GENERAL MEDICAL COUNCIL
FITNESS TO PRACTISE PANEL (MISCONDUCT)
Monday 3 September 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
CENGIZ ALTAN TARHAN, Affirmed
Examined by MS SMITH 1
Cross-examined by MR COONAN 43
Re-examined by MS SMITH 56
Questioned by THE PANEL 60
Further re-examined by MS SMITH 64
THE CHAIRMAN: Good morning, everyone. Ms Smith?
MS SMITH: I am going to call Mr Tarhan.
CENGIZ ALTAN TARHAN, Affirmed
Examined by MS SMITH.
Q Mr Tarhan, could you begin by telling us your full name and address, please?
A Cengiz Altan Tarhan. My address is XXX.
Q I think it is correct that you are presently the managing director of UCL Business Plc?
A That is correct.
Q I am going to be reverting to that role in more detail much later on in the story, but just so everyone knows that is a company that relates to technologies developed by the Medical School, is that correct?
A Not just the Medical School. It is the whole of the university. So it is University College London. The Medical School is a part of the university.
Q Between 1989 and 1998, which is the period with which we are most concerned, did you work at the Royal Free Hospital School of Medicine originally as a deputy finance officer and then as finance officer?
A That is correct.
Q When did you actually become finance officer?
A Around 1993.
Q In that capacity to whom did you report?
A The reporting line was to the school secretary, Mr Bryan Blatch, who has unfortunately passed away now, and above that was Professor Arie Zuckerman as the dean.
Q I want to ask you first of all about the general financial procedures at that time at the School of Medicine. Were the finances run distinctly from the Royal Free Hospital NHS Trust finances?
A That is correct, two separate legal entities. The hospital is a hospital and the Medical School was a charity in its own right until 1998 when it merged with University College London.
Q We have not heard this from a witness before but can you help us as to the physical set up? Were they all on one site?
A It is a single building site. 25 per cent of the hospital building is owned by the Medical School under a lease arrangement. It is difficult to know what is hospital and what is Medical School in the building unless you know where you are, but it is one building basically.
Q Back in 1996 did academics at the Medical School hold sets of research grants?
A That is correct, yes.
Q How did the accounts holding the money in those research grants operate? Were they designated to a specific research project or were they general discretionary research accounts?
A There were two types: there were the general discretionary ones which were held by each academic for discretionary purposes and there were specific ones that were for specific projects, so we distinguished between whether it was a specific project or a discretionary account.
Q Did they have separate account numbers?
A Yes, they did.
Q Was it common for an academic in the Medical School to have more than one account relating to more than one project going on at the same time?
A Yes, each project would have a different account reference to keep a track of it and there would generally be one discretionary account which would be like a single account where anything that was not specifically allocated would be allocated into that discretionary account.
Q What was the position as far as research projects in the School of Medicine was concerned? Was it common for the researchers to have honorary contracts in the NHS hospital as well?
A I believe so, yes. Clinical colleagues would need to have honorary contracts and they would also on the technical staff as well if they were involved with the hospital in any capacity the hospital would issue them honorary contracts.
Q Normally if a research project is envisaged when would the account for it be created?
A Once we realised there was a project to manage we would need to see a grant application or a funding approved or the description of a project which we would then allocate as a project account. If it was a discretionary sum then we would need to wait until we understood where the funding came from and if it was appropriate funding then it would be credited into a discretionary account. Discretionary accounts would not be used for specific research projects. There would not be a specific deliverable. It would be the two types.
Q When a specific project was underway did costs accumulate under that project?
Q How did you actually claim the cost from whoever it was who was funding the project?
A Again, it depended on the individual project. If it was cash up front, i.e. the grant came up day one, then it would be credited into the account and the researcher would then know how much was in the account. They would spend it out of that account. If it was a charity-type grant or an MRC-type grant, then it would be set up as a project and it would be claimed in arrears, generally three monthly in arrears.
Q When you say MRC, you mean one granted by the Medical Research Council.
A Yes, one grant from the Medical Research Council.
Q In 1996/1997 can you help us as to about how many separate project accounts would be existing in the Medical School?
A I guess around 590/600 or so.
Q Would such an account ever be opened without a funder at least being in mind for the particular project?
A Historically there were a lot of accounts that were opened but once the new legislation came in especially relating to value added tax and the fact that universities had to charge VAT, we had to clamp down on the number of accounts that could be opened in order to make sure that we did not break any rules and regulations as far as statutory VAT issues were concerned.
Q As far as the legislation in relation to VAT, roughly speaking when did that come in?
A I remember it was in the mid 1990s. It certainly caused us a lot of problems.
Q Did that involve whoever was funding the research project to be sent a VAT invoice?
A That is correct. We were obliged to charge VAT on research projects which we did not have to charge prior to the introduction of that legislation which then meant that for a period of years we would be receiving cheques with no VAT on it and we would subsequently submit a VAT invoice to recover the VAT.
Q On a related matter, as far as the Royal Free Hospital as opposed to the Medical School was concerned, were you aware that they had a body known as he Special Trustees?
Q We have heard about that in more specific terms from those involved with it, but did you understand it to be a set up in a similar way to the Medical School with a number of accounts for different projects?
A The Special Trustees are a separate charity from the hospital and they were operating similar to the university on the basis that we were both charities, so yes, they did have a separate set of accounts as distinct from the hospital.
Q As far as they were concerned, who on the whole were they holding accounts on behalf of?
A Generally clinical members of staff, their own staff. Occasionally there would be people that were Medical School employees holding accounts within The Special Trustees. Historically those were the circumstances but we tried to tidy those up in the mid 1990s, trying to distinguish who should be holding Medical School accounts and who should be holding Special Trustee accounts.
Q For preference as far as you were concerned, where would you pay cheques into?
A If I had the chance obviously into the Medical School. That is where the Medical School’s cash is important and as far as The Special Trustees were concerned, a separate organisation, nothing to do with the Medical School.
Q I want to ask you about some specific funding which came from the Legal Aid Board. Did there come a time when you were aware of a cheque which had been received from the Legal Aid Board?
Q Do you recall who the payee of that cheque was?
A No, I cannot.
Q If we look at the covering letter which came with it at page 338A in bundle FTP1, that is a letter from Dave Wilson.
Q Who was he?
A Dave Wilson was the research grants administrator who worked under me.
Q It is from Dr Wakefield dated December 1996.
A That is correct.
Q It says:
“Enclosed herewith is a cheque for £25,000 from the Legal Aid Board for the funding of Ms Schepelmann’s salary. This is the first payment received from the Legal Aid Board. We will advise you of any other grants we receive to support her salary.”
A That is correct. Obviously the cheque was made payable to RFHSM – the “RF” is deleted but it obviously said RFHSM which is the Royal Free Hospital School of Medicine.
Q It is from Dawbarns Solicitors in King’s Lynn.
Q Going to page 362A, this is a letter dated January 1987, again to Dave Wilson from Dr Wakefield and it says:
“Further to our conversation on the telephone, I would like to establish an account to pay for Dr Schepelmann and, for the next two months, Dr Anthony who is currently funded by Professor Roy Pounder. He is being paid from Account BXBXA until January 1997.
This account will be funded from a variety of sources, mainly from charitable institutions …”
Then he refers to two cheques from charities: one The John Ellerman Foundation and one the Crohn’s and Colitis in Childhood Research Charity. Then he says:
“This allows us to free up half of the salary promised by the Welton Foundation from which I also enclose a letter confirming the funding. This rant will also receive funds from the Legal Aid Board in respect of studies conducted on children who suffered intestinal injury following MMR vaccination. The funds raised for this will be coming in over the next three years and will more than cover the salaries of Dr Schepelmann and, for the next two months, Dr Anthony. There will also be some expenditure on materials and consumables that should also come out of this account. If there are any questions in relation to this, please do not hesitate to get in touch with me.”
There is a note in that in handwriting. Do you know whose handwriting that is? Is it yours?
A That is Dave Wilson’s handwriting.
Q I want to ask you generally, Mr Tarhan, when the cheque originally came in the December did it cause problems as to what it related to?
A Yes, the original cheque that came in from the Legal Aid Board did cause some problems. We did not know what the purpose of the cheque was. We had to investigate and try and find out what the background was. Specifically it was the VAT issue; we wanted to know whether or not we should submit a VAT invoice on top so that was our purpose. Within the Finance Department that would have been the rationale for holding back the cheque.
Q Do you have a member of staff whose job it is to undertake a background search to match a cheque to any invoice that is raised?
A Yes, Dave Wilson would have had an individual underneath who worked for him called Linda Macy. Linda Macy would have been the sales ledger clerk and she would have been responsible for checking matching invoices and receipts.
Q In this case, at first was it possible for you to match the cheque to a specific research project?
A Not initially, no.
Q I think it is right that the cheque was brought to your attention by Mr Wilson. Is that correct?
A Correct. It caused some problems and it came up to me, in which case I believe I referred Dave to talk to Mr Blatch to get further background on it.
Q Why did you do that, Mr Tarhan? What was your difficulty? You say you could not match it to a specific project and you needed to know about the VAT. Why did you feel it had to be referred on to Mr Blatch?
A There were a number of issues relating to Dr Wakefield’s affairs that Mr Blatch was more involved in than I was, and I felt it was appropriate for Mr Blatch to look at that, and decide on whether it was appropriate or not that we should accept the cheque.
Q Was the Legal Aid Board a source of funding that you had ever come across before?
A No. It was the first one that I came across.
Q You received a note from Dave Wilson about it. Let us go to page 366, please, in the same bundle, this is a note to you. Is that correct?
Q Can I just run through it. It says:
“Firstly apologies for springing the subject of the Legal Aid Board on you just as you were leaving.
Around 12.30 Bryan had informed me that he felt we had no other option but to accept the funding and requested that I open an a/c [account] for the £25K received.
He said we should make it clear to Dr A Wakefield that this is done reluctantly because of the contentious nature of his research.
Given that Dr S Schepelmann (nominally funded out of LAB monies) started work in Sept/Oct ’96 the School is not in a position to terminate her 2 year contract.”
Then he has put a little arrow and put “said Bryan”, i.e. that is what Mr Blatch had said.
“My argument is why was a letter of appointment issued before finances could be discerned? In any case, does the appointment have to be directly linked with LAB funding. It is obvious that Dr Wakefield is active in obtaining funds from a variety of sources that could support her post.
Therefore, what is now the way ahead? As you mentioned to me, the LAB do not just hand over money like that some procedure must have been followed and correspondence/documents …”
I think that is ---
A “… documentation”.
Q “… documentation” – thank you.
“… documentation produced. Is a third party involved? Was funding channelled through Dawbarns the solicitors? If you want to see me about this prior to opening an a/c [account] please let me know. Do you still have the papers.”
A I think “Bryan still has the papers”.
Q “Bryan” – I am sorry.
“Bryan still has the papers.”
Then it is signed “Dave”. Can you tell us about the handwriting – there is a “PS”:
“P.S. I have asked Bryan to return papers to me.”
That is obviously from Mr Wilson. Is the other note also from him?
A The other note is mine.
Q And what does that say? Can you read it to us?
A It says:
“We spoke since – BAB [Bryan Blatch] will reconsider in view of the political overtones.”
Q Thank you. Can you tell us first of all – it is plain that Dave Wilson had some concerns that he was asking you to resolve. What did you mean by that note about “political overtones”?
A I think my feeling was that I was unhappy, that we seemed to being bulldozed into accepting the cheque without understanding what the background was and despite the fact that, yes, Bryan Blatch was my boss, I still felt uncomfortable accepting a cheque into the Medical School without knowing exactly what the purpose was.
Q Mr Wilson has said, “As you mentioned to me, the LAB [Legal Aid Board] do not just hand over money like that – some procedure must have been followed …”.
Q “Is a third party involved? Was funding channelled through Dawbarns the solicitors?” These were all queries that you had, were they, at the time?
A They were concerns that I had at the time. As I said, when we receive a cheque from out of the blue, or with an academic sending a cheque to us saying, “Please accept this into a research grant”, we had to look at the legal position as to whether we could legitimately accept the cheque. This was not to do with the research aspects of the work; it was more to do with, is it appropriate for the Medical School to receive a cheque and accept it as far as VAT and all sorts of other considerations are concerned. As a charity, when we receive a cheque, we had an obligation to use the cheque for an appropriate purpose so there were charity law issues involved, there were VAT issues involved; it was not just the research aspects of the work.
Q When you say “the political overtones”, were there matters in particular that were in your mind when you said that?
A I seem to remember there were some discussions at the time between Bryan Blatch and Arie Zuckerman and certainly there were issues. I think one comment was that I believe Bryan had written – I am not sure if it was the GMC or BMA, but one of the authorities – to find out whether or not it was appropriate, if there was some evidence of that somewhere.
Q Whether it was appropriate to ---?
A To accept the cheque.
Q You were subsequently copied into a memo of the 24 February 1997. That is at page 371.
A This is the one I referred to.
Q Do you have that?
Q And that is to Mr Wilson from Mr Blatch, copy to you?
Q It says:
“I have written again to the BMA…”
You said you had a memory of the BMA or the GMC.
“… and, for the time being, the grant of £25,000 from the Legal Aid Board should remain on a suspense account notwithstanding my recent verbal advice to you. I hope to clarify this situation soon.”
Q It would appear that Mr Blatch had had some second thoughts?
A Or he had taken my advice.
Q Or taken your advice, yes. The next document is a note to you from Mr Wilson, which is at page 429 in the second volume. Would you put that one away for the time being, Mr Tarhan, and turn to FTP2. This is a note to you from Dave Wilson.
“For your information
We can extend the appointment of Dr Anthony for a further two months, but should not be funded out of LAB money still on suspense.
Still no idea about what is to happen with LAB issue, and I’m a little surprised Dr Wakefield has not queried the matter with Bryan/Dean.”
And it is signed “Dave” on 29 April. There is a note saying, “OK” beside it. Is that your handwriting?
A That is mine, yes.
Q That took care of Dr Anthony. Can you assist us at all as to whether you knew anything about what was to happen to Dr Schepelmann’s salary?
A No idea at that stage.
Q Did you know who both these individuals were, Dr Anthony and Dr Schepelmann?
A No. We had 700/800 people employed and some of these individuals would come and go and I would not necessarily see.
Q Then I think the next link in the story is that you sent a memo to the Dean, Professor Zuckerman. Could we look at page 469, please. In fact, there are two copies of this, if you just flip over to page 470, Mr Tarhan, because one has come from the Dean’s office and one has come from the Finance Department and so they have different notes on them. Let us just look at the memo to Professor Zuckerman and Mr Blatch from you.
“Mr Wakefield is unhappy with the fact that the School has not formally accepted the research funding and has asked that the funds be returned to the Solicitors.
I will be arranging for this however there is likely to be a problem of an overspend as he has already committed part of the funding for salary costs. He says he will find an alternative means of funding the research but we may have to carry an overspend in the meantime.”
Do you recollect the events that led up to you knowing that Dr Wakefield was unhappy with the School’s view about the money?
A I cannot exactly recollect how that happened. I can only assume that we either spoke…. It may be we spoke in the car park; it may be that we spoke in the senior common room, but no doubt we made some communication and my awareness of the fact that Dr Wakefield was unhappy about this came to light.
Q The notes on that – can you help us as to the handwriting please?
A Yes. The first memo, “Dave can you let me have details etc” – that is mine.
Q Yes. And then there is a note from Dave Wilson underneath, “Details attached.” Is that right?
“Bryan has all other paperwork. Also attached is an unpaid invoice for £747.54. This can be paid out of BXDXA”.
Which I presume was another account.
Q Another account held by Dr Wakefield?
A Dr Wakefield, correct.
Q Then the note at the bottom – is that you again?
A Yes. What I am asking there is,
“Do we have details of who we pay the cheque to,”
i.e. Dawbarns, and which account we would need to pay the cheque payable to, and I was asking Dave to give me the information for that.
