I want to take you on rather later because of the involvement of a particular doctor to 2001 when you referred Child 6 to Dr Harvey. Would you turn to page 247 of the GP records. This is a letter from you,
“I understand that you are willing to see this child who is known to be on the autistic spectrum disorder and is one of the children who is currently part of the litigation cohort against the manufacturers of the vaccine MMR.
[Child 6]’s problems currently are around his apparently worsening symptoms of autism and his persistently severe and frequent headaches.
He has been seen by a great many professionals, who fear that his headaches are not easily explainable.
In my view these are related very much to the stress that he feels through his autism and his poor understanding of his environment. I agree that he does appear to be functioning less well than he was at one time, although this is a pattern that I am not unfamiliar with. The issue is whether we can do anything to help this poor boy with his severe headaches. Medication appears not to be helpful.”
Do you recall why you were referring to Dr Harvey?
A I do not know Dr Harvey; this was a specific request by his mother.
Q Were you aware of whether Dr Harvey had played any role in the previous admission when you had referred Child 6 to the Royal Free Hospital?
A I was not aware.
Q You say that this was a referral at the request of Child 6’s mother. Did you have any views as to the request by Child 6’s mother for referrals?
A I did. I was getting increasingly concerned about the amount of intervention she was requesting with her child and I worded my letter such that I feel if conveyed that I felt this was not an organic problem and that it did not warrant investigation, or at least that is what I feel I put in the letter without saying it as such.
Q When you say that you were becoming increasingly concerned, can you explain to us what the nature of your concern was. Why were you concerned about the mother frequently requesting referrals?
A I was concerned because I felt that her expectations were unrealistic and, rather than dealing with the problems she had with her children, she was looking for solutions rather than a way of living with it and I felt that her anxiety and her concerns were detrimental to the health of her children.
Q As far as the admission of Child 6 to the Royal Free Hospital in 1996 for the trial you have referred to, what was your understanding of the funding arrangements? Who was paying for it?
A I had no knowledge of that at all.
Q Presumably one of the matters that was in your mind as a general practitioner when you refer a child is how it is going to be paid for.
A Not in those days. It was not a concern in those days. We seemed to be able to refer where we needed to.
Q When you say you could refer when you needed to, who did you assume was paying for it?
A I referred and he was sent an appointment. I did not have to deal with anyone else. I just sent it to the clinician, and the details of that were sorted out by someone else. As far as I was concerned, if a referral was appropriate, then it was justified and paid for. I do not know how it was paid for. It did not seem to be an issue in those days.
Q When you say that, as far as you were concerned, if it was justified you made the referral ---
A Yes.
Q …had you been asked at the time, “Who do you think is paying for this?” what would have been your answer?
A “The Health Service.”
MS SMITH: Sir, that is all I have to ask about Child 6. I am not going on to Child 7. I am entirely in my learned friends’ hands as to whether they would prefer me to go straight on. They are indicating that they would. (To the witness) Can we go on, please, to Child 7? If we look at the GP records ---
THE CHAIRMAN: Just give us two minutes, so that we can get the records.
MS SMITH: You will only need the GP records in relation to Child 7, sir.
THE CHAIRMAN: Thank you.
MS SMITH: (To the witness) Perhaps you would go to page 29 in those records, doctor. That seems to be the first entry which involves you. Is that your entry on 13 May 1996?
A Yes, it is.
Q Is that about the time when the mother registered the two children?
A It must be about that time, yes, because that is the first entry.
Q We see that there is a short history of convulsions aged six months.
A Six weeks.
Q Six weeks, I am sorry – and that the child is under the investigation of a Dr Trunce, is that right?
A Trounce.
Q Trounce. You have made a note in relation to vaccination. Can you tell us what that says? “Up to date…”?
A With the Hib vaccine, the triple vaccine and the MMR.
Q Then, underneath, “Doesn’t want…”?
A “…more jabs.”
Q Do you remember why that was a particular issue when you were discussing this child at that time?
A I do not recall. She will have said that she…. Well, she would have told me that she does not want any further vaccinations, because I would have asked her specifically as part of the history of what his vaccination status was; but she would have told me that she did not want any more.
Q There is a note of the prescription he has at the bottom.
A Yes.
Q Carbamazapine, is that?
A That is an anticonvulsant.
Q Perhaps we can look at the records, just to see the history in relation to why he was on anticonvulsants – page 334. This is again a letter before you were involved, to Dr Mills from Dr Trounce, the consultant paediatrician. He is a local paediatrician, is he? Yes, at XXX Health Care. Is that correct?
A Yes.
Q March 1995, saying,
“[Child 7] was brought to the Casualty Department here at the end of last week.
There had been concerns since he was six weeks of age where he would have episodes where he would cry out, go red in the face and appear to be choking”.
Then it gives a little more description of those attacks. Then, in the next paragraph,
“More recently, he has had what his parents describe as a second type of attack. During this he will become rather irritable and not himself for a short while for no obvious reason. He will then cry out, he goes blue and subsequently pale. He appears to be unresponsive”.
Then again a further description of those attacks. Then, on the next page,
“I am suspicious that these episodes may be seizures. They do not sound typical of breath holding attacks and seem to occur rather unprovoked. On the positive side he appears to be developing normally and there are no significant abnormal findings”.
There is an arrangement for him to undergo an EEG. He says,
“At this stage I did not feel we had grounds to commence…anticonvulsant(s). I think we need to keep a slightly open mind, but if the episodes increase in frequency I think we will need to consider this”.
Then there were some further febrile convulsions and another report from Dr Trounce, which is on page 326. By that time he was having some treatment, because it says – this is June 1995 –
“[Child 7] has undoubtedly been improved on sodium valproate. He still has some ‘attacks’ and typically these occur when he is upset. He then proceeds to cry and does not take another breath. He turns a mauve colour but does not suffer impairment of consciousness. This happens…(about) once per week”.
He says,
“It seems most likely that this is a blue breath holding attack.
Mother discriminates these from other episodes he had which sounded more ictal and these appear to have ceased at present”.
It refers to his developmental progress as “good”.
“His EEG was abnormal showing some sharp waves over the right frontal to central region.”
The doctor said that, in view of that, and “the fact that he occasionally drags his left leg”, he was going to arrange for him to have an MRI scan. He was keeping him on sodium valproate and planning to review him again in three months. As far as this little boy is concerned, was there any question of his suffering from autism, doctor?
A What? At this point?
Q Yes.
A I did not know him at this point.
Q No. I am sorry, I put the question badly. You are right to say that. By the time he got to you in 1996, we know that the mother had given a history of convulsions, because that was set out in your first note in relation to him; and we can see the history of how she would be telling you that. Was it your understanding that there had been any suggestion of autism then, when you saw him?
A No.
Q As far as bowel problems are concerned, again taking you back into the history prior to your involvement – page 23 of the records. We see on 27 September 1995 a reference to two “small fresh bleeds on motion. Was constipated last week”, and I think we see at the bottom that the doctor’s impression was that there might be a fissure, and he prescribe lactulose. Then the next page, page 24, October 1995, there is a reference to diarrhoea – at the top of the page, 11 October 1995, and also in the context, it would appear, of a fit. Is that correct?
A Yes.
Q As far as his vaccination history is concerned, there is not an official record on the vaccination sheet, but there are two references that I want to take you to in relation to MMR. One is in the GP records on the same page, page 24. We see that it says, “Immunisations up to date. Due MMR” – in the middle of the page, 12 October. Do you see where I am?
A Yes.
Q Then, if we go to 296, this is a letter for the playroom report, which I do not propose to go through with you; but if you look towards the end of the first paragraph, we see,
“[Child 7] had his MMR in November 1995 and appears to have been quieter since then. (Mother) is concerned that (he) is never happy and doesn’t laugh”, et cetera.
Is that correct?
A Yes.
Q That would appear to accord with your understanding that, when they came to see you, he had indeed had an MMR vaccination.
A Yes.
Q Then we come to the time when you were directly involved, and I have taken you to the first reference to that. Perhaps you could go to page 287, please? This letter is again from Dr Trounce, the consultant paediatrician, and it is to you.
“[Child 7] came with both parents today and unfortunately the consultation was marred by the fact that they…wished to strongly express their discontent in a report I made to Social Services. They took this as support for the previous Health Visitors comments about numerous medical presentations on somewhat dubious grounds. They felt that, in fact, I was now saying that a lot of [Child 7’s] ‘turns’ were not epileptic and they felt that I was accusing them of fabricating the symptoms. I did stress to them that this was not totally the case but there was certainly now a question mark over whether he had epilepsy, that there were other causes of paroxysmal episodes such as his and that the original abnormality on the EEG could have misled us into that diagnosis. We eventually came…to an agreement that we could try weaning (him) off the Carbamazepine” –
and he makes a suggestion to cut down the dosage. He again says,
“I was encouraged to read the various reports…suggesting that [Child 7’s] overall developmental progress is coming on well”.
What was your impression of Child 7 in terms of behaviour, doctor?
A He was an odd child, in the sense that he was quite independent; did not make great eye contact, and behaved in a way, in the consulting room, differently to other children. So he might focus on odd things, like a curtain or something that a child might not ordinarily do. So he was different – without putting a diagnosis to it.
Q Was it your view at the time – and I do appreciate you are talking as a general practitioner – that he was autistic?
A I think “autism” is probably too strong a word. I felt he had a social disorder of some sort, yes.
Q As far as this child is concerned, Child 7, at that stage were you aware of the mother having any concerns that the vaccine had anything to do with his condition?
A I am pretty sure that she would have told me that, yes; that would have been quite a dominant part of the consultation.
Q You referred this little boy to the Royal Free Hospital in December 1996, and we can see the referral letter at page 282. This of course is after you had referred Child 6 and the letter from you dated 3 December 1996, this time directed to Professor Walker-Smith:
“Dear Professor Walker-Smith,
I would be grateful if you could see this boy who is a child whose brother you have recently investigated as part of your programme for colonoscopy for children with autistic problems. He himself probably does not have autism although this is not certain at present but he does have convulsions which I believe may make him eligible for your study. He also suffers with bowel problems similar to his brother who is autistic. I would be grateful if you could see him.”
How did that referral come about? At whose instigation would it have been?
A That would have been at his mother’s instigation.
Q What, as far as you were concerned, was the purpose of that referral?
A I think she felt that to have these two children, both of whom she felt had autism, under the same team would be helpful. She also felt that Child 6 had benefited from the referral and I think at that time was still under the team. She asked me for that.
Q What was your feeling about making that referral?
A I certainly would not have instigated it myself for him but I felt it would satisfy her need for the child to be seen. Certainly, as far as the referral was concerned, I felt that he would be assessed there.
Q When you say you would not have instigated it yourself, can you tell us why you would not?
A Because we have facilities in XXX for looking after children. They do not need referral to London particularly. She wanted to by-pass that step really. She was dissatisfied with the services in XXX. I would have explored that further but she did not want any more dealings with XXX.
Q Did you think it was going to be that this referral was going to be of benefit? You said you think the mother wanted it and it would help the mother. Do you think it would be of benefit to the child?
A I did not know really. I hoped so.
Q By that time you had referred the brother, you have said in your letter, as part of your programme for colonoscopy for children with autistic problems. Were you any further forward on knowing exactly what else was entailed in the study?
A I do not think so, no.
Q You said in that letter that you did not think that the child had autism. Were you surprised when the Royal Free agreed to have him in the study?
A I cannot recall how I felt at the time, to be honest. I do not know. I think, knowing Child 7’s mother, I imagine she would have pushed quite hard for it but I do not know. She would have wanted him to be in the study but presumably there are criteria so it would depend whether he was suitable or not.
Q As far as you were concerned, whose job would it have been to decide whether he was suitable or not?
A That would be entirely the team at the Royal Free.
Q As far as his bowel problems, you mentioned the fact he suffers from bowel problems similar to his brother. Were you aware of those as being a problem yourself?
A Yes, in the sense that he had constipation and similar symptoms to his brother.
Q If we can go on to the next letter, which is the Professor Walker-Smith at page 279 dated 21 January 1997.
“Dear Dr N,
Many thanks for referring [Child 7]. I was very interested to hear the history of this
child in which there does seem to be a clear relationship between symptomatology
and the MMR. He had the MMR rather later than usual at the age of 21 months. His
mother tells me 24 hours afterwards he had a fit like episode and slept poorly
thereafter and she attributes changes in his behaviour to this event. I understand that
he has not been fully investigated although I understand it is your opinion he could be
within the autistic spectrum although it is not your view that he does have autism. I understand that he had had an abnormal EEG in the past and was for a period of time on anti-convulsants but is no longer on any kind of medication. From a gastrointestinal point of view from the age of 2 he has had intermittent episodes of passage of blood associated with constipation and diarrhoea mucous. His mother says he has intermittent high fevers although I understand that he has had recurrent ear infections which have been treated by antibiotics. He also has some intermittent vomiting at night. His mother says he cries a good deal at night. He has a somewhat inadequate diet but nevertheless he is gaining weight and growing satisfactorily and is on no particular dietary restriction. There is no clear history of any particular food poisoning symptoms.
Particularly in view of the findings in his brother, I think it would be appropriate for
this child to be investigated particularly by colonoscopy and I am arranging for him to
be admitted on Sunday 26 January 1997 and he will be having other investigations as
part of the protocol. We will let you know the results of these investigations in due
course.”
Do you think that that letter set out the history, as far as you understand it, in relation to MMR and the convulsions?
A Yes, I think so.
Q Professor Walker-Smith says that he had the MMR and 24 hours later had a fit like episode. What was your understanding of how long this child had had convulsions?
A The same as in the letter. He had convulsions from a young age.
Q If we look back in the history, I referred you to the letters from Dr Trounce. There was an admission in 1993 to hospital with febrile convulsions which turned out to be measles. Did you think this letter accurately reflected the sequence of events, i.e. the MMR and the convulsions?
A It is very difficult to be specific about that reply because she did vary her histories from time to time. It was difficult to be certain what she was telling different professionals. There was a history of her consulting several professionals for one problem and then take the answer she required. I think it was difficult to have clear thinking when consulting.
Q When you say “she”, that is Child 7’s mother?
A Yes.
Q There is a reference then to other investigations in the protocol. By that time did you appreciate what those other investigations were?
A I am not sure I did, no.
Q You need to refer to the local hospital records, Child 7’s local hospital records, which you should have in a separate file at page 71. This is a letter dated 27 February 1997 which you wrote to Dr Bennett, the consultant paediatrician. This is about a month after the letter that I just referred you to from Professor Walker-Smith. You wrote to Dr Bennett:
“I would be grateful if you could give me some information regarding this child who is a relatively recent registration with me and who would appear to have autism or at least within the autistic spectrum. I note from his previous records he has been under the general paediatricians regarding his absent seizures and has been on anticonvulsants. There is no diagnosis however in his records and I just wondered what the state of play was. He is not having any special education and I am not sure whether he has had a statement of education need planned.
I think you know his mother and I believe there have been some difficulties but I would be grateful if you could give me a resume so I could refer her and [Child 7] as appropriate.”
That letter is self-explanatory and resulted in a letter from you at page 64 to Dr Bennett having discussed the matter on the telephone.
“I would like to refer [Child 7] to you for review regarding his neuro development.”
You have spoken to his mother who had ambivalent feelings about the service in XXX.
“She is however keen to have him observed although she is hopeful that there will be nothing wrong with him. She does feel that he is quite similar to 6 and accepts that he is copying [Child 6]’s behaviour. [Child 6], as you know, is autistic.
He seems to be in the surgery setting a normal child thought perhaps a little
obsessional. I have seen no evidence in him of autism but I do not feel in a position to be able to reassure mum on this score given her anxieties. He does have digestive problems including diarrhoea and what appear to be food intolerances and is in fact being investigated under research programme at the Royal Free under the auspices of Professor Walker-Smith.
I am still awaiting reply from this hospital as to their findings but she tells me that mum reports to me that they have found what they think is inflammatory bowel disease and wants to start him on Mesalazine. [Child 6] incidentally has made great improvements in terms of dietary tolerance and to some degree his behaviour.
I would be grateful therefore if you could review him with a view to monitoring his neuro development. I am sure if you feel it is entirely normal and able to reassure [Mrs 7] that would be entirely satisfactory from everyone’s point of view.”
At that stage did you have any clear views as to the diagnosis of this little boy’s developmental problems, if any?
A No. I think that is what I was asking for, some kind of clarity. It was very difficult to manage from the clinical perspective.
Q If we go back to the GP letters, page 272, you will see the next notification to you from the Royal Free Hospital is an apology in relation to the discharge summary sent to you for Child 7.
“Basically though he had lymphoid nodular hyperplasia but on this occasion no evidence of inflammation in the distal bowel. Nevertheless he continues to have symptoms although these are chiefly behavioural. When I reviewed him in the clinic I thought it would be helpful to trial a therapeutic trial of Olsalazine in the same doses for his brother, three times a day for four months and then assess whether we need to continue.”
