Day 4 GMC Fitness to Practice hearing for Andrew Wakefield

GENERAL MEDICAL COUNCIL

FITNESS TO PRACTISE PANEL (MISCONDUCT)



Thursday 19 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 FOUR)



(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


OPENING SUBMISSIONS by MS SMITH contd. 1






THE CHAIRMAN: Good morning to you all. Very sincere apologies for starting a few minutes later than anticipated. Can I once again remind everyone in this chamber to make sure that your mobile phones are switched off. Ms Smith, you were in the middle of your opening.

MS SMITH: Yes. Thank you very much, sir. I had just finished with Child 3 and I was going on to Child 4. Before I do so, one short matter that Mr Hopkins has asked me just to make clear and I am very happy to do so. Mr Hopkins pointed out to me that I referred to a Dr Thompson, who is the doctor who performed a colonoscopy on Child 3, as a junior colleague of Professor Murch’s, and he has asked me to make it clear that Dr Thompson was a consultant, and indeed I was aware of that and did not mean to imply anything else. He had been appointed in November 1995 as a consultant at the Royal Free Hospital – Dr Thompson that is.

Now I am turning on, sir, to Child 4, and it might be helpful, before we begin, if you could just get out the GP records and the Royal Free records for Child 4.

Child 4 is a boy again, who was born in January 1987, and he was referred ultimately to the Royal Free Hospital in July 1996 when he was nine and a half years old, and thus one of the oldest children who was investigated. He was a patient of the same GP’s practice as Child 8, to whom I shall be referring later.

In brief terms, his background was that his records indicate some concerns from the age of six months onwards when it was noted that he had some motor delays and that his head was small, but those concerns lessened towards the end of his first year. There is a reference to diarrhoea in March 1988 when he was just over a year old, and in April 1988 he had the single measles jab vaccination. He is the only child to whom that applies, the single measles jab, and you will recall from what I told you yesterday about the chronology of vaccination that that is consistent with his older age. A month later it is recorded that his mother’s main worry was recurrent diarrhoea which kept clearing and recurring, and concerns were again expressed about his development. Those increased, and there was thought by his mother to be some regression in his language skills, and from then on references to diarrhoea and to developmental delay are increasingly manifest in his GP records. In fact, he then went on and had the MMR vaccination in February 1991, again rather older than the other children, when he was four years old.

There were a number of referrals to specialists over the years, including a consultant ENT surgeon, a consultant community paediatrician, a consultant geneticist and a consultant psychiatrist. The last, the psychiatrist, ultimately expressed the view when Child 4 was about three years old that he had problems of the autistic type.

Diet manipulation was found to help when he had diarrhoea, but then in 1993 and 1994 he had episodes of a gastrointestinal infection, and the identity of that infection was identified, and we will deal with the doctors later.

In September 1994 his GP, who is Dr Tapsfield, from whom you will be hearing, sought help from a consultant at the Manchester Children’s Hospital because his mother was concerned that he had some sort of metabolic disorder, and they undertook a series of tests and concluded that a neurometabolic disorder was an unlikely diagnosis.

Then in June 1996 Child 4’s father contacted Dr Wakefield. Dr Tapsfield, the GP, made his own inquiries, the precise nature of which he cannot himself recall, but seemed to have involved, as you will see, his contacting Dr Wakefield, and having made his own inquiries he then acceded to the parental request for referral to Dr Wakefield, and the referral letter is in the Royal Free Hospital records at page 27, and you will see why I referred to there having been contact, because the letter starts off:

“Following our recent ….. conversation I would be grateful if you could arrange an appropriate ECR appointment” – you will remember ‘extra contractual referral’ appointment – “for [this child] 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 [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 [4] certainly had MMR in 1988. In general [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 [4] since birth do not entirely agree with this however and there is a suggestion that some of [4]’s problems may have started before vaccination.

Since 1994 [4] has continued to have intermittent problems with his bowels with diarrhoea that [his mother] relates to food intake; he has had a negative test for coeliac disease and has on at least 2 occasions had giardia” – that is the gastrointestinal infection – “but he has had no further investigations regarding the cause of these symptoms.

As I say [the mother] is convinced that both [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 [but his mother] 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 [4] fits into the sort of category ….. that you are interested in looking at further.”

THE CHAIRMAN: Can I just interrupt for a second. Again, for the purposes of the press who are here, I think the child’s name has been divulged a couple of times. Can you please make sure that the child’s name is not reported. Thank you.

MS SMITH: I am sorry, sir, I am doing the best I can.

THE CHAIRMAN: I am sure that is right.

MS SMITH: Dr Wakefield then wrote to Professor Walker-Smith, having received that letter, saying that Child 4 sounded like a good candidate for their forthcoming study. On 28 August 1996, so that is a couple of months after the referral letter, Dr Casson (Professor Walker-Smith’s registrar/lecturer) wrote to Child 4’s parents arranging for admission. The significance of that will be readily clear to you. There was no outpatient consultation with Child 4 and no attempt to ascertain the nature of his symptoms, save as is set out in the GP letter. There was no testing for inflammatory markers and no apparent consideration of the need for invasive investigations. We say that that admission can only be consistent with a research purpose, i.e. it is wholly contrary to the individualised approach which must always characterise clinical medicine.

On 29 September 1996 Child 4 was admitted to the Royal Free. The admission clerking notes state that Child 4 was admitted for the study of disintegrative disorder, colitis, MMR, and although there is a clear indication in those notes that his gastrointestinal symptoms had resolved for most of the time and only seemed to be related to food intolerances, a plan was made at that time, and the plan has been included in the note, MRI, EEG, LP, bloods, chest X-ray.

THE CHAIRMAN: Sorry, I do apologise again for interrupting. I believe that one of the Panellist’s bundle is empty.

THE LEGAL ASSESSOR: It is Ms Golding’s, it does not begin until page 35 of the Royal Free Hospital records.

THE CHAIRMAN: Can she possibly have another bundle if one is available?

MS SMITH: I do apologise for that. We will make sure you get your own copy. (Same handed)

THE CHAIRMAN: Thank you very much. Sorry for the interruption.

MS SMITH: As I say, the plan which was set out on that admission was that the child should undergo colonoscopy, MRI, EEG, LP, bloods, chest X-ray. So those, we say, are the investigations that he was predetermined to have regardless of the symptoms or the lack of them.

There is a standard clinical consent form for colonoscopy and a consent form for the standard research biopsies, as I explained to you yesterday. On 30 September 1996 a colonoscopy was carried out. On this occasion the colonoscopy was carried out by Professor Murch. If we go to the Royal Free Hospital records at page 32, you will see this is a record of that procedure, and if you look down you will see the findings, “Lymphoid hyperplasia”. “Histology report to follow” underneath that, and then an assessment of precisely what it was that Professor Murch saw on that occasion, but then the words which we say are significant for the purposes that I have referred you to it, “NB. Investigation performed because of disintegrative disorder variant of autism.” So there appears to be an acknowledgement there that the colonoscopy was being carried out for behaviour problems, and, furthermore, we say, not for the behavioural problems that this child was in fact at that time thought to have, i.e. he was not thought to have disintegrative disorder.

Not only can it never be said that it is clinically justifiable to carry out a colonoscopy because of behavioural disorders alone, but you will bear in mind what I referred to a few minutes ago, that there appears not to have been any attempt to ascertain the nature of the child’s behaviour symptoms at all, let alone to confirm a diagnosis of disintegrative disorder.

The same day a request for a visual EP (which stands for evoked potential) was made. I have referred to this before and I am conscious that I have not given any explanation for it. A visual EP evaluates the child’s visual nervous system, and it is a procedure like an EEG, which involves putting electrodes on the patient’s head and then measuring the electrical activity of the brain whilst they look at a light or patterned screen to stimulate the appropriate nerves. That was ordered, and you will see that on page 67 of the Royal Free notes. That is the request form for an EEG to be carried out. You will see that it is signed by Dr Wakefield on the right-hand side, and the reasons for the procedure are listed as “disintegrative disorder” and “enteritis ? myelopathy”.

You will recall our case that Dr Wakefield had no clinical responsibilities for this or indeed any other child, and he is giving as one reason for the procedure being carried out disintegrative disorder, although we say there was no evidence available to him that this little boy suffered from that condition.

A couple of days later, on 2 October, there was apparently a psychiatric assessment, and the notes indicated that a detailed report was to follow, but there is no such psychiatric assessment that can be found in these records.

On 3 October Child 4 was unwell and suffered from episodes of vomiting. He nonetheless had an MRI scan on that day but a decision was made to postpone the lumbar puncture. The results of the last test ordered by Dr Wakefield became available, and if you look at page 68 of the Royal Free records, this is the EP investigation, “Normal waveform” says the reporting doctor:

“We do not have latency values from control subjects for this test. One would guess this is a normal response.”

You may wonder in the light of that fact why this little boy was given this test at all.

We then have a record of the department histology meeting with a note by Dr Casson, and that is at page 13 of the Royal Free records. You will see, on 4 October 1991, on the bottom of that page, the heading “Histology meeting” and the words underneath it are:

“Ileum – Dense lymphoid pattern.
- No acute [inflammation].
- Normal architecture.
- Prominent lymphoid follicles.
- No active [inflammation].

Then at the bottom, just before the signature, “no granulomas”

After that this child was discharged and we have the discharge summary, which is page 21 of the bundle. I will go through it I hope fairly but selectively so that I do not read it all to you because we will no doubt be referring to it again:

“Diagnoses: 1. Autism/development regression.
2. Food related symptoms including diarrhoea, rashes and abdominal pain.
3. Lymphonodular hyperplasia of the terminal ileum.

[Child 4] was admitted to the Royal Free Hospital for further investigation of a possible link between a disintegrative disorder and colitis. His main problems are:

1. Diarrhoea.
2. Behavioural disorder manifest by hyperactivity.
3. Developmental regression.
4. Sleep problems
5. Skin rashes/eczema.
6. Abdominal pain.”

It then sets out his birth history.

“It is relevant to this admission that he was followed until 18 months of age at North Tyne Side General and on discharge his development was normal.

At this time he began to lose various words and developmental disintegration appears to have taken place from then. This does not specifically correlate with his measles immunisation.

He had his measles immunisations initially at 15 months of age” – as I have told you – “and a 2nd subsequent measles immunisation at approximately 2½ years of age. Mum relates a change in his behaviour from a period extending 4 weeks after the 2nd measles immunisation. His play skills did not develop further. He became extremely hyperactive and indulged in destructive play. He started had banging and kicking out. Up to this time he had been quite placid and quite affectionate. He lost his eating skills ... He generally seemed to be more clumsy.

Socially mum noticed that behaviour responded to dietary variation.”

It then goes through the various foods and says:

“Since his dietary changes mum has noted that he has become less aggressive, has less tantrums and is less hyperactive. He appears happier in himself.

The diarrhoea also appears to be food related. This became a problem at between
1-1½ years of age. His stool was initially loose and watery and then became increased in frequency. It contained no blood or mucous and he has no peri-anal soreness. It generally contains undigested food. His diarrhoea became significantly worse from 4½ years of age. There was a marked increase in frequency and it became increasingly watery. In association with this his weight fell and be became increasingly lethargic. There were associated abdominal pains.”

Then mum started excluding various foods.

“On his present exclusion diet he remains well most of the time. If he does get an exacerbation of diarrhoea it does seem to be related to the introduction of new foods. He now has his bowels open once or twice a day and this is of normal consistency. Abdominal pain has largely resolved. It is worthy [of] note that he had Giardia grown from his stool a year ago.”

It then deals with the various other aspects of his health.

If you turn over to the next page:

“Colonoscopy was performed under sedation. There was mild granularity of the rectum with slight distension of the vascular pattern. The colon was normal, however the ileum showed marked lymphonodular hyperplasia. Histology of the ileum showed a dense lymphoid aggregate with no obvious acute inflammation and normal architecture. Within the colon there was noted to be several prominent lymphoid follicles but again no active inflammation. Rectum was normal. There were no granulomas.”

That is a quotation of the histology note that I have already referred you to:

“BARIUM MEAL AND FOLLOW THROUGH:
Unable to perform.

MRI SCAN:
No abnormality.

Lumbar puncture and Schilling test not performed.”

Nothing definite abnormal as far as the EEG was concerned.

Then if you go on you will see all the blood test results, a review of the diet by the dietician, and at the bottom of the page:

“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, ie barium meal, lumbar puncture.”

It also refers to the ECG being normal.

The GP notes indicate a discussion with Dr Wakefield, and that is on page 9 of the GP notes.

Sir, interrupting myself, I hope Panel members will tell me if they have got pages missing because I have just discovered some of my own are missing. The difficulty is that the files spring open in these boxes so that one leaves bits behind, so do mention it. Hopefully you have the GP records.

THE CHAIRMAN: The GP records are there, the difficulty is we cannot actually see the pagination.

MS SMITH: One can count through, because it is only the ones on this particular notation. It is dated 21 November 1996, if that helps, or we will find that for you. (Same done)

THE CHAIRMAN: I will just check that all the Panel members have that page. (Confirmed).

MS SMITH: You will see it says at the bottom, “Discussed Dr Wakefield” and then there are some numbers, and if you turn to the next page:

“Re GI abnormalities ? New syndrome. ? related to susceptibility to abnormal reaction to MMR [leading to] modified inflammatory bowel disease [leading to] neural lesion [leading to] autism. No idea of treatment yet.”

That was the note from the GP having discussed with Dr Wakefield, and then there is a letter from Professor Walker-Smith to the GP at page 111 of the GP records. You will see that that letter dated March 1997 says:

“In light of the histological finding of a 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.”

What we say is significant in that letter are the words,

“in light of a histological finding of colitis”,

and mesalazine, which is an anti-inflammatory, is suggested on the basis of that finding, although you will remember that the note of the histology meeting and the discharge summary by Dr Casson indicate that the histological findings suggested that there was no inflammation, i.e. no colitis. The criticism that we make on the basis of our expert evidence is that any clinician subsequently reading these notes is faced with a complete contradiction between the findings, the diagnosis and the consequent treatment, and no way of resolving that contradiction; that is, why is this child, with a histological finding of no inflammation, being given anti-inflammatories on the basis of an indication that there was a histological finding of colitis?

So far as the Royal Free Hospital consultants were concerned, that seems to have been the end of their involvement. You will be hearing from the GP that he felt that the follow-up of Child 4 was unsatisfactory by the Royal Free. But again, we say that that is consistent with the research nature of the enterprise; i.e. that is why there was no real clinical follow-up.

So far as the charges are concerned, the general charges relating to Dr Wakefield, Professor Walker-Smith and Professor Murch are that this child had investigations for research purposes, as with all the children, without Ethics Committee approval for that research. But it was clearly research pursuant to Project 172-96 but the child was enrolled before the due start date of 18 December 1996. This little boy did qualify on the basis of the vaccination that he had undergone, because you will recall that he had indeed had a single measles jab; but he did not, we say, qualify on the basis of his behavioural disorder because there is no evidence that he suffered from disintegrative disorder. Prior to his admission to the Royal Free, there had been a tentative diagnosis of problems of an autistic type, and there is no revision of that diagnosis by the Royal Free Hospital.

