Wednesday, February 1, 2012

Day 29 GMC Fitness to Practice hearing for Andrew Wakefield

GENERAL MEDICAL COUNCIL

FITNESS TO PRACTISE PANEL (MISCONDUCT)



Wednesday 29 August 2007

Regents Place, 350 Euston Road, London NW1 3JN



Chairman: Dr Surendra Kumar, MB BS FRCGP


Panel Members: Mrs Sylvia Dean
Ms Wendy Golding
Dr Parimala Moodley
Dr Stephen Webster


Legal Assessor: Mr Nigel Seed QC




CASE OF:

WAKEFIELD, Dr Andrew Jeremy
WALKER-SMITH, Professor John Angus
MURCH, Professor Simon Harry


(DAY TWENTY-NINE)



(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


DIANA MARY JELLEY, Affirmed

Examined by MR THOMAS 1
Cross-examined by MR MILLER 20
Re-examined by MR THOMAS 27
Questioned by THE PANEL 27
Further re-examination by MR THOMAS 29
Further cross-examination by MR MILLER 29

Discussion re timetabling 29
THE CHAIRMAN: Good morning, everyone. Ms Smith, I believe Mr Thomas is going to call the next witness.

MS SMITH: That is correct, sir.

MR THOMAS: I am going to call Dr Jelley. She is the GP for Child 8 and you will need the GP records, the Royal Free records and the local hospital records.

DIANA MARY JELLEY, Affirmed
Examined by MR THOMAS

(After introductions by the Chairman)

Q First of all, Dr Jelley, would you state your full name and address?
A Dr Diana Mary Jelley, XXX.

Q You are being asked to give evidence today in relation to one particular patient, and there is a key in front of you, is your patient child 8?
A My patient is child 8, yes.

Q Is it right that you are a partner in the XXX Surgery in XXX?
A I am.

Q For how long has child 8 been a patient of yours?
A She was registered since her birth in 1993 I think.

Q Given the structure of your practice, is it right that over the course of her life other GPs as well as yourself will have been involved with her care?
A Yes.

Q I am going to take you to a number of records in relation to child 8’s developmental history and as we go through would you remember to refer to her as child 8 rather than using her name, but if you do slip up the press are aware that the confidentiality of the patients must be respected. I am going to take you to three different sets of medical records, her GP records, records from the Royal Free Hospital and also records from the local hospital. Can we start with the GP records at page 164? This is a letter dated 5 May 1994, and it is from Dr Tapsfield, who I think is a GP in your practice …
A Yes.

Q … to Dr Houlsby, who is was a consultant paediatrician, is that right?
A That is right.

Q It says:

“I would be grateful if you could send an early appointment to assess [child 8] in your clinic. Her mother is expressing considerable concern about her health and development generally and in particular relating this to her performance compared to her older sister. She failed a health visitor hearing test probably because of some glue in her ears and I have seen her recently when she has had a moderate left sided ear infection.

She certainly appears to be a very quiet and passive child who is sitting with a fair degree of stability but is showing very little tendency to move and hardly rolling over at all. She has a slightly high forehead but I understand that this is probably a familial characteristic.

Her mother does have a number of other stresses in her life at the present time and I think it would be generally useful to have your opinion …”

At this stage in child 8’s life did you have any concerns in relation to her development?
A I do not think there is a record of me seeing in those medical records but I was doing the baby clinic at that time so she would have been in and out of the baby clinic. There is not a documented record of her mother having specifically expressed concerns to me.

Q If we can then turn to page 162, and this is a reply from Dr Houlsby to Dr Tapsfield, and it is dated 24 May 1994 and it says:

“Thank you for asking me to see [child 8] who is aged 10½ months. Her mother has been expressing concern about her health and development, particularly when compared to her older sister. Since you referred her to me she has learned to stand. She sits very stably. She does not crawl or roll. Her mother is now happy with her general health. She is vocal. She is beginning to manipulate small objects appropriately. She has mild eczema and a history of a tendency to cough particularly in the morning. Her hearing test is to be repeated, although her mother says she is not worried about her hearing.”

Then there is a record of an examination:

“… her weight is approximately 25th centile. Her head circumference is just above the 50th centile. Her face is slightly unusual … not cyanosed … no respiratory difficulty … could hardly feel her femorals.” – at the bottom of that paragraph: “Abdominal examination was normal. There were no neurological abnormalities and I felt that her development was within normal limits.

My impression was that she is a child who is developing within normal limits, but in whom I thought I may have found congenital heart disease as an incidental finding. I have arranged an EEG which was of very poor quality but probably within normal limits … I am therefore referring her to the Paediatric Cardiologists for a further opinion.”

I think it is right that that referral did take place, and if we look at page 155 we see a letter to your practice, addressed to Dr Tapsfield, dated 27 September 1994, from Mr Hamilton, consultant paediatric cardiac surgeon, and it records an admission on 18 September 1994; a diagnosis of congenital heart disease, coarctation of the aorta and the operation performed was a repair of the coarctation. The summary is:

“[Child 8] is now just over one year old and was admitted for elective repair of her coarctation. She is asymptomatic from the cardiac point of view but was referred initially because of possible developmental delay. A murmur was heard and the diagnosis of coarctation subsequently made. She was initially admitted by Dr Hunter for cardiac catheterisation and potential balloon dilatation of her coarctation but her anatomy was unsuitable for this and she was referred for surgery. She had been noted to be hypertensive and had been started on propranolol.”

Two months later, we see the letter at page 150, on 23 November 1994, a letter from the paediatric cardiologist Mr Hunter to Dr Houlsby, paediatrician and he says:

“I wonder if you would be kind enough to see this child again. She came back for follow up on 22 November 1994. At 17 months she seems to be making progress after her operation. However, her mother was full of worries and concerns, some of which appeared to be justified. At the present moment [child 8] is on Captopril 2mg three times a day and Atenolol 12.5mg per day. The problems that her mother perceives are failure to progress past developmental milestones. At 17 months she gets around in a baby walker and crawls but is not walking on her own. She stands holding on to furniture and pulls herself up. She is able to [walk] along the settee and will walk holding two hands. She has a somewhat bossed forehead and deep set eyes which we think probably resemble the facial appearance of the paternal side of the family. Nonetheless it is a slightly unusually shaped head and in association with the moderate amount of delay I think this merits some developmental follow up. Since her operation there has been disturbance of sleep pattern …”

And he gives details of that.

He concludes the letter on the next page, page 151, the final sentence:

“I would be grateful if you could see her and follow her from the developmental point of view and advise the parents.”

By this stage, November 1994 had you in your role as the GP become aware of worries and concerns over child 8’s development?
A Yes.

Q Had those worries and concerns been expressed to you by child 8’s mother?
A Yes.

Q Broadly speaking, were they concerns about her failure to progress past the expected developmental milestones?
A Absolutely, yes.

Q At this stage I think it is right that child 8 had not had her MMR vaccination.
A That is right.

Q Dr Houlsby replied to Dr Hunter, and we can see that reply on page 149. This is a letter dated 23 December 1994 from Dr Houlsby to Dr Hunter, and he states in the second paragraph:

“When I saw her in clinic yesterday she was coryzal and miserable. She did not cooperate well with developmental assessment but I felt that her abilities, although delayed on the average age of attainment were not outside the range of normal. Her growth has been satisfactory.

As I was unable to perform a satisfactory assessment, I am arranging to review her in two months time.”

Before that review was carried out, I think it is right that child 8 had her MMR vaccination, is that right?
A That is right, I think the review actually took place in February and she had her MMR at the end of January.

Q If we turn back in the GP notes to page 4, it records – although that part is cut off on my copy – that the MMR was given I think on 27 January 1995, do you see that at the top of the page under “immunisations”?
A Uh-huh.

Q Is that correct?
A It is the 27th not the 7th I think. On mine it says the 7th but I think it was the 27th.

