Tuesday, January 31, 2012

Day 11 GMC Fitness to Practice hearing for Andrew Wakefield

GENERAL MEDICAL COUNCIL

FITNESS TO PRACTISE PANEL (MISCONDUCT)



Monday 30 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 ELEVEN)



(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

MRS JOANNE COWIE, Sworn

Examined by MS SMITH 1
Cross-examined by MR COONAN 24
Re-examined by MS SMITH 28
Questioned by THE PANEL 30
Further re-examined by MS SMITH 32

DR GEOFFREY NORMAN SHILLAM, Affirmed

Examined by MR THOMAS 33
Cross-examined by MR COONAN 61
Cross-examined by MR MILLER 63
Re-examined by MR THOMAS 71
Questioned by THE PANEL 74




THE CHAIRMAN: Good morning everybody. Dr Wakefield, I hope you are feeling better this morning. I know that you were not really well on Friday afternoon. Ms Smith, I think you were in the middle of deciding which witness you were going to start with this morning.

MS SMITH: I am going to call Mrs Cowie, sir, who is a representative from the Legal Aid Board. Can I just say to you, you are going to be hearing from two witnesses from the Legal Aid Board. The other one, who unfortunately relates more to the general set-up, we are not going to be hearing from until a little later, simply because of the way we have been able to get the witnesses here. I hope you will bear with me in respect of that. It will all fit together ultimately.

MRS JOANNE COWIE, Sworn
Examined by MS SMITH

(Following introductions by the Chairman)

MS SMITH: Mrs Cowie, I am rather a long way away from you so I am sorry for that. Please tell me if you cannot hear me and if you can remember to keep close to the microphone so we can hear you. Tell us, first of all, your full name and address.
A Joanne Cowie. My practice address is 2 Edith Street, Consett in County Durham.

Q I think it is right that you are a partner in a firm of solicitors in Consett, Swinburne, Snowball & Jackson. Is that correct?
A That is correct.

Q In 1996 you worked as a solicitor at the Legal Aid Board
A Yes, I did.

Q You left the Legal Aid Board in May 1997.
A Yes, that is correct.

Q Mrs Cowie, I think you have been asked to review some documents which have been disclosed to the General Medical Council by what is now the Legal Services Commission but was the Legal Aid Board.
A Yes.

Q Which related to the funding of a multi-party action against the manufacturers of the MMR vaccine.
A Yes.

Q During the time when you were a solicitor at the Legal Aid Board, were you asked to work on issues related to the public funding of that piece of litigation?
A Yes.

Q I would like you to look, if you would, at Bundle 1, one of the three bundles you have beside you, at page 83. Have you found that?
A Yes, I have, thank you.

Q That is entitled at the top,

“The Legal Aid Board authority to do contract work”.

If you just keep your finger in that and look back at page 46, that is a document in similar terms, is that right, and that was the original contract with the Legal Aid Board and we see that it refers to the measles, mumps and rubella litigation and authorises work to be carried out by Dawbarns solicitors?
A Yes.

Q That is dated September 1994. Is that correct?
A It is.

Q If you go back to page 183, we see that that says,

“Authority to do contract work issued on 26 September 1994, amended as follows”.

Is that a customary system whereby there is an original contract and then it can be amended as the Legal Aid Board considers fit?
A That is exactly right, but it would only be amended after an application was made by the solicitor.

Q If we look at the end of it, we will see on page 184,

“Authorised signatory Legal Aid Area No. 8”.

Is that in fact your signature?
A It is.

Q If we go back to 183 we will see what that authority was for. I am not going to take you through every aspect of the document, Mrs Cowie, because you will understand that we are only concerned with the particular involvement of the medical experts.
A Yes, I understand.

Q If you want to refer to anything else, of course do so. If we look at 1 and 2, amended as follows,

“1. To obtain a preliminary report from Dr Andrew Wakefield pursuant to the Opinion of Counsel…dated 22 April 1996.

2. To facilitate the setting up of the clinical and scientific study proposed by Dr Wakefield in respect of 10 assisted persons at a maximum cost of £55,000 and to cover the work necessary by the solicitors in so doing at a maximum cost of”,

and the amount of money so far as the lawyers are concerned has been redacted.
A Yes.

Q We have seen that your signature is at the bottom of that document. Was it produced on your authority?
A Yes, it was.

Q Was it your decision at that time whether you would grant that amended contract or not?
A Yes, it was.

Q I am going to take you, if I may, to the documents which led up to the decision to authorise that amendment to the contract. We are very conscious that we are talking 10 years ago. Do you have any recollection outside the documents of your decision-making at that time?
A I have to say, 10 years ago is an awfully long time and this was one of a number of my responsibilities in my role as solicitor with the Legal Aid Board at that time. So whilst yes, I do have recollections, the specifics of that, I have to say, are really not very good.

Q If I may, I am going to ask you about some of the documents and you can tell me when you want to add anything to what is not clear on the face of those documents. Initially I want to take you to two letters in May and June 1996, and the first is at page 101. This is the first letter of two which in fact are not addressed to you but to a Mrs Simpson. It is dated 21 May 1996. Can you just help us as to who Mrs Simpson was?
A Mrs Simpson was one of my solicitor colleagues at the Legal Aid Board at the time.

Q Did she in fact leave shortly after 1996?
A She did. Since re-reading some of the statements and trying to remember when things happened, I seem to think that she left but she sort of came back to help us out pending the recruitment of another solicitor. So she left officially but there was a shortish period of time when she came back to do some helping out.

Q If we look at that letter, it is from Richard Barr. Was he the partner at Dawbarns solicitors who was dealing with this matter?
A He was, yes.

Q I will not take you to the first two paragraphs of the letter, which deal with the solicitors’ position as far as the Legal Aid Board is concerned, but we see, half-way down the page,

“There does at last seem to be an increasing acknowledgement among the medical profession that these vaccines actually are causing damage. Dr Andrew Wakefield (who has been mentioned to you in Counsel’s Opinion and by me several times) is actually quite astonished at the evidence that he is uncovering and feels that objective tests may well establish conclusively that the measles vaccine is causing a wide range of these injuries.

I am waiting for his protocol proposals but a significant part of the costing will be in a proposal for testing a selected number of children to try to establish the link. I should emphasise that the hope is that the tests will be so positive that they will actually find the measles vaccine virus (as opposed to the wild type) in the areas of inflammation in the children. If that can be done it must be rather like catching a burglar red handed!

We do really want to keep going with our researches. We have been dogged by delays”,

And he explains that there was a massive set of documents to collate.

“We do not have unlimited time and I would like to keep things moving. In addition, we are obviously still having to co-ordinate by dealing with enquiries, the media and so on. There are experts that we would like to continue to correspond with both in this country and in the USA and we would also like to start to see as many as we can in this country. We have already had several constructive meetings with Dr Wakefield but there are other experts that we would like to involve covering a variety of different fields”.

He then asks for an extension of the finances. If I could then take you on to the second letter, please, also to Mrs Simpson, that is one month later, 6 June page 103. That again is a letter from Mr Barr. If we go straight to the second paragraph he says,

“To give you further information on the costing proposals I enclose a copy of a draft (note entirely finished yet) of Dr Wakefield’s proposed protocol for the study and his costing proposals”.

Then if we go down to the bottom of the page, he says,

“I look forward to hearing from you”,

and offering to send things by fax if that helps. If I may, Mrs Cowie, I would like to take you to the documents attached to that. One is on page 104. Is that the proposed clinical and scientific study? Do you have that?
A Yes, I have.

Q With the co-ordinating investigator being Dr Wakefield.
A Yes.

Q If I can take you briefly through that, because we need to compare it with other documents. Page 105, the investigators from the Department of Paediatric Gastroenterology are set out, Professor Walker-Smith, Dr Murch and others, and the responsibility of those doctors, and the Department of Paediatric Gastroenterology, Dr Wakefield and others. Going over on to page 106, the Department of Child Psychiatry Dr Berelowitz. On page 107, Dr Harvey in the Department of Neurology. Then we see the introduction which says,

“There are indications of the emergence of a new syndrome”,

and the heading, “Disintegrative disorder” and the definition of what disintegrative disorder is. Turning over to page 110 we see a section on the science of complement, measles and disintegrative disorder. Then on 111, “B12 metabolism, enteritis and disintegrative disorder”. On to 113 the proposed studies half-way down the page,

“Identification and characterisation of any intestinal pathology in affected children by:

full clinical examination”,

blood counts, immunology, looking for the measles virus, colonoscopy, histology and immunohistochemistry, mucosal biopsies, RNA extraction from frozen biopsies and exclusion of other infections. On page 114 neuropsychiatric studies and the neuroradiological studies by Dr Berelowitz and Dr Harvey. Then on page 115 the practical issues setting out the demanding protocol and on page 16, characterise the pathogenesis of this condition, and under (ii) the referrals to be co-ordinated by Dr Wakefield, Professor Walker-Smith and Professor Murch, and a plan that the children would be admitted for colonoscopy on Sunday afternoon with their parents for a week, with various tests done during that time and an out-patient follow-up in a month.

If I could take you over to the costing proposal which is on page 121, this is the second document enclosed in the letter to Mrs Simpson,

“Proposed protocol and costing proposals for testing a selected number of MR and MMR vaccinated children.

A protocol giving the detailed technical specification is attached”,

and that I have taken you to.

“Objective: The objective is to seek evidence which will be acceptable in a court of law of the causative connection between either the mumps, measles and rubella vaccine or the measles/rubella vaccine and certain conditions which have been reported with considerable frequency by families of children who are seeking compensation.

It is hoped that using the testing protocol attached it will be possible to establish the causal link between the administration of the vaccines and the conditions outlined in this proposed protocol and costing proposals. The standard of proof aimed for will be at least the balance of probabilities but it is hoped that in many respects the level of proof will reach certainty or near certainty”.

Then it sets out the conditions, Crohn’s disease and IBD, persistent reports of children suffering from symptoms akin to autism,

“(here described as disintegrative disorder) coupled with inflammatory bowel disease”.

We then see the costings. First of all,

“Setting up costs: The testing proposals for the two groups are different but there will be a common one-off setting up cost in the sum of £26,500 to cover the use of laboratory equipment, laboratory staff, testing materials. It is anticipated that this sum will need to be paid once only even if the trial lasts for more than a year”.

We see on the next page, 122, the two groups. One of those groups are inflammatory bowel disease cases and there are various tests set out in 2.1 to test for measles virus £500, and for the evaluation and reporting of clinical, endoscopic, histological and tissue analyses £600, with reports from three independent experts. So a total cost per patient of £1,100. Then we go to paragraph 3 to the children who were being tested for a connection between enteritis and disintegrative disorder.

“In contrast with the IBD cases [those set out in paragraph 2] which have a prima facie gastrointestinal pathology, children with enteritis/disintegrative disorder form part of a new syndrome. Nonetheless, the evidence is undeniably in favour of a specific vaccine induced pathology. Many more tests have to be carried out for investigating these conditions and accordingly the costs of investigation are considerably higher.

The children will come into the Paediatric Gastroenterology Ward under the care of Professor Walker-Smith. Costs for four nights stay for the child and their parent plus colonoscopy will be £1,750.

The magnetic resonance imaging plus evoked potential studies will cost £1,000 and the combination of the molecular, immunohistochemical, vitamin B12 and complement studies will cost a further £1,000.

The medical reports which will be the compilation of reports from the individual experts in each of the disciplines, including Dr Harvey, Dr Berelowitz, Professor Walker-Smith and Dr Dhillon, Dr Linnell, Dr Law and Dr Wakefield will cost £1,400. The total cost per child will therefore be £5,150”.

Going on to page 123,

“The costings are based on a proposal that in each category five children should be tested making a total as follows,

“setting up: £26,500
First category £5,500
Second category £25,750

Estimated total £57,750”.

Then there is a note,

“Should more children be tested under the protocol within the first year the set-up charge will not increase but will remain fixed. For each additional child in the first category the sum of £1,100 is to be added and for each additional child in the second category, the sum of £5,150 will be added.

It is not of course possible to anticipate the conclusions that will be reached but the indicators are that it should be possible to establish a clear causative link between the vaccines and the two sets of conditions mentioned above”.

So that was the second document, Mrs Cowie, and then we come on to a letter in fact to you from Mr Barr dated 27 June, and that is on page 124 if you will go there, please. If you look at page 126 you will see this is from you to Mr Barr. Can we assume at this stage at least that you had taken over Mrs Simpson’s role?
A Yes.



Q You say in this letter:

“Dear Mr Barr



I refer to your letters of the 21st May 1996 (in answer to Mrs. Simpson’s letter of the 17th May 1996), your letters of the 4th and 6th June 1996, the 10th June 1996 (answered by mine of the 11th June 1996) and the 13th June 1996 in answer to my other letter of the 11th June. I thought it appropriate to write to you at this stage to answer some of your outstanding queries and address some of your concerns.”

Can I interrupt myself briefly, Mrs Cowie, just to ask you, there are references there to letters that we have not seen.
A Yes.

Q These documents were disclosed to the General Medical Council by the Legal Services Commission, as they then were. Did you have any part to play in what they thought it was appropriate to release?
A No, I did not.

Q If we go on down to the bottom of that page:

“Turning to your letter of the 4th June 1996, addressed to Mrs. Simpson …”

and then saying that Mrs Simpson had left the Board and, as you rightly have told us,

“…she is very kingly helping us out in a rather difficult period.”

Then if we go down to the middle of the page where it says:

“Turning now to your letter of the 6th June 1996 …”,

do you see where I am?
A I do, yes.

Q It goes on:

“… I note the contents of Dr Wakefield’s propped protocol for the study. As you will no doubt anticipate, having regard to the contents of Mr. Ullstein’s Opinion”,

and he was the barrister involved,

“relating to the pilot study, it is of course bound up in the general request for extension to the Contract about which we are awaiting guidance. In the circumstances, albeit that I have read the details of the proposed study, I cannot say anything further about it at this stage. I also note the kind offer made by Dr Wakefield to your goodselves to meet with representatives of the Legal Aid Board if required.”

Then at the bottom of the page:

“…we cannot do anything other than proceed cautiously. This caution is in no way reflective of our thoughts about you or the way in which you are dealing with the cases, but is essentially reflective of our past experiences. If there is one thing all of the Solicitors here who have dealt with and deal with Vaccine Damage Cases appreciate, it is the amount of work which is being done. However, we have a duty not only to the assisted person but also to our other stakeholders, including the taxpayer and must be able to justify our decisions at all junctures.”

So did that set up your thoughts about where you were going to be going from then on in relation to this protocol; you were proceeding with caution?
A Yes, it did, but I think it is important to say that the bit that you read out about proceeding with caution and that being reflective of our own past experiences is taken out of a much longer paragraph where I am talking about the area officer’s experience of vaccine cases over the previous 15-20 years.

Q Absolutely.
A So it was not just about this particular application, it was about the area officer’s general experience with applicants for legal aid in respect of vaccine cases generally.

Q Is that because of the number of complainants involved and the complexity of those cases that you were referring back to previous experience in relation to?
A That is right, not so much my personal experience but those of my other solicitor colleagues who had been doing that sort of work far longer than I had over that period of time.

Q From the time of your involvement onwards, Mrs Cowie, can you just tell us, in very broad terms, remembering that we have got a Panel with lay members on it, and certainly lay as far as the law is concerned, what exactly was your role from then on? We are going to be looking at lots of letters of you communicating with the solicitor. What did you see as your central role?
A My central role as the solicitor tasked with dealing with this application was to make sure that I had enough information to feel sure that my responsibility to protect public funds, amongst other things, was being properly looked after, and the only way of doing that in a complex case in my view at the time was to set up a dialogue with the solicitor who was dealing with the applications. You are talking about lay persons on the Panel. It is very difficult for me as a legal person to try and understand the medical aspect of what was going on, and this was not a regular application that would come across my desk. It took a lot of effort to understand sufficiently what was going on to make sure that I was not being blinded by the science, that is, but that I understood that the application was merited.

Q You refer in that letter to the fact that you had read the details of the proposed study. When you took over, would you have reviewed the file prior to the time of your involvement?
A Yes.

Q We have looked at the study and the costing proposal. Would they have been documents that you would have reviewed in order to take over?
A On the basis that they were on the file at the time, and yes, that would have been part of my responsibility, to look at whatever was there to make sure that I, if necessary, could justify the decision that I had made at the time.

Q I want to turn on to the next letter, which is from Mr Barr to you, and it is dated 20 August and is at page 155, please. This is a letter from the solicitors expressing concerns about whether funding was going to be permitted to them and how much funding, and again I am going to take you just to the paragraphs that I want to refer you to. Please refer to anything else you wish to, Mrs Cowie. As I say, I am going to go straight to the second page, page 156. If we look at paragraph 2, this is Mr Barr setting out his understanding of what he has to show:

“(2) In every individual Legal Aid application we have to show prima facie that there is a valid claim”,

in other words, at least that there is the beginning of one on the face of the claim.

“Your office requires a far higher level of initial proof in vaccine cases than would be appropriate (or required) in medical negligence cases. If we have satisfied you in individual applications that there is a prima facie case, I find it hard to understand how you can now (apparently) say there is none.”

Then the part I want to take you to, and I am trying to put it into context, is at (3):

“Having established that there is a prima facie case both individually and generically the next obvious step is to obtain the evidence. That is what leading Counsel has advised, and that of course is how we should progress the cases.

(4) That evidence is intended to tie in with individual cases. That is the object of the proposed pilot study which is intended to prove causation (ie the mechanisms of damage in respect of a wide range of the injuries the children have suffered). It does not, of course, cover them all, but we hope to establish the general principle of causation and to apply it to other cases (eg multiple sclerosis, leukaemia, SSPE etc).”

So we know that the pilot study was connected with IBD and with the behavioural disorder of disintegrative disorder and IBD, but was it your understanding that there were other claimants claiming in respect of other damage?
A That is right, yes.

MR COONAN: Would you read paragraph 1?

MS SMITH: Yes. Are you referring to paragraph 1 on this page?

MR COONAN: On the previous page.

MS SMITH: Yes, of course. (To the witness) Page 155, if you would just go back, Mrs Cowie:

“You have said in your letter that you think we are trying to establish a prima facie case ‘where there is at present no evidence.’ I have to record my very strong misgivings about what you have said. The points I would like you to consider are:-

(1) Leading Counsel has advised that there is a prima facie liability on the part of the manufacturers – see page 48 onwards of his opinion.”

Then it went on to the (2) that I have read to you, and then the passages about evidence gathering. Then if we go on to paragraph (5) on this page, Mrs Cowie, page 156:

“Please also bear in mind that as the cases are to proceed under the Consumer Protection Act, our primary task is to establish causation. It is not expected that negligence will even be an issue.