In addition, the charge reflects that there were no proper research consent forms filed with his records as the Ethics Committee had specified. Then there are additional charges in respect of each doctor, as far as Dr Wakefield is concerned for ordering investigations on the child when he was not paediatrically qualified and in contravention of the limitations on his honorary contract; further, for giving as one of the reasons for ordering the test a diagnosis of disintegrative disorder when there had been no such diagnosis. Furthermore, he is charged with exposing Child 4 to a test – that is the evoked potential responses test – which was of no benefit either to Child 4 or indeed as a research tool, since there were no controls and the tester indicated that it was uninterpretable.

In addition, there are charges against Professor Walker-Smith for failing to undertake himself or cause to be undertaken a proper assessment of the child’s clinical condition prior to subjecting him to a colonoscopy; failure to carry out any preliminary tests for inflammatory indices, and causing him to have a colonoscopy which was not clinically indicated. Furthermore, the last matter that I opened to you, that Child 4, having been expressly reported at a histology meeting as having no inflammation, nonetheless diagnosing colitis and consequently prescribing anti-inflammatories without giving any explanation in the records as to his justification or reasons for doing so.

There are additional charges against Professor Murch because this is one of the cases where he undertook the colonoscopy, and again the same point that I have made in relation to those children with which he had been previously involved, that although it was originally ordered, we accept, by Professor Walker-Smith, Professor Murch, we say, had a responsibility not to carry it out unless he himself regarded it as appropriate to do so.

That is all I have to say about Child 4. You can put those records away and I am now going on to Child 6, who is the next chronologically. Child 6, again a little boy – there is only one girl, as you will be hearing, in this series – born in April 1992 and referred to the Royal Free Hospital in August 1996 when he was four years and three months. As far as his background is concerned, there are difficulties in relation to this. When the records of this child were disclosed by the hospital to the General Medical Council, the Royal Free Hospital records prior to 2001 were missing altogether. Some have been produced in the last couple of weeks by Dr Wakefield, but they have been obtained from the solicitors in the MMR litigation and so obviously we do not know if they are complete. So I will outline the background to you but you will know that that is why, on occasions, with this child I am unable to give you some details.

So far as the GP records are concerned, this child is the brother of Child 7, who I am going to be referring to later. Within about one month of his birth, there are references to diarrhoea and vomiting and that continued on and off until March 1993, when he was admitted to his local hospital with febrile convulsions and diagnosed as having measles. He had his MMR vaccination in June 1993. In December 1993 there are references to behavioural problems and those references continue, as indeed do the references to diarrhoea. By February 1995 he had been referred to a consultant paediatrician and the first mention that autism might be the problem is referred to by the GP in October 1995 when he was about three and a half. He was then referred to a community consultant paediatrician. She noted that his younger brother was subject to seizures and that there was a family history of learning difficulties, and she concluded that the likely candidate was Aspergers syndrome, although she thought that it would not be clear what his diagnosis was until he was rather older.

Child 6 had problems with soiling and holding on to his motions for long periods, causing abdominal pain, and in March 1996 he saw a consultant paediatric surgeon. Shortly thereafter his mother registered him with a GP from whom you will be hearing, who is a Dr Nalletamby, who is a GP who had a particular interest in autism. In March 1996 Child 6’s mother requested Dr Nalletamby to refer him to Dr Wakefield, and Dr Nalletamby made inquiries to Dr Wakefield and then wrote to him on 9 August 1996. That letter is in Child 6’s GP records at page 125:

“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”.

Dr Wakefield passed that letter on to Professor Walker-Smith and there is a letter which is in your additional records file. You should have a records file on Child 6 which is headed, “Additional records”, and this is because these are the records that have recently been disclosed. It is on page 2. As I say, it is from Dr Wakefield to Professor Walker-Smith:

“I received this letter from a GP who has a child with autism and bowel disorder who may be suitable for our study and who, I am sure, would be appropriate to be seen by you in Outpatients”.

After that, an outpatients’ appointment did take place with Professor Walker-Smith, and was followed by a letter to the GP. That is back in the ordinary GP records at page 123:

“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 27 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”.

Those symptoms enumerated by Professor Walker-Smith, our expert Professor Booth accepts do indicate a colonoscopy. On that same date, Professor Walker-Smith writes to Dr Wakefield, and this is back in the additional records at page 1. It has what must be a typo in relation to the date and I will tell you why in a moment. You see the date at the top of that letter on page 1 is 4 October 1995 but it is arranging for admission in October 1996, so the inevitable conclusion is that it is 4 October 1996, we say.

“I was very interested to see [Child 6] in clinic. This is a child who has been diagnosed as Asperger’s syndrome. In relationship to the MMR, he apparently had a measles rash [a] week before MMR at the age of 15 months, but the doctor proceeded with the MMR injection. He had behaviour changes within a week although mother has only relatively recently associated the change of behaviour with the MMR. He also believes that he had a blotchy rash a week or so after MMR which lasted 2 days and she thinks was accompanied by fever and a cold. He subsequently was diagnosed as Asperger’s syndrome by Dr Bennettt. Mother is rather vague about precise details, but apparently he has had recurrent episodes of abdominal pain and diarrhoea with blood and mucous in his stool intermittently from the age of 18 months. She says she has seen several doctors about this. On examination his nutrition is good but he is clearly quite a disturbed boy. He fits well into the spectrum of children we need to investigate. I have arranged for him to be admitted on Sunday 27th October 1996.”

Subsequently Child 6 was admitted to the Royal Free on 27 October and, during that admission, he underwent a colonoscopy which, as I have told you, our expert does not criticise in this particular child’s case, an MRI, lumbar puncture and an EEG and again, because of the uncertainties about the completeness of the available records, Professor Rutter, who is our psychiatric expert, does not feel in a position to comment on the decision to undertaken lumbar puncture in this case. Nonetheless, it should be mentioned that this is an instance of why lumbar puncture should not be lightly entered into because this little boy, like one other child, Child 5, whom I am going to be coming to, suffered a reaction to it with vomiting, headache and pain in his chest and that resulted in a local medical consultation after he had gone home.

Taking up the story again, Child 6 was said to have an indeterminate colitis and anti-inflammatories were prescribed and, in January 1998, he was seen again at the Royal Free Hospital by Professor Walker-Smith when the principal problem seemed by then to be constipation, but that of course had not been a feature earlier. So, the charges relating to this child are limited to the general ones which I am enumerating in respect of every child with respect to all three doctors, that this child was entered into a research project without proper ethics committee approval because he was one of the children who was seen before the start date of 18 December specified by the ethics committee and he again is a child who did not qualify for the study at least on one basis, that basis being that he had not had either measles or MR vaccinations.

I am going to turn on to Child 9, so you can put away those records and get out the Royal Free and general practitioner records for Child 9. It has been pointed out to me that I am going to refer to a local hospital record: local hospital records volume 2 for Child 9. This is a boy who was born in June 1990. He was referred to the Royal Free Hospital in September 1996 when he was six years of age. This child was born in Jersey and, although he was under the care of a GP there, he was principally looked after by a consultant paediatrician, Dr Spratt. He had his MMR vaccination in October 1991. When he was two-and-a-half in October 1992, he was referred to a consultant ear, nose and throat surgeon because of a recurrence of otitis media ear infection and because there were concerns about his speech development which was thought possibly to be attributable at that stage to a hearing problem. There was speculation over the next few months between Dr Spratt and the education psychologist and speech therapist involved in his care as to the diagnosis of his problems but, by June 1993 when he was three, it was felt that he had some from of autism and he was referred for assessment to a consultant paediatrician in Southampton who confirmed, although rather tentatively, that diagnosis of autism.

Thereafter, Child 9 was referred by Dr Spratt to an ENT consultant in relation to his ear problems and his parents took him directly for assessment at the vitamin B12 unit at the Chelsea and Westminster Hospital and thereafter Dr Spratt referred him to a consultant paediatric neurologist, a Dr Kavanagh, at that hospital. The boy underwent three admissions to the Chelsea and Westminster Hospital, one under this paediatric neurologist; two for vitamin B12 investigations. During the second of these admissions, he was given a lumbar puncture under general anaesthetic because it proved impossible in his case to do it under sedation. A diagnosis at the Chelsea and Westminster was ultimately made that the child had a B12 deficiency – that was in November 1995 – and it was mooted at that hospital that a referral be made to Professor Walker-Smith but Dr Spratt did not in fact make the referral at that stage because Child 9 had no gastrointestinal symptoms and, as far as he was aware, never had had them.

Then, apparently out of the blue, in September 1996 came a letter from
Professor Walker-Smith to Dr Spratt – it appears that they knew each other personally – and that letter is on page 91 of the GP records which is dated 11 September 1996,

“Dear Clifford

We recently have become aware of a syndrome of enteritis and disintegrative disorder or autism. We have in fact investigated two children so far and during treatment they both had evidence of bowel inflammation. Whether this relates to Crohn’s disease or whether it is related to measles immunisation or measles itself is quite unclear. However, I have heard from Dr Wakefield that there is a child called [Child 9] who is resident in Jersey whose parents would be quite keen for us to investigate the child in our protocol. I am just wondering whether you think that this is at all appropriate. If you felt it appropriate I would be happy to see the child.

Just in case you may be interested, I am enclosing a copy of Dr Wakefield’s detailed proposal. I look forward to hearing your comments.”

That letter enclosed a document which is by now familiar to you, if you turn over on to the next page, page 92, namely the proposed clinical and scientific study document which was the subject of project 172-96 and again in almost identical form to that submitted to the ethics committee.

Dr Spratt responded to that letter from Professor Walker-Smith and his response is in the Royal Free records at page 38,

“Thank you for your kind letter of 11 September, and enclosures.

I would of course be very pleased to have your opinion of [Child 9]’s distressing case history, and to take your advice about his proposed referral to Dr Wakefield’s service.

If convenient could I suggest you send his parents notice of a clinic appointment or short-stay admission to your ward – as you prefer – directly?”

On 8 November 1996, Child 9 attended an outpatient appointment with Professor Walker-Smith and the results of that appointment are reflected in the letter that Professor Walker-Smith subsequently wrote to Dr Spratt which is at page 36,

“I duly saw [Child 9] in the outpatients. From a gastrointestinal point of view it is interesting that he does pass 1 loose stool a day which in fact seems to be his pattern from the age of 2. He also has screaming attacks which are clearly related to food which his parents attribute to abdominal pain, it is difficult to interpret this. As you know his diet has become severely limited but despite this he is gaining weight and growing to above average with height and weight both above the 90th centile. We have now seen several children with autism and gastrointestinal symptoms, all of whom on gastrointestinal investigation have proved to [have] some kind of bowel inflammation. It is quite difficult to relate this directly to autism. Dr Wakefield, as you know, believes that immunisation may play some part, although I remain neutral on this issue for the moment. However the parents are keen that we should endeavour to investigate [Child 9], and I have therefore arranged for him to come in to have a colonoscopy, He will be admitted on the 17th November; we will then endeavour to follow this by barium meal and follow through and also to do a repeat lumbar puncture. We will let you know the results of these investigations.”

It is our case that this boy had no history of gastrointestinal problems save the relatively minor symptoms elicited from the parents at that outpatient interview and Professor Walker-Smith did not, as our expert says he should have done, order blood tests to test for inflammatory indices. He simply arranged for a colonoscopy to be carried out, for a barium meal and follow-through and for what he was expressly aware was a repeat lumbar puncture and the child was admitted on 17 November 1996. Again, consent forms in the standard clinical format for a clinically required colonoscopy and for the extra research biopsies were signed.

There is a note at that stage that the parents refused for the child to have a lumbar puncture although, as you will hear, a lumbar puncture in fact did take place at a later date under general anaesthetic.

On 18 November, the colonoscopy was carried out and was subsequently reported as indicating no abnormality up to the terminal ileum except for a small area of erythematous, that is reddening, and with a marked increase in the size and number of prominent lymph nodules. A full blood count was reported the next day as being normal and thus, we say, it would have been normal had it been carried out when it should have been, namely prior to making the decision to embark on colonoscopy.

On 20 November the boy underwent a barium meal and follow-through. The records indicate that the histology showed no active inflammation, and I will refer to that as a relevance later, but if you look to the Royal Free Hospital records at page 48 you will see the description of the histology at the bottom of the page:

“Small bowel mucosa showing no histological abnormality.

Large bowel mucosa showing prominent lymphoid follicles but no histological abnormality”.

Then if you go to page 8 of the record you will see that reflected in the little boy’s clinical records, where it says:

“Histology: No active information
No crypt distortion.”

He was discharged on 22 November 1996, but he was readmitted on 9 December, so that is nearly three weeks later, for an MRI scan and for a lumbar puncture under general anaesthetic, and on that occasion he also underwent an EEG.

At no point during either of his two admissions does there appear to have been a neurological or psychiatric assessment of him, and thus we say he was investigated in a research study for which he did not qualify since he had arrived at the Royal Free with a diagnosis of autism and that was never reassessed. Furthermore, he had a lumbar puncture without any neurological assessment to see if that investigation was clinically indicated, and in fact we shall be calling expert evidence in the form of Professor Rutter that on the basis of the only diagnosis that was available, autism, a lumbar puncture was not clinically indicated.

He was discharged again on 11 December, so a couple of days after those investigations had been carried out, and at that point Professor Walker-Smith reported back to Dr Spratt, and that letter in the Royal Free records is at page 33.

“[Child 9] was duly admitted. Endoscopy revealed a marked increase in size and number of prominent lymph nodes in the terminal ileum ie. lymphoid nodular hyperplasia. The colon was endoscopically normal except for an area at the hepatic flexure which was slightly erythematous.

Histologically there was an increase in chronic inflammatory cells throughout the colon with a moderate increase in intra-epithelial lymphocytes.

Other investigations were however normal and are begin collected and you will have a discharge summary soon.

Our diagnosis is indeterminate colitis with lymphoid nodular hyperplasia.

A therapeutic trial of Mesalazine” – which is an anti-inflammatory – “may be worthwhile.

We have now studied seven children all of whom have had some evidence of enterocolitis and disintegrative disorder following MMR. Two of these may have Crohn’s disease. One of these has improved significantly on enteral feeding.”

That is the liquid feeding you will recall with Child 2.

“Clearly this is a difficult group of children and our work is only beginning but we will keep you informed.

I wonder if you have seen any other similar cases in Jersey.”

Now, you will appreciate that that histological description given to Dr Spratt of an increase in chronic inflammatory cells with a moderate increase in intra-epithelial lymphocytes is at contrast to what is said in the histology report that we have looked at. There is no explanation anywhere as to how that change came about. Again I reiterate, this is not just a mere formality. The difficulty, on our expert’s view, is that any clinician subsequently treating this child is faced with apparently normal findings and yet a diagnosis of inflammation and advice of treatment to be given for it, and no way of making sense between those two positions.

Dr Spratt wrote back to Professor Walker-Smith on 10 January 1997, and that is at page 29 in the Royal Free records, thanking him for his interesting letter.

“Clearly your findings are interesting and I shall be pleased to take your advice about the details of any useful therapeutic trial of mesalazine in [9]’s case. Please let me know.

For my part I have no evidence to link the little boy’s history of severe developmental delay and learning difficulties within a significant gastrointestinal history – nor indeed, for that matter, his receipt of immunising agents in his first two years of life. I shall of course be interested to follow his gastrointestinal [history] from a bit of a distance in future months/years and to learn more of your research in due course. In particular the source of your control material for the studies you are undertaking at the moment.