He then refers to blood results and says he has is going to repeat a full blood count and he says he will be reviewing him again with his brother in four months time. Did you have you any understanding, as a general practitioner, as to Professor Walker-Smith information that he had lymphoid nodular hyperplasia but no evidence of inflammation in the distal bowel?
A No.
Q As far as you were concerned, what was olsalazine prescribed for?
A As an anti-inflammatory drug to reduce inflammation in the bowel.
Q Did you understand the basis upon which Professor Walker-Smith was saying he should be prescribed it?
A I presumed it was for this condition lymphoid nodular hyperplasia which I had not heard of apart in the previous letters regarding Child 6. That was the first time I had heard about it.
Q You were aware that the diagnosis, in broad terms, i.e. the lymphoid nodular hyperplasia was the same in respect of Child 6 and Child 7.
A I think so. I do not know if it was at this point I knew that.
Q At any rate Child 7 was indeed prescribed olsalazine. What was your understanding of whether his mother regarded it as being a successful treatment or not?
A From my recall it did make a difference for a while.
Q Do you remember a difference to what?
A No, I do not remember without looking at my notes. I do not know if I have written anything.
Q Was your impression that it was making a difference a consistent impression? In other words, you said for a while, did that change?
A I think it is very difficult to be consistent in my answering in the sense that she was a very confusing person and the story would vary between consultations. It was difficult to a get a consistent pattern. At times she would say it is fantastic and made a huge difference, then a week later it would be a different story. It was very difficult to give you a clear answer about that. Certainly at times she said it made a huge difference and other times she would say it is not working.
Q Child 7 continued to be seen at the Royal Free Hospital. Was that related to the prescription of the olsalazine? Would that have been something you would have been happy to prescribe unless it was being prescribed by the Royal Free Hospital?
A No. As in Child 6, I would only do with that consultant supervision.
Q If we go on in the GP records to page 254. This is a letter to you from Dr Casson, having received an abdominal X-ray performed in order to see if there was any evidence of faecal loading. There was no significant pathology. Then at the bottom of the page:
“I note our previous communications in which [Mrs 7] was concerned that the Olsalazine despite improving [7’s] behaviour seemed to worsen his diarrhoea. She therefore has been through a procedure of stopping the Olsalazine to see if his symptoms changed and once again re-starting it. The outcome of this has been that he has been off his Olsalazine and we should await to see how the situation develops. Nevertheless if his diarrhoea persists we will be happy to review him in our clinic.”
I am sorry, I should have referred you to one letter before that, but the point is still there. That letter was September 1997 and if go to page 259 we see Professor Walker-Smith in July 1997 says:
“His mother says he continues to have diarrhoea now up to 4-5 times a day and a week ago he had an episode of blood and mucus in the stools which settled spontaneously. This is a bit surprising as he continues Olsalazine 250 mg tds …”,
and then he wonders whether it is the way the medication is being kept.
“His behaviour however has become more testing in that he is very much livelier than before and has considerably increased wordpower. This is really quite notable. When I examined him myself I could have quite a lively conversation with him. [Mrs 7] has believed has ‘woken him up’. She also says that he also has very few petite mal attacks since he started Olsalazine. Whether this is coincidence or not it is hard to judge as indeed is all this kind of response to this therapy. I would like to continue to review him and see him in clinic in 4 months’ time …”
So that is the July, and now if you could go back to the letter at page 254 (that is September) we can see that there were concerns, which I have just read out, about whether the medication was worsening his diarrhoea. I think you have answered this already, Doctor, but was it a clear picture really at this stage as to whether this drug was helping and what it was helping?
A It was really not a clear picture.
Q If we go on to page 265 we see a referral by you to Dr Gillian Baird at Guys’ Hospital. Can you help us as to her specialism?
A She is a developmental neuropaediatrician at Guys.
Q You ask for assistance with this complex family, and going down to the last paragraph on that page:
“I would be grateful if you could see [Child 7] with a view to assessing his learning and behavioural difficulties to help in further management of [Child 7] He has been going to the Royal Free Hospital for investigation and both of the children have turned out to have a degree of proctitis and terminal ileum lymphoid hyperplasia. He is receiving Olsalazine for this and is under review from Professor Walker-Smith. She has also been seen by the Psychiatrist up there who tells her [presumably mum] that [Child 7] is autistic. This is not based however on a formal and extensive assessment as usually done in XXX, or by the Newcomen Centre, but on a one hour consultation, I believe.
I would add that Mum is very active medico-legally and has been involved with the groups suing The Department of Health for the MMR and its possible association with autism”,
and you say you would be grateful for any assistance and some degree of normality in all this. Even at that stage, Doctor, were you still seeking a clear diagnosis as to Child 7’s condition?
A Yes.
Q The information you refer to in relation to a one-hour consultation at the Royal Free Hospital, where did you get that information from?
A I will have got that from her. I will have quizzed her as to how the diagnosis came about.
Q Can you tell us the thinking behind that further referral to Dr Baird from your point of view?
A I really wanted an expert to do a thorough assessment so that we knew exactly where we were, because I felt there was a lot of confusion because of Child 7’s mother’s inconsistent history-giving and I felt really that the only way to get a diagnosis was through a good look at the child as opposed to his mother, because my only contact obviously would be in the consulting-room setting where mum would always be present and I would have very limited amount of time with the child. I felt that it really needed a multidisciplinary approach that the Newcomen Centre would have used.
Q If we go on to January 1998 we see a further letter from Professor Walker-Smith and that is at page 240:
“Dear Dr N
…
I reviewed [Child 7] in the Outpatients’ Clinic. This child did have large lymph nodes but in fact did not have any evidence of colitis. He was tried for a time on Olsalazine but this was stopped as it appeared to cause diarrhoea. At the moment this child is passing one stool a day but plain x-ray of the abdomen also shows quite marked faecal loading. I have therefore commenced him on Lactulose 10 mls twice a day.”
Then there are concerns by the mother about excessive thirst and not passing a great deal of urine, and Professor Walker-Smith said that it might be important to check for sugar in his urine and he was arranging for that, and repeating the urine aminoacids. Then he says:
“I do not believe that [Child 7] should be followed further at the Royal Free Hospital as the main practical problem gastroenterologically is to try and help with his constipation. Lactulose in the first instance may be satisfactory but he may need more powerful medication. I would recommend again that it may be best that he may be seen on follow-up by a consultant paediatrician in XXX. I have not made another appointment to see the child again.”
What was your feeling about this, Doctor? First of all, did you regard the constipation as being a serious problem for this little boy?
A Yes, on the basis of X-rays showing marked faecal loading. It is quite a common problem in children with learning difficulties and one that can be managed locally. So that seemed quite reasonable.
Q Did you, as a result of this letter, think that any kind of inflammation or inflammatory bowel disease was any longer anything that should concern you?
A I do not really know the answer to that question because I do not know how … I mean, in a pragmatic sense, if the anti-inflammatory was helping then I would have been happy to continue with it, but if it was not – and I think I must have advised her anyway to stop it to see if the diarrhoea would stop, because that was a concern. So, whether it was a major factor I do not recall. The children were otherwise well.
Q There is a final follow-up letter which I should take you to at page 236, dated 5 August 1998:
“I reviewed [Child 7] again in outpatients. Six weeks ago he had a major episode of quite severe abdominal pain which I understand was severe enough to warrant him being referred to hospital for ? appendicitis. However the pain settled down. It is difficult to know just what this pain was due to but it may well have been related to his chronic constipation and with a kind of gut colic. Currently he is on no medication despite my recommendation that he should have Lactulose in fact he has not been taking this since then”,
and there is a suggestion that lactulose be given in a dose of 10 ml twice a day.
“If there are further episodes of constipation otherwise we will be reviewing him in the clinic in 6 months time.”
Did you in fact get a diagnosis from the centre at Guys’ Hospital? Can you turn to page 222 please? I am sorry, Doctor, this is a very long letter and I am not going to take you through it all because it sets out a lengthy history as to this child’s difficulties. If we can go straight to the conclusion on page 222:
“This assessment confirms that, although [7] has good cognitive abilities, he has serious difficulties with understanding social rules and with interaction and communication with other people. There is an associated lack of imaginative play and rigid and obsessional behaviour, with insistence on particular routines and dislike of change. As has been previously suggested, this pattern is that of an autistic disability. There are some aspects of [Child 7’s] behaviour which are rather different from that of most children with classical Autism or Asperger’s Syndrome, in particular he is more actively defiant and avoidant, and we concluded that, at present, his problems are best described as being due to a Pervasive Developmental Disorder in the Autistic Spectrum. In addition to his autistic difficulties, he also shows symptoms of Attention Deficit Hyperactivity Disorder, with excessive physical activity, lack of impulse control and inability to concentrate unless he is engaged in the repetitive activities that he enjoys.”
It then sets out the various things which will help him, having complex educational needs. Then, at the bottom of the page, a suggestion of new management strategies to bring about an improvement in behaviour:
“… his parents would be greatly helped by input form a clinical psychologist. There is also the possibility that [Child 7] might be helped by medication …”,
and the suggestion that they approach the GP for referral to the local Child and Adolescent Mental Health Service. Did that give you the degree of rigour that you were looking for in an assessment and some reassurance as to what was the matter with this child?
A Yes, that was very helpful.
THE CHAIRMAN: I am sorry to interrupt, Ms Smith, I am just wondering. Dr N has been in the witness chair for something like an hour and three-quarters and the Panel would probably also need a short break. Wherever you do find a natural place to pause, we would then have a comfort break.
MS SMITH: Yes, sir. I think that is actually quite a good spot. I am not going to be very much longer with Dr N, he will be pleased to hear, but I probably will be about five or ten minutes.
THE CHAIRMAN: Thank you very much. (To the witness) First of all, can I thank you, Doctor, and I know it has been a rather long time that you have been in that chair and I think you would now need a little break. Can I just remind you, you are under oath and in the middle of giving evidence. During this break someone from the Secretariat will look after you for a cup of coffee or tea, or whatever you need, but please do not discuss about this case with anyone during this break.
We will now adjourn and resume at twenty to twelve.
(The Panel adjourned for a short time)
THE CHAIRMAN: Yes, Ms Smith?
MS SMITH: Thank you, sir. (To the witness) Doctor, if I could just take you on to the next thing chronologically that I wanted to ask you about, which is in the GP records on page 215. This is 21 December 1998 and it seems to simply be a statement, “TO WHOM IT MAY CONCERN”, not addressed to anyone in particular.
“This is to confirm that [Child 7] is one of a number of children investigated at the Royal Free suffering from a newly identified syndrome comprising of chronic bowel inflammation and autism. The long term natural history of this condition is yet unknown but it is likely that the bowel disorder as well as the autism will require long term medical supervision.
It is notable that the novelty of this syndrome and the lack of understanding of the origins of developmental disorders in children has often led to conflict between parents and the medical profession and the various authorities”,
and it is dictated by Dr Wakefield and signed in his absence, as we see at the bottom. Can you help us at all as to how that came into Child 7’s GP records or who it was addressed to?
A No. I have filed it because I have written “file” on the side there, but I am not sure the purpose of the letter or why I had a copy.
Q Can you help us as to whether it would have been sent to you by the Royal Free or whether Mrs 7 would have given it to you?
A No, I do not know.
Q As far as Mrs 7’s beliefs were concerned, you have told us that she believed that the vaccine had played a part in both Child 6 and 7’s problems. Did that belief continue as far as you were aware?
A Yes.
MS SMITH: Could you just glance quickly at the local hospital records, please, at page 444?
THE CHAIRMAN: Would this be the Royal Alexandra Hospital?
MS SMITH: Yes. (To the witness) This is much earlier, in March 1996, and it is simply a nursing note on the evaluation sheet. We see on the right-hand side:
“Mum very anxious re [7’s] ‘jumpy L leg’”,
and then:
“Continues to be anxious re post effects of MMR vaccination.”
So this is back to very shortly before Child 7, and indeed Child 6, came to your surgery.
Does it accord with your understanding that those were the mother’s concerns right back to when she first came to see you?
A Yes.
Q When I say that those were her concerns, that the MMR vaccination had played some part in her child’s disabilities?
A Yes, she was convinced of that.
Q I think there were occasions when you spoke to the doctors at the Royal Free Hospital during this time; is that correct?
A Yes.
Q Did you gain any understanding of whether and, if so, what practical benefit there was to the children in the condition that they believed that they had seen?
A I believe my understanding at the time was that if the children had an inflammatory bowel condition, treating that might have some influence on their behaviour.
Q You have told us that you had concerns in relation to the mother’s suggestions of referrals and investigations of her children; did you continue to be concerned about that?
A Could you repeat the question, please.
Q You have told us that you had concerns about the mother wanting the children to be referred and investigated and you have told us why. Did those concerns continue during the time?
A Yes, they did.
Q Was there an occasion when there was meeting between you and Professor Murch in relation to that?
A There was.
Q Can you tell us the circumstances of that.
A This is from recall. I think that Professor Murch came down to XXX and we had a multidisciplinary meeting with the local consultants, health visitors I believe and myself to share our concerns and to see if we could be consistent between us as to how to manage the problem.
Q Did you become aware that Child 6 and Child 7 had had their results written up in a paper which was published in The Lancet?
A Yes, I did become aware of that.
Q How did you become aware of that?
A I think that the article was in the national news and I knew that the two children had both been seen there and she certainly spoke to me about it.
Q That is the mother?
A Yes.
Q I am sorry, are you saying that it was through the mother that you learned that these two particular children had been involved?
A It was through her that I learned that the two particular children were involved, yes.
Q Was she instrumental in the registration of other families to you with children with autism?
A Possibly. I am not aware of that. I have a lot of patients like that anyway.
Q I think ultimately she and the children left your practice when there was a move to XXX; is that correct?
A Yes, they moved out of the area.
Q I have asked you about the finance issues in relation to Child 6. Does the answer that you gave in relation to Child 6 also apply to Child 7?
A Yes.
Q Would you look at the Royal Free Hospital records on Child 7 at page 157. That is in fact a request for some neurological investigations in fact signed by Dr Wakefield during the admission of Child 7 and do you see the words “ECR” circled in the middle of the page?
A Yes.
Q Does that accord with your understanding that that admission would be paid for, I think you said, by the National Health Service?
A Yes.
MS SMITH: Thank you very much, doctor. If you would stay there, you will be asked some questions.
THE CHAIRMAN: Dr N, that was the examination-in-chief by Ms Smith. Now the three members of counsel have the opportunity to cross-examine if they wish to and Mr Miller is going to cross-examine you first on behalf of Dr Wakefield.
Cross-examined by MR MILLER
Q Good morning, Dr N. Cross-examining sounds rather fearsome because I am only going to ask you questions really arising out of your evidence and we may have to go a little further into the notes but only in correspondence to which you were a party, I am not going to take you to anything else in which you were not involved. You were the general practitioner for Child 6 and Child 7 from about May 1996 until the family moved away from the practice to XXX.
A Yes.
Q Again, I do not want to alarm you but you had personal experience of autism because your son was autistic.
A Is autistic.
Q Because of your experience, did that mean that parents with children with autism joined your practice because you had an understanding of what it might involve?
A Yes. They would not have known that I had a son with autism.
Q No, but you had a reputation in Sussex for being understanding and knowledgeable about autism?
A Yes.
Q As far as referrals are concerned, not only did you refer these two boys to the Royal Free but your son went there as well, did he not?
A He did later, yes.
Q I think some time in 1997?
A That is correct.
Q And also a number of children as well from your practice?
A Yes.
Q I think four or five others over a period of time?
A I cannot recall the exact numbers but, yes, that could be.
Q Dealing with your son, I am not going to ask you about the details but he went for investigation I think in 1997. As far as you were concerned, did that involve investigation by colonoscopy in his case?
A Yes.
Q I do not think that he had MRI but he had a number of investigations, did he not?
A Yes.
Q Was he treated with anti-inflammatories subsequent to those investigations?
A Yes.
Q And again, as far as the other children are concerned, just in general terms, some, if not all of them, also treatment as well from this unit at the Royal Free.
A Yes.
Q That is all I want to ask you about that aspect, so we can get on with these two children. Can we look at Child 6 first. The situation is that he came to you in May 1996 but it looks from the first note that appears in your handwriting that you reviewed the records when he joined the practice; would that be your practice?
A I would review the records when I received them which was several months after he had joined the practice.
Q You would have seen the letter that had been written by Dr Bennett who was a community paediatrician that she considered that he fell within the autistic spectrum and probably had Asperger’s syndrome.
A Yes.
Q I think that was as a result of a multidisciplinary investigation that took place in 1995.
A Yes.