I think it is vital that progress should be made and fast. I don’t know what your suggestions are because you have not told me but my proposals are as follows:

1. To ensure that your concerns are dealt with comprehensively and to ensure that there is no more delay I suggest we have a full meeting with you to include Mr Augustus Ullstein”,

he was leading counsel, I think,

“Dr Andrew Wakefield, Paul Balen and Kirsten Limb and myself.”

Were they the solicitors involved?
A Yes. Paul Balen was from the other contracted firm, Freeth Cartwright, and Kirsten Limb worked for Dawbarns.

Q Then he says it has to be at the full expense of the Legal Aid Board and he suggested a meeting taking place at the London office of the Legal Aid Board. We then have some handwritten notes by you, Mrs Cowie, and if I could ask you to turn on to page 158, is this your handwriting?
A I am afraid it is.

Q We see it is a draft letter by you to Mr Barr and numerous other notes attaching to it, and if I could ask you to turn on to page 162 we have had it transcribed. It is no offence to your handwriting, but to make it easier to read. (After a pause) I am sorry, I am told you yourself transcribed it for us.
A I did, yes. I helped out.

Q Thank you. Just so that everyone is clear, it follows the manuscript form and that is why some parts have got a line through, because there was a line through on the original. I hope you will bear with me, Mrs Cowie, while I take you to various parts of it. The first, as I said, is a draft letter to Mr Barr and Mr Balen, and you make two suggestions as to the way that work was to proceed. You say:

“I would like very much to work closely with you to agree in reasonably precise terms what work should be done next week and at what cost…”,

and then the crossed out bit:

“Drawing from Counsel’s opinion and the information you provided about Dr Wakefield’s protocol and adding them? My suggestions are …”,

and then you set out:

“1. To carry out a review of a sample of claims already made along the lines suggested by Counsel …”,

and then going on to the next page, page 163:

“A review to be carried out of a sample of claims already made (a ¼ maybe) along the lines suggested by Counsel …”,

and you then set out again the caution that is required in relation to these large pieces of litigation. Then:

“2. The obtaining of a preliminary report from Dr Andrew Wakefield the terms suggested by Counsel …

2. The setting up of the clinical and scientific study proposed by Dr AJ Wakefield in respect of ten assisted persons in the area of disintegrative disorder and enteritis at a maximum costs of £57,750 inclusive of the setup costs and the costs attributable to and incidental to the testing of the assisted persons …”,

and you put a note to yourself with a number of question marks:

“(is this subject VAT, if so, does it include VAT or is this to be added).”

Then going on to page 164, the top of the page:

“Given that I am prepared to extend the contract for the Wakefield protocol study, it occurs to the writer that as that study only relates to children affected by two conditions, namely ‘disintegrative disorder’ and enteritis, that you may need to carry out some investigation work into other types of condition which you attribute to the vaccine. I am concerned that other children (i.e. non-Wakefield) should not be overlooked in over concentration on the Wakefield protocol, but am also concerned that at this stage of play, any further work should primarily concentrate on areas where there is at present a reasonable prima facie case. I would invite your comments on this area. What experts would you consider needed instructing sooner rather than later.”

You then go on and make various other queries in relation to experts reports. Then on the last page you set out plainly some draft notes to yourself about the various things that you needed to cover, and we will see, half-way down it:

“Preliminary report from Wakefield (how widely will this be? Only his particular areas).”

Is that a reference back to what you said on the previous page, that you do not want other conditions to be forgotten?
A I do not know. I assume that was probably why, but I have to say I cannot remember whether that was in my mind at the time.

Q Then we have another set of handwritten notes, page 166 to 169.
A Excuse me, just before you go on, I do think it is terribly important, and I mentioned this in my statement, that that handwritten letter of mine – and I did have a tendency to draft out letters rather than just dictate them cold – I do not even know whether that letter was sent, because there was no copy of the carbon that would have been kept on the Legal Aid Board file produced to me, which is we have all had to go through the torture of looking at my handwritten notes. But I think it is really important to remember that, because at such a distance of time I certainly cannot remember whether that letter was ever typed and signed even.

Q Absolutely, and I am grateful to you for pointing that out, Mrs Cowie, and indeed I should have pointed it out because nobody is suggesting that in fact it was sent. I am simply asking you, because as I understand it, these are rough notes that you made a the time?
A Yes.

Q And presumably they were the thoughts that were going through your head?
A Yes, quite.

Q Going on, we have a further lot of notes which start on page 166 to 169. Again, you have helpfully transcribed these notes for us. Perhaps you could just help us as to these. They start “JC received letter from Dawbarns … “, and is that “JC” a reference to yourself?
A That is me, yes.

Q Can you help us, at least from your general knowledge of the way you work, as to why you would have made these notes?
A We were always in the habit of keeping a note of telephone calls, purely practical. It helped you to remember what had been discussed, but similarly if someone else had to pick up the file they could see what had been done and it was effectively just an aid memoir to what had been said.

Q We see at the top that you noted the fact that you had received a letter from Dawbarns by fax in August 1996 and you note in the second paragraph that you tried to speak to Dawbarns on the phone and no-one had been available, but ultimately there was a call back. We see in the next paragraph?

“After lunch, Mr Barr called back …”,

and you then gave an explanation of the long letter that you had written to him. We see, lastly:

“Mr Barr was altogether more relaxed after this explanation and we went on to discuss in great detail and over some time what needed dong next. He gave me rough estimates of costs for each state. He said he would outline his proposals and we could take it from there”,

and we see:

“1. PILOT STUDY – will have cost implications for selection and look up costs. £10,000. £50,000 odd for the study …”,

Then going on to page 171 we see at the top of the page:

“Includes costs of solicitors in the selection of 10 children and the preliminary work necessary to set up the study from that point of view. The preliminary report of Dr Wakefield suggested by Counsel would be needed too. Mr Barr considered whether he might throw it in if he was doing the pilot. Setting up costs already laid out in the protocol in very detailed fashion, down to how much the testing will cost per child depending on nature of disorder at a maximum cost of £65,000.”

Then you seem to have notes that relate generally to the progress of the litigation.

Let us go on to page 172, we see “JC to do”. Is that you?
A Yes, it is.

Q
“1. Draft amendment to the authority to do contract work.
2. Send copies to each firm.
3. Ask Mr. B to let you know when the ten children to be studied are chosen so that individual certs [certificates] can be amended.”

Then we see:

“Telephone call with Mr Barr

5 steps

1. Pilot Study

The obtaining of a prelim [preliminary] report from Dr A Wakefield
10,000 work and preparatory costs
50,000 odd thousand
Select and proceed with pilot study as outlined by Dr Andrew Wakefield.”

Can you help us, Mrs Cowie. You talk there about the amendment of individual certificates for the ten children to be studied, and in your previous notes you talk about individual costs and generic costs. Can you just explain to us in as simple terms as you can the distinction between those, as far as the Legal Aid Board is concerned?
A Certainly. With individual applicants, each individual applicant would have a Legal Aid Certificate for their claim, but because this was a multi-party action there was a generic or an overview, if you like, in respect of those causal issues, or those issues which would be common to all applicants. So the generic work would benefit all, hopefully, or a substantial number, whereas individuals would always have their own individual claim but would benefit from positive outcomes of generic investigations.

Q Thank you. That is very clear. Is that a characteristic, normally speaking, of class actions? In other words, actions involving lots of claimants?
A As far as I am aware, yes.

Q Then, could we just turn on to the last handwritten notes. They are from 174-177. Again, you have kindly interpreted those for us, and that is at page 178. We see:

“Possible Changes to Authority to do Contract Work

Continue provision of reports to the Legal Aid Board and claimants’ solicitors as required by the Legal Aid Board Multiparty Action Arrangements … to include correspondence and communications with the Legal Aid Board and as between the contracting firms and claimants’ firms.”

We see the details of that set out:

“A review of all legally aided claims …

Continue maintenance of the computer database

Continued correspondence with lawyers and potential medical experts in this and other jurisdictions as necessary.

To obtain a prelim [preliminary] report from Dr Andrew Wakefield.

To facilitate the setting up of the clinical and scientific study (protocol) proposed by Dr AJ Wakefield in respect of 10 assisted persons at a maximum costs of £57,750 inclusive of the set up costs and the costs attributable to and incidental to the testing of the said assisted persons.”

Then we have brackets and your reference to other experts, and medicals on area over the Wakefield study. If we go on to page 181, we see that you expressed the view at the top:

“Protocol – very expensive. Covers a lot of the cases but only on two main effects. Are others. What would happen to them.”

Then on 182, Dr Wakefield’s proposed protocol:

“(See letter 6/6/96)”

That is the letter from Mr Barr to Mrs Simpson that I have referred you to:

“DISINTEGRATIVE DISORDER AND ENTERITIS – Crohn’s disease, inflammatory bowel disease (Heller’s disease) symptoms akin to autism.

Cost: setting up £26,500”

Then the IBD cases, £1,100 per patient.

“Enteritis/Disintegrative Disorder Cases £5,150 per child

5 children in each

Set up 26,500

First category 5,500

Second category 25,750

Total 57,750.”

Those are the notes you made relating to the costing proposal that had been sent?
A They are.

Q Are you able to assist us, Mrs Cowie, to the part that was played by the protocol and the costing proposal that Mr Barr had provided for you from Dr Wakefield? What was the part played by that in your decision to grant the amended authority?
A Having reviewed the paperwork to re-establish in my own mind as far as possible, given that ten years has gone by, it was accepted that the solicitor already had leading counsel’s opinion, which said, “There is a prima facie case”. The next logical step was to try and obtain the evidence to move the case forward, and to progress it. So that effectively would be providing the evidence.

Q Sorry? What would be?
A The outcome of the study, the medical study, was going to effectively take the case on to another step. Leading counsel had said in law there was a prima facie case, but then it turn to the medical side. My view was that the study was going to provide the evidence so that the cases could be progressed.

Q Then, just chronologically, so we remind the Panel, we then come on to the document that I began with, which is page 183, the next page on, which is indeed your granting of the money to enable that to take place. Is that right?
A Yes, yes.

Q Could I go on in the bundle to page 187. That is the letter that accompanied the amended authority. You sent that to Messrs Dawbarns.

“I now enclose for your file a copy of the amended authority to do contract work which should I think cover all of the matters which we agreed on the telephone. I would be obliged if you would let me know during the course of your dealing with the work specified in each area if you run into difficulties with regard to the costs limit attributable to that aspect of the work.

When the 10 children have been chosen for Dr Wakefield’s study please let me know so that their individual certificates can be properly amended.

In all the circumstances, now that the authority to do contract work has been amended in the terms it has, I will now just wait to hear from you as to what progress is made. I would be most interested to keep in touch with you during the period in which the work is being carried out and will try and ring you from time to time just to have a general chat.”

Can you just assist us, Mrs Cowie? Where you say, “When the 10 children have been chosen for Dr Wakefield’s study please let me know so that their individual certificates can be properly amended”, can you just help us again with reference back to your previous answer about the difference between generic and individual costs, why you were specifically referring there to the individual certificates?
A I think if we remember, one of my handwritten notes, I had written to check with a colleague of mine in London, Simon Morgans, who worked in the legal department, whether or not the individual certificates needed to be amended, that was because in my own mind, I have to admit, I was not absolutely clear whether the children who were chosen for the study would need to have their individual Legal Aid Certificate amended to show that certain work was being done in respect of their case. So all I can assume – and it is an assumption because of the distance of time – is that I was pursuing that query in my own mind by keep it alive with Dawbarns so that in the event that I was told, “Yes, the individual certificates need to be amended,” then I would have been equipped with the information to do that.

Q As far as the pilot study was concerned in respect of those particular claimants, in your mind did you envisage there being a general benefit as well as an individual benefit?
A Absolutely, yes, and the ten children chosen whilst yes, they would have a personal benefit in the event that the evidence was positive or supportive, if the outcome of the investigations for those ten children were all positive, then other children suffering similar conditions would effective benefit as a result of that, so a generic benefit as well as an individual benefit.

Q Can we go on to page 199, this is a letter back to you from Mr Barr:

“Thank you very much indeed for your letter of 27 August. I am glad that we are on the move again. Thank you for your assistance. We will now get down to work again and I will report to you on any key developments.

There is to be a meeting of the organisation JABS at the beginning of October, and our proposal is to send out another Newsletter shortly after that meeting to report on any developments that arise out of it.”

He asks whether that was in order so far as compliance with the contract was concerned. Then we go on to page 268, this is to you in October 1996, talking about various letters sent to him and videos relating to adverse events. This is obviously for your files. Then, at the bottom of the page:

“Dr Wakefield is about ready to get up and running with his testing of the clients and I enclose a copy of his preliminary account to cover the setting up charges.

I also enclose a CLA28 and I should be grateful if you could arrange for £25,000 to be issued to us so that we can pass it on to him. In view of the substantial size of this sum is there any additional documentation that the Legal Aid Board would like before the money is released to the Royal Free. We have of course already emphasised to him that the work must be done in accordance with the pilot study already submitted to you.”

The remainder of that letter deals with his own costs position. Could we go on to page 279. It is from you to Mr Barr.

“Thank you for your letter of the 23rd October …. I left a message with your secretary to confirm that your application for the payment on account with respect to Dr Wakefield’s initial sum of £35,000 has been authorised. I understand from Mr Crawford my financial colleague that as it was authorised today, (the 1st November) you should have it in your next payment.”

Then you say:

“Do not worry about providing a formal report even on an interim basis at this stage. I am happy to wait until January 1997.”

Are we to assume from that, that you were content with what Mr Barr had said to you in his letter on page 268, that the money could be released to the Royal Free on Mr Barr’s emphasis that it must be done in accordance with the pilot study submitted?
A Yes.

Q Then we turn on to page 280, you may not be able to assistance us with this, Mrs Cowie. We have one of your colleagues from the Legal Services Commission coming as well, so tell me that. Do you recognise this as the LSC computer system?
A I have no idea. I did not have anything to do with the dishing out of the money.

Q Can we go on to 317, please. This is again Mr Barr to you, dated 22 November 1996.

“Thank you for your letter of the 4 November 1996 and for so promptly authorising the payment to the Royal Free. You might be interested to know that they have already started testing some of the children and so far every single child tested has come out positive with positive staining for measles virus in the inflamed areas. They will now need to do very much more detailed testing to confirm that it is the measles vaccine virus that is causing the damage. This, of course, is being put in hand.”

Going down to the next paragraph but one:

“There are two matters that I would like to raise with you …

1. When we talked on the telephone we discussed obtaining the preliminary report from Dr Andrew Wakefield but I did not specifically put any figure in for Dr Wakefield’s fee personally. I had understood (wrongly it turns out) that his fee would be included in the figure of £55,000. It now turns out that that is not actually correct and that he does require a separate fee for preparing his preliminary report.

I am afraid this is almost certainly my misunderstanding, but would it be possible to extend the contract to include a provision of £5,000 for Dr Wakefield’s report? This would effectively mean amending item number 2.

2. We have seen an absolute explosion in the number of autism cases. Autism claims are far and away the greatest number of cases now and it is very important to try to establish a level of proof that the autism is connected with the vaccines. Dr Wakefield has suggested that one way of producing quite convincing evidence is to do a survey of the autism cases. At the time of dictating this letter 170 cases have been referred to us (either directly or through JABS). This represents nearly 50% of all the MMR cases. Those that we have already investigated show a very similar pattern of children developing normally right up until the time that they are vaccinated. In some cases the evidence is very strong that there was totally normal development up to that point. We have only found one or two cases where there has been any question mark over the development or ability of the child prior to the vaccination. If these come through as legal aid applications we will, of course, address the issue in the applications.”

Then, going down the page, skipping the next two paragraphs:

“The position is interesting because our earliest autism case stems from the end of 1988 (just over two months after the introduction of the MMR vaccine).”

Then the next paragraph but one:

“It very much appears that autism is associated with the triple MMR vaccine. It is not showing up at all in any of our Mr cases (though the reason may be that children vaccinated with that vaccine are older).”

Then down to the last two:

“I would like to try to establish that there is a fairly consistent time link between the administration of the vaccine (MMR) and the onset of autistic features. To achieve this we have prepared a survey questionnaire (enclosed). This has been approved by Dr Wakefield. The aim is to send it out to all 170 families who are now on our database and invite them to fill it in as accurately as they can.

We would then collate the data and in particular we would be looking very closely at the date of onset of the beginning of the autistic condition. Mostly this appears as children becoming withdrawn, losing speech, losing coordination etc. The onset seems to be approximately between two and six months after the vaccination but that is not hard and fast. We have one or two cases where it took quite a lot longer than that. Dr Wakefield feels that if we can show a clear time link between the vaccination and the onset of symptoms we should be able to dispose of the suggestion that it is simply a chance encounter. The reason for this is that there is quite a wide range of ages between which the vaccination is administered. If we can show that the onset of the autism is related in time to the vaccine we should be able to establish the point that it is no coincidence that children become autistic after the vaccination. To set up and send out this survey will involve some additional costs.”

And he then sets those out.

He refers to the time spent entering the data in the computer and says at the bottom of that paragraph,

“After that analysis and collation of the reports by Kirsten Limb and myself plus discussions with Dr Wakefield (along with his fee for examining the data and possibly writing up the report himself), say, £2,500 plus VAT”.

So he asks for a further extension to cover that work. Is that again a customary way of things progressing, Mrs Cowie? In other words, for solicitors to write to you again saying, “We need more money for these various steps to be taken”?
A It certainly was at the time I worked there.

Q If we come on to page 340, still in the same bundle, we see your response to that request, to Mr Barr,

“As I confirmed with Mr Barr’s secretary I am prepared to amend the authority to do contract work with regard to the cost of Dr Wakefield’s preparing his preliminary report and the carrying out of the autism questionnaire. I have amended the authority to do contract work accordingly and enclose your own copy herewith. You are correct in saying that the cost condition does not include VAT”.

You then set out the legal costs involved.

“I have not amended the total figure but rather have amended the wording of the actual scope of the authority.

One question I have been meaning to ask you is how you are managing the sharing of costs as between your legally aided clients and your non-legally aided clients. I really ought to know for my own records and would appreciate hearing from you on this point. I presume that the autism survey costs are only referable to legally aided cases but would appreciate your clarification. You will also need to let me know which of your clients are taking part in Dr Wakefield’s study. No doubt you will recall that we discussed this at one point in the past as to whether those individual legal aid certificates should be amended and if so in what terms. I think what I am getting at is whether the individual certificates of the children who are taking part in the study should bear some or all of the costs involved in testing them individually. To be quite frank, I am not sure at this stage what the answer to this point is, whether individuals should have their certificates amended and bear the brunt of the costs incurred or whether because the outcome of the study will potentially affect all legally aided individuals, whether the costs of the individual testing should just be borne by all on a pro rata basis. I would be grateful if you could contact me about this point so that we can clarify it between us”.

If I can just ask you, there are two issues in that letter, Mrs Cowie. One is that you are making a distinction between legally-aided clients and non-legally-aided clients – I am sorry if this is a statement of the obvious – but were you only concerned with the public funding of those who were entitled to legal aid?
A I was.

