GENERAL MEDICAL COUNCIL
FITNESS TO PRACTISE PANEL (MISCONDUCT)
Thursday 9 August 2007
Regents Place, 350 Euston Road, London NW1 3JN
Chairman: Dr Surendra Kumar, MB BS FRCGP
Panel Members: Mrs Sylvia Dean
Ms Wendy Golding
Dr Parimala Moodley
Dr Stephen Webster
Legal Assessor: Mr Nigel Seed QC
WAKEFIELD, Dr Andrew Jeremy
WALKER-SMITH, Professor John Angus
MURCH, Professor Simon Harry
(Transcript of the shorthand notes of T. A. Reed & Co.
Tel No: 01992 465900)
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
MARTIN THOMAS ELSE, Sworn
Examined by MS SMITH 1
Cross-examined by MR COONAN 17
Cross-examined by MR MILLER 24
Re-examined by MS SMITH 27
Further cross-examined by MR MILLER 29
Questioned by THE PANEL 29
Further re-examined by MS SMITH 33
Further cross-examined by MR MILLER 33
DAVID JONES (Statement read) 35
ANDREW FREDERICK MILLS, affirmed
Examined by MS SMITH 37
THE CHAIRMAN: Good morning. I apologise for a few minutes delay. One of our Panel members was stuck on the Underground. I believe there are some delays. My apologies to all of you. Ms Smith, I think you were going to introduce the new witness this morning.
MS SMITH: I am going to call Mr Else.
MARTIN THOMAS ELSE, sworn
Examined by MS SMITH
(Following introductions by the Chairman)
Q Mr Else, could, you give us your full name and address please.
A Martin Thomas Else and my work address is Royal College of Physicians, 11 St Henry’s Place.
Q I think it is right that that is your work address because you are now the Chief Executive of the Royal College of Physicians.
A I am.
Q You have occupied that post since October 2005?
A That is correct.
Q Prior to that, you were a Policy Adviser with the NHS Trust Unit at the Department of Health?
A I was.
Q Prior to that, which is the period with which we are concerned from July 1994 to May 2005, were you the Chief Executive of the Royal Hampstead NHS Trust?
A The Royal Free Hampstead NHS Trust, yes, I was.
Q I think it is right that you supplied to the General Medical Council a number of documents from your files from that period at the Royal Free Hospital?
A I did, yes.
Q When I say from “your” files are they the separate files of the Chief Executive as opposed, for instance, the Dean’s office or any other department?
A The documents that I have seen that have been provided are from various sources but were put together largely from my office at the time.
Q It is those documents I want to ask you about. First, I want to underline matters which we have dealt with passing before, but so we are clear about them I would like to ask you about the various institutions and terminology relating to them. The Trust is a statutory body established under the National Health Service legislation, is that correct?
A That is correct.
Q As far as the Royal Free School of Medicine in 1996, was that a separate body?
A That was a separate body.
Q Is that now part of University College, London?
A It is, yes.
Q But at the time was it an independent school of medicine.
A It was an independent school of medicine, yes.
Q As far as you are concerned, just to underline it, you were the Chief Executive of the NHS Trust, in other words, the hospital rather than connected with the school of medicine?
A Yes, I was the Chief Executive of the Trust.
Q We have heard mention in this case already of the Special Trustees of the Royal Free Hospital. Could you explain exactly who and what they were?
A The Special Trustees are the body, or a body that was established for the major teaching hospitals, largely to manage the charitable and endowment funds associated with teaching hospitals. They were separate from the Trust and, because of the scale of charitable monies and other endowment monies associated with teaching hospitals, it was always thought appropriate that there should be a trustee body to manage those funds separate from the day to day running of the NHS funded NHS Trust.
Q You say they were separate, but were they affiliated to the Trust rather than to the medical school?
A Yes, to the Trust not the medical school.
Q Any research funds related to the medical schools were not administered by the Special Trustees?
A That is right. The medical school would have had its own research funds and own research administration.
Q Carrying with your post as Chief Executive, did you occupy a position in relation to the Special Trustees?
A Yes, I was also the Honorary Secretary and Treasurer to the Special Trustees for the period we are talking about.
Q Were the Special Trustees governed by a set of regulations which permitted them to take certain action?
A Yes, I forget the exact regulations now, but I think it went back to 1970, sorry 1990 I think it was. It was changed in 1990.
Q In broad terms, which is all we are concerned with at this stage, what did they permit the Special Trustees to do in relation to particular sums of money?
A Manage endowment funds, charitable monies, oversaw various disbursements of those funds and that included research.
Q How did you maintain records of the money that was being administered by the Special Trustees?
A There was an accounting system and a reporting system based on individual accounts for particular purposes. The records were amalgamated for annual accounting purposes and these were a pre determined format set by the Department of Health and had to be submitted in the usual way. They would be audited both internally and externally.
Q As far as the sums of money, in broad terms – we will drill down into the detail in a short while – the sums of money that were administered by the Special Trustees, were they necessarily linked to specific research projects or might they be general research founds as well?
A There were two types of expenditures, either coming from general funds, which were monies given for non specific purposes, and then there were special funds which were tied to specific purposes.
Q You used “purposes” in both those phrases, both general purposes and specific purposes. Can you tell us what sort of purposes, what are we talking about?
A General funds by their very nature were restricted and could be used for buildings, could be used for staff, could be used for expenditures that fell within the remit of the Trustees. Special purposes were those that were restricted in some way and had to be used in a way predetermined, defined, in a particular way. A large proportion of that were within accounts which were for, usually, held by individual clinicians and those accounts were specified as to what their use was for.
Q What were the uses, in general terms, that a clinician would hold an individual account for?
A Usually, quite often, for research purposes.
Q As far as the accounts, you told us that a ledger was maintained and with regard to the financial records for this period I think many of the records are non existent or strictly limited. I would like you to turn to bundle FTP3 to page 1139.
A Yes, I have that.
Q This is a memo that has been prepared by the Head of Information Systems for the Director of Finance. I do not propose to read through the whole of it because it is simply setting out how the technology relating to the computer system used at the Royal Free changed over a period of time and, as it changed, records were stored and ultimately deleted. If we can go to the last paragraph:
“The endpoint of these actions is the position today whereby the earliest data of Trustees’ financial records available is 1 April 1998.”
A That is correct.
Q Is that your understanding?
A That is my understanding, yes.
Q In practice, Mr Else, the Special Trustees, when they are dealing with specific projects, does the individual researcher hold a separate account. You have told us there are general accounts and, in addition to that, there are separate individual accounts, are they identified by a researcher or a project?
A They are allocated to an individual researcher. Sometimes they can cover more than one project but, generally speaking, it deals with one project.
Q Did Dr Wakefield have such an account with the Special Trustees?
A He did, yes.
Q If you look at FTP1, page 43, we can see this is a suggest letter from the Special Trustees on 13 January 1994. We see that it is entitled “Grant 106”. It says:
“I confirm that all funds held in the above grant have been vested with the Special Trustees of the Royal Free Hospital and will be used for the benefit of the histopathology/inflammatory bowel disease study group. The Account Name will be called Inflammatory Bowel Disease Study Group and it will be used for the following purposes.”
We then see a tick by the purchase of equipment and materials, books and journals; a tick by courses, examination and conference fees including travelling and expenses; and a tick by salary expenses.
Is that correct?
A That is correct.
Q It has two authorised signatories signed by Dr Wakefield and a second one who is nominated but has not signed it. It appears to be Professor Dhillon?
A That is correct, yes.
Q Is that in a standard form indicating a particular account for a particular department?
A That was the standard form at the time.
Q It says “Grant No 106”, were they referred to by the initial “G”?
A G 106, yes.
Q I want to revert for the moment to the various institutions. We have already heard from Dr Pegg, who was Chairman of the ethics committee at the time. That was the Camden and Islington Health Authority, is that correct?
A That is correct.
Q Were you ever a member of that committee?
Q We have also been told that Dr Wakefield was employed by the medical school as a senior lecturer and later a reader, did the Trust ever at any time employ him other than with an honorary contract?
A No, it never employed him.
Q Did there come a time when you were aware of a particular research project that Dr Wakefield was involved with which entailed a syndrome of enteritis and disintegrative disorder following measles/rubella vaccination?
A Yes, it did in 1996.
Q I was going to say, can you tell us roughly when you became aware of it.
A I cannot remember the exact month, but it was about July or so, it might have been slightly later in 1996.
Q Can you recall how you became aware of it?
A I was advised of it by Professor Walker Smith and by Dr Wakefield.
Q Did you from the time, when an ethics committee application was made in relation to that particular study, automatically receive copies of the paper work submitted to the ethics committee?
A Not personally, not directly, no. I did ask for the documentation.
Q Would that be a normal thing to do as a study progressed for the Chief Executive to be asking for the ethics committee’s documentation?
A If we were involved – for me personally I would not have seen all the documentation, if that is the question. I would not have seen all ethics committee submissions, but I did see this one because there had been discussion about it specifically and, particularly, in relation to whether there would be any financial support for it.
Q I would like you to turn to a letter from yourself to Dr Wakefield in volume 1 at page 192. That was a letter that you wrote in September 1996?
Q It says:
“Dear Dr Wakefield
A New Syndrome: Enteritis and Disintegrative Disorder following Measles and Mumps/Rubella Vaccination
I am writing to confirm that the Special Trustees will fund the salary of Ms Rosslyn Sim to support the above project for a period of two years. I understand that children who would fall within the scope of the project are currently being seen at the Royal Free as part of the normal process for the delivery of health care and that tests, investigations and procedures that are clinically indicated are being undertaken. No tests, investigations or procedures will be undertaken that are not clinically indicated but which do form part of the research study protocol, until approval for the study has been received from the Ethical Practices Sub Committee. The Special Trustees will wish to see evidence of this approval within the very near future. I would therefore be grateful if you would kindly forward me a copy of the Committee’s approval as soon as this has been received.
Please could you liaise with the Human Resources Directorate to ensure that the necessary personnel documentation is completed.”
Is that personnel documentation relating to Ms Sim?
Q And the letter is signed by you and it is copied to Professor Walker Smith. Now you have already told us you were informed of this proposed study by Dr Wakefield and Professor Walker Smith.
Q When you say “informed”, do you mean orally informed?
A Orally, yes.
Q By them together or separately, do you recall?
A I think it was separately but I cannot be absolutely sure.
Q And can you explain to us why it was you wrote that letter to Dr Wakefield rather than to Professor Walker Smith and copied it into Professor Walker Smith?
A It was presented to me that Dr Wakefield was the lead, effectively, in the project.
Q Now, you have at the top a title which is plainly the specific title of the study. Where would you have got that title from?
A From the description, presumably, of the ethics committee submission that was going to go forward later.
Q And you have given in that letter a broad account of your understanding of the fact that there were going to be investigations which were clinically indicated and you have expressly said “no investigations which were not clinically indicated but which were part of the research study could be done without approval from the ethics committee”. Again, where did you get that understanding of what you have set out there was to happen?
A I got that understanding from discussion with Dr Wakefield, and I think Professor Walker Smith, that the study was intended to be entirely based on investigations that were required or clinically indicated. So I was responding to that and saying that that was my understanding of the nature of the research project. We may go on to it later but that was my continuing understanding, that that was clinically indicated, tests were going to be undertaken as part of the research project.
Q On the point that you have raised which is set out, that if anything was being done which was not clinically indicated you needed to know about the ethics committee approval, was there any particular reason, Mr Else, for you asking for that particular information, or would that be the standard sort of request you would be making before a study started?
A I think from my point of view this was a fairly standard statement, to say: Well, the project as presented was that it was going to be based on clinically indicated tests, and if it was going to change from that then I needed to know about that.
Q And what was your understanding of how Ms Sim was involved? You said “to support the above project”. What was your understanding of what she was going to do?
A I understood she was a laboratory technician and that she would be collecting samples and presumably managing the data that was going to be necessary to support the project.
Q Say if you do not recall, please, but did you understand her to be playing a major role?
A I understood her to be a significant player in the process in terms of collecting data. That was my understanding at the time.
Q And remembering we have a lay Panel so if you could explain it clearly, why would the Special Trustees be being asked to fund her salary? How does that come about as a situation?
A Because the research project needs financial support, one of the trustees’ objects is to support research activity and, therefore, it is potentially one of the sources of funding that could be approached in order to support research, and that is what happened in this case.
Q And was supporting her salary, as far as you were concerned, a perfectly proper purpose for the Special Trustees to be taking on?
A I identified it as one of the areas that was an additional cost that I thought was a legitimate additional cost to the production of the research and, therefore, a legitimate charge to the trustees, if it was deemed to be appropriate research.
Q And did Dr Wakefield mention to you any other source of funding at this stage, in September 1996, in relation to this research project?
A I do not recall any other reference.
Q You say that you understood that clinically indicated tests and investigations and procedures were being done and that they were clinically indicated. Was it your understanding that you were going to have any involvement in the funding of those clinically indicated tests? I mean any involvement via the Special Trustees?
Q And would that be the norm, that for clinically indicated tests the Special Trustees would not have an involvement?
A If they were clinically indicated tests, in other words, that patients would be treated in this way in any event, then they would be being seen at the hospital on the basis of NHS funding and they would be receiving treatment under the NHS banner and, therefore, be supported through NHS funding streams.
Q And as far as the issue relating to ethical approval, was it possible for the Special Trustees to be involved in the funding of research if that research did not have final ethical approval?
A No. All research projects require ethical approval and, therefore, the trustees would not get involved and neither would any other source within the hospital get involved if it had not had proper ethical approval.
Q Now, I have asked you, Mr Else, whether there was any other source of funding mentioned to you. Did you at that stage understand this to be an ordinary research project, or was there anything unusual about it to your knowledge?
A Only unusual in the sense that I know there had been some discussion about proceeding with the research, but I was not aware of anything else significant.
Q When you say discussion about proceeding with it, what do you mean by that?
A I mean in the sense that the fact that researchers had come to see me and I knew it was a medical school project and so on. Just coming to see me directly and so on was not necessarily something that happened all the time.
Q If we can look, please, at page 1137 in FTP3, this is a memo from Mr Phipps, and we will be hearing a written statement from him read out later, but he is the assistant director of finance, is that correct?
A That is correct.
Q And if we can just read through what this has to say about Ms Sim’s salary,
“As you know, the Special Trustees agreed to fund the salary of Rosalind Sim for two years for work on the above project. This was confirmed in the letter from Mr Else to Dr Wakefield dated 4 September 1996 in which Ms Sim’s first name was misspelled”
and that is the letter I have just taken you to.
“For that two year period, Ms Sim’s salary costs were therefore charged directly to the Trustees’ own unrestricted or general funds and not to Dr Wakefield’s fund number 106.
This arrangement ensured that control of the expenditure remained with the Trustees and not with Dr Wakefield who was not in a position to incur any costs on behalf of the Trustees other than the salary. The Ledger Listings for fund number 106 in Dr Wakefield’s delegated authority previously supplied contain references to the cost of Ms Sim’s salary for the period when those costs were a charge to that fund. The first monthly charge appears on the Ledger Listings for 1998/99” - and it gives the code number and the amount - “The brief narrative on that line includes the self explanatory description ’NOV 98 SAL: SIM’. Prior to this date was the two year period of the Trustees’ funded project and for most of that time Ledger Listings are not now available for the reasons discussed” - and we have already been to that - “however, they are available for the period April 1998 onwards. Therefore it is possible to demonstrate that Ms Sim’s salary was a charge to the Trustees’ unrestricted, or general funds for that time and I have attached a print of the relevant Ledger Listing for that purpose.
The salary costs for each of the months of April to October 1998 are shown under the coded heading” - and then it gives a number - “which is notated ‘Research General’. I hope this is helpful in explaining the source of funds for Ms Sim’s salary for this particular time of her employment.”
So what that indicates, Mr Else, is that for the two years referred to in the letter from 1996 98 Ms Sim’s salary was indeed, as envisaged by you, paid ultimately by the Special Trustees but it says that the cost was charged to the Special Trustees’ general funds and not to Dr Wakefield’s own G106 account. Is that correct?
A That is correct. The reason for being clear about this is that occasionally it is mentioned that funding came from 106, or came from Dr Wakefield’s account. Actually it did not go through that account directly; it went from the general funds account to pay for the salary, and did not pass through 106. There was an alternative mechanism; you could have paid 106 which in turn would have reimbursed the salary, but that was not the mechanism used in this case. It was directly from general funds.
Q Now, we will look at the ledger in a moment but can you just tell us how this mechanism would have worked? If the Special Trustees were going to pay the salary from their general account, how would the salary actually have been paid to Ms Sim? Would it have been paid direct from the Special Trustees or by the Trust and then the Special Trustees reimbursed?
A It would have been paid by the Trust and then reimbursed by the Special Trustees.
Q That is the standard procedure, is it?
A That is the standard procedure. The trustees did not directly employ anybody. If there were salaries involved and supporting salaries from the trustees then it would be on a reimbursement basis, not by direct employment.
Q And you have explained to us what the Special Trustees’ general funds were. Now, if we look at the next page, 1138, this is the actual ledger that was attached by Mr Phipps when he did that memo?
Q And we can see at the top, can we, the very top, “30 April 1998”, and we see underneath that, “Research General”, and then “SAL: SIMS”. Is that correct?