Q As far as bowel problems are concerned, would you have looked at the general practice notes to see what the history of bowel problems would have been when you did your overview of the notes?
A Yes, I would have done but that would have been later on; I would not have had it at the first consultation.
Q If we look at the notes just in the general practice notes part of that bundle, this is for Child 6, at the beginning of the bundle, the early numbers, and at page 13 there is an early note from 1994,
“Miserable for 2 weeks. Screaming & complaining of abdominal pain for 5 minutes. Bowels open more frequently.”
Do you have that? It is right at the bottom of the page dated 19 May 1994.
A Yes, I have it.
Q Over the page on page 14, 14 July 1994, at the bottom of the page, it looks like,
“Some diarrhoea. One stool contained mucous and a little blood”
and then on the next page, page 15, “diarrhoea occasionally” against the date of 23 April 1994. This aspect, looking at the GP records generally, appears to have been referred to a Mr Allaway, a consultant paediatric surgeon, because, in that same bundle at page 74, there is a letter from Mr Allaway to a Dr Mills and was he your predecessor or in the predecessor practice …?
A The predecessor practice.
Q Referring to the fact that he had come into casualty in March 1995 and had been referred to Mr Allaway’s clinic but, in the week prior to the referral, he had abdominal pain, frequency of micturition and frequency of defecation which was driving Mrs 6 “round the bend”, that is what it says. To complete the picture, back in the GP records at page 25, there is a note against the date of 30 October 1995, “Abdominal pains” and then, at the bottom of page 28, “Soiling still. … Holds on to motions.” Do you see that?
A Yes.
Q Was that a pattern overall that you recognised when he became your patient?
A Yes.
Q That there were a number of troubling bowel symptom; they varied but they were nonetheless troubling and difficult to deal with.
A Yes.
Q There is then the note that you were asked to look at this morning on page 29 for 25 March 1996,
“Dr Wakefield – Royal Free. To discuss association [between] measles and autism and inflammatory bowel disease.
Discussed general concerns re family.
If we feel [it is] relevant can refer for [investigations] to Professor Walker at the Royal Free.”
That is not your writing, is it?
A No. This is before they were registered with me, is it not?
Q Yes. That was my next point. Clearly, some time before they joined you, there was some sort of discussion about a referral for investigations, if the practice felt it relevant but, to be clear, it is not your practice and it is certainly not you because we can see your writing on the next page. So, somebody had had a conversation with that in mind at a earlier stage before the child joined you. On page 31, the neat entry against the date of 13 May is your handwriting, is it not?
A Yes.
Q We will see that, if we need to, in the other notes that follow. I am not going to go through the note because Ms Smith did so earlier on but that is the sort of history with relevant features as they become relevant to this case, namely the Asperger’s syndrome diagnosed in December 1995 which you have looked at and the bowel problems and then setting out what you understood those to be.
A Yes.
Q At the bottom of that note, you have written, “Refer to Mike Tettenbaum”. I have not found whether that referral ever got to Dr Tettenbaum. If it did, I have not seen the document, but it may not matter because the next thing we seem to see in sequence is the referral to Dr Wakefield. Can you say whether or not there actually was a referral by you to Dr Tettenbaum.
A There was a referral at her request because she wanted to be referred out of area; he was an XXX paediatrician; so I sent him there.
Q At page 125 in that bundle, 9 August 1996, again a letter that we have seen which, on the face of it, although you cannot remember the circumstances, followed a discussion over the phone but it is a referral letter to Dr Wakefield.
“… [Child 6] is a little boy with autism syndrome who does also suffer from bowel disorder. His mother is interested in entering him into your trial and I would be grateful if you could see her for discussion.”
What you received back in response to that letter was the letter of 11 September from Professor Walker-Smith which is at page 124,
“I have been asked by Dr Wakefield to see [Child 6] as I am the Paediatric Gastroenterologist associated with Dr Wakefield in our study on autism and bowel disorder. I have taken the liberty of sending [Mr and Mrs 6] an appointment for [Child 6]. I would be grateful if you could explain the situation to them.”
The position is that, having spoken in advance to Dr Wakefield, you referred the patient to him but Professor Walker-Smith wrote back to clarify that in fact he was the clinician who was dealing with it and that is the route by which the child got to see Professor Walker-Smith.
A Yes.
Q And he wrote to you explaining that that was the position and asked if you would explain to the parents that they would be seeing Professor Walker-Smith.
A Yes, that is right.
Q That was followed after an outpatient clinic appointment, the appointment
to which you referred in that letter, in October 1996 by the letter from
Professor Walker-Smith of 4 October which is at page 123,
“Many thanks for referring this boy, he certainly fits into the spectrum of a child diagnosed as autistic who has bowel symptoms ...”
That is correct, is it not, as an observation?
A Yes.
MR MILLER:
“... as there is a history of recurrent abdominal pain and diarrhoea with passage of
blood and mucous over several years. I am arranging for him to come in to have a colonoscopy and entering our programme of investigation of children with autistic problems.”
THE CHAIRMAN: Can you answer yes or no? The problem is the shorthand writers are noting everything that is said and nodding the head is not going on the record.
A I am not clear there is a question to answer.
MR MILLER: It is my fault because if I want you to answer yes or no I shall ask you to answer if there is a question.
THE CHAIRMAN: There has been some nodding of the head.
MR MILLER: In order to set the scene as to what the letter says, I read it and reasonably enough the question comes after that.
A I am nodding in consulting style.
Q That is the sort of letter you expect from a clinician who is going to investigate what is wrong with this child.
A It is, yes.
Q You were presumably content with what Professor Walker-Smith was suggesting.
A Yes, I was.
Q I think you appreciated by then certainly at least that he was the clinician, or his department, were going to be looking after this child and investigating the child. I think you never thought that Dr Wakefield was going to be involved in anything other than research.
A My understanding was that Dr Wakefield was accountable to Professor Walker-Smith and that the paediatric department basically had care of the patient.
Q The letter that you sent to Dr Wakefield that we saw earlier was addressed to the paediatric department but, in fact, all the correspondence that came back from Professor Walker-Smith and his team was from the department of paediatric gastroenterology, was it not?
A Yes.
Q We can see as we go through, because I am going to ask you to look at some of those letters, that from the time he became involved all of the correspondence comes from the paediatric gastroenterology department.
A I think at the time, and following the letter of the 11 September, then I realised that Dr Wakefield was a scientist and not actually a clinician. I do not think I had known that before.
Q I think you learned, over a period of many years as it turned out although you would not have known it at the time, that you were going to have to be corresponding and speaking on occasions with a number of doctors all of whom were in the department of paediatric and gastroenterology. They were either consultant colleagues, for example Professor Murch, subsequently Dr Heuschkel I think, but also the junior doctors who wrote you discharge summaries and also corresponded about particular problems, were all within Professor Walker-Smith’s department.
A Yes, that was my understanding.
Q This appears to be the first contact with that department although, as you have said, it involved sending other children subsequently including this boy’s brother. This is the first time you are told what is in contemplation. Presumably, as a general practitioner, you felt that if there was any prospect of this department clarifying a diagnosis for this child, or if possible providing some form of treatment, then you would be happy for that to be dealt with.
A Yes.
Q If you turn to page 117 this is a letter dated the 2 December 1996 after Child 6 had been admitted and investigated. Just to make the point I was making a moment ago, if you look at the left-hand side in bold type it is the University of Paediatric Gastroenterology with the participants involved. Basically they all came from this department, did they not?
A Yes, they did.
Q In this letter, which we have looked at, Professor Walker Smith is apologising for the fact that he did not have the full discharge summary, explained the results of the investigations which had taken place during the admission as far as the gastroenterology side of things is concerned.
A Yes.
Q It starts of by saying what had been found on colonoscopy and what is the histology showed as a result of the biopsies being taken?
A That is right. It was an interesting letter from my perspective because clearly something had been found that was considered significant.
Q In summary, what he says, first of all, giving you the actual findings but then explains that they had found evidence of bowel inflammation and indeterminate colitis and that they had decided to begin treatment with olsalazine.
A Yes.
Q By the time this letter had been written it looked as though that treatment was having a beneficial effect.
A It did.
Q In the second paragraph it says in general he is making excellent progress on olsalazine, a beneficial effect on his abdominal pain and, if one looks at the last paragraph, on his behaviour as well so a combination. That is what was being reported at the time.
A Yes, it is.
Q We have seen in a later letter, jumping ahead - we do not need to turn it up - when you were corresponding about Child 7, his brother, you made the point, writing to another doctor, this child appeared to have done very well at the outset on Olsalazine.
A Yes, that is correct.
Q Mrs 6 told you that the prescription made a big difference to her child and she was thrilled with that?
A Yes, that is correct.
Q What happened, as far as he was concerned, was that you carried on with the prescription. You had been given advise by a professor of paediatric gastroenterology and a tertiary referral unit. Something that you would not have chosen to do yourself you were content to do on the advice of somebody who was a specialist in the field.
A Yes. In practical terms I could not expect her to go travelling up to the Royal Free every time she needed a prescription so I was happy to comply and it seemed to be helping.
Q That said, he, as we will see, did remain in the care of that department at the Royal Free because that letter December 1996 was the start of involvement on a clinical basis with this child because afterwards, as we will see, there were a large number of referrals and out-patient clinic visits where aspects of treatment were considered and discussed and reported to you?
A I guess so if it is in here.
Q We will go with. We did not go all the way through with Ms Smith before we stopped in 1998. Page 117, which we just looked at, is the first page after the in-patient visit and the treatment. Then 17 January, 116, is a letter from Professor Walker-Smith following an out-patient clinic visit. The clinic is the 15 January and this is the letter that follows it. Again, he is talking about the response to the drug.
“As you know, he made a good response to Olsalazine. However apparently over Christmas he had had some relapse of symptoms in terms of soiling and also behavioural. He may not have taken his Olsalazine consistently over this period. He
is now back on consistent intake of Olsalazine and his symptoms have rather improved.
On examination there was no evidence of faecal loading and I did not feel in any other investigation a change of treatment was warranted for the moment and I recommend that he continues. I have not made a further out-patient appointment.”
At that stage there is a treatment regime being proposed which Professor Walker-Smith says he should continue on. Although there was not an appointment made at that time, we can see that Professor Walker-Smith saw him again on the 16 April 1997. If you look two pages back to page 114, the letter is dated the 17 April, the clinic we can see on the top left is the 16th. “Pleased to see [Child 6] again in the paediatric inflammatory bowel disease clinic.” Then he is talking about what appeared to be a little bit of disappointment about the response to the treatment and then discusses or tells you things that he would like to do, in the second paragraph, and that he would like to review him again in the clinic in four months’ time.
A Yes.
Q Although initially the first letter we saw appeared to suggest that he would not be seeing him again or had not made an appointment, here is an appointment he has taken and there is another one in prospect as well. In the meantime you were making other referrals as well to other doctors not simply dealing with the bowel symptoms or bowel problems, you were dealing with other paediatricians in the area.
A I think so. Without referring to the letters I cannot be specific.
Q Again we went through them this morning. We saw the sequence but you had to look after the patient on the ground rather than simply seeing the clinic and you made other referrals as well to see others.
He went back to the Royal Free. If you look at page 371, this is in 1998 following an out-patient clinic appointment on the 12 January 1998 and he is reporting to you what he has seen in the clinic.
“I reviewed [Child 6] again in the Outpatients. He does continue on Olsalazine three times a day. Generally his parents feel that this has had a good effect on his behaviour and he is overall more calm although recently there may be some deterioration in his behaviour. At the moment his mother’s main concern is that he is incontinent and appears to have no control over his stools and this is obviously a burden for her.”
Then we get the evidence, quite generalised, of faecal loading with distension of the rectum.
“From a practical point of view the most difficult problem with his child is trying to
achieve control of his constipation. In an attempt to get the colon empty, I have recommended giving Senna, Picolax sachet as a single does as we used to clear his bowel for endoscopy.”
Then he gives advice about what else might be considered. He says, in the middle of the paragraph on the top of the next page:
“I do not believe that this should be done at the Royal Free as it is so far away. I understand that there have been problems with the XXX hospital and it might be
appropriate to be seen in XXX. However, I do think in fact that further follow-up should be done locally rather than here as basically we have nothing further to offer diagnostically.”
You think that was a reasonable position to take at that stage.
A Yes, that was a reasonable position to take.
Q That said, 1 April, 1998, there was a further clinic appointment which may not be in the general practice notes. Then, if you take it from me and if it is necessary we will deal with it, there was an admission to the Royal Free in May 1998 to deal with the chronic constipation that had developed. Do you remember that there was an admission to deal just with that particular problem?
A I do not recall, that, no.
Q If you look at page 365, dated 23 June 1998, it is from the lecturer of paediatric gastroenterology, still the same department.
“[Child 6] was admitted to our ward on the 5 May 1998 for further management of his constipation. His medication at the time of admission was Olsalazine. I note that his lactulose and senna had been stopped two weeks previously. It was initially
decided to start him on Klean-Prep however Mum during the first day of admission, declared that she had problems in arranging child care for her other son and decided to go home. If appropriate we will arrange a further admission date when it is possible for mum to arrange further child care.”
That is a contemplated admission for them to deal as an in-patient with the constipation, is it not?
A It is.
Q But difficulties about that practically. Then at page 362 this is a letter again from Dr Casson. This time it appears to be successful because he is writing to you on 6 August:
“[Child 6] was admitted to the ward at Royal Free Hospital on the 11 July 1998 for a Klean-Prep treatment to clear his constipation. This was administered successfully over the course of two days by which stage his bowel was effectively clear. He was
discharged to continue on his lactulose medication. He can be reviewed in clinic to assess his progress.”
I have read that, rightly or wrongly, as being an aborted attempt in May and a successful admission in July, is that fair?
A I think that is probably correct.
Q Ms Smith, when she asked you about these questions before, said that is the end of the Royal Free Hospital involvement at that stage but that is not right, is it, because he continued to be seen for several years thereafter on a regular basis, did he not?
A Yes, he did.
Q If you look at the letter starting with Professor Walker-Smith’s letter to you on 11 August 1998, page 363, looking at the bottom you may or may not know this but maybe he saw Professor Murch but there was a clinic appointment on 5 August 1998 and the doctor is reporting to you in that letter what had happened, first of all, at the time of his admission and then as to what ought to happen in the future, changing the approach to dealing with his problems. There is quite a thoughtful strategy as to how they are going to deal with the constipation problem.
A Yes.
Q Two thirds of the way down:
“The aim of the strategy is endeavouring to empty the rectum effectively by having a full rectum this is virtually anaesthetizing sensation in the rectum as accounting for
his ongoing symptoms. Otherwise he should continue on Olsalazine in a dose as before and we will review him again in six months time. I would be grateful if you could give some advice about fine tuning the care of his constipation as there may need to be further dose modifications of the Picolax or the lactulose as may be clinically indicated.”
That was a reasonable thing to say to the general practitioner, is it not?
A Yes, very reasonable.
Q Then on page 161, this is following a clinic appointment on the 22 January 1999 from Professor Walker-Smith to you reporting upon that.
“As you know [Child 6] is continuing on Olsalazine and Lactulose. He would not take the Picolax sachets that Dr Murch suggested on the last visit. His mother tells me his stools are rather hard.
On examination his abdomen feels quite soft and there was no gross faecal loading. I think it may be helpful to change his medication from Lactulose to paraffin …”,.
and he gives the dosages, and then this could be increased up to 10 ml.
“Olsalazine does seem to have some effect on this child although it has not been dramatic. At some point it would be sensible to consider Olsalazine withdraw.
I have made another appointment to see him again but Dr Wakefield will be in touch with the family in due course.”
Again, this, presumably, is the sort of assistance that you like to get from a referral unit, thought about what the treatment is and then suggestions to you as to how that treatment could be managed on the ground?
A Yes.
Q I think there was a further admission then quite shortly after that, in February 1999, because there is a discharge summary dated 26 March 1999 at page 151. This is from a different registrar, Dr Greenberg, dated 26 March 1999:
“[Child 6] was admitted on 18th February 1999 to Malcolm Ward for problems of severe constipation.
[Child 6] has not been able to take his Picolax at home. His Olsalazine was also stopped three weeks ago. His mother reports that since then his behaviour has slightly worsened with increased hyperactivity.
They attended the Royal Alexander Hospital for [and I think it should be] sick children and an abdominal x-ray there revealed a loaded colon. He was treated with Klean-Prep and liquid paraffin [to] good effect.
We have also instituted a trial eight week period of milk-free diet. This has been shown to improve constipation plus soya milk with added calcium or [and it may be] goats-milk to be used instead.
An abdominal x-ray repeated prior to discharge showed no evidence of constipation.
[Child 6] was discharged home on liquid paraffin …
He will be reviewed again in outpatients in three months time.”