Q If we look over to page 470…… Before I go onto that, I am sorry, Mr Tarhan, can I ask you: BXDXA – was that a general research account rather than one for a specific research project?
A I cannot recall, sorry.
Q I am turning on to page 470. Is that note the Dean’s note?
A Yes, that is correct.
Q We see:
“Discussed with Mr Tarhan – 2/6/97”.
“Transferred to Special Trustees
They are aware of the situation + overspend
? Discuss with Martin Else”
He was the Chief Executive of the hospital – is that correct?
A That is correct.
Q Do you recall whether you had any discussion with Martin Else?
A I do not believe I spoke to Martin directly.
Q Why was that?
A I believe by the time the Dean had asked me to speak to Martin Else that he had already raised the matter with Martin, so I was left with talking to one of his assistants.
Q And was that Mr Phipps?
A I believe so, yes.
Q Subsequently on 23 May 1997 you were copied into a letter to Mr Phipps, and that is at page 471. This is a letter from Dr Wakefield to Mr Phipps. We have looked at it before, but just to remind everyone:
“Dear Mr Phipps,
My group, the Inflammatory Bowel Disease Study Group…”
I should have said, you were copied into this letter. Is that correct?
“…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 XXX. 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 the 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 Cengiz Tarhan who is happy to transfer the funds once he receives your approval.”
Now that letter, Mr Tarhan, suggests that you were of the view that the money was more appropriately held by the hospital. You have told us that you were unhappy yourself about the Medical School accepting it. Was it up to you to decide whether it was appropriate for the hospital to accept it?
A It is certainly not up to me to decide whether the hospital should accept it. The hospital needed to make their own minds up, and obviously this letter went to supporting or making up their minds for them.
Q Did it in fact express your view? As I say, you have said that you did not think that the Medical School should accept the cheque, but did you think that it was more suitably located at the hospital for some reason?
A I felt that, given Dr Wakefield had started some of the research work, and if you actually look at the statement in the letter which says that a certain amount of research has already taken place involving certain special trustee funds that it made more sense to link the two, and have all the activity going through the one account rather than disperse it between 50 per cent in the Medical School and 50 per cent in the hospital.
Q The letter says that queries had been raised by the Dean?
Q And, of course, you were aware of that by then?
Q Because you had been involved in the correspondence that I took you to. Did you have any knowledge as to the nature of the queries he had raised?
A Not the specifics. I knew he was concerned. Just to add one further point, I did subsequently, subsequent to this letter, speak to Mr Phipps on the telephone, so certain comments were made on the telephone. I cannot recall the exact nature of those, but I did point out there were issues and the hospital had to make up his own mind whether they wanted to take the funds.
Q Can you assist us, Mr Tarhan? You said you cannot remember the specifics and of course we understand that. We are talking a long time ago but what was the nature of the issues?
A The Dean’s queries, basically – the fact that the Dean had queried some of these aspects; the fact that Bryan had written to the BMA, and I do not recall him getting an answer for it, so the fact that we had certain reservations. I am certain that I raised the issue of the VAT on the matter as well, purely from the fact that the special trustees would have had exactly the same obligations on charging VAT if there were appropriate research projects that they were handling. The special trustees, I believe, did not do that.
Q Obviously VAT was a concern for you because you were a finance officer.
Q What was your understanding of the nature of the Dean’s queries with the BMA? That was not related to the VAT; is that correct?
A No, certainly not. I think that the Dean’s concerns were something else and, as I said, at the time they were not an issue for me.
Q The next letter is from Mr Phipps to you. Would you turn to page 495, please. Again, there are two copies of this letter, one with and one without annotations on it. The next one is at page 496, the next page. Mr Phipps says,
“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.”
Who was Tony Needham?
A Tony Needham was the accountant responsible for the Special Trustees, so reporting through to Russ Phipps, I believe, and Russ Phipps reporting through to the Finance Director of the Hospital.
Q Would you turn over on to page 496 and run through the manuscript on this.
A By that time, I believe that we had another finance officer or we had a deputy finance officer, Hilary Rotherham or Hilary Mellis(?) as she was known at the time. So, the note to Hilary from Dave is,
“Not sure if Cengiz gave this to me. Can a cheque be made for £25k (will the Dean need to countersign?) payable to Special Trustees for the [Royal Free Hospital] (G106). This £25k is still on suspense account.”
That is from Dave Wilson to Hilary asking Hilary to raise the cheque. Emma was my PA and she was responsible at that stage for drawing certain special cheques, one-off cheques, and Hilary has written to Emma saying, “Please draw a cheque for 25,000 payable to the Special Trustees …”
Q Did you understand G106 to be the account number?
A That is the Special Trustees’ G106 account.
Q Is the last note from you?
A Yes. The last note from me is to say, “Please initiate transfer …” I am trying to figure out exactly what the sequence of events was here but there is a reference from Dave that says “How?”, so I presume that at some stage we either drew a cheque and sent it across to the hospital … I think that is exactly what happened: we drew a cheque and sent it to the hospital.
Q Ultimately, the funds were indeed transferred as requested to hospital funds rather than Medical School funds.
A That is correct.
Q Would you turn to page 605B.
A The statement shows the cheque for £25,000 issued.
Q Is this the oracle accounting system transaction report as we can see from the top of the page?
Q If we look down to the 14th line, we see “[Royal Free Hospital] Special Trustees G106 A Wakefield” and a cheque for £25,000 with the cheque number given; is that correct?
Q Would you turn over the page to page 605C where we see the cheque which is for £25,000 payable to the Special Trustees for the Royal Free Hospital and signed by the Royal Free Hospital School of Medicine.
A That is correct.
Q I want to turn to the matter of the receipt in relation to that money that was apparently originally planned and sent, Mr Tarhan. Firstly, I want to take you to a letter of 6 December 1996, so going back somewhat in the story, from the solicitor at Dawbarns, Mr Barr, to Dr Wakefield. Would you go back to FTP1 and turn to page 337. This is a letter addressed “Dear Andrew” to Dr Wakefield at his home address from Mr Barr,
“Re: MMR/MR Vaccines/Disintegrative Disorder & Inflammatory Bowel Disease
Further to our discussions on Thursday, I enclose a cheque for £25,000 made out to the [Royal Free Hospital School of Medicine] in respect of the setting up costs and first year’s costs of the MMR investigation. I shall be grateful if you could arrange to let me have an official receipt and also for the enclosed receipt to be signed.
This funding has been provided directly by the Legal Aid Board and the payment should go exclusively for the furtherance of investigation into the side effects to the MMR/MR vaccine.
It is also subject to the conditions set out in my letter to you of 14 October 1996.
The findings you and your colleagues are making sound extremely impressive and I certainly have to say from our point of view that we are delighted with the help that you and the rest of your team at the Royal Free are giving us in investigating these tragic cases. I believe it is a unique exercise that we are carrying out and I for one am certain that the MMR vaccine has a lot to answer for.
One thing I think we do need to do fairly soon is to have a meeting (Kirsten and myself) with all of the team that you have put together to investigate the cases. We must not, of course, lose sight of the fact that in addition to the inflammatory bowel problems and disintegrative disorder we need to cover as far as possible the whole spectrum of vaccine damage.
I look forward to hearing from you.
In accordance with the first paragraph, “I shall be grateful if you could arrange to let me have an official receipt and also for the enclosed receipt to be signed”, there is a receipt on the next page, page 338, to Messrs Dawbarns from the Royal Free Hospital School of Medicine,
“The Royal Free Hospital School of Medicine acknowledges receipt from Dawbarns of a cheque for the sum of £25,000 being appropriate payment provided by the Legal Aid Board for the purpose of investigating inflammatory bowel disease, disintegrative disorder and other conditions apparently arising from vaccination by the MMR and/or MR vaccine.
We confirm that this sum is to be used exclusively for the purpose of investigating allegations that children have been damaged by the vaccine.”
That receipt has not been signed or dated. I will ask you about these documents in a moment, Mr Tarhan. I just want to identify them first of all.
Would you turn to page 339 where we see another receipt dated 9 December 1996 to Messrs Dawbarns on Royal Free Hospital School of Medicine letterhead and it says,
“The Royal Free Hospital School of Medicine acknowledges receipt of twenty five thousands pounds from Messrs Dawbarns, King’s Lynn, provided by the Legal Aid Board, with thanks”
and this one is signed by Dr Wakefield,
“Senior Lecturer in Histopathology & Medicine
Hon. Consultant in Experimental Gastroenterology to the Royal Free NHS Trust
Director, Inflammatory Bowel Disease Study Group.”
I think that you have seen those receipts before because you were shown them by the General Medical Council when this investigation was being carried out.
A That is correct.
Q Had you ever seen either of them prior to that?
Q Turning back to the first one, if you had seen that receipt in those terms at the time when the cheque was sent, would that have assisted in your difficulties as to knowing what precisely the cheque was intended for?
A We certainly would have clarified what the specific funding was for but it would have also raised a whole number of other issues in there especially the fact that I remember from previous occasions that Professor Zuckerman was very much against receiving funds from patients’ support groups where the results of an outcome of a clinical trial or something would have helped that patient group. I do not know if I have explained myself but he was very much against receiving cash from patients supporting their own family needs or their own family ailments or whatever and this letter would have raised significant concerns for him.
Q In fact, as we have already seen, that receipt was not signed. Would Dr Wakefield in fact have been permitted to sign a receipt such as this?
A The official receipts from the Royal Free Hospital School of Medicine could only have been issued by either Mr Blatch as the School Secretary or myself as the Finance Officer. They were the original receipts. Anything else was not official.
Q Would you turn on to page 339 which was the one that was in fact apparently signed by Dr Wakefield and is in a different format, does the same apply to that? Was he entitled to sign that one either?
A Not on behalf of the Royal Free Hospital School of Medicine. He could well have signed it on behalf of himself personally or his research group but certainly not on behalf of the Royal Free Hospital School of Medicine. He was not a signatory.
Q As far as that one is concerned of course, that would not have assisted you in relation to the purpose of the payment; is that correct?
A As I recall, if you look at the receipt that was sent by Dawbarns, they were asking for certain other confirmations and that receipt does not actually deliver on all those confirmations. So, to me, if it was a proper receipt, it should have been signed with the commitment to say, “This is what we have received the funding for, this is the outcome and this is how we are going to deal with it.” Dr Wakefield’s statement merely says “thank you”. It does not actually say what the funding is going to be used for.
Q You have touched briefly on who has the authority to issue receipts of the Medical School. Can you tell us what the normal procedure is with regard to a receipt. Does it come from somewhere in particular?
A At the time, the Royal Free was slightly behind the times, I have to say. We used to have a receipt book and we used to sign off receipts formally in the receipt book. That is slightly antiquated but that was the procedure at the time. So, if somebody wanted a specific receipt in order to prove that they had received it, we would have a receipt book and we would sign off a receipt through that book.
Q If you had seen the first receipt – and you said that it would have raised concerns for you – the first one being the one on page 338, would you have allowed it to be issued in that form?
A Certainly not myself, no.
Q Equally, if you had seen the second one on page 339, would you have allowed that to be issued in that form?
A If I had seen the second one, then an immediate letter would have gone to Dr Wakefield to say that he should not have done that.
Q Who do you read the receipt on page 339 as purporting to be on behalf of?
A I would read that as being on behalf of Dr Wakefield but it does refer to the Royal Free Hospital School of Medicine. As I said, he was not authorised to sign on behalf of the Medical School.
MS SMITH: Sir, that is all I have to ask Mr Tarhan about the finances and I am going to turn to a separate topic which is a fairly lengthy one about the patents. I do not know whether you think it is appropriate to give Mr Tarhan a brief break now or whether you would like to go on.
THE CHAIRMAN: Mr Tarhan has been in the witness box for about an hour now.
THE WITNESS: I would like to carry on.
THE CHAIRMAN: Would you like to have a short break now?
A Whatever the Panel feels.
Q Are you comfortable to continue?
A Yes, certainly.
THE CHAIRMAN: In that case, I suggest that we continue for the next 15 to 20 minutes or so.
MS SMITH: (To the witness) I want to ask you about your role in relation to intellectual property within the School of Medicine, Mr Tarhan, and I would like you to remember, if you will, that this is quite technical and we have lay members on the Panel. In the broadest of terms, is intellectual property a term relating to the legal ownership of ideas and inventions?
A Yes. It broadly covers patents, copyright, design rights and know-how. Anything that has some value attached to it is intellectual property.
Q If it has a value attached to it, then who actually owns it might become significant commercially; is that correct?
A That is correct. The legal ownership position especially in the UK is that, for employees, the employer owns the intellectual property.
Q You have touched on patents. As far as that is concerned, for an inventor or someone who has had an idea, is one way of protecting that invention or idea by doing what is called registering a patent, taking out a patent on it, in order that other people cannot pinch it?
A That is correct. It is a way of protection. It is not supposed to stop other people using it. It is supposed to encourage ideas to be published in order that other people can use it but under strict guidance. So, they would need to license it, they would need to buy it or they would need to do something.
Q Absolutely, and someone would be registered as having been the person who invented it.
A The whole point of patents is to get that idea out into the public domain whereas before people used to keep them secret.
Q As well as being the Finance Officer at the Medical School, I think that you had an involvement in matters of this kind, of intellectual properties within the School.
A That is correct as well. It was generally more interest at that stage but that is my profession now, so it started off from that sort of time.
Q Did you have a particular role as the secretary of the company at the Royal School of Medicine that dealt with it?
A We set up a company called Freemedic at the time. The purpose of Freemedic was to look at intellectual property issues and try and maximise gain as well as public benefit from those. There is a long history of products that have come out of the Medical School which have helped society and also brought back cash into the Medical School;
Q Is that company still existing and are you now, coming back to the start of your evidence, the MD for that company which is existing for the whole of UCL?
A That is correct. The company started as Freemedic plc in 1990 … In I think about 2000/2001, it changed its name to UCL Biomedica and enlarged its activities across biomedicine across UCL when the integration of the Royal Free and University College took place and, in 2006, it changed its name again to UCL Business.
Q You have touched on this already but, as clearly as you can, tell us what the purpose and aims of Freemedic were.
A The purpose of Freemedic was clearly to identify intellectual property which could be of value to society, to the country and to the Medical School, commercialise it to the best of our ability, which meant either to put the technology into a spin-out company, it meant protect the technology and license it to a big pharma company or whatever. That was the logic of Freemedic, to identify areas which required support and bring them to a level where a commercial company would be interested in taking them forward and exploiting them.
Q What happened to any profits that you made as a result?
A All the profits that came out of Freemedic were donated back into the Medical School and the same thing still happens today. So, University College London is the benefactor of any profits that UCL Business makes.
Q Did Freemedic in fact make significant profits?
A Freemedic made significant - as far as the size of the Royal Free Hospital was concerned, yes, it was significant.
Q Was the aim to plough it back into research? You say it went it back into the school, but was that for future research?
A Yes, that is correct, and the sums of money that were made from that resource was ploughed back into the Medical School and it built research facilities and other facilities.
Q You were the Company Secretary of Freemedic, is that correct?
A I was the Company Secretary, yes, for a period, before I became a director.
Q I was just going to ask you, when did you go on to the Board of Directors?
A I think 96, 95, something like that.
Q Who else was on the Board of Directors?
A Initially we set the company up with Bryan Blatch as a director and Arie Zuckerman as a director and David Dutton, who was the Chairman of the Finance Committee at the time. We then extended the membership and invited other people as necessary, so in 1995/96, when I joined, I believe we may well have brought in a couple of people from UCL as well, University College London, on the basis that we would be merging with them.
Q If we can just deal now with the period around the mid 90s, 95-98, did Freemedic look for themselves at proposals from researchers within the hospital and decide whether they were viable, and if they wanted to take them further and see whether they could exploit them commercially?