Q What was the mother of Child 8’s perception of Child 8’s reaction to the vaccine?
A I felt that the mother was concerned fairly soon after the vaccine – I think I saw her at home on a home visit shortly after the vaccination – she had had a kind of feverish reaction to it. There obviously was no suggestion of delay at that point. Several months later her mum said she had been looking at a video when Child 8 had a little bit of speech before the vaccination and she felt that that had reduced post-vaccination.

Q The incident you describe of the video was some time later, was it?
A Yes.

Q In terms of the more immediate reaction to the vaccine, you say that mum reported a fever.
A Yes. I remember seeing her at home and then I think she was admitted with a febrile convulsion shortly afterwards.

Q There are two records I want to take you to in relation to that. First, the GP records at page 20. This appears to record, right at the foot of the page, a telephone call on 7 February 1995.
A Sorry, no, it is a late call that says. It says “V” – visit – it was a house call.

Q Is that your writing?
A Yes.

Q Could you read that out?
A It just says,

“Reaction to measles vaccine and pink left ear – amoxyl”.

Q In relation to the febrile convulsion could you take up the local hospital records please at page 1? Does this record on page one the admission under Dr Houlsby on 13 February in relation to the febrile convulsion following the MMR by some two weeks?
A Yes.

THE CHAIRMAN: Can I just check something, Mr Thomas. On the first sheet of paper it says, “Take out”.

MR THOMAS: I am sorry, sir, I did not hear that.

THE CHAIRMAN: On the first sheet of paper in the bundle, after “General Medical Council Dr Wakefield, Professor Walker-Smith and Professor Murch”, it says “Take out”.

MR THOMAS: My bundle simply has an index with the patient’s name and the page numbers.

THE CHAIRMAN: I have got that. The Legal Assessor is just showing you.

MR THOMAS: If it is simply an index page you can leave it in or take it out as you choose. Dr Jelley, the entry I was asking you about was on the first paginated page, page 1, and I think we had got to the position where you agreed that this was the admission that occurred to the local hospital in relation to the febrile convulsion.
A That is correct.

Q Can we now go back to the GP notes and turn to page 25? At the top of this clinical note, is that your writing?
A No, that is Dr Tapsfield’s writing.

Q I think this also records the convulsion. It is an undated note but it says “May 1994”, and then an arrow, “discover heart”. It may be a reference to the discovery of the heart murmur, “op September”. Then,

“MMR Jan 95: -> Grand mal convulsion Feb 95 2 weeks after MMR (no letter). Never the same again. Frequent diarrhoea, not infected but no tests done. Eats well and gains weight”.

You referred a moment ago to the fact that Dr Houlsby had not been able to conduct his formal assessment when he was asked to. Can we now turn to 131 in the same bundle where we will see the result of his formal assessment? This is a letter from Dr Houlsby to Dr Shabde the consultant paediatrician, copied to your practice and dated 2 March 1995, but you are quite correct to say that the assessment took place in February because we can see at the top of the page it says, “Dictated 17 February 1995”, so a matter of a few weeks after the MMR. He says,

“I was asked to see [Child 8] last year when there was concern about her development generally. When I saw her in clinic at the age of ten and a half months I discovered that she had a coarctation, and referred her to the paediatric cardiologists. This was repaired surgically, and she is now well from this point of view. However concern about her development persists. She was born at term”,

and he gives some details in relation to that.

“She was recently admitted to the ward following a febrile convulsion in association with gastroenteritis.

When I reviewed her in clinic recently I confirmed that she is globally developmentally delayed, functioning at about a one year level on Denver Developmental Assessment. Her growth has been satisfactory. Her appearance is somewhat unusual with a bossed forehead and deep set eyes, but I could find no other dysmorphic features. General examination is unremarkable. There were no neurological abnormalities other than the developmental delay.

I would be grateful if you would arrange for further assessment through the Special Needs Team”.

He ends on the next page by saying,

“I will continue to review her in my clinic and have made arrangements to see her again in three months time”.

Dr Jelley, is that the first time that the worries that had been expressed at an earlier stage were formally confirmed on assessment by Dr Houlsby?
A That is correct.

Q Can we next turn to page 145, moving on from March to April 1995? This is a summary note by Dr Morley of a Special Needs Team meeting on 19 April 1995 and it states under the paragraph, “progress discussion”,

“[Child 8]’s mum is concerned about her development and feels that [Child 8] is delayed in most areas. [Child 8] has had a repair of coarctation of aorta. Mum’s major concern is about the shape of [Child 8]’s head and ‘spongy’ forehead. There have been sleeping difficulties in the past but she takes Vallergan now and this is fine. [Child 8] has no feeding difficulties. Speech is delayed and [Child 8] has failed three hearing tests”.

Above “recommendations” it says,

“[Child 8] is sociable and has quite good concentration. Mum claims that her co-ordination is poor and that her walking is still a little unsteady”.

So it is clear that at that stage the concerns in relation to Child 8’s development were continuing.
A Yes.

Q If you turn back one page, going on to June 1995, we see a letter from Dr Houlsby again to Dr Tapsfield at your practice recording details of the clinic that Child 8 had attended at 22 months. It says,

“Her mother is very pleased with her progress. She has been reviewed by the special Needs Team and I understand that following an Education Psychologist’s review speech therapy has been recommended. Her mother’s main concern at present is that she is occasionally appearing vacant and difficult to rouse. These episodes last for only a few seconds but mother is concerned that she may be having fits. Examination revealed no new abnormalities.

I have arranged for her to have a skull x-ray which is reported to show no significant lesion. I am also arranging for her to have an EEG”.

In relation to that EEG, we can see the results but in the local hospital records at page 25. Looking at this letter it is a letter from Dr Houlsby to Mrs 8 dated 30 June 1995 and it does not appear to have been copied to your practice. Is that right?
A That is correct.

Q What it states is,

“I now have the results of [Child 8]’s skull x-ray and EEG and am pleased to be able to tell you that both tests were reported to show no abnormalities. I look forward to seeing her again in clinic in due course”.

We have seen already reference to hearing problems, Dr Jelley, and I would like next to take you to page 142 of the GP records. This is a letter to the Collingwood Surgery addressed to Dr Tapsfield from the ENT department at the Freeman Hospital from Dr Meikle. It is dated 1 August 1995 and he says,

“I reviewed this little girl and unfortunately her speech has now regressed. She looks to have glue hear with a hearing loss consistent with this, and her mum says that what speech she has seems to have gone backwards. In view of this I think we should get her in for grommets as a day case and I am arranging this”.

Is that consistent with the worries that Child 8’s mum was expressing to you about her speech difficulties?
A That is correct, yes.

Q You can also see some reference to this if you turn to page 139. This is another note by Dr Morley, a summary of the special needs team meeting of 16 October 1995. Under the heading Progress/Discussion he says:

“[Child 8] has been found to have a 45 50dB hearing loss by Mr Meikle and is to have grommet insertion. Kath McAulay has seen [Child 8] and found her to have some delay in all areas but particularly in speech. Mother stated that [Child 8] had several words before her MMR immunisation which are no longer used. She will follow directions without gesture being used and gives an exaggerated response to noise. Her mother expressed anxiety that the cause of [Child 8’s] delay is not known.”

Can we turn back to the clinical records in the GP notes to page 21. The entry that I would like to take you to is 1 November 1995. Is that in your writing?
A That is my writing, yes.

Q Can you read what that note says?
A “T” means there was a telephone call from, presumably from Mrs 8.

“No word from Freeman Road Hospital.
Chased again will ring us this week and let us know and I will phone [Child 8’s] parents.”

Q Could you read the next entry as well, is that also in your writing?
A That is Dr Linford. Do you want me to read that?

Q Yes.
A That is:

“Surgery appointment:

Screening constantly.
Mum at the end of her tether.
O/E [on examination] cervical lymph nodes and slightly red throat. Discussed with health visitor and one ...”

one of the other doctors.