So a slightly different problem. He was seen locally. He has come to the clinic and they have made another treatment suggestion and dietary suggestion as well, which presumably they believe might ameliorate his constipation problem. It was a considerable problem to manage, was it not?
A It was, yes.
Q Then page 144. This is a letter, again the same department, and 15 October is the clinic appointment, 21 October 1999 is the letter. It is from another of the registrar’s, Dr Kerkar, and we are on the same basic theme which they, in that department, are trying to crack or the problem they are trying to crack. In the last paragraph:
“He has been commenced on Omeprazole 20 mgs bd as an empirical treatment for gastro-oesophageal reflux. We have recommended that he increases liquid paraffin to 20 mls at night and be given Mg sulphate at the weekends. He will be reviewed here in clinic in three months time.”
So they are still trying to find a way through, are they not? This is the theme all the way through ---
A It is, yes.
Q … that he comes back, the problems are there, and they are giving thought as to how they can deal with him. Then it looks as though he was seen in January 2000 in the outpatient clinic on 14 January 2000, because the senior registrar I think writes to you on 25 January. That is at page 302. This is Dr Furman writing and I think this is the first time we have seen him, but he is a specialist registrar. Following the clinic:
“I saw [Child 6] today together with Dr Andy Wakefield. He recently was restarted on Olsalazine which seems to have improved his behaviour. He requires 15 mls of liquid paraffin twice a day still and sometimes this needs to be increased. He is now off Omeprazole and this does not seem to make too much difference. He continues to have the same epigastric pain however.
Although he is still constipated and in view of the fact that he can not tolerate Picolax, he should continue on the liquid paraffin which should be increased from time to time.
On discussion with Dr Wakefield, we have decided to give [Child 6] an open appointment and have not booked him for repeat follow-up at this point”,.
and by now we are in January 2000, so it is 18 months on, three-and-a-bit years after you first referred him. There was a different sort of problem, I think, which you have already dealt with in passing, that emerged in 2000, which was the headaches which concerned you. I will take you to the documents. If you look at page 318 there is a clinic appointment with Professor Walker-Smith on 15 September 2000 and following that clinic he writes on the 20th:
“I was concerned as you were by [Child 6’s] quite severe headache which seems to have been worsening over the past year and is currently associated with dizziness.
On examination I could detect no gross neurological signs, in particular his fundi was clear. I have, in view of the family history, of a sibling with autism and abnormal EEG, have arranged for an EEG to be performed. I am also asking my colleague in the Department of Paediatric Neurology, Dr Andrew Lloyd-Evans to review him.
I have made no plans to see him again in the clinic, but I will be looking forward to hearing Dr Lloyd-Evans opinion.”
I think you got in contact with Dr Lloyd-Evans yourself, did you not, to get an earlier appointment?
A I do not recall.
Q He was certainly seen by Dr Lloyd-Evans at the Royal Free about that?
A Is that a question?
Q Yes. You do not remember?
A I do not remember.
Q If you look at page 324, so there is not a loose end, this is a letter from you to Dr Lloyd-Evans, on 6 October 2000.
A Okay.
Q I have had the advantage of being able to read these. You are not expected to have total recall of all these. You say:
“I would be grateful if you could make the appointment to see [Child 6] sooner, if possible …”.
I can take it quite shortly after that. I think Professor Walker-Smith retired at this time and so did not see [Child 6] again after this, but he continued to be seen by members of the paediatric gastroenterology team, did he not? I think other doctors were involved, Dr Heuschkel, who became a consultant there. You are nodding your head?
A Yes.
Q So beyond the time of Professor Walker-Smith’s retirement he is still being seen there?
A Yes.
Q And you are still being given advice and help about how to treat him?
A Yes.
Q Going over that history – and I apologise for doing it at such length, but it goes over so many years – this unit seems to have been tireless really in trying to find the correct balance and the answer to what was going to make this child’s life a bit more comfortable. That is fair, is it not?
A I think that is very fair. I think at the time – we are going back a long time and autism was – there were very few services available and I think the parents were struggling to understand what was going on with their children. I certainly saw a lot of them and they found the help from seeing the paediatric gastroenterology department at the Royal Free really supportive and helpful and so it helped me in managing those children.
Q Can we turn to Child 7 which is not going to take as long. Could you put aside that bundle for the moment and could you just take up the general practice records for Child 7. The general practice history of this child before he joined your practice includes references which you were taken to this morning of fresh blood bleeds and constipation and the question over whether or not there was an anal fissure, I think, in 1995, and there is a note in October 1995 about diarrhoea. Perhaps we can just look at page 305, please. This is a letter of 19 March 1996 from Dr Bhermi, I think, who was in the predecessor practice, was he not? I think he is one of the general practitioners in practice.
A Yes, she.
Q She, I am sorry, and writing to Dr Trounce, the consultant paediatrician.
“[Child 7] has been passing fairly hard”,
and I think it should be “rabbit” rather than “rabid”,
“droppings with each motion. Although he does appear to have his motions open each day it is obviously fairly hard and he has occasionally had blood in his motions. He does appear to get abdominal pain prior to the bowel motion which is relieved once he has opened his bowels.”
So there are echoes of constipation problems which you said basically that the two boys had. There were similar features about both of their bowel problems.
A Yes, there were.
Q Dr Trounce recommended that he be given Senna and Lactulose and then you referred him, when you took over the care of this child, to Professor Walker-Smith on 5 December 1996, which his at page 282. (After a pause) Obviously, of course you had by then already referred his brother and you knew that Professor Walker-Smith or his department would be involved in any clinical investigations. That is why he goes straight to him.
A Yes, that is right.
Q In the letter:
“I would be grateful if you could see this boy who is a child whose brother you have recently investigated as part of your programme for colonoscopy for children with autistic problems. He himself probably does not have autism, although this is not certain at present but he does have convulsions which I believe may make him eligible for your study. He also suffers with bowel problems similar to his brother who is autistic.
I would be grateful if you could see him.”
Presumably, at the time you thought, well, his brother at that point had appeared to do well as a result of the investigations that he had had and if there was any prospect that they might be able to achieve some sort of result in terms of investigation and treatment with this boy, it was worth taking?
A Yes.
Q Obviously, you would have been aware at that stage that he probably was going to have a colonoscopy if he was considered suitable?
A Yes.
Q Professor Walker-Smith writes to you, saying that he is happy to see him, arranges an outpatient clinic appointment in response to the referral, and then he wrote to you again in January 1997, which is at page 279. This is after the outpatient appointment that he had had on 15 January:
“I was very interested to hear the history of this child in which there does seem to be a clear relationship between symptomatology and the MMR”,
and he explains what that is and the history that has been given to him by the mother. Half-way down that paragraph:
“From a gastrointestinal point of view from the age of 2 he has had intermittent episodes of passage of blood associated with constipation and diarrhoea with mucous. His mother says he has intermittent high fevers although I understand that he has had recurrent ear infections which have been treated with antibiotic. He also has some intermittent vomiting at night… There is no clear history of any particular food causing symptoms.
Particularly in view of the findings in his brother, I think it would be appropriate for this child to be investigated particularly by colonoscopy and I am arranging for him to be admitted on Sunday 26th January 1997 and he will be having other investigations as part of the protocol. We will let you know the results of these investigations in due course”,
and again, given the history up to that point, Child 6 having been dealt with and in the process of treatment, you were content with that response from this unit, were you not?
A Yes, I was.
Q On 17 April, at page 272, you received a letter which we looked at earlier. The clinical appointment was 16 April:
“I am sorry we have not yet had the discharge summary sent to you for [Child 7]. Basically though, he had lymphoid nodular hyperplasia but on this occasion no evidence of inflammation in the distal bowel. Nevertheless he continues to have symptoms, although these are chiefly behavioural. When I reviewed him in the clinic I thought it would be helpful to try a therapeutic trial of Olsalazine in the same dose as for his brother of 250 mg three times a day for four months and then to assess whether we need to continue.
As he had a somewhat low serum IgA, I am arranging for his immunogloblins to be repeated as well as his full blood count and T-cell subsets and liver function tests. I will be reviewing him a gain with his brother in 4 months time.”
I think it was a letter that we looked at earlier where you said it had worked for the brother. I see no reason against being treated in that way for this boy, I think at this time when it is being suggested that it might be a treatment that had worked because it had worked for the brother?
A Yes.
Q You were happy with that as a treatment strategy?
A Yes.
Q I think there is a discharge summary from Dr Casson, dated 19 May 1997, which is at page 267. This document again, which we have looked at, is a letter which was written to Dr Bennett, the consultant community paediatrician, with a copy to you.
A Yes.
Q Because Dr Bennett wants you to know what the results of the investigations had been at the Royal Free. That is right, is it not?
A That is right.
Q She had been involved, as we have seen, with the family, and had been advising on other aspects with the families, so she wanted to see what the result of the investigations were, and as a result he writes to her?
A Yes.
Q On your side, clearly the diagnosis of the developmental position or behavioural position was not clear, as you said, at this stage in June 1967, I think. It was not clear what, if any, diagnosis there had been about his behavioural problems?
A Does this pre-date my letter to Guys?
Q Yes.
A Yes, it does, so that is correct.
Q I think what you do, on 1 June 1997, I think – so just after this – you write to Gillian Baird at Guys.
A Yes, that is correct.
Q Because you wanted a proper work-up of that aspect of this child to see whether a working diagnosis could be obtained?
A Yes, that is correct.
Q Because she was recognised as being a specialist in that area. Had she in fact seen the brother, do you know?
A I do not think that she had, no.
Q Ms Smith took you to that long document where the conclusion is at page 222 – it took some time to get the report because the date of this is in September 1998 on page 216 – halfway down the last paragraph starting just a few words in,
“There are some aspects of [Child 7]’s behaviour which are rather different from that of most children with classic Autism or Asperger’s Syndrome, in particular he is more actively defiant and avoidant, and we concluded that, at present, his problems are best described as being due to a Pervasive Developmental Disorder in the Autistic Spectrum …”
At the time, was that quite a new classification?
A It was fairly new, yes.
Q But it did end up with something within the autistic spectrum in their hands anyway, that is what they believed to be the position.
A Yes.
Q As far as the bowel pathology was concerned, although there had not been a diagnosis of bowel inflammation, you were content that Child 7 should be prescribed olsalazine in the advice of a specialist consultant unit.
A Yes.
Q And particularly because certainly initially it had led to an improvement in his brother’s condition and you had been told by Mrs 6 and Mrs 7 that they had both benefited from it.
A Yes and it also seemed logical because there was the lymphoid hyperplasia; I did not know what that was but it sounded like an inflammatory process, so I presume that was the logic.
Q Invariable treatment – try to treat, if the findings were there, as you understand it, the thought process was, if they are there, then they may be susceptible to the treatment.
A Yes.
Q Even though there are no signs of active inflammation, nonetheless if they are there and can be treated, it may be that it will benefit the child.
A Yes.
Q That treatment continued. Throughout 1997, he was seen – and we are fairly close to the end – by Professor Walker-Smith on 16 July 1997 if you look at page 259. He was seen on the 9th but the letter is dated 10 July. Again, this is the result of an outpatient clinic appointment where he is telling you what his findings were in that clinic and, for what it is worth, that his mother was saying two thirds of the way down that letter that she believed that this has woken him up, i.e. the treatment that he had had.
A Yes.
Q On page 254, it looks as though you had telephoned Dr Casson, the lecturer – either you rang him or he rang you, though it is probably that you rang him, is it not?
A Probably.
Q He had received the X-ray performed on 23 August which had been done in Sussex rather than in London, so it looks as though he was provided with that and you had been in contact with him over the time. He then asked the radiologists in the Royal Free to look at it and they felt that there was no evidence of faecal loading, so it looks as though you were asking for help because of the emergence of significant problems with constipation.
A Yes, that is right.
Q He ends that letter by saying,
“If his diarrhoea persists, we will be happy to review him in our clinic.”
On 9 January 1998, he is seen I think by Professor Walker-Smith and, on the 12th, Dr Heuschkel, who was a locum consultant at the time, wrote to you at page 240 … I am sorry, it is in fact that Professor Walker-Smith sees him, if you look at pages 242 and 241. Again, although he is telling you what his findings were and what his position was as far as the treatment was concerned, he is suggesting that maybe it would be better if he is followed up in XXX, which you said would be reasonable given the geography but in fact he continued to be seen in the Royal Free, did he not?
A Yes, if that is supported by the letter.
Q There is no trick. If you look at page 236 from Professor Walker-Smith: clinic, 5 August, letter 11 August,
“I reviewed [him] in outpatients. … had a major episode of quite severe abdominal pain … enough to warrant him being referred … for ? appendicitis. However, the pain settled down. … Currently he is on no medication despite my recommendation last time that he should have lactulose in fact he has not been taking this since then.
… I have suggested that lactulose be used in a dose of 10 ml twice a day. If there are further episodes of constipation otherwise we will be reviewing him in the clinic in 6 months’ time.”
Page 155, clinic appointment on 27 January, letter dated 29 January,
“We saw [Child 7] again in the outpatient clinic because over Christmas there was an episode of abdominal pain, diarrhoea, mucous with some intermittent blood. This was rather reduced in severity and also the mother is concerned by a lemon-yellow colour of his skin. As you know, he is taking olsalazine and at present is not on any therapy for constipation. He is passing up to three stools a day which vary in consistency from hard to diarrhoea.”
The results of the examination,
“On examination I can see that he has a slightly lemon-yellow colour but I am interested to see that he does not have elevated bilirubin from your investigations. However, he does have some local reddening of the anus. It was also important to repeat particularly his CRP, liver function test and full blood count. Should these be abnormal, it may be helpful to do a repeat colonoscopy. Otherwise I would continue on his present medications for the time being.”
I think the position is that he went on, as has his brother, to be seen on a regular basis by the doctors in this department at the Royal Free for a number of years after this, as I say like his brother, and, when there was a problem about his symptoms or his management, they were always happy to try to help, were they not?
A Yes.
MR MILLER: Thank you, Dr N.
Cross-examined by MR HOPKINS
Q Dr N, as you know, I ask questions on behalf of Professor Murch. There is only one matter that I want to ask you about and that is in relation to Child 7 and it is a document that I do not think we have looked at yet in the GP bundle that you have open. Would you turn to page 260. We see there a letter dated 15 July 1997 that I think you wrote to Dr Gillian Baird; is that right?
A Yes, that is correct.
Q And you set out at the beginning of that letter problems in the family relationship with local services and, towards the bottom of the first paragraph, the debate as to whether or not Child 7 is on the autistic spectrum but you go on to say this,
“He is under Professor Walker-Smith for his digestive problems and certainly since he has started his olsalazine he is a markedly different child from my perspective as the doctor consulting in the surgery.”
Would it be fair to say that not only was the mother thinking at that time that this treatment recommended by the Royal Free was having some beneficial effect but you yourself had observed it as of July 1997?
A Yes, that is correct.
MR HOPKINS: Thank you.
THE CHAIRMAN: We will now adjourn for lunch but I would like to make a couple of announcements. First of all, for the purpose of the press, during Mr Miller’s cross-examination, Child 6’s name especially was divulged on quite a few occasions. I wish to remind you to make sure that the child’s anonymity is protected. Ms Smith, I believe that you wish to say something.
MS SMITH: I was only going to say that, as far as Dr N’s timing is concerned, I shall be about quarter of an hour with him in re-examination and then of course he has the Panel’s questions as well, so we should finish with him in the early part of the afternoon, that is finish with him in the nicest possible sense of the word!
THE CHAIRMAN: Thank you, Ms Smith. I am sure that what Dr N has just heard will reassure him that hopefully he is not going to be in that chair for very long. The situation now is that we will now adjourn. It is now 1.00 and we will resume at 2.00.
(To the witness) Dr N, I have to remind you once again that you are still under oath and I am sure that you will be looked after and be provided with a sandwich of some kind. Please, make sure that you do not discuss this case with anyone during this interval. We will now adjourn and resume at 2.00.
(Luncheon adjournment)
MR COONAN: I have no questions.
THE CHAIRMAN: Thank you, Mr Coonan. Dr N, Ms Smith will now re-examine and then the Panel members will ask questions if necessary and I will then introduce them to you.
Re-examined by MS SMITH
Q I have a couple of matters, one in relation to each of the children. You said when you were answering Mr Miller’s questions that your understanding originally was that Dr Wakefield was accountable, as you put it, to Professor Walker-Smith and that the paediatric department had the care of the patient. Then you said that, by the time you were writing your referral letter in September 1996 in relation to Child 6, you realised that Dr Wakefield was the scientist and Professor Walker-Smith was the clinician. I want to take you back to a couple of the questions that Mr Miller asked you to have a look at. Child 6 first of all, the GP records in relation to Child 6, page 161. This is after an outpatient appointment on Child 6; the outpatient clinic was in January 1999 and the letter in February 1999 and Mr Miller read out the part relating to the child’s treatment,
“… [he] is continuing on olsalazine and lactulose. He would not take the Picolax sachets …
On examination his abdomen feels quite soft and there is no gross faecal loading”
and then he refers to what would be another helpful medication.