A Correct, yes. As with all universities, there is an obligation on looking at intellectual property and trying to protect it.
Q How did you assess research proposals which came in?
A We normally asked for some sort of a two or three page document to sort of get an idea. We would then bring that idea to the board’s attention. The board generally would have limited idea about the scientific merits of a specific project, so we would need to call in external consultants. We used to use a company called Medical Marketing International (MMI plc), so that would be our first port of call, so we would refer the project to MMI plc to give us guidance as to whether there was any commercial merit in pursuing the project.
Q In 1995/96 was there one such intellectual property issue involving Dr Wakefield?
A I remember a couple of events involving Dr Wakefield. I think, as with most university employees, we would proposals from a lot of them, and Dr Wakefield was another individual who would be putting projects our way.
Q Thank you. Now, we are going to look at the proposal that was made in 95/96, which is at page 127, please.
A Which file is that?
Q It is 127 in volume 1, but I am told, sir, that this is a document that was removed from the Panel because there were objections originally, so I have to ask you whether you could pop that back in. (Same handed)
MR COONAN: Sir, could I ask that Mr Tarhan has the microphone a little closer to him. It may just be me, but I have a little difficulty trying to hear some parts of his voice, I have to say. I do not know whether other people have a similar difficulty. I see Mrs Dean nodding too, so I am not alone.
THE CHAIRMAN: I think, Mr Tarhan, you have got a very soft voice.
A I will try and speak a little louder.
THE CHAIRMAN: I think it might be helpful if you could actually pull the microphone a little bit closer to you. Thank you very much indeed.
MS SMITH: Page 127, Mr Tarhan. I wonder if I could ask you just to pop it into that bundle at the right page.
Q I am just going to read that letter through, but I would underline that this is earlier to the patent that we are going to be asking you to consider in a moment, sir, and references to publications in The Lancet are not to the 1998 Lancet publication with which we are concerned, but to an earlier paper by Dr Wakefield.
“Dear Mr Blatch
It is sometime since we had discussions of a commercial nature; accordingly, I thought it was time to come to you with another proposal for your consideration.
By way of background, in 1987 whilst in Canada, I formulated the hypothesis that Crohn's disease was caused by a virus-induced endothelial infection (persistent viral infection of the cells lining blood vessels in the intestine). When I returned to England, working at the Royal Free Hospital with Roy Pounder, we tested the hypothesis that Crohn's was a vascular disease. This was subsequently proven and, latterly, I targeted measles as a likely candidate – cause. We now have considerable evidence to suggest that this is the case. [Most] recently, we have extended our observations to include ulcerative colitis and we now believe these two to be part of the spectrum of inflammatory bowel disease that might have a common cause, that is, measles virus.
In 1995, immediately prior to the publication of our article in the Lancet linking measles vaccine to inflammatory bowel disease, I read a paper showing that persistent measles infection in cultured cells could be treated with a novel molecular therapy (antisense oligonucleotide therapy). That week-end I sat down and wrote a patent, in order to try and protect the interests of all parties concerned, covering the diagnosis and treatment of inflammatory bowel disease using reagents and therapies directed against measles virus. You will appreciate that at this stage we had no conclusive evidence of causation and no specific therapy for treatment of patients with inflammatory bowel disease directed towards the measles virus. [Nevertheless] I thought it was worth putting in provisional cover since, on publication of our vaccine paper, it would then fall into the public domain and any chance of patenting would be lost.
Over the course of the last year, we have with Professor Ian Bruce, a molecular chemist working at the University of Greenwich, designed an assay which will detect measles virus that falls under the jurisdiction of this patent. We have not yet applied the system to Crohn's disease tissues but we believe we are very close to doing so. In April this year, the patent was refiled and paid for by the two Directors of the Inflammatory Bowel Disease Study Group, Roy Pounder and me. Naturally, as you will appreciate, the Royal Free Hospital School of Medicine is a major player in the exploitation of this and it is about this that we wish to come and talk with you. I enclose a copy of the patent which deliberately, has very broad implications for [diagnosis] and treatment of inflammatory bowel disease. It is filed as a PCT and the international filing date comes up in April of 1997.
Roy and I, through our contacts in the gastrointestinal pharmaceutical business, have identified individuals with the interest, capital and contacts to put substantial funding into the exploitation of the discovery. Before proceeding, we would like to seek both your approval and your input into strategies for exploitation. Professor Pounder’s secretary is in the process of arranging a date for a meeting which I hope will fall towards the end of July when Roy is back from his summer vacation.
Kind regards and best wishes”.
Now, can I ask you, first of all, were the Medical School aware that Dr Wakefield was taking out that patent application?
A I do not believe so, no.
Q Did they ever in fact agree to take on that application in relation to the work that Mr Wakefield sets out there?
A I do not believe so.
Q Do you recall why they did not?
A I presume this is coming back to Bryan’s concerns about the whole issue, and the publications, and everything else that goes round it.
Q Concerns relating to what, Mr Tarhan?
A Concerns about linking certain---
MR COONAN: Well, either the witness knows or he does not, and rather than speculating it is a bit dangerous---
MS SMITH: Well, he has not suggested he is speculating. He said there were concerns. I am very happy to ask him, do you know what the concerns were?
MR COONAN: He predicated it by saying “I presume”.
MS SMITH: Well, then, perhaps I can rephrase the question, Mr Tarhan. Do you know why that patent matter was not carried forward by the Royal Free Hospital School of Medicine?
A We carried out an assessment on it and we felt that it was not appropriate for the Medical School to be associated with that patent.
Q Were you involved in that assessment?
A I was not directly involved in it. I was at the periphery.
Q Now, later on, I think it is right, Dr Wakefield took out a further patent in 1997/99, and we can see the information about that in a letter which is copied to you from Dr Wakefield, which is in volume 2 at page 474. This is a letter dated 24 June 1997 to Ruth Bishop at the Bursary of the Royal Free Hospital School of Medicine from Dr Wakefield, and was copied to you and to Mr Blatch.
Please find enclosed copy of a further patent that we have filed regarding the issue of measles and Crohn's disease. It appears that we may now have a treatment for this condition based upon a substance called Transfer Factor which, although it has been around for a long time in other forms, can now be made specifically for measles virus. I felt that in view of the potential of this therapeutic and the imminent disclosure of data, we should cover this application since it was not adequately covered in the first patent. The patent, as you will see, is filed in the School’s name, and that of NIT Research Foundation who produce the Transfer Factor and with whom we are collaborating on our clinical trial. The School may wish to fund this at this time; in the meantime, I will cover the cost with Roy Pounder. I do feel however that this is a potentially valuable strategy and gets us away from the anxieties expressed by the Dean over diagnostics and litigation, although a diagnostic kit is still a desired goal of our research.”
He puts on a PS:
“I am just back from the States after two weeks and will try and catch up with Roy Pounder as soon as possible regarding his meeting with Cengiz Tarhan.”
Now, again, did the Medical School know that that patent was being applied for until that letter arrived, Mr Tarhan?
Q Would they have expected to do so?
A Normal procedure is for patents that are going to be applied for in the name of the Medical School to be discussed by the Medical School. The Medical School then takes a decision, appoints a patent attorney. The patent attorney will then take the decision whether there is a patentable idea. We would then go ahead and patent. That is the normal process.
Q Who is Ruth Bishop?
A Ruth Bishop was assistant to Bryan Blatch and she was responsible for intellectual property matters, i.e. patent know-how and similar agreements at the time, before Freemedic was actively going.
Q Now, that letter describes a new treatment based on a substance called Transfer Factor, and enclosed with it there are a number of other documents which I would like to take you through.
MS SMITH: Sir, if you were going to break, and it is not that I am trying to make you break, if it just that these documents all go together and I think a break in the middle of them would not be very helpful for your understanding.
THE CHAIRMAN: Yes. It is now quarter-to eleven. Mr Tarhan, we will now adjourn for about twenty minutes break. I have got to remind you that you are under oath and are in the middle of giving evidence, so please do not discuss this case with anyone. I am sure someone from the Secretariat will look after you.
A Thank you.
THE CHAIRMAN: So we will resume at five minutes past eleven.
(The Panel adjourned for a short time)
THE CHAIRMAN: Ms Smith.
MS SMITH: Thank you, sir. Mr Tarhan, we had looked at the letter on page 474, and I was then turning over to the documents which were enclosed with it. So if you go on, please, to page 475. This is a letter from a firm called Ablett & Stebbing, who are chartered patent attorneys, to Dr Wakefield. If we can just read through that letter, sent to Dr Wakefield at his home address, “Dear Andy”, and then it gives the application number for the patent “9711663.6”:
“Applicant: Royal Free Hospital School of Medicine and NeuroImmuno Therapeutics Research Foundation
Short title: Pharmaceutical Composition for Treatment of IBD and RBD
Further to your instructions, I can now formally confirm that a new patent application has been filed at the UK Patent Office on 5th June 1997. Please find enclosed the official filing receipt together with a copy of the specification as filed and our invoice in this matter.
I also enclose herewith a further copy of the specification as filed for onward transmission to Dr Fudemberg at the Neuro Immuno Therapeutics Research Foundation. I have not contacted this gentleman directly but if in future you would like me to do so could [you] please ….. let me know.
The application number, filing date and applicant are shown on these documents. Kindly check to ensure that the [application] is correctly identified. The application has been filed without a request for preliminary examination and search.
If the filing date allocated to this application is to be maintained, it is essential that within 12 months of the filing date either the abstract and request are filed or a superseding application with abstract and request are filed together with a claim to the maintenance of the original filing date of the earlier application.”
Then there is a reference to foreign patent protection.
“Since this application has been filed without a request for preliminary examination and search, it may be prudent to file a request in the next few months so that the results of the search are available in good time before the above mentioned 12 months expires. Please let us know if you would like to file such a request”.
So that was the letter to Dr Wakefield from the lawyers who actually filed this patent. Following on from it we see their invoice at page 477, and then at 479 the filing receipt from the UK Patent Office, and we see again the number at the top 9711663.6 and the date of 6 June 1997.
“The Patent Office confirms receipt of a request for grant of a patent, details of which have been recorded as follows”.
We see the filing date 5 June 97, the applicants the Royal Free Hospital School of Medicine and Neuro Immuno Therapeutics Research Foundation, and, going down to the bottom:
“The application number included in the heading above should be quoted on all correspondence with The Patent Office.”
So that is its identifying number. As far as the applicants are concerned, Mr Tarhan, what is the underlying assumption as to the inventor?
A Well, the assumption there, on the basis the Royal Free Hospital School of Medicine is the applicant, the assumption is that one of our employees was an inventor, and that is the rationale for us being named as an applicant.
Q You have said that you did not know about this application when it was being made.
A That is correct.
Q Although it is in the name of the Medical School.
Q Is that an unusual occurrence?
A It is not usual. The assumption that I can make here is that the previous application that Dr Wakefield put in place was in his personal name, and he was told at the time that he should not do applications of that nature, so that if he did come up with any new applications it should be done in the name of the Medical School. So in a sense I believe he was trying to comply with the rules of the Medical School by applying in our name. The only issue here was that he did not give us the opportunity to say whether we wanted to apply.
Q You say the assumption is if the employer is named, that the employee is the inventor, and who was it your understanding was the inventor of this?
A In this application I believe it was Dr Wakefield and someone called Fudenberg, and that is the rationale for having Neuro Immuno Therapeutics Research Foundation as a co-applicant.
Q Yes. You understood that to be Dr Fudenberg’s organisation?
A That is correct.
Q If you close that volume up altogether, please, and go to your volume FTP3 at page 1227. (After a pause): I do apologise, Mr Tarhan, I have forgotten to go to the last document which is important in FTP2 on page 480. I took you to page 479, which is the filing receipt and I just want to go on to look in very broad terms at the terms of the patent attached to it, which starts at page 480. It says:
“Pharmaceutical composition for treatment of IBD and RBD”:
The present invention relates to a new vaccine for the elimination of MMR and measles virus and to a pharmaceutical or therapeutic composition for the treatment of IBD, particularly Crohn’s disease, and ulcerative colitis and regressive behavioural disease (RBD).
In my earlier patent application I have described how persistent measles virus infection, whether of a wild type of vaccine mediated, is the origin of some forms of IBD.”
That is a reference to the patent application that we looked at earlier. Going down to line 22:
“At present vaccination is used for the prophylactic prevention of measles virus and as a public health measure has proved to be generally effective. Infants are injected with an attenuated virus often within the first year of life and lately a booster vaccination schedule has been introduced to all school children approaching primary school age.
Unfortunately, as I have shown previously in the above-mentioned patent application, the use of this vaccine has been shown to be instrumental in development of Crohn’s disease and other forms of IBD over the ensuing 30 to 40 years and particularly has been instrumental in a substantial increase in Crohn’s disease in children since vaccination started in 1968.
The physician is therefore confronted with a difficulty at the individual level in that whereas as a public health measure measles vaccination is called for, it can have unwanted effects in those subjects who are unable to immunologically eliminate the virus so introduced.”
Going down to line 8:
“What is needed therefore is a safer vaccine which does not give rise to these problems and a treatment for those with existing IBD. I have now discovered a combined vaccine/therapeutic agent which is not only most probably safer to administer to neonates and others by way of vaccination, but which also can be used to treat IBD, whether as a complete cure or to alleviate symptoms.
As disclosed in my earlier patent application, Crohn’s disease is most probably caused by a failure of the body to completely eliminate the measles virus, probably because of the failure of the initial dosage rate to elicit a full immune response, which in turn allows the remaining virus to collect at various sites in the body, particularly in the small intestine and colon thereby causing the granulomatous vasculitis associated with Crohn’s disease.”
It then sets out in detail the scientific mechanisms which I am not going to take you to. Going to page 482 at the top of the page:
“The compositions of the present invention have the ability not only to condition the recipient to raise a specific immune response to MMR and measles virus when used as a vaccine, but also to re-establish the appropriate antiviral immune response of an immune system to persistent measles virus infection in IBD.
I have also found that regressive behavioural disorder in children is associated with measles, mumps and rubella vaccination.”
He then sets out his views as to that and his findings in relation to regressive behavioural disorder.
“I have reviewed a cohort of children who, following a period of apparent normality, have lost acquired skills, including those of communication. These children all have gastrointestinal symptoms, including abdominal pain, diarrhoea and, in some cases, food intolerance. It is significant that this syndrome only appeared with the introduction of the polyvalent MMR vaccine in 1988 rather than with the monovalent measles vaccine introduced in 1968. This indicates that MMR is responsible for this condition rather than just the measles virus and that accordingly a transfer factor specific for the components other than the measles virus in MMR is required.”
Going on to page 485 at the bottom:
“The compositions may be particularly adapted for use as a vaccine or for use as therapy for IBD or RBD.”
On to page 486:
“The invention is described by way of illustration only with reference to the following example.”
There are then examples set out. Going to page 488 you see the conclusions from those examples:
“The results of examples 1 and 2 show anecdotally that transfer factor is an effective agent for the treatment of IBD and as a vaccine for measles virus.
In order to investigate a consecutive series of children for a new syndrome comprising chronic enterocolitis and regressive behavioural disorder 12 children with a mean age of 6 years, range 3 to 10, all but one of whom were male, were referred with a history of achievement of normal developmental milestones followed by loss of acquired skills including language along with bowel symptoms, diarrhoea, abdominal pain and in some cases food intolerance all associated with the presence of MMR viruses in the gut.
The children underwent gastroenterological, neurological and developmental assessment including review of prospective in developmental records. Under sedation, ileo-colonoscopy and biopsy, MRI, EEG and lumbar puncture were performed. Barium meal was undertaken where possible. Chemistry, haematology and immunology profiles were examined.
It was found that the onset of behavioural symptoms were associated with MMR (mumps, measles and rubella vaccinations) in 8 of the 12 children and with measles infections one child otitis media in another. All 12 children had significant intestinal pathology ranging from lymphoid nodular hyperplasia to aphthoid ulceration.”