A That is correct.
Q And we can see all the way down to October 1998 in the same way. Each month there is an entry, “Research General, SAL: SIM”?
A That is correct.
Q So that takes us up to October 1998 and I now want to look at the position after October 1998, and if you go in volume 3 to 1120, this is the ledger not for the general funds but for account G106, and we can see that because if you look down the left hand column it says “Account Wildcard”, and then it gives the number “106”. Is that correct?
A That is right.
Q And if we look at page 1124 we can pick up the “SAL: SIM, 30 November 1998”, and now it has changed from Research General to Research Special, and we still have the SAL: SIM, is that correct?
A That is correct.
Q Now this ledger, of course, starts at an earlier point. I took you straight to 1124 so we can see Ms Sim’s salary from November 1998, but if we go back to page 1122, we can see “April 1998” at the top of the page, and the research travel expenses which was one of the provisions for G106, is that correct?
A That is right.
Q On the face of the records would it appear that Ms Sim’s salary was paid as the Special Trustees had agreed to do?
A Yes. I had agreed for two years’ payment from general funds and that is what happened, and then it reverted to 106 at the end of that period.
Q Ultimately in May 1997 did Dr Wakefield write requesting approval to receive another source of money into his Special Trustees account? Perhaps I can take you to the letter.
A That would be helpful.
Q Yes, I am sorry. It is on page 471, volume 2.
A Yes, I have that. It is not to me; it is actually to Mr Phipps.
Q Yes, the assistant finance director, is that correct?
Q If we can just read through that letter, this is May 1997:
“Dear Mr Phipps,
My group, the Inflammatory Bowel Disease Study Group, is currently involved in the investigation of a cohort of children with regressive autism and inflammatory bowel disease. The study is being undertaken in collaboration with Professor John Walker Smith in the Department Paediatric Gastroenterology. The study has provided some ground breaking insights into the mechanisms of autistic spectrum disorders, and in particular the role of intestinal inflammation in this condition.
Children for this investigation have been recruited as ECRs from all over the country and indeed as private patients from the United States of America. In order to initiate the study, Martin Else and the Special Trustees of the Royal Free Hampstead NHS Trust were kind enough to set up an account to fund Ms Rosalind Sim as the technician to process the samples taken from children. This has proved to be most successful and will continue to be a major source of revenue for the Trust itself. In addition, we have been awarded a grant of some £50,000 by the Legal Aid Board to investigate the possible association of this syndrome with the MMR vaccine. This money has been provided through Dawbarns Solicitors (see enclosed documentation) for the express purpose of performing the study outlined in the enclosed protocol. This protocol, as you will see, has been approved and passed by the Ethics Committee of the Trust. The cheque for the first instalment of this grant was initially paid into the Medical School, but queries have been raised by The Dean, since this source of funding has never been obtained before. I have discussed this with both Professor Pounder and Cenghiz Tarhan and we are agreed that the money would be more appropriately located in the account currently held to pay for Ms Sim, since this account pays the existing expenses of the same study (ie salary).
I should add that conduct of this study and the discoveries we have made have elevated the Royal Free Hospital to great heights in the world of autism research. The clinical profile that it has provided has greatly benefited the trust. We are receiving referrals on a daily basis and the funding provided by the Trustees will continue to help us investigate these patients appropriately. The study itself, although commissioned by the Legal Aid Board, seeks only to establish the validity of the parents’ claims of an association with MMR or not, and not to provide a specific answer, that is that vaccine was the cause. This is the condition upon which we undertook to do the study and the Legal Aid Board have agreed to it. I would be very grateful if you could indicate your willingness to receive these funds. At present they are held by Cenghiz Tarhan who is happy to transfer the funds once he receives your approval.
If there are any queries, please do not hesitate to contact me.”
and a copy was sent to Mr Tarhan. Can you tell us who Mr Tarhan was, Mr Else?
A I think his title was finance officer for the medical school at the time.
Q And it is signed from Dr Wakefield, and there was documentation enclosed with that letter, and I think it is right that that documentation is not any longer available?
A That is correct.
Q Were you, in fact, asked to deal with this issue?
A Mr Phipps brought it to my attention, and so I was aware of the letter.
Q Dr Wakefield refers to the fact that queries had been raised by the Dean since this source of funding has never been obtained before. Other than that reference by Dr Wakefield, were you aware of any disquiet being expressed by the Dean?
A I cannot remember the exact date but, by the spring of 1997, then I was aware that there had been discussion about LAB funding within the Medical School.
Q Did you know when the money had been first received by the Medical School?
A I do not think that I knew specifically, no.
Q It may be from your previous answer that you have no recollection in which case tell us, but do you recollect whether you had heard concerns about this source of funding prior to this letter or was this letter the first intimation of this source of funding for you?
A I cannot be sure; I think that I might have known something before this letter but not very much before.
Q The letter refers to the fact that the money from the LAB had been provided for the express purpose of performing the study outlined in a protocol and it was said that that protocol had been seen and approved by the ethics committee. What protocol do you believe was being referred to in that letter?
A I believe it to be the submission that was made to the ethics committee at the time, so 172-96.
Q Were you aware of any other research project by this group that it could have been referring to?
A I am not aware of any other.
Q What would you have understood, if anything, as to the purpose for which the Legal Aid Board had granted Dr Wakefield £50,000?
A I understood it to be in support of that particular research project and they were presumably expecting some form of report for them particularly coming out of that research project.
Q I want to take you to volume 1 at page 104 which is the protocol that was in fact submitted to the Legal Aid Board. It runs on to page 120. Would you take a moment to look at the title page on page 104 and then just flick through it seeing the investigator’s responsibilities and the departments involved. Obviously you cannot possibly answer word for word at this distance but does that appear to you to be the same protocol as the one that was submitted to the ethics committee at the time?
Q Would you look at page 121. This was the costing proposal that was submitted to the Legal Aid Board. If you look at page 122, you will the nature of the investigations that the Legal Aid Board were being asked to fund: four nights’ stay in the hospital with their parents, colonoscopy, magnetic resonance imaging, the vitamin B12 and complement studies and medical reports.
Q I move to page 123 which sets out the figures. Did you at the time of the letter that we have been looking at or indeed at any time thereafter see that costing proposal, Mr Else?
A I do not recall seeing it at the time.
MS SMITH: If you had seen it, do you think it would have given you any pause for thought?
MR COONAN: He said that he cannot recall seeing it and this is now ranging into speculation. He said that he cannot recall it and that is the end of it, with respect.
MS SMITH: Perhaps I can put it in different terms. If you had seen it, do you think you would have recalled it, Mr Else?
A Recalled it?
A Yes, I would have recalled it, I am sure.
Q Reverting to the letter which I was asking about which, just so you know again, is on page 471 in volume 2; I expect that you still have that open.
Q You do not need it for the moment, it is just that I want to revert to it in a minute. When you saw that letter addressed to Mr Phipps setting out this proposed grant, did you yourself have any concerns about it?
A I had concerns as to its purpose and I wanted some clarification as to its purpose.
Q Was there in theory at least anything to prevent the Special Trustees accepting money from this source?
Q As far as you were aware during your experience, had they ever in fact been asked to receive money provided by the Legal Aid Board?
A I am not aware of it.
Q The letter at which we have been looking says that the existing expenses of the study are paid from the Special Trustees and it says, “i.e. salary” and of course this is a reference to Ms Sim’s salary. Were you aware of any other expenses of the study that were being supported by the Special Trustees except for Ms Sim’s salary at that stage?
A I am not aware of any others at that stage. As a point of clarification of course, it talks about the location of the account currently held to pay for Ms Sim. I think the implication there was that it was coming through 106 but, as we established earlier on, it was coming from the general funds directly.
Q That is exactly what I was coming on to ask you. Given what we know from what we have already looked it and where Ms Sim’s salary was in fact being paid from, i.e. at that stage the general account held by the Special Trustees, which account did you take Dr Wakefield to be referring to as the one he wanted the Legal Aid Board money to be paid into, the general account or account 106?
A Account 106.
Q We see a reference to the children being seen as ECRs; what was your understanding of the ultimate source of a funding for an ECR referral?
A That is NHS funding, mainstream NHS funding.
Q You wrote to Dr Wakefield and we can look at that now at page 492. This is a letter dated 30 June 1997 to Dr Wakefield,
“SPECIAL TRUSTEES FUND – MMR RESEARCH
Further to our conversation regarding the establishment of a fund within the Special Trustees for your income and expenditure associated with the MMR research, I can confirm that a grant will be established for the purpose given your written confirmation that there is no conflict of interest involved.
As you will appreciate the Special Trustees fund arrangements can effectively carry out the accounting functions you require, but the purposes must be clearly evident and within the regulations which govern the Special Trustees overall status.”
You talk about the establishment of a new fund; had you in fact in that letter overlooked the fact that Dr Wakefield already had an account with you, the G106 account?
A Yes, I had overlooked that and forgotten that he already had an account established.
Q Were the funds subsequently, as far as you are aware, paid into G106?
A Yes, they were.
Q As far as you were aware, Mr Else, were there any other funds being funded by G106 other than study 172-96, the MMR research?
A As far as I am aware, that was the only one.
Q You expressly refer in that letter to wanting a written confirmation that there was no conflict of interest involved. What was your concern in relation to that by this stage? Why did you raise that matter?
A I was concerned partly because it was an unusual source of funding that there would be no undue pressure for a delivery of a particular result from the research and therefore I wanted to be clear as to whether there were any preconditions. I was also concerned about whether there was any proposition that this might lead to some litigation against the NHS in some way.
Q Had you by that time become aware of the nature of the Dean’s concerns and the communications with the British Medical Association in relation to this matter?
A I had not seen the correspondence but I had been advised by the Dean himself that there had been some concerns that had been going on for a month or two prior to that.
Q May I ask you this, Mr Else, and again tell me if you do not feel able to answer this. Do you think that your desire for written confirmation that there was no conflict of interest is something that you asked for because you know of Professor Zuckerman of the Medical School’s concerns or do you think that it was something that you would have come up with of your own volition?
A I think that I would have done it anyway because it was an unusual source and because I wanted to know whether there were any preconditions.
Q You had a reply to that letter and it is at page 493, the next page. It would appear that you had a conversation with Dr Wakefield as well as the letter we have just looked at because Dr Wakefield’s reply says, on 3 July 1997,
“Further to our conversation the other day and your subsequent letter, I am writing to confirm that there is no conflict of interest in relation to the Legal Aid funding for our clinical study of children with autism and intestinal inflammation.
This study, which has been sponsored by the Legal Aid Board, is similar to a study they have sponsored as an investigation into Gulf War Syndrome. There are no preconditions to our grant. Furthermore, there is no intention whatever on behalf of the Legal Aid Board or its agents to take action against the National Health Service: it is against the manufacturers of vaccine that any future actions will be taken if and when our studies indicate that is a valid strategy.
Please find enclosed a copy of our first paper submitted to The Lancet concerning the children under investigation. This has been an extremely successful study and has clearly demonstrated a new pathology in these children and put the Royal Free Hospital as the world leader in this field. We are aware of 300 children who merit investigation under this protocol, most of these as ECRs (or commissioned referrals for the future).
Thank you very much for your help in this matter. If there are any further questions, please do not hesitate to get in contact with me.”
First of all, Mr Else, were you satisfied with the assurances given in relation to the fact of Dr Wakefield’s thought that no conflict of interest existed?
A I was satisfied that he had been explicit about that and put that in writing and the money was taken on that basis.
Q In the end, if you have a written assurance from a researcher in those terms, would you, as the Chief Executive, regard it as appropriate to question that in any way?
A One could always question it further but it was my judgment at the time that this was a responsible, important clinical researcher and that he had been very clear in his response and I took that as sufficient.
Q Do you recall the paper? It says, “… our first paper submitted to The Lancet …” Do you recall the paper being attached? It is not attached now.
A I am afraid that I cannot remember the detail of that now.
Q You have already told us what you understood ECR to mean as far as the source of funding was concerned. What do you understand “commissioned referrals for the future” to mean?
A I think this was slight shorthand. I am not sure whether we have explained that ECR means extra contractual referrals.
A There are essentially two mainstream sources of funding at the time for paying for patient referrals. One was commissioned referrals in the sense that health authorities would establish a contract with the hospital to deliver a range of services which were costed at the beginning of the year and this would form the basis of a payment by that health authority for general services delivered to that health authority’s population over the given year. Because negotiations with every health authority was impossible across the UK and often, the further away from the hospital you got, the numbers of referrals were obviously much smaller, then, to supplement this, there was a system called extra contractual referrals, which in other words were on top of those commissioned arrangements, and it meant that very distant referrals to the hospital were individually priced and charged for, and so ECRs refer to that latter element and commissioned referrals I think refer to the standard block contract nature of referrals.
Q You have told us that the source of ECR funding was the NHS.
Q What about commissioned referrals?
A Similarly, yes. They were two different mechanisms to pass NHS funding to hospitals, largely.
Q We can follow this up with a letter just to see how the money was transferred. Would you look at page 495. This is a letter between Mr Phipps and Mr Tarhan. Would you go to page 496 which is an identical letter but which has the notes on it.
“Dear Mr Tarhan,
Following your recent conversation with Tony Needham, I can confirm that it is in order for you to transfer the total amount of funds in question to the Special Trustees. Please quote the reference G106 on your remittance”
and we see, “Dr A Wakefield: Legal Aid Board sponsored research”.
Q Underneath it, there is a series of notes saying,
“Please draw a cheque for 25,000 payable to Special Trustees G106”.
Is it Mr Wilson with reference to “Dave”?
A Dave Wilson was another member of the finance department in the Medical School.
Q It would appear that he arranged, if we look at the left-hand note, the payment of the cheque out of the Medical School to be made payable to the Special Trustees for the Royal Free Hospital G106 with a note saying, “(will the Dean need to countersign?)”; is that correct?
Q That is how the money fetched up in the hospital rather than in the medical school?
Q Just for the sake of completeness, Mr Else, that was £25,000 of it. If we look in volume 3 at page 1121, this is back to the ledger that we have for G106 that we looked at before. If you look down to 1998/99, 31 March, about two thirds of the way down the page; are you with me?
Q Do you see an amount for £25,000?
Q Is there a reference on the left hand side to “Hodge Jo”?
A “Hodge Jo”, yes.
Q Do you see where I am?
Q You may or may not know this, but it is a matter of record; we shall be referring to the record later, but this is the firm of solicitors where Mr Barr, the partner of Dawbarns eventually went. All I am asking you to confirm is that there was another £25,000 paid into the same account at that time?
A In addition to this? Sorry?
Q Yes. We have gone to the original Legal Aid Board monies that were transferred from the medical school. I am just asking you to confirm the presence in the ledger at a later date.
A Yes, £25,000; that is correct.
MS SMITH: Would you excuse me for one moment, please? Sir, I am going to turn on to another matter shortly with Mr Else. I see it is nearly 11 o'clock and it would assist me, I have to say, if I could have a very quick word with Mr Mellor and Mr Thomas before I turn to it. I wonder if this might be an appropriate time.
THE CHAIRMAN: I think it would be an appropriate time for us to adjourn. It is, as you said, just going to be about 5 to 11. We will now adjourn and resume at quarter past 11.
(To the witness) I remind you, Mr Else, you are still under oath and in the middle of giving evidence. Please do not discuss about this case. I am sure someone from the secretariat will look after you for you to get a tea or coffee. Please do not discuss about this case, including with any of the lawyers.
(The Panel adjourned for a short while)
MS SMITH: Mr Else, in fact, I only have one short matter that I want to ask you. It is sometimes the case that Chief Executives at hospitals have medical qualifications. Do you, in fact, have any?
A I do not, no.
Q You do not?
A I do not.
Q When it came to any knowledge that you needed to have about whether tests were clinically indicated or whether they were being done as part of the research processes who were you dependent upon for that information?
A I would be dependent on the clinicians themselves advising me of that.
MS SMITH: Thank you very much. If you stay there, you will be asked some questions.
Cross examined by MR COONAN
Q Just two documents I hope to complete the picture. If you look at bundle 2, and look, please, at page 605C. You were asked to look at a note this morning which, in effect, captured the background to the drawing of a cheque.
Q To be paid into the Special Trustees on the account of the medical school. 605C appears to be the cheque paid in favour of the trust.
A In favour of the trustees.
Q Of the trustees, that is right, yes. We can see the date on it: 4 September 1997.
Q In effect, we looked earlier, and you were taken to it by Ms Smith, to a second sum of £25,000 which was paid in 1999. This clearly is the clear evidence of the first payment?
Q Now, what I think you have described in terms of the available documentation, and it is the available documentation now, is that we have before us a ledger for account number G106, which runs from June 1998.
Q That is page 1121. We have a ledger for the general account of the Special Trustees from April 1998, which is page 1138.
Q But we do not have any ledger evidence or material before those dates?
A No, we do not, for the reasons that were set out in Mr Taylor's letter.
Q Absolutely. I emphasise by, of course, introducing the word “now” because at one stage that material would have existed.
A Yes, of course.
Q Equally, we do not have the monthly statements which would have been generated for the accounts.
A Not for that period, prior to 1998.