“Olsalazine does seem to have some effect on this child although it has not been dramatic. At some point it would be sensible to consider olsalazine withdrawal.
I have made another appointment to see him again but Dr Wakefield will be in touch with the family in due course.”
Q Can you help us at all whether that occurred and to what it was in relation?
A No, I do not know.
Q Could we go on to the letter in relation to your referral to Dr Lloyd-Evens, the paediatric neurologist. On page 324 is your letter to Dr Lloyd-Evens and you say:
“I would be grateful if you could make the appointment to see [Child 6] sooner, if possible.... Clinically I think he is suffering from severe headaches with no organic cause but I spoke to Dr Wakefield who suggested I needed to consider diagnosis of sub-acute sclerosing panencephalitis in view of his other presence of measles vaccine virus in his gut. Apparently this has an insidious onset.
In view of the worsening symptoms of headache I would be grateful if you could see him.”
Is it correct that you had a conversation with Dr Wakefield in relation to a possible diagnosis?
A Yes.
Q You set out there the advice you have been given and the suggestion that had been made to you that you consider a sub-acute sclerosing panencephalitis.
A Yes, that is correct.
MS SMITH: Can we have a look at Child 7? If you could go to Child 7’s records, the discharge summary, which both Mr Miller and I referred to, page 272.
MR COONAN: Perhaps we can have the date of the letter on page 324.
MS SMITH: The 6 October 2000. The discharge summary for Child 7, page 272 of the GPs records, you will remember that was not a full discharge summary, just a letter written to you from Professor Walker-Smith - and no criticism of that - setting out that he had lymphoid nodular hyperplasia and continues to have symptoms although they are chiefly behavioural. He was reviewed in the clinic and olsalazine was given. In the last paragraph he says:
“As he had a somewhat low serum IgA, I am arranging for his immunoglobulins to be repeated as well as his full blood count and T-cell subsets and liver function tests.”
That was in April 1997, is that correct?
A Yes.
Q If you then go to the medical records for Child 6, at page 365, this is a letter Mr Miller referred you to. This is a letter to you in relation to Child 6, and the treatment being given in relation to Child 6, and it ends up “We also took this opportunity to take bloods from [Child 6’s ] brother”, that is 7 for measles serology.
A Yes.
Q Other than the obvious, that the bloods were taken for measles serology on the occasion when his brother was admitted to the ward, can you help us at all as to the reason for that?
A No, I do not know.
MR MILLER: The mere fact a letter was referred to does not mean this letter arises out of cross-examination.
MS SMITH: The letter was referred to in the context of Mr Miller, as I understood it, extracting from this witness the fact that the examinations carried out in relation to this child were clinical. I wanted to ask, arising out of the letter he referred to, whether the doctor could help us at all as to an apparent taking of a sample for measles serology which may or may not be clinical.
MR MILLER: He is asked to speculate as to the reason why something was done in the clinic in London.
MS SMITH: I expressly did not ask him to speculate. I expressly said can you, other than reading the letter, assist us at all in relation to that matter.
MR MILLER: The reason for going through this correspondence was to show there was a continuing investigation and treatment of this child throughout the whole of the period in the clinic with a number of different doctors. That was the purpose of leading this evidence. I did not invite any speculation as to what was done merely because this witness could tell us that his patient was being dealt with over a period of many years. I suggest that this question does not arise out of any issue I raised in cross-examination.
MS SMITH: That is exactly right. Mr Miller took this witness to this letter because he was, as he says, tracing through what he says was the clinical management, to use a neutral word, of this child. In the very letter to which he is apparently referring for that purpose there is a reference to bloods being taken from the other child for measles serology. In my submission Mr Miller cannot pick those pieces of the letter that he wants to refer a witness to.
I deliberately did not ask this doctor to speculate as to the reasons for that. I simply asked him whether he could assist at all in view of the fact he is the child’s GP and I have referred him to a previous discharge letter in relation to that child. I am perfectly entitled to refer to another part of a letter that Mr Miller is wanting to rely on in relation to the care of the child.
THE LEGAL ASSESSOR: In so far as Ms Smith is referring to a part of the letter not referred to and is raising a new issue, and I am not clear she is, but if she is and if Mr Miller feels he is prejudiced he could always be allowed to cross-examine on this issue if something new is opened up. My advice is it does not appear that is the case but if it is being said that is the case and it is something Mr Miller has not had an opportunity of dealing with you can allow him to ask further questions if an issue is opened up that he has not had an opportunity to deal with.
MR MILLER: My point is that I do not want to ask any questions about this because this is the receiver of this letter and it is the writer of the letter who is saying what he was going to do. I do not want to ask any questions but I want to say this line of questioning does not arise out of cross-examination. It is not cured by saying I can ask questions because he is still in the same position as being the GP who had no knowledge of what was going on as far as the assessment is concerned.
MS SMITH: I do not think I can add a great deal. Mr Miller has made it perfectly plain that the reason he wanted to refer to this letter is in explanation of his case that these children were seen by Professor Walker-Smith’s team for clinical reasons. In those circumstances it seems to me perfectly proper if that letter should be put to this doctor for that purpose I am entitled to put it as well for the purposes of asking this doctor whether he has any comment that he wishes to make about that aspect. The answer may well be that he does not. I do not know but I am not asking any more than Mr Miller is asking about a different paragraph in the same letter.
THE CHAIRMAN: In view of Mr Miller’s further comments, is there any change in the advice?
THE LEGAL ASSESSOR: My advice is that in so far as Mr Miller referred to this correspondence for the reasons Ms Smith has just given to show that the referrals were all clinical she is entitled to use the correspondence to rebut that suggestion if that is what she is seeking to do with this witness.
THE CHAIRMAN: We can proceed then Ms Smith.
MS SMITH: The question I asked you, and I deliberately tried to ask in exactly the same terms, other than the obvious, which is that it appears there were blood samples taken on that occasion for measles serology, can you help us at all as to that last sentence of the letter?
A No, it is just for information as far as I am concerned. I can only speculate as to the reasons.
Q Going to Child 7’s records, this is a letter dated 29 January 1999, page 155, following an out-patient’s clinic on the 27 January 1999, a letter to you in relation to child 7 referring to an episode over Christmas of abdominal pain, diarrhoea, mucous with some intermittent blood, reduced in severity, but the mother concerned about the child’s skin. Professor Walker-Smith said:
“On examination I can see that he has a slightly lemon-yellow colour but I am interested to see that he does not have elevated bilirubin from your investigations. However, he does have some local reddening of the anus. It was also important to repeat particularly his CRP, liver function test and full blood count. Should these be
abnormal, it may be helpful to do a repeat colonoscopy. Otherwise I would continue on his present medications for the time being.
Dr Wakefield will be in touch in due course with the family about these investigations.”
As far as that is concerned, can you assist us at all as to whether that was followed up by Dr Wakefield?
A I do not know unless it is in the correspondence.
MS SMITH: Thank you very much, I have no further questions but the Panel may have some.
THE CHAIRMAN: Mr Miller, the point was raised and you were given the further opportunity to cross-examine. I know the witness has not said very much on that aspect but nevertheless if you would wish to ask any more questions on that issue.
MR MILLER: Thank you for the invitation but I have no further questions.
THE CHAIRMAN: As I said earlier on and repeated later, 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: Prior to the family registering with your practice how long did you have an interest in the autism spectrum?
A I am just working it out - about two years.
Q Did you refer any patients to different hospitals for investigations?
A Only locally but yes.
Q When the two children, Child 6 and Child 7, were referred to the Royal Free, did you think that the investigations were normal compared to the ones that the local hospitals would carry out?
A Normal is a difficult question.
Q Were they the usual type of investigations?
A They were not the sort of investigations that would have been available locally. They were tertiary referral style investigations that might be expected of a teaching hospital. I had no experience of that before so it seemed normal to me in that sense.
Q When you were told that the hospital was carrying out a study of this condition what did you understand that to mean?
A My understanding is they were looking at possible causes or trying to identify some pathology that might explain the syndrome that these children had.
THE CHAIRMAN: Dr Moodley is the medical member.
DR MOODLEY: When you referred any of the children to the Royal Free and they were having investigations, I would like you to compare this to if you refer a patient locally. If a patient is going to have some what might be considered as invasive investigations would you expect to be kept informed of that in order to provide follow up?
A I would expect to be informed but it is not surprising when I am not in the NHS.
Q I am asking particularly in relation to the LP and subsequently what happened with the child. Would you have expected to be told by the Royal Free that an LP was going to be part of this investigation and that patient is coming back to you post-LP?
A Yes, I would because of the follow up. I would want to know that.
THE CHAIRMAN: When you read that article in The Lancet which you quite correctly quoted as attracting the international media’s attention, were you aware at that stage, first of all, that these two children, Child 6 and Child 7, were included in that paper before the mother came to see you?
A No, I was not.
Q Then you actually saw the mother of Child 6 and Child 7 and that was the time you realised that these two children were part of that Lancet paper.
A Yes, that is correct.
Q What was going through your mind at that stage? If you can think of what happened at that time, do tell us. If you think that it is too long ago and you cannot remember just say that you do not remember.
A I was interested and that was a fair proportion of my general practice work at the time. I was interested that there was a potential connection between what was happening with these children and their behaviour.
Q Did the mother of Child 6 and Child 7 give you any impression of any kind?
A With regard to the trial, no.
MS GOLDING: Child 7, on page 24 of the GP records, under 12.10.95 it says “due MMR”. Did anyone check whether that had been carried out at all?
A This was before this child was a patient of mine.
Q Should it be in the records whether the injection was given?
A It should be in the records, yes.
Q Did you, at any time, ask about when it was carried out?
A I think when I saw the child I asked mum and my recall is that I had written that it had been done but if it is not in here there is no proof of that.
THE CHAIRMAN: We have no more questions but the counsel might have.
MS SMITH: I have no questions.
MR COONAN: I have no questions.
MR MILLER: I have no questions.
Further cross-examined by MR HOPKINS
MR HOPKINS: I have just one question arising out of Ms Golding’s question. Could you go to page 296, please, in the GP records?
THE CHAIRMAN: Is this Child 7?
MR HOPKINS: Yes, Child 7. This is a document that has a title, “Introductory Group Playroom Report”. It relates to Child 7 and identifies you as the GP at that point. If we turn on a few pages we see the author of this document, XXX, who is a teacher at XXX. Going back to page 296, we see the first paragraph sets out a background history. If you go about 10 or 11 lines down, we see a reference to Child 7 having had bowel problems, constipation and bleeding, and then it says that he had his MMR in November 1995 and appears to be quieter since then.
A Yes.
Q That would fit with your understanding, would it, of what happened?
A Yes.
THE CHAIRMAN: Thank you, doctor. You will be relieved to know that you are now released, and can I thank you once again on behalf of the Panel for coming and helping us from the witness chair?
(The witness withdrew)
MS SMITH: Sir, we are going to call Dr Letham next and Mr Thomas will examine him. This is Child 5.
BRUCE BAIRD LETHAM, Sworn
Examined by MR THOMAS
(Following introductions by the Chairman)
Q Good afternoon, Dr Letham, could I ask you to give us your full name and professional address, please?
A It is Bruce Baird Letham, Eastfield House, 6 St John’s Road, Newbury, Berkshire.
Q Could you lean as close to the microphone as you feel comfortable so we can all hear you. You were a GP at that practice. Is that correct?
A Yes.
Q You are being asked to give evidence in respect of one particular patient at your practice, and we are going to refer to that patient by a number. Could you look at the laminated card in front of you, which contains the anonymised key that we are using and confirm that the patient who was registered at your practice is Child 5.
A Yes.
Q It is right, is it not, that Child 5 was not a patient of yours. Is that right?
A Yes, it was a patient of one of my partners.
Q Who in fact was Child 5 registered as a patient with?
A It was Dr Shillam.
Q Do you have a bundle of GP records there for Child 5?
A Yes.
Q Could I ask you to look in the bundle of GP records at page 106? This is a manuscript note. Who wrote that note?
A I wrote the note.
Q The note is dated 30 September 1996 and it has, at the top left hand side, “Geoff”, is that a reference to Dr Shillam?
A Yes.
Q Then it says,
“Re [Child 5], Dr Wakefield, consultant gastroenterologist Royal Free rang and gave a v. lengthy and convincing case for [Child 5] to be referred to Professor John Walker Smith”,
then giving the contact details at the Royal Free Hospital,
“as they have findings suggesting that there is an association between inflammatory bowel disease/enteritis causing a failure to absorb B12, which is needed to myelinate till age 10”.
Then there is an arrow pointing towards,
“neurological problems/autism. (Measles vaccine may be implicated but that is being researched and uncertain of implications). Anyway – see fax – parents are keen. Will you refer – presumably is extra contractual”.
What does this note record?
A It records a telephone conversation, that Dr Wakefield rang the practice wanting to speak to Child 5’s general practitioner but he was not available so I was on call so I spoke to Dr Wakefield.
THE CHAIRMAN: Could I ask you to speak just a little bit louder, Dr Letham. There are a lot of people trying to make a note of what you are saying, so if you could speak just a little louder, please.
A Do you want me to repeat that?
MR THOMAS: That would be easier, thank you very much.
A It is a record of a conversation. Dr Wakefield rang the surgery wishing to speak to Child 5’s general practitioner, Dr Shillam, but he was not available that day so I spoke to Dr Wakefield as I was the doctor on duty that day.
Q Why did Dr Wakefield want to speak to Child 5’s general practitioner?
A My understanding, my recollection from reading this is that he wanted Child 5, or was suggesting that Child 5 be referred to Professor Walker-Smith.
Q Did he give any indication as to why that was the suggested course?
A I can only refer to my note that I wrote at the time, that they had this suggestion that there was an association between inflammatory bowel disease/enteritis, B12, possibly causing neurological problems. I understand that Child 5 had autism.
Q From your note it says,
“Dr Wakefield, consultant gastroenterologist”,
so it seems to be the case that you understood what Dr Wakefield’s status was.
A Yes.
Q Did you know Dr Wakefield before this telephone conversation?
A No.
Q Is it likely that that information came from him?
A Yes.
Q Did you regard this type of approach from a consultant telephoning a GP as normal practice?
A It was unusual practice for a consultant who I do not know about to ring me as a GP.
Q The note also says, in the last paragraph, “see fax”. Can you remember what the fax was?
A I am sorry, I have no recollection what that was at all. I understand it was not filed in the notes so I really do not have any recollection of it.
Q Is it that you do not have any recollection of its contents or you do not have any recollection of whether indeed there was a fax?
A I do not recall there being a fax. I wrote that there was a fax so I presumably gave it to my partner, Dr Shillam, with this, but unfortunately I have got no memory of that at all.
Q Did you have any further contact with Dr Wakefield after this telephone conversation?
A No.
MR THOMAS: Thank you very much. Those are all my questions. If you wait there, there will be more.
THE LEGAL ASSESSOR: I just want to check something with the shorthandwriter before you cross-examine. (Pause while the Legal Assessor conferred with the shorthandwriter) I was right. When the doctor repeated his answer, when Mr Thomas asked him to repeat it, it was not quite the same as what he said which was not heard by everybody. I wonder if she could read that out, please, before cross-examination takes place.
THE SHORTHANDWRITER: “It records a telephone conversation, that Dr Wakefield rang the practice wanting to speak to Child 5’s general practitioner but he was not available so I was on call so I spoke to Dr Wakefield”.
THE CHAIRMAN: Perhaps you could read out the repeated answer, so it is quite clear to everybody.
THE SHORTHANDWRITER: “It is a record of a conversation. Dr Wakefield rang the surgery wishing to speak to Child 5’s general practitioner, Dr Shillam, but he was not available that day so I spoke to Dr Wakefield as I was the doctor on duty that day”.
THE CHAIRMAN: I hope that is all quite clear now.
Cross-examined by MR COONAN
Q Dr Letham, I want to ask you some questions on behalf of Dr Wakefield whom you spoke to on that day. Just before I ask those questions, it might help if you pull the microphone a little closer to you. Your voice is very soft and it is a very large room. I hope you forgive me for mentioning that. Dr Letham,
you wrote this note now some 11 years ago.
A Yes.
Q It is a long time ago, is it not?
A It is.
Q It is obviously not a verbatim account of the conversation you had with Dr Wakefield.
A No, it is a summary for my partners, for the benefit of my partner.
Q Did you know anything about Child 5 at that stage?
A No. I had seen Child 5 on occasions but when I was speaking, as far as I remember, when speaking to Dr Wakefield I did not know anything significant of the case.