He sets out the histology results of patch chronic inflammation in the colon in 11 cases and reactive ileal lymphoid hyperplasia in seven but no granulomas.
“Behaviourally they all formed a heterogeneous diagnostic group which included autism (9/12), disintegrative psychosis (1/12) and possible post-viral vaccinial encephalitis (2/12). All the children exhibited features of severe developmental regression.”
At the bottom of the page:
“Accordingly a significant gastrointestinal pathology has been identified in association with behavioural regression in a selected group of previously apparently normal children. In the majority there is therefore a clear association with possible environmental triggers.”
Going on to the claims on page 490, I am only going to the first three:
“1. A pharmaceutical composition for the treatment of an MMR virus mediated disease comprising a soluble dialysed leucocyte extract comprising a transfer factor formed by the dialysis of virus-specific lymphocytes in a molecular weight cut-off of 12,500 disposed in a pharmaceutically acceptable carrier or dilutant therefore.
2. A composition according to claim 1 adapted for use as a vaccine for the prophylaxis of measles virus.
3. A composition according to claim 1 adapted for use as a therapy for IBD and/or RBD.
Those were the matters which were encompassed in that patent – the actual pharmaceutical composition itself and its use as a vaccine and its use as a treatment therapy, is that correct?
A That is correct.
Q Putting that bundle away, please, and going to bundle FTP3, page 1227, we see the ultimate register entry for the patent. We see that the application at the top of the page “Priority claimed 6 June 1997 in the United Kingdom” and the document number 9711663. Title: Pharmaceutical Composition for Treatment of IBD and RBD and the applicants: Royal Free Hospital School of Medicine and Neuro Immuno Therapeutics Research Foundation and under that we see the inventors names as Andrew Jeremy Wakefield and Dr Hugh Fudenberg of Neuro Immuno Therapeutics, is that correct?
A That is correct.
Q When that transfer factor proposal was put to you and to Freemedic, what sort of an idea did it seem to you to be originally?
A As I am not a scientist I could not judge the project on its scientific merits, but to me as a lay person I looked at it and thought there appears to be a cohort of people with this potential problem and here is a possible cure or a possible treatment for what is being suggested is a cause from the MMR vaccination. To me it was worthy of being investigated and assessed.
Q Did you understand that funding might be available already for the project?
A Again, I believe there were some proposals and discussions from external pharmaceutical companies, one precisely from Germany I seem to remember, where there was an interest in carrying out some sort of a trial to investigate whether or not this treatment had some merit.
Q Do you remember the name of the German company?
A I cannot remember off-hand, no.
Q You have told us that it was your understanding that if there were a susceptible group of individuals that it would be a treatment for them. Did you also have an understanding that what was being proposed, if the patent that I have taken you to is correct, was a vaccine evolving out of the same substance?
A Personally I would not have gone into the detail of whether it was a treatment as a vaccine or a compound or whatever. It was a treatment so to me it was a potential treatment and if there was a requirement for a group of individuals who needed treatment then this was a solution for their problem it was appropriate for the Medical School to make the appropriate assessment.
Q What was the next step that was taken?
A We involved Medical Marketing International in looking at the project in more detail and I believe I may have asked for some guidance from experts in the area.
Q You have mentioned Medical Marketing International previously. That is MMI, is it?
A MMI Plc. It is a commercialisation organisation which works with universities to help them commercialise early stage ideas into products for the benefit of society.
Q Do you recall that there was a meeting involving MMI?
A I personally would not have got involved in the meetings. I believe there would have been a meeting between Dr Wakefield and probably Ruth Bishop and a lady called Nicola Baker-Munton from MMI.
Q Who was Nicola Baker-Munton?
A She would have been one of the consultants working for MMI to assess projects.
Q Going back to FTP2, page 628, this is from Ruth Bishop copied to the later you have just mentioned, Mrs Baker-Munton, and to you dated 24 November 1997 from Ruth Bishop to Dr Wakefield:
“Thank you very much for the meeting with myself and Dr Baker-Munton recently. I am just writing to confirm the action points which you agreed to take as a result of this meeting.
You were to send me copies of the proposed publications on the link between measles and autism. I will forward these to Dr Baker-Munton. MMI have a confidentiality agreement with the school so the papers will be kept confidential to MMI.
You were to let me know what plans and work NIT (Neuor Immuno Therapeutics) are forming to characterise the transfer factor.
You are also to include any information on how NIT are fundraising, in particular whether they are planning to form a company.
I am due to see the directors of Freemedic this week in order to discuss your proposals concerning the transfer patent application and the clinical trial with Falk. I will let you know what the results of these discussions are and how the school wishes to proceed.”
Who were Falk?
A That is the German company I was referring to earlier on. I believe they are called Dr Falk.
Q The company is called Dr Falk?
A I believe so, yes.
Q There is a letter which is said to be a draft with “Not yet sent” on it which elaborates on this issue at page 627. It is dated 18 November 1997 from Dr Baker-Munton directly to Dr Wakefield:
“Thank you for an informative meeting on 11 November and the copies of the paper and first patent filing which I received this morning.
First, I should confirm that it will be very difficult to excite a pharmaceutical company based on the current intellectual property position of the transfer factor. I believe you agreed with this and acknowledge that further work needs to be carried out to try to characterise the active component(s). The proposal we discussed for the funding of such work arises from your existing collaboration with NIT and it would seem sensible to exploit this opportunity. If NIT are willing/able to raise funding for clinical trials on the transfer factor and to progress the characterisation work, this would be ideal. The consideration for this and the incentive for them to do so should involve the patent rights and in principle the school are supportive of a transfer of these rights [it has the words “to confirm” by it] which would also deal with the patent cost issues assuming NIT are willing to meet these costs too.
In order to progress this matter for you, we require more details about the proposed arrangements with NIT and the source of funds.
The 5-amino salicylate work is, as you noted in your letter of 15 October 1997, of some interest to Dr Falk Pharma, who is wiling to fund the filing of a use patent. Again, the school are supportive of this work [it has to confirm] forward in principle. The imminent Lancet publications require prompt agreement if such a patent filing is not to be invalidated and I am recommending you thus proceed on the basis of a heads of agreement with which we can be of assistance.
As both of these items are primarily licensing issues, I have passed all the paperwork to Tony Christmas, MMI’s licensing director, and I would be grateful if you could send any additional information to him. He will be in touch shortly to discuss the most appropriate way of structuring these arrangements to ensure you receive the financial support you need to undertake the trials and that you and the school receive adequate remuneration from any future commercialisation.
I hope these prove to be fruitful relationships.”
Mr Tarhan, can you assist us as to whether that letter was actually sent? Do you know if it was sent in that form?
A I cannot. I believe that was a copy in the files. I am not sure whether that was actually sent by Nicola Baker-Munton.
Q Does it reflect your understanding of the position that had been reached by MMI, at least in broad terms?
A The contents of the letter were discussed subsequently within the board of Freemedic so we were aware of what the recommendation was. The gist of it was that we should not get involved in the project. If NIT were interested in taking this project on then they should put a proposal forward. We would not stop the activity; we would actively support and hand over any intellectual property to a commercial collaborator such as Dr Falk Pharma and we would ask them to take the project forward and then generate the necessary evidence to demonstrate that the therapeutic actually works.
Q If I can ask you to go on to another document which is in the same bundle, page 507 in volume 2, do you recall also, Mr Tarhan, receiving this document?
A That is correct, yes.
Q And I think it right that you in the end sought some assistance from Professor Revell in relation to it?
A I indeed did. There are too many scientific terminologies and all the other aspects which I felt, firstly myself, and then some of the other members of the Board of Directors of Freemedic, could not understand.
Q I will take you to your letter to Professor Revell in a moment, but can I look very quickly at it – we have looked at this document in some detail so I am only going to jog your memory as to what it contains.
“Measles Virus and Crohn’s Disease”
And this document is called,
“A Clinical Strategy
A preliminary study of the effect of oral measles virus-specific dialyzable lymphocyte extract – transfer factor … in Crohn’s Disease”.
Let us go page 510, to the introduction:
“This proposal is based upon the premise that Crohn’s disease is caused by persistent measles virus infection. The purpose of this document is to:
• summarise the evidence for measles virus as the cause of Crohn's disease
• present preliminary evidence that persistent measles virus infection ins Crohn's disease results from a failure of the cellular immune system and specifically, cytotoxic T cells, to eliminate measles virus infected cells during the primary infection;
• propose that adoptive transfer of measles virus-specific cellular immunity as transfer factor offers a new therapeutic approach to this condition;
• present a proposed clinical trial of measles virus-specific transfer factor for the treatment of Crohn's disease;
• and present the budget for the proposed trial.”
We then go on to page 530, please, and we see in the summary:
“Preliminary data indicate that persistent measles virus infection of the gut is associated with a failure of specific cytotoxicity. A therapeutic agent that could boost measles-specific cytotoxicity and allow the body’s own immune system to clear the virus would therefore have a clear rationale in the treatment of Crohn's disease and, potentially, other conditions associated with persistent measles virus infection. In addition, a biological agent, that is stable and can be administered orally and capable of transferring specific antiviral immunity without the need for exposure to the live virus has the potential to be a valuable vaccine.”
Attached to this document, which sets out the science thereafter at page 549, is the clinical research protocol. Is that correct? Or a preliminary study of the effect of transfer factor on clinical status in patients with Crohn's disease?
A That is correct.
Q I am not going to take you through the detail of that, Mr Tarhan, because we have been through it with Professor Revell. If we look back, though, to page 506, please is this the letter that you wrote asking for assistance from Professor Revell?
A I believe that is a copy of it, yes.
FREEMEDIC – SCIENTIFIC ADVICE
You may be aware that Andy Wakefield has put forward a proposal to Freemedic to fund his research work which we understand may identify a treatment (not cure) for Crohn's disease. The procedure has been patented. The problem I have is understanding the science involved.
Are you able to assist in reviewing the attached documents and making any scientific comments in confidence to the Directors of Freemedic to assist with their deliberations.
I realise the documents are substantial for which I apologise, unfortunately that is the way Andy gave them to me
If you are not able to assist please return the documents and I will pass them onto someone else.”
Was that a usual thing for you to do, Mr Tarhan, to ask for some assistance from someone within the hospital?
A When we could not understand the science. Actually, we still use that same concept. We would use an internal consultant to give us advice. Peter Revell was selected in this case because Peter was also Andy’s head of department, or 50/50 I think; Andy was in medicine and histopathology, so Peter Revell was selected because he was head of histopathology. We felt he would understand a little bit more about the specific project.
Q We need not trouble with actual contents of the report, but I think it is correct that he did indeed produce a report for you in relation to your query?
A I believe he gave us some indications as to which areas we should look into further because his experience was also not complete.
Q Then, I think, the next step was a memo from the Dean, Professor Zuckerman, to you. That is at page 607 in volume 2 still. It is dated 15 September 1997 from the Dean to you.
“I note that the meeting of the Freemedic Board on 8th August 1997 considered a proposal from Mr Wakefield for funding in the order of £200,000 over two years for work on Transfer Factor.
I have considerable research experience with Transfer Factor and viral infection. I would not support the investment of Freemedic funds in this project. The case for an association between measles and Crohn's disease is highly controversial, and is yet to be confirmed independently.”
Was the project in fact supported by Freemedic?
Q Did that memo from the Dean play a part in the decision that was made?
Q Was there anything else that did that you can recall?
A I think MMI’s report, which required certain further information from Dr Wakefield, a lack of certain information arriving from Dr Wakefield, certain issues obviously, but Professor Revell’s report. There was a combination, but I think the fact that the Dean of the Medical School would not support this project was a big factor in our decision not to proceed with it.
Q In the event that the proposal got stronger – the scientific evidence on the basis that the proposal had been made had strengthened in the future – did the Freemedic have any views about that?
A The feeling was that, as Professor Zuckerman says there, this research is highly controversial and is yet to be confirmed independently, so during that period there was always a niggling doubt in the back of everyone’s mind that there was something there, but we did not know what it was. It would have been inappropriate for Freemedic to totally distance itself. The approach that was taken was, we needed to be distanced sufficiently; but in the event that the science was proven at a subsequent date, that the Medical School could then re-engage in some capacity or another. At the time we were looking at this, these reports and these suggests and proposals, etc., it was not a clear-cut position. It was certainly not black and white.
Q What was your understanding, Mr Tarhan, as to what Mr Wakefield subsequently did? You said Freemedic at that stage were not interested.
A Freemedic was not interested, but the way the universities function in this country is to allow individual academics to pursue their own research interests. In this case, the fact that Freemedic was not interested, or that the Medical School would not necessarily support the research project, would not by itself stop Dr Wakefield go off and do this himself. We did not actively block the activity but we did not feel it was appropriate.
Q Did Dr Wakefield return with a further proposal in relation to that?
A Yes, he did.
Q And can you tell us in broad terms your recollection as to what that proposal was?
A The proposal was to set up the spin-out company and take the intellectual property out of the Medical School, put it into a spin-out company, get external funding into the spin-out company with the support of other individuals, distance the science specifically from the Medical School so that the science can be conducted in a commercial environment, and that was the proposal. That was the next proposal that was put forward to us.
Q Can you explain to us – what do you mean by “a spin-out company”?
A A spin-out company? There are two types of spin-out companies. One is called a start-up company; the other one is called a spin-out company. The spin-out company is one where the university puts all its intellectual property into the company, and the spins it out of the university, so it is no longer associated with the university. A start-up company is when an academic individual sets up his own start-up company, and then goes off and licenses the technologies into the company. This proposal here was a combination of a spin-out and a start-up. A spin-out would have required a lot more involvement from the university. A start-up would have basically meant that we would just license everything across to the company, and off it went.
Q The company that he was proposing to set up in that way, what was it called?
A Sorry – it has gone! If you remind me, I will ---
Q Immunospecifics Ltd.
Q Immunospecifics – correct. It had a number of other names: Immunospecifics and then, I believe, it changed its name to Carmel Health Care. There were a number of changes of names.
Q We are interested in the start of it, when it was called Immunospecifics. Did Dr Wakefield come to see you about that proposal?
Q That suggestion?
Q Was he accompanied?
A I believe he brought two of his colleagues with him, yes.
Q I do not want their names for the moment, but do you remember what their particular specialisms were?
A I think one was another doctor, and the other one was a commercial individual who would be interested in raising funds to take the project forward.
Q As far as the doctor was concerned, again I do not want you to tell us, but do you remember what his name was?
Q Could you look? You have a plastic sheet in front of you. I think it is underneath your file. I can see it from here. It is a laminated sheet, which is called an anonymisation key. It refers to specific children who were subsequently written up in The Lancet. Could you look down that, Mr Tarhan, and tell us if you can see there the name that you recall?
A Yes. Yes, I do.
Q And against which child is it by number?
A Number 10.
Q Sir, I am going to call this gentleman from now on in order to protect the confidentiality of the boy, his son, as “Dr 10”. Could we go, please, in volume 2, to page 756a. This is a letter that was sent to you before a meeting. It is from Dr Wakefield to you dated 26 February 1998.
“Re our meeting on Tuesday, 3 March 1997, please find enclosed two references for Alex Korda, our proposed Chairman. I have applied for references for Dr , our proposed CEO [Chief Executive Officer], and will pass these on as soon as these are available .
In addition, Dr Kirkpatrick from Denver, Colorado, will be giving a guest lecture on the use of Transfer Factor in the treatment of viral disease on the same Tuesday lunch time in the Department of Paediatric Gastroenterology. I realise that this may be of limited value to you other than reassuring you that Transfer Factor is a credible and rational alternative treatment for viral infections. Dr Kirkpatrick holds certain IPR [intellectual property rights] that may be relevant to our endeavours, and Alex Korda, [Dr 10] and I will be meeting with him to discuss this. I will feed back as soon as I have more information.”