Q Because Mr Taylor's memo, let us just turn it up because I do not think we looked at this small note, it is volume 3, page 1139. We can see at the bottom of that document that it appears to have been generated in 2005. You can see at the bottom.
Q I am sorry to labour the point, but it may be important because that, therefore, represents a snapshot of the position that had been reached by 2005, so in other words, at that date everybody could say confidently that these documents were no longer existing?
A Yes. It is known that they did not exist prior to 1998.
THE CHAIRMAN: I wonder if you would be able to repeat that question and answer so that we can all make a note of it because I do not think I have the proper answer.
MR COONAN: Of course, sir. (To the witness) Mr Else, I will do it again. The position is, therefore, that in 2005 we have a snapshot of the position that, by then, these documents were noted to be no longer existing?
A That is correct.
Q I have really two matters I want to raise with you and can we just deal with them wholly separately? I think you will need volume 2 and if you turn, please, first of all to page 493.
Q In the beginning of that letter, there is a clear reference to a conversation that you and Dr Wakefield had clearly had a day or two before this letter?
Q That followed, I would suggest, I wonder if you can agree, the letter on page 492. We note in passing that the letter at 492 is dated 30 June. You say in the body of that letter two things, but the second thing is that you asked for written confirmation of no conflict of interest.
Q Over the page, a reference to another conversation, or appears to be another conversation, and then leading to this letter by Dr Wakefield?
A Yes. I cannot be precise about the time, for obvious reasons. I may have spoken to him earlier than my first letter pre warning him that I was sending him such a letter. I cannot be certain.
Q That is fair enough. I would not dream of trying to tie you down to a particular conversation on a particular day after this passage of time, but, quite clearly, one of the topics of the conversation was the fact that you wanted assurances that there was going to be no possibility of any legal action against the National Health Service. That is right, is it not?
A That is correct.
Q At that time – we are talking about end of June 1997 beginning of July 1997 – you had become aware from the Dean of some concerns about the receipt of this Legal Aid Board money?
Q One of the matters the Dean raised with you was the possibility or the risk of potential for legal action against the National Health Service?
A He did, and in one of the letters I think he referred to that as well.
Q Did he appear to be somewhat concerned about that possibility?
A He was concerned about a number of aspects, mostly to do with the novelty of this particular source of funding.
Q That to you, at least, loomed large in his mind, the novelty aspect of this, and it was novel to you too?
A It was new, yes.
Q Did it also, therefore – and I am not seeking to put in any particular form of hierarchy – did the risk or potential for action against the NHS also loom large?
A It was one of the issues I wanted clarification about.
Q But with the Dean, did it loom large when he talked to you in his discussions with you?
A It certainly was one of the issues he raised. I cannot recall whether that was the priority or anything else, but certainly that was one of the issues that he raised.
Q Dr Wakefield, in this letter on page 493, gave you an assurance that there was no intention to take any action against the National Health Service.
A Yes, I regarded the phrase as unequivocal, no intention whatsoever.
Q You must have treated that as reassuring?
Q Did he relay that to the Dean do you know?
A I cannot recall an actual conversation, but I cannot imagine some discussion about this transaction would not have taken place at some point.
Q The next matter I would like to ask about concerns the account again, G106. We know that a total of £50,000 was paid into that account from the Legal Aid Board?
Q And the two amounts were paid in during September, August/September 1997 and, secondly, in March 1999?
Q We know that now?
Q £25,000 each?
Q I think you had been asked the question as to what purposes was the sum of £50,000 or any part thereof spent on. That is right, is it not?
A I was asked what the purposes were, what I believed the purposes to be for and what expenditure might be incurred in that respect.
Q You were also asked what you understood the monies were spent on, were you not?
A I was not asked what the money was spent on. I was asked what I believed the purposes would be for this fund.
Q There are two matters I am going to ask you about. In 2004, were you asked this question that I have just put to you by a journalist, Mr Brian Deer?
A There were a number of questions put by a journalist, Brian Deer, but I cannot recall them and I do not have that documentation with me.
Q I am going to try and jog your memory if I may. Do you remember him sending you an e mail and asking you, specifically, upon what elements was the Legal Aid Board money spent on?
A I think that was one of the questions, yes.
Q At the time, Mr Else, that was an important question that Mr Deer was asking, was it not?
Q Did you send him an e mail on 11 March 2004 in which you said that that the Legal Aid Board money was spent on, one, laboratory technicians – you used the word in the plural – £38,000; laboratory consumables for studies on tissues; and some travelling expenses?
A Yes, I think I did send that, yes.
MR COONAN: Can I just repeat it again so there is no doubt.
MS SMITH: Mr Coonan is plainly referring to some document and, given the length of time ago, it seems to me very unfair that Mr Else should not answer the question with the e mail, if he has it, in front of him.
MR COONAN: I will do it in my way for the moment if I may. Mr Else, just bear with me. I think we had reached the position where you had said, even without looking at an e mail, that, first, there was a question put to you by Mr Deer and that you told him – and I shall repeat the evidence so there is no doubt – that the money had been spent on “laboratory technicians (£38k)” was the phrase used. Do you remember saying that?
A I do not remember the figure, but if it was in the e mail I assume that is the correct number.
Q Laboratory consumables for studies on tissues. Does that ring a bell?
A Yes, the title rings a bell.
Q And some travelling expenses?
Q I am more than happy to show you the e mail, but just bear with me because the e mail is not going to help on this point. That was 11 March 2004. In order to answer that question, you would have had to have gone back and looked at documents, would you not?
A Yes, although not the documents that were not available before – we did not have the documents before 1998 in terms of the account itself, which has already been established.
Q What has been established is that the documents that are missing have been said to have been missing as of 2005. That is Mr Taylor’s memo.
A I understood the documents to be missing before that because they disappeared as part of the project 2000 work.
Q Let us assume that is the case. I want to take this slowly, you understand, in fairness to you. Let us assume that is the case. When you were addressing the question which you have agreed was put to you by Mr Deer, and in order to come to a figure, or at least in order to answer the question, you would have to look at documentation, would you not?
Q Or, and/or
A And/or – I know what you are leading to.
Q You anticipated me – and/or sought advice and information from those folk who would know?
A Yes, and also possibly made an estimation from what we did know.
Q Doing the best you could, and of course acting honestly, as you would, you were able to come to a view that this Legal Aid Board money was devoted to those elements that I have put to you and suggested to you. Is that right?
A That is right, that was the best estimate that had been made at the time.
Q Bear with me. I have in front of me and you can see it by all means, if you would like to, it might be safer if you did, if there is a copy of your supplementary statement that you made this year (same handed). Mr Else, again, I do not want to take any unfair advantage of you at all, but you see this is a statement dated 6 July 2007. It is signed by you and, of course, you were being asked to deal with matters – we all are – which occurred a long time ago; that I understand?
Q If you just look at paragraph 27, just read it silently to yourself and paragraph 28 (short pause). I am just dealing with the question of your understanding of what the Legal Aid Board money was spent on.
Q I think you were able to say to Field Fisher Waterhouse, and I quote:
“It was my understanding that £50,000 paid into the account of the Special Trustees from the LAB was spent on the salary of Ross Sim and costs associated with the project 172 96.”
Is that what you said about this subject?
A To try and clarify that, what I was saying was that I believed that was, in essence, what the sum was intended to be paid to – towards, I should say.
Q That is not quite what it says, is it?
A Yes, I agree. That is why I am trying to clarify it.
Q A reader like myself, I suggest, would read that as you indicating to Field Fisher Waterhouse that you are saying your understanding is that it was spent on – LAB money was spent – on the salary of Ross Sim, do you see?
A Yes, I understand that. What I am saying is that I think the question that was being asked at the time was about the purpose of LAB funding and I was responding to that question.
Q That is why, is it not, the e mail in March 2004 is important because Mr Deer’s question was a barn door question, was it not – what was the LAB money spent on?
Q You told him?
A I did.
Q But not the purpose?
A I made the best estimate I could at the time.
Q Is that your position now – irrespective of what you were seeking to say in the statement you made to Field Fisher Waterhouse, let us put that to one side – that the best estimate that you came to, looking at all the available information, both written and advisory, this Legal Aid Board money was in fact spent on laboratory technicians, laboratory consumables for studies on tissues and some travelling expenses?
A That was the estimate and, yes, I stand by that.
Q You stand by that?
A Well, that was my e mail, or I assume you have my e mail there, so on the basis of that, then I agree with that.
MS SMITH: I am sorry, I am going to renew this application because I am very unhappy with the way Mr Coonan is hugging this document to himself in this extraordinary way and asking questions which have now gone on for another nearly ten minutes since I last objected, without putting the e mail in front of Mr Else so he can refresh his memory.
MR COONAN: My learned friend has to be a little patient. I was about to invite Mr Else to look at the document. As I have indicated, I was at all times intending to be extremely fair to Mr Else.
THE CHAIRMAN: Would it be possible at some stage that we be circulated with a copy of this?
MR COONAN: Certainly, I just want him to identify the e mail first. I do not want to be presumptuous, I need him to identify it. (Same handed).
THE WITNESS: Yes, this is a statement that was made by the media office and, yes, I do recall it.
MR COONAN: (To the witness) Perhaps I could have back the original, Mr Else.
THE CHAIRMAN: This is 1217a, so that will be something FTP3. (Document distributed)
MS SMITH: This is not an e mail and it is not from Mr Else. The basis upon which this was put to Mr Else is that it was an e mail from him, from him. We now see a statement to Brian Deer from the Royal Free and University College Medical School. I am very unhappy about this given the time that Mr Else has been asked questions without being shown the document.
MR COONAN: Mr Else has already seen this document and agreed its status. (To the witness) Whether it was in e mail form or not, Mr Else, do you recognise the document.
A I recognise the statement, as I said.
Q Did you have a hand in compiling it?
A I would have seen it, I cannot recall actually how much involvement I had in the whole thing, but I would have had some involvement in it and certainly seen it.
Q Mr Else, I was under the impression, forgive me, that this was communicated by way of e mail to Mr Deer.
A It may have been sent by e mail through the e mail system, but it was a statement.
Q And it was communicated to Mr Deer?
THE CHAIRMAN: Is that something that is within his direct knowledge or has somebody told him that?
MR COONAN: That is a fair question.
A It came from the press office which worked both for the Trust and for the Royal Free Medical School.
Q So when you looked at this, did you have any part in its compilation?
A I saw the figures. I did not personally do the calculations. I do not recall doing them myself.
Q Do you know who did?
A No, I do not know who did at the time. I cannot recall. I would have to think about that. I do not remember.
Q And we can see on the top left hand corner “Press office”. When you say the press office, you are saying there is a joint press office for both institutions?
A There was a press officer who worked for both the Trust and the Medical School. She had a retainer also for the Medical School.
Q And this was going out in the name of the Royal Free Hampstead NHS Trust, wasn’t it?
A It was going out jointly, actually, because both logos appear to be on it.
Q But the information, the raw data, for underpinning these assertions would have been kept by the Trust?
A I am assuming so, although I cannot recall whether that included Medical School expenditure.
Q How do you mean?
A Well, the Medical School may have incurred some expenditure, in which case that may have formed part of those figures.
Q But are you saying you simply do not know?
A I simply do not know at this moment. I cannot recall the detail behind those figures and that particular statement. I recall the statement being put together but I cannot recall the details of it.
Q And who would have been the person in the Trust who would have been in the position to provide the material underpinning this document?
A It probably was the press officer going to someone in the Trustees’ office.
Q And who might that be?
A That might have been Russ Phipps. I cannot remember whether Russ Phipps was still around at that time, but I think it probably would have been.
Q And his position was exactly?
A He was assistant director of finance.
Q So you are obviously a tier above that, but he would be the man to ask, then, would he? He would know the figures, and have access to the figures?
A I think probably the best, to try and get back to this, would be to go back to the Trust and to ask how the calculations were put together at the time, because there may be some records supporting that, but I cannot recall it now.
Q Again, obviously we are going back a long time, but from what you knew of the set up there, Mr Phipps is the important person to speak to about this?
A I think it probably was, although I cannot remember when Russ retired. But I think he probably was there at this time.
MR COONAN: Forgive me one moment. (Counsel took instructions.) Mr Else, in the light of that I will have to take this up with Mr Phipps.
A Can I suggest you take it up with the Trust first, because I know Mr Phipps is not terribly well, so I would hope that you would take it up with the Trust first, as to whether that is the right person.
Q Well, I am sure that can be done. But, again, I am drawing on your experience from when you were there, in the absence of Mr Phipps, if for any reason he cannot help the Panel, is there anybody else who might throw any light on this?
A Well, I would start with the press office.
Q And that would be Philippa Hutchinson?
Q Is she still in post?
A I believe so.
MR COONAN: Thank you. That is all, sir.
Cross examined by MR MILLER
Q I have no questions about that aspect of the case; there are just a couple of letters I want to ask you about. I think you were, in fact, at St Bartholomew’s Hospital, or the Trust that ran St Bartholomew’s, before you came to the Royal Free?
A A very long time before, yes. I started my career there.
Q How long ago was that?
A Mid ‘70s.
Q Was Professor Walker Smith there then?
A I was such a junior person, I have to say, I am not sure I would have seen somebody so eminent.
Q No. But certainly you had, from time to time, dealings with him when he was at the Royal Free?
A Oh, yes.
Q And not infrequently he spoke to you on a variety of matters?
Q Now, you were asked to look at the letter which we have in FTP1 at page 192. This is a letter which you wrote to Dr Wakefield with a specific purpose, but copied it to Professor Walker Smith and, I think, those in the financial department of the Trust, or Special Trustees?
A Mr Phipps was; Mrs Holroyd was, in fact, the nursing officer, and Mr Thomas was an accountant in management accounts.
Q And I would just like you to look at the second sentence:
“I understand that children who would fall within the scope of the project” –
and the project is “A New Syndrome: Enteritis and Disintegrative Disorder”, et cetera, which is there?
“Are currently being seen at the Royal Free as part of the normal process for the delivery of health care and that tests, investigations and procedures that are clinically indicated are being undertaken”.
You go on to say:
“No tests, investigations or procedures will be undertaken that are not clinically indicated but which do form part of the research study protocol, until approval for the study has been received from the Ethical... Committee”.
So am I right in saying that the letter is saying (a) that it is your understanding that the children were being seen anyway at the Royal Free as part of the normal process of the delivery of healthcare, and that the tests were clinically indicated, and they could, by implication, carry on because it was nothing to do with the Special Trustees. In other words, if they were clinically indicated it was a matter for the clinicians
A Yes. The concern is they should continue to be seen, yes.
Q But, and it was an important but, no tests or procedures which were not clinically indicated should be undertaken until ethical committee approval had been given?
A That is right, and the reason for that was I was not aware whether there on be investigations or procedures not clinically indicated at that stage. I was simply pointing out the fact that, should that be the case, then clearly they had to be approved.
Q Clinical service was one thing but research which was not clinically indicated would be different.
Q And as far as the Special Trustees are concerned they would not be financially interested or involved in the clinical aspect. That would be pure National Health Service, would it not?
A That is correct.
Q But as far as the research aspects of the study, ie the laboratory work and the dealing with data, that might well not be, and probably would not be, part of NHS clinical care?
A If they were additional tests or investigations, as it said, then it would not be part of routine clinical care and therefore would be a potential additional cost associated with the research project.
Q Yes. And what this letter tells us is that the Special Trustees were being asked, or had been asked, by Dr Wakefield, I think we saw the earlier letter, to pay for that assistance, the laboratory and, you say, collation of data assistance, and the letter is notification that funds would be available for that laboratory assistance from the Special Trustees?
A That is correct.
Q So the letter makes two points. First, as far as clinical care that is one thing, you can have for two years your laboratory assistance from the named scientist who is there, Ms Sim, but you need to get ethical approval first.
Q So at this date, which is the beginning of September 1996, you clearly contemplated that there were two aspects of this study: first, clinically indicated tests, investigations and procedures carried out by the clinicians at the Royal Free under the NHS, and, secondly, research, including research assistance, to be provided by Ms Sim to Dr Wakefield, which would be funded by the Special Trustees?
A That is right.
Q Now, we will just leave that letter and come on a couple of years to 1998. The Committee has been told from a number of different sources, principally from Professor Zuckerman, of a letter written by Professor Hull to the then Dean, Professor Zuckerman, which led I think to discussions about this study, which meant the issue of clinical need had to be revisited?
A Yes. I had been told of that. I was not party to any of the correspondence on the matter.
Q No, but I think Professor Zuckerman told us you had discussions with him about it. You were not involved in the correspondence between Professor Zuckerman, Dr Pegg and Professor Hull, but I think you discussed it with Professor Zuckerman, and I think with Professor Walker Smith.
A Professor Zuckerman raised it, I am sure, in one or two of our routine meetings, that is true.
Q But we have seen from the documentation, I will not ask you to look at it, that you were copied into Professor Zuckerman’s reply to Professor Hull, where he set out a number of paragraphs about his understanding of the position.
Q And Professor Walker Smith wrote personally to you on the 24 July 1998, FTP3, page 953. I do not think you have been asked about this yet, have you?
Q This is 24 July 1998 which the Committee will know is about the time that the correspondence took place, and it is a letter to you, copied to Professor Zuckerman and Professor Pounder, from Professor Walker Smith, dated 24 July.