In an historical way I would also be grateful for your opinion about the boy’s present and likely past Vitamin B12 status – in the context of what I interpret as likely fairly mild terminal ileal inflammation, long-running significant dietary ‘deficiency’ and the general cognitive characteristics which I at least without any semantic allegiance have considered a form of autism.

If you could respond with reference to trial use of medical treatment soon I would be most grateful, I will take your further reply as my cue to try to re-establish clinical contact with the little boy’s parents and their family doctor in Jersey.”

A formal discharge summary was then sent on 14 January 1997, and that is at page 31, the next page. I am going to read it through briefly, or parts of it:

“[9] was admitted ….. for investigation of his autistic behaviour and gastro-intestinal symptoms.”

His birth history:

“At 18-20 months ….. he started ….. regressing mentally. His mother links that with MMR which was given at 16 months of age. He started having loose stools around the age of 2-3 ….. with no blood or mucous. There is also a history of screaming episodes which last for 10-30 minutes ….. investigation for vitamin B12 deficiency and is currently on ….. supplements ….. general physical examination was unremarkable. His motor development is appropriate for his age ….. underwent neurodevelopment assessment, the results of which will be forwarded to you. He had a colonoscopy done on 18th which showed a marked increase in size and number of lymphoid follicle in terminal ileum. Histology of the large bowel mucosa also showed prominent lymphyoid follicle and increase in chronic inflammatory cell infiltrate. An attempt was made at barium meal and follow through but he was not co-operative so it could not be done.”

It sets out the other investigations; all normal except for a very high lead level and request that that be repeated. An MRI, which was normal.

“In summary the gastrointestinal investigation suggested a diagnosis of indeterminate colititis and lymphoid nodular hyperplasia. A therapeutic trial of Asacol” – which is the anti-inflammatory that Professor Walker-Smith had referred to – “may be useful. We have [not] arranged a follow up appointment for the moment.”

Very shortly thereafter Professor Walker-Smith wrote directly to Dr Spratt, recommending a trial of mesalazine - these are all different preparations of what are very similar anti-inflammatories – and Dr Spratt duly arranged for that prescription with the GP. Thereafter the records indicate that different anti-inflammatories were prescribed, but ultimately in July 1997 Dr Spratt wrote to Professor Walker-Smith asking for advice, and that is in the GP records at page 54. I do not propose to read out the first part of this. It relates to Dr Spratt’s following up the high lead level in this child’s blood, which is not relevant to the issues that we are considering. Then at the last paragraph he says:

“Could you also advise whether or not to carry on with anti-colitic therapy, as the boy has never had specific gastrointestinal symptoms and neither his bowel habit nor his autism seems to have altered in response to his use of medication over the past three months? Would you want [to let] him ….. have another colonoscopy and biopsy at a future date? Please let me know.”

Professor Walker-Smith responded, and that is in the child’s local hospital records, volume 2, at page 163. From Professor Walker-Smith to Dr Spratt:

“Many thanks for your letter ….. I have discussed the situation with Andy Wakefield. If there has been no change in symptoms on Sulphasalazine ….. I would stop the drug. Ideally perhaps one would consider repeating endoscopy but without any symptomatic improvement this does not seem to be relevant. Later on as our knowledge of this disorder develops we may indeed need to repeat endoscopic and biopsy studies.”

Then he deals with the lead level question.

“Sorry not to have been of more help. I would be interested to hear from time to time about [9]’s subsequent progress.”

Subsequently, Dr Spratt kept Professor Walker-Smith intermittently involved with his care of Child 9, and sadly his behavioural problems continued and indeed became complicated by the onset of epilepsy, and there the story ends as far as this case is concerned.

Insofar as the charges are concerned, Professor Walker-Smith, Dr Wakefield and Professor Murch all face the general charges that they carried out research on Child 9 without ethical approval, in that Child 9 was enrolled earlier than the start date for the project, had never had the measles or MR vaccination and in fact had had MMR, and did not qualify because he did not have disintegrative disorder, his diagnosis was autism at admission, and there appears to have been no attempt to reassess that. Furthermore, the consent forms and information sheet were not filed in Child 9’s records as had been requested by the Ethics Committee.

There are additional charges in respect of Dr Wakefield and Professor Walker-Smith. Dr Wakefield is additionally charged in respect of his responsibility for causing Child 9 to have a lumbar puncture without having him properly assessed to see if it was clinically indicated, and subjecting him to it when in fact it was not clinically indicated. He is charged arising out of that with misrepresenting to the Ethics Committee that the investigation was clinically indicated when it was not.

Professor Walker-Smith is charged with failing to test for inflammatory indices prior to making the decision that Child 9 should undergo a colonoscopy, subjecting him to a colonoscopy and barium meal and follow-through which were not clinically indicated on his history and symptoms, and with further charges relating to the lumbar puncture, that he again failed to ensure that the child was properly assessed to see if a lumbar puncture was appropriate and subjected the child to it when it was not in fact appropriate. Furthermore, in relation to those investigations, again misrepresenting the position with the Ethics Committee.

Lastly, Professor Walker-Smith is charged with his failure to provide any explanation in Child 9’s records for his change of the histological description of the biopsy samples.

So that is Child 9, sir, and I now propose to go on to Child 5. Again, if you would get out the GP and the Royal Free records in relation to that child.

Child 5 was a little boy born in December 1988, referred to the Royal Free in October 1996 when he was nearly eight years old. The GP records indicate that when he was eleven months old, in November 1989, he suffered a febrile convulsion with vomiting and diarrhoea, and he was admitted to hospital for two days. In April 1990 he had his MMR vaccination. From August 1990 concerns started to be expressed about his development and behaviour, and a referral was made to an ENT consultant first of all to see if there was a hearing problem which might be responsible for his delayed language. He attended thereafter a developmental language clinic, but by March 1991 the family was still very worried, and in view of a family history of learning difficulties referral was made then to a consultant paediatrician, and thereafter to a clinical psychologist and psychiatrist, the latter thinking that it was likely that he was autistic, and he was also sent to a consultant immunologist.

The only references in the GP records to gastrointestinal symptoms are to some food intolerance, tentatively attributed to candida, which is a fungal condition, and nystatin was prescribed for that.

On 30 September 1996 Dr Wakefield contacted Child 5’s GP by telephoning the surgery, and he spoke there to a Dr Letham, who was not in fact Child 5’s GP but was another partner in the practice, and he gave what Dr Letham described as a very lengthy and convincing case for Child 5 to be referred to the Royal Free Hospital. We can look at the note that Dr Letham made of that call, which is relevant of course to the issues relating to referral, and that is on page 106 of the GP records. You will see that that is a letter which is in fact written to the GP from whom you will be hearing, from one of the partners who had taken the call.

“Re [Child 5]

Dr Wakefield, consultant gastroenterologist Royal Free rang and gave a very lengthy & convincing case for [Child 5] to be referred to:

Prof. John Walker-Smith [address and phone number] as they have findings suggesting that there is an association between inflammatory bowel disease/enteritis causing a failure to absorb B12 which is need to myelinate till age 10 [leading to] neurological problems/autism. (Measles vaccine may be implicated but that is being researched & uncertain of implications.) Anyway – see fax – parents are keen – will you refer – presumably is extra contractual.”

As a result of that, the child’s GP, Dr Shillam, wrote a referral letter, which is at page 105, the page before:

“This 7¾ year old autistic child’s parents have been in contact with Dr Wakefield and have asked me to refer him to yourself regarding your current study into association between autism and childhood bowel problems.

[Child 5] has presented with developmental delay, and severe communication problems, and autism was diagnosed when he was aged three. He has the classic features of autism and appears to be continually frustrated by his inability to communicate with anybody. His behaviour has been very bizarre and he is often very difficult to contain [within] a room, house or garden. His parents have managed him remarkably well, but he needs one to one attention virtually all the time. His behaviour has become more violent in recent months and it is possible that he may be excluded from the school for mentally handicapped children which he attends in Newbury.

He has also seen …”

He lists the consultant clinical psychologist, consultant paediatrician, a doctor at the child guidance clinic and a consultant psychologist at the Oxford Radcliffe Hospital:

“His parents are concerned about an association they have read in the “Daily Mail” between MMR vaccine, childhood enteritis and possible brain damage. [Child 5] had his MMR vaccine on 10.04.90. He did not have pertussis vaccine, but received three doses of diphtheria, tetanus and polio, followed by another dose at age 3½ years.

Thank you for seeing this child.”

Those were the terms of the referral letter.

We say it is a significant letter in a number of respects. It is clear that the impetus for referral has been the parents via Dr Wakefield; the child’s diagnosis at that time was one of classical autism; most significantly and a matter that I have already alluded to, there is no mention at all of any gastrointestinal symptoms and the referral was plainly prompted by the parents’ concerns in relation to the MMR vaccine.

Child 5 attended at outpatient appointment with Professor Walker-Smith on 8 November 1996, and Professor Walker-Smith subsequently wrote in a letter reflecting that appointment on 12 November 1996, and that is at page 361 of the Royal Free records:

“Dear Dr Shillam,

Many thanks for referring this child with autism and disturbed behaviour. He demonstrated how difficult his behaviour can be when I saw him in the clinic and we did not proceed with any blood tests. He has a number of episodes which have been interpreted as abdominal pain when he draws up his legs and appears to suffer from abdominal pain. He has intermittent episodes of diarrhoea which apparently responded in part to Nystatin which has been prescribed over the past year. Several of these children with autism have had gastrointestinal symptoms and on investigations have proved to have gastrointestinal pathology. I am arranging for him to come in for a colonoscopy on Sunday 1st December 1996.”

So there we see a decision was made to proceed to colonoscopy and if an attempt, not a conclusive attempt, to take any blood for inflammatory indices (sic) and although on the basis of our expert evidence we say that the gastrointestinal symptoms were minor and/or highly speculative. The child was admitted to the Royal Free on 1 December 1996: consent obtained on the standard clinical consent form, and a research consent form, again, was used for the proposed biopsies. The colonoscopy was carried out on this occasion by Professor Murch, who observed some loss of vascular pattern in the colon and caecum and prominent follicles in the ileum but not sufficient to call them lymphoid nodular hyperplasia, that is a quote from his observations.

The histopathology report also recorded only minor changes, although it was recorded on the report that Professor Walker-Smith believed the inflammation to be more significant than the report indicated.

On the same day a request was made for an EEG. That was signed by Dr Wakefield, although you will recall he had had no clinical responsibilities. He gave as his reason for the investigation, again, disintegrative disorder plus autism, although he had no basis, we say, for saying that Child 5 was suffering from disintegrative disorder, and, indeed, as you will see, the contrary became apparent by the next day when this child was one child who was seen by Dr Berelowitz, the psychiatrist, and who then wrote to Dr Wakefield with a different view, and that view is in a letter on page 354 of the Royal Free records:

“Thank you for asking me to see [Child 5]. I saw his mother and observed [him] briefly on the 3rd December 1996.

His mother reported that the birth and pregnancy were fine and that [Child 5] was born healthy baby and he initially seemed to be advanced in his milestones. However, from 18 months be began to lose his language, become less sociable and less responsive. Now he has few words, his play is not purposeful and his affection is muddled with aggression. Certain foods make his behaviour worse, but there is no correlation between bowel problems and his behavioural problems.

[Child 5] was diagnosed autistic at the age of 3 and was in Special School but has now been excluded because of his aggression.

I think the likely diagnosis is a developmental disorder, such as autism. However, I thought he was a slightly unusual looking child and so obviously the usual chromosomal studies need to be done.”

That letter was sent to Dr Wakefield and copied to Professor Murch from the psychiatrist involved in project 17296, Dr Berelowitz.

Our criticism is that that psychiatric assessment was obtained after the colonoscopy had taken place. It did not confirm the diagnosis of disintegrative disorder which formed the basis of the study. Two days after that he was seen by Dr Harvey, the neurologist, so he had played no part in the decision that had been made that he should undergo these invasive tests. Subsequent to that, he had an MRI scan, the EEG that had already been ordered by Dr Wakefield and a barium meal and follow-through. It appears that an attempt at a lumbar puncture was carried out, but, if so, for some reason, it was regarded as unsatisfactory, and subsequently, on 15 January 1997, Child 5 was readmitted to the Royal Free, and on this occasion he underwent a lumbar puncture under general anaesthetic.

Our expert, Professor Rutter, does not criticise that lumbar puncture because the procedure in that case, unlike some, was undertaken after neurological assessment by Dr Harvey, but, again, it is relevant to point out that in Child 5’s case it did lead to an emergency admission to the Royal Berkshire Hospital with back pain and vomiting. So, as I say, we do not criticise the carrying out of the procedure because what is criticised by Professor Rutter in some cases is the lack of any psychiatric and/or neurological assessment. In this case there was a neurological assessment, but nonetheless the unfortunate consequences highlight our case that this procedure is not one to be embarked on lightly since it is one indeed which carries real, albeit small, risks, and this is another child to whom that applies.

Child 5 was subsequently prescribed liquid paraffin for his constipation, and anti-inflammatories, and ultimately – and there is a lengthy history attaching to this – he became very unwell with gastrointestinal symptoms which were ultimately investigated by a laparotomy and open procedure, carried out at the Royal Free Hospital, which revealed that by then he had, sadly, swallowed multiple foreign bodies.

The charges relating to this case, with regard to Dr Wakefield, Professor Walker-Smith and Professor Murch, the general charge that this child had investigations for research purposes without ethics committee approval for the research; the research was clearly research pursuant to project 17296 and yet the child was enrolled before 18 December; Child 5 was not vaccinated with measles or measles rubella vaccination and there is no evidence, we say, that he suffered from disintegrative disorder prior to decisions being made to carry out an invasive colonoscopy, and, indeed, even afterwards, ultimately, there was a tentative diagnosis of autism, with the suggestion of a chromosomal disorder; the proper research forms and patient information sheets were not filed with his records, as the ethics committee had specified, and the additional charges, this time in respect of all three charges, are that Dr Wakefield ordered an investigation when he was not paediatrically qualified and in contravention of the limitations on his honorary contract (EEG) and gave as one of the reasons for the test a diagnosis of disintegrative disorder when there was no such diagnosis.

In addition, there are charges against Professor Walker-Smith for failing to carry out tests for inflammatory indices, and causing Child 5 to have a colonoscopy and barium meal and follow-through which were not clinical indicated, and, further, that he did that in circumstances contrary to his representations to the ethics committee.

Lastly, there are additional charges against Professor Murch arising, again, from the same point, his role in the carrying out of the colonoscopy ordered by Professor Walker-Smith.

Sir, it is five past one and that is three children, and I think probably, given their similarities, three is enough for anybody to assimilate so I wonder whether you would consider that the appropriate point to break for lunch.

THE CHAIRMAN: Yes indeed. As I said yesterday, we are going to have a slightly shorter lunch break of about 45 minutes today. It is 1.05 so we will resume at ten minutes to two.

(Luncheon adjournment)

THE CHAIRMAN: Good afternoon. Ms Smith, would you continue?

MS SMITH: Thank you sir. I am going to look at Child 12 next, so if you were able to find the GP records and the Royal Free records for Child 12 at this point.

This is another boy, born in December 1990, so when he was referred to the Royal Free Hospital in September 1996 he was nearly six years old. As far as his background from the GP records is concerned, there were no concerns indicated in his medical records from his birth until his MMR vaccination, which was in March 1992.

In June 1992, when he was 18 months old, there was a suggestion of some speech delay, and by the time he was three years old that was becoming an obvious problem.