Is that correct?
Q Would you go on to 797, please. That is a memo from you. I am told that is a document that needs to be put back into the bundle. Actually, sir, this is a tranche of documents which goes all the way from 797 to 816. Perhaps I can give them all to you at once so I do not do it piecemeal.
THE CHAIRMAN: I have 797a here.
MS SMITH: In that case you need 797 to precede it and then, after 797a, you go on with the rest of the documents, which go from 798 to 816. Could we go first of all, Mr Tarhan, to 797.
Q This is a memo from you and sent to Mr Dutton, Professor Zuckerman, Mr Blatch and Miss Bishop, dated 6 March 1998.
“Mr Wakefield and potential company proposal
Andy came to see me with two of his colleagues who expressed an interest in setting up a company and acquiring the patents from the School. I asked for some background papers on the two individuals. One is a XXX (10) and the other appears to be an entrepreneur with previous experience with start up companies and is prepared to raise funds for the company.
I have asked them to put forward what they saw as the business plan and way forward and will report back as soon as I have further information.”
Can we then go on to 798. This is your second memo, 6 March 1998, to the same people.
“Further to my memo of 4 March I have now received the attached document from [Dr 10] the Managing Director designate for Immunospecifics Biotechnologies Ltd.
Any comments would be appreciated.”
Attached to that, was there a business plan document?
A That is correct.
Q That starts at page 799. Can I just look in brief terms at the contents of that.
“Immunospecifics Biotechnologies Ltd is a new biotechnology venture specialising in the isolation, production licensing and marketing of a new range of immunotherapeutics, generically known as transfer factors. These compounds are a naturally occurring part of the human immune system and promote specific cell mediated immunity towards the target antigen.
The first clinical condition targeted will be measles virus induced inflammatory bowel disease. It is estimated that this disease costs the NHS about £15,600,000 per annum. The incidence of measles induced inflammatory bowel disease is increasing dramatically in Europe and the States. Immunospecifics … will undertake the start of a two year, double blind, phase 1 clinical trial into the effectiveness of measles specific transfer factor in the treatment of inflammatory bowel disease and an open label study into the effectiveness of the same product in ameliorating pervasive developmental disorder within 3 months of securing funding.
In parallel with the clinical trial the company will develop a clinical diagnostic for the presence of the measles virus. It is estimated that the market for this diagnostic is about £4,000,000 per annum in the UK alone. The company will also investigate the potential of transfer factors as vaccine alternatives. An animal model trial of the value of measles specific transfer factor in preventing inflammatory bowel disease will begin upon securing funding.
On completion of a successful phase 1 clinical trial the company will move towards phase 2 and phase 3 trials for the measles specific transfer factor whilst introducing new potential transfer factor therapeutics to its development portfolio. Prior to the completion of this first phase trial, the company expects to have finished the laboratory development of the clinical diagnostic, completed the open label study into pervasive developmental disorder and finished the animal study into the potential of transfer factor as a vaccine.
The company is looking to raise about £2,100,000 to undertake this development programme.”
Moving on to page 800,
[Immunospecifics] will specialise in the production, formulation and sale of a wide range of immunotherapeutics, generically known as transfer factors (TFs). [Transfer factors] are a naturally occurring component of the immune system which have been shown to confer antigen specific cell mediated immunity. This form of immunity is important in overcoming viral infectious agents. Many viral agents have the capacity to suppress the body’s cell mediated immune system (e.g. Human Immunodeficiency Virus). Overcoming this suppression through the introduction of an antigen specific cell mediated immunity promoter has enormous potential clinical significance.”
Then it sets out the history. Would you go on to page 801, the top of the page and second paragraph down,
“It is [Immunospecifics’] aim to use a high potency, standardised TF preparation in one of the first properly controlled clinical trials of these materials. The target conditions for the trials will be specific forms of inflammatory bowel disease (IBD) and a condition affecting children known as pervasive developmental disorder (PPD). These trials will begin within the first three months of the company’s establishment. Whilst these trials are taking place, the company will be purifying and characterising the active compounds in the TF preparation. Once isolated and characterised, the potential for this molecule as a measles specific vaccine will be evaluated in animal model systems.”
Going on to page 802 and just past the middle of the page,
“STRATEGY AND OBJECTIVES
[Immunospecifics] is at present no more than a concept, but one with a unique opportunity. The strategic goal for the venture will be to achieve full regulatory approval for the use of antigen (infectious agent) specific transfer factors in a variety of clinical conditions where existing treatment regimes are either non-existent or have limited effectiveness. This strategy will permit the company to establish a clear technical and medical lead in this area with a resulting dominant market share. Paralleling the use of [transfer factors] as therapeutics will be a research programme aimed at demonstrating the value of [transfer factor] as a vaccine.
The objectives and associated tasks for the first two years to develop the concept into a full-scale venture are summarised in the following points.”
Turning back to page 801 for a moment, Mr Tarhan, and the bottom of the page, the last paragraph reads,
“It is [Immunospecifics’] aim to undertake a phase I clinical trial of a high potency measles specific transfer factor supplied by Fudenberg’s group at a very early stage in the life of the Company.”
Would you turn now to page 804 and this is still under the heading, “STRATEGY AND OBJECTIVES” and to number 7 of 9,
“Establish the potential of the high specific active preparations as a potential measles vaccine
This study will be done in conjunction with ‘Immuno’ a subsidiary of Baxter Health Care, in Austria using simian model systems. The efficacy of the [transfer factor] will be assessed by its ability to prevent measles specific IBD during challenge experiments. ‘Immuno’ have agreed to undertake the preliminary work with the [Royal Free Hospital] at no cost, although Immuno’s contribution is estimated to be of the order of £100,000. If successful this concept will be developed further in collaboration with a major pharmaceutical company, such as Glaxo Wellcome’s Jenner Institute. The full relationship between ISB and Immuno needs to be resolved.”
Going on to page 805,
“Medium term objectives for the venture will be: 1) to take the purified and characterised measles specific [transfer factor] through formal product registration by undertaking phase II and phase III clinical trials; 2) establish the most appropriate route for the commercial development of the product; 3) develop the potential for use of [transfer factors] as vaccine replacements; 4) introduce new anti-infectious agents TFs to the company’s product development portfolio and take them through to formal product registration.”
Then we see that there is a section on competitors in the field and we see in the third paragraph under the heading, “COMPETITORS”,
“One of the [Immunospecific] team, [Dr 10], has visited Cytokine Science in Denver”
and it describes them as a small and under-funded group who have been doing some work on transfer factors.
THE LEGAL ASSESSOR: Ms Smith, I meant to mention this before. I think that there is the potential for confusion in the future over the person you are referring to as Dr 10 because of course he is a parent rather than a doctor of a child. Bearing in mind how long this case is going to take and when people are looking at transcripts, there might be some confusion in the future when reading this evidence between the doctors of the various children and somebody who is a parent. I think that it might help if you referred to that person as “Mr 10”. Although he is a medic, he is actually a parent.
MS SMITH: Actually, he is not a medic. He is a XXX, as I understand it, and in fact I think that Mr Tarhan did just say that when I asked him.
THE LEGAL ASSESSOR: Yes, he is a XXX. I think that it would be better if he were called Mr 10 rather than Dr 10 to make it clear that his involvement is as a parent.
MS SMITH: I can certainly do that, sir, and I think that it will mean a small amendment in the charge as well which also refers to him as Dr 10. I will now try and remember to call him Mr 10.
THE LEGAL ASSESSOR: I am just thinking about how this will all look when people read the transcript in several months’ time.
MS SMITH: Yes. It is a very good point, if I may respectfully say so. Thank you.
(To the witness)
“… [Mr 10] has visited Cytokine Science in Denver”
was the last point to which I took you and that is at page 805. Would you look further down that page, page 805, where we see the history of the intellectual property right’s position and the history of the patents to which I have already taken you.
I ask that you go to the bottom of page 806 where it says,
The four individuals involved in this venture at this early stage has been mentioned previously. [Mr 10] will be the Managing Director of the venture. It is not envisaged that Dr Fudenberg, Dr Wakefield and Professor Pounder will be full time members of the company. It is anticipated that Dr Wakefield will play a vital role as the Research Director and will be a key member of the scientific advisory panel. Dr Fudenberg will bring many years’ experience of the production and clinical application of [transfer factors] to the company. He is no longer scientifically active but his involvement will bring technical and medical credibility to the venture and he will be a key member of the scientific advisory panel. Professor Roy Pounder of the [Royal Free Hospital] will fulfil the role of clinical consultant and oversee all the clinical trials and sit on the scientific advisory board”
and then it deals with the role of Mr Korda as part-time Executive Chairman and then it says,
“[Mr 10], Dr Andy Wakefield and Alex Korda will sit on the board of the company.”
It then sets out the various brief CVs and we see,
“[Mr 10] … (Managing Director Designate)”
and he does indeed have
“a PhD in XXX from the University of XXX and an MBA from the University of XXX. He has worked within the XXX industry … since returning from a research position at the University of XXX at XXX.
[He] has particular experience in the establishment of start-up XXX companies …”
Sir, I will not read out the whole of the rest of it, but it might be a document that you wish to read to yourselves. It sets out a brief CV for Dr Wakefield and for Mr Korda, Professor Pounder and Dr Fudenberg.
(To the witness) We see at the bottom of the page the initial equity position, in other words the division of the equity.
“The initial equity ownership of the business will be split amongst the following individuals and organisations.
Dr A. Wakefield
Dr R. Pounder
Dr H.H. Fudenberg
Royal Free Hospital School of Medicine”
and it says,
“The [Royal Free Hospital] owns the rights to certain key patents and would be heavily involved in the clinical trials of the [transfer factor] products. In exchange for an exclusive licence to the patents and use of facilities, the [Royal Free Hospital] will be offered an equity stake in the venture.
A Charitable Trust
The initial founders of the business have always envisaged that a proportion of any profits and capital growth achieved by the business should be used to fund research into specific conditions relating to chronic intestinal inflammation, chronic viral infections and related conditions. It is our aim that this should be through a charitable trust, who would have an initial equity stake in the business”
and then it sets out the cash requirements and the staff requirements on page 810.
Would you go on to page 814 where we see the proposed timetable, a milestone time chart, for the set-up of the company and we see the months at the top of the page and I ask that you look at number six, which is the animal model vaccine trial. Was the proposal that that would start in the fourth month of the company?
A That is correct. This is also subject to raising the funds, presumably.
Q Of course. What was the view taken, Mr Tarhan, by the Medical School in relation to this proposed business project?
A The first thing to say is that this one appeared to be a little more advanced than some of the other proposals that we would normally get. It seemed that a lot of effort and work had gone into it and that made it look as if it was more credible than something which had just turned up on a piece of paper. There was a lot of information in there, so the case had been worked up. It was always a positive move that there was some external interest. Obviously the fact that there was a proposed managing director and a potential funder for the project also gave it the good soundings that it was viable. With most of the proposals that come to the Medical School and continue to come to the University, the crux of the matter is, if the funding is available and there is a venture capitalist or a private funder that is prepared to pay for this sort of stuff, then the Medical School will normally support it. There is no reason for the Medical School to say, “No, we are not interested in supporting this”. So, this was then on the basis of, if the funding could be raised and if the external management could then put a proposal forward, come back and work with the Medical School to take this project forward and demonstrate that what they were saying worked, then it seemed like a reasonable thing to do at the time. I think that the view was, “Yes, we are interested in transferring our intellectual property into this company. Please, go ahead and raise the cash, come back, take the intellectual property and off you go” and that was the proposal.
Q Would you go on to page 815 in FPT2 where we see a memo to you from Ruth Bishop dated 10 March 1998 which just recaps on the history of this matter.
A That is correct.
“Thank you for your recent memos.
I thought that I might recap on some of the immediate history to the business plan.
Last summer, Andy Wakefield wrote to the School describing a patent application which he had personally filed along with Neuroimmuno Therapeutics Research Foundation (NIT). This was filed without the School’s knowledge, although in the name of the School. This application concerns the ‘transfer factor’ and Mr Wakefield asked if the School would be prepared to take on the prosecution and costs – he was (and is) meeting these himself.
About two years prior to this Mr Wakefield had filed an application in a similar manner (not with NIT) on a diagnostic method for detecting measles-related inflammatory bowel disease. The School has never agreed to take on this application, due to the controversial nature of the work”
and that is the first application that we went through.
“I asked MMI to provide a commercial assessment of the transfer factor work. The results of our discussions were:-
1. MMI’s advice was that the patent application deals with transfer factor as a ‘soup’ of ingredients. The active components, i.e. those capable of defeating viruses and promoting immunity, were not really identified or characterised. To give solid commercial value, the active ingredients would have to be characterised. This work, apparently, was to be carried out by NIT based in the USA – NIT is a charity, I believe.
2. MMI advised on a strategy for dealing with both of the ‘rogue’ patent applications” and then there is a word missing but I think it should be “could assign the applications to NIT, or any spin off company set up by NIT/A Wakefield to exploit the technology, under an appropriately worded agreement. This would put the ipr at arms length from the Royal Free, but could provide for a revenue return on any exploitation. Taking a stake into the proposal would continue to link the Royal Free closely with this project.
3. After meeting Andy Wakefield before Christmas, Andy agreed to provide details on how NIT were planning to characterise the transfer factor, together with a business plan for the exploitation of this work. You might consider inquiring further into the prospects for achieving characterisation, as MMI saw this as a key issue (briefly dealt with in point 6 of the plan’s strategy and objectives). The section on ‘Products’ (page 2) mentions the fact that transfer factors have been known to have therapeutic qualities for many years, but they have never been systematically developed for medical use. Perhaps characterisation has been a key stumbling block.
Another issue is the controversial nature of the measles virus/IBD hypothesis at the core of the proposal. This concept is rejected by many scientists and doctors – and by the Government. On page 11 it is proposed that [Royal Free Hospital School of Medicine] remain involved in the company as licensor, and owner of related patents, host for ongoing [research and development] activities and equity holder.
On a separate point, Andy states (top of page 8) that the diagnostic patent application has been assigned to himself and Professor Pounder. Do you know if a formal assignment has been executed – I have not been asked to arrange this.”
That was obviously a recap of the matters that we have already been to, Mr Tarhan, with Ruth Bishop’s observations added on in relation to the proposal with the business plan to which I have taken you. Can you tell us what in the end was done?
A In the end, we agreed. There was no problem with Ms Bishop’s comments here; they were already on board anyway. There was concern that we should not be associated with a company as the Medical School. So, the proposal in the business plan that we said we should take an equity stake in the company was renegotiated into a manner which meant that we would not take an equity stake in the company but we would have an option. In the event that the science was proven, we would then exercise that option and then become a part of the company but, until the science was proven, we would not take an equity stake in the company.
Q What was the rationale as far as you were concerned in distancing yourself from the company at that stage?
A The story was exactly the same. The science had still not been proven, and nothing had changed from the previous time that Freemedic had said, “No, we are not interested. We are very happy to assign the intellectual property out somewhere else for someone else to do the work, but we would not be able to do the work ourselves”. So on the basis of that, the fact that we had a company that came into the equation did not change that perception. The offer of an equity stake was, in our view, a way to tie the Medical School back into the organisation, and that was made perfectly clear at the discussions that that will not be feasible, for the Medical School to be associated with a company. So the reality was at the end of the day we agreed, as I said, we would take out an option in the event something was proved, and the science was proved, and what the company was saying would be achieved. If it was achieved, then it seemed reasonable at that stage that the Medical School and Freemedic should take an equity stake in the company, but only after the science had been proved.
Q If you could go to FTP3, please, page 927. This is a letter of 25 June 1998 from you to Dr Wakefield, and it says, “Dear Andy” – I am sorry, sir, 927.
A This is a letter that I wrote to Andy.