“I am just writing to you personally in relationship to the letter the Dean sent to me from Sir David Hull concerning the ethical nature of the studies we are undertaking on children with autism. These children with autism who have gastrointestinal symptoms, from the very beginning, have been investigated according to clinical need. This has been approved by the Ethical Committee. Also it is routine for us to have ethical approval to take endoscopic biopsies for research purposes with parental consent for all children who are endoscoped. We have never moved outside any frame that has not been approved by the Ethical Committee or indeed that is outside the bounds of ethical behaviour in the widest range. We have the clearest evidence both published and unpublished that these children have a form of chronic inflammatory bowel disease. The only investigations they now have apart from blood tests is ileo colonoscopy”.
So this letter, Mr Else, is very much as you had understood the position to be when you wrote in September 1996.
A I understood the position to be that children were being investigated based on clinical need, and the only identifiable piece of expenditure at that stage associated with the research that I thought was legitimate to charge to the Trustees was the cost of Ross Sim.
Q Yes, because everything else, as far as the clinical side, would be the Royal Free Hospital NHS?
A It would be.
MR MILLER: Thank you, Mr Else.
THE CHAIRMAN: Mr Hopkins?
MR HOPKINS: No, thank you.
THE CHAIRMAN: Ms Smith?
Re examined by MS SMITH
Q Just a couple of matters, Mr Else. A small matter: Mr Coonan suggested to you that the G106 ledger was available from June 1998, and perhaps I could just ask you to look back at page 1122 in volume 3. Do we see that, in fact, the first entry there is 30 April 1998, at the top of the page?
A Yes. Sorry, yes.
Q No, no. It was Mr Coonan’s mistake. He has asked you about the destruction of the documents, and I took you to the memo dealing with that, 1139. I only took you to the end point of that document but in light of the questions you have been asked I think perhaps it would be useful if the Committee knew exactly what had been said in relation to financial records, so will you bear with me while I run through it, please?
“For a number of years the Trustees’ financial records have been maintained on the same computer systems used by the Royal Free Hampstead NHS Trust for reasons of economy and uniformity. Each of the two organisations used discrete areas of the systems to maintain the integrity of their own records and generally employed different formats for their different reporting requirements”,
so that is the Special Trustees’ financial records and the hospital NHS Trust financial records.
“From 1990 both bodies were using a suite of computer programmes supplied by a company called Ross Systems which were run on a VAX mini computer. These programmes were not Year 2000 compliant and had to be replaced in good time before the year 2000 to avoid the risk of the financial system failing. The NHS Trust undertook a tendering exercise to replace the financial systems for both the NHS Trust and the Trustees organisations under the usual NHS Trust tende3ing requirements within its Standing Orders.
The outcome of the exercise was the award of a contract to a company called B Plan Information Systems Ltd to supply a financial system package called Aptos which runs on a Windows 2000 server with an Oracle 8i database. This database is fundamentally different from the previous storage employed VAX machines which became redundant at the point of changeover of systems on 1 December 1999.
The replacement Aptos system came into effect at that date for all current transactions and was backloaded with transaction data from 1 April 1998. At the time it was considered that the amount of data was adequate for foreseeable purposes and to backload more data would detract from performance in the future when further data was being added.
Additional historical data was stored on tapes which could be restored to the VMS System on Vax machines but these being already redundant, these computers were later disposed of, there being no use or space for their retention. In due course, the tapes of historical data were reviewed as part of the on going housekeeping function of computer records and were also discarded”.
Is it your understanding that it is that history which led to the storage of the earliest data available being April 1998?
Q I only have one other question arising out of the document which Mr Coonan described to you when he asked you questions as being an email from you but which turned out to be a press release on behalf of the NHS Trust. We see it enumerates some financial details. Ross Sim: what was Ross Sim’s status? What was she?
A She worked in the laboratory.
Q Was she a technician?
A Yes, a laboratory technician.
MS SMITH: I have no further questions. Thank you, Mr Else.
MR MILLER: Sir, to my embarrassment, I did not put to this witness his reply to Professor Walker-Smith’s letter which is three lines and I think that, for the sake of completeness, I would like to get him to verify that it is there and then have it in the bundle. It is here now. I wonder if I may introduce it. I cannot imagine that it will be controversial.
THE CHAIRMAN: Ms Smith, do you have any objection to that?
MS SMITH: I have no objection at all, sir.
MR MILLER: It will go at page 957A in FTP 3. (Same circulated)
Further cross-examined by MR MILLER
Q Mr Else, is it not a particularly startling document but it looks as though this is the letter you responded to Professor Walker-Smith with.
Q It is dated 10 August 1998 and reads,
“Thank you for your letter … which we briefly discussed at the time.
At the time of writing I have heard no more about this issue, at least as far as this particular external interest is concerned, and therefore I hope that the matter is closed.
I am grateful to you for keeping me informed.”
MR MILLER: Thank you very much.
THE CHAIRMAN: Ms Smith, is there any point on this particular letter that you would like to come back on with this witness?
MS SMITH: No, I have no questions.
Questioned by THE PANEL
MS GOLDING: Would you look at page 192 in FTP1. You say that the Special Trustees will need to see evidence of approval; did you receive any evidence at all?
A Yes, I did, otherwise I would not have released that funding.
Q On page 337, a letter from Richard Barr to Dr Wakefield in which he mentions the conditions of this grant in the middle of the page; did you see a copy of those conditions?
A No and I have not seen this letter before either.
Q You did not see the conditions. Was it attached to any of the papers you received from Dr Wakefield?
A I do not think so.
Q Was Dawbarns mentioned at all in any conversations with Dr Wakefield?
A I knew that Dawbarns were involved in the Legal Aid Board issue.
Q Was the £25,000 a second payment from the Legal Aid Board or a first one?
A There were two payments. One was handled through the Medical School, effectively a payment to us, and £25,000 direct to the Trustees was the second tranche.
Q What was the first payment used for?
A As we have heard, the calculations that were done in the press statements refer to issues to do with technicians, travel expenses and so on.
Q The money for the salary for Ms Sim was coming out of the Trustees’ fund but not the Legal Aid Board money.
A No. The difficulty was that this was going on over a long period of time and, to attribute which bits of expenditure to which source is difficult to say now.
Q When you wrote the letter confirming the funding of the salary to Ms Sim, was that a special request for that funding? I cannot recall seeing a request for funding from the previous set of money.
A The request for support for Roz Sim came from Professor Walker-Smith and from Dr Wakefield, as I recall.
Q But they did not ask for funding for the previous assistant?
A Not that I recall, no.
DR MOODLEY: I want to stay with page 192. When the application came to you for the funds, did it come in a written form or was this a discussion with Professor Walker-Smith and Dr Wakefield?
A I think that it was a discussion. I cannot recall any direct correspondence on the matter but I cannot be absolutely sure about that.
Q Did it usually go to a committee or did it go directly to you? This starts with you writing to confirm the moneys. It does not give us the background as to how the application arose and what the usual format was.
A For a sum of this scale, it would have fallen within my remit to make a decision. This was an organisation which even at that time was an £200 million organisation. So, the clinicians would have come directly to me and put a proposition.
Q Would they put it in general terms about funding a project or would it be about specific details about how the money would be used?
A It would have been in the context of a project and how the funding was going to be used or what funding they were looking for and what they wished to fund.
Q In your response it says that it will fund the salary of Ms Sim.
A That is right.
Q We have also heard something about laboratory assistants, so there seems to be a bit of flexibility. Could you clarify it for us, please.
A The specific question that was being raised here was that a particular project was being looked to be pursued which was the 172-96 project, that because the proposal was largely to do with clinically indicated treatments for children, I took the view that the majority of that would be covered by NHS funding and there have been references to either commission funding or on the basis of ECRs. However, one element that might be seen as additional was the salary of a technician to do some data work and laboratory work in support of this particular research project and therefore seen as over and above the NHS funding. So, at that stage, I felt that that was an appropriate element of the project to be supported from Trustees’ funding.
Q You were thinking in terms of the funding of the salary?
Q Not additional expenses.
A Not beyond that from this source, no.
THE CHAIRMAN: Mr Else, I would like to ask you a couple of questions. First of all, I think you said to Ms Smith this morning that you had actually seen the protocol for this project 172-96.
A I had seen the protocol, yes.
Q Did you actually anticipate, looking at that protocol, that there would be some investigations that would need to be done which were clinically unnecessary?
A I asked the question. I did not foresee that that was going to be the case in the sense that I expected it to be the case. I did not expect that it would be the case because it had been suggested prior to that that only clinically activity would take place. However, the purpose of my letter or one of the purposes of my letter was to ensure that, if there was going to be any addition, then that had to be properly supported through the ethics committee process.
Q Does page 192, the letter to which you are referring that you wrote to Dr Wakefield, not imply that there could be or would be some investigations which may clinically not be needed and would only be done after the ethical approval has come?
A I am afraid that perhaps the letter is not subtle enough. It is very difficult, with hindsight, to capture all the nuances. All I can say is that my purpose in writing the letter was to say that I believed that the clinically indicated procedures were going to be undertaken but, if I was wrong and there were going to be tests and so on, then they had to have proper ethical approval.
Q My next question is – and you have been asked these questions by Mr Coonan and also by Ms Smith – about this new document that was introduced, page 1217A, which is now in FTP3. I want to know what your position is because I think that you have given different answers and some conflicting answers to questions that you were asked on this. First of all, you said that you remembered the email or you recalled the email, and we now know that it was not an email. Secondly, at one stage, I think you said that you would have checked through the figures with someone in the office in the documents at that stage before you put this 38K figure on that document or email or whatever it was. Finally, I think you said that it was done by the press office and that you had no knowledge of it or something to that effect.
A No, with respect, I did not say that I did not have knowledge of it. I did say that I had knowledge. When there was reference to the email, I was just taking it generically in terms of, this is the way it was communicated, and I do remember that there were questions put by email and there was a response by email. The format of that email was a press statement and I recall the fact that there was a statement. I cannot recall the details of the calculation and I cannot remember how that was put together now and I would have to go back to some records in order to see how that was calculated. I have suggested that perhaps you might ask the press office whether there are any original documents to look at it.
Q I have noted that. As the Chief Executive, when the document went out, even if it went out from the press office, it would still have had your approval before it went out from the Royal Free.
A Yes, I was aware of it.
Q If, in that document, there was a figure that you did not understand, then you would have made sure that the figure was checked from one source or the other to ensure that it was an accurate figure because it was going from the Trust of which you were the Chief Executive.
A As I say, I cannot remember the details of it, but, yes, I would have seen that number and I would ---
Q Maybe I am putting a hypothetical question but, as your normal practice when you were the Chief Executive of the Trust, if a document had come before you which was going out from the Trust with the figure of £38,000, you would have wanted to make sure that the figure was correct.
A I would have asked questions about it.
Q You would have asked questions and probably seen the document or some kind of supporting document.
Q Do I take it that this figure would have been checked from one source or the other before this reply went out?
A I knew about that figure, as I have said before, and I would have noted that number and probably asked questions about what the source of that figure was.
Q And you would have been satisfied before this went out?
MS GOLDING: Would you turn to page 1124 in FTP3 as, in trying to understand this, I would like some clarification. Where we have at the top of the page “1998/1999” and then “30-Nov-1998” we have “SPECIALNOV98SAL” and then “SIM”. Does that indicate the salary for this person Sim?
Q And that goes all the way down and then we have Thomas at the bottom. Is that a salary as well?
Q If we go to page 1123 and to the middle of the page where we have “SAL:LEWIS” and I do not know if that is short for something but that is from the same research special account.
A That means it has come from 106; it has been charged against 106.
Q What was the other one charged to?
A Similarly 106. This can be contrasted with the general fund where Sim had some support for a period. So, that was a separate account from 106.
THE CHAIRMAN: We do not have any more questions but counsel have another opportunity to come back to you to clarify issues if they want to. Ms Smith?
Further re-examined by MS SMITH
Q Mr Else, I would like to ask you one quick question arising out of the first questions that Ms Golding asked you. She asked you whether any request had been made for funding for a previous assistant, an assistant previous to Roz Sim, and you said that there had been no such request. Do you have any knowledge of there having been a previous assistant or was this the beginning of the study as far as you were concerned when Ms Sim’s salary was covered?
A I simply do not know whether there was an assistant before in that particular role. My engagement with this process was at the point at which there was a request for support for Ross Sim.
MS SMITH: Thank you very much. I have no other questions.
Further cross-examined by MR MILLER
Q Mr Else, page 192 again in FTP1.
Q This specific project was identified in your letter, bold in the second line of the letter. It is not just a general request for funding for a researcher. This was a request for funding in relation to that specific project, was it not?
A It was, yes.
Q That is what you say.
Q “To support the above project for a period of two years.” It was only the additional element of laboratory assistance that required funding.
A In my view at that stage, yes.
Q It must follow that if you were going to have to fund it, it was not being funded by the NHS, that aspect of support for the study?
A For the Ross Sim post?
A That is correct. I took the view that it would not be covered by NHS funding.
Q The Special Trustees were agreeing to fund the salary of a person who had already by that stage been identified as Ms Ross Sim?
A The name was identified to me at the time, yes.
Q It was not: you must go and get one. You were being asked: will you fund Ross Sim's salary for a period of two years.
Q May I suggest, Mr Else, that the request for funding for such a person came from Dr Wakefield rather than Dr Wakefield and Professor Walker Smith because Dr Wakefield was the one who was solely involved in research at the hospital, was he not, at the medical school?
A It is very difficult to recall individual conversations. I know the specifics certainly did come from Dr Wakefield and that is why I was responding to him particularly. However, there had been conversations with Professor Walker Smith on the generality.
Q I was going to say exactly that. There had to be conversations with him as well about the clinical side of things. Presumably you got the understanding about the investigations of treatment from him.
Q In order for you to be able to write that letter. What I would suggest is that they may both have talked to you about the project, but the clinical aspects were addressed by Professor Walker Smith and the research by Dr Wakefield. Does that sound about right?
A Probably, but I do not remember the individual conversations.
Q It would make some sense because Dr Wakefield was, after all, the person who was asking for the assistance and to whom you addressed the letter, albeit you sent a copy to Professor Walker Smith?
MR MILLER: Thank you.
THE CHAIRMAN: Mr Else, you will be pleased to know that you have finished your evidence now and you are now released.
A Thank you very much.
(The witness withdrew)
THE CHAIRMAN: Ms Smith, I am looking at the time. I wonder whether you would find it appropriate to introduce a new witness now or after the lunch break.
MS SMITH: The position is this, sir. The next witness is Dr Mills, who relates only to the case of JS. Although it was planned that he would be here by now, in fact, we had a message that he is stuck on the train and will not be able to be here until 2 o'clock. Also in the case of JS is the general practitioner, Dr Jones, and the charges relating to JS relate to Professor Walker Smith. Mr Miller has kindly indicated that he would be happy for Dr Jones' statement to be read. I wonder whether this might be a convenient moment to do it
prior to calling Dr Mills this afternoon. It will not take long. Mr Thomas is going to do it and I do not anticipate it taking more than a few minutes.
THE CHAIRMAN: Mr Miller?
MR MILLER: It is such a long time since looked at the statement. I was not told that this was going to happen now, but I know that I said I do not wish this witness to be called, so this is as good a time as any to read his statement, if the Legal Assessor agrees.
THE LEGAL ASSESSOR: Has it been edited in any way?
MR THOMAS: No.
THE LEGAL ASSESSOR: Is there any reason why the members of the Panel should not have copies to follow while it is being read? They will see it in the transcript in due course, of course.
MR MILLER: I would be content with that.
MS SMITH: We have copies so perhaps if we could hand those round.
THE CHAIRMAN: Ms Smith, do you want to give us a separate number? Are we going to put it in somewhere within the documents?
MS SMITH: No. I think if it is a statement it should not go within the documents, which means it will be C6.
THE CHAIRMAN: (Same handed to the members of the Panel and marked as exhibit D6). This is the statement of Dr David Jones.
MR THOMAS: I should say that Mr Miller has asked that two parts of JS's GP's records be read as well. If the Panel could take up JS's GP records I am going to be referring to those in the context of the statement. The statement is dated 2 August 2007.
THE CHAIRMAN: Only one request to you, Mr Thomas: if you could go a little slowly for us.
MR THOMAS: I will try my best to go more slowly than is my normal practice.
It is a statement from Dr David Jones. He says:
“I, Dr David Jones, will say as follows: I am a General Practitioner and partner at the Demontfort Medical Centre in Evesham. I saw JS occasionally in 1996 7 but was only nominally his GP. I can recall that we rarely saw JS in the surgery as he was so disruptive. The majority of JS's medical care during that period was provided by Dr Mills, the community paediatrician. I have been shown pages 97 98 of JS's GP records. The entries dated 22/4/96 and 11/11/97 were made by me.”
I will now pause and take you to the GP records. If you could turn to page 98, I will read that record on to the transcript. It is a clinical note dated 22 April 1996, A, for attendance:
“Professor John Walker Smith, Royal Free Hospital, Rowland Street, London, NW3 2PS.”