In July 1994, when he was three and a half, he had an attack of vomiting and diarrhoea, which was diagnosed by his GP as a viral illness, and then from November 1994 onwards concerns were expressed about his behaviour and his general development, and soiling was noted to be a particular problem.

In March 1996 his GP records a further episode of diarrhoea and vomiting, and by then soiling is described as a significant problem, and he was referred to a consultant psychiatrist who felt that he suffered from Asperger’s Syndrome.

Meanwhile, Child 12’s mother, to whom I am going to be referring as “Mrs 12” and from whom you are going to hear evidence in due course, had met the mother of Children 6 and 7 at a parent and toddler group, and that mother had told her about Dr Wakefield and his work on the link between bowel problems and the MMR vaccine, and she said that when she heard that she felt as though a jigsaw had fitted into place. She telephoned Dr Wakefield direct in July 1996 and subsequently there was an exchange of letters between them, which you will be hearing about. At the same time she contacted, you will recall, Dawbarn’s solicitors, who she had heard were investigating the same sort of cases, and instructed them to act on her behalf.

Dr Wakefield’s letter to Mrs 12 is in the GP records at page 126, and that letter reads:

“Dear [Mrs 12]

Thank you for your letter regarding your son. We have recently taken a profound interest in this subject, particularly in view of the link between bowel problems and Asperger’s Syndrome. I would greatly appreciate if you would mind calling me at the Royal Free before 3rd August and in addition I would like you to seek a referral from your GP to Professor John Walker-Smith, Professor of Paediatric Gastroenterology at the Royal Free Hospital, for investigation. It will be necessary for me to discuss the nature of the referral with your GP and I would be very grateful if you could let me have his/her name telephone number. Also, could you please let me have your telephone number so that I can speak to you directly on the subject.”

He followed that letter up the next day with a phone call to Child 12’s general practitioner, Dr Stuart. Dr Stuart made a short note, which I shall refer you to later when she is called to give evidence, of the call in which she recorded that Dr Wakefield had called and said that Child 12 needed a colonoscopy.

Meanwhile, Mrs 12 requested from Mr Barr, her solicitor, a copy of Dr Wakefield’s proposed client’s clinical and scientific study. That is the document, you will remember, that sets out the aims of Project 172-96. Dr Stuart duly referred Child 12, by a letter dated 23 September 1996. That is on page 124. You will see from that that the address at the top is to Professor Walker-Smith, but underneath it says, “For the Attention of Mr Wakefield” and the letter indeed starts, “Dear Mr Wakefield”,

“Thank you for seeing 12 who we have discussed on the phone recently. He initially presented at his 18 month check with delay in talking and communication skills. He was seen locally at the Speech Therapy department and has been under the care of our local community paediatrician since that time with behavioural difficulties. He has been rather hyperactive and difficult to control and became easily distressed when his routine was changed. His early years were unremarkable apart from the usual upper respiratory infections. He had chicken pox in January 1992 and his routine MMR vaccine in March 1992. He has for some time had bowel problems but did not present to my surgery until March this year when Mrs 12 came along to discuss his soiling habit.

On examination at that time his abdomen was normal with an empty rectum. He has seen Dr Ing our local Consultant Child and Adolescent Psychiatrist who has expressed the opinion that 12 may well have Aspergers Syndrome”.

She then says she looks forward to hearing the doctor’s opinion regarding 12’s further investigation and outlook.

Professor Walker-Smith arranged an outpatient appointment, which took place on 18 October 1996. At that appointment blood tests were taken. Subsequent to that, Mrs 12 wrote to him a letter whose terms make plain the outcome of the consultation, and it is at page 68 of the Royal Free records. This is a letter from Mrs 12 directly to Professor Walker-Smith after the outpatient’s appointment:

“I am writing following 12’s visit to the Royal Free Hospital last Friday 18 October 1996. My husband and I have thought long and hard about this situation since the appointment. We have also reread Dr Wakefield’s proposed clinical and scientific study notes.

We do feel that 12 does have a problem in that most children his age do not soil themselves a number of times a day. As well as being pale in colour and foul smelling (as are his motions in general), this soiling is always very loose which might explain why he is not always aware that he has done anything. Although I would not say it was diarrhoea exactly.

Obviously I do not wish to put my son through any procedures unnecessarily but there must be a reason why he has these problems. Also, as I mentioned to you at our meeting, 12 is not growing or putting on weight like my other two children.

I keenly await the results of the blood tests and if you feel they warrant further investigation my husband and I are happy for him to be referred on to Dr Wakefield’s study project. As you pointed out, it might not help 12, but if not, hopefully it will be of benefit to others. There is also the chance that 12 has a problem that can be detected and helped”.

Thereafter Professor Walker-Smith wrote to the GP, and you can see that letter if you turn back to page 67. That letter thanks the GP for referring the child,

“certainly he seems to fit the spectrum of autism. I am interested that he in fact does not have very significant gastrointestinal symptoms, although as you say he has had some soiling. I note that you found his rectum was empty. When I examined him today he certainly had no evidence of faecal loading. He is gaining weight and growing satisfactorily. Some of the previous children I have had referred to me with autism have had clear cut gastrointestinal symptoms with quite severe abdominal pain and intermittent bleeding and we have gone ahead with our programme of colonoscopy and intensive investigation. However in 12’s case there is relatively minor gastrointestinal symptoms. I felt it right to perform a full blood count ESR, CRP and I will discuss further with Mrs 12 concerning the need for intensive further investigation and if the parents wish us to proceed we could certainly arrange this. For the moment I have told Mrs 12 to be in touch about the results of the blood tests and I have not given another outpatient appointment”.

Professor Walker-Smith also then wrote to Dr Wakefield, and that letter is at page 66. That letter too is a highly significant one for reasons I will go into in a moment:

“Dear Andy, it is interesting to see this child who really has the features of autism but rather minimal gastrointestinal symptoms. I did not feel it right in fact to proceed with our intensive programme at the moment until we have had Ethics Committee approval and it is clear that the parents wish us to proceed”.

The reason we say that that series of letters is a significant one, is because it in fact sets out what Professor Booth, our expert, says is the proper approach: i.e. the child has what Professor Walker-Smith regards as minor gastrointestinal symptoms. A decision to undertake an intensive colonoscopy is not warranted without first seeing if there are any inflammatory markers in the blood. We would also add that Professor Walker-Smith is clearly, we say, acknowledging there that the investigations are not clinically indicated; they are research driven and that is why he cannot proceed without Ethics Committee approval.

So far so good, but unfortunately he did not adhere to those principles. The blood results showed that one inflammatory marker was elevated by what our expert, Professor Booth, describes as a “minimal” amount; that is, it was very marginally above the normal range for the Royal Free Hospital’s laboratory. Professor Booth will tell you that it was within many labs’ normal range. But its relevance is that we say Professor Walker-Smith used it, in effect, as an excuse to proceed and admit this child for colonoscopy. He wrote to Child 12’s mother, and that letter is at page 38,

“Dear Mrs 12, Many thanks for your letter of 20 October. I have now got back the blood tests. One was slightly abnormal. As I see that you are keen for us to proceed with investigation” –

that being a reference to her letter which I have read to you –

“I think it would be appropriate for us to arrange for 12 to come in for a colonoscopy. I explained in the outpatients what this involved. Basically he is sedated and the colonoscope is passed through the lower bowel and pieces of tissue are taken. The children are usually admitted for the course of a week and various other aspects of the protocol are undertaken.. If you would like us to proceed with this, please let my secretary know and we will arrange a date for 12 to come in in the new year”.

Apparently that was approved and you will see in manuscript on it,

“Go ahead and arrange colonoscopy for new year”.

It was arranged and Child 12 was admitted on 5 January 1997. A consent form was signed and the standard form for a clinical procedure, as was a consent form for the standard research biopsies. The plan, which was set out in the admission record, was for bloods to be taken, a colonoscopy, barium meal and follow-through, MRI and lumbar puncture. Professor Murch carried out the colonoscopy and recorded that the findings were almost normal, albeit with slight changes in vascularity and prominent lymphoid follicles. There is a note that on a ward round Professor Walker-Smith queried whether those findings constituted “minor inflammatory changes”. The subsequent histology report on the colonic biopsies was normal.

On 6 January – that is the same ward round as the one I have just referred to where Professor Walker-Smith queried the histology – Professor Walker-Smith also apparently said that Child 12 was not to have an MRI or a lumbar puncture, although he was to have the planned barium meal and follow-through. On 9 January the child was visited by Dr Harvey, the neurologist, who made a note that he was fast asleep, and Dr Harvey indicated in the notes that therefore he would do a home assessment at a later date. However, in circumstances where a neurologist had not authorised it, because the child was asleep and he did not do a proper examination and where Professor Walker-Smith, for reasons which are not clear from the records, had at least initially said that the child was not to have it, this little boy still underwent a lumbar puncture and an MRI scan as well as an EEG. It is our case that that is consistent with what I can only describe as the “conveyor belt” nature of this project; namely, that investigations were standardised and planned and carried out regardless of individual circumstances.

The evidence of our expert is that there was no clinical justification for lumbar puncture, given the unrevised diagnosis of autism with which this child had gone into hospital. In so far as the EEG is concerned, this is another example of the request for that being signed by Dr Wakefield, although he had no clinical responsibilities.

On 10 January, very shortly before his discharge, Child 12 was seen by Dr Berelowitz, who gave a diagnosis of language delay, query attention deficit disorder, query features of Aspergers. The significance of that diagnosis is, of course, two-fold. Firstly, the assessment was not made until after the child had been admitted to hospital and subjected to the invasive investigations. Those investigations were carried out pursuant to research, we say, into disintegrative disorder, when prior to admission he had not had that diagnosis – the diagnosis of disintegrative disorder – and no attempt had been made to diagnose the nature of his developmental problems on admission. Secondly, of course, the second significance of Dr Berelowitz’s ultimate diagnosis is that when he was ultimately assessed, he did not have a diagnosis of disintegrative disorder.

When he was discharged, a discharge summary was sent to his GP by Dr Casson, the registrar and lecturer. That is at page 32 of the Royal Free Hospital records:

“Dear Dr Stuart, further to having been seen in clinic 12 was admitted to the Royal Free Hospital for further investigations of his gastrointestinal problems”.

There is then reference to a normal pregnancy.

“He had been followed by paediatricians locally for one year because of poor apgars scores”.

Those of course are scores on birth.

“Nevertheless, his development was recorded as normal until the age of 16 months. Subsequent to this his parents noticed a loss of language skills. He was also noted to stop playing and his behaviour has progressively deteriorated”.

It then says he can only talk incomprehensively. He has difficulty in expressing himself, poor social skills and temper tantrums.

“In regard to gastrointestinal symptoms, he was noted to be clean and dry by the age of 3 years, subsequent to this his soiling started and he is presently soiling up to 8 times a day. He does not realise he has opened his bowels and that he has soiled. The faeces are very pale, loose and smelly. The abdominal pain occurs approximately once a week, occasionally associated with vomiting and anorexia” –

that is, no appetite.

“He had his measles vaccination at 15 months”,

then there is the family history set out. Blood test results are given.

“A colonoscopy was performed under sedation. This recorded almost normal appearances to the caecum. There were minor changes in the rectum and the caecum these consisting of slight changes in vascularity and prominent lymphoid follicles…Histological report on the biopsies taken on this series do not show any significant abnormality. A barium meal and follow through demonstrated lymphonodular hyperplasia of the terminal ileum.

It was notable that following the bowel clear out, prior to the colonoscopy, 12’s behaviour appeared to improve as did his soiling. It is therefore conceivable that many of his problems are associated with a degree of constipation. In view of this he has been started on liquid Paraffin medication”.

Then, in April 1997, we get a letter from Professor Walker-Smith to the GP again, which is at page 31,

“Dear Dr Stuart, We have had quite a remarkable success with the use of sulphasalazine or 5 ASA derivates in children with autism and evidence of lymphoid nodular hyperplasia and non-specific colitis as we found in 12. I think it would be appropriate to consider a therapeutic trial of one of these agents. These drugs appear not only to help gastrointestinal symptoms but also rather surprisingly helped behavioural symptoms. I have therefore suggested that you might consider a therapeutic trial of Olsalazine 250 mgs 3 times a day for 12. I would be very interested if you decide to do this to hear about his subsequent progress”.

Those anti-inflammatories appear to have been prescribed on the basis that Child 12 had evidence of non-specific colitis. There is no explanation whatsoever of the basis upon which Professor Walker-Smith came to that conclusion, given the findings on colonoscopy and the normal histology report, and it is our case again that such an explanation is extremely important as far as clinicians subsequently treating this child are concerned.

He was followed up in outpatients and an abdominal x-ray was carried out which showed marked faecal loading. In other words, it was entirely consistent with the discharge diagnosis which had been constipation. Yet despite what our expert describes as compelling evidence that this child was suffering from constipation, Professor Walker-Smith subsequently advised the GP that the anti-inflammatories should continue and the treatment with laxatives – i.e. the constipation treatment – should be withheld. Subsequently, in July 1997, the liquid paraffin for constipation was reintroduced and he was discharged with the recommendation that he continue on both that and the anti-inflammatories, but it is the withholding of the obvious treatment in favour, we say, of the research interest as to the effect of anti-inflammatories that Professor Booth, our expert, criticises.

In so far as the charges are concerned, again, there are general charges relating to Dr Wakefield, Professor Walker-Smith and Professor Murch that this child had investigations for research purposes without ethics committee approval. We say that whilst this child was enrolled after the start date given by the ethics committee, he did not qualify in other respects because he was not vaccinated with measles or measles rubella vaccinations and there is no evidence that he suffered from disintegrative disorder as opposed to a relatively mild form of autism and indeed no attempt was made to ascertain the nature of his behavioural disorder prior to the investigative procedures being carried out. Again, we criticise the fact that there were no proper research consent forms and no patient information sheets filed with his records as the ethics committee had required.

There are additional charges in respect of all three doctors. Dr Wakefield is additionally charged with causing Child 12 to undergo a lumbar puncture without ensuring proper neurological and psychiatric assessment and furthermore a lumbar puncture which was not clinically indicated and was therefore contrary to the child’s interests and in respect of which he had informed the ethics committee of course that the test was clinically indicated. He is also charged with ordering an investigation, that is the EEG and associated tests, when again he was not qualified to do so and had no clinical responsibilities.

In addition, there are charges against Professor Walker-Smith for causing the child to undergo colonoscopy, barium meal and follow-through although they were not clinically indicated and a lumbar puncture without ensuring proper neurological and psychiatric assessment again when they were not clinically indicated. Sir, may I help?

THE CHAIRMAN: You read this earlier – and I was looking at the spreadsheets as well – about Child 12 and it is mentioned, “not vaccinated with measles or MR vaccine” and I think that you read one of the discharge summaries on pages 32/33 from Dr Casson that he had had his measles vaccination at 15 months of age. That is on page 33. Maybe I have misunderstood something.

MS SMITH: It has been pointed out to me that in the GP records at page 10 – and you may like to look at it – you will see that he was given an MMR, mumps measles rubella, on 6 March 1992. It may be that the term “measles vaccine” is used as an umbrella term.

THE CHAIRMAN: I would imagine that that is probably what it is.

MS SMITH: Dr Casson will be giving evidence, so we can ask him to clarify.