A The issue is, again with any intellectual property that comes out of the Medical School and/or universities these days, there is generally a revenue sharing agreement that underlines the employee/employer relationship, and as Andy was an employee of the Medical School, whatever the Medical School did with its share of any intellectual property it had a duty to share part of that with the inventor. So this document was to deal with that aspect of it. So in the event the Medical School did make some money out of this invention, this document determined how that revenue sharing that was properly attributable to Andy Wakefield would be distributed.
Q Thank you. If we can just read it through, it says:
“I am writing to confirm our discussion of this morning.
It is proposed to assign the two patent applications to Immunospecifics and discussions are in hand to do this.
It is noted that the interest the School will derive from the assignments subsumes within it a share which is attributable to the Inventors. We have agreed that a reasonable apportionment between the School and the inventors be 2/3rds for the School/Department and 1/3rd to inventors.”
When you say “the School/Department”, which department are you referring to there?
A It would have been Dr Wakefield’s department, either histopathology or medicine. The revenue sharing agreement says that any profits or revenues that are made by the Medical School are shared with the inventors, with the School centrally and with the individual departments that have participated in that invention.
Q It goes on:
“I understand that you wish for 1/3rd attributable to inventors to be placed into a designated charity.
If you are happy with the above please confirm by signing and returning to me the copy letter attached.”
We see Dr Wakefield’s signature at the bottom.
A That is correct.
Q I have already taken you to the business plan suggestion that some proportion of these monies should be ploughed back into research relating to inflammatory bowel disease and related diseases.
A That would be completely different from this though.
Q Exactly, and I was just going to ask you, as far as this is concerned, this is a different matter, because, as you have explained, this is the amount of money which would be attributable between the School and the inventors. Do you have any knowledge of who the charity would have been?
A No idea about the charity. Just to clarify the issue, we have to do this in order to protect the School, because in the event that we were assigning all our interests in this intellectual property to an external company, we could not have an inventor then subsequently coming back and saying, “Well, you have assigned my interests and therefore I have lost out”, so we have to do this sort of assignment every time we assign technologies out of the Medical School. So this was a way of protecting the Medical School and also establishing that Dr Wakefield had no further rights on those intellectual property items – any further rights from the Medical School that is.
Q Yes. Thank you. I know the story went on after that, Mr Tarhan, but not for our purposes, and I think we can conclude it by saying that I think it is correct that in the end all the intellectual property was assigned outright to Dr Wakefield as part of a compromise agreement which was signed when he left the Medical School in 2001?
A I believe that was the case, but, as I was not directly involved in the compromise agreement, I believe that was the case.
Q Now, that is all I have to ask you, except that it is pointed out to me that I missed out a document, and I am sorry to confuse matters by taking you back to it, but I wonder if we can just deal with it, please. If you go back to page 429, which I think is volume 2, this is in relation to the position when the cheque was first sent to the Medical School, Mr Tarhan, and we went through this document, do you recall, earlier this morning?
Q If you turn back, what I should have asked you about and did not was a letter at 428a, which was dated 28 April 1997 to Dave Wilson.
Q It says:
Dr Andrew Anthony BXDXA
I would like to extend Dr Anthony’s contract for a further two months to be paid from the funds available to us from the Legal Aid Board. I will review the situation in the meantime. Since Dr Anthony’s contribution is vital to the work being funded by this source, I may keep him on this for longer. I will contact you as soon as I have reached a decision.
Thank you for your help.”
So that document needs to also be seen in the context of the communications from Dr Wakefield.
MS SMITH: Thank you very much. If you stay there, you will be asked some questions.
THE CHAIRMAN: I am looking at the time, and also considering the fact that Mr Tarhan now has been once again for about an hour and a half. Unless you feel compelled to start it, I just wondered whether this would be a time to have lunch. I know it is slightly earlier than expected.
MR COONAN: I am entirely in your hands, sir. It has been a bit of a dense morning for all of us and it may well give you a break.
THE CHAIRMAN: Yes. I think that is how I feel as well. Can I then say that I think we will now adjourn for lunch. Mr Tarhan, you are still under oath and still in the middle of giving your evidence, so please make sure that you do not discuss the case with anyone. It is now 12.25, so we will resume at 1.25 after the lunch break. Thank you.
THE CHAIRMAN: Mr Coonan, I think you were just about to start your cross-examination.
Cross-examined by MR COONAN
Q Mr Tarhan, this morning you were taken through a mass of documentation. You will be pleased to know that I am not going to take you through all that again, and indeed I will not detain you terribly long, but I would like you, please, to try and assist with a number of matters by way of clarification, and in some respects perhaps, if you can, feel able, by way of emphasis.
Q Can I just start, please, by dealing with the question of the patents. I will come back and deal with the legal aid funding later. The first one in time, if we can just refresh our memory, is at volume 1, page 127. We looked at it this morning. It is from Dr Wakefield to Mr Blatch, and, as we can see on page 128, copied to you.
A That is correct.
Q I would like just to look with you, if I may, for a minute or two at a number of the elements of this document. It is dated, we can see, in July 1996. I am going to pick it up in 1995, in the second main paragraph, do you see that?
Q What Dr Wakefield writes is as follows:
“In 1995, immediately prior to the publication of our article in the Lancet linking measles vaccine to inflammatory bowel disease, I read a paper showing that persistent measles infection in cultured cells could be treated with a novel molecular therapy ….. That week-end I sat down and wrote a patent, in order to try and protect the interests of all parties concerned, covering the diagnosis and treatment of inflammatory bowel disease using reagents and therapies directed against measles virus.”
Then he says this:
“You will appreciate that at this stage we had no conclusive evidence of causation and no specific therapy for treatment of patients with inflammatory bowel disease directed towards the measles virus. Nonetheless I thought it was worth putting in provisional cover since, on publication of our vaccine paper, it would then fall into the public domain and any chance of patenting would be lost.”
Q So on the basis of that explanation that we see in the letter, taking it at face value, which we must, what Dr Wakefield is talking about is reacting to the potential shift in the legal position by a protective act, was he not?
A I cannot disagree with that.
Q It is a protective act to ensure that the interests he has identified at least achieve some measure of protection?
A Only one comment, that I think Dr Wakefield would have known or should have known the process though, that filing a patent in his own name and that of Professor Pounder at the time was probably against the financial regulations for the Medical School. So yes, I agree the fact that he did take action to protect any potential value, but proceeding without telling the Medical School was, in my view, not appropriate.
Q No. Well, it may well be that proceeding without telling the Medical School in advance was something that you would disapprove of, but here he is, having taken that step, telling the Medical School what he has done.
A Yes. I actually do not see any problem with this letter. The letter turned up and it was advising Mr Blatch on what Dr Wakefield did.
Q Absolutely. So we can agree that, certainly from the standpoint of the Medical School, he should have told you first.
A Well, he should have told Mr Blatch, not myself.
Q Well, I say “you” in a collective sense.
Q One has then got to look at explanation and motive, and of course we have not had Dr Wakefield’s evidence on this yet, but that appears to be, on the face of it, what he was seeking to do?
Q Over the page, he is dealing with subsequent events. The patent was refiled over the passage of time and the refiling process was paid for by Professor Pounder and Dr Wakefield.
A That is my understanding, yes.
Q He, Dr Wakefield, identifies the exploitation potential (and I am using that in a proper sense), the exploitation potential of this idea encompassed by the patent in favour of the Royal Free Hospital School of Medicine.
A Well, I am not sure, when you say “he identifies”. I mean, he obviously refers to the fact that there will be a benefit derived to the Royal Free Hospital School of Medicine, which---
THE CHAIRMAN: I am sorry. I think, Mr Tarhan, your voice is dropping down a bit. Can you please speak a little louder.
A Okay. As I say, I think he is obviously indicating that there is an interest in the Royal Free Hospital School of Medicine as a major player, but does not define what that is.
MR COONAN: No. It may well be in the course of that letter, we will have to wait and see, that that was not the purpose of the letter, to identify precisely what that was. Now, that letter of course is in 1996, and you told us in your evidence this morning that the School, or indeed Freemedic, did not in fact proceed with funding the idea encompassed with the patent. I think that is what you have told us?
A Just to be clear, I think this is the patent prior to the one that was considered by Freemedic. There are two.
Q Absolutely. The Transfer Factor was considered by Freemedic.
A That is correct. This one was not considered by Freemedic, correct.
Q It was considered by the School.
Q Now, do you remember that in 1997 the School nonetheless considered funding this, and I am going to call it “the idea”, if you do not mind, funding the potential exploitation of this idea through central School funds on a 50 per cent basis?
A I am not aware of that one. School, not Freemedic?
A Not aware of it.
Q Well, again I do not want this to be a memory game. I would like you to look at a letter, please, which has come to light. Perhaps you would have this document distributed, please. (Same handed)
THE CHAIRMAN: Is it going to go in the bundle of papers or is it going to be one of the defence documents?
MR COONAN: It is going to go in the main sequence, sir, bundle 2, page 620a.
THE CHAIRMAN: Thank you, Mr Tarhan, if you could just insert it there.
Q Perhaps we can look at it together. It is dated 20 October 1997. Is that your signature at the bottom?
A That is correct, yes.
Q I just simply introduce this, as I say, simply to try and assist in jogging memory, do you follow? Looking at the first part of the letter, I ought to read it into the transcript:
“Further to our brief conversation in the [senior common room] last week I am writing to confirm that despite numerous meetings on the subject of financially supporting your work it has been agreed that in view of the controversy surrounding the work no funds can be allocated from Freemedic for this purpose. I understand the Dean has encouraged the work and expects the work to be supported by external grant giving bodies and or pharmaceutical/external venture capital funds but not internal funds available to the School or Freemedic.
The patent issue is one that we will need to consider separately. I understand MMI---”
Pausing there, you referred to that body this morning.
A Correct, yes.
Q “---are reviewing the second patent and will provide comments back to me shortly. The position on the first ‘diagnostic’ patent is that I am prepared to cover 50% of the costs through central School funds if you/Professor Pounder can identify the resources to cover the balance through your research funds. This arrangement will continue up to 31 July 1998. At that date we need to assess the level of commercial interest to determine whether the support can continue. I am sure you are aware that merger with UCL could take place in August 1998 and decisions on which Intellectual Property rights to protect and which to abandon may be influenced by UCL.
I am sorry that it has not been possible to fund this project internally but I have done as much as I could to ensure the issue was considered and evaluated at the highest level within the School.”
Just for my purposes, looking at the second paragraph and the reference there on the third and fourth line to the first diagnostic patent is a reference, I suggest, to the patent which in fact appears in descriptive form on our page 127 in bundle 1.
A It would appear so.
Q Again, it may well be that the letter speaks for itself, but it looks, does it not, that you, acting in your official capacity on behalf of the school, was prepared to cover 50 per cent of the cost through the central school funds, subject to that proviso.
A The letter was written to assist the process. As we said, we were going through a process at the time. As I remember, Professor Pounder and Dr Wakefield made certain representations about the fact that they were running out of cash and that the whole project could potentially be jeopardised if we lost that patent. In response to that what I put in place was some form of amelioration of the process. I would remove the costs burden from them while the assessment for the commercial project went ahead so it was a transitional arrangement to help the two individuals concerned.
Q I am not disputing that. It is just another piece of the jigsaw.
A There is no debate about the issue. We did look at both the projects and we kept on looking at them to see if there was commercial value and scientific merit.
Q The Panel have seen a great mass of pieces and so forth but sometimes it may just help to have another little piece in the whole.
Q Can we look briefly at the question of transfer factor. We could start this by looking at page 479 in volume 2. To set the scene, you have told the Panel that in respect of the application for a patent in respect of transfer factor Dr Wakefield did not seek or obtain express formal permission to make the application before he made it.
A That is correct.
Q We know that on page 479 we can see the dating of the filing of the patent and the document is dated 6 June 1997. That is page 479. Turning back to page 474, on 24 June 1997, about 18 days later, Dr Wakefield is telling the school that he has filed this further patent.
Q These are just another few pieces of the jigsaw, the school having been alerted by Dr Wakefield to the filing of this patent. At that stage as a matter of fact the school took no steps at all to cancel the registration; the school, as we know, being a registered applicant and owner of the patent.
A I do not think it is necessary to cancel the registration until the evaluation took place as to whether it was valid or not.
Q Absolutely, and I for one on behalf of Dr Wakefield applaud the commercial sense of that. It is the fact that there was no suggestion of seeking to cancel it outright because, for example, he had gone ahead and registered it without formal permission.
A I would not have seen any rationale in that.
Q It would have been absurd, would it not?
A At the time, yes, that is correct.
Q It looks, does it not, filling in a few blanks, looking at page 477 we see that the fees for filing payable to the attorney £1,236 and then if we move back to page 474 on the letter we looked at earlier this morning Dr Wakefield, towards the bottom of that letter, says this:
“The school may wish to fund this at this time. In the meantime I will cover the cost with Roy Pounder.”
That was the position, was it not, that Dr Wakefield and Professor Pounder covered those initial formal costs?
A That is what it says, yes.
Q Again, I think I can take this quite shortly. The Medical School having become through the action of Dr Wakefield the joint owner of this particular piece of intellectual property jointly with Neuro Immuno Therapeutics wanted to consider the commercial potential of that ownership.
A That is correct.
Q Taking this shortly, over the next 12 months the Medical School considered the potential commercial viability of this to see whether or not the Medical School could achieve a stream of revenue if in fact it was exploited.
A I think revenue is a second benefit. It is curing the patients, number one.
Q Let’s take that as a given.
A That is not a given when it is a commercial transaction. We take decisions on the basis of is it of any use to patient benefit and then income next.
Q I do not dispute or quarrel with that. If the concept had no commercial viability whatsoever then there is no particular purpose in the school being involved with it.
A That is correct.
Q A certain amount of time was spent, as you have described, and the school took the view that since the underlying science had not been confirmed that the question of independent replication was an issue, that for the time being the matter should be kept at arms length but that the school should keep the matter well in hand in order to benefit from a turnaround in the fortunes of the idea.
A I think you are skewing it towards the income generation component again. The school had no option but to keep the research in-house because Dr Wakefield was our employee and hence anything that Dr Wakefield did was associated with the school. Somehow we had to keep the activity going while the commercial evaluation took place.
Q Mr Tarhan, the school could get rid of its interest in this at the drop of a hat.
Q You could assign it to Dr Wakefield.
A That still would not distance the school from it. The school’s employee was Dr Wakefield.
Q You could distance yourself from it and not therefore benefit from any income stream, but you did not do that.
A It is possible, yes.
Q It is not just possible. You kept a hand on this, did you not?
A I think as a medical school, as I said earlier on, there is an obligation on a charity to make sure that any profits that are made are then piled back into the Medical School. In this case we were not aware the information that was being provided by Dr Wakefield was indicative of commercial interest. We would have been naïve and it would have been inappropriate for the Medical School to walk away from it without doing the due diligence necessary.
Q Mr Tarhan, I for one applaud that and I would suggest to you that it makes sound commercial business sense to keep a grip on this, either by having an equity share in a start-up venture which you considered, or alternatively having an option to take an interest which you considered. Either way, if the science was good the school stood to benefit, did it not?
A That was the expectation, yes.
Q The ultimate position that we looked at again this morning in volume 3 at page 927, when ultimately in 1998 proposals were firming up, the ultimate plan was to assign the two patent applications to Immunospecifics and the intention was that the inventors share – would that include Professor Pounder as well?
A It would include Professor Pounder, yes.
Q Both the inventors, Pounder and Wakefield, the plan was that the share of any revenue stream should go to charity.
A That was Dr Wakefield’s intention, yes.
Q Going back to the question of the legal aid funding – FTP1 – I am going to take as a marker to assist yourself if you need it, but certainly to assist the Panel in light of the wealth of material that we had to deal with this morning, is to take page 338a as the starting point. This has been photocopied in such a way as the cheque comes out in the same document as the photocopy of the letter.