Q Can I just ask you now, 11 years or almost 11 years down the line, do you have any independent recollection of that telephone conversation with Dr Wakefield?
A No.
Q Can I suggest to you that it would be surprising if you did. So essentially what you are doing is this, is it? By looking at this document you are reconstructing from it what Dr Wakefield said to you or at least part of what he said to you. Is that fair?
A Yes.
Q Because when one reads the expression, “A lengthy and convincing case for referral”, that might suggest to somebody reading this 11 years down the line, that Dr Wakefield was actually asking for this patient to be referred.
A It could do, yes.
Q It could do, and that is why I want to explore that with you, to see whether or not I might be able to jog your memory about this telephone call. Do you remember Dr Wakefield saying to you that Child 5’s parents had discussed this case with him?
A I have no recollection of that. I have written that the parents are keen, but I have no recollection on what basis that was.
Q So it must have been, must it not, that you got from Dr Wakefield that the parents were keen for a referral to the Royal Free?
A Yes, I would assume so. Certainly I had no contact with the parents so that information must have come from Dr Wakefield.
Q Absolutely. There appears to have been a fax. Do you remember if the fax was from the parents or from Dr Wakefield?
A I really have got no recollection of this fax unfortunately. I would be guessing. So I really unfortunately do not remember.
Q I do not want you to guess, obviously, but we do not have the fax. Obviously, if the fax had been from Dr Wakefield, it might well have set out in a verbatim style the nature of this conversation, might it not, as a precursor to it?
A Yes, but I really have no recollection.
Q But your recollection is that you handed that fax, did you, or leave it out for Dr Shillam?
A I assume that I put it with this note and put it in Dr Shillam’s room or his tray where we pass messages.
Q Do you remember, can I just attempt this exercise – I know it is 11 years ago – do you remember Dr Wakefield telling you the information had been gleaned by the Royal Free clinical team, gleaned from previous patients? Do you remember him saying that to you?
A I am afraid not, no. My memory obviously is not that great of this telephone conversation, as you say, 11 years ago.
Q When you write down something like “a very lengthy and convincing case”, that may have been how it appeared to you, do you follow, at the time?
A Yes.
Q One has got to make allowances, do you agree, for the fact that Dr Wakefield was or may have been giving you at that stage a description of the background to what was going on at the Royal Free and that Child 5’s symptoms appeared to be similar to that of other patients who had been seen at the Royal Free. Do you follow?
A I do follow, yes.
Q On that basis again I have to suggest this to you, that Dr Wakefield was saying, in effect, hoping you would pass this on to Dr Shillam, that Child 5 fitted the general symptomatology of other patients and that, therefore, if Dr Shillam wanted to refer, he would and should refer to Professor Walker-Smith?
A It may well be, but unfortunately I do not have the recollection of him saying that.
Q I suspect that I am not going to be able to improve in jogging your memory, but I wanted to put these matters to you to see whether I might, because Dr Wakefield himself has got to deal with matters himself from 11 years ago. Do you follow?
A I do. I understand, yes.
MR COONAN: Yes, thank you very much.
THE CHAIRMAN: Mr Miller, Mr Hopkins?
MR MILLER: I have no cross-examination.
MR HOPKINS: No, thank you, sir.
THE CHAIRMAN: Mr Thomas?
Re-examined by MR THOMAS
Q Just a few matters, Dr Letham. On the basis of this note that you wrote, is it the case that Dr Wakefield mentioned Child 5 by name during the course of this conversation?
A Yes.
MR THOMAS: So are we to understand correctly that it was not a general inquiry that Dr Wakefield was making?
MR COONAN: That is leading.
MR THOMAS: (To the witness) Was it a general inquiry that Dr Wakefield was making or was it a particular inquiry in relation to one patient?
A On the basis of my note it was certainly particular reference to Child 5.
Q You were asked by Mr Coonan about what happened to the fax that is referred to in the note. Do you have any independent recollection of seeing the fax?
A No. My only knowledge of the fax is – my only knowledge now of the fax is what is on this note.
MR THOMAS: Thank you very much.
Questioned by THE PANEL
MS GOLDING: Good afternoon, Doctor. On page 106 you say:
“… gave a v. lengthy and convincing case …”.
What is lengthy in terms of this and what do you mean by “convincing”, if you can remember?
A Lengthy, again it is an estimation. I suspect it is a term, probably because
I was busy on call and so lengthy can be anything more than five minutes. “Convincing” means that he was making … I wrote that and when I write that it tends to be a good case for the suggestion.
Q Then at the bottom it says “Parents are keen.” How would you have known that?
A I can only assume that this came from the conversation with Dr Wakefield, because I have no record of speaking to the parents.
THE CHAIRMAN: Dr Letham, I think it is on the same line. Can I just ask you that question on a similar line to Ms Golding. Is it possible that the events we are talking about actually happened in September 1996? 30 September 1996?
A Is it ---?
Q That is the date on this letter.
A That is the date on it, yes.
Q “Lengthy”, what it might mean today might have actually meant something different in 1996, and the reason I am asking you this question is I am a GP, like yourself, and I know that in 1996 not many GPs were giving ten-minute appointments to the patients. We are now giving ten-minute appointments to the patients. That is reasonable. In 1996 a ten-minute appointment would have been considered a long or a lengthy appointment.
A Yes.
Q So I am just asking your views on this issue.
A Yes. I mean, I think “lengthy” could mean anything more than five minutes when you are busy.
THE CHAIRMAN: I do not think I can take you any further on that. Thank you. Are there any questions? (No further Panel questions) Mr Thomas, are there any questions on the basis of the questions that have been asked by the Panel?
MR THOMAS: Nothing, no.
THE CHAIRMAN: Mr Coonan?
MR COONAN: No, thank you, sir.
THE CHAIRMAN: Mr Miller and Mr Hopkins?
MR MILLER: No, sir.
MR HOPKINS: No, sir.
THE CHAIRMAN: Dr Letham, you will be pleased to know that you are now released and thank you again for coming this afternoon.
THE WITNESS: Thank you.
(The witness withdrew)
THE CHAIRMAN: Could you just give us five minutes, I think? We have had some water spilled and let us get that cleared up. (After a pause) I am just thinking, the Legal Assessor has just reminded me that while we are doing this we might as well use this time as an afternoon break. We will resume at quarter past three.
MR THOMAS: Thank you.
(The Panel adjourned for a short time)
THE CHAIRMAN: Mr Thomas?
MR THOMAS: Thank you. The next witness is Dr Tapsfield. This witness relates to Child 4, so could the Panel could dig out the GP records and the Royal Free records for Child 4?
WILLIAM TAPSFIELD, Affirmed
Examined by MR THOMAS
(Following introductions by the Chairman)
Q Could you state your full name, please, and professional address?
A I am Dr William Tapsfield. I work at the Collingwood Surgery in North Shields.
Q If you look in front of you there is a laminated sheet of paper which contains an anonymisation key. The names of the patients are down in one column and we are referring to those patients by number. Can you confirm that the child in respect of whom you are being asked to give evidence and who is registered at the Collingwood Surgery is Child 4?
A Yes.
Q Is it right that Child 4 was registered at that surgery from his birth in 1987 until 1999?
A Yes.
Q During that period, what involvement did you have in his care?
A I was his GP. We were a group practice so the child could consult any of the GPs in the practice, but I think probably I was more involved than most of the other doctors.
Q Have you had an opportunity to review again Child 4’s GP records?
A I have reviewed most of them, yes. I do not think I have had them in their entirety.
Q Because of the system that was in operation at the practice where patients were not strictly registered with one practitioner only, is it right that from time to time other partners in the practice would have had involvement in Child 4’s care?
A Yes.
Q I am going to take you, Dr Tapsfield, through a number of the GP records which relate to Child 4’s developmental history and also notes which relate to his gastrointestinal history. To begin with, could I ask you to turn in the bundle of GP records, which should be to your right, to page 271.
A (After a pause) Yes.
Q This is a letter from Dr Shabde, a paediatric registrar, to a Dr Sendall. Could you tell us, was Dr Sendall then Child 4’s GP?
A As I say, it was a group practice. The letters would go to whichever GP the hospital records happened to have recorded . It would not necessarily be the named GP.
Q That letter records that:
“[Child 4] is nine months old and appears to be growing and developing normally. As you may recall, the main worry initially was his small head which in fact is growing quite nicely between the 50th and 75th percentile. His general growth appears to be satisfactory with his weight just below the 50th centile. His mother is quite pleased with his progress and is no longer unduly worried.”
Then can I ask you to turn, in relation to his early gastrointestinal notes, to page 23.
A (After a pause) Yes.
Q Just to the entry for the date 7 March 1988.
A Yes.
Q Does that say:
“Diarrhoea for 2/12 [two weeks]. Better for 2 days in the middle. 0 [no] sickness.”
A Yes.
Q Then it says, is this right:
“Approximately 3-4/ day [times a day] semi formed.”
A Yes.
Q Then:
“Eating & drinking well & cheerful. O/w [otherwise] N AB [nothing abnormal].”
A Yes.
Q Next, in relation to Child 4’s vaccination, can I ask you to turn to page 139? (After a pause) Does this page record the immunisation status of Child 4?
A It does, that is correct. I have to say before coming down I did review the computer records in the surgery and the computer records suggested that in March 1988 Child 4 had had an MMR vaccination. I do not know which record is actually correct.
THE CHAIRMAN: I am sorry, did you say in March 1991?
A The computer records – no, in March 1988 the computer records recorded it as MMR, not as measles, and I have not had the opportunity to clarify. We no longer have any other records.
MR THOMAS: Doctor, would it be possible to obtain a printout of that computerised record?
A Yes.
Q I think arrangements will be made after you have given your evidence for a printout to be made available. As far as this paper record is concerned, this is a record from the Health Visiting Service and it records, on 28 April 1988, on the left-hand side, just above the words written in, “MMR”, it has “Measles 28.4.88”?
A Yes
Q Can I ask you to now to turn on to page 269, to a letter written almost a month later?
A Yes.
Q Do you have that? That is a letter from a Dr Steel, again to Dr Sendall.
A Yes.
Q It is dated 19 May 1988. It records a clinic and initial worries about this child’s head and appearance, and says:
“However he seems to have done well.
Mum says he has been a little wingey for the last few days with a cold but her main worry is the fact that he seems to be getting recurrent diarrhoea. He has loose brown motions four times a day for a couple of weeks, this then clears up and recurs again.”
Then it goes on to detail other developmental factors, and then the concluding paragraph:
“I have taken the liberty of suggesting to mum that she should try cutting out vegetables from his diet for a couple of weeks to see if this makes any difference to his diarrhoea and since I feel we should see him once more regarding his development I have suggested that if this does not work and he is still having diarrhoea, that she brings in a stool for reducing substances when I see her again in two months time.”
Can I now ask you to turn to page 266?
A Yes.
Q This is a letter from a Clinical Medical Officer named Jackson to the health visitor and it says:
“Thank you for referring [Child 4],who presents with development delay. His mother is recently aware of this.”
So it seems that over the course of 1988 there had been a concern about developmental delay.
A Yes.
Q Just before I take you on, Dr Tapsfield, and on the question of the different immunisations that Child 4 has undergone, could I ask you to look at page 150?
A (After a pause) Yes
Q This appears to be a document which was signed by you on 9 September. Is it 1995 or 1988?
A I would suspect that was 1995 but I could not be certain from the copy I have.
Q Again, if you look at the vaccinations column, after the first triple vaccine it says:
“Measles 28.4.88 XXX”,
and then it gives a batch number.
A Yes.
Q Does that assist in your evidence as to whether or not this vaccination was a measles vaccination or an MMR vaccination?
A I suspect that under the circumstances our computer records are inaccurate. This was an early stage of us using computerised records and I would think that the health visiting records are much more likely to have been the accurate contemporaneous records and the computer one was probably put in later. So I would, looking at this data as well, think the accurate one was the measles in 1988 and the MMR in 1991.
Q Can I now take you back to the GP notes at page 21 and this time moving into the middle of 1989. There are a number of notes here. The 19 June 1989, the second one down on page 21, does that say,
“Mild diarrhoea and vomiting [six days] ? now settling. [No] dehydration”?
A Yes.
Q Then we have a week later, 26 June,
“Still vomiting 1-2 [times] a day mainly at night. Intermittent diarrhoea [times]
2-3. Appetite poor”.
A Yes.
THE CHAIRMAN: Mr Thomas, would you take it a little more slowly because the pagination is not clear on our bundle papers and we are having to count to get to the right page.
MR THOMAS: Do the Panel members now all have the three entries that I am looking at? The three entries: 19 June 1989, 26 June 1989 and I am just about to go on to the last one which is 29 June 1989 which records halfway down the page, “Much better” and then does that say, “Not being sick”?
A That is correct.
Q And then “slight diarrhoea”?
A Yes.
Q Moving on into 1990, I ask that you turn back two pages to page 18 and this is a page that begins with an entry on 13 July 1990. On either 20 or 29 September 1990, there is an entry which says, “diarrhoea and occasional vomiting persists”.
A That is correct. That is not my entry but that is correct.
Q That is not your writing?
A No.
Q We know, having looked at the immunisation record on page 139, that just over six months later or in February 1991, Child 4 had his MMR vaccination.
A Yes.
Q I ask you now to turn to page 240. This is a letter from Dr Shabde, the consultant paediatrician from whom we have already seen some correspondence relating to Child 4’s development and this appears to be a referral to Dr Gibson, another consultant paediatrician in the child development centre.
A Yes.
Q Looking at this letter,
“I would be grateful of your assessment of this interesting little lad with developmental delay. He was born at …”
and it then gives details of his birth.
“His developmental milestones were normal according to mother, until he was 18 months of age. He crawled at 14 months of age and was walking by 18 months. He was said to be saying at least 6 words by 18 months but she felt that his comprehension was normal. She also mentioned that at 10 months of age he was able to build a tower of 3 to 4 bricks, but now he is lost as to what to do with them.
The past history revealed that he has had recurrent ear infections and was seen by Mr Meikle/Dr Cresswell at Freeman Hospital and had grommets inserted …”
Turning over the page to the top of the next page,
“[Child 4] has also been investigated by Dr Houslby at Rake Lane because of blanking episodes lasting for a few seconds. The EEG done on 13.10.90 was unremarkable and it was reported to be within the normal range for a child of his age.
[Child 4] has been followed up by the Special Needs Team and there was a regular input from the pre-school teacher … Mother was extremely concerned that [Child 4]’s development is regressing although it is sometimes difficult to find evidence of regression of skills. A delayed development was acknowledged by the health visitor at 1 year of age but at this stage [Mrs 4] did not accept that [Child 4] was slow. I was concerned that we may be missing a syndrome, particularly in view of his odd looking head, and I would be grateful if you could arrange to see him in a Joint Clinic with Dr John Burn.”
Do you happen to know what specialty Dr Burn was?
A He is a geneticist.
Q Then it goes on to say,
“[Child 4] is a well nourished little boy with blond hair and has very little interaction. He appears to be in a world of his own. He often gets very distressed and agitated, flapping his arms. The clinical examination is otherwise unremarkable …”
This letter appears to record a number of referrals to a number of different consultants in different specialisms at or around this time in relation to his developmental problems.
A Yes.
Q I want to take you to the records which flesh out a bit more what that letter summarises. First of all, in relation to his hearing, I take you to page 264. Again, this may be a letter which has black at the bottom of it. It is a letter dated 22 December 1988 from Dr Jackson to Mr Meikle who is a consultant ENT surgeon and is that the referral to which that previous letter related?
A Yes.
Q If you look back a few pages to page 258, you will see that there was a reply to Dr Jackson from Dr Cresswell who is the associate specialist.
A Yes.
Q He says,
“Further to my last letter [Child 4] was reviewed in clinic. He continues to have bilateral effusions and in fact gave us very poor responses on distraction testing as he was very restless. We did however have definite responses at [various frequencies].
[Child 4] still is unable to follow the simplest of commands and did not appear to have made any progress whatsoever in the past few months in general terms. He has definite moments in clinic when he seems even less aware of what was going on than usual. All in all I think his general behaviour seems increasingly abnormal.”
Then, in the last paragraph,
“In view of the history mum gave you of some language development which then was lost (although she did not give me this history on the first occasion I saw her) I wonder if [Child 4] does require perhaps further paediatric investigation to consider perhaps some form of epilepsy. Can I leave this in your hands.”
We also saw reference in the first letter to which I took you to a Dr Houslby and I ask that you now look at page 248. This is a letter from the ENT doctors to Dr Houslby. Is it right that this issue was addressed at consultant level rather than from GPs asking for referrals to each of these consultants?
A Yes.
Q Dr Cresswell writes,
“I think you have seen this child in the past who now attends” a particular school. “He has problems of general delay with a very fleeting attention span. There has been some question always in mum’s story of regression of his ability.