Q Does a class action sometimes involve people who are not, as well as people who are entitled to legal aid?
A I am not sure, not having had a great deal of experience with them. The main reason for having raised this – that would be a regular question – is if someone does not have the benefit of public funds to bring a case in litigation, because they cannot afford it or whatever, then it may well be that they stand back and wait for someone who does have the benefit of public funds to pursue the case and effectively sit on the coat tails of the legally aided person. So if that is the case, the Legal Aid Board at the time were under an obligation to make sure that public funds were not being used effectively to look after everyone.

Q Leading on from that, the issue we have already discussed, were you trying to clarify this issue about what should be covered for the individual child and what was of generic backing?
A Yes.

Q We have a reply to that which is on page 360 and I want to take you to one part of that. First of all, in the second paragraph he deals with the point I have just been asking you about and says,

“this multi party claim is essentially one hundred per cent legally aided”.

Skipping the next paragraph,

“So far as the pilot study is concerned we had a similar kind of problem to the one that you have raised when we dealt with the Opren cases some years ago”.

That was a different vaccine damage case.
A I did not have any involvement in that.

Q He says,

“Individual Opren clients took part in a pilot study to test the skin sensitivity. Those were actually the days before generic certificates but I took the view that because the pilot study was also for the benefit of the individual clients their certificates should bear a proportion of the cost”.

So that is Mr Barr simply saying what he thought should be done. Then he says this,

“As the financial limit on the individual certificates is quite high might I suggest that the individual certificates bear the cost of the individual testing (stay in hospital, MRI scans etc) and then the generic certificate bears the cost of the overall look at the chosen cases, the setting up costs and the global report when it comes through. Does that make sense?”

Can I ask you, does it make sense so far as you are concerned?
A It does make sense, yes.

Q What did you understand the individual testing, the stay in hospital, the MRI scans, etc, was a reference to?
A That would be a reference to the study.

Q If we go on to the next page, we see two paragraphs from the bottom,

“It might be helpful actually to have a meeting with you at about the same time as the next appeal hearings so that we can see each other face to face”.

If you could put that bundle away, Mrs Cowie, and go on to your bundle 2, so we can follow on in the chronology, and turn to page 409, please. I am not going to read out the whole of that long letter, which deals with your consideration of appeals by various individuals in respect of whether or not they are entitled to public funds. If we turn to page 410, you will see a list of names at the bottom of the page. Is that correct?
A Yes.

Q Again, I am not going to read those out. I am going on to page 411, the second paragraph down, where you agree to it being a good idea to have a meeting and say you will fall in with any arrangements Mr Barr made. Then if we go on to page 415, please, this is apparently a telephone call from Kirsten Limb, who was working with Dawburns Solicitors.

“Re invitation to meet them (ie her and Richard Barr) on Wednesday 9 April 1997 because they are attending an Autism conference at Durham University. Dr Andrew Wakefield will be attending and it will be a good opportunity to meet them all”.

If we go on to page 416, are these notes again in your handwriting?
A They are.

Q Are they the notes that you made of a meeting that you did indeed attend and we can see at the top it was with Dr Andrew Wakefield, Richard Barr, Kirsten Limb of Dawbarns at Durham University on 9 April.
A That is correct.

Q Again, you have kindly transcribed those for us if we go on to page 420,

“Joanne Cowie was invited to meet Dr Wakefield and Richard Barr and Kirsten Limb at Durham University, St Aidan’s College as they were attending a conference on autism at which Dr Wakefield and one Paul Shattock of Sunderland University were scheduled to speak. Unfortunately, Dr Wakefield’s talk had been rescheduled to the afternoon so I was unable to hear it because of other work commitments, but met with Dr Wakefield, Richard Barr and Kirsten Limb in the morning.

Dr Wakefield was enthusiastic about his investigation. He is a gastroenterologist and didn’t enter these investigations on a crusade and in fact has been completely convinced by his subsequent studies and tests of a link between the vaccine (MMR) and the gastroenterological effects showing various bowel disorders. He referred to them as indeterminate colitis which he’d identified in all but one child in the protocol study. The children in the study are autistic and have bowel problems. Are probably on the way to developing Crohn’s disease. They are in the process of having specimens studied in Japan of the children + controls. Japanese don’t know which is which and if they come up trumps they will be on their way to establishing a causation. He mentioned that they had also managed to identify the measles virus in the affected tissue of the children (don’t know how many). Are going to be doing some gene sequencing to identify the strain of the measles virus i.e. wild virus or vaccine. They have grown the virus from a sample for the first time, but my understanding is that it was not from one of the legally aided children.

All three were keen to stress that they had to get the science right first before launching into new steps. They feel confident that they can now show a temporal association at work at least. They now need to show biological mechanism.

They seem reasonably confident about the progress being made in the IBD field and autism and less so with the epilepsy cases and others would propose doing everything together however not separating them by type of condition.

Dr Wakefield indicated he was travelling to America to meet Dr Fudenberg who is the foremost expert in the world in this field. Dr Wakefield intimated a potential treatment cocktail by Dr Fudenberg. See if the measles strain in these children can be eradicated.

At the end of the research we would propose to have a meeting of experts”.

You then go on to say that you were also introduced to Paul Shattock, who had been doing research into autism and to a Dr Reichtel from Sweden who had been doing similar research. There are some detailed notes by you as to the science. You say at the bottom of the page,

“I was on the other hand very impressed by Dr Wakefield who has very definitely put his head above the parapet in this research he is doing and he seems to be producing results.

All in all it was clear that the Wakefield protocol may produce favourable results for the P[laintiffs] and that there is mileage in further work being done at SL”.

What is SL?
A Just looking at it in context, I suspect that my abbreviation there was Sunderland, probably referring to Mr Shattock.

Q When would you have made those notes, Mrs Cowie?
A I am not sure if it would be the same day or the day after, but the fact that I have made them in such detail, I suspect I would probably be in the habit of doing it within a day or so.

Q Those are the last documents which involved your communications in respect of this piece of litigation. Can we just go back to Bundle 1, page 183, please? Can we just remind ourselves, as you have already explained, what that amended contract was to cover, and in particular I want to ask you about paragraph 2, the setting up of the study as proposed by Dr Wakefield. What would you have expected to happen, Mrs Cowie, if the costs in relation to any particular item which were listed in the costing proposal did not in fact arise?
A At some stage the solicitors dealing with the application would have to submit a request for a payment on account or for the payment of that particular item, and I would imagine that in the event it was anything substantially different from what had been anticipated, that there would perhaps have been some correspondence about it, a telephone call about it or, when the application was submitted for payment, some sort of comment about it.

Q What if the funds that were granted were only spent on part of the study which is referred to in the amended contract, for some reason that arose?
A Again, I would I suppose only know about that as and when that information was passed on to the Legal Aid Board.

Q But if the funding is for some reason, whatever the reason, not used for the purposes for which the Legal Aid Board has granted it, would you expect the Legal Aid Board to be informed of that?
A Yes, I would, on the basis that it would fall outside the scope of the authority which had been granted.

MS SMITH: Thank you very much, Mrs Cowie. That is all I ask. You will now be asked some questions from others.

THE CHAIRMAN: I am looking at the time and it is 11 o’clock so what we will do, Mrs Cowie, is have a short break. It will probably also give you a little breathing space as well. We will resume at 11.20 and even though you are a solicitor and know the importance of this, I still have to remind you that you are under oath and in the middle of giving your evidence so please do not discuss this case with anyone. We will resume at 11.20.

(The Panel adjourned for a short time)

THE CHAIRMAN: Ms Smith?

MS SMITH: Sir, there was one last letter that I meant to refer Mrs Cowie to, the last letter in the sequence, and I am afraid I omitted to do so. Perhaps you could just bear with me for a few seconds longer before I finish.

(To the witness) Mrs Cowie, it was literally the letter after the last one that I referred you to, and it is on page 422 in bundle 2. This is a letter that you wrote to a
Mr Cornish from Messrs Burnetts. Was that another firm of solicitors involved in the litigation?
A No, Mr Cornish was one of the solicitors who was on the Area Appeals Committee.

Q We have already referred to the fact that there were some appeals from various litigants who had been refused legal aid and who had the right to such an Appeal Committee, and you are just letting him know about the meeting. You say:

“You may be interested to know that I have agreed that Dr. Andrew Wakefield can attend the meeting with Mr. Barr and Kirsten Limb from Dawbarns to speak to the Committee with regard to the outcome of his protocol study which was authorised under the Authority to do Contract Work pursuant to the Generic Contract. The presentation is likely to take about 20 minutes and I thought it would be most instructive both for the Committee members and also the office.”

Is that correct?
A Yes, that is what the letter says. I do not recall whether that actually happened, however.

MS SMITH: Thank you very much.

THE CHAIRMAN: Mrs Cowie, now is the time for you to be cross-examined.
Mr Coonan represents Dr Wakefield.

Cross-examined by MR COONAN

Q Just a few matters, really by way of clarification, and in particular bearing in mind, of course, this is, as you have said, so long ago. It might just be helpful to take that last document you were shown and then I will go back to the beginning. This is a letter that appears to be part of the process of encouraging a meeting of those people who were involved, so that at least in part the Legal Aid Board can be kept up to date and up to speed with what was going on. Is that fair?
A Yes, that is a fair point.

Q We see that the solicitors were going to be there, including the partner
Mr Barr, as well as Dr Wakefield, so that the committee members who were hearing appeals could hear it, but also the Legal Aid Board itself (in other words, through you) would be brought up to date?
A Yes, that would have been the idea.

Q You say I think that you do not know now whether this meeting took place.
A I do not recall.

Q I think you left very shortly after this?
A I did, yes. I left in May.

Q It is possible of course that your successor, whoever that may have been, might have attended that meeting?
A I really do not … Well, if it was not me then it would have been one of my colleagues, but it is just the distance of time, I am afraid.

Q Let us go back to the beginning, please. You will need volume 1 for this. If you turn to page 183 we can see that this grant of authority was made by you, if we turn over the page to page 184, on 22 August 1996?
A That is correct.

Q The grant of authority – it may be self-evident, but let us spell it out – was a grant made to the solicitors?
A Yes, that is right.

Q In effect, because of the statutory framework, there was a contract between the solicitors and the Legal Aid Board?
A Yes.

Q As a result of that?
A Yes.

Q The background that you have been taken through – and I am not going to go through it all again, I just want to draw a few strands together – appears to be this, that you had two letters from Dawbarns – in other words, from Richard Barr – and we see those, firstly at page 101. That is the first letter that was available to you, again from Dawbarns. The second letter on page 103, dated 6 June, again from Dawbarns, and if you turn to page 124, again this is still before the grant of authority, and in the first paragraph you will see a number of other letters referred to, again from Dawbarns.
A Yes.

Q All those letters would have been in the mix, would they not?
A Yes.

Q We have not been supplied with those letters in the first paragraph, so you are at a disadvantage and so am I. Do you follow?
A Yes, I do.

Q In addition, there were the two enclosures, the first one at page 104 and the second enclosure was page 121. Is that right?
A Yes.

Q I think also, for completeness, you would have had an opinion from leading counsel?
A Yes, that would have been on the file.

Q From Mr Ullstein, Queen’s Counsel?
A Yes.

Q In relation to this matter. So that is the background, is it not? Those are the materials which would have informed your decision making leading to the grant of authority?
A Yes, that is correct.

Q There is, of course, in this mix, as I have described it – it is my expression – no letter from Dr Wakefield of course, is there?
A No.

Q Again, before the grant of authority that we see on page 183, again just using it as a benchmark, by that stage you yourself had not had any meetings with Dr Wakefield?
A No.

Q That came later on?
A Yes.

Q In volume 1, if you turn to page 187, this is where you send a copy of the amended grant of authority to Dawbarns as an enclosure and the thrust of that letter – if you want to take a moment just to re-read it to yourself, do – is this: Here is the grant of authority. In other words, “Here is the amended contract and from now on Mr Barr, you let me know of progress and you let me know of changes, if any”?
A Yes, that is right.

Q Is that the thrust of it?
A It is, yes.

Q We can see that in the last paragraph:

“I will now await to hear from you as to what progress is made. I would be most interested to keep in touch with you during the period in which the work is being carried out.”

That sort of arrangement was a particular feature of multi-party litigation at that time, was it not?
A It was. It was the best way of trying to keep a dialogue to assist understanding.

Q That is the grant of authority. The next stage, obviously, concerns the payment of money and we know that Mr Barr requested the payment of £25,000 and we can see that at page 268. We have looked at it already this morning but I am not going to go through the detail again, save in respect of two matters. In the fourth paragraph Mr Barr writes that Dr Wakefield is about ready to get up and running with his testing of the clients,

“… and I enclose a copy of his preliminary account to cover the setting up charges.”

He then encloses a form, a CLA28, and requests for the payment of £25,000 to be issued “to us.” In other words, he was asking for the money to be paid directly by the Legal Aid Board to Dawbarns, was he not?
A Yes.

Q We may see a preliminary account. If you go back to page 237, which I think is a document you were not asked to comment one earlier this morning, this is a letter written by Dr Wakefield to Dawbarns and it is 25 September 1996, obviously pre-dating the letter I have just drawn your attention to. I am going to read it out:

“Dear Mr Barr”,

and he sets out the heading:

“We are now in a position to start work on this study on behalf of affected children identified by yourself and approved by the Legal Aid Board. I would be grateful if the initial sum of £25,000 could be transferred to the Royal Free Hospital School of Medicine”,

and he sets out the notation of the account, and then this:

“for the purposes of initiating and carrying out the initial phase of this analysis I will write to you once again when the remainder of the funding is required. Naturally, we will keep you [that is Mr Barr] appraised of progress and let you have the results and reports as soon as they are complete.”

Would you have received that document?
A I do not remember seeing it, but I would not have expected to receive a letter like that though.

Q You would not?
A No.

Q At any rate, it was a communication between Dr Wakefield and Mr Barr. It was just that I drew your attention to it, of course, because of the penultimate paragraph on page 268. Do you see where it says:

“I enclose a copy of his preliminary account to cover the setting up charges.”

I would like to know, please, where the setting up account is if page 237 is not it?
A At ten years hence I have no recollection of what came with the letter of 23 October.

Q Mrs Cowie, I am not criticising you, believe me, but this is an absent document, is it not?
A It would appear so.

Q At any rate, if one goes back to page 237, the request of money in those terms that we see is precisely within the terms of the grant of authority which we looked at earlier on page 183?
A Yes.

Q The content of page 237 does not take you by surprise in anyway?
A No.

Q An unremarkable letter, is it not?
A Yes, quite.

Q Mrs Cowie, can you just help me with one discrete matter? If you can get your bearings again by looking, please, at page 340, in the major paragraph towards the bottom of the page, about eight lines up, the topic of amending the individual legal aid certificates for those children who were taking part in the legal aid study had been raised by you?
A Yes.

Q Obviously, everybody is going to appreciate the wisdom of that suggestion, because it was a method, possibly an accounting method, by which one could locate specific costs arising in respect of the individual ten children to their individual legal aid certificates?
A Yes.

Q Whereas, on the other hand, the generic costs, such as, for example, setting up costs, which might be said to benefit all the children, would be in relation to the generic certificate?
A Yes.

Q Mr Barr appears to agree with that suggestion, does he not, if you turn on to page 360? You were taken to this by Ms Smith. It is the paragraph beginning:

“As the financial limit on the individual certificates is quite high …”,

and the rest of that speaks for itself.

So there appear to have been really a meeting of minds about this; that it seemed a sensible way to proceed, to load the individual certificate in such a way as to indicate if costs had been incurred why, then, they should go on the certificate?
A Yes.

Q That is the scheme?
A Yes.

Q And that was the expectation, was it not?
A Yes.

Q But if those costs were to arise, they would be loaded onto the certificate?
A Yes.

Q And if those costs were to arise and be loaded onto the certificates, that would be a matter of record and that the Legal Aid Board – your successors – would be able to see the presence of that loading?
A Yes.

Q Would they not?
A Yes, quite.

Q And obviously the absence of any loading on the certificates might, without more, be an inference that no such costs have been incurred?
A Yes, that is right.

Q Thank you.
A It might equally be because it was decided that there was no need to deal with it in that way.

Q Absolutely. But of course, if you, Mrs Cowie, can show me, or anybody else show me, documents which demonstrate that, why then my point falls away, but I can tell you there are no such documents available. Do you follow?
A I follow.

MR COONAN: Thank you very much indeed.

THE CHAIRMAN: Thank you, Mr Coonan. Mr Miller, have you any question of this witness?

MR MILLER: No.

THE CHAIRMAN: And Mr Hopkins?

MR HOPKINS: No.

THE CHAIRMAN: Ms Smith, any re-examination?

Re-examined by MS SMITH

Q Mrs Cowie, could I just ask you to turn back to page 422, which was the last document that I referred you to, and the first one that Mr Coonan asked you about? Mr Coonan suggested to you that this meeting was an opportunity for, as he put it, the Legal Aid Board to be kept up to date with what was going on in the litigation. Can I just ask you – what in fact are the purposes of these appeal meetings?
A It is to consider individual appeals and to listen either to individual solicitors and applicants who come in person, or to consider their written representations.

Q And if you can just spell out, what is the appeal about? Why is the individual applicant appealing?
A Usually it would be because the initial application for Legal Aid had been refused.

Q So that they would be coming along to ask the Legal Aid Board Committee ---
A To reconsider.

Q --- to think again?
A Yes.

Q In relation to the questions you have been asked about whether the individual certificate would cover the specific costs relating to that child, can I ask you first of all, Mr Coonan said to you, if those costs were to arise, as far as you were concerned, were you in fact expecting them to arise?
A Looking back at the documents, yes, I think I was expecting that there would be individual costs for individual children, but to what extent, I do not know.

Q If we look at page 422 again, the page relating to the appeals, we see that you say:

“… I have agreed that Dr Andrew Wakefield can attend the meeting … to speak to the Committee with regard to the outcome of his protocol study which was authorised under the Authority to do Contract Work pursuant to the Generic Contract.”

Does that assist at all as to whether in fact this idea that was mooted of putting the costs on the individual certificates was carried out?
A That is what the contract was called – a contract to do generic work – but from what I can remember, looking at the correspondence which has been disclosed, I think I was the one that raised the point as to whether the individual certificates ought to be amended for those children who were part of the study.

Q What was your expectation, Mrs Cowie, as far as the individual certificate was concerned? The children who were covered by the study that was being done at the Royal Free, was it your expectation that they would have individual Legal Aid Certificates?
A They already had Legal Aid Certificates. It was a question of whether those individual certificates ought to have been amended to reflect what was going on in the study and that was effectively – I think I had said in correspondence somewhere or perhaps in one of my notes – I was not too clear about that myself. That is why I think I had explored it in correspondence.