Q We can see, although it has been badly photocopied, the cheque is drawn on Dawbarns payable to the Royal Free Hospital School of Medicine in the sum of £25,000 dated on the cheque 6 December.
Q It is in a covering letter addressed to Dave Wilson. Do you see his name is almost cut off?
A That is correct.
Q It is address to “Dear Dave”, signed by Dr Wakefield and refers in the body of the letter to Dr Silke Schepelmann, Funding by the Legal Aid Board which is the subject heading.
Q It reads:
“Enclosed herewith is a cheque for £25,000 from the Legal Aid Board for the funding of Dr Schepelmann’s salary. This is the first payment received from the Legal Aid Board. I/we shall advise you of any other grants we receive to support her salary.”
Then we see a few notes at the bottom. The one on the left-hand side says “Reneé”. Do you know who Reneé is?”
A The cashier.
“This cheque cannot at present be coded. We may have to return the cheque. I will advise later.”
That is signed presumably by Dave Wilson, is it?
A That is correct.
Q It is dated 11 December and then somebody has written to one side: “This has already been banked, Reneé” and then a date.
A I believe the sequence is Dave probably passed the letter to Reneé for coding, or sorry, Reneé passed it to Dave for coding and Dave responded by saying, “I cannot code, I do not have a code for it,” and she then specifically said I have banked the cheque.
Q That is fairly obvious from the note on the right. We can deduce from this, can we not, that the cheque was dated the 6th. It is then sent as we know by letter, because we saw it this morning, to Dr Wakefield who then forwards the cheque with this covering letter to the School of Medicine who bank it on the 10th.
Q So there are four days between the date on the cheque and being banked. The question of coding has been raised. What is that a reference to?
A The coding is allocation of the sum to an account which is what we were discussing earlier on.
Q The problem, as you understand it, Mr Tarhan, was from the staff’s point of view in the financial section where to put the cheque. Have I put it too crudely?
A No, I think that is correct, which account to allocate it to and whether it is a discretionary account or a specific project account.
Q As we know, the money was held in an account which was later described as a suspense account.
Q Lest it be thought that this cheque came out of the blue, that would be wrong, would it not, to say that it just came out of the blue?
A As I said in the correspondence with Dave, it would be unusual for a cheque to arrive without some backing documentation so that is what we were looking for.
Q Also some prior knowledge?
A Prior knowledge, backing documentation and probably some sort of grant application. That is what normally happens.
Q Perhaps nothing is perfect in this world, but prior knowledge would go a long way, would it not, towards telling people what it was all about?
A I think in this situation a formal grant application is what these people would have been looking for.
Q Whatever the arrangements within the cashier’s office, or the financial department, may be one thing but let us look at the position from Dr Wakefield’s standpoint. I am going to start this sequence of documents, please, by asking you to turn back to page 199a. It is not a letter you were shown this morning, but it is from Dave Wilson?
A Correct, yes.
Q And this is in September of the same year. He is writing to Dr Wakefield against the background of information that he, Dave Wilson, has obtained, that a Dr Schepelmann had been appointed as a research fellow. In the appointment letter to which Dave Wilson is referring he picks out the reference, which is in quotations:
“‘The appointment is supported by a grant held by Dr Wakefield…’”.
Do you see that?
Q And, not unnaturally, Dave Wilson asks Dr Wakefield, does he not, in the last paragraph,
“… let me know how this appointment is being funded … I want to ensure that the funding is in place to meet accumulation of salary costs …”
In other words, Dave Wilson quite properly is wanting to know details about the nature of this grant?
Q And no doubt, once he gets the details and so forth, he can decide where to put it?
A I would assume so, yes.
Q That is a matter for him?
A He is doing his job.
Q Doing his job?
Q If we now turn on to page 237a, Dave Wilson writes to Dr Wakefield again. This letter is dated 25 September.
“Are you in a position to respond to my letter dated 13th September…”
- and we have just looked at that. That is page 199a.
“I am anxious to learn from which fund/account is supporting this post…”
for reasons he then sets out, quite sensibly if I may suggest.
“If the funding is from a completely new source, please can you provide me with all relevant financial details.”
Q A perfectly sensible question, is it not?
Q The sort of thing he would need to know the answers to?
Q On page 237b, a document you were not taken to this morning, Dr Wakefield springs into life, two days later.
Thank you for our letter regarding Dr Schepelmann’s appointment. We have recently been awarded a grant from the Legal Aid Board …”
“… to fund research into measles virus and inflammatory bowel disease. This is am most unusual source of funding but one cannot complain. Please find enclosed a copy of a letter from the Legal Aid Board to the co-ordinating solicitors. I have written to the solicitors requesting the first £25,000 to be paid Account BXBXA (ZP31). We will seek further remuneration from the solicitors in due course. If there are any questions, please do not hesitate to get touch with me.”
Have you seen that letter before?
Q In the light of your evidence this morning, it is a bit of a surprise, I have no doubt.
A It is a bit of a surprise, but it does not actually clarify any further unless you are going to produce another piece of paper that tells me something else.
Q Let us just look at its constituent parts. Dr Wakefield is telling Dave Wilson, “You have had a grant from the Legal Aid Board,” and he encloses a letter from the Legal Aid Board to the solicitors. In connection with this letter, we have not been supplied with that correspondence, although I shall show you some other correspondence in a minute. So there was a letter, on the fact of it, from the Legal Aid Board to the solicitors which, without speculating too much, no doubt sets out at least some of the details touching upon this question of the Legal Aid Board funding for research. Do you see?
A It would look that way, but until I see the letter I cannot comment.
Q No – you and I are in the same boat. And Dr Wakefield tells Dave Wilson that he has written to the solicitors requesting that the first £25,000 be paid into a specific account, and that is one of the accounts that Dr Wakefield had at the School, is it not?
A It probably is a discretionary account. I cannot be sure.
Q On the face of that it looks, therefore, does it not, that Dave Wilson is apprised of the grant and the account in which to put the money when it arrives?
A It is a discretionary account and, as I said before, if it was a special project account it would need to be a separate account.
Q That may well be, but that is all a matter of internal book keeping, is it not?
A Yes, yes.
Q He says if there are any questions, “Do not hesitate to get in touch with me”. We have been shown no document from Dave Wilson to Dr Wakefield which says or raises any questions at all.
A If somebody receives a piece of paper like this, if you can imagine in the finance department, an individual receives a letter which says, “We are applying for a £25,000 grant. I will let you know in due course,” they will probably put it on one side and wait for the documentation to arrive.
Q You just wait for such documentation to arrive, but when the money did arrive, and if the documentation was not complete, at least you as the recipient – not you personally but Mr Wilson – would put two and two together and realise that the money was in connection with this, would he not?
A One would expect that.
Q Doing his job properly, he would. Yes?
A I cannot disagree.
Q And it would appear that when Dr Wakefield wrote that letter to Dave Wilson there was no question at that stage on the assumption that the money was going to be paid directly into an account, any question of a request for some form of receipt or documentation as a matter of fact, was it not?
A I do not understand the question.
Q We have been shown no document which demonstrates any request by Dave Wilson for any specific form of documentation relating to this transaction?
A It was standard practice at the time that anybody submitting a grant application would have a grant application document, or there would be a grant award letter or something significant to actually explain where the funding was coming from.
Q So you would expect some piece of documentation to accompany the paper?
A Yes. Two types of documentation – one from us, or the Medical School, to the grant giving body, to say, “This is what we need the money for,” and subsequent letter from the grant giving body to us, to say, “That is what it is for”.
Q Certainly we can say, can we not, when Dr Wakefield wrote to Dave Wilson about the nature of this money and where it was coming from, the Royal Free themselves did not raise any invoice at all?
A The Royal Free could not raise an invoice on the back of the letter. How would you expect them ---
Q Again, I do not want to get too much involved ---
A The process ---
Q --- in the arcane back office practice.
A The process is clear. Grant applications are put in place by academic colleagues.
A They request a grant application, and a grant awarding letter is then provided. On the back of that grant awarding letter, on the face of it, wherever, it will say how you would go about claiming the funds. Dave’s job would have been to look at those letters and raise invoices appropriately.
Q Yes. But that was not done.
A No, because a cheque arrived, and I think that is the difference here in this instance.
Q But Mr Tarhan, the cheque arrived nearly three months’ later.
A It is not the timing that is the issue. The issue is, when the cheque arrived was there correspondence behind the cheque to say what it was for.
Q Let us not try and telescope too much. In nearly the three months – let us say two months plus – Dave Wilson, being alerted and armed with this information, took no steps to seek to clarify any matter or seek to obtain any documentation either from Dr Wakefield or from the Legal Aid Board. Correct?
A I do not believe that was Dave Wilson’s job. That is the job of Dr Wakefield to provide the information to the finance department.
Q And it may become a matter of argument as to whether or not the correspondence that I have just taken you to is adequate or not.
A Correct. In my view that is not adequate documentation to set up and account.
Q You are speaking from your standpoint as a finance officer and no doubt you are entitled to those particular views, and we respect that.
A Thank you.
Q But when the money comes in December, back to 338a, the money, as we know, was banked within a day or two, it must be the case.
A The general process was if a cheque turned up, and it said “Royal Free Hospital School of Medicine,” for cash flow purposes it would have been banked.
Q When the money was banked at that stage, I just want to explore with you what you said about the absence of documentation. Dave Wilson, in receiving this letter at page 338a, whether or not he connected the subject matter with the letter at 237b we have touched on, but the fact remains that in so far as there might have been any issue about the absence of a receipt, or the absence of an invoice, whatever term you want to give it, no steps were taken by anybody to seek information from Dr Wakefield.
A I believe the matter was referred to Mr Blatch, and it was Mr Blatch who was seeking the clarification.
Q We have seen no documentation from anybody.
A I think there is evidence that says from Dave that the matter is being dealt with by Mr Blatch, and Mr Blatch has written to the BMA and all sorts of other things.
Q That is not about the absence of documentation – forgive me, Mr Tarhan.
A It is about the cheque, yes, correct. Should we or should we not receive the cheque?
Q But that is about more fundamental issues. We have seen the correspondence with the BMA. The question of the absence of documentation is not a matter which features in any correspondence between the school and Wakefield.
A I cannot comment on that. As I said, I was not involved at the time.
Q Therein lies the potential danger.
A Mr Blatch, unfortunately, cannot attend.
Q So we understand. There was never any attempt by the School to seek documentation, by way of clarification, from the Legal Aid Board?
A I do not think when you say there was “never any attempt,” I think there was attempt. It is just that there is no correspondence to support it.
Q This matter has been investigated for over three years now, Mr Tarhan, and I have not been provided with any documentation, so I made that conclusion. Do you follow? No attempt to seek clarification from the Legal Aid Board and no attempt to seek clarification from Dawbarns?
A I cannot comment.
Q Would you just forgive me for one minute, please. (After a pause) Can I just take you back, please, to page 237b. That is a letter which, you tell the Panel, you had not seen before I showed it to you.
A Can I ask where the letter came from?
Q Just forgive me for one moment. (After a pause) It was exhibited – if this is wrong I will be corrected – to the statement of Mr Phipps.
A Okay. I wonder how Mr Phipps got it.
Q There it is.
A The reason I am asking is normally, when a letter turned up, it would have some of writing on it, and this one does not have any writing – so Dave’s squiggle or some date or some reference to it. There is nothing on it.
Q Mr Tarhan, I am not going to play detective. I am just dealing with a document which has been produced in this case by the GMC. Can I take you, please, to the body of this letter, 237b.
“Please find enclosed a copy of a letter from the Legal Aid Board …”.
As I said and remarked earlier, the letter that actually came with this letter from the Legal Aid Board has not been provided to us as a separate individual document. On the assumption that there was such a document, can I ask therefore what we are to derive from your comment that you would need in the ordinary course of events in a case involving grants a grant award letter? Do you see my point? That grant awards letter can, of course, indicate where the grant is coming from. It can have the letterhead of the grant awarding body and so on. This letter from the Legal Aid Board, which has not been provided to us, would be the equivalent of such a letter, would it not?
A I cannot dispute that, but I do not have the letter in front of me to comment.
Q You see, it may be, if we just turn to volume 2 please and look at page 402---
A I am sorry. Which document was that?
Q Page 402.
A In file?
Q In volume 2. You can start at page 401 to set the scene – it might help.
Q I am not suggesting you have seen this letter before, but it is a letter from Dr Wakefield to the Dean, and we have looked at it already. For my purposes it is a letter which, if you look at the first three lines, deals with the involvement of Dawbarns and the Legal Aid Board, and Dr Wakefield encloses “all documentation relating to this matter”. Do you see that?
A I do indeed.
Q And includes, he says, a letter to Dawbarns from the Legal Aid Board specifying the conditions for making the award. If you turn on to pages 402, 403 and 404, those are documents which we know were generated by the Legal Aid Board ended up in Dr Wakefield’s hands and which he was able to provide to the Dean.
A That is correct.
Q The date of that material of course is August 1996 which predates the letter at page 237B at which we have been looking because that letter is in September. Therefore – and I can put it no higher than this at this stage – if the material which we see at pages 402, 403 and 404 were copies of the documents which were sent to Dave Wilson, then that would provide him with everything he would need to know, would it not?
A It would appear so.
MR COONAN: Thank you very much.
MR MILLER: I have no questions.
MR HOPKINS: I have no questions.
Re-examined by MS SMITH
Q I have two or three matters, Mr Tarhan. I would like to take you back to the questions you were asked first of all by Mr Coonan in relation to the patents, please. He put to you a letter which we had none of us had seen before at page 620A. Would you go back to that, please. It is in FTP2. This is the letter where Mr Coonan was asking you about a proposal to cover 50 per cent of the costs through the central School funds rather than through Freemedic and you said that that had been offered as a provisional arrangement because you said, “They said the whole project would be jeopardised if the patent was lost”.
A That is correct. It was a package.
Q Who is the “they” you were talking about then?
A Professor Roy Pounder and Dr Wakefield.
Q That letter expressly says that the arrangement would continue up to 31 July 1998. So, some eight/nine months from the date of the letter in October 1997. What were you envisaging was going to happen after July 1998?
A On 1 August 1998, the Royal Free Hospital School of Medicine merged with UCL and my view was that beyond 1 August 1998 I would not have authority to be able to deal with these sort of matters. So, I could only commit the Medical School up until that date and not beyond.
Q What was the purpose behind this offer that you were making there?
A The offer was to enable the Medical School and Freemedic to assess the recent findings and to see whether there was any commercial merit in continuing to support the project.
Q Would you turn to one other matter which is at page 927 in FTP3. This is a matter which you did deal with when I was asking you questions originally but in case there is any confusion. Mr Coonan put to you that that letter indicated an intention that the inventors included Professor Pounder and Dr Wakefield and that the intention was that any share of any revenue stream should go to charity.
A Which the School derived from this project.
Q That is what I wanted to clarify with you. That is what Mr Coonan put to you and you agreed with him. If we look at this letter, it expressly says,
“It is noted that the interest the School will derive from the assignments subsumes within it a share which is attributable to the Inventors.”
A That is under the revenue sharing process that the Medical School would have had with each individual academic it employed.
Q When you agreed to the proposition that a share of any revenue stream should go to charity, it was a share of any revenue stream relating to that specific aspect, namely the interest that the School would derive.
A That is correct. If the School got nothing, then there would be nothing going to the charity.
Q Would you look at page 808 in FTP2 – as I say, I know that you have already made the point that there is a distinction – this is the document which we have been through, the business proposal plan for Immuno Specifics, and I have already taken you to the initial equity position and that names the following individuals and organisations:
Dr A. Wakefield
Dr R. Pounder
Dr H.H. Fudenberg
Royal Free Hospital School of Medicine”
and it then specifically says under
“A Charitable Trust
The initial founders of the business have always envisaged that a proportion of any profits and capital growth achieved by the business should be used to fund research into specific conditions ... It is our aim that this should be through a charitable trust …”
So far as the initial equity in the business was concerned, it was to be split between those individuals and they were proposing that a proportion of it went to them as individuals and a proportion to charity; is that correct?