We have been seeing him because he has had recurrent glue ear and in fact he does need reinsertion of grommets. [Mrs 4] continues to be convinced that [Child 4]’s problems are all due to the fact that he is ‘deaf’ and has not been able to accept his normal brain stem evoked responses on 9.6.89. In view of this we are in fact going to repeat this test when he has his general anaesthetic.”
The next referral that I would like to take you to is at page 217. This is a letter dated 17 December 1992 and, if you look at page 219, it looks like you were copied in on this letter.
A Yes.
Q It comes from a Dr O’Brien, a consultant psychiatrist, and, by that stage, is it right that there had been a request for an assessment to be made by him coming from Dr Shadbe?
A Yes.
Q What he says in the first paragraph on page 217 is,
“My colleague and I … have now completed our assessment of [Child 4]. As I indicated before, the most important question as I see it is one concerning the prominence of his autistic symptomatology. At risk of seeming pedantic, I would like to briefly consider the principle components of autism, and the extent to which they apply to [Child 4] separately and together.”
Stopping there, was this, as far as you are aware, doctor, the first formal assessment of whether or not Child 4 fell within the autistic spectrum?
A Yes.
Q Various elements are then gone through in the letter and I certainly do not propose to read all of them out but the first paragraph says,
“First of all, there is the issue of the age of onset. Usually, but not invariably, there is some sign of impaired development before the age of 3 years in autism. Now, in [Child 4], there is certainly evidence of some impaired development in these early years. We do seem to have evidence that at certain points in his development he has been more promising, but clearly at this early age he did show global signs of impaired development.”
Then he goes through the three cardinal features of autism and goes through those in detail. The concluding section starts on the next page, page 218 halfway down the page,
“It is clear therefore that [Child 4] has problems of the autistic type to such an extent that some people would indeed definitely make a diagnosis of autism.
(I refer to the fact that there is a divergence of opinion regarding autism’s status – some see it as a kind of ‘all or none’ phenomenon, others as a condition which does occur, while having greater or lesser degrees of severity.) It would be equally appropriate to use a phrase like ‘prominent autistic tendencies’ to describe his state. The overriding importance is that this is taken on board in his development and particularly his education.”
At the foot of the page, he records a discussion with a dietician. He says,
“In short, the current stage of play is that there are attempts being made to see whether any diet manipulation may be of benefit to [Child 4]. Personally, I am happy to go along with this, as there is evidence that this does occur in some cases.”
Lastly, in relation to the reference to a geneticist’s involvement, would you look at page 213. This is a letter from Dr Oley, a consultant clinical geneticist, and it is to you. It is dated 19 January 1993. Did you seek this referral?
A I suspect that this referral was made as part of the continuing consultant to consultant re-referral. I have no recollection of making this referral and I have not seen a letter suggesting I initiated a referral.
Q You will see that it records that Child 4 and his mother were seen in clinic and that there was understandable concern as to his problems and, in the second paragraph, it states,
“I think it is very unlikely that [Child 4] has Fragile X mental retardation but, in view of the fact that he has recently been diagnosed as having autism by
Dr Greg O’Brien, I think it is worthwhile making sure that [he] does not have Fragile X on DNA analysis.”
At the foot of that paragraph,
“Clinically [he] does not appear to have Fragile X but I did take blood for DNA analysis so that we can at least exclude it.”
In the next stage in the chronology, would you look at page 209. There was a reference in one of the letters at which we have been looking to a dietician called Adams, a senior dietician, and this is a letter from her to Dr Shabde on 1 March 1993. The purpose of the discussion seems to have related to Child 4’s diet and, in the second paragraph, it says,
“To determine if dietary manipulation would benefit [Child 4]’s behaviour on …”
and could you help us with what that says.
A I cannot tell. I presume that it is some sort of additive that they were exploring, some sort of colorant, but I do not know the details.
Q
“… colour free diet was tried during the summer months. No change was noted in his behaviour although [Mrs 4] reported that his persistent diarrhoea had stopped. However, the diet was stopped in September as it was difficult for other carers to comply with.”
If we go on to the next page, having noted that the special diet had been stopped, it says,
“Unfortunately [Child 4] has had intermittent diarrhoea again in the last month and this may delay the reintroduction of foods. I feel that his mother is keen to manipulate [Child 4]’s diet further to determine the aetiology of his diarrhoea. However I have suggested it is important that the medical significance of the diarrhoea is discussed with you. [Child 4] is also taking nystatin which I believe is for intestinal candida.”
Can you help us with that, doctor. Was it in fact the case that Child 4 was taking nystatin at that time?
A I have no recollection of that. I would have to review the general practice notes at the time. I have no recollection of having prescribed nystatin but it is certainly possible. I do recall a number of conversations about Child 4’s diet.
Q I ask that you turn to page 203. This records the progress of the genetics investigations and it is a letter to you again from Dr Oley, the consultant clinical geneticist, and she says,
“I saw [Child 4] with his mother … and stepfather … in the genetics clinic. As you know. I had taken blood from [Child 4] previously to exclude the possibility of Fragile X in view of his developmental problems and severe autism. Cytogenetically [Child 4] did not have any evidence of Fragile X but because we now have a new DNA test available we did go on to do further testing.
The results of this are still confusing. It appears that [Child 4] does have a very small deletion within the Fragile X gene and this is different from the usual finding in Fragile X positive males”
and there was some further testing that needed to be done. Meanwhile, the position in relation to his gastrointestinal symptoms, would you look at page 14. Page 14 should be clearly marked and I hope that is the case for everyone’s bundle. At the very first entry at the top of that page, page 14, does it say, “malaise and diarrhoea”?
A Yes.
Q Can you help us with the rest of it.
A Disprol and Dioralyte was a prescription of medication and his ears were normal on examination.
Q Then we drop down one entry to 20 October, a few months on. Is this your writing?
A Yes.
Q Would you tell us what it says.
A
“Dr Shabde phoned. [Child 4] has giardia” which is an infection of the bowel. [Mrs 4] said he was better, but we agreed to try treatment with metronidazole. [Mrs 4] feels it is related to sugar in diet.”
Q At that stage was it envisaged that the treatment for the giardia would be co-ordinated through you?
A I would assume I was issuing the prescriptions, co-ordinating the treatment and following it up, yes.
Q Can I ask you to turn on to page 28? This is a microbiology report on a sample collected on the 10 January 1994 from Child 4. You can see there “Shigella sp ISOLATED” is the result. Could you help us with what that is?
A That means on that occasion he had a bacterial infection called Shigella in the stool sample.
Q As far as you know what was the response to that?
A I would have to see the relevant general practice records but that would depend on symptoms. Sometimes it would be treated but often that would not be treated. I am not sure. I would have to review the notes.
Q If you look at page 192, this may not help you much further but on the 12 January, so the same day as the report that I have just taken you to, Dr Shabde writes to you and says:
“As you will be aware, [Child 4] has been suffering from diarrhoea and his stools were checked .... The results are as follows.”
Again it sets out Shigella sp isolated.
“The Environmental Health department are involved and all necessary action is being taken.”
Do you take it from that that the action was being co-ordinated by Dr Shabde or not?
A I think that is difficult to say. I would interpret her letter as saying the necessary environmental health protection agency. Shigella is a notifiable disease which is followed up by the environmental health people. I am not sure that she is referring to her taking clinical responsibility for follow-up. I have no recollection. I could not be sure from that letter.
Q In fact, if we go on, on page 187 you will see in relation to this Dr Shabde writes to you:
“Just to let you know that [Child 4‘s] stool specimen remains positive. I believe clinically he has no problems.”
A Yes.
Q Are you aware of any notes which indicate otherwise?
A No.
Q Can you turn one page further on to page 188? Looking at the genetics picture, this is another letter to you from the geneticist where she says:
“I saw [Child 4] in the genetics clinic on the 22 February ... As you know [Child 4]
has severe autism and DNA analysis has shown that he has a very tiny deletion within the Fragile X gene. We have also shown that his mother has a similar deletion but has no problems, and the pre-natal diagnosis showed that his sister also has the same abnormality as her mother. We are not sure whether this deletion is significant at all and certainly there is a very high possibility that it has nothing to do with [Child 4’s] autism.”
Aside from the two episodes of gastrointestinal infection, Giardia and Shigella, and the other notes that I have taken you to, were there any other symptoms of gastrointestinal problems in Child 4’s case that you are aware of?
A Other than the fact that obviously we had had recurrent episodes of diarrhoea and that these, in his mother’s view, seemed to be related to the diet. I am not aware of any other problems.
Q At this stage, as far as you were concerned, what was the diagnosis in relation to his behavioural problems?
A I think I would understand it to be a possible diagnosis of autism.
Q In that connection can I ask you to look at page 166. On the 30 September 1994 you made a referral to Dr Wraith. What is Dr Wraith’s specialism?
A My recollection is that he was a paediatrician, a specialist in metabolic diseases of children.
Q What was it that prompted you to make this referral?
A I suspect this was at his mother’s request and certainly that would be my understanding.
Q You say in the first paragraph:
“Following our recent telephone conversation I am writing a letter about [Child 4] to ask your advise about whether there are any particular tests you would recommend or whether you feel [Child 4] might benefit from seeing you. I have asked his mother to write a letter detailing her concerns that [Child 4] might have a metabolic disorder and will enclose her letter with mine. [Child 4] has a very complex history which I have attempted to summarise.”
Did you know of Dr Wraith before you wrote this letter?
A I had telephoned him but I suspect again that was at his mother’s request. I had spoken to him on the phone to understand whether it might be worth writing him a letter.
Q If you look at the last paragraph, on page 168:
“The nature of [Child 4’s] handicap has made life extremely difficult for his mother and there is no doubt that this has been made more difficult by the absence of any clear diagnosis.”
What absence of any clear diagnosis are you referring to there?
A His mother was still searching for an explanation of the cause of his illness.
Q Did you regard there to be an absence of any clear diagnosis?
A Yes. I think that he had developmental delay. Often with children with developmental delay there is no very clear explanation and reason for that.
Q Your letter then goes on:
“I think Mrs [4] herself would accept that she has been trying to find an explanation for [Child 4’s] problems ever since they became apparent and I think it is fair to say that she has tended to read clinical descriptions of types of disorder and think that they fit [Child 4’s] condition. However she is [Child 4’s] mother and she knows him better than any of us and therefore I think it is very important to acknowledge the possibility that she may well be right and therefore I am interested in your comments as to whether you feel you have anything to offer.”
Can I ask you to turn to page 159. This is Dr Wraith’s response. He writes, on the 24 March 1995, to you and says:
“I received a sample of the urine from [Child 4]. The result was completely normal and excluded ... disorders, in particular the Sanfilippo Syndrome which was the condition I was interested in from the history. In addition we confirmed the results confirmed in Newcastle of normal amino acid patterns and normal organic acid excretion.
I stick by my original opinion in my letter to you of 8 November. In particular with this presentation a neurometabolic disorder is unlikely. We would however be
happy to see the child if you felt it would help the family come to terms with this.”
As far as you are concerned, was that the end of the road with Dr Wraith?
A Yes.
Q Can I ask you to turn to page 138. This is a letter addressed to you by name at the Collingwood Surgery and it is dated 18 September 1995 from the benefits agency Vaccine Damage Unit and it says:
“Dear doctor, re [Child 4], a claim has been made in respect of the above named against the Department of Social Security for payment in respect of alleged severe damage caused by vaccination.”
What did you know about any alleged severe damage caused by vaccination at this stage?
A I do not have any recollection of that. Clearly there was a child with severe developmental delay and his mother was feeling there was a reason for this that was not explained. I do not recall discussions of concern about vaccine damage.
Q Can I ask you to look at page 125. This appears to be a letter dated 12 June 1996 to Mrs 4 from Dr Wakefield which says:
“Thank you very much for your letter regarding your son. I would be very grateful if you could phone me or my secretary with your telephone number so we can discuss this directly. It is much easier to answer many of the questions in this way. I look forward to hearing from you.”
Before we look at the manuscript notes that have been made on this document, could you say how this document came to be in the GP records?
A I assume that his mother brought it in to discuss the contents with me and discuss a possible referral.
Q Who made the various annotations on the document?
A Some of the crossed-out annotations are irrelevant to this particular child and were made by myself. The annotations saying “blood test history. One week in hospital” was not made by myself. I would assume that was made by Child 4’s mother but I do not know that. I made the annotations saying “ECR John Walker-Smith.”
Q Do you recognise Mrs 4’s writing or is that an assumption you are making?
A It is an assumption.
Q You do say that the words “ECR” then “John Walker- Smith” circled is written by you.
A That is my writing, yes.
Q Why did Mrs 4 show you this letter?
A She was discussing the possibility of a referral down for investigation of Child 4.
Q What did you understand to be the nature of that investigation?
A I do not think I knew very much at the time. I think, as a result of this letter, I rang Mr Wakefield to find out more about it prior to making a referral.
Q Before you telephoned Dr Wakefield did you know anything of his work prior to that?
A Only what his mother would have told me at that consultation. I think this was completely new to me.
Q Did you know where Mrs 4 had got Dr Wakefield’s name from?
A I have no recollection of that.
Q Can I ask you to look at the GP notes at page 12?
A That has not got a page mark on it. I assume it is the one with the entry 21.11.96, is that right?
Q No. If you turn to page 14, which is a clean white piece of paper, and then turn back two pages. Right at the foot of that page is an entry for the 20 June 1996.
A Yes.
Q This entry actually goes over on to page 9 but if we, first of all, look at 20 June 1996: “[Mrs 4] attended. Has diarrhoea since has been going on higher fat.” Then if you turn back to page 9, three pages, “higher fat diet”. Is this your writing?
A Correct.
Q It says “No weight gain. School nurse dietary changes can cause diarrhoea and/or behavioural problems. Discuss doctor in London, her request, school nurse and dietician.” Who is the doctor in London?
A That would be Dr Wakefield.
Q What does this note record? Does it record your intention to telephone Dr Wakefield or does it record the fact you have already contacted him?
A I assume this was the consultation where Child 4’s mother brought in the letter from the Royal Free and I discussed that letter with her and said I would get further information about London and discuss whether a referral would be appropriate.
Q As a result of all this you wrote a letter to Mrs 4. Can I ask you to look at that page 123? This is dated 1 July 1996 and you say:
“Dear [Mrs 4], I have received further information from the Royal Free which suggests that [Child 4] falls into a group of patients they are interested in looking at
further. I have sent them a letter down asking them to see him and I think they will be contacting you in due course with an appointment. If you have any worries or concerns about it please come in to see me and ask me but I think in any case it might be useful if you pop in and see me before you went down there so we can take it a little bit further ourselves.”
What was the form of the further information that you received from the Royal Free?
A I do not have detailed recording of that. There is a very brief entry at the bottom of page 9 or 10 saying I had discussed it with Dr Wakefield. That is the only recollection I have other than is contained in my referral letter.
Q If we look at page 9, right at the foot of the page, “Discussed Dr Wakefield” and then a phone number is set out. Is this in your writing?
A Yes.
Q Could you tell us what it says?
A It says;
“Discussed what Dr Wakefield re gastrointestinal abnormalities. Query new syndrome. Query related to susceptibility to abnormal reaction to MMR causing modified inflammatory bowel disease causing neural toxin causing autism. No idea of treatment yet.”
Q Can I ask you to look at the referral letter that you actually wrote, page 121. You will see on page 121 that this letter is dated the 1 July 1996.
A Yes.
Q The note on page 9 that we have just been looking at appears to be dated in November 1996. Is that right or is that date incorrect?
A I assume that one of the dates is incorrect. I would have to check that in more detail to know which one.
Q Looking at the information that you record on page 9 in relation to GI abnormalities, query new syndrome. Query related to susceptibility to MMR, are you saying that is information that you were aware of prior to the referral of Child 4 to the Royal Free?
A I think that looking at this I suspect that the date on that entry is wrong. I suspect also that I saw Child 4 and his mother on the 20 June. I suspect that entry saying “discuss Dr Wakefield” is not contemporaneous. At the time we had to get records out every time we wanted to make them. Clearly there is an intervening record from one of my partners, which unfortunately is even more illegible than my writing. I suspect I was adding that entry at a later date. I suspect that that is an incorrect date, the 21 November. I suspect the sequence of events is I spoke to Child 4’s mother on the 20 June. I then spoke to Dr Wakefield soon after that and then made a referral on the 1 July.
Let us then look at your referral letter at page 121. It is dated 1 July 1996 and you wrote this letter to “Mr Wakefield Consultant in Experimental Gastroenterology”. Why was it that you made a referral to Dr Wakefield at that stage?
A This was at his mother’s request and following a telephone conversation to try and establish a diagnosis and possibly help in treatment and management.