MS SMITH: That is all I have to ask as questions for Mrs Cowie, sir, but there is one matter that I should just raise whilst she is in the witness box in case Mr Coonan wants to deal with it. He asked her about the letter at page 237 in your first volume, just to remind you, which is a letter from Dr Wakefield to Mr Barr. Just so I can make it clear, that letter was indeed supplied to the General Medical Council by the Legal Services Commission, so it was part of the Legal Services Commission file. The reason I did not take Mrs Cowie to it was because it is not exhibited to her statement, and you will be hearing another Legal Aid Board witness. It is just in case Mr Coonan wanted to ask anything coming out of it.

MR COONAN: No, thank you.

MS SMITH: And I have no other questions, thank you very much.

THE CHAIRMAN: Thank you very much indeed, Ms Smith and Mr Coonan. Mrs Cowie, as I think I mentioned earlier, this is now the time if Panel members have any questions from your, I will introduce them to you. Dr Webster is a medical member.

Questioned by THE PANEL

DR WEBSTER: Were the 10 legally aided individual children ever identified by the Legal Aid Board?
A I do not know.

Q So they could have been and they could not have been. You just do not know?
A Yes. I do not know. Sorry.

Q If money allocated to the ten children was not used, either in total or partially, would you expect a refund?
A No, I do not think so, because I think it was almost like in a melting pot. There was some general work which was being done, and some specific work, and I do not know that anybody necessarily would have looked at that very closely until after the application for payment was submitted.

Q If you were not going to get a refund, why would it be important to identify the individuals?
A Very much just so that if those individuals were the only ones benefiting from the investigations which had been done, then they are the ones who ought to be bearing the brunt of the cost of that rather than the hope to get some sort of general positive outcome that might assist other or all legally aided individuals.

Q But as you do not know who the ten were ---
A No, I do not.

Q --- we cannot go further.
A No.

DR WEBSTER: Thank you.

THE CHAIRMAN: Ms Golding is the lay member.

MS GOLDING: I think, in a sense, this is the same question put a different way. Were the applicants to Legal Aid participants in the medical study as far as you were concerned?

THE CHAIRMAN: I am sorry, Ms Golding. Can you just speak a little louder. I think the people on this side might be having some difficulty.

THE WITNESS: Sorry – could you repeat the question.

MS GOLDING: Were the applicants to the Legal Aid Board – the applicants in terms of the people involved in the study – as far as you the participants of the medical study?
A My understanding was that the people, or the children, who were chosen would be legally aided individuals.

Q And would they have been chosen before the study started, do you know?
A I do not know. I expect so, but I do not know.

Q If the certificates were being signed prior to the study being started, does that mean they would have had to be identified – not necessarily by name, but identified by ---
A I think it is a question of going back a couple of steps, in the sense that these individuals would already have had Legal Aid certificates. So they were not having them just for the purpose of being able to take part in the study. They already had Legal Aid certificates as far as I remember.

Q How would they have got those, and why would they have got those?
A An application would have been made on their behalf that alleged that they had suffered damage or injury as a result of the vaccine, and that would have established a prima facie case. That is why the Legal Aid certificate would be issued in the first place, and then the subsequent authority was another step in the process of trying to establish the evidence sufficient to enable them to hopefully progress a successful case, in their view.

Q But they would not necessarily be the members of the medical study?
A Not necessarily. There were only going to be ten in the study, so there would be others that were not.

Q As far as you are concerned, who were the parties to the contract as laid out with Dawbarns?
A Yes. It would be Dawbarns Solicitors and Freeth Cartwright, and I think they had other names, but Freeth Cartwright, Solicitors.

Q Between yourselves and those two?
A That is right, yes.

MS GOLDING: Thank you very much.

THE CHAIRMAN: Can I just ask you a question on lines similar to those my two colleagues have asked you. Again, I am just trying to understand the inside workings on this particular issue. I think what I understood was that you needed to amend the authority to include the individual children demonstrating the generic effect, as well as the individual benefits that those children could derive from these results. Is that right?
A There was a generic contract, but there would be legally aided individuals who would have individual Legal Aid certificates, and it was the separation between what would benefit all or many as opposed to what would benefit only the individual. The authority was simply another step in the process of trying to establish evidence that would help either the individuals, who were part of the study, or legally aided applicants in this particular multiparty action generally.

Q But that would not have made any difference to the total amount that was authorised, because you expected that to fall within the same parameters as the ones that you use?
A Yes, yes. That is right.

Q So it was only for maybe technical reasons, or for accountability of the public purse, that you wanted that clarification –
A Exactly.

Q --- rather than any difference in the money?
A Yes. It would not have made any difference to the decision.

Q Thank you. That is only a small question. The word is mentioned “CLA28” on page 268. Do you know what it is?
A I seem to remember, although it was a long time ago, that that was the abbreviation for the application for a payment on account made by the solicitor to the Legal Aid Board. I might not be right – I think it is a payment on account.

Q For the time being. I will make a note of it, that it is a payment on account.
A Best to check. It is a long time ago.

THE CHAIRMAN: I think Ms Golding has indicated that she may have a further question.

MS GOLDING: I just wondered whether the decision to fund the study was based on just the one costing proposal?
A As far as I remember, although in the correspondence there are references to drafts of this document and drafts of another, it would be based on that and the discussions with Dawbarns, who were the solicitors acting for the applicants.

MS GOLDING: Thank you.

THE CHAIRMAN: Thank you very much indeed. We do not have any further questions. Ms Smith, do you have any questions arising from the Panel’s questions?

MS SMITH: I do have one.

Further re-examined by MS SMITH

Q I have just one short matter, Mrs Cowie. Perhaps I should have made this clear before. As far as the Legal Aid Board funding of the litigation was concerned, did that cover sums of money – large sums of money wholly unrelated to this particular medical study?
A In relation to the MMR cases, do you mean?

Q Yes.
A Yes. This was part of a much wider pursuit by the solicitors on behalf of the applicants, and this was one part of it.

Q And were you paying out significant sums of money which do not need to concern us, in relation to their pursuit of the litigation?
A I do not recall what the figures were, but this sort of litigation is always, unfortunately, costly in the investigative steps. But I do not know, and do not recall what the sums were.

MS SMITH: Thank you, sir, I have no other questions.

THE CHAIRMAN: Mr Coonan?

MR COONAN: No, sir.

THE CHAIRMAN: And I suspect Mr Miller and Mr Hopkins do not either. Thank you very much indeed, Mrs Cowie, and I thank you on behalf of this Panel for coming this morning. Thank you for giving us the benefit of your evidence. You are now released.

THE WITNESS: Thank you.

(The witness withdrew)

MS SMITH: The next witness is another general practitioner witness. It is Dr Shillam, who is the GP for child 5. Mr Thomas is taking this witness.

THE CHAIRMAN: Can I just ask you, Mr Thomas, are we going to need only the GP records, or are we going to need ---

MR THOMAS: You are going to need the Royal Free records only for one page, but it comes much later on, so I would take up simply for now the GP records.

DR GEOFFREY NORMAN SHILLAM, Affirmed
Examined by MR THOMAS

(Following introductions by the Chairman)

MR THOMAS: Dr Shillam, could you state your full name and professional address, please?
A I am Dr Geoffrey Norman Shillam and I practice from Eastfield House, St John’s Road, Newbury, Berkshire.

Q Thank you. You should have on the table in front of you a laminated sheet with an anonymisation key. Could you please confirm that one of your former patients is listed there as Child 5?
A Yes, that is right.

Q We are going to refer to your former patient as “Child 5”, and I would be grateful, when you give your answers, if you could at least try and remember to do the same. In any event, the press are aware that the name of the patient should not be disclosed in case you or I make a mistake. I think it is right that, as I have said, Child 5 is one of your former patients. Is that right?
A That is right.

Q You were his GP from 10 December 1988 until 6 June 1997, were you?
A Yes, that is right.

Q I am going to take you to a number of entries in the medical records, first, leading up to his MMR vaccination and then dealing with some of the referrals that were made to various specialists in various fields looking into Child 5’s health difficulties. Can I ask you to take up Child 5’s GP records bundle and turn to page 13?
A Yes, I have that.

Q The entry that I would like you to look at is 24 November 1989. Do you have that, about one-third of the way down the page?
A Yes.

Q Is that in your writing?
A Certainly.

Q Would you read that out, please?
A Yes. That was a visit, so I presume I was called to the patient’s house, and the history says that the child was found with a generalized convulsion at 12 pm. That probably means 12 midday,

“which lasted 10 minutes. The child was hot. There were two further convulsions”.

Just a minute, I said 12 pm, it must have been the following morning in fact because the other convulsions were one at 1.30 am and the other at 7 am, and they also lasted 10 minutes.

“A fever was reported. The child had vomited three times and had had diarrhoea once. I examined the child. There was no neck stiffness. He was alert. Throat, ears and chest were clear”.

My provisional diagnosis was “Query febrile convulsion” and I admitted the child to the Royal Berks Hospital, Reading.

Q Can I now ask you to turn to page 160? Is this a record of the admission from the Royal Berkshire Hospital?
A Yes, that is right.

Q We will see that it is a summary sent to you and it says,

“This 11 mth old baby who has a strong family history of febrile convulsions was admitted having had a recent upper respiratory tract infection. He had been found in his cot that night by his mother, unconscious with his eyes rolling and all limbs shaking. He was not blue and was breathing regularly”.

Then it gives a description of the fit.

“On examination on admission he was pyrexial at 37.8 with a running nose and left cervical lymphadenopathy. His right tympanic membrane was pink. Chest clear, heart sounds normal”.

Towards the end of the paragraph,

“Full blood count, U&E, blood sugar and calcium were normal, urine microscopy was negative.

[5] remained on the ward for 24 hours during which time his temperature settled. Mum was given further advice as to fever control and the management of fits. No follow up arranged”.

A That is right.

Q Can I ask you, in relation to Child 5’s immunisation, to turn to page 2? In the middle of the page, Child 5’s immunisation is set out and on 10 April he received the MMR vaccination. Is that right?
A Yes.

Q That was in 1990.
A Yes.

Q Prior to his admission to the Royal Berks, is it right that Child 5 had been seen by a number of clinicians to whom he had been referred?
A Yes, certainly.

Q Can I first take you to page 158 of the GP records? Rather unhelpfully the actual date in August 1990 is hole-punched through on my copy. It probably does not matter either way, but in august 1990 at any rate, this is a letter to the health visitor from Dr Sumitra. If we look down to the first paragraph, it is apparent from that that this was an attendance at the audiology clinic. Is that right?
A Yes.

Q In the middle of the first paragraph that relates, I think, to Child 5’s sister. Is that correct?
A Yes.

Q Then the second paragraph says,

“I am more concerned with [5] whose behaviour is very difficult. He is a very strong willed little boy who thrives on defiance. He throws tantrums both at home and in public. Mrs [5] is finding it exasperating in containing his behaviour. I was not able to do any sort of hearing test, but I am not unduly worried about this. I feel that Mrs [5] needs help and we discussed some aspects of behavioural therapy, but what he needs is help from Child Guidance Clinic. Mrs [5] said she will think about this and let us know.

Meanwhile, I am recalling both of them after about 6 months to check on hearing and general concerns”.

Are you able to help with the reason why that particular referral to Dr Sumitra was made?
A Not directly. I certainly did not make that referral myself. I presumed it was made by health visitors.

Q Indeed, the correspondence is actually addressed to the health visitor.
A Yes.

Q Can I next ask you to look at page 14? The entry I would like you to look at is the fourth entry. Again that looks like your writing. Is that correct.
A Yes.

Q It is apparent that four months later, does it say,

“Still concern re hearing”.

A Yes. I have written,

“Still concern re hearing. Difficult hearing test at NDH”.

Q What is “NDH”?
A Newbury District Hospital. Then I say,

“wax left ear. Right clear. Poor speech, few words only. Discuss with health visitor”.

Q What was the purpose of having a discussion with the health visitor at that stage?
A I think to discuss further follow-up of possible hearing or speech problems.

Q We can see the review from Dr Sumitra at page 156. This was a letter written by Dr Sumitra and copied to you on 20 March 1991. Again, it relates to Child 5 and his sister and he says,

“I saw these two children at the Newbury Community Audiology Clinic...I am concerned about [5]. His language and social development is delayed. He does not respond to gross stimuli and tends to withdraw into a world of his own. Both parents find him difficult to respond to or give affection. His speech is limited to two to four single words only. I did not hear him say a word and found it difficult to establish a rapport. I suspect there is a serious problem here”.

That letter was written to Mr Heyworth, an ENT consultant at the Royal Berkshire. Is that right?
A Yes, certainly.

Q Soon after that, if you look at page 153 there is a letter from Dr Scanlon to “Julia”. Can you help us with who Julia is?
A She was one of our health visitors at the time.

Q Dr Scanlon, a senior clinical medical officer says,

“Thank you for referring [5] to the developmental language clinic and for attending the clinic when he came with his parents and elder sister…Mr and Mrs [5] are concerned about [5] because he does not respond to them although his own activities seem to them to be normal for his age”.

Then it goes through the family history. The history of the pregnancy is then set out.

“Around the time of the second immunisation [5] had febrile convulsions but otherwise he has remained well. There was no adverse reaction at the time of the first immunisation. He was walking by the age of nine months. However early communication and language skills have been very slow to develop and his interactions tend to be very strongly on [5]’s own terms. He is reported to wave ‘bye-bye’ now when he wants to, and is also reported to understand ‘no’ and ‘hot’”.

Dropping down,

“My colleague…has already seen [5] in the community audiology clinic and referred him to Mr Heyworth” –

we have already seen reference to that.

“It seems to me unlikely that [5]’s significant communication and learning difficulties are caused by hearing loss, though it is obviously very important to exclude such a deficiency. In view of the family history of learning difficulties, I think it is important to exclude any obvious cause so I will ask Dr Newman to see [5] in the paediatric department for his opinion and advice”.

Is it right that Dr Newman is a consultant paediatrician at the Newbury District Hospital?
A Yes.

Q Sticking with the subject of the potential hearing problem, can I ask you to turn to page 144? This is a letter written to you from the audiology clinic on 28 August 1991. Is it right that the conclusion from this visit on 8 August was that the indications were that 5’s hearing was within normal limits?
A Yes, that was the assessment.

Q Child 5 was reviewed again in January 1992, and can I ask you to turn to page 142? This is a letter again from Dr Sumitra to you dated 9 January 1992. This letter says,
“This is to let you know that [5], who has severe language and communication difficulties has been considered for a Special pre-school education. Dr T Williams, Chief Clinical Psychologist is involved with the family. [5] has autistic-like features and he needs considerable help. As you know he was investigated in hospital(Dr Newman and audiology department) and no definitive cause was determined for his problem”.

Are you able to help us with who initiated the referral to Dr Williams?
A That was not myself. I always presumed that was either Dr Sumitra or Dr Scanlon.

Q We see in this letter a reference to “autistic like features”. Is that the first mention, so far as you are aware, of that as a potential diagnosis?
A Yes, it is.

Q We will see at page 138 Dr Williams’ letter. This is a letter from Dr Williams, Divisional Clinical Psychologist to Dr Wilkinson, Psychiatric Registrar, but if you look at page 140 you will see that it was copied to you.
A Yes.

Q Just to take you through some of the paragraphs in this letter, it begins by saying,

“Thank you for referring this interesting young boy to me for assessment of his behaviour”.

It then goes through the family history, which I will not read out. Then in the second paragraph, starting four lines down,

“At one year he had convulsions which led to a further hospital admission but these appear to have been due to a high fever. From then on his parents noticed a difference in his development and feel that these febrile epileptic seizures continue to the present day. In general he showed a good physical development, sitting up at 3 months, walking round the furniture at 6 months and walking properly at 11 months. At 10 months of age he was saying mummy and daddy but then became very miserable and appeared to lose ground in his development after he had been in hospital.

“His parents record that [5] has always related to people well and in an affectionate manner. They describe how he runs over to his mother when she comes in but on the basis of my own observations I would suggest that this was in a fairly automatic manner”.

The next paragraph,

“[5] also shows a number of rituals which include carrying objects around from which he will not be parted”.

Next paragraph,

“He is able to feed himself, climbs well but is not yet properly toilet trained. He does not however wet the bed, rather he gets out of bed and wets the floor beside the bed.

[5] also presents a number of behaviour problems”.

It sets those out and concludes the paragraph by saying,

“He also has very severe temper tantrums related to frustration. Management of these behaviour problems is compounded by additional family stresses”,

which are then enumerated in six subparagraphs and I will not read those out. In the penultimate paragraph,

“Since first seeing the family in November, [5] has developed a habit of taking all his clothes off. This has resulted not only in him being cold and being difficult to take out of the house but also in inappropriate defecation and urination. This is unlikely to be sorted out before the temper tantrums”.

In conclusion,

“[5] is a boy with uneven development. It seems very likely to me that he is suffering from autism, that is, he shows delays and deviance in language and communication development and social development together with rituals or other routines that started before the age of 3. This is a lifelong condition and whilst he will show some improvement in sociability over the years, he is unlikely to recover fully”.

So far as you are aware, Dr Shillam, is this the first time that a formal indication is given as to the likely diagnosis for Child 5’s behavioural problems?
A Yes. This is the first actual confirmation of the diagnosis and detail of it.

Q We can see, if you turn to page 15, the diagnosis having come from Dr Williams in January 1992, these are entries at the foot of the page in 1994 and 25 August 1994, does that say,

“Difficult behaviour continues”,

and then it is noted that he attends a special school?
A I think that actually relates to 16 August 1994, because the entry for 25 August 1994, I think, I presume, relates to me filling in a disabled living form.

Q So the entry that I have just read out to you is 16 August which begins,

“Cough 3 weeks, worse at night. Impossible to examine”,

and the prescription of the Amoxicillin.
A Yes.

Q Can I then ask you to turn to the next piece of correspondence which is page 127? This is a letter from you to Dr Richer, a Consultant Clinical Psychologist dated 23 February 1995, so six months after the GP notes that we have just been looking at. So this is a referral that you made.
A Yes.

Q For what reason?
A The reason was the parents’ request that they wished to have a further consultant opinion and there was also some input from the teacher at the special school that he was attending as well.

Q Were you aware of Dr Richer at this time at all?
A I would not have been. Although I cannot be sure, I think the name either came from the parents or even from the teacher or via the teacher at XXX School. I cannot be sure, but I think that is most likely.

Q As far as you are concerned, what was the purpose of seeking that referral?
A The parents were having awful difficulties managing the child and like a number of people in that situation, they were casting around for more help and an opinion that might lead to some successful treatment. This referral was suggested. It seemed perfectly reasonable to agree to the parents’ request in those circumstances.

Q Dr Richer’s response to you is at page 121. As I think I have already said, Dr Richer is a consultant clinical psychologist. He says:

“As you mention, [Child 5] is an autistic boy with considerable behaviour problems.”