Q Would that be Dr Tapsfield?
A No, that is DT, Dr Tomson:

“One GP needs a grasp as Mum has concerns re MMR and wants yellow card sent.”

That is because Dr Tomson had a role doing some family therapy within the practice, so he was sometimes involved where there are issues that whole family needed to address. I think possibly he had been involved with the family in that context.

Q What is a yellow card?
A A yellow card is when a clinician or anyone else suspects an adverse drug reaction.

Q Who do you send the yellow card to?
A I think it is the Committee on Safety of Medicines.

Q Can we turn to 136, in the same bundle, GP records. This is a letter from Dr Meikle, the ENT surgeon, again to Dr Tapsfield. He says:

“I reviewed this nice young lady following insertion of grommets. Her ears are now fine with the grommets in place and visual reinforcement audiometry shows that her hearing is fine at all frequencies in both ears.

Unfortunately this improvement in her hearing has not made any difference to her speech as yet. Mum dates the deterioration in her speech development back to the difficulties she had after the MMR immunisation and I am sure that this is a more complex problem than just the glue ear. I am sure it is a good idea to have her ears as good as possible which they do seem to be at the moment and I will see her again in six months time but I hope the more complex difficulty gets sorted out.”

If we now turn on to page 137, this is a letter from Dr Shabde to Dr Bushy, a senior lecturer and honorary consultant in clinical genetics. It is dated 29 November 1995 and says:

“Thank you for seeing [Child 8] jointly with me with me on 7 December.

[Child 8] has global development delay. At the age of 10½ months it was discovered that she had coarctation of the aorta which was repaired. She has rather unusual appearance with a bossed forehead and deep set eyes which could be familial. However, there is no doubt that this young lady has dysmorphism and with her developmental delay and congenital heart merits your expert opinion. I should add that she has had her chromosomes checked, the results are awaited. There have been a number of other investigations done – so far nothing positive has been found.”

So it seems to be the case that at that stage there were some investigations being done in relation to a possible genetic explanation?
A That is correct, yes.

Q The next letter in the sequence I would like to take you to is July 1996, so moving on six months, at page 121. This is a letter from Dr Bushby, the geneticist and it is to Dr Tapsfield dated 31 July 1996. It states:

“[Child 8’s] mother came to the Genetics clinic recently without [Child 8]. Unfortunately we are still unable to reach a firm diagnosis to explain [Child 8’s] developmental delay, coarctation of the aorta and slightly unusual face. Her mother reports that she is still without speech.

Much of our discussion recently centred around [Child 8’s] mother’s concerns that her problems stemmed from her MMR vaccination at 19 months. She tells me that a couple of weeks after the injection she developed a measles rash and was very poorly with it. She subsequently fitted and was admitted to hospital where she was found to be dehydrated. [Child’s 8] mother is aware that there may be an underlying cause for [Child 8’s] problems but is obviously also anxious that the MMR injection either caused her developmental delay or exacerbated it. She has been in touch with an organisation Jabs and is in contact with a mother of a child who similarly feels that her child’s problems date from the MMR immunisation. Interestingly [Child 8’s] mother feels very strongly that [Child 8’s] speech was coming on well before she had her immunisation and that she had several words at that stage which she subsequently lost.”

This letter appears, for the purposes of the Panel’s notes, in a number of places, including three places in the Royal Free Hospital notes at pages 28, 37 and 49. Dr Jelley, it seems at that stage that there were again concerns being voiced by Child 8’s Mum that the vaccination, if not entirely responsible for her developmental delay, had certainly exacerbated it?
A That is correct, yes.

Q As far as you were concerned, was that a relatively consistent worry or concern that was voiced by Child 8’s Mum?
A Absolutely, yes.

Q The next note that I would like to take you to is page 28 of the GP notes. The particular entry that I want to draw your attention to is the entry of 30 September 1996, two thirds of the way up on the left hand side. Do you see that?
A Yes.

Q Is that your writing?
A That is my writing, yes.

Q It appears to record a telephone call?
A That is right.

Q Was it a telephone call with Child 8’s mother?
A That is correct?

Q Could you read the note out?
A It says:

“Mum taking her to Dr Wakefield, Royal Free hospital for CT scan and gut biopsies.
? Crohn’s – will need a letter.
Dr Wakefield to phone me.
Funded through legal aid.”

Q When you say “will need a letter” does that say “ref”?
A Will need a referral letter, yes.

Q “Dr W to fund me, funded through legal aid”, so you had a telephone conversation with Child 8’s Mum. Did all the information in that note come from her?
A I cannot see any reason why it did not.

Q Had you, prior to this stage, been aware of any potential involvement with Dr Wakefield at the Royal Free Hospital?
A No.

Q At that stage did you know who Dr Wakefield was?
A No.

Q Do you recall whether Child 8’s Mum told you how she came about Dr Wakefield’s name?
A No, I do not recall that.

Q Did you know anything about the Royal Free’s work at all at that stage?
A Nothing at all.

Q Other than what is recorded in that note, “CT scans and gut biopsies”, were you aware of any particular investigations which were to be carried out?
A No, not at all.

Q What do you understand Child 8’s mother to be asking for?
A That she wanted some further investigations carried out. I think there had been several references to Child 8 having diarrhoea, so I presume that when she heard of this study linking MMR and possible gut problems that she wanted to put her child forward to be investigated along those lines.

Q Can we look at your referral letter at page 119 of the same bundle. This is dated 3 October 1996. Before writing this letter did you take any further steps to contact anyone?
A No.

Q We can see it is a letter from you to Dr Wakefield dated 3 October, as I said, and it says:

“ 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 [Mrs 8] 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 for [Child 8]. I enclose photocopies of some recent correspondence which gives 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 do not think we can be entirely convinced as yet that 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.

Best wishes.”

Did you know what Dr Wakefield’s status was when you wrote that letter to him?
A No, I presumed he was a researcher based at the hospital, but that was the only information I had.

Q Why might you have presumed that he was a researcher?
A Because this was a research programme based at the Royal Free.

Q You state in that letter state that there was correspondence enclosed with it. I just want to take you, in that connection, to the Royal Free records to show you the correspondence that found its way into those records and ask if those were the letters you were sent. Can we look at page 21 one of the Royal Free records. This is the referral letter. If we turn on to page 22, we see there a letter from Professor Walker Smith to Mrs 8, which is later on so we can pass over that for the moment. If we look at pages 23 and 24, a letter from Dr Houlsby to Dr Shabde; pages 25 and 25(a) Houlsby to Tapsfield; pages 27 and 26, which are photocopied the wrong way round in these notes, are minutes of a Special Needs Team Meeting; and 28 is a letter from Dr Bushby to Dr Tapsfield of 31 July 1996. Those are all letters that we have seen in the GP records. Would it be your understanding that those were the letters that were enclosed with your referral?
A Yes.

Q Going back to the referral that you made to the Royal Free, there was a reference in your clinical note of the telephone call you had with Mrs 8 that Dr Wakefield was to phone you. Do you remember whether in fact he did phone you?
A I cannot recall a telephone conversation at this stage. I did speak to him at a later point but I do not think that it was prior to the referral because I am sure that I would have mentioned something in the letter saying, “Following our phone call …” which would be my normal practice. I think that he probably did not phone me prior to the referral letter being written.

Q You also say in your notes that you made prior to the referral that the referral was to be funded through legal aid. What was your understanding about the connection between the referral of Child 8 to the Royal Free and legal aid?
A I am not quite sure, to be honest. Looking back, I do not know. Obviously referrals made outside the local primary care area require special funding in some circumstances and she was not asking me to arrange special funding because in some cases you have to arrange extra contractual referral funding if somebody wants to go outside the area. I do not know whether I questioned her about why it was legal aid funding and whether I made a connection between the fact that she had been involved with the group JAWS (sic) at that stage; I do not think I did. I think I just took what she said, “I am funded by legal aid and I won’t need the funding” but I do not think I thought about what that actually meant in any depth.