On the next line in brackets appears the name Dr Wakefield and then from the address of the Royal Free is an arrow to the following words:
“Investigating link between autism/measles and IBS. ? Referral by me, (would be better from Dr Mills)”.
That is the first note.
The second note, if you turn one page back, page 97, this is dated 11 November 1997 in the middle of the page “TE” for telephone:
“Dr Kirrage re cancelled colonoscopy. ? Defer until more evidence forthcoming”.
Resuming the statement:
“The appointment on 22 April 1996 was with JS's mother without JS present. She gave me the information about the consultants at the Royal Free. She was very keen for the investigations to be done. I cannot remember what those investigations were. As I knew very little about JS and was only nominally his GP I told Mrs S that it would be more appropriate to have the referral made by Dr Mills who was far more involved in the medical care of JS. I had nothing further to do with the referral to the Royal Free and have no idea how it was funded. The note of a telephone call with Dr Kirrage on 11 November 1997 was made by me and I can remember Dr Kirrage. However, I cannot remember anything about the telephone call. I understand that my statement may be used in evidence for the purposes of a hearing before the General Medical Council's Fitness to Practise Panel and for the purposes of any appeal, including any appeal to the Council for Healthcare Regulatory Excellence. I confirm that I am willing to attend the hearing to give evidence if asked to do so.”
That is, as I said earlier, signed by Dr David Jones on 2 August 2007. He says:
“I believe that the facts stated in this witness statement are true.”
THE CHAIRMAN: Thank you very much indeed. Ms Smith?
MS SMITH: I was just standing up because I anticipated that you were going to ask me what the position was with regard to the next witness. As I have already indicated, we cannot unfortunately have Dr Mills until 2 o'clock, so you might feel it is appropriate at the moment to rise.
THE CHAIRMAN: We will now adjourn and resume at 2 o'clock.
MS SMITH: If there is any continuing difficulty of course we will let you know.
THE CHAIRMAN: Thank you very much indeed.
MS SMITH: I will call Dr Mills, who is the consultant for Child JS. You will be needing the local hospital records for JS, the Royal Free records, probably not the GP, or only one or two.
ANDREW FREDERICK MILLS, affirmed
Examined by MS SMITH.
(Following introductions by the Chairman)
Q Dr Mills would you please tell us your full name and address?
A I am Dr Andrew Frederick Mills. My address is XXX.
Q Your qualifications, please?
A MD, BS, MRCP, FRCPCH, MSc, DCH.
Q Dr Mills, you should have in front of you a laminated sheet, do you have that?
Q It is an anonymisation key. It is headed “Lancet children on an anonymisation key”. If you look down at it, was your patient the child whose name appears opposite Child JS?
Q I should make it absolutely clear, that although it says “Lancet children” at the top, we know that JS was not one of the “Lancet children”, in other words the children written up in The Lancet. We are trying to anonymise the children by referring to them by initials or number, in this case “JS”. If you could try and do that. Equally, when we are looking at records it is very easy to slip. Be reassured the press have been asked to preserve confidentiality even if you do mention the name. I think it is right that you are a consultant paediatrician and you were appointed as consultant paediatrician to Worcestershire Health Authority in 1992, and you have been employed in that position ever since?
A That is correct. The Health Authorities have morphed and changed a great deal over the last few years, but, effectively, Worcestershire Health Authority has been my employer.
Q As far as your actual specialism as a paediatrician is concerned, what has been your area of work?
A I work as a paediatrician with a special interest in disability, complex needs and child development. I suppose in the trade we call ourselves a community paediatrician because I tend to deal with children with long term special needs who tend to have their needs met in the community rather than in an acute hospital setting.
Q I think you had the opportunity when you made your statement to review the medical records relating to Child JS. Can you remember to respond with a “yes” or “no” rather than a nod because it does not go on the transcript.
A Yes, I examined the bundle of letters, papers and documents that had been presented to me when I prepared my statement.
Q Can you remember seeing JS, first, on a few occasions in the pre school period at the age of about four?
A Yes, I can.
Q I am going to ask you to go with me through a series of records, just so that we can see the way in which he developed. You should have some local hospital records which are entitled “Local Hospital Records 1”.
A I have a bundle marked “Local Hospital Records Various Institutions Volume 1”.
Q If we turn to page 14. Is this a letter from a Dr Seyler, who was the Clinical Medical Officer, to you requesting you to see Child JS. There had obviously been some discussion between you. We then see:
“[Child J] is a child with severe communication problems (probably in the autistic spectrum), and has been seen by Dr Green at Birmingham Children’s Hospital.”
Who was Dr Green, what was his specialism?
A He was a paediatric neurologist. I use the term “was” because he died last year. He was a paediatric neurologist at Birmingham Children’s Hospital.
Q Continuing with the letter:
“An EEG was normal. He has made some progress recently, and has just started part time at XXX Nursery.”
Was that a pre school institution for children with developmental problems?
A Yes, that is right. It is a nursery run by the education authority for the assessment of children pre school, presenting with developmental delay and other problems.
Q He says:
“He will hopefully be assessed by the Education in the near future.
So far I have not managed to assess him on the Griffiths Developmental Scales, due to his lack in corporation, but the feeling is that his general intelligence is probably normal.
As [Child J’s] problems are complex and ongoing, I feel he would benefit from local supervision by yourself, and I would be grateful if you could see him.”
I think it is right that in response to that you did indeed see this child?
A I did, yes.
Q If we go on to 19, page 19 in the same volume, we can see your letter in response to Dr Seyler, having seen the child. I am not going to read through it all, but I will take you to some of the salient points. You give what the problems were at the start of letter:
“(1) Severe delay in expression and comprehension of language.
(2) Poor social interaction with limited range of play activities.
(3) Possible regression from the age of 18 months.”
“Thank you for asking me to see this 4 year old boy who I saw for the first time on 12 January with his Mother at XXX Nursery.”
You say that his perinatal events were uneventful; his mother described him as a cuddly, affectionate baby; he walked at the age of twelve months and early language skills are said to have been advanced; his mother remembers him as communicative and highly sociable.
“From the age of 18 months the family remember his expression and his use of language becoming less and less. He started to avoid eye contact and from the age of 3 years he was saying virtually nothing and had started to live in a world of his own. At that stage concerns were expressed about his hearing and he was referred to Mr Cable. I do not know the results of any hearing tests but he had had adenoid and middle ear ventilation undertaken at the age of 3½ years. Unfortunately, this did not make any difference to his problems. In view of the history of regression, he was seen by Dr Stuart Green who organised an EEG and made a referral to Dr Sungum Paliwal the child psychiatrist. I understand from Mother that Dr Paliwal, who has a special interest in autism, diagnosed [Child J] as child with difficulties in the autistic spectrum and the parents now use the term ‘autistic’ to describe their child.”
You say you, yourself, had not had a report from Dr Paliwal.
“The family believe that [Child J’s] problem started to develop several weeks after his MMR immunisation, but there was certainly no history of any acute neurological episode at that stage. In view of this I have advised them that compensation to the Vaccine Damage Payment scheme may be difficult to achieve, although they should still explore this avenue if they wish.”
You then deal with the family and you said:
“On examination, [Child J] presents as a healthy well grown child...nothing to suggest fragile x.
During the assessment he showed various problems, virtually no eye contact, I could not engage him in meaningful assessment, no words, virtually impossible to verify whether his hearing was in the normal range and in many respects and in many respects he acts like a very deaf child.”
Going on to the bottom of the page:
“Interestingly, he was fully toilet trained at an early stage.
It is clear that [he] has a very major problem in his development of communication and social interaction. It seems very likely that he is going to have a long standing difficulty and is going to have very special educational needs.
I spent some time discussing the able of ‘autism’ with Mother. I think as part of [his] further assessment it would be useful to have the opinion of Betsy Brua our Clinical Psychologist, who has a special interest in children like [Child J].”
You say that a DNA analysis fragile x would be useful and you will check to see if Dr Green, the paediatric neurologist had done that.
That is the first letter. Was it your understanding from that first encounter with the family of JS that they believed MMR immunisation to be implicated in some way in the problems that he was manifesting?
A Yes, the family have always, ever since I have known them and been involved with them, were convinced that MMR had been the caused of Child J’s difficulties.
Q It is clear from the letter that we have just read that JS had already been seen by a number of specialists. Referred to in that letter was Dr Cable. Is he ear, nose and throat?
A Mr Cable is an ear, nose and throat surgeon based in Warwick.
Q Dr Green is a neurologist, as you told us. Dr Paliwal, is the child psychiatrist?
A She was the child psychiatrist working in Birmingham with a special interest in autism.
Q Joanna Bridges, who is a speech and language therapist?
A That is correct.
Q Last, but not referred to in that letter, I think it is also right that he saw a clinical psychologist called Ian Mackenzie?
A That is also correct.
Q Does that range of specialisms, is that the normal way that you would approach the assessment of a child like JS who was showing developmental problems?
A Yes, I think it is. Every child presenting with development abnormalities, difficulties or developmental delay is different and we may have a slightly different approach to every one but, given the severity of J’s presentation, the difficulties that he was presenting with, I think the range of professionals there is entirely appropriate. In other similar cases we would involve a similar number of professionals.
Q What part do they play in coming to a conclusion as to the diagnosis of the particular child’s condition?
A In terms of diagnosing autism as such, autism is a developmental condition and there are no specific blood tests or scans that would diagnose autism. Autism is a condition that is diagnosed based on the history of the presentation and the child’s difficulties in terms of communication, socialisation and the child’s presentation of behaviour in terms of repetitive and of stereo typed behaviours. Those things are identified by assessment by a number of different individuals or, ideally, by a number of different individuals over a period of time seeing the child in several different settings.
The paediatric neurologist was important because of Child J’s history of regression. In fact by the time I saw Child J that regression had been reported to have happened about two and a half years previously. The neurologist would have been important in terms of ruling out known recognised causes of a child’s development to go backwards. An ear, nose and throat surgeon was important because in Child J’s case there were concerns regarding his hearing. A speech and language therapist would have been involved in parts of his assessment regarding his autism. Ian Mackenzie had been involved at an early stage because of people’s initial worries regarding Child J’s development also.
Q You refer in your letter I have just taken you to, to a lady called Betsy Brua, who was a clinical psychologist. Is it right that you did, as you were planning in that letter, write to her requesting an assessment?
A That is correct.
Q If we look at page 16, you say:
“I enclose a report about this lad who has recently started to attend XXX Nursery. He seems to have come to us a little late although he has seen a large number of people in the past including Dr Sungum Paliwal and Ian Mackenzie.
He certainly has severely impaired communication and social interaction, although he does not have much in the way of stereotyped repetitive behaviour and the reluctance to change.
The parents have accepted the term ‘autism’ but I feel your opinion would be extremely helpful.”
If we turn to page 17, the next page, we see a letter from you saying:
“I am sure we should refer [Child J] to the Panel for a assessment now.”
Can you tell us what that letter refers to, what was the purpose of the assessment?
A The assessment refers to statutory assessment under the terms of the Education Act – it is a Statutory Instrument – in which children undergo an assessment in using formalised statutory procedures leading to a statement of special educational needs. Effectively it is a means of the local education authority diverting funds or special services to a child who has complex special educational needs.
Q Did you also make an audiology referral to Dr Ruth Owen, who I think is a local specialist in audiology?
A I did, yes.
Q If we look at page 18, that is your referral letter. You say:
“As far as I can identify [Child J], although he has seen Mr Cable and has had adenoids and middle ear ventilation surgery, he has not had a formal hearing test. He will be difficult to test but I think we should try hard to assess this area.”
When you refer to the fact that he would be difficult to test, were you meaning more difficult than the normal child his age?
A Certainly. Testing a child’s hearing can be difficult and challenging if the child does not understand the nature of the procedure and is able to let you know whether they have heard or not. There are electronic means of testing hearing but, as a general rule, they are not as accurate or as necessarily informative as performance testing. What I mean to say is, in the standard test of hearing, a sound would be made and the individual would tell you whether they have heard the sound or not. Because of [Child J’s] communication difficulties and his understanding difficulties, he would not be able to do that, so we would need to use other means of testing him.
Q If we turn on to page 55, we see a letter to Dr Smith, who I think was the GP at that time, with a copy to you, from Mr Cable the consultant ear, nose and throat surgeon.
“[Child J] was admitted as a day case for brain stem evoked response audiometry under general anaesthetic at Warwick Hospital on 17 July 1995 and to our surprise we found that he had a 60 dB loss on the right and a 70 dB on the left. He has been previously diagnosed as autistic but from the history and the fact that I have never seen autism with a hearing loss, it appears that he could well have had MMR vaccination damage with associated deafness. I think the whole situation needs to be re evaluated and my suggestion is that we fit him with a hearing aid for the right ear and that consideration is made to transferring him to a partially hearing unit. I must say that his actions with eye contact and smiling do not fit in with the diagnosis of autism and he may well be copying some of the behaviour of children he sees at his present assessment unit. I will see him myself in 6 months’ time to assess the response to his hearing aid, but if you wish to discuss him with me at any stage in the meantime I would be delighted to help all I can.”
I do not want to take us down too much of a byway, doctor, but it is clear that at that stage it was felt that all his problems might stem from significant deafness rather than any behavioural disorder, but did it ultimately turn out to be the case that deafness was not the major problem?
A I think that is correct. Mr Cable’s letter and assessment at that time was interesting and made us think very hard, if I remember correctly, but there were other bits of information which made us question whether that assessment was, in fact, correct, and time showed that in fact Child J we believe heard very well and treatment of his hearing loss was probably a bit of a red herring - but understandable. I made the point before, diagnosing children with autism is very difficult and they need to be seen by a number of people in several settings, and I think Mr Cable has pointed out the dangers of a one off assessment in that case.
Q Absolutely. I think you also, as you had already anticipated you would, made inquiries in relation to an analysis for fragile x syndrome, and if you look at page 15 you will find that there. This was to Dr Green from you.
“I have recently met this child who to me appears autistic. Have you undertaken fragile x analysis? If not shall I go ahead and do this?”
and if we then go to page 44 we see the result of that which is that the result indicated no abnormality in the fragile x gene. Just in very brief terms was this exploration into whether there was some kind of congenital developmental problem?
A Fragile x is a recognised genetic condition causing severe learning difficulties and sometimes autistic features. It is important to diagnose because it can recur in other family members and the parents need genetic counselling if it has been identified.
Q Ultimately I just want to look at the verdict that was reached in respect of Child J’s condition, and if you would look at page 37, please, you see that this is the end of the psychological report that was prepared by the lady to whom we have already referred, Betsy Brua, a clinical psychologist?
A That is correct.
Q I am not going to take you through the whole of it, doctor, but if we go back to page 30 we see you named as the paediatrician, the other specialisms who have been involved, and then on page 31, under Health.
“[Child J] appears to be a healthy child but his mother reports that he seems to be sensitive to any form of medication. His bowels tend to be loose if he has anything different to eat. He has currently been on Fenigan to help with sleep problems but his mother feels that this has given him diarrhoea and has stopped the medication”.
Then, going on to his developmental history, we see a normal pregnancy under the birth section, a first year of life described as “normal”, but then if we go on to page 32,
“The only unusual feature was that he did not seem to babble; his parents also reported that they could not have ‘a conversation without words’ which you can have with normal children. He was a healthy baby but some breathing difficulties occurred at six months when he spent three days in hospital and was very ill”,
and then in the second and third years of life he
“began to walk, he became very active and fairly difficult. He had no awareness of danger and was hard to occupy.”
“The parents were not concerned”,
but then going on one paragraph down:
“Following his MMR at 18 months his parents noticed a gradual change in [Child J]. His eyes became less focused, eye contact was difficult, his concentration became worse and he stopped using much of his language. Hearing tests were eventually done and some hearing difficulties were discovered”,
and going on to now on page 33,
“[Child J]’s behaviour fluctuates but he generally avoids eye contact and is difficult to occupy. He is very active and needs constant supervision...since starting at the nursery the parents have noticed some improvements in [Child J]’s behaviour. He is a little calmer and is much more vocal. His eye contact is better”,
and we see under the Developmental Assessment his self help skills, toiletting, he is dry during the day and takes himself to the toilet, and going on to page 34, Social Skills, [Child J] “showed very little awareness of other children and ignored me during the visit”, and then on to page 35 we see the analysis of autism, the three features that must be present from an early age, and we see that,
“[Child J] showed the following behaviours which would suggest autism”,
and then they are listed, and there is reference to impairments in his communication and imagination and some suggestions of restricted behaviour. Then turning on to page 37, Conclusions,
“Different systems of diagnosing and describing autism use criteria that overlap but differ in detail. Using the DSM IIIR classification system [Child J] would be described as being autistic. Using the ICD 10 classification system, however, [Child J] does not totally fulfil the criteria for autism and would instead be described as having ‘Atypical Autism’. In my opinion [Child J]’s severe social difficulties, impaired language abilities and lack of imaginative play are certainly autistic like. Although he does show a few signs of repetitive activities and rigid thinking, this is not sufficient to describe him as having classical autism. I believe that ‘Atypical Autism’ is a very suitable description for [Child J] as he shows many features of autism but does not meet the full criteria”,
and then it refers to circumstances regarding his placement.
Does that report from Ms Brua conform with your impression of this little boy? Were you of the view that that was a reasonable assessment?