In the third paragraph:

“I was able to show his parents how to hold him in a comforting way … This marked a turning point and for most of the rest of the session [Child 5] was better behaved in clinic than his parents could remember.”

Then three paragraphs up from the bottom:

“Most autistic children have food intolerances however [Child 5] does not have many of the physical indicators of this so I doubt whether he has significant ones although he does react adversely to stimulants (Coke, chocolate etc.).”

Then the family stresses are again mentioned and he proposes, at the foot of the page, to see the family again in the autumn so that they can bring questions, having read some of the literature that he had given them. It is correct that Dr Richer continued to see Child 5
A Yes, yes he did.

Q He reviewed him again in October 1995, if you look at page 116. This was a follow-up meeting and it notes, in the second paragraph, that a major change had taken place in the household with three of his elder siblings leaving home and that calmed the house down, it says, considerably, and that Child 5 had responded well to that. Then, five lines up from the bottom of that paragraph:

“I suggested his parents withdraw as many of the additives which generally have an adverse effect, of which they have a list, added sugar and chocolate from his diet. They might even consider doing the full Hunter Gatherer diet investigation although, as I mentioned in my previous letter he hasn’t got many of the physical signs that suggest dietary involvement.

We discussed a little of the history and I note that after a period of fairly normal development he had one febrile convulsion and was hospitalised in The Royal Berkshire where mother was prevented, much of the time, from cuddling him. She noted that when she could cuddle him he calmed down, but for the rest of the time he screamed. From that point onwards his speech became growly and then disappeared and he became avoidant.”

Is that a reference to the 24 November 1989 admission to the Royal Berkshire?
A Yes.

Q Then if you turn on to the next page – it has been photocopied the wrong way round –it says, three paragraphs up:

“We discussed how these factors can precipitate going down an autistic path in a predisposed child, especially with combined with the factors promoting overactivity.”

If you turn to page 114 you will see a further follow up by Dr Richer, this time two months later in December 1995, on 15 December. This is a letter to you. He records:

“… [Child 5’s] behaviour was much better for a month or so but then, repeating a pattern that they had seen the previous two years, his behaviour started to deteriorate in late October/early November and he has become much more overactive, skills have dropped away, including speech, and he has started hitting himself, scratching himself intensely, picking at himself, and sometimes hitting others in distress. He was doing this when he came to see me and could be calmed a little bit by holding him in a comforting way which he did not struggle to escape from.”

THE CHAIRMAN: Can I just interrupt? Can you just go a little slowly because we need to find those places where these words are?

MR THOMAS: I am sorry, this is paragraph 1, the middle of the paragraph. I started reading I think from:

“Following their last visit [Child 5’s] behaviour was much better …”,

and we have got down to the stager where I said:

“… he has started hitting himself, scratching himself intensely, picking at himself, and sometimes hitting others in distress. He was doing this when he came to see me and could be calmed a little bit by holding him in a comforting way which he did not struggle to escape from.”

He then notices some physical characteristics, very hot red ears, somewhat pasty, and at the foot of the page:

“All of this makes one suspect fairly strongly that there is some allergic or intolerant reaction going on”,

and then the last line on that page:

“Already his parents have clear evidence that some things he eats affect him adversely.”

Then at the top of the next page, page 115:

“I believe he has had in the past oral and anal thrush. His craving for sugar and bread and marmite and similar foods made me wonder whether he may be suffering excess candida. I suggested [Mr and Mrs 5] discuss this with you with a view possibly to trying to reduce the candidia concentration.”

Do you remember this being raised in this case?
A Yes.

Q Is it correct that he had in the past had oral and anal thrush?
A No. There had not been a clinical diagnosis as far as I am aware, but the suggestion that he would benefit from anti-candida treatment was a certainly made.

Q Did you recall what action was taken in that respect?
A I was asked to give a prescription for nystatin on several occasions by the parents, which I agreed to.

Q What is nystatin?
A That is an anti-fungal, almost certainly oral suspension, although it could be cream as well.

Q If we look at page 112, Dr Shillam, remembering that the last letter we looked at is December 1995, this is a letter of 22 April 1996. Again, it is from Dr Richer to you and I want to go half-way down the first paragraph to the sentence beginning:

“All this is pretty clear evidence that he was suffering from candidiasis and that this was having an adverse effect on his behaviour. I would be most grateful if you could re-prescribe the Nystatin.”

Do you as a matter of fact recall when you began to prescribe nystatin?
A I would hope the prescription was noted in my notes and I think it is, so I would have to refer there, frankly.

Q If you turn to page 16 this appears to be the GP notes.
A Yes, so in fact ---

Q And the first entry is 4 January 1995 and the last entry is September 1996. If you look in the middle of the page you will see that on 24 April 1996 there is nystatin.
A Yes.

Q Is it earlier on as well?
A I do not think there … I have not seen a reference to nystatin before but I certainly prescribed two bottles of nystatin oral suspension on 24/4/96.

Q Actually if you look at 13 February 1995 ---?
A Fair enough.

Q The second line down?
A Yes, absolutely.

Q Does that say: “Parents seen”, and does that say “Repeat prescription”?
A It does say “Repeat prescription for Candida” or “Re Candida” or whatever, so yes, it does say “Repeat prescription.”

Q After “Candida” does it say “Nystatin suspension”?
A Nystatin suspension, 1 ml tds, 30 ml x 2.

Q So on the face of it it looks as if that was not the first time on which that particular drug was prescribed?
A The most likely thing is that it was prescribed in Oxford by Dr Richer and I was continuing the prescription. I cannot be sure, but that is the most likely.

THE CHAIRMAN: Was this on 6 June as well?
A Yes.

MR THOMAS: Can I ask you, Doctor, to turn to page 107? This is a letter dated 25 September 1996 from you to Dr Brostoff, who is a consultant immunologist, and can you assist us with why this referral was made?
A It was made at the request of … I might need to look at my general practice notes, but I think it was actually made at the request of the parents.

Q Can you look at the first paragraph of that letter?
A Certainly on the letter here it says, and I have written, the suggestion for the referral was made by Dr Richer from Oxford.

Q At that stage were you aware of any suggestion that there were possible metabolic factors in this case?
A In that those had been suggested in Dr Richer’s letter, yes. The suggestion had been made in Dr Richer’s letters.

Q We can see from that letter from you to Dr Brostoff that you say:

“[Child 5] has presented with developmental delay, and severe communication problems, and autism was diagnosed when he was aged three. He has the classical features of autism and appears to be continually frustrated by his inability to communicate with anybody.”

We then go through his behavioural problems, his prescription of nystatin which Dr Richer had suggested, and then you also say that he has been seen by Dr Williams, Dr Wallis (who we will come on to) and Dr Van Boxel. At the foot of the page you will see:

“P.S. I am also writing to the Berkshire Health Authority to confirm that they agree to this ECR referral.”

What were you referring to there?
A At that time as GPs we were expected to inform the health authority of any referral to outside the usual area, so that is what I would normally have done.

Q For what purpose?
A For the purposes of financing the referral.

Q Who would finance the referral outside the area?
A Presumably it would have been the Berkshire FHSA.

Q There is a manuscript note there which says:

“Oct 96. Confirmed with Sharon Stone”,

is that right?
A I do not know who wrote that note.

Q Do you know what “Safe Haven” is?
A That entry there is not anything I know anything about.

Q What it says is:

“Confirmed with Sharon Stone (Safe Haven) that contract exists with Middlesex.”

But you are not able to assist us with that?
A No, I had not seen that before seeing these copies.

Q Can I now ask you to look at page 123 in relation to the referral to Dr Wallis? This is a letter from Dr Wallis, a consultant paediatrician, and you will see from page 126 that it is copied to a number of people, but this letter is dated 31 March 1995 and it is written to you. Is that right?
A Yes.

Q The opening words,

“Thank you very much for referring this little 6 year-old boy …”,

suggests that you made a referral to Dr Wallis?
A Yes.

Q Can you assist us with why you made that referral?
A Yes. I think there is an entry in my GP notes saying that I had a consultation with the parents, I think mother and father, if I remember, who again were fairly desperate to get some help with the management of their child and things were progressively getting more difficult. Again, they asked me to refer the child to another consultant, and in fact Dr Wallis was the consultant dealing with children with developmental problems in the Reading area, so that was a logical referral.

Q I think I can help you in that connection, Doctor. If you look at page 16 you will see, towards the top of the page, on the right-hand side, Sheila Wallis?
A Yes.

Q Are you able to tell us whether that is an entry on 4 January or 13 February?
A It is 4 January and it says:

“Father requests another referral”,

and then that is my arrow, meaning I am referring to Sheila Wallis.

Q Thank you. Turning back to the letter from Dr Wallis at page 123, she sets out a number of concerns, and point one is the confirmation of the diagnosis of autism, that being a concern,

“…as they [and that is a reference to the parents] found the unevenness of [Child 5’s] skills confusing. They had also read about newer forms of brain scan such as MRI and SPECT and wondered whether these would be helpful.”

It goes on to say, two paragraphs up from the bottom:

“[Mr 5] wondered if a specific diet would help [Child 5] as he tended to become very ‘high’ after drinking Coca-Cola…”,

and in the last paragraph, in the middle of the paragraph:

“[Child 5] is toilet trained so blocking his access to the kitchen would cause regression in this area.”

Then in relation to the diagnosis on the next page, under the subheading “Diagnosis of autism” she states:

“This is usually made by completing a check list of behaviours from the history and observations of the child over a period of weeks or months. Dr Williams usually uses the check list designed by Professor Rutter from Maudsley Hospital in London and I am sure this would be the procedure he followed by making a diagnosis of autism in [Child 5].”

She then goes through a number of the early developmental concerns and at the conclusion of the middle paragraph states:

“These features fill sufficient of the diagnosis criteria of autism to indicate that the diagnosis is correct. Further confirmation would require a period spent working through the detailed check list again.”

Then turning on to page 125 she deals with the question of other investigations which have been carried out and she says:

“In 1991 Dr. Newman carried out a number of investigations on [Child 5] and excluded a digs of Fragile X syndrome … Other investigations which included a full blood count, biochemical screen, blood and urinary amino acids, were normal. Brain scan was not carried out as there were no indications to do so from either the history or physical examination and I found no further clinical signs to indicate a scan would be helpful. Reports on a series of MRI scans carried out in autistic children have shown evidence of congenital malformations, or non-specific brain damage in some children, but these findings have not been helpful in management.”

Then her plan on the final page of the letter, page 126, is that she hoped it would be possible to arrange a meeting between Mr and Mrs 5 and members of the CHASAC and learning disabilities team. Could you help us with what CHASAC stands for?
A “Challenging Behaviour …”, and I cannot remember the rest. At the moment it has gone out of use, but certainly it starts with “Challenging Activity.”

MR MILLER: Page 131.

MR THOMAS: Page 131, Community and Home Advisory Service for Children with Autism and/or Challenging Behaviour.
A There we are.

Q So the “Challenging Behaviour” bit was right.
A Yes, it was.

Q I have taken you to a number of referrals which were made in this case, Doctor, prior to Child 5 being referred to the Royal Free. As far as you know, are those all of the referrals that were made to various specialists?
A Yes.

Q Can I next ask you to look at page 106? This is a note addressed to “GEOF.” Is that you ?
A That is me, yes.

Q Do you recognise the writing?
A Yes, it is the writing of my partner, Dr Bruce Letham.

Q It is dated 30 September 1996 and it says:

“re [Child 5]

Dr Wakefield consultant gastroenterologist ROYAL FREE rang & gave a v. lengthy & convincing case for [Child 5]to be referred to …”,

and then he gives Professor John Walker-Smith’s name and 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 needed to myelinate till age 10 → 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”.

How did you become aware of this note?
A It is difficult to be sure of my memories at the time, but I would expect to be aware of it when I either came back from the practice that day – I might have been out on a visit – or if not, the following morning.

Q When you did come back, do you recall reading this note?
A I do not recall anything specifically about that time, but I would normally have read that with all my other practice correspondence and messages from any other members of the practice team.

Q Do you remember seeing a fax with it, or not?
A No.

Q Before reading this note, had you heard anything of Dr Wakefield’s work?
A Almost certainly not.

Q And what about Professor Walker-Smith?
A No. Certainly not.

Q Was it normal in your experience for a consultant to telephone the practice suggesting referral to hospital?

MR COONAN: It was a direct leading question.

MR THOMAS: It is not a leading question at all. I am asking the doctor whether it is normal or not for a consultant to ring the practice at which he is a member, suggesting referral to a hospital.

MR COONAN: That is the leading part, the latter bit.

THE CHAIRMAN: Legal Assessor?

THE LEGAL ASSESSOR: Technically it is not a leading question in that it gives two alternatives, but it is suggesting what the expected answer is. It would be better if Mr Thomas could rephrase it.

MR THOMAS: If it is the case, Dr Shillam, during the course of this telephone conversation Dr Wakefield suggested that Child 5 be referred to the Royal Free, is that something that you would regard as normal practice in your experience?
A It is unusual to be asked to refer a patient via telephone call.

Q What do you say in your experience is the normal method by which a referral to a hospital comes about?
A Usually I would get a letter from the consultant concerned with that request.

Q Do you recall Child 5’s parents mentioning anything about Dr Wakefield prior to this time?
A No. In all fairness, my contacts with the parents were not as frequent as perhaps you might expect with the level of trouble that they were having. So in fact, looking back on the notes, I noticed the fact that the amount of contact and times they actually consulted with me were less rather than more, shall we say.

Q What did you do after you read this note?
A I actually made the referral because I had formed the view over previous months that the difficulties with this child’s management were getting almost intolerable for the parents, and although some of their requests were, if you like, for more mainstream help, there were obviously times when they made requests for, shall we say, less mainstream help. But really to block those requests was just going to make their life even more difficult, and I wanted to be as helpful as possible within reasonable limits.

Q Can you look at page 17, please. This is an entry dated 30 September 1996. Is that in your writing?
A Yes.

Q Can you just read out what it says?
A It starts off with a dash which implicates that it is not actually a consultation and it says:

“Request referral to Professor Walker-Smith, paediatric gastroenterology, Royal Free via Dr Wakefield. ? association … inflammatory bowel disease, failure to absorb vitamin B12 needed to myelinate till age 10, leading to autism ? measles vaccine implicated.”

Q Where did you get the information in that note from?
A That is almost verbatim from my colleague’s note, which he sent to me – from Dr Letham’s notes.

Q Can you turn on, please, to page 105, which is the letter of referral itself. It is dated 1 October 1996, and it is a letter from you. Is that correct?
A Yes, yes.

Q You made a referral to Professor Walker-Smith, the Department of Paediatric Gastroenterology at the Royal Free Hospital. You say there:

“This 7 ¾ 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.”

Pausing there, how did you come to know that Child 5 parent’s had been contact with Dr Wakefield?
A I think it is important to say that that was a presumption on might part. They did not say to me specifically, or make me aware that they had been in contact with Dr Wakefield. That was a presumption because that was what the note from my partner, Dr Letham, had said. Dr Letham, I think on his note, inferred that the note from Dr Wakefield’s phone call, in fact the parents had been in contact with him.

Q If you just look at that note at page 106, perhaps you can tell us which part you are referring to.
A The only part on the note I can see which makes a reference to the parents is at the bottom, where it says: “Parents are keen”.

Q Can we now carry on with page 105, you say:

“Child 5 has presented with developmental delay, and severe communication problems, and autism was diagnosed when he was aged three. He has the classical 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 [when in] 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 XXX.

He has also seen:”

And then you list Dr Williams, Dr Wallis, Dr Van Boxel and Dr Richer.

“His parents are concerned about an association they have read in the ‘Daily Mail’ between MMR vaccine, childhood enteritis, and possible brain damage.”

Again, pausing there, where do you say you got that information from?
A That would have been discussed by the parents during one of the consultations. I cannot say which consultation, but I presume that must have been discussed during a consultation.

Q Then you say:

“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 3 ½ years.

Thank you for seeing this child.”

And again, at the bottom of the page, there is a manuscript note:

“Confirmed with Sharon Stone … that contract exists with Royal Free.”

Are you able to assist us with what sort of contract might exist with the Royal Free?
A No. Again, that entry I have no knowledge of. It is only a relatively short time since I had written the referral letter to Dr Brostoff, where I mentioned ECR. When I have looked through this correspondence, again it is surmise, but I probably did not feel the need to write about ECR referral on the bottom of this letter as, in fact, on the face of it done a similar letter only a week or two before.

Q As far as you were concerned, how as this referral to be funded?
A If I would have presumed that ECR funding was necessary, it would be funded via the FHA in Reading.

Q If a contract exists between the Local Health Authority and the hospital to which you are referring the patient, is an ECR necessary?
A Yes. At that time it was, but that really, as far as I was concerned, that was a matter for the health authority. Frankly, I did not spend too much time concerning myself. My concern was with the clinical issues.

Q We have been through a number of referrals that you made in Child 5’s case to clinicians in various disciplines prior to this referral to the Royal Free. Were any of those referrals, Dr Shillam, made at the request of the clinician to whom you were referring the patient?
A Looking at the list of clinicians the child had seen previously, Dr Richer had requested that the child be seen by the immunologist in Oxford, as far as I am aware.

Q What action did you take in response to that?
A I made the referral we have discussed. Neither of the other three consultants there asked me to make any referrals.

Q When you made this referral, what did you understand would happen at the Royal Free?
A I had no knowledge of what would happen at the Royal Free.

Q As far as you were aware, what was the nature of the allegation that they were making in relation to the methadone maintenance centre?
A I never wrote that specifically in the notes, and I do not recollect the parents actually specifically discussing that with me at any length.

Q Were you content to make this referral?
A Yes. Yes.

Q Can I ask you to look at pages 95 and 96. This was about a fortnight after your referral letter. It is addressed to you from the Vaccine Damage Unit, dated 17 October 1996. It says:

“A claim has been made by Mr 5 on behalf of 5 against the Department of Social for payment in respect of alleged severe damage caused by vaccine.

In order that we can consider the claim fully we need details of [his] medical history, vaccinations, and reactions soon after vaccination.”

Would you now turn over, is that your signature at the foot of the page?
A Yes.

Q And the date, 24 October 1996?
A Yes.

Q And did you in fact set out the vaccination history in that form?
A Yes. That is not in my handwriting, those details.

Q I see.
A I really cannot tell whose handwriting it is in unless, in fact, it is a photocopy in some way of the actual record. I think it is a correct record, but I cannot tell you whose writing it is in.

Q Under 3, it says:

“Diagnosis of any major cause of continuing disability.”

And then it says:

“Autism with developmental delay.”

Is that in your handwriting?
A I am not sure it is, frankly. I do not know I can answer that, but it does not look typical of my handwriting at all. I know that is not very helpful, but I am not convinced that is my handwriting.

Q Then, under 5, it says:

“Details and dates of any encephalopathy.”

That is typed.
A Yes.

Q But do you recall typing this form, or would somebody else have done it?
A I certainly would not have typed it myself.