Q Were you aware at the time as to whether or not Mrs 8 had been seeing solicitors?
A I do not think I was aware at the time but I cannot remember.

Q What did you know at the time as to whether or not the work that was being done at the Royal Free was linked to the Legal Aid Board?
A I do not know; I cannot remember, I am afraid.

Q You made a reference to the group JAWS; did you mean JABS?
A I apologise. JABS was the one that the geneticist mentioned and we did have later correspondence from them about the MMR vaccine.

Q I think that we can see that at page 99 in the GP records. This was a letter some time later on 17 June 1997 addressed to you from Mr Richard Barr of Dawbarns. He says in this letter:

“Accompanying this letter is a letter requesting medical records for the above child.

My firm is co-ordinating claims by as many as 700 parents that their children have been seriously damaged by the MMR/MR vaccine.”

At that stage, is it right that you provided medical records to the firm of solicitors?
A Yes, I imagine that I did if they were asked for.

Q Prior to Child 8’s actual admission to the Royal Free, there are a couple of records that I want to take you to which intervene between your referral letter and the admission date. First of all, would you look at pages 116 and 117 of the GP records. Page 117 first, a letter from the Vaccine Damage Unit dated 16 October 1996 and this is addressed to the health authority in XXX and XXX,

“In order that we can consider a claim for payment against the Department of Social Security in respect of alleged severe damage caused by vaccination, could you please supply photocopies of the following information:-

1. Immunisation history
2. Infant Welfare Clinic/Health Visitor notes.”

Would you turn to page 116. On 29 October 1996, again the Vaccine Damage Unit writes to you to say,

“Thank you for sending us [Child 8]’s medical notes that we asked for.”

Is this correspondence a reference to the yellow card that was sent or is it something different?
A I do not know or I cannot quite remember when the yellow card was sent and whether the yellow card would specifically have triggered a claim for payment as such. I would have thought that there would be some intervening steps or the yellow card might have triggered the original concern but I think that there would have had to have been an ongoing connection to the Vaccine Damage Unit.

Q At this stage in the middle of October 1996, there would have had to have been some form of ongoing claim against the Vaccine Damage Unit.
A I think that a process must have occurred from the submission of the yellow card to the Vaccine Damage Unit considering a claim for payment because the yellow card is simply a suggestion that a reaction might have happened, it is not proof that it happened.

Q Next, would you turn to page 115. This is a letter from Dr Houlsby to Dr Tapsfield on 29 October 1995 and it is informing Dr Tapsfield that Child 8’s recent EEG is reported to have shown no significant abnormalities. So, that is an EEG taken some time after the first one that we looked at a little while ago.
A Yes, that is correct.

Q Would you turn backwards to page 110 where we see a letter to
Professor Le Couteur, Professor of Child and Adolescent Psychiatry at the Fleming Nuffield Unit in Newcastle dated 13 October 1996 from you. You set out on page 110 a detailed history and on page 111 in the concluding paragraph you say,

“Her mother is now convinced that [Child 8]’s problems effectively started after her MMR injection. She had quite a severe reaction to this vaccine and was admitted with a febrile convulsion following an episode of gastroenteritis a few weeks after her MMR. Her mother says that [Child 8] definitely had some words prior to her MMR injection and says she has a video which demonstrates [Child 8]’s vocalising at the age of 18 months. However over the last year her vocal skills have not developed at all. She has obvious developmental delay globally and is difficult to handle most of the time. I feel it is quite clear from her records that there were significant concerns about [Child 8] from well before her MMR although it may be that something to do with the vaccine made things worse for her – I really don’t feel qualified to comment on this. I enclose a series of letters photocopied for you to review. If I can help you further in any way please don’t hesitate to write or phone.”

Dr Jelley, you had already made a referral to the Royal Free at this point; what was the purpose of making this referral?
A “I am writing in response to your letter of 4 November 1996 …” There must have been a request for this referral; I cannot remember from where it was generated, whether mum came in and asked for it or whether she was referred via the special needs team. This is a professor of a specialist unit in XXX which is a sort of second tier referral from the local special needs child mental health service’s team, so I would have to try and check where that ---

Q Would you look at page 113, this is a letter from Professor Le Couteur to you saying,

“… I have been asked by Ms Jean Clydesdale, Consultant Clinical Psychologist, to see [Child 8] for assessment.”

A So, that is the referral from the primary level services locally to the secondary level services in XXX.

Q Lastly before we go to the admission to the Royal Free, would you take up the local hospital records at page 18. At the foot of the page, we see an entry dated 5 January 1997 and it records the age, height and weight and it says,

“Not seen Dr Berney yet”

and is it right that Dr Berney is a child and adolescent psychiatrist?
A I cannot recall but, if that is what is in the records, I am sure that is correct. I cannot recall the name.

Q
“Not seen Dr Berney yet – try to expedite.
Mum has given Evening Primrose Oil.
Diarrhoea settled.
Going to London next week – Dr Wakefield
– connection MMR + bowel symptoms.”

Is that right?
A That is what I read it as, yes.

Q Turning to Child 8’s admission to the Royal Free, that occurred on 19 January 1997 and would you now take up the Royal Free Hospital notes at page 5 where we see a record of an admission on 19 January 1997 at number 3; do you see that at the foot of the page?
A Yes.

Q Under “Admission Details”, the category of the admission is said to be NHS. As far as you were concerned, who was funding the referral to the Royal Free?
A I have to say that, at the time, it was not something that I was concerned about in the sense that I was not asked to try and get local funding for this, so I presume that it was funded by local NHS funding at the Royal Free in that we were not asked to request funding from XXX for it.

Q If we can now turn back to the GP records to see how the results of that referral played out: following the admission on the 19th the first record is a letter from Dr Houlsby at page 107, dated 22 January, but relating to the clinical notes that we have just been to. The middle paragraph records the information that we saw in those clinical notes relating to Evening Primrose Oil and the fact that her diarrhoea is reported to have settled.

Next if we could go to page 25 in the GP, and if you would look at the entry for 28 January 1997, is that “T” for telephone?
A That is correct, yes.

Q And it says:

“Been to London RF” – presumably Royal Free – “no results yet – will phone when has them – requests orange badge.”

Is that right?
A Yes, for parking.

Q And “yes”.
A “Yes” meaning yes, I agree that she can have it.

Q The next letter in the chain is the letter from Dawbarns, at page 96. This letter is from Dawbarns to you, dated 17 June 1997, and it is therefore some months after the admission to the Royal Free and it states in the body of the letter:

“We are acting for the parents of [child 8]. Legal aid has been granted to enable us to investigate a claim for compensation …

In order that we may fully investigate this claim we shall first of all need to have sight of all the child’s medical records.”

On this letter in manuscript on the right-hand side it says “Yellow card sent 26/6/97”. We saw some correspondence with the Vaccine Damage Unit in October 1996.
A Yes.

Q How does that tally?
A I cannot remember. There was a previous reference to requesting a yellow card and I cannot remember what the date of that was, whether a further yellow card was sent or whether this was the vaccine damage from the benefits agency was generated from something else. Whether that was related to the JABS connection I cannot recall but it seems likely that I sent a card on 26 June, I think that is likely.

Q At page 83 is a letter from you to Dr Thomas and it says:

“I write in response to your letter of 29 July 1997. I enclose a photocopy of a recent report from the Fleming Nuffield Unit which summarises quite a lot of [child 8’s] problems to date. I also enclose a photocopy of my summary referral letter to the Nuffield Unit November 1996. I don’t have a lot of information about her bowel problems because [Mrs 8] took [child 8] down to the Royal Free Hospital who have a particular interest in this and I have had no word from them about what they found. As far as I understand it she has had episodes of constipation and diarrhoea over the last year and this is what prompted [Mrs 8] to make enquiries at the Royal Free.