THE CHAIRMAN: I am sorry to bring it to your notice but …

MS SMITH: Not at all, I am grateful. I have dealt with the additional charges against Dr Wakefield. With respect to the additional charges against Professor Walker-Smith, those are causing the child to undergo colonoscopy, barium meal and follow-through although they were not clinically indicated, and also causing the child to undergo a lumbar puncture without ensuring proper neurological and psychiatric assessment and again which was not in any event, we say, clinically indicated. In respect of both those investigations, he is charged with giving contrary information to the ethics committee that the tests were clinically indicated and he is furthermore lastly charged with the matter I referred you to in relation to the anti-inflammatories, failing to record his reasons for giving anti-inflammatories for colitis when the investigations for inflammation had been normal, and further for withholding laxatives in a child who was plainly suffering from constipation.

Lastly, sir, this is a case where Professor Murch carried out the colonoscopy and he is additionally charged in respect of his role in that regard.

Sir, that is Child 12. Sir, if it assists the Panel at all to have a few minutes between children to look at the spreadsheet or assimilate themselves or whether you would like me to go on, I am entirely in your hands of course.

THE CHAIRMAN: The speed this afternoon has been fine. I think that members of the Panel did feel earlier on that they were struggling a little.

MS SMITH: I had that conveyed to me and I do apologise. It stems partly from my being rather used to it but also to my knowing that there are witnesses pilling up outside. I am now putting them out of my mind and I am glad that the speed is better.

THE CHAIRMAN: The only thing I would suggest is that, when you do start a new child, give us maybe a couple of minutes to put the old bundles back and get the new bundles out.

MS SMITH: I will indeed, sir. Child 8 is the next one, the GP and the Royal Free records. Child 8 is the only girl in this series. She was born in July 1993 and she was referred to the Royal Free Hospital in October 1996 when she was three years old. The GP records indicate that, when she was ten months old, her mother expressed considerable concern about her development in comparison to that of her older sister and because of that concern, she was referred to a consultant paediatrician at her local hospital. He detected congenital heart disease and she was referred on to a paediatric cardiologist and ultimately, as a result of his diagnosis, she underwent a repair of a coarctation of the aorta. The cardiologist himself advised developmental follow up and noted that there was some developmental delay and also that she had a slightly unusual shaped head.

In January 1995 when she was a year and a half, she had her MMR and there is some reaction to it noted. In February 1995, she was admitted to hospital with a febrile convulsion and diarrhoea. She continued thereafter to have quite severe diarrhoea and she was noted to be delayed developmentally and her mother attributed her symptoms to her MMR vaccination. She remained under the care of both a consultant paediatrician and the consultant community paediatrician and there were other specialist referrals to an ENT surgeon first of all because it was thought that her speech delay might be attributable to a problem with her hearing, to a consultant psychiatrist and to a consultant in clinical genetics and subsequently to a consultant clinical psychologist and she underwent two EEGs, one in 1995 and one in 1996.

In September 1996, her mother off her own bat sought a referral to Dr Wakefield and we can see the note in the GP records at page 28 and the note to which I am referring is on 30 September 1996,

“Mum taking her to Dr Wakefield Royal Free Hospital for CT scans/gut biopsies. ? Crohn’s. Will need referral letter. Dr Wakefield to phone me. Funded through legal aid.”

As a result of that, the GP, Dr Jelley, from whom you will be hearing, wrote to Dr Wakefield on 3 October 1996 and that is in the Royal Free records at page 2,

“Dear Dr Wakefield,

[Child 8]’s mother … has been into see me and said that you need a referral letter from me in order to accept [Child 8] into your investigation programme. I gather this is a specific area of expertise relating to the possible effects of vaccine damage and her ongoing GI Tract symptoms. As far as I am concerned if [mother] is happy to proceed with this and it gives her any further information and peace of mind I am sure it would be beneficial for both her and [Child 8].”

Then she encloses photocopies of recent documentation to give a fair idea of Child 8’s current state.

“I would simply reiterate Dr Houlsby’s recent comment that both the hospital and members of the Primary Care Team involved with [Child 8] had significant concerns about her development some months before she had her MMR Vaccination. I take Mum’s point that she has video evidence of [Child 8] saying a few words prior to this vaccination being given and her vocal abilities are now nil but I don’t think we can be entirely convinced as yet the vaccine is the central cause of her current difficulties. However I am quite prepared to support [Mrs 8] in her quest for further information and I hope some useful results come from these tests.”

On 9 October, Dr Wakefield writes to Professor Walker-Smith and that letter is in the Royal Free records at page 35,

“Please find enclosed some details of the girl who was referred to me with secondary autism and bowel problems. I requested that a letter of referral be sent to you and I hope that this has been done. Nonetheless, here is confirmation of the referral.”

So, the problem appears to have been thought by Dr Wakefield to be secondary autism. That is not of course something that is referred to in the GP letter although it is fair to say that there may have been something in the enclosures which referred to the term “autism”. Certainly there is no mention of disintegrative disorder.

Meanwhile and before that referral, Child 8 was referred to a professor in child psychiatrist, a Professor Le Couteur, and, on 3 December 1996, Professor Walker-Smith wrote directly to Child 8’s mother and the letter is at page 22 of the Royal Free records,

“Dear [Mrs 8],

I have had documentation concerning [Child 8] and I have heard that you would like us to go ahead with the investigations. I have arranged for [Child 8] to be admitted to Malcolm Ward on the afternoon of Sunday 19 January 1996. The colonoscopy will be the next day and other investigations will be arranged during the week. [Child 8] will be able to go home on the Friday or Saturday.”

So, that is another occasion, like the one we saw this morning, where he has arranged for Child 8’s admission to hospital for invasive tests without even seeing her, i.e., we say, with no attempt at all to ascertain either the nature or the seriousness of her symptoms and we say again that that is quite simply wholly consistent with an admission for research purposes and wholly inconsistent with an individualised clinical approach.

As it happens, there is evidence that in fact the diarrhoea from which she had undoubtedly been suffering was by then no longer present. I am not going to refer you to all the records at the moment. Her local hospital records for January 1997 indicate that her diarrhoea had settled. Then, on 19 January, when she is actually admitted to the Royal Free for these investigations that Professor Walker-Smith sets out in that letter, there is a clerking note which is at page 8 and the note to which I am referring is the second paragraph on that page,

“About the same time she developed diarrhoea which continued for more than one year 5-6 loose stools per day. According to mother she tried primrose oil in November and her diarrhoea got better.”

Professor Booth criticises the carrying on with these investigations when, on her admission into hospital, there is a clear indication from her parent that the diarrhoea was not a problem at that time and we say that the reason that the investigations continued despite the indication of improvement was because this was a research-driven pre-ordained investigation which was going to be carried out on this child come what may.

The same procedure was followed: a standard clinical consent form for colonoscopy was signed. The next morning, which was 20 January 1997, a colonoscopy was carried out on the child. The endoscopy report described the findings as normal except for a mild increase in lymph node tissue in the terminal ileum. It is relevant that Dr Wakefield’s PROT, i.e. protocol, is written on that report and we say plainly shows that this was part of the research study.

There is then a histology report on the biopsies which had been obtained at the colonoscopy, concluding “minor inflammatory change. Possibly the result of operative artefact”, and in the clinical notes that is interpreted as “histology normal”.

The day after the colonoscopy, that is 21 January 1997, arrangements were made for the child to see Dr Berelowitz, the psychiatrist involved in Project 172-96, and thus although Dr Wakefield’s research was purportedly on children with disintegrative disorder, no assessment was requested to ensure that she qualified prior to subjecting her to the colonoscopy. She afterwards had a barium meal and follow-through, which were normal, and an MRI scan, which was also normal. On 28 January 1997, so a week after he had seen her, Dr Berelowitz set out his views on Child 8 in a letter to Professor Walker-Smith, and that letter is in the Royal Free Hospital records at page 18.

“Thank you for referring [8] to me. There is a detailed history in the correspondence in the file and I will not go over all that history but will summarise certain key features.”

I do not need to go into the details of her development. It sets out her heart condition:

“found to have coarctation of the aorta which was operated on successfully when she was ….. 14 months old. Because of the surgery, her MMR was delayed until she was 19 months.

Mother reports that following the MMR there was a catastrophic deterioration in [8]’s level of functioning. She lost all language, became docile, with poor co-ordination and was, from her mother’s point of view, a different person.

She developed diarrhoea from the age of 1 year. This has been chronic and there has been no direct or obvious correlation between her gut symptoms and her behavioural problems.

Now, [she] has no language. However, she is affectionate and responsive and makes good eye contact. She certainly tried very hard to communicate with me when I saw her.

I note that following the vaccination there was a period of fever, diarrhoea and developmental regression. I am therefore left wondering whether in fact she had post vaccination encephalitis rather than anything more complicated than that. I don’t think autistic spectrum diagnosis is merited here. I am sure that Andrew Lloyd Evans’ opinion would be valuable.”

Andrew Lloyd Evans being the consultant developmental paediatrician at the Royal Free Hospital.

“She is seeing Professor ….. le Couteur in Newcastle” – who is the psychiatrist I mentioned – “and I will ask [her] to send us the results of her assessment.”

So that is Dr Berelowitz’s view when he did ultimately see the child.

In November 1997, which was eleven months after her discharge, a discharge summary was sent by Dr Casson, and again Professor Booth, our expert, highlights the fact that that in itself is more consistent with an admission for research purposes than on the basis of clinical need, but that summary is on page 15 of the Royal Free records.

“[8] was admitted to our ward at the Royal Free Hospital on the 20th January 1997 for further investigation of possible association between developmental delay, gastrointestinal symptoms and vaccination.”

It sets out her history.

“At 18 months of age she had a MMR immunisation, within 2 weeks she had developed diarrhoea and intermittent temperature. She also had a febrile convulsion and had a hospital stay duration of 5 days. Subsequent to that, her parents noted dramatic deterioration. She stopped vocalising and had some myeclonic jerks at night. She also started having screaming episodes. Co-incidentally with this she developed diarrhoea which continued for over a year. During this time she passed 5-6 loose stools [a] day. She was given primrose oil in November 1996 and subsequently her diarrhoea improved.”

So you can see that this shadows the admission notes.

“Colonoscopy

A colonoscopy was performed which was macroscopically normal except for mild increase in lymph node tissue within the terminal ileum. Histology of biopsies taken during this procedure noted lymphoid follicles within the terminal ileum. All piece of colonic tissue demonstrated minimal inflammatory changes.

A barium meal and follow through was normal as was an MRI scan.”

Then it sets out the results of the blood tests.

“These results therefore are not indicative of marked ongoing inflammation. The results from Dr Wakefields specific investigations concerning the measles antibody would be available from him.”

I should say, again on the basis of our expert evidence, that although the inflammatory indices were not reported until after the colonoscopy had been carried out, they were in fact then found to be normal.

It was Dr Wakefield not Professor Walker-Smith who wrote next to the GP, and if you would turn to the GP records at page 74:

“Dear Dr Jelley

I have recently been contacted by Mrs [8] and realise that we have not spoken for some time. We are now coming up to the 38th child investigated ….. and the findings have been remarkably consistent. Please find enclosed the first paper covering the initial 12 ….. including [8]. This is due for publication ….. in the next few weeks.

We have had some success (striking, in some cases) in treating these children with mesalazine” – that is the anti-inflammatory – “Both gastrointestinal and behavioural improvement have been noted. I have written to Professor Walker-Smith suggesting that we start [8] on mesalazine, and he will be writing to you in the near future.”

Then Dr Wakefield wrote to Professor Walker-Smith, and that letter is in the Royal Free records at page 14. That is a letter, as I say, from Dr Wakefield to Professor Walker-Smith:

“[8]’s mother has phoned me to say that her gastrointestinal symptoms are particularly severe at present. I note that she has [had] changes typical of the syndrome in her gut, although they are mild. She has not received any 5-ASA and I think she would be an ideal candidate for mesalazine. If you decide to put her on this, Jill and I” – that is a reference to Jill Thomas, who was Dr Wakefield’s research nurse – “will keep in touch with Mrs [8] and Dr Jelley, the General Practitioner, to monitor progress in view of the long distances involved.”

So according to the discharge summary, based on the results that had been obtained, there was no ongoing inflammation, yet anti-inflammatories were prescribed in the form of mesalazine, and Professor Booth again criticises the fact that there is no way of telling from the clinical notes why that treatment decision was made in respect of this child.

That was the end of her involvement at the Royal Free Hospital. She continued to have difficulties, particularly behaviourally. In October 1999 she was seen by a local consultant psychiatrist who gave a different diagnosis of attention deficit hyperactivity disorder (ADHD).

Insofar as the charges are concerned, Dr Wakefield, Professor Walker-Smith and Professor Murch are all charged generally arising out of their role as responsible consultant that these investigations were done for research purposes without research Ethics Committee approval. This is a child who was investigated after the approval start date, but we say that she did not qualify for other reasons: firstly, she was never vaccinated with the measles or measles/rubella vaccination; secondly, there is no evidence anywhere that she suffered from disintegrative disorder. On the contrary, at the time of referral she was said to have a developmental delay of an unspecified nature, and the subsequent diagnosis by Dr Berelowitz, when he eventually did it – I mean eventually in terms of the series of investigations that had been done – was of post vaccination encephalitis and expressly not anywhere on the autistic spectrum.

The proper research consent forms and patient information sheets were never filed with the records, as the Ethics Committee requested.

So those are the general charges. In addition, there are charges relating to Professor Walker-Smith only. These arise from his total failure, we say, to undertake himself, or ensure that someone senior undertook, a proper assessment of this child before admitting her to hospital and subjecting her to colonoscopy; failing to carry out any preliminary tests for inflammatory indices; causing her to have a colonoscopy and barium meal and follow-through, which we say were not clinically indicated, having expressly represented to the research Ethics Committee that those tests were clinically indicated; and then, and lastly, in circumstances where there were no apparent indications for it in the medical records, prescribing anti-inflammatories without proffering in her records any explanation for that prescription.

So that is Child 8, sir. There are three more children to go. I do not know whether you would feel it appropriate just to break for a few minutes after two, or whether you want to go on and do another one.

THE CHAIRMAN: Maybe a ten minute break.

MS SMITH: Yes sir.

THE CHAIRMAN: We will now adjourn for ten minutes, a short break, and we will resume at just after three o'clock.

(The Panel adjourned for a short time)

THE CHAIRMAN: Ms Smith.

MS SMITH: The next child I am going to deal with is Child 7. I do not know whether you have the records.

THE CHAIRMAN: Yes.

MS SMITH: Thank you. This is a boy who was born in February 1994 and he was referred to the Royal Free in December 1996 when he was nearly three. Child 7 is Child 6’s brother, and he is the one, you will remember, for whom I told you we were not certain we had the full medical records, but in respect of this child, Child 7, we do indeed have the full records. These two children, unsurprisingly, had the same GP, Dr Nalletamby, from whom you are going to be ultimately hearing evidence. In fact, Child 7 is the younger of the two, two years younger than his brother Child 6. He had his MMR later than is normal in November 1995, when he was 21 months old. Prior to that there are references to diarrhoea and vomiting when he was a month old, and he began to have convulsions subsequently and was suspected to be developing epilepsy. He was referred to a consultant paediatrician at Ipswich Hospital, who arranged an EEG. His fits continued and he also underwent an MRI scan, and it was after that, as I say, that he had his MMR in November 1995.