A That is correct, yes. So, within the Royal Free Hospital School of Medicine’s component, there would be another charitable component.
Q Absolutely, yes. That is very clear. That is all I have to ask you about the patents but I want to ask you one or two questions about the Legal Aid Board funding. Mr Coonan took you to the letter at page 237B and perhaps we could turn back to that for a moment. That is in FTP1. When you were asked about that, you said, “When somebody got a letter like the one at page 237B, they would put it on one side and wait for documentation to arrive.”
A That is correct.
Q Mr Coonan then suggested to you that you would have expected Mr Wilson, when any money arrived, to match that money to that letter and you said that, in normal circumstances, you would expect that. When you said “wait for documentation to arrive”, what did you mean by that?
A This letter indicates that there is a grant, that we have recently been awarded a grant. If it is a recently awarded grant, I would expect a formal grant award letter to arrive.
Q May we go back to page 366 which again you dealt with this morning, which is the handwritten letter to you from Dave Wilson, and look down to the last section which starts,
“Therefore, what is now the way ahead?”,
“As you mentioned to me, the [Legal Aid Board] do not just hand over money like that – some procedure must have been followed and correspondence/
Q That is obviously a quote from you because it says, “As you mentioned to me …”
Q Presumably, there had been some conversation between you and Dave Wilson in relation to this issue.
A Yes. As I said, when a cheque arrives from nowhere and there is no backing documentation, I would be surprised. So, I said to him that he needed to find out whether there is any backing documentation and I would be surprised if the Legal Aid Board just produced a cheque and sent it out without a grant award letter or a grant application or something.
Q From whom did you derive the understanding that there was no backing documentation?
A I assume from Dave Wilson.
Q Did you ever see a grant application to the Legal Aid Board from Dr Wakefield?
A I do not recall one, but subsequently in normal correspondence etc I may have come across something. At the time, I certainly do not recall one.
Q It has been suggested to you that this is something you could have queried with the Legal Aid Board. Whose responsibility would you have regarded that as?
A The finance department generally left those sorts of matters to the academics concerned, so we would not have approached the grant giving body unless we had a contact or we had some reference. The obligation in this specific case would have been on Dr Wakefield to produce the evidence and the information.
Q You have told us about your internal procedures and in particular in relation to how you matched the grant to the fund and your arrangements as far as issuing receipts are concerned. Mr Coonan has been rather dismissive of this as being just part of your internal accounting system, but how do researchers know what general form they have to follow?
A There are procedures that are laid out, financial regulations.
Q Is it the case that researchers in the Royal Free Hospital School of Medicine would be in doubt at all as to the way in which grants were linked to accounts and/or receipts were produced?
A I would be surprised but there are occasionally one or two individuals who would not play by the book, so …
MS SMITH: Looking again at page 237B, Mr Coonan suggested to you that if – and, as he says, that is all that could be said – the material at page 402 had been enclosed with that letter, it would have provided Mr Wilson with what he needed to know … You had better remind yourself what page 402 says before I ask you the question. So, that is page 402 in FPT2.
MR COONAN: I just remind myself that the witness’s answer to that question was “yes”. My learned friend will be careful, I am sure, not to be embarking on cross-examination.
MS SMITH: I have not asked the question yet, so I am not sure what the objection is to unless it is an empty threat! I shall ask the question that I proposed to ask which was this. (To the witness) Mr Tarhan, if you would remind yourself as to what that documentation consisted of from pages 402 to 404, would it have conveyed information as to a specific project to which a research account could be matched?
A The first problem is that this is funding to Dawbarns, as I understand it, or the contract firm is Dawbarns. It is not the Royal Free Hospital School of Medicine. So, yes, it would be indicative ---
MR COONAN: I am sorry, I do rise because my question in cross-examination was whether or not this material, if it was available, would have told Mr Wilson all he needed to know and the answer was “yes” and I think this is ---
THE WITNESS: Excuse me, given the fact that I only saw the document ---
THE CHAIRMAN: Mr Tarhan, you will just have to wait. There is a legal point and we have a Legal Assessor here to advise us.
MR COONAN: I do not wish to be rude but Mr Tarhan looked at the document and his answer was “yes”. Having obtained the answer, I did not pursue it. My learned friend is now, by disguised method, seeking to cross-examine on that and that is impermissible.
MS SMITH: I am not seeking to cross-examine him at all. I am simply seeking an answer as to the specific question that I asked, namely whether it could be linked to a research project, and Mr Tarhan has himself made the point that he had only just looked at this document. He said “yes” and I am not cross-examining him about his answer. I am asking him whether he would have felt that it provided him with the material he needed to know to link into a specific research project and I shall be bound by the answer he gives. That is not the question that Mr Coonan asked him.
THE CHAIRMAN: Legal Assessor?
THE LEGAL ASSESSOR: My advice is that Ms Smith is entitled to ask that question.
MS SMITH: (To the witness) Do you remember the question now, Mr Tarhan, or would you like me to repeat it?
THE CHAIRMAN: I think that you should repeat the question.
MS SMITH: I asked you whether, when you looked at the documents between pages 402 and 404, if that had been information that had been provided, would it have enabled whoever looked at it in the finance department to link it to a specific research project and a specific account?
A Certainly the account would not have been set up, so it would have been difficult to relate it to a specific account that had been set up. This is the sort of information we would have needed to set up an account. As I said before, with the number of issues that arise out of here, it is not clear how the claims are going to be working. For example, how do you claim for the funds? It is quite clear that the letter is to Dawbarns as opposed to the Royal Free Hospital School of Medicine, so it is quite legitimate to assume that only part of the funds will be coming back to the Royal Free. It is useful information. It would have given a lot of pointers to pursue, but I do not think that it would have been completely sufficient. So, going back to the previous question, yes, on first looking, it would have been very useful evidence. As I said, having looked at it again now, it is not as complete as I would have expected it to be.
MS SMITH: Thank you. I have no other matters.
Questioned by THE PANEL
MS GOLDING: May I ask what BXBXA means.
A That is the account code. BX would have be represented medicine and the second BX would be either a separate account or a code or something relating to the actual research project itself. So, we would have had BX, BY, BA, BC etc, a whole number of them.
Q We have the salary for Dr Schepelmann to come out from the Legal Aid Board funding and that was £25,000. We also have money from the Legal Aid Board spent on lab consumables which came to £38,000, I believe. I can only give a reference from the transcripts but at the moment I cannot take you to where this information is but it comes to more than the Legal Aid Board’s funding.
Q How was that dealt with, or was it dealt with at all, questioned at all?
A Again, there are two ways. If you look at some of the letters from Dr Wakefield, there would be references to “I will deal with the overspend. I will be applying for additional grants”, et cetera, so a certain amount of leeway would have been given to individuals to pursue other funding opportunities, so we would not have necessarily blocked an account purely on the basis that there was not enough money to do the research work at day one.
Q Going on to the Transfer Factor, what would be the definition of “inventor” in terms of a product?
A The definition of an inventor is actually defined by law, patent law, which says that the person who made the inventive step, so the step that you would need to make, that it would not be common for someone else to come to the same conclusion. So you would have to make a clear inventive step. I believe in the case of the Transfer Factor, the inventive step may have been making the Transfer Factor as an application for the cure or treatment of IBD. So that would have been the step, i.e. seeing something which is out there but making the two links.
Q I see. So even though it has been used for other problem diseases---
A If it is not obvious to someone else.
MS GOLDING: Okay. Thank you very much.
THE CHAIRMAN: I have got a couple of small questions for you, Mr Tarhan. I think, first of all, it is the document that you have been actually taken you to by Mr Coonan and Ms Smith. It is document 237b, and I suspect that it might already be open in front of you.
A Yes, it is.
Q Can I just ask you a question: keep your finger on that one, and also on 199a and on 237a.
Q Three letters, putting it together. If this letter comes to you in the finance department, you still do not feel that that is adequate information?
A Well, the first one, 13 September 1996, all that says is that an individual has been appointed.
Q Yes. That is the background.
A Which is fine, yes.
Q You want to know where the salary is going to come from.
Q You also are told that it is supported by a grant.
Q So you know that the salary is going to come from a grant, but you do not know probably at that stage from where and which grant.
Q Right. Looking at page 237a, which starts actually clarifying that particular situation, and then coming on to 237b, that actually says:
“We have recently been awarded a grant from the Legal Aid Board”.
So we know now the source, where it is coming from. That also includes a copy of a letter from the Legal Aid Board.
A I believe that is the assumption, and I think the question was whether Dave Wilson---
Q Well, we can only see what is on the document, and it says on the fourth line:
“Please find enclosed a copy of a letter from the Legal Aid Board”.
Q Nobody has questioned the authenticity of this particular document. So I am only just going on this document, which says:
“Please find enclosed a copy of a letter from the Legal Aid Board to the coordinating solicitors.”
Then at the end it gives you the option:
“If there are any questions, please do not hesitate to get in touch with me”.
I think your answer was, if I remember it right, that it was a standard policy, that you have to include those details anyway. Is that still---
A I think what I am trying to say is that obviously if we get correspondence like this, we will need as much evidence in the file so that we can then pursue it, or do whatever is necessary to administer that account. If it is not robust enough, if it does not have the claim times, if it does not know to say who we are going to ask the invoicing for, when it is overspend what do we do, when it comes to the end of the grant who do we account for, who prepares the project report at the end of it, all those conditions are generally expected. So receiving a cheque for £25,000, I would have taken the view, “Well, that is fine, but now what have we got to do for it?”, and this would not have been sufficient for us to deal with all the issues.
Q Thank you for raising all those questions, but does not this last sentence give you exactly the option, and you have actually raised those questions now, to raise those questions to the author of this particular letter, “If there are any questions, please do not hesitate to get in touch with me”?
Q Exactly the same type of questions that you have just raised.
Q So does it not give that option---
A I am not disputing that the issues have not been raised. I think the issues were raised. It is just that they were not raised from my department, they were raised through Bryan Blatch and/or Arie Zuckerman. I believe they were raised, because that is the rationale for holding the cheque back and all the issue---
Q Yes, but this letter actually has been sent to your department, I mean not to you individually but to your department.
Q If somebody else raises those questions, that is a different matter, but you have been given – “you” means your department – the opportunity to ask those questions.
Q It is up to you then, is it not, whether you---
A Well, on 25 September 1996 there is a letter in which Dave Wilson has responded. I am assuming that is the one that may have crossed in the post.
Q It is the same, 25 September, which is the letter at 237a.
A 237a is where he is asking the information and---
Q Yes, and it is the same date when this letter from Dr Wakefield has come to you, which is at 237b.
A That is correct, so I am not sure whether the letter of 25 September 1996 went out and then this one turned up, or whether this one turned up and Dave Wilson responded to that one. I have no idea. I am not Dave Wilson and I cannot comment.
Q Yes, I know, but I am just talking from the departmental position’s point of view.
A Yes. The departmental position is on 25 September we need information and he has written the information, so it may well be that Dr Wakefield felt that his response, if indeed this was a response, was sufficient.
Q Thank you. Can you also look at page 337. Now, there are two receipts . One is an unsigned receipt on 338, and then there is another receipt, which is signed by Dr Wakefield, on 339.
Q Now, can you identify, and if you cannot just say so, because I think at some stage we might or might not have Dr Wakefield’s evidence and then we can clarify that particular issue, but 337 actually is speaking of two receipts, one is the official receipt and one is the enclosed receipt, both of those receipts to be signed. The first paragraph, page 337, the last sentence: “I shall be grateful if you could arrange to let me have an official receipt and also for the enclosed receipt to be signed.”
A Yes. I am assuming the enclosed receipt is the one that says “This is the grant. We are accepting the cash and we will deal with it in---”
Q Sorry, which page are you referring to?
A 338 I assume is---
Q 338 you reckon is the official receipt?
A I think that is the acknowledgement. I think the official receipt is probably – I do not know what they mean by an official receipt, but I presume maybe they believe that we would issue an individual receipt statement, like the ones I said before; we used to have a specific receipt book, like a ticket book, where we would sign it and say “Received from such and such £25,000”.
Q The only thing I can think is that the 337 typing looks very similar to 338.
A Well, 338 is attached to 337. That is my understanding.
Q So 339 is the official – that is your---
A 339 is the one that---
Q Is the official one?
A No. ---Dr Wakefield did. We never issued an official one.
THE CHAIRMAN: Thank you. I do not think I can take it any further because you are only more on the peripheries of this particular document. I do not have any further questions, but counsel might. Ms Smith.
MS SMITH: Sorry, I did not quite hear what you said at the end of your questions. You asked about the receipt. You said “You are only---” – I do apologise.
THE CHAIRMAN: I was just saying that because the author of this letter is Richard Barr, the recipient is Dr Wakefield, so I felt it is unfair to ask this particular witness any more details about these two receipts because he is neither the recipient nor the sender, and nor has it been copied to him, but I just wondered whether he has any view on this, because he has been taken through these documents.
MS SMITH: Yes, but you referred to it, with respect, sir, as the official receipt, and I just want to ask Mr Tarhan, was document 339 an official receipt as far as you were concerned?
THE CHAIRMAN: Specifically where I am coming from, 337 mentions two words, “official receipt” and “enclosed receipt”, and I just wanted to know which one is the official receipt and which one is the enclosed receipt.
MS SMITH: Sir, that is a letter from Dawbarns talking about an official receipt. What I was seeking to elicit and have indeed elicited from Mr Tarhan is that this was not an official receipt as far as the Royal Free Hospital School of Medicine was concerned.
THE CHAIRMAN: Yes, I understand that.
Further re-examined by MS SMITH
MS SMITH: One other matter arising from the chairman’s questions, Mr Tarhan: you were asked whether these issues had been raised and you said “I believe that they have been raised by Mr Blatch and by Professor Zuckerman”, and the chairman said to you, “Yes, but they were not your department”. What is Professor Zuckerman’s overall position in the Royal Free Hospital School of Medicine?
A Dean of the Medical School, so he is the top person in the Medical School.
MS SMITH: Yes. Thank you.
THE CHAIRMAN: Mr Coonan.
MR COONAN: No, thank you, sir.
THE CHAIRMAN: Mr Miller?
MR MILLER: No, thank you.
THE CHAIRMAN: Mr Hopkins.
MR HOPKINS: No.
THE CHAIRMAN: Mr Tarhan, can I on behalf of this Panel thank you for coming today to give us the benefit of your evidence. You are now released.
(The witness withdrew)
MS SMITH: Sir, I do not have any further witnesses for this afternoon. I am calling Dr Davies, who is the histopathologist at the Royal Free Hospital, tomorrow morning, and we anticipate she will be a lengthy witness, if only because she is dealing with numerous individual medical records. The time will not be wasted as far as we are concerned this afternoon because we have matters to deal with as to the way in which her evidence is to be presented to you so as to be as clear as it can. So, as I say, I would invite you now to adjourn until first thing tomorrow morning.
THE CHAIRMAN: Yes. Thank you very much indeed. We will now adjourn and resume at 9.30, but can I just actually announce this, and I think most of you probably already know about it, about this tube strike, which is starting at 6 o'clock this evening for the next 72 hours. Now, I know that four Panel members all will be travelling locally and they are all still hoping to be here on time by making some alternative arrangements because the roads are going to be busy and the alternative public transport is going to be very busy as well. More than that, obviously we cannot say anything. I will be here definitely on time because I just walk from my hotel to here. I am hoping that the other Panel members will be here. So we expect to resume at 9.30 tomorrow morning, subject to the public transport difficulties that are anticipated. I cannot say any more at this particular stage, but thank you all and we will resume, hopefully, at 9.30 tomorrow morning.
(The Panel adjourned until 9.30 am on Tuesday, 4 September 2007)