A Yes, I was. Betsy Brua was an experienced psychologist with a particular interest in autism. She had seen him in several environments and brought in information from other sources, and I felt that her analysis was reasonable and appropriate.
Q And if we go on to 45, we will see that he was also seen by another child psychiatrist, a Dr Cooper, and this is a letter again written to the GP dated March 1995.
“Thank you for asking me to see [Child J] ... I understand that since you made the referral [Child J] has also had contact with Dr Andrew Mills, Consultant Paediatrician, and Mrs Brua. ... I would be grateful if you could arrange for Dr Mills to know that I am involved and ask him if he would be kind enough to send me any further investigations that he has undertaken or is intending to do. If he is due to see him in the next week or two, perhaps you could arrange for him to check the wee lad out for antibodies to gluten. I am also asking [Mrs S] to send me a copy of Mrs Brua’s recent report”.
He says he is not going to replicate the autistic criteria that have already been used but is going to approach it using the Autistic Society’s checklist to see if he has the full criteria for autism.
“I think it is jumping the gun a little bit but I just wonder if it might be worthwhile pursuing further investigations of the dietary aspects of his condition as I am pretty interested in it within the spectrum condition. I have asked Mum to make a list of foods which he appears to be sensitive to, in so far as his behaviour changes if he has them or if they are removed from his diet. This is increasingly seen as important in his condition after a period of being marginalised, but it is certainly not the answer to the entire problem by any means. Be that as it may, I will write a fuller report after I have seen them in April”.
Were you aware that Dr Cooper, as he sets out there, had a particular interest in the relationship of behavioural disorders and diet?
A Yes. Dr Ounsted, Child J’s GP, had made a referral independent of the rest of the things we were doing to Dr Cooper. I think there is a letter in the bundle setting that out. I was not aware of Dr Cooper at the time but clearly his letter sets out his interest, and I was copied into that.
Q And were you content that he should have a role, if he could help them, Dr Mills?
A I had no objection to that.
Q As far as Child J’s mother was concerned, you said that when you first met her she had a view as to the part that MMR might have played in developmental problems that he had. Did that view continue?
A Yes. I think that Child J’s mother and Child J’s parents had, I think it is fair to say, believed very strongly that MMR had had a role in their son’s difficulties, and my memory is that that belief continued for as long as I had contact or provided care for Child J.
Q And were you prepared to countenance and give consideration to her view as to the possibility of that being the cause of the damage?
A Yes, indeed. I was aware that that is what they felt, and I suppose I had an open mind to some extent on that, although having looked already at the issues regarding MMR and autism to some extent and having discussed it with colleagues and been to various meetings, I was aware at the time the evidence underpinning that theory was not great.
Q We will come on to that but perhaps I can just ask you to look, first, at page 65. That is a letter you wrote to Child J’s mother and father. You say:
“I enclose two recent reports concerning [Child J] which you can use to forward to the vaccine damage payment scheme”.
To that degree were you responding to their concern that the child might be damaged by a vaccine?
A Very much so. They believed that Child J had been damaged by a vaccine and I knew the vaccine damage scheme existed. I cannot remember if they asked me for details specifically about it but obviously the information here is that I supported them in following that through, which is what they wished.
Q Can I go on to page 88, please? This is a letter from you to the then GP, Dr Ounsted, is that correct, dated 29 November, 1995?
Q And you say:
“I saw [Child J]’s parents at a case review at the school. We discussed several issues. Firstly, the family were anxious to know whether undertaking a brain scan was likely to be useful. A general anaesthetic would be needed in order to undertake a brain scan and I am not convinced that useful information is likely to be available from this. However, I have arranged for the family to see Stuart Green in one of his joint clinics in Worcester in the near future to discuss this in more detail.
Secondly, we discussed the possibility of food additives irritating his condition. I have suggested they keep a diary of his behaviour and try withdrawing certain foods starting with fruit juices.
Thirdly, the family asked me about the use of vitamins. There is some evidence from several studies in America that the use of Pyridoxine with or without magnesium in high doses, may sometimes be beneficial for children with autism. We are due to have a psychology student in post in the near future who will be able to monitor [Child J] and I feel it could be worthwhile trying this treatment for a trial period under close supervision.”
As far as the possibility of help from vitamins, this was apparently raised by the family to you. Again, was it something you were prepared to think about and give credence to?
A The family, if I remember correctly, the family had raised the issue with me and I had looked at the sources and the research that had been done, predominantly in the United States, and there had been some papers written regarding it, and I felt it was reasonable with appropriate monitoring for us to try that as a means of treating Child J. The family wanted that and I was happy to sanction it as long as we could monitor it closely.
Q And did you, in fact, have some correspondence with the pharmacy as to the precise nature of the vitamin supplement you would be using?
A Yes, I did.
Q We can see that at page 94. That is a letter from the senior pharmacist from Drug Information to you concerning treating autistic children with high dose pyridoxine and magnesium, and it sets out the concentrations in relation to that product and what commercial product you can use. I am not going to take you through all the detail, doctor, but did you institute those inquiries to assist in trying out this?
A We started Child J on a dose of vitamin B6 pyridoxine, which we gradually increased. I made inquiries as to adding magnesium in but I think, if my memory and the records are correct, then we did not, in fact, add magnesium in at the end of the day. We stopped the trial before we got to that point.
Q And did you, as you were planning to do, also ask Ms Betsy Brua, the psychologist, through her assistant, to monitor Child J to see the effects?
A Yes, I did.
Q And if we look at page 104 we can see the report from the assistant psychologist, and that is a brief progress report dated 6 February 1996.
“[Child J] is currently receiving vitamin B6 treatment for his autism”,
and it sets out the details of how it was being given, and if we go to page 105, we see the conclusions which, sadly, were not very positive. He has become more fidgety in his behaviour since he started on it, he has cried more often as the dosage level increases, and he has had mood swings over the past four weeks, and that was done by the application of a particular form of analyses, and Ms Link, the assistant psychologist, says:
“The results of the above analyses agree with my own observations of [Child J] at school”.
So was that an attempt made that was not particularly successful in outcome?
A Yes. We tried it; we analysed it; the family also had a view. I think initially they felt things were helping but then they agreed subsequently it was not helping Child J.
Q Now, we come on in the chronology to 29 April 1996, doctor, when we see a letter to Dr Wakefield from you, and that is at page 117.
“Dear Dr Wakefield,
I understand you have recently spoken to the Mother of this four year old boy who lives in XXX. You suggested to her on the telephone that a referral to Professor Walker Smith may be appropriate and [Mrs S] has contact me asking if I would make a referral.
I have been involved with [Child J] for several years. He presents as a child with classical autism and his language development and social interaction is several impaired. At one stage a hearing loss was suspected, but has not been confirmed. In addition, he has mild diarrhoea which has not really been a clinical problem. There have been no problems with growth or weight gain.
The family date [Child J]’s problems to happening after MMR vaccine at the age of 18 months and they are convinced that this is the aetiology of his autism. There certainly seems to have been several linked reports in the literature of association with MMR with other children, but this is commonly the case in conditions where we do not have a clear aetiology and 95% of children in the UK receive MMR vaccine anyway.
Mother has asked me to make a referral to your team. Could you let me know what you would be able to offer [Child J] and the family?
I am quite happy to be open minded about unsubstantiated causes and possible future treatments, but I am not keen on sanctioning detailed investigations unless there seems to be some logic behind them.”
That was the letter that you wrote to Dr Wakefield and I would like you to deal with the circumstances in which you came to write that letter. First of all, we see that you start by saying, “I understand that you have recently spoken to the Mother of this 4 year old boy …” and “You suggested to her on the phone that a referral to Professor Walker-Smith …” From where would you have got that information?
A I presume that I got the information directly from Child J’s mother herself. I do not have precise information or a record of the precise contact but I presume that I would have had the contact initially directly from her saying that she had this contact with Dr Wakefield and wanted to pursue it further.
Q Do you recall whether you had in fact heard of Dr Wakefield at the time that you wrote this letter to him?
A I do not think that I was aware of Dr Wakefield at all at that stage.
Q I see that you copied the letter to Professor Walker-Smith and indeed you refer in it to the fact that the suggestion was for a referral to Professor Walker-Smith. Did his name mean anything to you at that stage?
A Yes. I was aware that Professor Walker-Smith was an eminent paediatric gastroenterologist at that time.
Q You say in the letter,
“…he has mild diarrhoea which has not really been a clinical problem …”
Can you explain what you mean exactly remembering that we have lay members on the Panel as well as doctors. What do you mean when you say that something is not really a clinical problem?
A I think that it had been reported as a feature but that it was not causing him undue pain or discomfort. The management of it was not particularly difficult and I did not feel that it represented significant underlying pathology that required further management or treatment.
Q Prior to your writing of that letter, had it occurred to you that the problem was such that the involvement of a paediatric gastroenterologist was necessary?
A No, it had not.
Q You wrote that letter plainly at the request of the little boy’s mother. What was your attitude at that stage? Were you content to write it?
A I was very content to write the letter. Child J’s mother was very keen on this approach and I wanted to do Child J justice by exploring further what was on offer.
Q Do you remember talking to Child J’s GP at all about it at that stage?
A I do not recollect it, no. It may have happened but I do not recollect it.
Q You say in the letter that you were quite happy to be open minded about possible future treatment but you were not keen on sanctioning detailed investigations unless you felt there was logic behind them. Were you at that stage aware of the nature of any investigation which might be proposed in respect of this little boy?
A No. Well, Child J’s mother may have given me some verbal information regarding what was proposed, I cannot remember precisely why I should have written the letter in this … I had not seen or was not aware of any detailed proposals at that stage.
MS SMITH: We know that in fact Mrs S wrote to Dr Wakefield with a brief report on the little boy and I want to know whether you recall seeing this document at all. This is in the Royal Free Hospital records at page 80. So, you are in a different volume: JS RFH at page 80. We see,
“Dear Dr Wakefield,
Thank you for your telephone call last week. I enclose a record of [Child J]’s development and regression following the MMR vaccine.
Please let me know if you would like any other information”
and then she says underneath,
“PS If you know of a neurologist or anyone else you think could help please would you let me know – as I want to try anything possible to have our son back.”
I should ask you about the rest of it, so could you go back to page 79. We see that accompanying it was a statement from mum about the normal development, as she says, up until the time of the MMR and, within two weeks of getting his MMR, how it was noticed that his eyes were glazed and concern was expressed. I suspect that there is a page missing to this statement in any event, doctor, because it comes to a grinding halt.
MR MILLER: Pages 81 and following.
MS SMITH: I am grateful, I had a blank page. It does indeed, as you see on page 81 ---
MR MILLER: It goes on to page 92.
MS SMITH: It is a very long statement indeed, doctor, setting out the exact details in relation to the mother’s concerns as to whether the child should have a second MMR injection and the concerns in relation to his behaviour. What I really want to ask is, do you have any recollection of seeing this lengthy statement about his condition or the letter to Dr Wakefield which it was sent with?
A I know that Child J’s mother would write letters and sometimes letters in some detail. I do not recollect seeing this particular letter.
Q As far as you were concerned, was there anything particularly unusual about the apparent fact that it appears that Dr Wakefield had told Mrs S to ask for a referral to Professor Walker-Smith and she had come to you for that referral to be made? Was there anything unusual about it?
A In this particular case, I did not think that it was particularly unusual. I knew that Mrs S was, as she says in her report here, desperate to find something to help her son and I knew that she was someone who was channelling her energy into finding something that would help him. So, it did not surprise me that she was continuing to look at all options and the fact that she had found Dr Wakefield and the service there would be entirely appropriate. It is entirely the kind of thing that would have happened in a case like this.
Q Did you have any understanding of what the respective roles of Dr Wakefield and Professor Walker-Smith were?
A At that stage, no, I did not.
Q Did you in fact subsequently speak to Dr Wakefield yourself?
A Yes, I remember that I did.
Q Can you remember how many times?
A I know that it was more than once; I think it was twice but it may have been more.
Q Do you remember who initiated the call?
A I am sure that Dr Wakefield phoned me on at least one occasion. I think that he probably phoned me on both occasions but I do not actually have a contemporaneous record to back that up, so it is memory only.
Q Can you tell us, at least in broad terms, your recollection of what was said during those telephone calls?
A If I remember when Dr Wakefield first phoned me or our first conversation, he introduced himself and said that he had had contact from Child J’s mother. He talked about his interest and his research; he seemed to be interested and enthusiastic about what he was doing and feeling that it was very important research.
Q I am sorry, I did not catch that.
A I remember that he was enthusiastic and he felt that the research was very, very important. I remember talking to him in some detail about it and I know that I formed the view that, although the research was interesting, given the extent of the investigations that were being proposed and given the extent of Child J’s disability – his challenging behaviour and, if you look at the rest of the record here, you will see that the records are that the family were dealing with huge problems in terms of his development and his behaviour and just simply managing him – the detail, depth, extent and invasive nature of the investigations were not going to help him and, in my view, they were not appropriate.
Q We will come on of course and look at the correspondence where you set those views out very clearly, Dr Mills, but, in relation to the telephone conversations, you mentioned the proposed research. Was it your understanding that it was research that was proposed?
Q You referred to the intensive investigations; do you recall that they were discussed at that stage?
A I am sure that they were discussed, yes.
Q You are sure that they were?
A I am sure that they were. I cannot remember precisely what was discussed. If someone had said, for instance, “Pop him down to London, we’ll see him, we’ll do a blood test and we’ll take it from there”, I might have had one view. I am sure that if they said, “Pop him down to London, we’ll admit him to hospital and go through a range of fairly invasive investigations”, that would clearly have been my view, which is why I formed the view that these did not sound as if they were going to be easy to perform on [Child J] or necessarily in his best interests.
Q Was it your impression that the invasive investigations were themselves research?
A Yes, that was my impression.
Q You have said that there were two conversations – and do say if you do not remember because I appreciate that I am asking you to rely on memory now – but do you remember whether that spanned the two conversations or was there other content in the second conversation?
A My memory is that the second conversation was Dr Wakefield saying, “Why haven’t you referred [Child J]?”
Q I want you to look at the Royal Free Hospital records on page 77. That is the same letter, that is your letter of Dr Wakefield, that I took you to in the local hospital records but, if you turn over to page 78, please, you will see the words, “Discussed with Dr Mills” and then underneath jotted down, “Happy to make”. If – and I accept that this is an interpretation – that is intended to suggest that you were happy to make the referral, would that have been an accurate representation of your views at that stage?
A That is not my memory.
Q What did you understand was Dr Wakefield’s particular research interest? What did you understand he was going to be looking at if you referred Child J?
A If I remember rightly from our first telephone conversation, he described to me his interest in inflammatory bowel disease, his interest in that being caused by the measles virus and his initial surprise and then increasing interest that there appeared to be association between those things and autism and he was the researcher looking at those things.
Q When you say measles virus – and it may be that you did not – but did you understand that to be in the context of the wild measles virus or the vaccinated virus?
A I think that it is difficult for me to remember the detail of the conversation given the weight of information that has filled the last 12 years or so. If I remember rightly, I think his logic was that originally it was measles virus but then the logic, not unreasonably, went on to say that there was not much wild disease around and therefore the virus must be coming from the vaccine.
Q Can we look on in the local hospital records again to page 114. This is a letter that you wrote on 3 June 1996 to the child’s then GP, Dr Shore, and you set out, as is obviously your practice, the three problems at the top of the page and then you say,
“I saw [Child J] with his Mother in my Outpatients in Evesham on 21st May.
His normal physical appearance and abilities coupled with his limited understanding and use of speech and poor social interaction makes him an extremely difficult child for his family and others to manage.
He is currently settled at XXX School and seems to enjoy it.
The recent trial of B6 therapy was not a success [and] has been stopped.
The family remain convinced that [Child J]’s problems developed after MMR vaccine and they have been in contact with several other families around the country who believe the same. They have recently tracked down a Dr Wakefield, gastroenterologist at The Royal Free Hospital in London. I have discussed the issue with Dr Wakefield myself and his team are undertaking research into measles associated chronic diarrhoea. I [sic] have, incidentally, identified several children who apparently have autism …”
I am sorry, is it “They have …”?
A I think I would change that to “they” and that is the meaning of the letter.
“They have, incidentally, identified several children who apparently have autism as an association and he was very keen to offer [Child J] detailed gastroenterological investigations, including a brain scan in London.
[Child J] seems to have loose motions two to four times each day. At one stage they were associated with mucous, but this has now settled. There are no other symptoms which point to his GI tract and there is certainly no clinical evidence of malabsorption.
I have to say I was rather reluctant to refer [Child J] to a far flung centre of gastrological investigation and research. However, I did agree to undertake some blood tests to look for more subtle evidence of malabsorption after which we can reassess the situation. It does seem unlikely that any of this is actually going to help [Child J]’s behaviour or day to day management.
I have arranged to see [Child J] and his family in three months.”
Dr Mills, did that accurately sum up how you were feeling at that time?
A Yes, I think that is a fair representation of my feelings at the time.
Q You say that you agreed to have blood tests and an EEG performed. No, sorry, you did, indeed, I know have an EEG performed, but you say, “I did agree to undertake some blood tests to look for more subtle evidence of malabsorption”. With whom did you agree that?