Q Is the information it gives correct nonetheless: “No encephalopathy has been diagnosed.”
A Yes, that is correct, yes.

Q And in relation to what it says about the diagnosis of his disability, is the diagnosis autism with developmental delay and accurate one, from your viewpoint?
A Yes, that is correct.

Q Aside from that, I would just like to ask you to look at page 98. This is a letter, again from the Vaccine Damage Unit. This time, instead of being addressed to you by name, it is address to the Berkshire Health Authority.

“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:-“

And it is asking for the immunisation history. Aside from those entries or those documents contained the GP records, were you aware of any involvement that Mr and Mrs 5 had in litigation at this time?
A I was not aware of any involvement, but as you probably gather, they saw my role as a GP perfectly reasonably but they did not necessarily involve me in things they saw as outside my role as a GP. But I certainly was not involved in litigation. They certainly did not make me aware of any litigation involved at all.

Q When you made your referral to the Royal Free on 1 October 1996, were you aware of any particular investigations that would be carried out there
A I was not aware of what investigations would be performed at all.

Q In response to your letter, would you look at page 93, you received a letter dated 12 November 1996 from Professor Walker-Smith. That letter is addressed to you, and it states:

“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 gill pathology. I am arranging for him to come in for a colonoscopy on Sunday 1st December 1996.”

Now, Dr Shillam, was that, given your previous answer as to your understanding of what was to happen at the Royal Free, is this letter all of the information you received prior to the admission of Child 5 on 1 December?
A I certainly do not recall receiving any other information at all.

MR THOMAS: Sir, I notice that it is nearly one o’clock. I am just about to turn on to the child’s admission to the Royal Free and the follow up, so perhaps that would be a convenient moment.

THE CHAIRMAN: I am sure that is a convenient moment. It is one o’clock, and we will now adjourn for lunch, and we will resume at two o’clock.

Dr Shillam, you are still under oath and are in the middle of giving evidence. I am sure someone will look after you, but please make sure that you do not discuss this case with anybody during the break, including any of your lawyers. We will resume at two o’clock.

(Luncheon adjournment)

THE CHAIRMAN: Good afternoon to you all again. Mr Thomas, I think you were going to move to the next topic.

MR THOMAS: Indeed I was. Doctor, before lunch I asked you questions in relation to your view as to whether or not this referral was an extra-contractual referral and you gave your answer to the effect that you anticipated it to be an extra-contractual referral. I just wanted to ask you to look at one document in the Royal Free records, not the GP records, in the bigger bundle, at page 453. This I an investigation form in the Royal Free records. Can you see there that ECR is ringed?
A Yes.

Q Does that accord with your understanding as to the nature of this referral?
A I presume it does, but I cannot say that I put great emphasis myself on the importance of the ECR. I was more concerned about clinical matters.

Q Can I ask you to put away the Royal Free records now? You will not need those again. In the GP records we had got to the stage where Child 5 had been referred to the Royal Free and now I want you to look at a discharge summary, which you will find on page 89. This is a letter addressed to you from Dr Casson, copied to Dr Wakefield. It is dated 27 December 1996 and relates to Child 5,

“Diagnosis: 1. Part of autistic spectrum
2. Persistent diarrhoea.

[5] was admitted to our ward at the Royal Free Hospital on 10 December for assessment of his persistent diarrhoea”.

Then the developmental history is given and three lines from the end of paragraph 2 it says,

“diagnosed at 3 years of age as having autism. Presently his condition is exacerbated by violent episodes for which his parents find difficult to control…With regard to his diarrhoea, he has apparently been having bouts of diarrhoea on and off since he was 4 years of age. There is no blood or mucous in the stool. He has occasional abdominal pain during which he suddenly clutches his abdomen and flexes his knees. This has a duration of about 10 minutes and then resolves.

His parents feel that the onset of his neuro-developmental symptoms stem from the period 2 months after having had the MMR vaccination which he received on 10 April 1990. A few months subsequent to this he started losing his skills.

He had a colonoscopy performed under sedation. This demonstrated a mild proctitis with a granular mucosa and loss of the vascular pattern, but there was no friability or ulceration. The colon was otherwise normal throughout. There did appear to be a slight loss of vascular pattern in the caecum without any ulceration. There was prominent lymphoid follicles within the ileum. The ileal mucosa appeared normal. Biopsies showed normal crypt architecture. There was a very minimal increase in the chronic inflammatory cells within the superficial laminar propria although no active inflammation was seen. Very occasional polymorphus were seen within the surface crypt epithelium. No granulomas were seen. Overall it appears that these are minor changes, the significance of which is uncertain”.

Then it goes through a series of blood test results. At the foot of the page it says,

“Barium meal and follow through demonstrated a 5cm stricture just proximal to the terminal ileum. This appearance is highly suggestive of Crohn’s disease. We are still awaiting results of his CNS MRI scan and lumbar puncture”.

It follows on the next page,

“It is therefore apparent that although there is no histological evidence of over inflammatory bowel disease, there was some hyperplasia of the terminal ileal lymph nodes. The barium would suggest the presence of a stricture which would be in keeping with Crohn’s disease. We will need to consider these findings at greater length when we review him in clinic”.

Did that discharge summary require any action from you?
A Not that I am aware of, no.

Q The next document I would like to take you to is page 87. If you turn this document on its side you will find it easier to read. This is a further discharge notification from the Royal Free, recording an admission on 15 January and discharge on 16 January. Do you see that from the right hand side?
A Yes.

Q Were you aware of that second admission or not?
A No, I do not think I was.

Q What it says in relation to that is, procedures undertaken: barium meal and follow through and lumbar puncture. At the foot of that document it says, “Drugs to take home”. Then both entries appear to be dated 15 January liquid paraffin and Picolax. Again, did that require you to make any prescriptions or take any action?
A I would have to check my general practitioner notes. I think at one stage I did make some prescription for bowel preparations but I would have to check my notes to see when that was.

Q By this stage were you aware of anything other than the discharge notifications to which we have been taken as to what was happening at the Royal Free in respect of Child 5?
A No.

Q In relation to subsequent prescriptions, can I ask you to look at page 17 of the GP notes? Can you see there an entry which looks as though it is dated 7 December. Is that right?
A Yes.

Q There is a prescription there of salazopyrin.
A Yes. That is the handwriting of Dr Davies, my partner, on a Saturday morning and was presumably a request for salazopyrin as written.

Q As we have just seen, there was an admission to the Royal Free on 15 January until 16 January 1997. Can you look on the same page, page 17, to your entry? There seem to be two date stamps there. Does that mean the entry beginning, “Dr Casson” and the “LP yesterday”, are in fact separate entries or is it just that someone has stamped it twice?
A It is me that would have stamped it and it suggests to me that the first entry relates to the prescription for Mesalazine, 400 mg from the Royal Free via Dr Casson, and the second entry was made at 6.30 and was a telephone call because I have put “T” and relates, as it says,

“LP yesterday under GA. Now screaming for two hours, no vomit”.

Q That says “LP”, which stands for lumbar puncture.
A Yes.

Q “Under GA” – general anaesthetic.
A Yes.

Q The second part of the entry says, “Now screaming”,
A “Now screaming for two hours. No vomit”. Underneath that I have put “SIW”, which is my mnemonic for “see if worsens”.

Q If we turn over the page to page 18.
A My entry for 17th, now that looks very much as though it is a sticky label which has been put in, which suggests that I actually made those notes when I was doing a visit. That says, if you want me to read it out,

“LP under GA 15/01/97 Royal Free London. Drowsy since. Screams when wake. Complaining of back pains. Vomit times 2 this afternoon, screaming overnight. Will wake and respond. No definite neck stiffness”,

and then I put an arrow which means admit, “to RBH [Royal Berkshire Hospital] in Reading”.

Q If you turn on in the GP records to page 83, you will see there a discharge summary dated 18 January 1997 from the Royal Berkshire Hospital.
A Yes.

Q It records the diagnosis as,

“Unwell following a lumbar puncture. Awkward posturing. Known autistic”.

Management is described as,

“Observation. No investigations. Discharged day after admission”.

Is that correct?
A Yes.

Q In terms of the follow-up from the Royal Free after the second discharge of Child 5, can I ask you to turn to page 79. This is a letter from Professor Walker-Smith to you concerning a clinic attendance by Child 5. He says,

“It is interesting that liquid Paraffin and Picolax has had a remarkable effect on his gastrointestinal symptoms. He is no longer having diarrhoea and has three loose stools per day. I think the vicious cycle of chronic constipation with overflow has been broken.

Of more interest is that when his mother subsequently gave him Mesalazine there was a further symptomatic improvement with the disappearance of his abdominal pain and apparent general improvement in his behaviour and well being. As you know we did find some evidence of microscopic colitis and we have had several children who have now responded remarkably well to Mesalazine. However, the way in which the Mesalazine was administered was not satisfactory as his mother was smashing the capsule with a hammer in order to administer it. I have therefore changed the medication to Pentasa 500 mg twice a day. This is provided as a tablet which cannot be crushed but when water is added it forms a slurry and I think he will be able to take this.

I would suggest that he continues on this medication definitely for the moment and if there is a measurably sustained improvement he should continue on this. I have not made an appointment to see this child again in the outpatients and will leave it to you and the parents to decide how long he needs to go on Mesalazine for the moment.

In relation to the research that is being done concerning this group of children I suggest that you or Mrs [5] should be directly in touch with Dr Wakefield who is directing the research aspect of this study. If you have any further queries please do not hesitate to contact me”.

What did you understand that last paragraph to be a reference to?
A To be honest at the time I really did not analyse that paragraph at all.

Q Do you recall whether you did in fact get in touch with Dr Wakefield?
A No, I did not.

Q Can you recall why, if at all, you did not?
A Because I had no clinical reason to and I had no request from the parents to do so either.

Q If you look at page 78, you replied to Professor Walker-Smith on 10 April recording that Child 5 was taking Pentasa and Picolax,

“His mother would be very grateful if he can have a follow-up appointment with your clinic in the next three months or so as she is rather hesitant about continuing him on the Mesalazine indefinitely without attending your clinic again”.

Pausing there, do you recall whether there was any particular reason for that?
A I really do not have any recollection at all.

Q It then goes on,

“I note in your recent letter you suggest [5]’s parents should be in touch with Dr Wakefield. Would it be possible to arrange that contact via your secretary?”

Professor Walker-Smith replies on page 77 on 14 April 1997 in a short letter, again addressed to you, where he says,

“Many thanks for your letter. I would be delighted to see [5] and I have arranged for an outpatient appointment to be sent. Mrs [5] can telephone Dr Wakefield’s office to make an appointment”.

There is then a letter on 14 May 1997, if you turn to page 75. This is from Professor Walker-Smith again to you and he records having seen Child 5 again,

“he doesn’t seem to be doing so well on the Pentasa treatment as well as he was formerly. I think it might be helpful if we try a Sulphasalazine suspension. As you recall, Mrs [5] was giving him Mesalazine but she was smashing the capsule with a hammer. This was not thought to be satisfactory by our pharmacy, however paradoxically she feels that [5] might have been better on that administration. Nevertheless, I think it would be more rational to put him on Sulphasalazine suspension.

In relation to Picolax, I don’t think he needs any more Picolax. When I examined him today he did not appear to be faecally overloaded and I would for the moment just continue on liquid Paraffin 5ml daily”.

Then in the middle of the paragraph it says,

“What was clear today was that [5]’s pain is enormously improved from the last time I saw him when he was quite destructive and very difficult to examine. He certainly is still a behaviour problem but there has been quite a remarkable improvement”.

The increase in weight is referred to and then he concludes in the last paragraph of the letter,

“Although the overall diagnosis isn’t totally clear therapeutic strategy of using 5-ASA derivatives and related drugs has made a measurable difference to this child’s symptoms. I think it would be helpful if I did go on seeing him and I have given the parents an appointment for the six months. I would be happy to hear from you if you encounter any problems before then”.

If I can ask you next to turn to page 69, this is the next correspondence from the Royal Free. Is it right that at this stage, Dr Shillam, you had now ceased to be Child 5’s GP?
A Yes. As far as I understand, Child 5 moved from the home to a residential care home, or whatever, for children with similar problems nearer XXX.

Q That entailed going to a more local surgery.
A Yes.

Q This letter is from a research nurse called Jill Thomas and it is to Child 5’s new GP, Dr Hiorns:

“Mrs [5] tells me you are now the physician caring for [5] and that you are still awaiting transfer of [5] medical notes from previous GP. Please find enclosed copies of the most recent communication from the Royal Free Hospital to Dr Shillam. I hope that this will help in the interim while you are awaiting [5]’s notes. I have also taken the liberty of enclosing a copy of the rationale for the study in which [5] was involved. If there is anything else we can help you with please do not hesitate to contact the department”.

Q Dr Shillam, just to complete the story in relation to Child 5’s later admissions to the Royal Free and follow up I am just going to take you to a number of the entries in the medical records. I appreciate that you will not have generated any of these, but could you just turn to page 63 this is another letter from Professor Walker-Smith to the GP and it records the clinical appointment which he earlier referred to in his last letter to you. He says:

“I was rather concerned to see that [Child 5] had lost a good deal of weight”,

and then he says:

“I have therefore arranged for plain X-ray of the abdomen to be repeated to assess to see whether he is still currently constipated and work well as a routine inflammatory markers just in case his bowel inflammation is more active. He does in general seem to have had symptomatic response to Pentasa, but I feel that he needs to be re-evaluated”,

and then he refers to a routine out-patient appointment. That is recorded at page 61.

THE CHAIRMAN: Just wait for a second, Mr Thomas. (The Chairman and the Legal Assessor conferred) Just to be clear, what I was actually asking the Legal Assessor was that it seems to me that these documents have neither been generated by, nor addressed to, this GP, whether these would be appropriate. The Legal Assessor tends to think that it is perfectly appropriate to go through them.

THE LEGAL ASSESSOR: Subject to any objections. If they are from the records of the practice or they related to the patient, they are matters that he can speak to, I have advised, subject to any objection, then it is appropriate for them to be put.

MR THOMAS: As I, I think, indicated, the purpose of putting these records is this. The GP records have been produced in their current form in this bundle to the General Medical Council and I have taken this GP so far to all of those entries which involved him when he was Child 5’s GP. There are subsequent entries which continue the follow up from the Royal Free and which also entail further admissions which I propose to put to this witness, simply to complete the story from the gastrointestinal point of view, because that is, we consider, a helpful way of proceeding, unless of course there are any objections to that course.

THE CHAIRMAN: The reason why I ask this question was that if it is purely reading material then we can actually maybe visit it in our own time, but I think the Legal Assessor, as you have all heard, has suggested that, subject to the objections, that it is probably better to complete this story. Let us just hear what Mr Miller has to say about it.

MR MILLER: Sir, the only difficulty is that this patient has moved to another practice, so it is not even the practice notes, it is consultations that have occurred with another GP and correspondence with that GP, and he really has no input in introducing this. I would have no objection if the Panel read this, and in due course if and when my client gives evidence he will be dealing with the correspondence from his side, but he obviously can deal with that because he was party to it. I am not sure how this witness really can add anything from his own testimony about things he knows nothing about, except to say “I see on page 63 that there is a letter from Professor Walker-Smith to Dr Hiorns.”

THE LEGAL ASSESSOR: My microphone does not appear to work.

MR THOMAS: Perhaps while the Legal Assessor is having difficulty with that, I can indicate that I have absolutely no difficulty with the course that Mr Miller proposes and I am perfectly content in those circumstances simply to give you a list of page references which complete the story and record Child 5’s subsequent admissions to the Royal Free and invite the Panel to read the documents at those page references. There will be nine or ten references, and I can quite see that taking this doctor to them will be a rather more mechanical exercise than is strictly necessary and I can simply leave the Panel to read them.

THE LEGAL ASSESSOR: I was merely going to add that since the documents are admitted as documents, this witness is merely being used as a vehicle to get them on to the transcript, so whichever way you deal with it, Mr Thomas, we can leave it to you.

MR THOMAS: Perhaps now that I have embarked on this exercise, unless Mr Miller has got any very strong views, I will simply take the Panel to the documents that I am proposing to refer to and give you the references.

MR MILLER: I am happy for the documents to go in in that way. I would not be happy if the doctor is invited to comment about any of those documents, which have nothing to do with him.

MR THOMAS: I am certainly not going to invite him to comment on them.

THE CHAIRMAN: Thank you, I think that resolves this question.

MR THOMAS: (To the witness) Dr Shillam, I am now simply going to take you through a number of these entries which deal with the subsequent history, and as you will have heard, we all appreciate that you had no direct involvement in that.

This is a letter from a Fellow in the Paediatric Gastroenterology Department at the Royal Free, page 61, recording to Child 5’s new GP that he had been seen in the food allergy clinic and was still at that stage taking Pentasa liquid paraffin daily. His weight is recorded. His parents recorded constipation again after six months of therapy with paraffin, and he says:

“They restarted the liquid paraffin of which he now has his bowels open three to four times a day with a normal stool consistency. They also report that his behaviour improved and is quite calmer since the above mentioned therapy was started. His appetite remains very poor. We therefore started therapy with Ensure Plus.

He will continue on Pentasa … and will also continue with the liquid paraffin.

We will review [Child 5] in six months time together with Dr Andy Wakefield. We will keep you informed regarding the outcome.”

That letter is, as I said earlier, copied to Dr Wakefield.

Can we then look forward to page 62. There is a reference to an attendance at the North Hampshire Hospital on 27 November 1998, so the day after the letter from Dr Furlano. It says:

“Your patient attended this A&E Dept at 17.40 on 26/11/1998 with the following complaint – SWALLOWED HAIR CLIP.”

The investigations record an X-ray having been taken and no treatment and discharged to GP.

Then page 56, a further follow-up letter from the Royal Free, this time from Dr Shah. The problems listed this time are (1) autism, (2) poor oral intake, (3) Pica (eating metal objects including screws, chains etc.). The drugs are Pentasa, Ensure and paraffin, and then:

“I reviewed [Child 5] today. He is currently a child with autism who has inflammation ii his small and large bowel. His current treatment for this is Pentasa and Ensure.

The Ensure itself is a supplement in terms of his calories … However, it also has an anti-inflammatory response and the parents report, which is not surprising in view of the anti-inflammatory response, that he is doing much better in terms of his bowel habit since the administration of Ensure.

We would strongly recommend this continue as this has a dual role to play in [Child 5].

He continues with the Pentasa as an anti-inflammatory for his bowel and his current dosage of 5 mls once a week of paraffin is inadequate. The parents are currently only giving him a sachet of Picolax and then subsequent to this he is going to continue with paraffin at a dose of 5 mls once daily initially, but probably needs increasing.

His current bowel habit is four to five times a day which probably overflows diarrhoea in that he is straining on a regular basis as well as occasional soiling.”