In January 1996 he was seen again by the consultant paediatrician because of a change in his behaviour in the preceding two weeks when he had become aggressive and difficult to control and was wetting himself, and then there are a series of records referring to constipation and to blood in his stools.

On 5 December 1995 Dr Nalletamby, who was by then his GP, wrote to Professor Walker-Smith, and that letter is in the GP records at page 282:

“Dear Professor Walker-Smith

I would be grateful if you could see this [little] 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.”

Now, you may think that suffering from convulsions is a rather far cry from the original criteria for the study, but nonetheless Professor Walker-Smith, on the basis of that information, arranges an outpatient appointment for Child 7. A consultation then took place in outpatients, and he subsequently wrote to Dr Nalletamby about that consultation, and if you turn to the GP records it is at page 279. This is a letter from Professor Walker-Smith:

“Dear Dr Nalletamby

Many thanks for referring [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 investigated although I understand it is your opinion that 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 anticonvulsants but he 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 with mucous. His mother says he has intermittent high fevers although I understand that he has had recurrent ear infections which [might] have been treated by antibiotics. He also has ….. 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 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 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.”

So that is the letter that was sent and we say it is a relevant letter for the following reasons: firstly, Professor Walker-Smith was plainly aware from it that there had been no formal diagnosis of Child 7’s behavioural problems, save for the GP’s assessment that he could be within the autistic spectrum, although he did not have autism: secondly, Professor Walker-Smith appears to be attaching significance to the brother’s condition in coming to the conclusion that a colonoscopy was an appropriate investigation: thirdly, he was arranging admission with the prior intention of giving him all the investigations in the protocol: fourthly, and this is a specific clinical matter that Professor Booth criticises, he made no plan, despite the history of constipation to give this child an abdominal X-ray.

On the same day in this case Professor Walker-Smith wrote to Dr Berelowitz requesting his assessment, and that letter is at page 85 of the Royal Free records and says:

“This child will be admitted on 26 January 1997. He is a sibling of [Child 6] who is already in our protocol. In this case, although there are some autistic features, the GP has not referred the child for full investigation. I would be grateful if we could have your quite detailed opinion concerning [Child 7] while he is in hospital as to whether or not he falls within the autistic spectrum and any appropriate investigations could be done. He will be having the colonoscopy on Monday 27 January in the afternoon and he will be remaining in for the rest of the week.”

On 26 January the child was indeed admitted to the Royal Free, and the notes, which you can see on page 7, indicate the plan for him.

The bottom two paragraphs where it says “Plan”:

“Colonoscopy mane. Preps [preparation]” – presumably for the colonoscopy – “autism protocol. Consent. Venflon, bloods mane”.

So the plan was for him to undergo the next day a colonoscopy and for bloods to be taken, and then you see underneath that, on 7 January:

“Ward round, professor. Colonoscopy today. For barium meal and follow through Wed. To see Dr Berelowitz re autism. MRI EEG.” and then “Dr Lloyd Evans re developments.”

Thus we say the plan is that he is going to have an invasive colonoscopy prior to any assessment psychiatrically from Dr Berelowitz which would determine whether he qualified for the study. Interestingly, in this case there is a plan, at least, that he should see Dr Lloyd-Evans with regard to his development. Dr Lloyd-Evans, from whom you will hear, is the consultant in paediatric neuro-disability at the Royal Free, and you will recall that the neurologist involved in project 17296 is Dr Harvey, who is an adult neurologist.

You will be hearing evidence from Dr Lloyd-Evans that he would not have been prepared in this case to do a developmental assessment on the ward because, as far as he is concerned, such an assessment is multi-disciplinary. It requires a paediatrician or child psychiatrist, a child psychologist, an occupational therapist and a speech therapist. They all need to be involved.

In fact, that kind of assessment did not take place and the assessment apparently envisaged by Professor Walker-Smith when he wrote that note that Dr Lloyd-Evans should be involved did not take place, and, as I say, no attempt was made to reach any assessment, either psychiatrically or neurologically, from either the doctor referred to there or Dr Harvey prior to embarking on the colonoscopy.

A standard clinical consent form for colonoscopy and research form for samples in the standard way were completed. Professor Booth, our expert, accepts, and this is only the second case, that in this case, on the gastrointestinal symptoms elicited it was appropriate to carry out colonoscopy, but in this case he is critical that no abdominal X-ray preceded it to investigate the constipation element of the child’s symptoms.

The colonoscopy revealed a marked degree of lymphoid nodular hyperplasia in the terminal ileum. The histology report on the samples taken at colonoscopy, however, indicated no significant abnormalities.

On 27 January, the next day, a request was made for an EEG. One of the reasons for that request was disintegrative disorder, and, again, the request was signed by Dr Wakefield, although he had no clinical responsibility and, furthermore, the diagnosis of disintegrative disorder had not been made.

Two days later the child had a barium meal and follow-through and the day after that a lumbar puncture, and on that same day there is a reference to a plan for the child to be seen by Dr Berelowitz the psychiatrist, although there is no report from Dr Berelowitz in the records, and he was discharged three days later, on 1 February 1997. Thereafter, he was seen in outpatients by Professor Walker-Smith, firstly on 16 April 1997, and, having seen him, Professor Walker-Smith wrote a letter to Dr Nalletamby and there was no formal discharge summary, it would appear sent, but there was this letter which is the Royal Free Hospital records at page 59:

“Dear Dr Nalletamby,

I am sorry that 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” – the anti-inflammatories – “in the same dose as for his brother … and then to assess whether we need to continue.”

He then refers to a low element in the blood testing, and he says he will review him with his brother in four months time.

Professor Booth, our expert, is critical of that prescription of anti-inflammatories in circumstances where there was no inflammation and thus no gastrointestinal indication for them, and you may think, and we invite you to draw this conclusion, that the implication of the letter sent by Professor Walker-Smith was that he was prescribing them for behavioural reasons.

As far as the lumbar puncture is concerned, Professor Rutter has felt unable to comment with regard to the lumbar puncture in the absence of any clear report in these papers as to the full nature as to the investigations that this child was given.

Thereafter, he was seen as an outpatient at the Royal Free. Dr Casson wrote to the GP that his mother had stopped the anti-inflammatories because she thought that though they improved his behaviour they worsened his diarrhoea and ultimately, by January 1998, Professor Walker-Smith was writing that he thinks Child 7’s main problem was constipation, and thereafter it is fair to say that there is a very complex story of both gastrointestinal and behavioural symptoms continuing, but that, as I say, is as far as I am going to take the story with you for now.

Professor Walker-Smith, Dr Wakefield and Professor Murch are all charged with general charges, in that they investigated this child for research purposes without ethics committee approval. Although he was investigated, in this case, after the approved start date of 18 December 1996, he was never vaccinated with the measles or measles rubella vaccination, and there is no evidence anywhere that he suffered from anything remotely approaching disintegrative disorder. Indeed, as you will have gathered from the history that I have given you, he had no formal diagnosis on admission or thereafter in relation to his behavioural disorders.

Again, there is no proper research consent form or patient information sheet filed with the records.

The additional charges as far as these doctors are concerned is that Dr Wakefield is additionally charged with ordering at EEG when he had no clinical responsibilities, nor paediatric qualifications, and for giving as the reason for ordering those investigations a diagnosis of disintegrative disorder when there was no reason for that to be an appropriate diagnosis, and Professor Walker-Smith is additionally charged with failing to carry out an abdominal X-ray, although, as I said to you, the symptoms were suggestive of constipation, and for prescribing anti-inflammatories when there were no gastrointestinal findings requiring them.

So that is Child 7, and I am going to turn on, when you have had a chance to find the records, to Child 10, so you will need the GP and Royal Free records for Child 10. I should say that in this case there are two volumes of Royal Free Hospital records, and at the end I am going to make reference to one of those.

Child 10 was a boy born in February 1993, and who was referred to the Royal Free in October 1996 when he was about three and a half years old. The GP records indicate that he had an episode of diarrhoea, if it is of consequence, I know not, when he was two weeks old. He had his MMR vaccination in February 1994, when he was a year old. In June 1994 it appears that he had a viral illness whilst staying away, and hence his GP records give no detail of it, but retrospectively he was found to have a significantly raised measles titre and the illness was thought, retrospectively, by the medical professionals to have been measles. By the end of 1994 the mother was expressing concerns about his development and in March 1995 he was referred to a consultant paediatrician and subsequently numerous referrals were made, to a professor of paediatrics, a consultant ear, nose and throat surgeon in relation to his hearing, a consultant community paediatrician who expressed the view that he had some autistic features although he was not autistic, and that he was more likely to have had a transient regression due to the viral illness and was progressing towards recovery: that was the hope at that time.

He underwent an MRI, which was normal. He also saw Dr Wallis, a consultant paediatric neurologist, who wondered if the appropriate diagnosis was a disintegrative psychosis associated, again, with the viral illness he had had at age 16 months. He was assessed by a clinical psychologist, and, ultimately, at the time of his admission to the Royal Free Hospital, he was said to have a severe speech and language disorder with some autistic features but no firm label of autism, so by then he had had six referrals.

Child 10’s father than approached the GP, Dr Hopkins, in October 1996, asking that Child 10 be referred to the Royal Free Hospital, and the referral letter is at page 35 of the Royal Free Hospital records, dated 14 October 1996:

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

He was presented by his mother in late February 1995 with a history of loss of acquired skills. This appeared to follow on from a viral-type illness which [Child 10] caught whilst visiting his grandparents in Hertfordshire. This was apparently accompanied by a rash and thought to be a measles-type illness. Unfortunately he was not seen by any doctor from this practice and we have no documentation on this.

He had been given the MMR vaccine on 21.2.94. Of all the investigations performed by Dr Paul Davis, Consultant Community Paediatrician locally, the only thing of significance was that his ‘measles antibody was significantly raised’.”

There were signs that he was low on iron and he was given a replacement for that. He is on low dose penicillin in an attempt to prevent a recurrent ear infection.

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

Mr 10, who holds a PhD – has heard of your work and is keen for 10 to be assessed by yourself.

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

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

Then he offers to send photocopies of any letters in his possession or suggests that Professor Walker-Smith liaise with the consultants directly if he wishes to do so.

We say that that letter is significant for a number of reasons. It indicates very clearly to Professor Walker-Smith that there had been extensive previous consultant involvement with the child. The diagnosis at that stage was severe language disorder with some autistic features. The reference to the father having heard of his work can only, we say, be a reference to Project 172-96 research since there is no reference in that letter anywhere to any gastrointestinal symptoms.

Professor Walker-Smith arranged an outpatient appointment and he saw Child 10- on 8 November 1996, and recorded his findings in a letter to the GP of 11 November. That is in the same volume of the Royal Free Hospital records at page 32. This is to the GP:

“Dear Dr Hopkins, Thank you so much for referring this very difficult problem with 10’s history of loss of acquired skills, and somewhat autistic features which have improved. From a gastroenterological point of view it is interesting that he has intermittent episodes of water diarrhoea and has episodes of screaming when he clutches his abdomen which could be related to abdominal pain. The parents are keen that I should investigate him for possible gastrointestinal disease. It is very interesting that he has a high measles antibody and I think that this needs to be taken into account with the possible relationship of measles immunisation and inflammatory bowel disease. I am therefore arranging for him to come in to have a colonoscopy on Sunday 12 January, that was the earliest date that suited the parents”.

Then thanks for referring him. Despite the non-specific nature of his symptoms, you will note that no plan was made to test his inflammatory indices, and it is our case that
the terms of this letter again clearly indicate a research intent; i.e. the possible relationship of measles immunisation and inflammatory bowel disease. In fact Child 10 was not admitted for those investigations until February 1997, and during the interim between outpatients and admission, Professor Walker-Smith was sent background information from another doctor involved in Child 10’s care. The consultant community paediatrician wrote saying that Child 10 had had an MRI scan which was normal, sending blood results from the previous August which were also normal, stating that Child 10 had autistic features but not enough to amount to a diagnosis of autism, and also saying that he had never presented as having an over-gastroenterological problem, although his parents in retrospect reported some loose stools.

That happened, as I say, between outpatients and admission. The child was then admitted on 16 February. Consent forms were signed for an ordinary colonoscopy, a clinically indicated colonoscopy in the standard clinical form and lumbar puncture in the standard clinical form, and a research consent for extra biopsies. The boy underwent a colonoscopy on 17 February, the day after his admission and that colonoscopy was undertaken by Professor Murch. The report of the colonoscopy described the findings as “definitely abnormal”, “a more striking example of the pattern seen in the cohort of autistic children”. It went on,

“The rectum showed mild abnormality. There were prominent lymphoid follicles throughout the colon. Abnormalities in the mucosa of the caecum and in the ileum, minor inflammatory change and striking lymphoid hyperplasia”.

Professor Murch recorded his suspicion that with those colonoscopy findings, the biopsies would show striking abnormality. In fact there is a clinical histology report indicating inflammation within normal limits and concluding that there was no significant histological abnormality. However, on a separate document, different histological findings were given and a note was made that the conclusion to be drawn was that there was sufficient inflammation to merit anti-inflammatories.

Child 10 also had a lumbar puncture, and we know that because we have a record of the cerebro spinal fluid sample that was removed from it. The day after that, 18 February, he had a psychiatric assessment in the form of an interview with the father because the child was asleep, and that was undertaken by Dr Berelowitz on the ward, and a note made that a report would follow. It did follow. He was discharged the day after that on 19 February and there is a psychiatric report from Dr Berelowitz dated 20 February. You can see that at page 28 of the same bundle. It is to Professor Walker-Smith from Dr Berelowitz,

“I saw Child 10 [date given]. In fact I saw his father as he was sleeping and father said mother would not wish to participate in a research interview”.

He then gave their background and says,

“In terms of his present state, he does not talk, making no discernible words at all. He is not yet potty trained and according to his father, appears to have no bowel control and virtually no bladder control. He is friendly and affectionate, recognising his parents, seeking them out, and enjoying cuddling with them. His sleep is now good. He watches and enjoys videos”.

He goes on with his various attributes. He sets out his birth history.

“His father said Child 10 was a brilliant child up to about 18 months. He played peekaboo and he walked before his brother. He never got to use any clear words.

Then, according to father, he ‘just disappeared’. This was in June when he was about 15 months old. He had his MMR at 12 months. In June he had a febrile illness with fever, rash, vomiting and a low level of consciousness for three days. The GP diagnosed German Measles”.

Then he sets out the behavioural problems which have arisen following that illness. Then Dr Berelowitz says,

“You will see from the above account that 10 has certain features of autism and certain of the features of disintegrative disorder. However in fact he does not meet the criteria for either of these two conditions. He is far too affectionate, by his father’s account, for a child with full-blown autism, and a clinical cause, apart from the bowel and bladder problems does not really fit with disintegrative disorder. Furthermore it is possible that he does not truly lack bowel and bladder control but has merely not yet been successfully toilet trained. Only time will tell.

I was very troubled by certain things that father said to me. He said that I should not mention the word autism to the mother as she hated that word and she was convinced that Child 10 had disintegrative disorder. The father did not know that disintegrative disorder is a condition with a very much worse prognosis than autism. He said that they had been in considerable communication with” –

this is the lady who is the mother of Child 2 so I will call her Mrs 2 –

“Mrs 2 and they may have picked up this misinformation from her. He did not say that but I wondered if that were the case”.

You will recall, I should say, Child 2 was the first child in the project.