There is no doubt that [child 8] is developmentally delayed, the issue of course is what might or might not be the cause of this delay and whether the MMR vaccine actually has anything to do with it. There was certainly evidence of delay present before [child 8] had her MMR vaccine but her mum is absolutely clear that she had speech present before the vaccine which then disappeared once she had had the vaccine. Her bowel problem developed in the last year or so and her mum feels they may also be vaccine related. It may be possible to get more information from the Royal Free but I have heard nothing from them since [child 8] was seen there earlier in the year. Please let me know if I can be of any further assistance with best wishes.”

We can see from page 84 that Dr Thomas was from the Committee on Safety of Medicines. Is this correspondence therefore the correspondence that was entered into following your filing of the yellow card?
A Yes, except the dates do not tally, do they – or was it June, sorry?

Q June 1997 on the manuscript note that we looked at?
A Okay, that is fine, then it would, sequentially, yes, that is correct.

Q You state there that you had not heard anything from the Royal Free. In fact the next letter in the sequence, November 1997, is the first communication from the Royal Free to you, and page 76 is a discharge summary. It is addressed to you from Dr David Casson, copied to Dr Wakefield and Jill Thomas. It is dated 27 November 1997. Is it in fact correct that this was the first you heard from the Royal Free following the admission in January?
A That is correct, yes.

Q It says:

“Dear Dr Jelley,

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

It sets out her developmental history, and on the next page it sets out that she underwent a colonoscopy:

“Histology of biopsies during this procedure noted lymphoid follicles within the terminal ileum. All pieces of colonic tissue demonstrated minimal inflammatory changes.”

It records that a barium meal follow through and an MRI scan were done. It records the blood tests:

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

Were you aware of any particular reason for the delay between the admission in January 1997 and the discharge summary in November 1997?
A No, and it would be quite unusual in most letters not to refer to it. I apologise for the delay but, no, I have no understanding of why it took so long.

Q Next, may I take you to page 74 in the same bundle? Nearly three months later, this is a letter from Dr Wakefield to you, dated 15 January 1998, and he says:

“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 for this syndrome and the findings have been remarkably consistent. Please find enclosed the first paper covering the initial 12 children, including [child 8]. This is due for publication in The Lancet in the next few weeks.

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

Were you aware of how the contact between Mrs 8 and Dr Wakefield had come about, was this something she had mentioned to you?
A No.

Q He says in the first sentence, “I have recently been contacted by [Mrs 8] and realise that we have not spoken for some time”, do you in fact recall having spoken to Dr Wakefield prior to this time?
A I do not recall.

Q He tells you in that letter that they are coming up to the 38th child investigated for “this syndrome” and says it is enclosing the first paper covering the initial 12 children, including child 8, due for publication in The Lancet. Were you aware that child 8 was to be included in a publication in The Lancet before this letter or was this the letter that informed you of that?
A This was the letter that informed me of that.

Q Then there is a manuscript note on the right-hand side, is that in your writing?
A That is my writing, yes.

Q It says, “Was this enclosed? If not please ring and ask for it.” Do you know whether it was in fact enclosed?
A It was not enclosed to my knowledge because I am sure I never saw the paper until it actually came out in The Lancet.

Q Did you have any particular reaction to the suggestion that mesalazine would be appropriate?
A No.

Q Were you aware of what mesalazine was?
A Yes, it is used in inflammatory bowel disease, but is usually something initiated in secondary care.

Q If we turn back to page 28, this is an entry dated five days after the letter from Dr Wakefield, and at the foot of the page we see the entry for 20 January 1998, is that your writing?
A That is my writing, yes.

Q Is that “T” for telephone call?
A “T” for telephone, yes.

Q Can you read what that says?
A It says “Telephone Dr Wakefield ? needs mesalazine” – I cannot read that bottom bit.

Q Does it say “await [something]”?
A “Await letter.”

Q Are you able to remember whether this was a telephone call that you initiated with Dr Wakefield or whether he telephoned you?
A I think he initiated it but I could not swear on it.

Q Do you recall why it was that it was suggested that child 8 might need mesalazine?
A Well presuming I had seen the letter we have just looked at, the study had found some benefit in resolving gut symptoms in these children using mesalazine.

Q Did you in fact prescribe it at that stage?
A I cannot recall that, it must be in the records somewhere if it was prescribed.

Q I will be corrected if I am wrong but I do not think there is a note of you having prescribed it at that stage.
A Right. All the prescribing is done on computer, and was at that stage, so it would be in the records if she had received mesalazine from us.

Q Could I ask you to turn now to page 73? This is a letter dated 14 April 1998 from Professor Walker-Smith to you, although your name is incorrectly spelt in the address and in the “Dear Dr” part. Was this the first time that you had heard, either by letter or in any other way, from Professor Walker-Smith?
A I believe so, yes.

Q Did you know what role he was playing at all?
A No, apart from the fact that there was a mention of him in Dr Wakefield’s original letter, that I would be expecting a letter from him but I do not know what his role was.

Q When you say “Dr Wakefield’s original letter” you mean the letter that he wrote in January concerning mesalazine?
A Of this year, yes.

Q This letter, which is copied to Dr Wakefield states:

“I understand that [child 8] continues to have gastrointestinal symptoms. I do believe that it would be appropriate to give [child 8] a therapeutic trial of the 5-ASA derivative of Pentasa in a dose of 500mg daily.”

This is dated 14 April 1998: were you aware of any outpatient clinic review or follow-up in the Royal Free that had occurred prior to this?
A No.

Q Moving on to page 59, this is a letter from Dr Berney and you will see from the foot of the page that it is confirmed there that he is a consultant child and adolescent psychiatrist. It is to you, dated 4 October 1999, and therefore it is a year and a half later than the April 1998 correspondence with Professor Walker-Smith and Dr Berney says in the first paragraph:

“I last saw [child 8] a year ago at which point the parents had decided to abandon imipramine as withdrawal did not make any difference. Apparently mesalazine did not help either her bowel or her behaviour. Although, from her mother’s reports, I thought she had improved substantially at that time. [Mrs 8] is now more doubtful. In retrospect, she thinks that she was probably focusing on [child 8’s] positive points in the hope that she might gain a placement at XXX School. She has not attained this, has continued at XXX and is not making any progress. [Mrs 8] believes she has not made any progress since the time of her injection and a move to XXX School (for children with SLD) has been suggested.”

As far as you are aware, has child 8 remained off mesalazine ever since?
A Yes.

Q In the second paragraph of this letter he says:

“I found [child 8] much as I had a year ago – constantly on the go, provocatively testing those around her and not persisting at any single task; in short exhausting. As before, I think the primary diagnosis is Attention deficit Hyperactivity Disorder in a child who has a language (and in particular speech) delay and probably has other specific learning difficulties as well. She may well have a generalised mild learning disability but I am not sure that it would be possible to identify this at present. She has a small number of specific sounds and uses pointing. I think there is some chance that she might show a spontaneous improvement in her speech over the next year but it is not a great one.

I have started her on methylphenidate …

I have arranged for [Mrs 8] to phone me in a week and, if necessary, I will increase the dose to BD at that point. I will continue to follow up [child 8] and will let you know how it get on.”

Is that the diagnosis that has been used on subsequent occasions in relation to child 8?
A I am not entirely sure whether that is the primary diagnosis at this stage, I cannot say.

Q You have already indicated that you were aware that child 8 was to be reported in The Lancet, when the article was published in The Lancet did you read it?
A I do not think I read it in depth, no.

Q Did you have any specific concerns in relation to The Lancet paper concerning vaccination?
A Well, yes. My concern, from our point of view, was that I felt there was clear documentation of developmental delay prior to the vaccination and I was keen that the child that I knew about, it was not portrayed that the MMR vaccination could have been entirely responsible for the delay, i.e. a totally normal child that became developmentally delayed after the MMR, therefore fuelling more concerns about the MMR as possibly causing that kind of problem with children.