Then three months later we see on page 55 another admission to the North Hampshire Hospital with the complaint “UNWELL/VOMITING”, and the diagnosis again given as swallowing a foreign body. Investigations are X-ray, no foreign body seen, no treatment, discharged to the GP.

The next entry in the GP records I would like to take you to is page 23, where it is recorded on 23 August 1999 “?constipated”, and ultimately, if you look at page 53, there is an admission to the Royal Free for an oesophageal duodenoscopy and colonoscopy if you look in the box under “Procedure undertaken.” The diagnosis is multiple foreign bodies in the gut and a laparotomy for removal of foreign bodies.

That is reported in a discharge summary on page 46 which shows an admission from 2 November 1999 until 11 November 1999 and a history of re-admission for evaluation in view of Child 5’s past history of mild autistic enterocolitis:

“He presented with significant weight loss … in association with vomiting and diarrhoea. He had severe abdominal pain and this is associated with difficulty standing and abnormal posture, tending to walk hunched over and walking on tiptoe. [Child 5] has a past history of ingestion of foreign bodies in particular a plastic Christmas decoration some 2 years ago prior to the admission and other metallic objects in the subsequent period.”

At page 47:

“Laparotomy and removal of foreign body:-

… At laparotomy it was found that he had multiple foreign bodies throughout his small bowel in particular a large bizarre mass in the jejunum from which a string arose and passed through the whole small bowel, it was ultimately attached to a gold chain lower in the jejunum …

Summary:

[Child 5] made an excellent post operative course following removal of multiple foreign bodies throughout his abdomen”,

and he was discharged on a list of medications.

He was then admitted for a further time at the Royal Free at page 45 for a day on 15 December 1999, again for ingestion of foreign bodies.

If we now wind forward to 2001. Page 39, the next piece of correspondence from the Royal Free, records an attendance at clinic on 6 June 2001. That is 18 months later, where it is said that the diagnosis was regressive autism and previous foreign body ingestion and pica, and the letter reads:

“I reviewed [Child 5] at his annual review and was sorry to hear that his autism has significantly deteriorated since his last review. He has again begun eating pieces of material, buttons and sellotape and his parents are constantly on the lookout to avoid a repetition of the previous foreign body ingestion that led to surgery. He has now been off Pentasa since November 1999 and his bowel habit seems to have regularised itself at 2-3 times/day passing a normal formed stool with no blood or mucus. His diet is low in gluten and dairy but not strictly controlled.”

Turning over the page the proposal at that stage, in the middle of the page:

“Rather than re-commence additional medication I feel a trial of strict gluten and dairy exclusion over a period of 4-6 weeks would be very worthwhile.”

Then, lastly, page 37, a review by the specialist registrar in paediatric gastroenterology on 29 May 2002, so a year later:

“I have reviewed [Child 5] in the clinic today and he is currently not on any treatments or exclusion diets.

We have talked about various issues regarding bowl problems and autism and I have checked [Child 5’s] mineral status and iron ferritin and liver function tests. He has also seen our Research Fellow for checking and assessment of his bowel flora …

I have given [Child 5] an open appointment and will see him in the clinic if there are any problems.”

That is, so far as we are aware, the last piece of correspondence emanating from the Royal Free in these records. Those are all of the entries that I was proposing to take this witness to, simply for the purpose of putting it before the Panel. If you wait there, Dr Shillam, there will be some more questions.

THE CHAIRMAN: Dr Shillam, as I advised you earlier, the defence counsel are now entitled to cross-examined you on the evidence that you have given. We appreciate that the later part was only for the transcript and you were not invited to comment on those things.

Mr Coonan?

Cross-examined by MR COONAN

Q Dr Shillam, I just want to deal with one very short matter and to get your bearings could you turn to page 105 please in the GP notes? This is the referral letter from yourself to Professor Walker-Smith, and the additional materials which bear on the question that I am going to ask you is, of course, Dr Letham’s note at page 106, and in order to have the complete clip, your clinical note on page 17. So those are all three documents that bear on this matter. Can we just look, please at the letter on page 195, dated 1 October 1996, and so we can remind ourselves that was the following day after Dr Letham’s note.
A Yes.

Q Again, if you look at the clinical note (page 17) that is also dated 30th?
A Yes.

Q So you get the letter of referral the following day?
A Yes.

Q We look at the first two lines:

“This 7¾ year old autistic child’s parents have been in contact with Dr Wakefield, and have asked me to refer him to yourself.”

I just want to de-construct some of those references in that sentence. Clearly, this is in 1996, some 11 years ago approximately, and you are saying there that the parents have been in contact with Dr Wakefield and – and we have to insert the word “they”, do we not, here? “They have asked me to refer him (that is, Child 5) to yourself”, that is, Professor Walker-Smith. That is how we should read that sentence, is it not?
A Yes, I think that is right.

Q When you were giving evidence before the break you said indeed that the parents had asked you to make the referral. Can you remember when they asked you that?
A No, that was a presumption on my part and that I what I said earlier. In other words, I cannot specifically remember the parents saying to me face to face that they wished this referral to occur. I do not recall them asking me face to face. That is a presumption which I made on the basis of the note from my partner Dr Letham.

Q Let us just look at those two factors. The presumption that you are making is presumably a presumption you are making in 2007?
A I made that presumption when I wrote that letter.

Q You have a memory of making the presumption, did you, 11 years ago?
A It is a fair comment that obviously that is my interpretation now, but I can be fairly sure that I did not have a face-to-face discussion with the parents where they made that request, as I say, face to face.

Q Can I just press you gently, but nonetheless ask you again. Are you excluding the possibility, the possibility, that either or one of these parents spoke to you before this referral, or is it the case that you do not have a memory of it? Do you see the difference?
A Yes. I certainly do not have a recollection that the parents spoke to me about a request for this referral.

Q That is as far as it goes. You just do not recall it?
A (No audible response)

THE CHAIRMAN: I think, Dr Shillam, you will have to answer for the transcript, rather than ---
A Yes, yes.

MR COONAN: Because another source of information which might have led up to the first couple of lines in the letter might have been, of course, the fax.
A Can you explain?

Q We have been told by Dr Letham, as indeed his note makes clear, that there was a fax.
A Oh, I see – fax. Yes.

Q And he says, if I can just take you to page 106, and these are his words:

“Anyway”

– he says –

“Anyway – see Fax.”

A Yes. He has no recollection of fax, and there was none recorded. We cannot explain what the fax was. There is nothing, nothing, on that basis.

Q Because, you see, just as a matter of general principle, the fax might have shed a bit of light upon these matters?
A The fax may have contained anything, but we have no record of the fax. What I can say from my clinical notes, I should have added, was that if I had seen the parents of Child 5 prior to writing that letter, I would have noted it down on the clinical notes, and I did not.

Q So in other words, on that basis the sources of the information would be either from Dr Letham’s notes or possibly from talking to him?
A Again, this is recollection, but I have no recollection of talking specifically to Dr Letham. He passed the note to me. No doubt there were lots of other things going on in the practice that day and the following day, and I almost certainly had no specific verbal interaction with him as well.

MR COONAN: Thank you very much, Doctor.

THE CHAIRMAN: Yes, Mr Miller?

Cross-examined by MR MILLER

Q Dr Shillam, I just want to ask you a few questions on behalf of Professor Walker-Smith. You have the GP records in front of you. Look at page 150, if you would. This is a letter from the County Teaching & Support Service. In fact, I think it is a report of which you were given a copy. It is certainly in the general practice records. The highlighted bit may well be you. Do you see it?
A Yes, yes.

Q It is page 150.
A Yes.

Q It is unfortunately scored out, but it does say “GP” on it?
A Oh yes. I am sure it would be me.

Q Would you just turn over the page to page 151. On the face of it it was extremely disturbed behaviour in relation to this child’s toileting. I think that is the first description. We started a little later on when Mr Thomas went through with you, but clearly that was something which was concerning those involved as early as May 1991. Then, six months after that, we have the letter from Dr Tim Williams, which you did deal with?
A Yes, yes.

Q Dr Tim Williams is a clinical psychologist, is he not?
A Yes, yes.

Q If you look at page 140 in the bundle, it is the last paragraph of the letter which you were asked to look at before. This is the psychologist making the diagnosis.

“In conclusion then 5 is a boy with uneven development. It seems very likely to me that he is suffering from autism, that is he shows delays and deviance in language and communication development and social development together with rituals or other routines that started before the age of 3.”

Is it right that the first diagnosis – a tentative diagnosis perhaps – of autism came from Dr Williams?
A I think that was the first confirmation of the diagnosis.

Q And he is really dealing, as one would expect perhaps, with his behavioural and developmental problems, is he not?
A Yes.

Q But he does describe on that page, page 140, about screaming and arching. It is at the top of that page in the paragraph that start, “The solution to 5’s behaviour…” of screaming and arching his back, which was said to be tantrums.
A Yes.

Q I think in the general practice records there are also references in 1991 to him having screaming attacks.
A Yes, yes.

Q You referred him to Dr Sheila Wallis, who is a paediatric neurologist, is she not, or a developmental paediatrician?
A She is a developmental paediatric consultant.

Q Yes. And that was at the father’s request?
A Yes.

Q Again – and I am not going to ask you to turn it up but we have seen the long letter that she wrote.
A Yes.

Q And again, concentrating on the autistic side of things, and his developmental and behaviour?
A Yes, yes.

Q Then Dr Richer became involved. Was he somebody whom the parents involved, or was it somebody that you went to off your own bat?
A No. I am not aware that I involved Dr Richer myself. I think that was predominantly the parents, and I think there was a suggestion from one of the teachers at the special school the child was at.

Q Again, it is another clinical psychologist, is it not?
A Yes.

Q Then, as you have indicated earlier, Dr John Brostoff, an immunologist who was involved ---?
A Yes.

Q And it looks from the letter which Dr Richer wrote, that it was at his suggestion that this child was referred to another consultant?
A Yes. That is the case.

Q Because if we look at page 109, I think it is, it is the letter which he writes to you on 17 September 1996 based upon a visit from the parents with the child on 11 September 1996.

“Mr and Mrs 5 brought 5 to see me on the 11th September to follow up progress in this autistic boy.”

Then he describes the behaviour, the problems with his behaviour, improvement following the prescription of Nystatin and then, over the page, in the second main paragraph:

“It is clear that few management techniques are going to achieve much of lasting value until his physical state has improved. We have already seen one way forward on this. Clearly this medical management is outside my sphere but I would like to recommend a referral to Dr Jonathan Brostoff, Consultant Immunologist in the Department of Immunology at The Middlesex Hospital who is very experienced with these sort of problems and is indeed one of the leading figures in the field.”

So this is another professional suggesting that there is a referral to somebody else with greater expertise in that particular problem?
A Yes, yes.

Q Presumably you were happy with his suggestion because you did make the referral?
A Oh yes, yes.

Q Then we know that in your absence, Dr Letham fields a telephone conversation which results in the note. The consequence of that is that we have your referral letter?
A Yes.

Q Of 1 October 1996. I am not going to take you to that because everybody has been through that, taken it to pieces and looked at…. It is, though, clearly a referral to Professor Walker-Smith, is it not?
A Yes.

Q And it is clearly a referral to a unit which was involved in looking at an association between autism and childhood bowel symptoms, because that is what you say in the letter?
A Yes, yes. That is what I understood.

Q And by whatever means it came, it is clear that you were referring the child to Professor Walker-Smith at the request of the parents?
A Yes.

Q Again, however that request was made, it is clear from the first line that you wrote that it came from the parents?
A Yes.

Q Again, Professor Walker-Smith wrote back to you. I think there is a little letter which simply says, “I will be delighted to see him. I have given him an outpatient clinic appointment. Then you get a letter from Dr Richer at page 102. It is fair, Dr Shillam, that there were at this time a number of balls in the air, because Dr Richer was being kept informed. We know that there had been the referral to Dr Brostoff and they had come in at various stages down the line to report on their particular aspect of the cases?
A Yes.

Q So Dr Richer has not been ditched in favour of somebody else; he is still involved in giving advice?
A Yes, yes. Certainly.

Q Looking at the letter of 7 October 1996, so after your referral, the second paragraph:

“As you know, 5 has been excluded from school because of his difficult behaviour. There is strong evidence that a major fact affecting his behaviour is his diet and certain gastrointestinal problems.”

That was something which Dr Richer had been concerned about, the gastrointestinal problems, from the time that he had become involved. I think he had, through you, got a prescription of Nystatin started?
A Yes, yes.

Q That is the position we reach, up to the point of the outpatient clinic appointment at the Royal Free. A number of different people were looking at this child’s problems – and there was certainly more than one problem. In your position as a GP, we do not see a whole lot of appointments in the general practice over this period with you seeing the child because he is not coming into the surgery very often?
A He is not coming in to the surgery because his mother has decided that he would just, in her words, probably wreck the place, and certainly not be controllable. There were, as you see, several times when she asked me to see him at home but, as I say, in all fairness to the lady who, it must be said, is a very capable lady indeed in dealing with these awful problems with the child, and she did not actually make lots of demands on myself.

Q Please do not think I was making any criticism about that.
A Oh no, it is just worthwhile saying. That is all.

Q It is worth you saying it because these were major problems that she was having to deal with. I think you had every sympathy with her when she made a suggestion that there should be a referral, provided it was not completely outlandish, if it was going to somewhere reputable, and a London teaching hospital professorial unit would not be, I hope, considered disreputable, you were happy to go along with that?
A Yes. I think that is right, particularly in the desperate situation or very difficult situation she found herself in.

Q I think the position was, I think you say in your statement, that you were not in contact with the child’s parents between 17 October 1996 and 16 January 1997?
A Right.

Q Which would cover the period after his referral to the Royal Free?
A Yes.

Q And the outpatient clinic appointment and subsequent events?
A Yes.

Q So you did not know exactly what investigations were contemplated when you went to London?
A No, no. I certainly did not.

Q But you were at least kept abreast of what happened in London because on 12 November 1996, at page 93 – this is from Professor Walker-Smith and this is the first clinical communication, apart from merely saying that he has an appointment. This is the first time that he has talked about the patient – explaining something which you would have had some sympathy with, that it was difficult to deal with him because if his behaviour in the clinic?
A Yes.

Q That was the point that you just made. It ends by saying that he – that is Professor Walker-Smith – had arranged for him to come in for colonoscopy on Sunday 1 December. Since it required no input from you, that was something that had been arranged, I imagine this letter went on a file, and you awaited development?
A Yes. I looked at the letter, and it was filed.

Q Then you did get a discharge letter from Dr Casson, which h we have looked at, at page 89, which is after the in-patient stay. It is quite a detailed letter and in its detail it may not have made a great deal of sense to you in terms you would not have attached very great significance to it, but it was quite detailed about the tests that they had carried out.
A Yes.

Q It concluded by saying, “Well, we do not really know how we are going to go forward” – on page 91.

“We will need to consider our findings at greater length when we review him in clinic.”

Then, in terms of the sequence, again that required nothing from you, it was clear that he was in the Royal Free system because they were going to see him in the outpatient clinic as well after that, according to Dr Casson. It looks from the records as though you had the telephone conversation with Dr Casson on 16 January, and that is the reference to the Mesalazine prescription?
A Yes, yes.

Q So in some form there was communication about a prescription for an anti-inflammatory. Then there was another letter, following the review in March, on 7 March 1997, from Professor Walker-Smith at page 80. This letter, Dr Shillam, is sharing with you his thoughts – do you have that, page 80?
A Yes, yes.

Q His thoughts about treatment, about trying treatment, although they had in fact already started treating him before this outpatient clinic appointment, by the look of the letter, had they not?
A Yes. He was having some medication.

Q You knew anyway, because you had spoken to Dr Casson about Mesalazine in January?
A Yes, yes.

Q This is reporting back to you on the thoughts of the Department of Paediatric Gastroenterology about one of your patients?
A Yes.

Q And presumably at the time, you thought they are obviously dealing with him carefully and thinking about ways in which they can make his life better, because that is what the letter is effectively trying to do, is it not?
A Yes, yes.

Q So having had one type of medication proposed, the medication changes. It ends up, as has been pointed out to you, saying:

“In relation to the research that is being done … I suggest that you or Mrs 5 should be directly in touch with Dr Andy Wakefield who is directing the research aspect of this study.”

This, and the question of treatment, prompted you to write, I think for the first time apart from your referral letter. You wrote back to Professor Walker-Smith, did you not?
A Umm….

Q Page 78.
A I think, again, I was reacting, or the reason for my letter on 10 April was at the parents’ request.

Q They say, “We do not want him to be left on this indefinitely without a review, so mother would like to have a follow-up appointment”.
A Yes.

Q Then you do take up the point about Dr Wakefield in the last paragraph.
A I do not know whether I am able to say this or not, but that comment in the last paragraph is the first time the word “research” had been mention in any contact with I had had.

Q What is that? The research aspects of the study?
A Yes. I had no knowledge or information about research in relation to any contact.

Q I think in fairness to you, you had used the word “study”, did you not, when you had written the referral letter?
A Can I just check that, please?

Q Yes. It is the second line. It is page 105 – I am sorry.
A Yes, fair enough: “current study”. Certainly I received no information from the Royal Free about research.

Q I think, just turn over one page, will you, to 106, and it may be it came from here. I do not know. If you look five lines up from the bottom of the page, the statement in parenthesis,

“Measles vaccine may be implicated but that is being researched and uncertain of implications”.

That is Dr Letham’s note. You talk about a “study”, but what Professor Walker-Smith was saying to you was that you would have to get in touch with Dr Wakefield directly because he is involved in the research aspect. These notes from Professor Walker-Smith are clearly dealing with the clinical aspect of treating the child, are they not?
A Yes. Certainly I was given no information about research in the letters which I received.

Q This was a clinical referral investigation with a view to treatment.
A Yes, that is what I understood. I was given no information about research at all.

Q Just taking it on, if you will – I appreciate you have done this already with Mr Thomas and I do not want to take too much time on it – it is just taking it to the end of your involvement. The page before, page 77, he says he would be delighted to see 5 again,

“Mrs [5] can telephone Dr Wakefield’s office to make an appointment”.

So he is obviously happy to see him as a clinician, and Mrs 5 can telephone to make an appointment with Dr Wakefield. That is what it is saying.
A That is what it says, yes.

Q Then page 75 or 76, is a letter that clearly follows a clinic appointment, is it not? It says, “Clinic 9/5/97”, and the letter is dated 14 May.
A Yes.

Q Again, this is follow-up as a result of what had been reported at the clinic, including in the middle of the main paragraph, in the middle of the letter,

“[5]’s pain is enormously improved from the last time I saw him when he was quite destructive and very difficult to examine”.

So as far as the Royal Free is concerned, you are certainly not cut adrift; you are kept up to date with what is happening over quite a long period of time. You can only talk up to the time when the child leaves your practice, but while you were still his general practitioner there was reporting back to you on each occasion he had an outpatient clinic appointment with the way in which the medication, at least, was going and its effects.
A This was on the gastroenterological aspects of it, obviously not on the behavioural.