A I would have discussed it with his parents and agreed it with them.
Q Where would the impetus for having blood tests have come from? Would you have suggested it to them or them to you? How did it come about?
A My memory of the situation was that the family were saying they wished to go to London for further investigation. The doctors in London were saying they wished him to be referred to London for further investigation. It was my view that those things were not indicated and would not help JS. However, I suppose in the back of my mind I was thinking: well, am I missing something, should I be thinking further, am I acting reasonably here? I felt that if I could identify other evidence that would point to clear significant pathology in his gastrointestinal tract that would increase my comfort in referring him to London for those investigations.
Q When you say “to look for more subtle evidence of malabsorption”, did you have any reason to suppose, at that stage, that there was a problem with malabsorption?
A No, I did not. He was well grown and had no evidence of anaemia or what have you. The diarrhoea possibly could have been a sign of GI disturbance, although, in my experience, children with severe learning difficulties and autism very frequently have bowel disturbance, either constipation or diarrhoea, or sometimes both. In my view, just the existence of some slightly altered bowel disturbance was not a sign that there was necessarily anything wrong with his GI tract.
Q If we go on, please, to page 125 we will see that you did, indeed, carry out your intentions. This is where I got the reference to EEG from. I was slightly jumping the gun:
“Dear [Mr and Mrs S], I have arranged for [Child J] to attend the ward to have an EEG under sedation and blood and urine tests undertaken,”
Then asking them to bring the child to the children's ward at the local hospital. What about the EEG, doctor? Can you tell us how that came into the picture? I am sorry, have you found the letter?
A Yes, I have.
Q Do you recall why the EEG was added on?
A In actual fact no, I cannot remember why the EEG was added on. The records that we have in front of us contain the typed letters. They do not necessarily contain my contemporaneous written notes. I do not know why I decided to add the EEG on at that stage. There may well have been other features that people had told me about and I felt that sometimes if a child is going to be admitted for investigation then we ought to do several things at the same time for convenience. I cannot remember why I added the EEG on at that stage.
Q The next letter that you wrote to the GP was in September, on 24 September 1996. It is at page 134.
A Sorry, can you repeat the page number?
Q Page 134. This is your letter, as I say, to the GP:
“I saw [Child J] with his mother on 17 September. He is an extremely difficult child to manage. No spoken language, comprehension of language similarly extremely limited, social interaction and behaviour considerably impaired and the family find caring for him an extremely daunting, challenging task.”
Then we go on to the next paragraph:
“Mother remains desperate to find out why [Child J] has developed the problems he has. We talked about referral to London, and gastroenterological investigations, which again I have advised against.”
That carries on your concerns about these investigations and your advice to the contrary. You say in that letter that the mother was desperate, Dr Mills. Can I ask you in respect of that, you were still advising against it: what was in your mind in relation to that? First of all, who is your patient?
A Well, Child J was my patient and what was in my mind was the best interests of Child J. I frequently deal with children with severe disabilities and their families are frequently desperate, desperate sometimes to sleep, desperate for help. In Child J's particular case, his family were desperate for those things, but also desperate for knowledge as to the nature of the aetiology of his difficulty. I formed a view and it was my opinion that the investigations that were being offered actually would not give them that information, and that the extent of the investigations was not in his best interest.
Q If these investigations had, to some degree, alleviated the distress of the parents does that necessarily in your view weigh in favour of allowing them to be carried out?
A Yes, it is a judgment. We would often manage children with similar difficulties differently, depending on the wants and needs of the family. At the end of the day, I had to be clear as to my view as to what was in Child J's best interests. The families of children with disabilities will often search and shop around and will often be given lots of different ideas or treatments or options. I see part of my role is to give a clear, concise opinion as to, or give them guidance on those things. My view on this one was clear that my guidance was that these things were not going to be helping Child J.
Q If we go on to page 141, please. This is a letter that was written by the clinical psychologist, Miss Brua, in November 1996, 1 November 1996, to you indicating that Child J's name had been put forward for residential schooling but there had not been a definite answer, that his behaviour was extremely demanding. We see:
“Mrs S was tearful and distressed at times during my visit”,
and it sets out the problems. Then going to the next page:
“To add to the above problems [Child J] has started wetting his bed”.
Then to the next paragraph:
“Suddenly in the last two weeks he has started wetting the bed up to three times a night. He seems to be dry during the daytime”.
Then there are various problems with inappropriate urination and defecation. Urine samples have been analysed. Then we go on to investigations:
“[Mrs S] is desperately hoping that [Child J] can have a brain scan especially as she now sees him going backwards in his toileting. As I said in my previous note to you, I am concerned at [Child J's] loss of toileting skills. I do not think it is emotional nor attention seeking. It is unfortunate that we do not have a proper baseline of his skills from a year or two ago. Certainly, from talking with [Mrs S] there are quite a few things that [Child J] does not do now that he used. I have asked Hanna Link to do an assessment of functional skills so that at least we have an accurate record of what he does at present so that we can compare it to future years. [Mrs S] is still in touch with Dr Wakefield at the Royal Free who is apparently saying [Child J] would come in for a week's investigation which would include a brain scan before Christmas. This would be free of charge. I was fairly confrontational with [Mrs S] about how she dashes from one approach to another. She acknowledges that she is inconsistent. I have also said how little I thought a brain scan would show. She, however, feels strongly that she wants to pursue the work with Dr Wakefield. I got the impression she would do it with or without our support. I find this situation extremely challenging. On one hand, [Mrs S] is offered medication by Dr Tesh and rejects the idea. On the other, she is prepared to spend a week in a hospital keeping [Child J] occupied in order to have a brain scan. In the end, I feel that [Child J] is probably the most difficult child in the learning disabilities service. I have not provided any real help.”
“Can you telephone me and let me know your thoughts”.
As far as that letter is concerned, doctor, first of all, just so that we can be clear there is a reference to loss of toileting skills there. Do you differentiate that at all from something which is a gastrointestinal problem or might be one? Can you explain to us what “loss of toileting skills” means?
A Loss of toileting skills here means that previously he would have gone to the toilet in order to open his bowels and pass urine, and that he was stopping doing that and he was soiling his pants and wetting his clothes. That is my understanding. The causation of such a change, in a child such as Child J, is complex and could have a number of different causes which would need to be thought through.
Q The reference to Dr Wakefield, who is apparently saying that Child J could come in for a week's investigation which would include a brain scan which would be free of charge; was that, in your experience, an unusual situation, that offer?
A We were able to do brain scans in Worcestershire quite effectively. Money was not an object. I do not recollect having a detailed discussion with Mrs S as to whether we should or should not scan Child J's brain. I think that I was aware that a brain scan, given the situation we had to that date, was unlikely to add any further information.
MS SMITH: Sir, I am going on to another letter now.
THE CHAIRMAN: I think it will be an appropriate time for us to adjourn and also for Dr Mills to have a little break. We will now adjourn and resume at 10 to 4. (To the witness) Dr Mills, you are still under oath and in the middle of giving evidence. Therefore, please do not discuss about this case with anyone. I am sure someone will look after you for a drink. We will resume at 10 to 4.
(The Panel adjourned for a short time)
MS SMITH: I was going to ask you to turn next, Dr Mills, to a letter from Child JS's mother to you. It is on page 144 in the local hospital records, dated 6 November 1996:
“Dear Dr Mills,
I understand you have been talking to Betsy, [that is Betsy Brua I assume], about [Child J] who has started to wet the bed up to three times a night, has also started dribbling. We are concerned that this seems yet another step backwards. I have, this week, heard from Dr Andy Wakefield who has sent me the enclosed information about Heller's disease. This sounds so much like [child J's] history but we find it most alarming. If this is what is happening to [Child J] we need to find out before any more time is lost. I would be grateful to hear from you as soon as possible.”
Accompanying that letter, if we turn over to page 145, we see a proposed clinical and scientific study. Was this the first time you had seen this document, doctor?
A I think it was the first time I saw it in this detail.
Q If we just look very briefly, page 146, we see the departments involved. First of all, Professor Walker Smith, Dr Murch, Dr Phillips, Dr Casson and Dr Wakefield in the department of histopathology. Going on: child psychiatry, Dr Berelowitz on page 147, and neurology, Dr Harvey, on page 148. Then there is a description of disintegrative disorder, which is also described as Heller's Disease, to which the child's mother refers in her letter. We see the signs set out there. On page 151, “complement, measles and disintegrative disorder”. On 154, the studies: full clinical examination, blood tests, measles and rubella, immunoreactivity, colonoscopy/ileoscopy and biopsy, histology and immunohistochemistry for measles virus, ultrastructural analysis of mucosal biopsies, exclusion of other GI infections.
Then on the next page:
“Neuropsychiatric studies, neurological and neuroradiological studies, including MRI, lumbar puncture and CSF profiles and EEG and brain stem auditory evoked potentials”.
Various other tests are referred to as well. Then on page 156 there is reference to the fact that it is a demanding protocol, at the bottom of the page, for the clinicians. On 157:
“Referrals will be coordinated by Dr Wakefield, Professor Walker Smith and Dr Murch such that they will be admitted for colonoscopy preparation on a Sunday. All blood tests performed on the Monday followed by colonoscopy. On Tuesday, psychiatric and neurological assessment. Out patient follow up.”
With regard to that protocol, doctor, did that describe in more detail the understanding that you already had of what was proposed for this little boy?
A Yes. It described the fact that the plans were for endoscopy of the gut, for general anaesthetic for a lumbar puncture and a brain scan, a number of blood tests and investigations, and obviously detailed other analyses and a prolonged in patient stay.
Q Did it do anything to allay the concerns that you already say you had?
A It confirmed the view that I had, that the level of investigation was not, in my view, appropriate for child J at that stage.
Q You have told us that when you spoke to Dr Wakefield your impression was that this was research. Did that protocol do anything to change that impression?
A I think it confirmed my view.
Q The next document which was enclosed with Mrs S's letter starts at page 162.
It is a long fact sheet from Dawbarns, solicitors. We see at the top, “Mumps, Measles and Rubella (MMR) Vaccines and Measles Rubella (MR) Vaccines”. It is a fact sheet with a long introduction and a background setting out the illnesses in context.
Would you turn to page 178. At the bottom right hand corner “Crohn’s and Autism”:
“There could also be a link between the two conditions (Crohns and Autism) AND the measles element of the vaccine. Our work also indicates a clear biological mechanism with for the two conditions. Indeed many children with autism have stomach disorders.
If your child has developed persistent stomach problems (including stomach pains, constipation or diarrhoea) following the vaccination, ask us for a fact sheet from Dr Wakefield who is looking into Crohn’s disease).”
Was that the other document you were sent by Child J’s mother?
A That was my understanding, yes.
Q As far as the fact sheet is concerned, if we look at the small type of the bottom, was that fact sheet dated 31 October 1996?
A Yes, I can see that, yes.
Q Did you read those documents through thoroughly – I have taken you to them very briefly?
A Yes, I did.
Q What was your reaction, did you have any further reaction to that which you already expressed in relation to these documents?
A The proposed research study described in detail the investigations that were being proposed for the children and the investigation protocol that was being set out which was clear. The fact sheet from Dawbarns, solicitors, I have to say, I found extraordinary. The fact that it seemed to have come at the same time as the proposal for the investigation I found extraordinary. I have to say I did read it through and noted that Dr Wakefield’s name was linked into that.
Q When you say “extraordinary”, can you elaborate a little on what you mean by extraordinary?
A I have to say I thought the Dawbarns fact sheet was full of pseudo-science. It was a poorly argued science, pulling out a range of random facts that were designed to promote a particular view without actually looking at a broader range of information that was clearly available to counter all the arguments.
Q I think the next relevant document is on page 183. This is a letter from Professor Walker Smith, dated 7 November 1996:
“Dear Dr Mills
Dr Wakefield has passed on correspondence concerning [Child J]. Through Dr Wakefield we have been looking at a group of children with autistic symptoms related to MMR vaccine and have found that a significant number of children have had gastrointestinal symptoms. When these have been present, we have so far found endoscope abnormalities in all five children we have investigated. I would be quite happy to see [Mr and Mrs S] and to discuss the situation with them and to indicate what investigations might be appropriate and then to get your advice on the right for us to proceed.
I look forward to hearing from you.”
Were you surprised to that letter?
A Yes I was, because I thought I had made my view very clear to the Royal Free team that I did not think that Child J was appropriate for their investigations, or that it was in Child J’s best interests for me to refer him to their investigations.
Q I think it is right that this is the first correspondence that you had from Professor Walker Smith as opposed to Dr Wakefield?
A I believe it is, yes.
Q What did you understand from that letter – you have told us you had heard of Professor Walker Smith – what did you understand as being the purpose of referral from that letter?
A My understanding was that Dr Wakefield and Professor Walker Smith were working together on this research and they felt strongly that Child J would be a good candidate for their research and they wished me to make a referral to them.
Q We can see your response at page 185 in a letter dated 15 November 1996:
“Dear Professor Walker Smith
Thank you four your letter concerning this boy. The family made direct contact with Dr Wakefield themselves following information from the JABS Parent Support Group. I have spoken to Dr Wakefield and I consider that [Child J] is not appropriate for the investigation schedule he recommends at present.
I understand that Dr Wakefield has been continuing to send the family information. In particular he has been sending them information from a firm of solicitors who seem to specialise in litigation in relation to immunisation.
I agree that your research findings are very interesting, however, as [Child J’s] main Consultant, I do not think that your research programme is appropriate for him at present. This, of course, may change and the family may disagree with my view.
I am beginning to wonder whether you and your department are rather pressurising this family and I would request this to stop.”
That is a stern letter, if I may say so, from one consultant to another. Was it unusual for you to write a letter in those terms?
A Yes, very unusual.
Q Tell us what prompted you to write as sternly as that?
A Because, in my experience, it is medical practice for a responsible medical practitioner to refer to a colleague when they feel that is appropriate. A colleague will then decide if they wish to take the referral and if they can help. On occasions, if you like, a specialist may make contact and say, “I think I can help”, but it is nearly always seen as the responsibility of the referring or the initially responsible clinician to make the referral. If they choose not to on the basis they have the most and broadest information regarding the patient, then, in my experience, that view is taken and that is usually the end of the matter.
Q We are in November 1996. At that time did you consider that this child needed to be referred to a gastroenterologist, any gastroenterologist, leaving aside this particular study?
A No, I did not.
Q What were you relying on in coming to that view?
A My knowledge of Child J and my clinical assessment of him.
Q Also, with your general experience, what symptoms in a child would have made you feel that it was appropriate to refer for a gastroenterological opinion at a tertiary centre like the Royal Free?
A First, it would be quite unusual for me to refer a child from XXX to a London based tertiary service. We have a specialist service at Birmingham Children’s Hospital and I would nearly always use that as my first point of call if I wanted a specialist gastroenterological opinion. Secondly, the symptoms that would make me concerned would be if the child had a range of symptoms and illness that was focusing on their GI tract. I include things such as chronic persistent diarrhoea such as is interfering in day to day life, or makes me believe that it signifies significant underlying pathology within the gut, such us a major inflammatory bowel disease or an unusual infection we have not managed to sort out. Also I might make a referral if the child had severe failure to thrive, they were not growing properly, suggesting that the food or their nutrition was not being absorbed properly. Thirdly, I might want to make an investigation of the child if they had other GI symptoms, such as persistent vomiting, if they were passing blood or they were vomiting blood or what have you. I would probably want to do some investigations off my own bat first, although I would make a judgment on that as to how likely those investigations were to show something and whether it would be important to leave it to the specialist to choose the investigation so the child were not, so to speak, being investigated twice. So it was extraordinary, first, because I would not normally refer from XXX to London and, secondly, I would only consider referring if I thought the child had symptoms that were sufficiently severe to make me feel that a tertiary gastroenterologist needed to see them, give an opinion and follow investigations through.
Q You say that you were beginning to wonder whether there was pressure on the family and you requested to stop. What was it in particular that made you write in those terms?
A Because the Royal Free team contacted me persistently regarding this young man. I could appreciate the family may have contacted them, but I, too, had spoken to the family about it and expressed my view. I might have expected the team to have taken my view and given some respect to my view, rather than persistently contacting me and recommending that I should make a referral to them.
Q You had a response from Professor Walker Smith on page 186, the next letter, dated 22 November:
“Dear Dr Mills
Many thanks for your letter. I can quite understand you feeling that it may not be appropriate for us to see [Child J] at the moment. However I would be happy to hear from you again should the position change.
In relation to your last comments, I am certainly doing nothing to pressure the family to see us. In fact my department is somewhat overwhelmed by the response of parents who believe that their children have autistic and gastrointestinal symptoms following MMR. I personally had no idea that there were such large numbers of patients in the community across the country where the parents had made this association. I am sure Dr Wakefield, who is not actually a member of my own department, would also say the same.”
There is then a letter from Dr Wakefield at page 191 dated 8 January 1997:
“Dear Dr Mills
Professor Walker Smith has passed on a copy of your letter to me dated 15 November 1996.”