MR THOMAS: Sir, I just want to check a couple of things before I finish with this witness. It is 10 to 11 and it strikes me that that might be a convenient moment to take a break.

THE CHAIRMAN: I think that is absolutely fine. I was wondering about that myself. So we will adjourn now and resume at 10 minutes past 11. Dr Jelley, I have to remind you that you are under oath and in the middle of giving evidence. So please make sure you do not discuss this case with anyone during the break, and I am sure somebody will look after you as to tea and coffee.

(The Panel adjourned for a short time)

THE CHAIRMAN: Mr Thomas.

MR THOMAS: Thank you, sir. I have just two matters, Dr Jelley. We were dealing with The Lancet paper just before the break. Leaving aside the circumstances of Child 8 for one moment, is it also right that you were concerned about the effect the paper would have on vaccine uptake generally, because the results of only 12 children had been reported?
A Absolutely, yes.

Q Lastly, we have not seen any note of an outpatient consultation in respect of Child 8 and no letter written to the GP in respect of any such consultation. If there had been an outpatient appointment which Child 8 had attended, would you expect to be notified in some way of that?
A It is normal practice if any patient attends outpatients that we receive a copy of the letter, which is usually written to us.

MR THOMAS: Thank you, Dr Jelley. Those are all my questions. If you wait there, there will be more.

MR COONAN: I have no questions, sir.

Cross-examined by MR MILLER

MR MILLER: Dr Jelley, you were Child 8’s GP from birth, although we can see from the records that a number of other members of the practice dealt with problems when they arose, particularly Dr Tapsfield, as we can see from the correspondence with Dr Houlsby. But you dealt with the referral and dealt with subsequent contacts with other specialists – Professor Le Couteur and Dr Berney – dealing with the behaviour or developmental side of this child.
A Yes, that is right.

Q The mother had concerns about her daughter’s development from an early age, and you had concerns about her development before she received the MMR in January 1995.
A Yes.

Q As you say in your witness statements, you believe her development did appear to get worse after the MMR.
A That was certainly her mother’s perception, who was with her all the time, yes.

Q There was an event, although it is quite difficult to chart it through the notes, but there was an event within a fortnight or so of the MMR.
A Yes.

Q If we can try to get it in sequence. In the general practice record, page 20, right at the bottom of the page – you looked at it before – it is the last entry on that page, is it 7 February?
A That is 7 February, yes.

Q “95 – visit. Reaction to measles vaccine. Late call”.

Is that “plus pink (L) ear”?
A Yes, pink left ear.

Q “Therefore amoxyl antibiotic”.
A Yes.

Q Then there is a note on page 23 in the same bundle. This is 2 March 1995. Is that an appointment at the surgery?
A Yes.

Q “Was in hospital”, is that “2 weeks ago”?
A Two weeks ago, yes.

Q “Febrile convulsion”. What is the next bit?
A It looks like, “bad chest”, to me.

Q “Not talking. 0 words. Glue ear”.
A “Walking. Understanding sl[ightly] slow. Mum thinks doesn’t look right”, it looks like to me.

Q The only other note again I would like you to put in context is on page one of the local hospital records. This is the only one I am going to take out. It is the first entry, which again you looked at. This is under Dr Houlsby, who is a consultant paediatrician. Would this be an outpatient or an inpatient?
A That looks to me like an inpatient admission note, because it is 4.20. Whether that is in the morning, I do not know. It could be afternoon.

Q You are right, 4.20. It is 13 February, so it is a week after the general practice note we have just looked at.
A Yes, that is right.

Q It says, “MMR two weeks ago” and it looks as though there is a complaint of spots. It says,

“MMR 2 weeks ago. 8/7 ago following [the MMR] - spots”,

and then, “phone HV” -- phoned health visitor. Temperature up. “Spots cleared”. Two days ago, vomiting all night, and then the rest of it. So it looks as though that is an admission as a result of a continuing condition that started two days before. Is that right?
A That is what it looks like to me, yes.

Q It referred to various notes along the way, I think, that she may have had a reaction to the immunisation at around the time.
A That is right, yes.

Q You went through in some detail the investigations and the problems this child had as far as her development, her heart and her hearing were concerned. But you did not or were not taken to any of the notes about her gut symptoms, and I think you volunteered that there was a history in this case of gut symptoms which was contained in the notes, and you referred to it in your referral letter to Dr Wakefield. I think those symptoms varied but were what could be described as diarrhoea – I will take you to the notes – and its earliest manifestation in 1994 to constipation, because she was treated with a particular medicine which deals with constipation. Is that your memory, that those were the problems she had, broadly speaking?
A I cannot say I remember in detail, but certainly there are one or two references throughout the notes to gut problems.

Q I am not going to ask you to try to remember them. I am going to take you to them, but I temporarily lost them. The general practice notes are not easy in this form to follow. They probably would be if they were in the proper form. If you look at page 20 again in the GP notes, in the entry above the one we have just looked at, is that 3 October 1994?
A That is what it looks like to me.

Q This is a visit to the surgery. There is a reference to the child being constipated and the treatment is Lactulose.
A Yes.

Q So that looks to be the first visit, which requires a visit to the surgery and it is treated with a medicine for that.
A Yes.

Q Just one more entry in the local hospital notes please, at page 11. This is a referral by the GP and the date is 1 November 1995. Presenting complaint,

“unsettled during night; screaming + for a week”.

Then the second entry refers to “6 bowel motions/day – family upset”.

Then the history of the presenting complaint, “eating a lot”, and then identifying what the child was eating. At the bottom it says, “No vomiting” under that list, does it not?
A Yes.

Q Then is that “complain of” abdominal pain?
A That is what it looks like to me, yes.

Q “Had diarrhoea a month ago. Mother thinks she has had more dirty nappies than [normal]. Smelly+. Sometimes formed; sometimes loose. No blood”.

So for whatever reason it looks as though the child was being referred to the local hospital for two things, first of all, unsettled during the night and screaming, and also the bowel symptoms.
A Yes. It was an admission, so I do not think she would have been admitted for the bowel symptoms. I think it was probably the unsettling, but they had picked up the bowel symptoms.

Q I mean, there is a very long note and we can see at some stage, if one goes to page 13, on the following day, on the ward round – do you see that in the middle of the page – I assume “WR” is ward round.
A Yes.

Q It says,

“Some undigested vegetables/BO [bowels opened] shortly after meals; loos/formed stools ?toddler diarrhoea”.

A Yes.

Q I promise that this is the last time, but we go back to the GP records and then I think we stay in the GP records. If you go to page 128, this is a letter from Dr Houlsby to Dr Tapsfield and in the second paragraph it says,

“Her mother’s major concern at present is that she is continuing to scream. From my observations in clinic this seems to be particularly when she is seeking attention or thwarted. Her mother was concerned whether she was in pain but on full physical examination I could find no abnormalities to suggest this”.

Then at page 27 – I know this is tedious Dr Jelley, but if we can just identify the places in the notes where certain references are which precede your referral – this is 30 March 1996. Again, it is a visit to the surgery on 13 March,

“Mum worried re intermittent diarrhoea and ?constipation. AS – difficult”.

A That simply means abdominal system; that means on examination. So abdominal system difficult to examine, crying.

Q Then page 127, at letter to Dr Tapsfield dated 27 March 1996 from Dr Bushby, the end of the first paragraph, the last sentence,

“She has no problems with eating or with sickness but does often have loose stools”.

Then page 126, the page before from Houlsby to Tapsfield,

“[Child 8] attended clinic for review at the age of 2 years and 9 months. Her mother feels that her sleeping pattern and tendency to scream have improved greatly. She is attending nursery regularly where she is reported to be making satisfactory progress. Her general health has been reasonably good. She appears to have toddler diarrhoea. Her mother remains concerned about” –

and he refers to progress in other areas.
A Yes.

Q At page 122, this is a Special Needs Team meeting note, is it not? It is the minutes of the Special Needs Team meeting under the directorship of the community paediatrician, Dr Shabde.
A That is right.