Q Yes. You are getting a response from the Professor of Paediatric Gastroenterology.
A Yes, that is right.

Q Finally, can I ask you to look at page 73. This is a letter to you from Dr Brostofff, who is the metabolic clinician I think to whom you referred on the recommendation of Dr Richer.
A Yes.

Q It is clear from the next page, 74, that he knew that he had been to the Royal Free.
A Yes.

Q Because on page 74, the third paragraph, he says,

“The recent admission of [5] to the Royal Free Hospital under Dr Wakefield has shown yet another facet which is also being investigated in the USA. Gut behaviour is abnormal in these children and the Pentasa that he has been given has also had an interesting and beneficial effect. [5] has changed from being very pale to being quite pink as a result of a few weeks of this treatment. This suggests a further effect of gut flora on the behaviour of the patient as a whole.

I mention all these threads in the investigation of autistic children and if you agree, I will send a copy of this letter to Dr Wakefield so that we can co-ordinate the therapy”.

So that is another strand. He is reporting back from his point of view but makes observations about what had happened in the Royal Free.
A Yes.

Q I think at that point this child moved to a practice in Basingstoke because he was in care and it was necessary to have a GP who was local.
A Yes.

Q We have seen what happened in terms of your successor and the contact that was maintained. While you were involved, Dr Shillam, you were content with the efforts that had been put in by Professor Walker-Smith and his team to try and make this child’s life better, were you not?
A I think really my concern was the view of the parents, really, and if they were content then so was I, but I realised that it was a very difficult dynamic situation and there were certain times when they had to deal with the child at home by themselves because he had been excluded from school and anywhere else. So I am not sure contentment came into it on any score.

Q Either content or satisfied. You went along with the parents’ suggestion and from what you could see, the Royal Free Gastroenterological Unit was giving it their full attention and trying to do the best that they could.
A It was a clinical contact the same as any other clinical contact, I would suggest.

Q Which they were trying to treat.
A Most clinical contacts do.

Q As you have said, the parents were having – in your words – “awful difficulty” with the child.
A Yes.

Q That unfortunately was the position throughout most of the time from 1991 onwards when you had to deal with him.
A The child’s problems steadily worsened.

MR MILLER: Thank you, Dr Shillam.

MR HOPKINS: No questions.

Re-examined by MR THOMAS

MR THOMAS: I just have a few short matters, Dr Shillam. You were asked by Mr Coonan about the possibility of having a face to face meeting with Child 5’s parents. I want to take you to one part of the GP record in that connection. If you look at page 17, to the note that you made on 30 September 1996, just before the first written word there, there is a dash. What does that dash signify?
A In my notes it means there was not a consultation made. It was a note made about something which I was doing, but it was not as a result of a consultation.

Q Can I now take you to page 105, the referral letter in connection with the answers that you gave to Mr Miller in relation to the information that you had at your disposal when you made the referral. In answer to a question from me earlier, you indicated that your clinical note on 30 September was more or less an exact transcription of the note from Dr Letham.
A Yes.

Q Can you recall any other information which you had at that time in relation to what was going to happen at the Royal Free other than that which is contained in the note at page 106?
A I cannot recall anything except my notes, and I certainly would have had no information about what would happen at the Royal Free.

Q Lastly, you were asked by Mr Miller to comment on a letter at pages 73 and 74 of the GP records, a letter from Dr Brostofff the immunologist to you in June 1997. On page 2 of that letter, third paragraph from the end, it says,

“The recent admission of [5] to the Royal Free Hospital under Dr Wakefield has shown yet another facet”.

Then it says,

“I mention all these threads in the investigation of autistic children and if you agree, I will send a copy of this letter to Dr Wakefield so that we can co-ordinate the therapy. My view would be that Nystatin is generally useful in these children and is unlikely to conflict with Pentasa. I will however ask Dr Wakefield for his opinion.

I am sure that he should have nutritional supplements and again I will discuss this with Dr Wakefield. I am sure that he will be in agreement”.

Can you recall whether you in fact did agree for this letter to be copied to Dr Wakefield?
A Again, I cannot specifically recall 4 June or 10 June 1997, but if I had objected or not objected to it being sent to Dr Wakefield, that would be in the records because it would have been a letter, and there is no record that I wrote a letter.

Q Can you think of any reason why you might have objected to Dr Wakefield being copied in on this correspondence?
A I cannot imagine there being a reason why at that time I would have objected at all. The name and the details would have had no specific significance for me at the time.

Q Could you tell us whether you would have regarded this request for Dr Brostofff to discuss the position with Dr Wakefield as giving rise to any particularly unusual issue or point?

MR COONAN: I am not sure how this arises out of cross-examination.

MR THOMAS: It arises out of questions Mr Miller asked this witness because Mr Miller took Dr Shillam particularly to this paragraph in the letter and it is the first time that this letter has been referred to, and he took him to the very two paragraphs that I am now asking Dr Shillam about. Those two paragraphs say that Dr Brostofff proposes to discuss the case with Dr Wakefield if Dr Shillam agrees, so it is plainly an issue which it is proper to ask this doctor about, and which arises out of Mr Miller’s questions.

MR COONAN: That is to misunderstand the point. Mr Miller may have taken him to the two paragraphs, but he did not ask him about the material within the paragraphs. It is a bit difficult to see how now it gives my learned friend full range to speculate about the basis on which these were written, and wholly different.

MR THOMAS: I am afraid Mr Coonan is quite wrong about that. He not only referred to the contents of this paragraph, but he took him to the contents of this paragraph specifically in connection with a suggestion from Mr Miller that this was part and parcel of clinical follow-up from the Royal Free. That was precisely the purpose of my asking this witness to clarify the extent to which he thought that was unusual or the extent to which he would have objected to it at the time. So it is not the case that this was simply a fleeting reference. This was in fact the only substantial part of this letter that Mr Miller asked him questions about and it was precisely in connection with the subject matter I am addressing.

THE CHAIRMAN: Legal Assessor?

THE LEGAL ASSESSOR: My point is that Mr Thomas is correct. There were questions on the correspondence on this paragraph about that, and he is entitled to ask these questions by way of re-examination, because it arises out of issues that were put to this witness on this correspondence in cross-examination.

MR MILLER: I have not risen to object, but may I make this one point. I think it is difficult for this witness to speculate about what the author of the letter said. He is entitled to say what he himself understood from the letter, but as to what might have been in the mind of Dr Brostofff, that is very difficult.

THE LEGAL ASSESSOR: I advise you that that is correct, but I thought what was being asked was the reference to whether or not he might have had any objection to one doctor consulting the other. He can answer that question, as to what his objection may have been if he had one.

MR COONAN: If that is limited in that way, I have no objection. But he has answered that question.

MR THOMAS: In connection with this paragraph, you were asked by Dr Brostofff, and he says,

“If you agree I will send a copy of this letter”.

I asked you whether you would have had any particular objections to that course of action?
A As a GP I would very rarely question one consultant’s referral to another consultant. As a GP I would take the advice of consultants and very rarely ever criticised or questioned them.

Q Did you have any difficulty with the idea that Dr Brostofff would be discussing and co-ordinating the therapy, from your point of view?
A I do not think I was aware that Dr Brostofff would be co-ordinating therapy because at that stage, in fact, Dr Richer was more involved and had been involved in therapy for some time.

Q If you look at the second line of the paragraph,

“I will send a copy of this letter to Dr Wakefield so that we can co-ordinate the therapy”.

If he was intending by that to send a copy of the letter to Dr Wakefield and discuss the issues with Dr Wakefield and ask for his opinion, as he says in that paragraph, is that a course of action with which you would have had any difficulty?
A Again, as a GP my basic presumption is that the consultants who the child has seen are acting in the best interests of the child and using their specialist knowledge. So I would have no reason as a GP to object.

MR THOMAS: Thank you very much.

Questioned by THE PANEL

THE CHAIRMAN: Dr Shillam, there is now an opportunity for the Panel members to ask questions.

DR WEBSTER: Did you have any concerns or regrets over the management of Child 5 by the Royal Free Hospital?
A No, I do not think so because quite honestly the wider issues of the child’s behaviour were more important. The letters from the Royal Free and their treatment had focused particularly on the child’s bowel problems. All right, the child was smearing faeces on the wall, but the child’s behaviour problems from my point of view, and I think from the parents’ point of view, were actually more important. Therefore I would have been far more concerned as to whether the child’s behaviour problems were getting adequate treatment than his bowel problems.

Q With regard to the information you were getting from the Royal Free, did you feel that you knew enough to actually manage the child on a day to day basis?
A I do not think I would profess to have any knowledge of the bowel pathology or problems they were hypothesising. I was merely doing what they asked me to do and responding to the parents as well as I could. I could not have claimed to have knowledge about what the Royal Free was proposing or hypothesising.

Q But you felt involved.
A I did what I was asked to do, frankly.

MS GOLDING: Could you tell me, what was the Nystatin prescribed for?
A The Nystatin, as far as I understand, was prescribed on the hypothesis that reducing Candida within the bowel, that may have some advantage in behaviour or bowel. That is a hypothesis which, as far as I am aware, is not proven, but that was the basis of giving it.

Q Were you aware that this child had persistent diarrhoea?
A When the parents talked to me about the child’s problems, they talked to me about his behaviour problems. If they mentioned diarrhoea, that was as a secondary issue.

Q Would the Nystatin be treating diarrhoea?
A Not as far as I am aware.

Q The letter on page 105, the last paragraph says his parents were concerned about an association they had read in the Daily Mail between MMR vaccine, childhood enteritis and possible brain damage. You said you did not speak to the parents about this. How would you have got the Daily Mail reference?
A I think what I was trying to say was that they had not spoken to me about their specific actions with regard to possible litigation or whatever about MMR, or concerns about MMR, but I think in consultation – again I cannot remember the specific time but I think that would explain why I wrote that sentence.

Q But it is quite specific, the Daily Mail reference?
A Yes, I agree with you.

Q Who do you think you got that from?
A I could have only got it from … I mean, the Daily Mail article was being talked about by a number of people around that time, but that reference would be from either the mother or father regarding this child.

Q You said that you had not any knowledge about Dr Wakefield and this study before?
A No.

MS GOLDING: I think that is it. Thank you.

THE CHAIRMAN: I have got a couple of questions for you, Dr Shillam. I think you have answered the Daily Mail question that I was going to ask you. Can I just tell you that my own background is as a general practitioner, so I come from a very similar background and the understanding that you are coming from, and I think it will become quite clear. This extra contractual referral that has been talked about: what was your understanding about it?
A I think extra contractual referrals were a bit of bureaucracy that, like a number of other things, GPs try and deal with.

Q Can you just keep your voice level a little bit up?
A An ECR at that time was almost certainly a piece of bureaucracy which GPs had to be aware of, but it was really dealt with by other people in general practice management, so we would … Our only real contact with ECR would be to write to the administrator who deals with ECRs at the FHSA for them to agree to the referral, and that would be all we would do.

Q I think in the late nineties they were health authorities rather than FHSAs.
A Whatever they were, we would just write to them.

Q But it was still the GPs responsibility to make sure that the referral is appropriate?
A Yes.

Q The GP had to make that referral to the management?
A Yes, absolutely.

Q And it was up to them whether to approve or not to approve?
A Yes.

Q First of all, on page 105, your referral letter, there is a reference and I think it says:

“Confirmed with Sharon Stone”,

and I know you have said that it is not your handwriting?
A No, no.

Q Would you know whether it is somebody in the practice?
A I really do not know. All I can say of course is that the letter I wrote to Dr Brostoff a few days previous to that, I say that an ECR is possible. I presume, again a presumption, that that is why I did not put that on the bottom of this letter, because presumably it will apply to both.

Q Obviously, I think in that health authority it was Sharon Stone who was probably the responsible officer in the health authority?
A More than likely.

Q It says that the contract is already in place and therefore, obviously, that you do not need the extra contractual referral. But then looking in the Royal Free Hospital records on page 453, somebody has half circled this “ECR”?
A Yes.

Q Do you know whether it is yourself?
A No, no. This is from the Royal Free and the Hampstead.

Q Sorry, yes. That is right.
A That is not me.

Q But you are not the one who has given them that information that this is an extra contractual referral?
A No.

Q Because as far as we can see from the other documents, there was already a contract with that ---?
A That would be the presumption from the health authority, yes.

Q Just give me one second to have a quick look. (After a pause) I think you have told us in your evidence that you were not given any idea of the research at all?
A Yes, That is correct.

Q When was the first time that you actually understood that there was a research element to this referral?
A I know it could be said that the letter or the note from my partner Dr Letham does mention study, but that did not necessarily mean to me that the child was being submitted into a research project. So probably one of these later letters from Professor Walker-Smith that we just discussed where the word “research” was actually mentioned on the end paragraph. I might not be able to find it, but I was not aware that this was research for most of this time.

Q Why I am asking you this question again here is that, of course, it is in your referral letter on 1 October that you have referred to, that you have mentioned:

“… regarding your current study into association between autism and childhood bowel problems.”

That is a research element, is it not? It does not only say “study”, it actually gives the details of that study, and the objectives?
A That really is quoting what my partner Dr Letham wrote on his note to me as a result of the phone call that was made. I was really just passing on the information I was given. You could say perhaps I should have been more critical and asked what that referral was achieving, but rightly or wrongly I passed over the information I was given.

Q I am not trying to criticise you.
A No.

Q I would have probably done exactly the same as you did, so please do not misunderstand me from that point of view. I am just going into the details of your understanding?
A What I am saying is that phraseology and those words – those words, let us face it – come from my partner’s note to me which was made as a result of the telephone call that was made to him.

Q Then looking at the other document that is on page 106, this document you have said was in front of you when you made that referral because you actually said that it is almost verbatim to what you put on page 17 in your medical records.
A Yes.

Q That document says, “Anyway – see FAX”?
A Yes.

Q I know that you have said that you do not remember the contents of the fax or you do not remember a fax at all?
A Neither myself nor Dr Letham – and we have obviously discussed this – have any recollection or knowledge of a fax. Literally a fax might not have been received, a fax might have gone astray, a fax might have gone inadvertently from the fax machine to the bin, we do not know. All we know is we have no recollection of a fax.

Q But it does not actually say that. It says, “Anyway – see FAX”.
A Exactly.

Q So it seems that it was probably enclosed, but it may have gone astray by the time that note reached you, but you do not remember asking Dr Letham any question about it: “You have put it on your note and I’m making this referral. What is on that fax”?
A No, not according to my memory.

Q My last point is I think you were asked a question about nystatin, the prescription.
A Yes.

Q Look at page 115, the first sentence. What it says is:

“In the past oral and anal thrush ...”

A Yes.

Q So that was probably the indication for nystatin, the prescription, was it not?
A I would need to just check my general practice records, but I am not sure that there was ever actually a clinical diagnosis of oral or anal thrush.

Q Do you want to have a look?
A Yes. That was not the explanation that was given for the reason for prescribing. It was to do with changing gut flora.

Q You did actually issue the prescriptions?
A Yes.

Q So at that time at least you would have taken that advice and thought that it was an appropriate prescription to be given? At least at that time?
A Yes, there were a number of times when we give prescriptions at people’s requests, even when there is no hard evidence that those prescriptions are effective.

Q Only if you think that they are going to be good for the patient?
A In this case the nystatin was being prescribed at the request of the specialist, and again I would see no reason to go against that request.

Q Again, on the basis of these papers it seems that at some stage there would have been a past history or oral and anal thrush?
A No, I do not think so.

Q That is what the document says. I am going from the document.
A Yes. As the child’s GP ---

Q But you did not question that?
A I do not think I am going to question specific sentences in a consultant’s description or letter, but I am going to also be aware of whether I have myself, as the child’s GP, seen the child with oral or anal thrush, and I am not aware I did say … According to my notes I did not. I am not going to write to him and say, “I dispute the paragraph, the first sentence in paragraph 4.” That is not what I normally do, but he is entitled to his opinion but I am also entitled to my clinical notes.

Q Could any other partner? It is not in the records, but obviously that history has come from somewhere to the consultant because the consultant Dr Richer would not have written that without getting that information from somewhere?
A Certainly as far as I am aware – and in our practice we call keep contemporaneous notes and therefore if there is a note about peri anal or oral thrush then that is obviously important. If there is not, then I can see no reason for assuming that the child would have been seen and notes were not written.

THE CHAIRMAN: Thank you. I do not have any more questions. I am again looking at the Panel members. (No further Panel questions) Are there any questions, Mr Thomas?

MR THOMAS: No, nothing arising from that.

THE CHAIRMAN: Mr Coonan?

MR COONAN: No, not for the moment.

THE CHAIRMAN: Mr Miller?

MR MILLER: Sir, it is not strictly a question. In view of Mr Thomas’s re-examination about the correspondence with Dr Brostofff, can I invite the Panel just to note a reference in the Royal Free Hospital notes, otherwise we will forget about it. The Brostofff letter is at page 320 in the Royal Free notes and Professor Walker-Smith’s reply to it is at page 319.

THE CHAIRMAN: Thank you, I think that is very helpful. I take it, Mr Thomas, that you are happy with those references?

MR THOMAS: Yes, indeed.

THE CHAIRMAN: Thank you. There are no other questions?

MR MILLER: No.

THE CHAIRMAN: Mr Hopkins?

MR HOPKINS: No.

THE CHAIRMAN: Dr Shillam, you will be pleased to know your evidence has come to an end and therefore you are now released. Can I thank you once again on behalf of this Panel for giving us this morning and this afternoon. Thank you.

THE WITNESS: Thank you very much.

(The witness withdrew)

MS SMITH: Sir, I do not have any more witnesses for this afternoon, but I wonder whether, if you were going to have a break, I could invite you to take it now in order to give me a few minutes conversation with both those instructing me and with the defence about the timetable of witnesses over the next couple of days, because there are some rather hard decisions to make. Then I can perhaps report back to you on that. I am sorry to have run out this afternoon, but you will appreciate that it is impossible to predict to the moment how long these witnesses are going to take.

THE CHAIRMAN: That is absolutely fine. We have no problem with that. I can understand, and I think there are practical difficulties for you to get those witnesses on the days that you need to.

MS SMITH: Yes.

THE CHAIRMAN: Can I actually suggest that we will adjourn now and maybe you can send us a message. We do not really need to reconvene for this. Maybe you can send us a message and we will be in the next room. If necessary, we will be very happy to come back.

MS SMITH: Thank you, sir. It might be necessary for you to do so, but certainly I will not drag you back in just for the sake of it.

THE CHAIRMAN: If necessary do not hesitate, we will be there. Either pass on a message or ask that you would like to see us and we will be very happy to return.

MS SMITH: Thank you very much indeed.

THE CHAIRMAN: We will now adjourn.

(The Panel adjourned until 9.30 a.m. on Tuesday, 31 July 2007)

No comments:

Post a Comment