I think he means a letter to Professor Walker Smith:
“In it you make several serious allegations. I wish to make it quite clear that I have at no stage sent this family any information from solicitors dealing with litigation in relation to immunisation.. Secondly, [Mrs S] phoned me initially and has continued to request investigation as part of our protocol. I find the accusation that we are pressurising this family grossly unfair and without any substance whatsoever. [Mrs S] perhaps quite justifiably has sought inclusion of her son in our investigations. It is our opinion that children with late onset autism such as [Child J] have been under investigated and their parents’ anxieties often dismissed too readily by those in charge of their care. I look forward to receiving your comments before deciding on how to proceed with this issue”.
Do you understand anything in particular by that last sentence, “before deciding on how to proceed”?
A I cannot remember what I thought at the time.
Q At any rate, you responded to it. Before I go on to that, may I ask you one other question arising out of this, doctor? What did you think about the suggestion that children such as Child J had been “under investigated and their patients’ anxieties dismissed too readily”?
A I think that might be a fair enough comment in some respects, perhaps. I think parents with children with severe disabilities will frequently say they feel their medical carers and other people have not taken seriously their worries and concerns about their child, and I am aware of that because I deal with a lot of these families. Some families feel their children need to be investigated and investigated and investigated until an answer is found; other families do not want their child touched because they feel they have suffered enough. It is my role to try and find a common path through that. I think every doctor who is dealing with these families may have a different view or feel differently, and I would certainly feel that I am sure Dr Wakefield if he was meeting some of these families, particularly families with these particular views, may well feel passionately about this, and I can understand that.
Q Did you feel it was a fair I will not say criticism - observation, as far as your treatment of this particular child was concerned?
A No, I do not, because I would like to think that I had thought about this very carefully and what had been proposed very carefully and had taken advice from colleagues, and I still came to the same conclusion that in fact, in Child J’s condition and situation, these investigations that his parents wanted were not in his best interests.
Q Did you feel he had been in any way under investigated, doctor, Child J at that stage?
A No, I did not, but I suppose the whole correspondence and the whole issue was making me quite sensitive and, perhaps, a little nervous, because like any medical practitioner you continue to think: Am I doing the right thing? Should I be doing more? Am I acting appropriately? It would be wrong to say that my mind had been closed and things, and you always review and rethink and think: Have I missed something here? Am I actually acting in the child’s best interests? Am I doing the right thing here? But at the time, and obviously the evidence here indicates, I felt he did not require, given the situation he was presenting with me at each individual time, further investigation.
Q If we go on we see your response to Dr Wakefield, page 195, and you say:
“I am sorry if you feel that the information contained in my letter of 15 November is inaccurate. [Mrs S] gave me a fact sheet from Dawbarns Solicitors ... She also gave me a study proposal entitled ‘A New Syndrome: Disintegrated Disorder and Enteritis following Measles/Rubella Vaccination?’ with yourself named as the co ordinating investigator. [Mrs S] told me that you have given her both these documents. It is quite possible that [Mrs S] may have been confused about the origin of the documents and failed to admit they came from separate sources. However, I certainly was led to believe that you were the source of both documents, particularly as the Dawbarns document encourages parents to contact yourself if” and then you have quoted “‘your child has developed persistent stomach problems (including stomach pains, constipation or diarrhoea) following the vaccination’. The article comments that you are looking into Crohn’s Disease. I apologise if I have incorrectly attributed the source of this document to you.
My comments concerning the fact that you may be pressurising the family are the result of the following facts. I fully accept that the family contacted you in good faith and you encouraged them to discuss with me the possibility of referral to your department for further investigation. I recollect that you and I have spoken on several occasions on the telephone concerning the possibility of referring [Child J]. I have always been interested in your research, but have always been of the view that, given [Child J]’s current clinical state, his lack of any gastroenterological symptoms of any significance, and the extensive nature of the investigations that you are recommending, your programme would not benefit [Child J] at present.
As I recollect I made this view known to you and [Mrs S] on a number of occasions. In addition I have asked one of my paediatric colleagues to review [Child J] and she is of the same view. In view of all these facts, I was rather surprised to receive a letter from Professor Walker Smith on 7 November continuing to recommend referral to your department.
[Child J] is an extremely difficult child to deal with clinically. He is extremely difficult to restrain in the home and school environment. Like [Child J]’s parents and yourselves we are desperate to find something that will alleviate both [Child J]’s symptoms and the family’s distress. However, on reviewing your research programme, myself and my paediatric colleagues have felt this is not what [Child J] needs at the moment.
I hope you will now take the clinical decision of those people who are currently looking after [Child J] that investigation by your department is at present not a pressing need. If [Child J]’s clinical situation should change in the future, or, indeed, if the results of your investigations indicate that [Child J] may benefit, then I will be happy to change my clinical advice. I do hope this clarifies the situation.”
Did that letter correctly sum up your position, doctor, at that time, both in relation to the issue as to where the Dawbarns fact sheet had come from? You say that Mrs S had told you that it had come from Dr Wakefield, and in relation to your continuing views that referral was not suitable?
A Yes. That summed up my views then.
Q And that letter, I think it is right, was copied to Professor Walker Smith, and we can see that at the bottom.
A Yes, it was.
Q Dr Wakefield replied to you at page 192, 19 February 1997, simply thanking you for your letter and comments and saying,
“I appreciate your taking the trouble to respond and I can now consider this matter closed”.
Was there no further contact with Dr Wakefield after this date?
A I think that was the last contact I have had with Dr Wakefield.
Q But then, if we go on to April 1997, did you receive another letter from Professor Walker Smith, page 199, and it is dated 23 April:
“Dear Dr Mills,
I am writing to you again as I understood from Dr Wakefield that the family are considerably distressed concerning [Child J]. We have begun to have some quite remarkable success in treating children with autism and evidence of bowel inflammation with Sulphasalazine and related drugs. I do believe it really would be helpful for us to do these investigations in [Child J], or for me to at least see the child to assess the situation. I enclose a copy of our protocol and would be grateful if you could reconsider this issue once more”.
Was that letter copied to Dr Wakefield on page 199?
MS SMITH: And if we look over the page, doctor, we see the enclosed document, which is a different document from the previous protocol that was sent to you, which is entitled, “Introduction to the rationale, aims and potential therapeutic implications of the investigation of children with classical autism, or the autistic spectrum disorder, who have gastrointestinal symptoms”.
I am not going to read the entire document, doctor, but if I can run through it then the Committee can read it more carefully to themselves:
“What is the background to this study?
Following publication of data demonstrating a possible link between measles virus, measles vaccination and IBD we have been contacted by an increasing number of parents who describe in their children features of autistic spectrum disorder (especially ‘late onset’) and also symptoms suggestive of intestinal dysfunction, including pain, diarrhoea, bloating and food intolerance. Behavioural symptoms and signs were reported to parallel intestinal disturbances, and specific foods in some cases appeared to trigger both deterioration in behaviour and [GI] symptoms.”
It then sets out the syndrome of regressive autism and how that comes about, relying apparently on a paper by Rutter et al, and differentiating regressive autism from classical autism, and we see at the bottom of the page:
“In those cases reported to us, many parents have consistently and spontaneously linked the onset to MMR vaccination. In a similar series reported from the US there has been a consistent link with MMR vaccination”,
and then it sets out the evidence that is accumulating and it says at the bottom of the page:
“It has been known for some time that GI symptoms and food intolerance may occur in autistic children. Some have associated this with coeliac disease. However, a study of 7 autistic children found no evidence of coeliac disease but did find a history of gastrointestinal symptoms in all cases”,
and it sets out those problems of food intolerance, and then if I can just ask you to go to the bottom of page 202:
“What does this study hope to achieve? The purpose of this preliminary clinical study is firstly to adequately and appropriately investigate the gastrointestinal signs and symptoms manifested by these children”
and then in bold type ---
“investigation is merited on clinical grounds”.
It is our experience that these clinical features often have been ascribed to the inevitable consequences of behavioural abnormalities upon bowel function, and as a consequence the children have not necessarily been investigated adequately. It should be stressed, therefore, that the investigations are clinically indicated in all cases that are admitted for evaluation. The validity of this approach is borne out by the fact that most children investigated so far have significant and consistent intestinal pathology (lymphoid nodular hyperplasia and microscopic colitis). Secondly, the purpose of the study was to seek the presence and characterise the nature of any intestinal and cerebral pathology in affected children. In view of the coincident changes in both behaviour and intestinal symptoms we believe that this form of regressive autism and perhaps other behavioural problems within the autistic spectrum may be linked to chronic intestinal inflammation. It is our aim to investigate and institute appropriate therapeutic measures aimed at controlling the intestinal inflammation and correcting any nutritional deficiencies that may be present. The impact on these measures will be monitored. Preliminary experience has shown that mesalazine or enteral nutrition may have significant benefit in some cases.
Finally we hope that the possible role of MMR will be elucidated and that further insights into the pathogenesis of regressive and classical autism will be provided.
Why should these children be investigated at the Royal Free Hospital?
The Department of Paediatric Gastroenterology and the Inflammatory Bowel Diseases Study Group are uniquely qualified to investigate this new syndrome. Not only has Professor Walker-Smith’s team (…) [have] a large experience in diagnostic paediatric colons copy, but also the range of tests required to investigate these children appropriately, and the basic scientific investigations required for analysis of tissues (including recognition of viral antigens) are all sited at the Royal Free Hospital. The molecular technology for detection of virus genetic material in blood, SCF and biopsy specimens has been optimised by molecular biologists in the Inflammatory Bowel Disease Study Group. In addition, investigations have been arranged with other workers both within the Royal Free and other institutions.”
MR MILLER: I think it is clear that this is not a complete document because a number of references are referred to. I think there are in fact three other pages which I do not have in the Chamber but I will get overnight in order to complete the document. I know that it ends with a list of references as we expect but there is certainly another page of text. I have not unfortunately copied it yet but we will have it tomorrow morning.
MS SMITH: Thank you for that indication.
MR MILLER: I have only just noticed it.
MS SMITH: Mr Miller can return to it if he wishes to. (To the witness) This is dated April 1997, doctor. What did you consider that it told you about the treatment and the success which the team at the Royal Free Hospital had had?
A It told me that they had a theory. They felt that they had a group of people presenting with the syndrome of bowel disorder and autism and that they felt that proper investigation of the bowel disorders in detail and potentially treatment of those may actually help them.
Q There is considerable emphasis – I mean literally emphasis by putting it in bold type – to the treatment being for clinical reasons. Had you seen a document of this kind from a hospital before?
A I do not recollect so, no. I am sorry, may I clarify: a document of this type from any hospital?
Q Yes, from any hospital.
A I have certainly seen research proposals in the past but I do not recollect seeing a document like this being attached to a letter requesting me to make a referral for a child to them, no.
Q You say that you have seen research proposals before, doctor, but this is a document which appears to be making it very clear that it was not a research proposal. There are numerous references to it being on clinical grounds. Were you convinced by that?
A No, I was not. I suppose that this came as a culmination of a previous few months/a year or so of correspondence and I thought that in a way our correspondence had finished in January and I was surprised to get this three months later.
Q The letter that was sent to you from Professor Walker-Smith refers to the fact – and I am looking back to page 199 – that he understood from Dr Wakefield that the family was considerably distressed concerning Child J. There is no reason why you should know the answer to this but did you know anything about the contact that had apparently been occurring between Dr Wakefield and the family at that time?
A I think I was aware that the family continued to have contact with Dr Wakefield but I was not aware of the detail of it.
Q You responded to Professor Walker-Smith on 12 May and we can go on to page 204 to see your response. You say,
“Dear Professor Walker-Smith,
Thank you for your letter …
Please send me details of your remarkable successes in treating children with autism. I need to have details of how these successes have been evaluated in terms of an improvement of:
a) speech and language development
c) obsessional behaviours
d) ease of management by the family.
Please send me details of all children you have treated and the results of the successes in these children.
Also could you send me details as to how your detailed gastroenterological investigations have helped these children, particularly those children who, like [Child J], have a minimum of gastroenterological symptoms.
Similarly, I would be interested to examine your evidence for the links between MMR vaccination and autism. The references you quote are obscure and I would be grateful for copies of the information that you have.
I need to be reassured about the contracting situation that any referral to your department would include. Your department has been very energetic in requesting me to refer [Child J] to you.
As a result of your contact with [Child J]’s family, they appear to be requesting further investigations in your department. From the documentation that you sent me I note that you are anxious to involve [Child J] in your research programme and presumably involve him in detailed follow up afterwards. Additionally, [Mrs S] has told me that the BBC have contacted her as they would like to follow [Child J] through his investigation week with you as part of a programme they are making.
I have never sought your opinion and I find that your correspondence puts me in a very difficult situation. I have a responsibility to ensure that [Child J] has the best possible care and appropriate investigations. This responsibility also includes advising his family about inappropriate treatment and advising them sensitively about the extensive ‘alternative therapy market’. You have never met [Child J] or his family or have any knowledge about his parents, their health and their wants and fears.
As this request for referral has so clearly come from yourselves, I feel that you have the responsibility to clarify the contracting situation with the Worcestershire Health Authority and [Child J]’s GP Fundholding Practice.
I look forward to hearing from you”
and you copied that letter to the GP. What did you mean first of all about needing to be reassured about the contracting situation, doctor?
A In those days at the NHS, any particular area would have, if you like, a contract with particular referring hospitals and money would follow the patient, it would follow through that contract. If we were referring in an extra contractual manner, then additional moneys would need to be found to pay that situation. If I, for instance, had made a decision to refer Child J to London for further investigation, I would have had a contracting manager asking me why I wanted to do that, why I was not able to get those investigations done as part of the recognised contract which probably would have been the Birmingham Children’s Hospital and what was it about the setup in London which meant that these services could not be provided within contract. That was generally hard work in those days and I felt that I did not want to refer Child J to London. I did not feel that London had anything that I personally felt that he needed, but they were continually contacting me asking me to make a referral to them. I felt that, in those days of contracting, they would need to make the argument, not myself.
Q Was that what you meant when you said that the correspondence put you in a difficult position?
A Yes, but it also put me in a difficult position because the family so clearly wanted this but, each time I looked at it and I discussed it with colleagues, we did not feel that it was in Child J’s best interests and we made that, I thought, plainly clear in previous correspondence.
Q Obviously you have a role to fulfil as the local consultant who is advising the parents of your patient. Did you feel that this had an effect on the nature of that relationship?
A I do not know. I know that Child J’s family passionately wanted him to have this referral. I know that I had a number of conversations with them and expressed my view. I suppose if the nature of the investigations had been less intensive, I might have said okay but, having known Child J and having known how difficult and challenging and difficult he was in a waiting room, he was difficult to contain in a waiting room let alone on a children’s ward, and then the extensive investigations and then the evidence that the investigations would actually find something that would actually benefit him or benefit his family I continued to have the view that they were not going to help him.
Q You asked for further information. Were you still keeping an open mind?
Q You had a response from Professor Walker-Smith and that is at page 206 and he said,
“The successes that we have had with treating autistic children is an unexpected secondary aspect of our study, we had expected improvement with the gastro-intestinal symptoms … but we had not expected the parents to tell us there had been such an improvement in behaviour. We are in fact with the help of
Dr Marc Berelowitz, planning a further study to analyse the successes but our work at the moment has been to provide a diagnostic service to determine the gastroenterological manifestations of these children. Dr Wakefield has written a paper with submission to the Lancet, which discusses the links between MMR and autism. It is under review at the moment and we are awaiting that decision.
I am afraid it is not true that my department was energetic in requesting me to refer [Child J] to you, the pressure is coming from his parents who have heard about the success with other children. My own position in this work is entirely responsive. When I transferred form Barts to the Royal Free I was quite sceptical about the research work of Dr Andy Wakefield, but since I came here it is absolutely obvious to me that there is a large unmet need of children with autism who have a variety of gastrointestinal symptoms ranging from quite mild symptoms to quite major ones. The unexpected outcome of this research has led to us being very interested in the treatment of these drugs. As to the BBC, I have obviously no involvement with this. I think there is a large parent network who is very excited about these findings. In relation to your final paragraph, I must again emphasise that I am reacting to parent pressure, the other children who come from distant authorities, the referring authority has agreed to fund these children’s referral as an ECR and the initiative must come from the general practitioner. I am myself not soliciting for patients to be referred to us, but I am reacting to parents’ requests. I hope this clarifies the situation”
and the letter was copied to the GP and to Dr Wakefield.
THE CHAIRMAN: Ms Smith, I note that your voice is starting to let you down and I think it is becoming quite clear that we are not doing to finish with this witness this evening. If you find a natural pause, then we could perhaps break.
MS SMITH: I have to say realistically, looking at my notes, that I may be another 20 to 30 minutes with this witness.
THE CHAIRMAN: Do you think that this is an appropriate place to break?
MS SMITH: Yes. If we are not going to finish tonight, I am content to stop there and, as I say, I will probably be about another half-an-hour.
THE CHAIRMAN: I think it would be better in that case to adjourn until tomorrow morning. I think that Dr Mills will also need a little break as well. We will now adjourn and will resume at 9.30 tomorrow morning.
(To the witness) Dr Mills, you are still under oath and I know that it is difficult to stay under oath overnight when you are not able to discuss this case with anyone but I am afraid the time has come and the situation is such that you will have to. Please, do not discuss this case with anyone and we will see you tomorrow morning at 9.30.
(The panel adjourned until Friday 10 August 2007 at 9.30 a.m.)