Q It says,

“[Child 8]’s mother reported that [Child 8] had been unwell with bouts of very loose stools, however the specimens were clear”.

Then on page 120, again Dr Houlsby to Dr Tapsfield. The letter is dated 13 September 1996,

“[Child 8] attended clinic last week at the age of 3 years and 2 months. There has been no great change in her condition. She is still screaming inconsolably”.

He talks about contact with the child psychiatrist and clinical psychologist. He makes the point that you made yourself. Unegmatically, Dr Jelley, in my bundle anyway, in the practice records this letter stops at the end of the first page.
A I have got a second page, 120a.

Q I am sorry, I may have got it in the Royal Free anyway. I just want again to look at this.
A Do you want me to read that bit out?

Q Is it the last paragraph on the first page of the letter:

“Her mother also brought up once again the relationship of her problems to her MMR immunisation. On reviewing her records I find that the concern about [Child 8]’s developmental delay was expressed by her mother and yourself [Dr Tapsfield] in May 1994, long before the MMR was given in January or February 1995. The fever associated convulsion which she had in February 1995 was in the context of a diarrhoeal illness associated with fever two weeks after her MMR immunisation. I feel therefore that it is extremely unlikely that the MMR was the cause of her present problems”.

I assume that is how yours ends up as well.

Would you look at the note in the general practice records at page 28, which is your note of how the referral came about, because the mother was taking the child to Dr Wakefield at the Royal Free Hospital. We have seen your letter which became the referral letter to the Royal Free Hospital. It seems you put in with that letter almost all the correspondence which Mr Thomas went through with you, and there is a big sheaf of letters, that could only come from you, so that they would have a complete picture of the developmental problems, in the copies that were there?
A Yes.

Q You made the point about that referral in your letter, that you seemed happy with the referral if it was a way in which somebody would investigate the child’s problems and might find an answer, you were happy to go along with it and prepared to support it?
A Yes.

Q You knew from the note that you made on 30 September, the one we have looked at already, that it would involve some form of gut biopsies which would have to be obtained by endoscopy, to see if there was any associated inflammation, presumably, within the gut that might be causing problems. I think you took the view that this was a big national centre, a London Teaching Hospital, and if it worked that was going to be a good thing for the child?
A That is right, yes.

Q For some reason, and we have heard other evidence in the case but we do not understand what happened, you did not get the discharge summary until nine months or so later?
A That is right.

Q As you rightly point out, there was no apology for the delay in that, but it set out, when you got it, what the findings were, the gut findings, and the results of all the blood tests and things.
A Yes.

Q The conclusion of that letter, again which you saw this morning, was that the results did not indicate a marked ongoing inflammation, which is one of the signs you thought they might find?
A Of course, yes.

Q You received the letter from Dr Wakefield in which he raised the question of treatment with mesalazine, a drug with which you are familiar, and he mentioned Professor Walker Smith. I think that is the first time you had ever heard Professor Walker Smith’s name?
A That is correct, yes.

Q You did receive a letter from Professor Walker Smith in which he is saying that it would be appropriate in his view to give her a therapeutic trial of 5 ASA derivative of Pentasa. Looking at the drug computer records from the practice, which are at the beginning of the bundle, there is a reference to Pentasa on page 3, just below halfway down the page. I do not whether it is 23 April or 13 April. I suspect it is 23rd because of the date of Professor Walker Smith’s letter to you which is dated the 14th. That would be the way in which it would be recorded in the general practice notes, is it?
A Yes, we were not recording consultations on the computer at that stage, but medication was, in most cases apart from home visits, was entered on the computer.

Q The only reason that I suggest it might be the 23rd rather than the 13th is because in Dr Wakefield letter he referred to mesalazine whereas there is a specific reference in the letter at page 73, keep keeping your hand at page 3, he specifically refers to a therapeutic trial of 5 ASA derivative of Pentasa in a dose of 500 milligrams daily and somebody – whether it is you or somebody else – has written on the right hand side:

“Please ring [Mrs 8] and ask if she can take tablets at all.”

That is the mother?
A Sorry, yes that is the mother of Child 8.

Q “If not please contact “
A Roger, who was our practice pharmacist at the time.

Q “And ask if it is possible to get this in liquid form.”

In fact a prescription looks to be in tablet dissolved in water.
A That is right, yes.

Q That suggestion was taken up and indeed she remained on that medication, presumably prescribed by the practice, for quite some time, did she not?
A Yes, it is not entirely clear from that how long she remained on it.

Q The only clue we get is from Dr Berney’s letter to you of 4 October 1999.
A Yes.

Q All we know is that at that stage she is unlikely to be on it because she has probably stopped it?
A Yes.

Q
“I saw [Child 8] a year ago at which point the parents had decided to abandon imipramine ...”

What is imipramine?
A It is an anti depressant, but it is used sometimes for behavioural problems in children.

Q
“Apparently mesalazine did not help either her bowel or her behaviour. Although, from her mother’s reports, I thought she had improved substantially at that time, [the mother] is now more doubtful. In retrospect, she thinks that she was probably focusing on [Child 8’s] positive points in the hope that she might gain a placement at XXX School.”

It sounds as though she was reporting an improvement on that medication but subsequently, in retrospect, decided it was not?
A That is correct, yes.

MR MILLER: Thank you.

THE CHAIRMAN: Mr Hopkins?

MR HOPKINS: No, thank you.

THE CHAIRMAN: Dr Jelley, if Mr Thomas wishes to come back for any re examination, he will ask questions.

Re examined by MR THOMAS

MR THOMAS: I have two short matters. Mr Miller took you to an admission to the local hospital and he took you to page 11. On this occasion there are bowel symptoms which are noted and he suggested to you that the admission might have been in relation to the bowel symptoms. You said to him that that was not likely given the context. I want to take you to the GP records at page 21. This is an attendance at the GP surgery on the same day as the admission to the local hospital, the 1 November 1995. We went to the first part of these notes when I was asking you questions earlier on, which begin “Screaming constantly”, but if you go down to the second part, which seems to record a telephone call, that appears to say “Discussed with” and that is the mother of Child 8, is it?
A Yes.

Q And:

“feel respite a need – Ward 10.”
A That is right.

Q Does it appear from that that the GP initiated the referral for the purposes of respite?
A Yes, it says:

“Lesley discussed with [the mother].”

Lesley is the health visitor. My feeling is that the admission looks as if it was primarily because of the family being upset and the child screaming. The diarrhoea was noted, but probably, on its own, that would not be the primary reason for admission, it was more the overall context of the child being upset and difficult to handle.

Q If you could go back to the local hospital records. Mr Miller asked you about some of the entries which relate to “toddler’s diarrhoea” and so on being noted in the GP notes, but he stopped in June 1996, so six months prior to her admission to the Royal Free. Can I ask you to turn to page 18 of the local hospital records to an entry dated 5 January 1997, right at the foot of the page. This is two weeks before her admission to the Royal Free. We have been through the reference to Dr Berney, but if you look on the third line and “diarrhoea settled”, is it right that that state of affairs was communicated to you in a letter we went to earlier as well?
A That is correct, yes.

MR THOMAS: Thank you, Dr Jelley, those are all my questions.

Questioned by THE PANEL

THE CHAIRMAN: Dr Jelley, the members of the Panel may have some questions from you and if they do I will introduce them to you. (No questions from Panel members)

Can I just ask you three or four questions. These are all very small questions, but I just ask them for clarification. Can you open the GP records page 164. You were shown this letter of Dr Tapsfield to Dr Houlsby.
A Yes.

Q What I understood from your evidence was that there is no specific record for mother to have expressed concern because you were doing the baby clinic. Is that correct?
A Actually, what I remember now is that she actually went to the local baby clinic in XXX, which is not our baby clinic, so I think the early developmental records were held at the XXX Child Health Clinic, whereas most of our children used to come to our clinic. I think she transferred into our clinic at a slightly later stage. I cannot quite remember the timeframe.