Q If we look at the letter, it says,
“Following our recent telephone conversation I would be grateful if you could arrange an appropriate ECR appointment for [4] to undergo assessment regarding his possible autism and his bowel problems.
[Child 4] has had long standing difficulties and shows severe learning difficulties and also bowel disturbance and his mother has always found it difficult to accept that there was no known cause for [Child 4]’s disorder. A few years ago she was chasing the idea that he might have a metabolic disorder and I enclose a copy of a letter I wrote to Dr Wraith in Manchester at that time although his reply was he did not see any value in further tests along these lines. I’m aware that you are looking at the possible links between measles vaccine and various difficulties and [Child 4] certainly had MMR in 1988. In general [Child 4]’s mother thinks that he developed normally initially and then subsequently his problems worsened and he lost some of the milestones he had achieved but that he has subsequently improved on something of a restrictive exclusion diet. The professionals who have known [Child 4] since birth do not entirely agree with this however and there is a suggestion that some of [Child 4]’s problems may have started before vaccination.
Since 1994 4 has continued to have intermittent problems with his bowels and diarrhoea that [Mrs 4] relates to food intake; he has had a negative test for celiac disease and has on at least 2 occasions had giardia but he has had no further investigations regarding the cause of these symptoms.
As I say, [Mrs 4] is convinced that both [Child 4]’s behaviour and his diarrhoea are triggered by his diet and she has him on something of a restrictive exclusion diet. He has not gained weight and we have been very concerned about this and [Mrs 4] feels that this is despite him being on a more normal diet. We have therefore not made any assessment as to whether his failure to gain weight might be due to an inadequate diet or to possible malabsorption.
I would be grateful if you could arrange an appropriate appointment and would be very interested if you feel [Child 4] fits into the sort of category of patient that you are interested in looking at further”.
When you say in that letter, “the sort of category of patient”, what category of patient were you referring to?
A I think this was the idea that they might find some explanation for 4’s behaviour and for his disorder and might therefore be able to help in managing the problem.
Q Where did you obtain the information in the middle paragraph on page 121, that Dr Wakefield was looking at possible links between measles vaccines and various difficulties?
A I have no recollection. This would either be from 4’s mother or from Dr Wakefield himself.
Q Were you content to make that referral, Dr Tapsfield?
A Yes.
Q What did you consider to be the purpose behind the referral?
A The purpose behind it was to see if there was an explanation for his problems and to see if we could help manage them in a more effective way.
Q What did you understand to be involved by way of investigations at the Royal Free?
A I do not have a clear recollection of that. My understanding was that they would certainly involve hospital admission. I would assume that they would involve some sort of bowel investigation such as a colonoscopy, but I am not aware that I had more detailed information than that.
Q Can I take you on to page 117? This is a discharge summary written to you on 16 October 1996 from a lecturer in the paediatric gastroenterology department, Dr David Casson. Was this, so far as you know, the next communication you received from the Royal Free in relation to the investigations that were performed on Child 4?
A Yes.
Q It indicates a diagnosis of,
“autism/developmental regression
food related symptoms including diarrhoea, rashes and abdominal pain.
Lymphonodular hyperplasia of the terminal ileum”.
Was that a term you had come across before?
A I was not aware of it, I do not think.
Q It records an admission to the Royal Free for investigation of a possible link between disintegrative disorder and colitis. Again, the phrase, “disintegrative disorder”, was that a phrase you had come across before?
A I would be hard put to say. I mean, I am probably more aware of it now. I doubt that I was aware of it at the time.
Q Then it lists the main problems. It records early details in relation to his birth, then a whole series of comments relating to the previous medical history. Then on page 119 a number of investigations are detailed, including colonoscopy, barium meal and follow through, MRI. It says,
“Lumbar puncture and Schilling test not performed”.
Then EEG and evoked responses, blood test results and so on. On the last page a review by a dietician. In the penultimate paragraph,
“Unfortunately, because [Child 4] had a period of vomiting and being generally unwell scan it was impossible to complete all the investigations. We will therefore need to consider repeating these on a further occasion, i.e. barium meal, lumbar puncture.
An ECG was performed which was normal. An echo cardiogram needs to be performed when we see him next”.
As far as you were concerned, Dr Tapsfield, was this the first time that the full detail of these investigations was made plain to you?
A Yes.
Q I am next going to take you to the follow up from the Royal Free, so can I ask you to turn to page 111?
A Yes.
Q This is a letter from Professor Walker-Smith to you. Was this the first contact that you had had with Professor Walker-Smith?
A As far as I can recall, yes.
Q What he says is,
“In light of the histological finding of colitis I believe a therapeutic trial of Mesalazine or Salazopyrin suspension may be useful. We have found some other children with similar features to [Child 4] have both benefited from the effect on gastrointestinal symptoms and behaviour. The duration of such therapy would depend upon its clinical efficiency. If there is no response after a month it would not be worth continuing”.
In relation to this letter there are again some manuscript notes made on it. Are those notes in your writing?
A Yes.
Q There is a line going up to the phrase, “this is a capsule”, and then it says, “not recommended for kids”.
A Yes.
Q Where would you have got that from?
A I have no recollection whether I got that from a standard British National Formulary or whether I sought specialist advice from a pharmacist. I do not know.
Q Then there is a comment,
“[Mrs 4] knows nothing about this. She will chase it up”.
A Yes.
Q Do I interpret that correctly to relate to the Salazopyrin suspension?
A I think that probably referred to the use of medication completely rather that specifically for one drug or another.
Q Had you come across Mesalazine and Salazopyrin before?
A Yes.
Q For what?
A They are common drugs for adults with inflammatory bowel disease, ulcerative colitis particularly.
Q What action did you take then in light of the recommendation contained in this letter that commencing [4] on some medication was sensible?
A My memory would be, from re-reading the notes, that we gave him a therapeutic trial for a while but it was not effective. I would have to double check that in the notes to be sure.
Q We will come on to some of the notes later on and if you wish to change your answer in light of those notes no doubt you will do so.
A Yes.
Q Next page 96. This is a letter from Dr Berney to you. Again, can you help us with Dr Berney’s specialism?
A He would be a consultant child psychiatrist with a special interest in children with learning difficulties.
Q He records in the first paragraph that he has met Child 4. He records that he is markedly autistic and appears to have a profound learning disability, oppositional when it comes to eating. Then there is an account given there – I will not read it out – of a very difficult social history.
A Yes.
MR THOMAS: After the account of that difficult social history there is an entry in relation to social services and then a number of points in relation to his difficulties. He then states, at page 96, at the conclusion of the letter,
“I will write to Dr Wakefield to see if I have any better luck at getting a summary of their investigations and conclusions. [Child 4] had a course of (I think) sulphasalazine after his investigation at the Royal Free Hospital. He became acutely distressed, apparently with abdominal pain and his autism and behaviour did not improve. It was therefore discontinued after a fortnight”.
In the first sentence he says,
“I will write to Dr Wakefield to see if I have any better luck at getting a summary of their investigations”.
What is that a reference to, Dr Tapsfield?
MR COONAN: How can he answer that question? It is not his document.
MR THOMAS: I am asking the witness whether he knows what that is a reference to. It is a letter which was written to him. It may be that Dr Tapsfield is able to say that he addressed a specific query to Dr Berney in relation to this, and it may be that he did not.
MR COONAN: If you have got a letter then it lays the ground properly. If there is a letter I would be grateful if we could see it.
MR THOMAS: There is one letter and this is it. It is a letter from Dr Berney to Dr Tapsfield.
A What I would say is that I could not comment on that because I have no recollection. However, in my referral letter to Dr Berney, which I think follows that, there is a reference to that in paragraph 6 on page 100. I am just reading this. I have not reviewed these notes recently.
Q Certainly. That says,
“Most recently [Child 4] has been referred to the Royal Free Hospital for the investigation of the possibility of the possible syndrome related to MMR vaccination. He had a variety of investigations although I do not have any very helpful summary conclusion of the letters. However the general impression is that he does fit into the spectrum of children with autism, some GI symptoms and a degree of abnormality of the bowel on colonoscopy”.
So as far as you were concerned, on page 98 Dr Berney was going to write to Dr Wakefield to address that?
A I have no detailed recollection of that but that would be the impression from his letter.
Q Can I ask you next to look at page 80 in the GP notes? This is a letter that you wrote in 1998 to Dr Colver.
A Yes.
Q Who was a consultant paediatrician.
A Yes.
Q You say,
“I enclose a brief summary of his medical history which I prepared for the panel and sent off to his social worker which is a very brief summary but essentially agrees with the points that you make in your report. In fact I do not have any other correspondence of consequence from the Royal Free although I have spoken to them once or twice on the phone. In general they have been very poor about making significant management recommendations or becoming involved in any way in [Child 4’s] long term care. At one time they did make a suggestion that treatment for colitis may have been helpful for [Child 4] and for a short time we started him on this but it had no effect at all.
As far as I am aware they were planning no long term follow up or treatment and would support the concept that his care could be offered effectively by a local paediatrician presumably with a background idea of expansion of his limited diet.”
Dr Tapsfield, does that accurately summarise your view at the time in August 1998 of the degree of follow up that Child 4 had received from the Royal Free?
A Yes.
Q Had you been given to understand from any of the letters that we have already been through that there was any other significant element of follow up that was envisaged?
A No.
Q The summary that you enclosed with that letter is at page 82 and 83.
A Yes.
Q You describe the referral that you made to the Royal Free in paragraph 5.
A Yes.
Q On page 83?
A Yes.
Q As far as you are concerned, is that an accurate description of the referral that you made?
A Yes.
Q In paragraph 5 it states that there is a paper written by the Royal Free regarding this (referring to the investigations that you have referred to in the first sentence) and you say that it included Child 4 as one of their cases. How did you become aware of that?
A I do not know. I think it might just have been an assumption that was made in our practice when the paper was written rather than specific knowledge. I am not sure if I had any detailed knowledge of that at the time.
Q We know, doctor, that the paper was published in February 1998. Can you recollect whether you knew that Child 4 was one of The Lancet children before it was published?
A I do not think I can recall that I had any awareness of the paper before it was published.
Q Just again going back to the referral you made to the Royal Free, what did you provide the Royal Free with by way of previous medical history, if anything, other than the referral letter that you wrote?
A It was the referral letter together with a copy of a previous letter which I referred to in the referral letter. The letter that was written to Dr Wraith was included as a copy, but there was no other information sent down.
Q Did you have any expectation at the time that more information would be asked for or not?
A I do not think I had any expectation that more information would be asked for, no.
Q Did you in fact receive any request for more records to be provided?
A No.
Q Have you had any contact with Dr Wakefield since the telephone call that we have addressed?
A I think the records would suggest that I have had one or two telephone conversations following his assessment down there. I have no recollection of those phone calls. It might have been about the time of initiating treatment for Child 4, but I would suspect I have had one or two telephone conversations but I have no recollection of them.
Q Why do you say that it might be at the time when treatment was suggested?
A Because I would imagine if there was a possibility of treatment, particularly of a relatively unusual nature for children, I might well have asked for specialist advice.
Q You regarded Dr Wakefield as being, at least potentially, an appropriate person to contact in that regard?
A Yes.
Q Did you have any knowledge in relation to Mrs 4’s involvement with any organisation, parental groups?
A I cannot be sure at what stage I was aware. I certainly was aware at some stage that she was involved with JABS, but I cannot give a comment as to when I knew that.
Q Lastly, Dr Tapsfield, can I address the issue of how the referral was to be funded. Can you look at page 12 of the GP records?
A (After a pause) Yes.
Q This was your referral letter and in the first paragraph you say:
“… I would be grateful if you could arrange an appropriate ECR ...”
A Yes.
Q Then if you look at page 124 you write to the ECR department at the Royal Free and you say:
“I have accordingly referred him down and I’m notifying you that obviously this will require an ECR.”
A Yes.
Q Then page 125, your manuscript note:
“ECR John Walker-Smith.”
A Yes.
Q As far as you were concerned, how was this referral to be funded?
A It is quite hard to remember. The various ways of funding health service referrals has changed about 30 times in the last ten years and I suspect that this was a time when we asked for extra-contractual referrals. I have no recollection of whether we got involved in being told they had been approved or whether the hospital made them. The system has changed so often now that I cannot recall, but I certainly expected it to be a health service funded referral.
Q Can I ask you to look in that connection in the Royal Free Hospital records, which will be in a separate folder?
A Yes.
Q Would you look at two documents there. The first is page 3.
A Yes.
Q If you look under two-thirds of the way down on the right-hand side it says “ADMISSION DETAILS” and then it says:
“Source of adm: …
Category: NHS.”
A Yes.
Q Then if you look at page 67 ---?
A Yes.
Q --- this is an investigation that was ordered and if you look in the middle of that page it says, “ECR/Contract” and “ECR” is circled?
A Yes.
Q Does that confirm your expectation that this was to be an NHS referral?
A Yes.
Q I am just going to complete, very shortly, the picture from the gastrointestinal point of view in light of your earlier answer in relation to how Child 4’s symptoms developed, in light of what had happened at the Royal Free. I am going to take you to some of the records which record his gastrointestinal symptoms. If others consider that there are other records that you need to be taken to, then you will be taken to them by them. Can I ask you to first look at page 71 of the GP records? You can put away the Royal Free records now.
A (After a pause) Yes.
Q This is a letter from Dr Colver, the paediatrician, to whom you referred Child 4 and if you look in the fourth paragraph down:
“[Child 4’s] paediatric care is now provided by me”,
and it contains details of a special diet and then it says:
“[Child 4] now has no abdominal pain and about once every three weeks, he has an episode of diarrhoea.”
That is a document in April 1999. Then, if you look at page 70, by September 1999 Dr Colver is writing to Dr Bendelow. He recently visited Child 4 and he says:
“He seems to be reasonably settled at the moment and in good health. He has had no diarrhoea or tummy pains and no rashes. He is eating well. He is into a good sleeping routine …”,
et cetera. Winding the clock forward to March 2000, if you look at page 68 again
Dr Colver writes to Dr Bendelow:
“It seems that things are quite settled… Apart from a flu-like illness around Christmas he has been in good general health. He has had no tummy pains and only one short episode of diarrhoea in the last 6 months. He has had no rashes.”
Then lastly, at page 34, a document in 2004, again Dr Colver to Dr Bendelow, and in the third paragraph down:
“His general health this year has been good … However there has been no abdominal pain or episodes of diarrhoea.”
Does that story conform, as far as you are aware, to the position that obtained when you still had an involvement with Child 4’s care in 1999?
A I had no involvement at that time. These letters that you are referring to were after Child 4 had moved into foster care and was therefore registered with another GP.
Q In 1999, however, when you were still the GP, were there any other significant entries that you are aware of in relation to gastrointestinal symptoms?
A I cannot recall that.
MR THOMAS: Thank you very much, Dr Tapsfield. Those are all my questions.
THE CHAIRMAN: I am also looking at the time and it has been a long afternoon, even more so for Dr Tapsfield, who has been sitting on that witness chair. I am starting to wonder whether we should actually call off today, because I think he definitely needs some rest.
THE WITNESS: Yes. I have got to travel back to Newcastle though, so I would be keen to get back tonight because if I have to take tomorrow off as well that will be very inconvenient for the practice.
THE CHAIRMAN: And you have to be back this evening?
THE WITNESS: I have a booked day tomorrow at work.
THE CHAIRMAN: I am going to look towards counsel. Do you have any idea roughly how long you will be?
MR COONAN: Sir, I do have some questions. I hear what Dr Tapsfield says, but I am not going to rush it.
THE CHAIRMAN: I think in that case it is probably right for this matter not to be rushed. We will adjourn for about ten minutes and maybe some arrangements could be made for tomorrow, because I am obviously conscious of the fact that this is such an important issue that I think rushing it is not going to do justice to anybody. I think Mr Miller wants to say something.
MR MILLER: Yes. I have a number of questions as well, sir, those which will not have been covered by Mr Coonan. So it is not just Mr Coonan who is going to be asking questions.
THE CHAIRMAN: Ms Smith?
MS SMITH: Sir, could I just intervene to say if you were adjourning for a few minutes I wonder whether my learned friends would be happy if I just had a word with Dr Tapsfield about his position tomorrow. Obviously I shall not talk about anything else except that.
THE CHAIRMAN: I think that is precisely what I was just going to ask, if that was possible. So we will adjourn for ten minutes and hopefully you will be able to make some arrangements for tomorrow, and then we can resume the cross-examination tomorrow morning. We will adjourn and I hope that you will be able to send us a message through our Panel Secretary about the situation.
MS SMITH: I will do that very quickly.
THE CHAIRMAN: Hopefully, we will then be able to adjourn until tomorrow morning. We will now adjourn and wait to hear from you. Thank you.
(The Panel adjourned for a short time)
(The Panel adjourned until 9.30 a.m. on Tuesday, 24 July 2007)
No comments:
Post a Comment