“I must say that I thought the most likely diagnosis was in fact an encephalitic episode which led to some low grade generalised brain damage. You will see above that in the acute episode he had fever, rash, vomiting and a low level of consciousness for at least three days. Father deeply regrets not having had him admitted to hospital at that time”.

So that was Dr Berelowitz’s view. In fact you will appreciate by now the significance of those views. Firstly, that assessment was not made until after this child had been admitted and subjected to invasive investigations pursuant to research, we say, into disintegrative disorder, when prior to that admission he had not had that diagnosis and no attempt had been made to diagnose the nature of his developmental delay on admission. Secondly, when he is ultimately assessed by Dr Berelowitz, he does not have a diagnosis expressly of disintegrative disorder but rather of an encephalitic episode leading to brain damage and following on from an illness which was suspected to be measles.

A discharge summary was subsequently sent by Dr Casson, and that is on 17 March 1997. It is in the Royal Free records at page 26.

“Child 10 was admitted for other investigations of his bowel symptoms in association with possible disintegrative neurological disorder and possible association with measles vaccination”.

It sets out his birth history.

“Mum reports that he was well until 16 months of age when he had a viral infection which was diagnosed by a GP as some form of measles. The exact history of this episode is somewhat confused. The mum was unsure as to the nature of the rash, in association with a pyrexial illness. Overall, that illness lasted four days and he seemed to recover well. Nevertheless she notes that over the next few months the person that she had previously known began to gradually disappear. She cites a very specific period between September – December of that year during which he appeared to lose eye contact, lose the basic verbal skills he had developed, and generally become less happy and outgoing. She notes no loss of motor skills. She notes that following this period he had episodes where he appeared to improve, however with each viral infection he contracted he seemed to revert to his previous condition….he began pulling up his knees, clutching his abdomen and screaming. When dairy produce was excluded from his diet, mum feels that his symptoms improved”.

She then refers to certain foods causing an improvement in his condition. He got calmer and showed more comprehension but nonetheless had no speech, and that he had never had bowel control or urinary control.

“On review of systems” –

that must presumably mean in this context gastrointestinal systems –

“he has a variable bowel habit. His stools are occasionally water and he has occasionally to strain at stool. He evacuates his bowel between 2-6 times a day. Further review of systems was unremarkable”.

You will see that he was previously investigated in Cardiff and had an MRI, EEG and various blood tests, all of which had been normal, although a measles antibody was noted to be quite elevated. It sets out matters in relation to his family history.

“Colonoscopy was performed and demonstrated a granular rectal mucosa and an abnormal rectal vascular pattern. There were prominent lymphoid follicles throughout the colon but no other mucosal abnormalities of note within the colon. His caecum had a slightly erythematous granular mucosa and a swollen ileo-caecal valve. The terminal ileum showed very striking lymphonodular hyperplasia with only minor inflammatory changes.

Biopsies were taken during this procedure and demonstrated normal crypt architecture but with mild, increased distribution of chronic-inflammatory cells throughout the colon”.

He was reviewed by the child psychiatrist who would be forwarding a report which in fact by then would have been available.

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

In this case, the prescription of the anti-inflammatories would appear to be consistent with at least one view of the histology reported, but in this case there is at least, unlike some of the cases we have looked at, you will recall, a recorded explanation elsewhere in the records as to why; i.e. that they were prescribed on the basis of a revised view of the histology. You will recall that I said to you that Professor Walker-Smith had expressed the view that there was sufficient inflammation to justify anti-inflammatories. I explain that to distinguish from other cases because in these circumstances we do not criticise the prescription because subsequent doctors are at least able to understand why the decision had been reached.

In April 1997 Child 10 was transferred to a gastroenterologist local to his home, and the letter requesting that transfer was by Dr Casson. It is the Royal Free Hospital records volume 2 at page 36. This is to Dr Jenkins, who was the consultant paediatric gastroenterologist in Wales, Cardiff.

“Professor Walker-Smith would be extremely grateful for your assistance in managing this child. As you know we have now seen several children with a syndrome comprising a neurological disintegrative disorder (part of the autistic spectrum) and bowel problems. In 10 we noted similar colonoscopic and histological findings to several of the other children. In view of this he was started on Salazopyrine. Nevertheless mum has not noticed a significant improvement and remains convinced that there may be an element of reaction to certain foods. On discussion with her it is also possible that constipation has a role to play in his symptoms”.

He enclosed the discharge summary and asks whether it would be possible for him to be seen in Dr Jenkins’ clinic. Subsequently, not that surprisingly in view of that conclusion, Dr Casson reports that the child was prescribed liquid paraffin for constipation and his behavioural symptoms have continued unabated,

“although it is fair to say that his GP will tell you that his parents believe that the Salazopyrine was a successful treatment for him”.

With regard to the charges, all three, Professor Walker-Smith, Dr Wakefield and Professor Murch, are charged with the general charges that they investigated Child 10 for research purposes without having Ethics Committee approval for that research; that whilst he was a child who was investigated after the start date approved by the Ethics Committee, he did not qualify in other respects because he had been vaccinated by MMR not MR, and nowhere is there any evidence that he suffered from disintegrative disorder. On the contrary there is positive evidence, if the researchers were relying on Dr Berelowitz’s assessment, that he had an encephalitis leading to brain damage. In any event, Dr Berelowitz’s assessment was made after he had been subjected to invasive tests, both the colonoscopy and the lumbar puncture.

The proper research forms, consent forms and patient information sheet were not filed with his records. There are additional charges against Dr Wakefield in respect of his responsibility for causing Child 10 to have a lumbar puncture without having him properly assessed to see if it was clinically indicated, and subjecting him to it when it was not in fact clinically indicated, again contrary to his representations to the Ethics Committee. There are additional charges against Professor Walker-Smith for failing to carry out blood tests for markers of inflammation, and subjecting Child 10 to a colonoscopy which was not clinically indicated on his history and symptoms.

Professor Walker-Smith is further charged with similar charges relating to the lumbar puncture, that he failed to ensure a proper assessment to see if it was appropriate and carried on and had it done in circumstances when it was not clinically appropriate. Again, that was contrary to what he represented to the Ethics Committee. This is one of the cases where Professor Murch is also charged in relation to his role in carrying out the colonoscopy, again, without satisfying himself that it was clinically indicated and contrary to the indications to the Ethics Committee.

With regard to Child 10 there is a separate matter which is one which has resulted in charges against Dr Wakefield and Professor Walker-Smith, and which is under the heading in your charge sheets of “Transfer Factor”. I am going to deal with it now because it is obviously the appropriate moment while Child 10’s history is fresh in your mind. In December 1997, so that is 10 months after his admission for the Project 172-96 investigations, he was still being seen now and again at the Royal Free Hospital. There is reference in Child 10’s medical records to the administration of this substance, Transfer Factor. It was presaged in August 1997, so that is six months earlier, when there is a reference in the correspondence from the community paediatrician to the GP and that is in your GP records at page 65. It accounts the sad fact that he was regressing suddenly, that the weather had been hot and he seemed very lethargic, and that he was physically well but switched off to a large extent socially and it then says,

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

and it then goes on to other circumstances relating to his condition. So, there was a reference to awaiting treatment with Transfer Factor.

Then, as I say, in December 1997, we know that this child was indeed being treated with it by reference to a fleeting note which is on an evaluation sheet filled in by the child’s mother and that is in the Royal Free Hospital records, volume 1 at page 181. This, as I say, comes in a checklist filled in by the parents. You can see the start of it at page 178 and it is called an “Aberrant Behaviour Checklist” and, if you would go to page 181, you see,

“Weekly diary card

Please list below up to 5 symptoms that have worsened or improved over the last week”

and, if you go to the bottom of the page, you will see about six lines up from the bottom,

“But he is not as good as he has been recently. Over Christmas and New Year, we felt very optimistic about the apparent effect of Transfer Factor – there seemed to be such a noticeable change in [Child 10] but this week we feel pessimistic. This may be a stupid question, but is it possible that the dose now needs to be …”

and it is not clear what the last word is.

THE CHAIRMAN: “Increased”?

MS SMITH: It may well be “increased” or “adjusted”. The point of that is it is plain from that that this child had been having this substance administered to him over Christmas and the New Year of 1997/98.

Subsequently, in February 1998, Dr Wakefield filled in a vaccine damage questionnaire for the Medical Controls Agency in relation to Child 10; this is a questionnaire that the Medical Controls Agency require to be filled in if somebody thinks that a child has suffered from vaccine damage. This is in the Royal Free Hospital records volume 1, so the same volume, at page 21. If you go to page 22, you will see that this is a form signed by Dr Wakefield and it says at the beginning which is on page 20, “Questionnaire to obtain information about possible adverse effect” and, if you would go to page 21 and paragraph 2 at the top,

“(c) Has any treatment been given for this possible adverse effect?”

and the answer was,

“Yes. In view of the colonic inflammation [Child 10] was commenced on mesalazine”

that is the anti-inflammatory and then it goes on,

“When measles virus antigen was detected in his bowel biopsy he was started on measles virus-specific transfer factor (details available on request)”.

Therefore, we say, it is clear, although not clear in the conventional form which you would expect to see in medical records, that this substance was being given. At the same time, that is in February 1998, a new application was submitted to the ethics committee separate from Project 172-96 seeking approval to do a preliminary trial using Transfer Factor and naming Professor Walker-Smith and Dr Wakefield as the principal investigators. I should make it clear that ethical approval was ultimately given for that trial but in fact it did not take place because of funding issues. The relevance to what we are telling you about and the charges that have been brought lies in the documentation which was submitted in relation to that separate ethics committee application. This involves going to bundle 2 of your chronological documents: not the ones relating to this child but the standard bundle 2. If you would turn to page 675, this is a letter to Dr Pegg, the chairman of the ethics committee from Dr Wakefield,

“Dear Dr Pegg,

Please find enclosed 18 copies of our trial entitled A preliminary open-label study of the effect of oral measles virus-specific dialysable lymphocyte extract transfer factor in children with autistic enteropathy. We would like this to be considered by your Committee at the earliest possible opportunity”

and then this paragraph,

“One child who has received this treatment on a compassionate basis appears to have made substantial improvement without any noticeable adverse effects.”

If you would turn on into the application – and we will be looking at it later – to page 676, you will see the principal investigators and responsible consultants Professor Walker-Smith and the principal scientific investigator is named as Dr Wakefield and, if you turn on to page 680, this is the standard application form which you looked at in detail for Project 172-96 and we will be looking at it again later with Dr Pegg, but you will recall that there is a paragraph in it “Discomfort” to which I referred you in that application and, in this, it is paragraph 12, “DISCOMFORT” and the reply to the question about what discomfort was involved said,

“There are no anticipated side effects of the drug.

Virus-specific transfer factor has been given in millions of doses without adverse effects, other than mild pyrexia” raised temperature “in rare instances.

Anecdotally, we have started one child with autistic enteropathy on [transfer factor] on an improved compassionate basis; he has tolerated the therapy, for one month so far, without any adverse effects and according to his parents has shown definite improvement.”

Although that child is not named, we say, given the timings and given the reference to the one child, that child must be the child who we know was indeed having that at this time, Child 10, and, if you would go on to page 682, you will see that again attached to this application, like 172-96, there is a parent information sheet which was the information sheet that it was envisaged would be given to the parents if this trial had gone ahead. I am certainly not going to through all of it, but if you look down at the third paragraph under, “Why is the study being carried out?” it says,

“A possible new treatment, called … Transfer Factor has been developed by Neuroimmuno Therapeutics Research Foundation” in America “in collaboration with workers at the Royal Free …”

and then it explains what Transfer Factor does and then, in the last paragraph,

“This is the first study of a measles-virus specific transfer factor in patients with this syndrome. There are no guarantees that it will work. To date, Transfer factor against other viruses, bacteria and tumours has been given and, as well as being an apparently successful treatment, has been extremely well tolerated without any adverse effects, other than a mildly raised temperature in rare instances. If this occurs, it usually lasts only a day or two, and is easily controlled with paracetamol.”

Then it sets out what the study would have involved had it gone ahead. In the second paragraph,

“If you agree to your child taking part in the study, your child will undergo a formal, standardised behavioural assessment …

… receive the [Transfer Factor] which should be collected from pharmacy … Instructions for treatment will be given explicitly on the label. During this time or any time after starting the treatment, you can call the hospital to discuss the trial, and any concerns that you might have. … you will be provided with a sublingual mineral supplement to help your child’s immune system respond effectively …”

and then at the bottom of the page,

“Are there any risks involved?

Along with the possible desired effects, any medication can cause unwanted effects.

If your child feels unwell or has any unusual discomfort during the study, it is important that you tell the doctor as soon as possible. Your doctor can withdraw you from the study at any time if he/she feels it is appropriate.

Are there any benefits?

It is hoped that your child will benefit from the study drug, in terms of both intestinal and behavioural symptoms, but it is not known how long this benefit could last.”

We say, had this trial gone ahead – had it gone ahead – that is the information that would have been given to the parents making it plain that it was new and that the effects were thought to be beneficial but were uncertain.

Over the ensuing months, you know that concerns had been expressed by the Dean of the Medical School, Professor Zuckerman, about the ethical background to Project 172-96 and you will recall that I told you that his concerns arose because he had been contacted by Professor Hull about the ethics approval of the project. As a result of him expressing those concerns, he was also informed by Professor Walker-Smith about this study, the proposed Transfer Factor study and, on 17 July 1998, that is six months after Child 10 has been given the Transfer Factor, Professor Walker-Smith writes to Professor Zuckerman and that is in bundle 3 of your chronological bundles at page 941. That is a letter to Professor Zuckerman from Professor Walker-Smith and the relevant parts start in the second sentence,

“I have now written to Dudley Dumonde who I have known for many years concerning the safety aspects of the ‘transfer factor proposal’”

and he attaches copies which I will go to in a moment.

“If it is regarded as safe I do feel in duty bound to the parents of these unfortunate children (where there are 3 pieces of evidence in favour of measles; lymphocyte PCR, serology and tissue immunohistochemistry) to proceed with initially an open trial” i.e. that is the application that is being made “evaluated by a psychologist or psychiatrist. Andy has promised me that this would not be published as such but would be a vital preliminary to a placebo controlled trial. Such a trial would not proceed if the first study were entirely without effect. I understand Roy” that is a reference to Professor Pounder “and Andy are planning a trial in adults with Crohn’s disease.”

If you go on to page 943 we see the letter attached to that, which was a letter to Professor Dudley Dumonde, who is the Professor of Immunology at St Thomas’s Hospital.

“Dear Dudley

Re: Transfer Factor

You doubtless will have heard about the controversial findings Wakefield et al have reported concerning the possible role of measles in children with autism. A study is proposed to give a group of such children who have evidence of measles antigen in tissue, positive measles serology and PCR positivity in circulating lymphocytes, dialyzable lymphocyte extract – transfer factor. These will be patients under my care and I will be responsible for safety aspects.

As I have known you so long and always valued your advice, I would [very] much appreciate your confidential opinion of the safety of this extract as will be supplied to us by Dr Charles Kirkpatrick, Professor of Medicine & Immunology, University of Colorado, USA.

I have discussed this matter confidentially with our Dean ….. and we both would value very much your advice, which I could pass on in confidence to Dr Michael Pegg, Chairman of our Ethical Committee if you were willing for me to do that. Or else you could give me your own opinion in confidence.

I would be happy to discuss this with you if appropriate on the telephone.”