Q Do you remember whether, at that particular stage in her life, May 1994 or thereabouts, was she under your baby clinic?
A I do not know.

Q That is fine. Can you now open page 121 of the same bundle. In this letter I think, again, you were taken to this letter. The mother she has been in touch with an organisation Jabs. I know it is a difficult question, but if you cannot answer it please say so. In 1996, did you have any information of that organisation?
A None at all.

Q So this organisation, this name, did not mean anything to you at that stage?
A No, not at that stage.

Q Page 117, this is about the Vaccine Damage Unit, again I think it was your evidence that the yellow card may have triggered a claim against the Vaccine Damage Unit?
A Yes, but then when we actually looked, did not the date of the yellow card – it was after this, was it not?

Q I think, that is right.
A I think that is an error, yes.

Q What was your understanding about the yellow card scheme and CSM and Vaccine Damage Unit – your understanding about the interrelationship of these organisations?
A No clear understanding except I am sure that yellow card does not immediately lead to the Vaccine Damage Unit. I think there has to be steps in between to ascertain that what the GP writes as a hypothesis actually does constitute vaccine damage, so I do not know how the two are related.

Q The yellow card scheme, they only just collect possible adverse reaction?
A Absolutely, yes.

Q And may or may not mean anything, it depends how many they get?
A Yes.

Q My last question is on the same bundle, page 74. This was a letter to you from Dr Wakefield?
A Yes, that is correct.

Q I think you said that the manuscript note on the right hand side of the page was your writing?
A Yes.

Q You actually said that the draft of the paper, as far as you could recollect, was not enclosed?
A I am sure that that was the case, yes.

Q Then you have written on the right hand side that:

“Was this enclosed, if not please ring and ask for it.”

A That is correct.

Q Did you or anybody in your practice ring and ask for it?
A Normally those notes are written on by the doctor and then they go back to the secretary who does what you ask, so I would assume that it was done, but that they did not arrive.

Q If it had been done, then it would have been brought to your notice, would it not?
A If it had been done, I would have seen the paper, which I am sure I did not see until it was published.

Q You do not actually know, or do you, whether this was effected or not?
A I do not know.

THE CHAIRMAN: Thank you very much. I do not have any further questions, but I am going to ask counsel if they have any more questions on the basis of these few small questions. Mr Thomas?

Further re examined by MR THOMAS

MR THOMAS: I just have one small matter of clarification. In relation to page 117, you were asked about this document in connection with the yellow card. In answer to one of my earlier questions we looked at the timing of this and I think you indicated that you, yourself, sent the yellow card some time in June 1997.
A That is correct, yes.

Q So, although so these documents on page 117 and 116, you can see on 117, is it right that they relate to a claim for payment against the Department of Social Security? I think you indicated in answer to my earlier questions that that must have resulted from a claim that had been made throughout that stage?
A That is correct, but obviously not related to the yellow card which had not been sent as far as I can tell at that stage.

THE CHAIRMAN: Mr Miller?

Further cross examined by MR MILLER

MR MILLER: To make it even less clear, Dr Jelley, if you look at page 21, in the middle of the page is that the note for 1 November 1995?
A That is correct.

Q Is that your writing?
A No that is Dr Linford.

Q Because against that entry it ends up by saying:

“[Mum] has concerns re MMR and wants yellow card sent.”

A That is correct and, presumably, nothing was actioned, or there is no copy of that yellow card.

Q That seems to be the first reference, because that is in 1995?
A That is right. That is why I was confused, but in fact it actually was not sent until, maybe, nearly eighteen months after that.

MR MILLER: Thank you.

THE CHAIRMAN: Thank you very much. I do not see any further questions for you. On behalf of this Panel, can I thank you, Dr Jelley, for coming this morning and thank you for giving us your evidence. You are now released.

(The witness withdrew)

THE CHAIRMAN: Ms Smith.

MS SMITH: May I tell the Panel what the plans are from now on and for the rest of the week, and indeed, for reasons I will explain, at the beginning of next week. I have no more witnesses for today. Tomorrow I have two. One is a lady called Miss Davies, who is coming along to deal with some employment records and is a brief witness. She may be here in person or she may be read. That is a decision which I have yet to make, but it affects Mr Coonan’s client and he has indicated to me that he would not object to her being read. As I say, that is a decision that I have yet to make having just been told that by him. The other is Miss Alwyn, if I may put it in those terms, lawyer from the Legal Services Commission. Due to the inevitable pragmatic requirements as far as calling of the witnesses is concerned, it has not been possible to have them together as would be ideal. I am anxious that the Panel should have time before they hear Miss Davies’s evidence to reread the transcript evidence of Professor Humphrey Hodgson who you will recall also came to produce employment documents and to relook at the documents that he produced and, before Miss Alwyn gives evidence, that you should reread the transcript evidence of Mrs Joanne Cowie from whom you have already heard, as you will recall, and who is the other lawyer at the Legal Services Commission.

Whether Miss Davies is read or is here as a live witness, I anticipate that those two witnesses will comfortably be dealt with tomorrow. Friday is a clear day. I am calling Mr Tarhan who is the Finance Officer at the School of Medicine on Monday. Again, I think you would, if I may respectfully suggest it, find it very helpful to reread the evidence of Mr Else who is the Chief Executive at the NHS Hospital Trust, those parts of Professor Zuckerman’s evidence that deal with the whole issue as to the finances and to reread for yourselves the statement that you will recall was read of Mr Phipps who is the Assistant Director of Finance at the NHS Hospital Trust. Actually, Mr Mellor is very kindly finding me the references for these witnesses. Sir, in order that you are clear, you will recall that Professor Zuckerman is the Dean at the Medical School, Mr Tarhan from whom you are hearing on Monday is the Finance Officer at the Medical School, and Mr Else and Mr Phipps are the Chief Executive and Assistant Director of Finance at the NHS Hospital Trust. So, they all tie in together over the finances. Although on Friday there will not be any witnesses, I think that you would find it quite helpful if, before you hear Mr Tarhan on Monday, you had refreshed your memory as to that evidence. After that, if you need to know it, the next witness after Mr Tarhan next week will be Dr Davies, the histopathologist, who is likely to be quite a lengthy witness because she is dealing with all the individual cases.

The next evidence you will hearing will be either Dr (sic) Davies read or in person, once that decision has been made, tomorrow and Miss Alwyn from the Legal Services Commission tomorrow.

Mr Mellow has looked up some of the transcript references if it is useful to you. Professor Humphrey Hodgson is Day 14/1; Mr Else is Day 19/1; Mr Phipps was read into the transcript at Day 21/20; and Mrs Joanne Cowie, the LSC lawyer, was Day 11/1. Sir, I hope that is helpful information as to where we are going and that will be satisfactory for the Panel to be working on.

THE CHAIRMAN: Yes, indeed. That is very helpful and very useful information and the Panel members will find it helpful to go through those transcripts. It remains for me to say thank you all. We will be spending some time doing some of this reading today and we will see you at 9.30 tomorrow morning.

MR MILLER: Sir, confusingly, there are two witnesses called Davies. One of them is Miss or Mrs Davies who is giving evidence either here or having her evidence read tomorrow who deals purely with contractual matters. Next week, Dr Davies. Inadvertently, Ms Smith said that Dr Davies’s evidence might be read.

MS SMITH: I am so sorry. Mr Miller is quite correct.

THE CHAIRMAN: I have made a note of it. Miss Davies is going to come tomorrow to give evidence and Dr Davies, who is going to be the lengthy witness, is going to come next week.

MS SMITH: Next week after Mr Tarhan.

THE CHAIRMAN: Yes, I have a note of that. Thank you, Mr Miller. Thank you very much indeed, have a good afternoon and we will see you at 9.30 tomorrow morning.

(The Panel adjourned until Thursday 30 August 2007 at 9.30 a.m.)

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