Now, in fact the response from Professor Dumonde is not available. In September 1998, Dr Pegg, Chairman, wrote enquiring what was happening with the Transfer Factor file, and if you go on in bundle 3 to page 960 you will see Professor Walker-Smith’s answer to that query to Dr Pegg, a letter of 23 September 98:

“I apologise for not replying before but there has been some time involved in determining details of European Safety standards requirements. We have no doubt that the transfer factor produced is safe but Dr Andy Wakefield will be flying shortly to Denver, Colorado to see the manufacturers to ensure that all the details of the European Safety Standards are met. It will not thus be possible for us to have the information ready for the October Ethical Committee Meeting but [it] will be for the following. I hope this is satisfactory.”

Then if you go on to 961 you will see Professor Walker-Smith writing, on the next page:

“I now have the safety details concerning the European Standards and Regulations on Drug Safety. I enclose the relevant correspondence”.

Attached to that, I am not going to go through it at length, although we will at a later stage, there is a long letter from Dr Kirkpatrick which starts on page 963, setting out his views on safety and the trials that have been done in relation to the safety of the substance.

Now, you will understand what the significance of this rather long, I am sorry, introduction is to what I have told you about Child 10, which is quite simply that he was given this substance prior to all those requirements as to safety being carried out, and prior to the Ethics Committee approval application.

If it is suggested, as it appears to be, in the ethics application, that the giving of this substance to Child 10 on a one off basis was done for compassionate reasons, then we say, on the basis of the expert evidence from Professors Rutter and Booth, that there was no such justification. There was nothing, they say, either behaviourally or gastrointestinally, that made Child 10 exceptional vis a vis the other children who were written up in The Lancet paper, and in those circumstances it is our case that this child was given Transfer Factor prior to checking its safety as part of what in the circumstances amounted to an irresponsible experiment. The safety position had not been checked. Whether it was in fact safe is of course immaterial. In any event, we do not know the precise nature of the preparation that was given to that child, and whether it differed from that ultimately to be obtained from Dr Kirkpatrick in Colorado as was envisaged for the trial. There is no record, except in the details that I have shown to you, in the child’s medical records of the fact of it being given, or why, or the dose. Still less is there any record of any discussion with Child 10’s parents as to risk and benefit. Child 10’s GP, from whom you will be hearing, was never notified, and he will be giving evidence that he had no knowledge that this substance was being given and would have expected to be told, and you may think that that is only common sense if only so that he knows if he is giving any other drug that he has to consider that matter.

Professor Walker-Smith has been charged as the clinician responsible for Child 10, and the evidence that he was involved with the administration of this Transfer Factor lies in the references in the child’s medical records and to the references to one child having already received the substance in the Ethics Committee application, when he was named as a principal investigator in that application, and, as I say, we say that he was the clinician responsible for the child, and there is no clinical justification for giving this substance to Child 10 as opposed to any of the other children.

The position with regard to Dr Wakefield is a little different. The relevance of the matters set out in the charge, you have heard, is that it is our case that one reason for singling out Child 10 lay not at all in his clinical circumstances, but lay in the business relationship which in fact existed between Child 10’s father and Dr Wakefield. Now, I should make it clear that we accept that that is a relationship that there is no evidence at all that Professor Walker-Smith was aware of.

The relationship arose as a result of a proposal for the setting up of a company (Immuno Specifics Biotechnologies Ltd) to specialise in the formulation and production of Transfer Factor, which is the very substance that was administered to Child 10, and the proposal was that Child 10’s father would be the CEO of that company. As a result of that, Dr Wakefield is charged firstly with causing this child to be administered this substance, when he was not a paediatrician and had no clinical responsibility, contrary to that child’s clinical interests, and furthermore, in the light of our case that the child was singled out because of the business relationship with Child 10’s father, he is also charged with an abuse of his position of trust as a medical practitioner in giving this child this substance in those circumstances.

So that, as I say, relates to Child 10, but is under the separate heading in your charges of “Transfer Factor”.

It brings me on to the last child, and this is a child who is not part of The Lancet 12, and to differentiate him we are using initials rather than a number, so he is Child JS. So if you put away the Royal Free records on Child 10, and extract the Royal Free Hospital records on Child JS. There is only one volume; it is the Royal Free Hospital records for JS.

THE CHAIRMAN: Sorry, Ms Smith, just in case you are wondering, I am just checking because I think my bundle 3, chronological bundle 3, the pages missing are from 972 to 1053, and I see that the Panel Secretary’s bundle pages are missing as well. Is it for any reason that they have been removed?

MS SMITH: Yes. Do not worry about them for the moment, sir.

THE CHAIRMAN: Right.

MS SMITH: So it is just Child JS and it is just the Royal Free Hospital records. You will not need them for the moment. I am just going to tell you a little bit about the background first.

The first thing that you should bear in mind is that these charges relate only to Professor Walker-Smith. As I have said, this child is not one of the twelve children written up in The Lancet article, but it is apparent, we say, from his records that he, like them, was investigated at the Royal Free Hospital as a result of the same overall research programme in the circumstances I am just going to tell you about.

He was born in November 1990. He had his MMR vaccination in March 1992, and there is an unresolved issue between his parents and the GP as to the possibility that he had a second MMR vaccination a year later. In June 1994 there are records of the first concerns of developmental delay and a note that the parents are very concerned that it is attributable to vaccination. A diagnosis was made in early 1995 by a consultant psychologist that the child suffered from atypical autism. There is one reference in the GP records to “loose stools” if he was given different foods to eat.

In April 1996 the mother contacted Dr Wakefield, and Dr Mills, from whom you will hear, and who had been the child’s community paediatrician for some years. He wrote to Dr Wakefield, but that letter was copied to Professor Walker-Smith, and, as I have said, you should remember the charges relate to Professor Walker-Smith, and the letter is in the Royal Free Hospital records at page 77. This letter is addressed to Dr Wakefield but copied to Professor Walker-Smith, and they are in the Royal Free Hospital records:

“Dear Dr Wakefield,

I understand that you have recently spoken to the Mother of this 4 year old boy ...

You suggested to her on the telephone that a referral to Professor Walker-Smith may be appropriate, and [the mother] has contacted me asking if I would make a referral.

I have been involved with [JS] for several years. He presents as a child with classical autism and his language development and social interaction is severely impaired. At one stage a hearing loss was suspected, but has not been confirmed. In addition, he has mild diarrhoea which has not really been a clinical problem. There have been no problems with growth or weight gain.

The family date [JS’s] problems to happening after MMR vaccine at the age of 18 months and they are convinced that this is the etiology of his autism. There certainly seems to have been several linked reports in the literature of association with MMR with other children, but this is commonly the case in conditions where we do not have a clear etiology and 95% of children in the UK received MMR vaccine anyway.

Mother has asked me to make a referral to your team. Could you let me know what you would be able to offer [JS] and the family?

I am quite happy to be open-minded about unsubstantiated causes and possible future treatments, but I am not keen on sanctioning detailed investigations unless there seems to be some logic behind them.”

So that is the letter that JS’s paediatrician wrote.

On 7 November, Professor Walker-Smith responded to Dr Mills, and indicated that they at the Royal Free were looking at a group of children with autistic symptoms related to MMR vaccine and found that a number had gastrointestinal symptoms and when investigated endoscopic abnormalities, and he said that he would be happy to see the parents and discuss it with them and then get Dr Mills’ advice as to the right to proceed.

So far so good: Dr Mills responded directly to Professor Walker-Smith saying that whilst he thought that the research findings were interesting, as child JS’s main consultant he did not think that the investigation schedule was appropriate for him at that time, and Professor Walker-Smith acknowledge that letter, accepted Dr Mills’ verdict and said he would be happy to hear from him if the situation changed.

There the matter rested, as far as Professor Walker-Smith was concerned, until April 1997, so a year after that first contact had been made, and you should remember that by April 1997 all The Lancet children had been investigated.

On 23 April 1997, Professor Walker-Smith wrote back to Dr Mills, having apparently heard via Dr Wakefield, of the parents’ distress concerning their son, and the letter he wrote after that year’s lapse is on page 70 of the same volume.

“Dear Dr Mills,

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

Dr Mills replied on this occasion, as you will see in somewhat firmer terms, and it is our case that the letter that he wrote to Professor Walker-Smith underlines what we say is the proper and responsible approach of a clinician and a paediatrician, and that letter is at page 68 of the same volume:

“Dear Professor Walker-Smith” – he thanks him for his letter.

“Please send me details of your remarkable successes in treating children with autism. I need to have details of how these successes have been evaluated in terms of an improvement of:

(a) Speech and language development.
(b) Behaviour.
(c) Obsessional behaviours.
(d) Ease of management by the family.

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

Also could you send me details as to how your detailed gastro-enterological investigations have helped these children, particularly those children who, like [JS] have a minimum of gastro-enterological symptoms.

Similarly, I would be interested to examine your evidence for the links between MMR vaccination and autism. The references that you quote are obscure and I would be grateful for copies of the information that you have.

I need to be reassured about the contracting situation that any referral to your department would include. Your department has been very energetic in requesting me to refer [JS] to you.

As a result of your contacts with [JS’s] family, they appear to be requesting further investigations in your department. From the documentation that you sent me I note that you are anxious to involved [him] in your research programme and presumably involve him in detailed follow up afterwards.”

Then he says that Mrs JS had said that the BBC were interested in following JS through his investigation. I am only including it for the sake of completeness of the letter and not because it is particularly relevant to the point I have to make. The next paragraph:

“I have never sought your opinion, and I find that your correspondence puts me in a very difficult situation.”

and this is the part that I say we rely on as underlining what we subsequently say should have happened –

“I have a responsibility to ensure that [JS] has the best possible care and appropriate investigations. This responsibility also includes advising his family about inappropriate treatment and advising them sensitively about the extensive ‘alternative therapy market’. You have never met [JS] or his family or have any knowledge about his parents, their health and their wants and fears.

As this request for referral has so clearly come from yourselves, I feel that you have the responsibility to clarify the contracting situation with the … health authority and … [the] fund holding practice.”

So the significance of that letter, we say, is both in its attempt to analyse what the investigations can do for this child who had a minimum of gastrointestinal symptoms, and its emphasis on a basic principle that I have already referred to, namely the principle that the patient is the child and the decision as to the investigations that he is to undergo are made by the clinician in conjunction, of course, with the family, but always with the needs of the patient put first.

Dr Mills will say to you that in JS’s case, and, indeed, generally, he regards that as a large part of his job as a paediatrician, namely balancing what the family want against the needs of the child, and it is the erosion of that principle which is criticised in this case by our expert, Professor Booth, and which is the subject of the charges against Professor Walker-Smith.

Professor Walker-Smith responded to that letter, and his response is at page 66:

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

That must be the decision whether The Lancet were going to accept the paper or not:

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

He then says he obviously had no involvement with the BBC in this, and we have no reason to doubt that. I am not going to go through that:

“In relation to your final paragraph, I must again emphasis that I am reacting to parent pressure, the other children who come from distant authorities, the referring authority has agreed to fund these children’s referral as an ECR and the initiative must come from the general practitioner. I am myself not soliciting for patients to be referred to us, but I am reacting to the parents’ requests. I hope this clarifies the situation.”

Ultimately, principally because of Dr Mills’ views, the ECR referral funding was refused. Child JS’s mother then wrote letters to Dr Wakefield and to Dr Mills, and Professor Walker-Smith then ultimately wrote to JS’s mother saying that as NHS funding was not available he would be willing to see the child privately. He did that on 30 July, and he concluded that Child JS did indeed have what he described as “rather minor gastrointestinal symptoms”; that there was parental concern about the role of MMR and that Child JS would be suitable to have colonoscopy and other investigations under the protocol and it was something that the GP and the parents might like to consider may be of value to the child. Professor Walker-Smith then wrote to Dr Mills, and that letter is at pages 58 and 59:

“Dear Dr Mills,

I eventually saw [JS] privately at the parents’ insistence. You are familiar with the earlier correspondence I have had concerning the child.”

Then he sets out his birth history:

“He developed normally from the parents judgment till the age of 18-24 months. He was admitted at the age of 6 months following an episode of breathing difficulty. He had his first MMR at the age of 18 months when he had fever and was unwell for 24 hours. The parents believe that following the MMR he frequently had running eyes and nose and he required antibiotics on several occasions for ear infections.

His maternal grandmother noted from the age of 2 years he had a somewhat glazed look in his eyes and there was a gradual loss of words. The loss of concentration was apparent very much at the age of two and a half years when he became hyperactive. A food elimination diet was tried without any effect although he continues to avoid colourings which make his behaviour more hyperactive.

He was diagnosed as atypical autism at the age of 3 years…Later he had a number of investigations by yourself. Deafness was excluded. From about the age of 2 years he had episodes of diarrhoea. However, his stools are much better now and only occasional loose. Typically he normally passes 2 large stools per day and currently his episodes of diarrhoea are quite infrequent. He does however sometimes have pain on defecation. He has never passed blood but at the age of 4 years there was some anal pathology which apparently was diagnosed as ‘piles’ from which he has subsequently settled…active child who is well nourished…Clearly this is a child within the autistic spectrum who does have currently some rather minor gastrointestinal symptoms. There is considerable parental concern about the role of MMR in the initiation of this child’s illness. This is very difficult to be certain about. However this is a child who would be suitable to have investigation by colonoscopy etc. and I enclose details of our protocol concerning this. I have explained the situation to the parents and I have made no definite arrangements for him to come in but I do believe that this procedure could be of value as I outlined to you in earlier correspondence”.

Subsequently an appointment was made for this child’s admission. There was still an issue over the funding and in that context Professor Walker-Smith wrote to the relevant department at the Royal Free saying the investigation was essential and that the kind of service they offered was not available elsewhere for children with autism and the especial investigations that Dr Wakefield could offer them. He was ultimately admitted, Child JS, on 12 November and he underwent a colonoscopy under general anaesthetic. Blood tests were taken and subsequently reported after the procedure as showing normal inflammatory indices.

The charges against Professor Walker-Smith arise quite simply out of the fact that we say that he carried out this colonoscopy as a result of parental pressure and for the purposes of research, and that he failed to consider properly, or indeed at all, what was his principal duty; namely, to treat the patient in accordance with the patient’s best interests. In fact, on the basis of this child’s minor gastrointestinal symptoms, as evaluated both by Dr Mills, his consultant paediatrician and by Professor Walker-Smith himself, who describes them in those very terms, it is our expert’s view that he should have undergone a blood test before such an investigation was considered, and that it is clear that on the basis of those symptoms, a colonoscopy was not clinically indicated. Those are the only charges relating to this child and they are all against Professor Walker-Smith. So you should differentiate that child, in your minds, from all the other children who are the children written up in The Lancet article.

That, you will probably be rather profoundly glad to hear, is the end of my opening. I see it is 10 minutes to five and subject, of course to your views, it would not seem appropriate to begin the first witness tonight, so I would propose that we will begin with the GP witnesses in the morning.

THE CHAIRMAN: Yes, indeed. It has been a long afternoon for the Panel as well. Thank you very much for completing your opening this afternoon. It will give us the time to absorb and assimilate some of that information that has been provided by you and we could start with the witnesses tomorrow morning at 9.30. Is that convenient?

MS SMITH: Certainly, that is fine, sir.

THE CHAIRMAN: We will now adjourn and resume at 9.30 tomorrow morning.

(The Panel adjourned until 9.30 on Friday, 20 July 2007)