Wednesday, February 1, 2012

Day 21 GMC Fitness to Practice hearing for Andrew Wakefield



Monday 13 August 2007

Regents Place, 350 Euston Road, London NW1 3JN

Chairman: Dr Surendra Kumar, MB BS FRCGP

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

Legal Assessor: Mr Nigel Seed QC


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


(Transcript of the shorthand notes of T. A. Reed & Co.
Tel No: 01992 465900)


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.


Page No


Examined by MS SMITH 1
Cross-examined by MR MILLER 13
Questioned by THE PANEL 15

Application to read statement of Ross Phipps 19

Statement of ROSS PHIPPS, read 21

THE CHAIRMAN: Good morning to you all. I hope the reason for this slight delay has been resolved.


THE CHAIRMAN: Ms Smith, I think you were going to introduce a new witness this morning.

MS SMITH: Thank you very much, sir, for giving us a little extra time in order for us to discuss the evidence you are going to hear this morning. It has indeed proved to be useful. I am going to call Dr Lloyd-Evans.


(Following introductions by the Chairman)

Examined by MS SMITH

Q Dr Lloyd-Evans, could you give us first of all please, your full name and address, and your professional qualifications?
A It is Andrew Lloyd-Evans, XXX.

Q Can you just tell us what your professional qualifications are?

Q I think it is right that you are a consultant in paediatric neurodisability?
A That is correct.

Q You were a consultant at the Royal Free Hospital in that capacity since 1990, is that correct?
A That is correct.

Q Are you still there, Doctor?
A No. I left the Royal Free a year ago, and I am now at Northwick Park Hospital.

Q Can you tell us first, remembering there are lay members on the Panel, what the difference is between a neurodisability paediatrician and a paediatric neurologist?
A Paediatric neurologists work in tertiary centres. There are many fewer of them than neurodisability paediatricians. We work at a district level to take a lead in services for children with neurological problems and we take more of a long term view in terms of chronic neurological impairment than the tertiary neurologists who are, perhaps, more diagnosticians for the more acute neurological problems that we see.

Q As far as you were concerned, when you were working at the Royal Free were you treating only chronic impairment, or did you also see some acute neurology?
A I was working as a general paediatrician with an interest, so I was doing general paediatric attending and on call, and certainly was seeing acute as well as chronic neurology, yes.

Q As far as numbers are concerned, in the UK is there predominance of one specialism above the other? I think it follows from the fact that you have said that one is only in a tertiary centre.
A I think we are probably about three or four to one in favour of the neurodisability physicians. I think I should say that this has only been a speciality for about three and a half years now. We got approval from the Paediatric College about three and a half years ago – actually four years this September – for approval of our particular interest as a speciality within the College.

Q Can I take you back to 1996, first of all was there a paediatric neurologist at the Royal Free?
A No.

Q And whose role at the hospital was closest to that of a paediatric neurologist?
A I suppose that would be mine, but I would be working in conjunction with tertiary neurologists at Great Ormond Street.

Q As far as your role at the hospital in 1996, did that include providing diagnostic opinions?
A Yes.

Q How often were you consulted in relation to autism as a possible problem?
A I suppose I should also say, the other part of my role was running the Child Development Centre in Hampstead at the time. That is a multi-disciplinary team of people who see children with developmental problems. One of those developmental problems, particularly in the pre-school age, might be autism.

Q Just tell us in general terms, on a day to day basis at the Royal Free Hospital, you say you had a role in the child development clinic. What was your job actually doing?
A There were quite a few facets to it, really. One was being part of the general paediatric rota, but seeing perhaps more of the neurology and getting referred the neurology from the other consultants. There were also outpatient clinics inside the hospital and out at the Child Development Centre where we would look at children with neurological presentations, developmental delay – all manner of different presentations.

Q You said you had some involvement in that through autism. Was it a condition that you were frequently consulted about?
A It is hard to give numbers at this stage. It would a regular thing. A child would be referred regularly for issues regarding social communication and language development some of which might turn out to be autistic after assessment.

Q Turning on to a more specific issue, did you at some stage begin to have some contact with Dr Wakefield in relation to the research he was doing?
A As far as I recall, Dr Wakefield approached me. I cannot tell you when but I think it was when the project was beginning.

Q Can you recall what he approached you for?
A I am afraid I really cannot. I cannot remember the details of our conversation. I am sorry.

Q You say it was when the project was beginning but who told you about the project?
A I imagine there was paperwork, there was discussion. I no longer have the paperwork and I do not remember the discussion in any detail. I am sorry.

Q Can you assist us to say whether you reached some understanding of what the project was about that Dr Wakefield was involved with, was interested in?
A Again, I have no recollection. I am sorry.

Q Can you help as to roughly when that was? Which year?
A Actually I cannot. I am told it was ten or eleven years ago.

Q Had you become at all aware of the admission of autistic children to the gastroenterology department?
A I think I did become aware at some stage, yes.

Q Was there a reason for you noticing that in particular?
A I think I may have been asked to see one or two of the children at some stage.

Q Did you know where those children had been referred from?
A I suppose if it was recorded in the notes I would have been able to see that, yes.

Q When you say you think you were asked to see some, was it unusual for the gastroenterology department to have autistic children in its wards, or was that a usual occurrence?
A I did not have detailed knowledge of what did or did not get admitted to the gastroenterology department, so I suppose in retrospect one might say there were too many autistic children but I could not say that I held the opinion at the time.

Q Do you actually recall? You say you think you may have seen some autistic children. Do you remember getting requests to go and see children on the gastroenterology ward?
A Yes, I do.

Q You are obviously trying to remember a long time back, but did you in fact undertake some assessments of autistic children on the gastroenterology ward?
A I remember seeing one or two children. We would not have done a formal autism assessment simply because we did not have the wherewithal to use not just a paediatrician but a psychologist and a speech and language therapist. We would normally assess these children in a multi-disciplinary fashion even ten or eleven years ago.

Q I am going to ask you a little bit more about that. After seeing what you described as “a few”, did you in fact stop seeing those children on the gastroenterology ward?
A Yes, I did.

Q Was that a conscious decision by you?
A I think it probably was, in that I was not quite sure, really, what I was being asked to do and what my role was.

Q You say you were unclear about your role. Can you elaborate on that? You say you did not know what you were supposed to do? What were your concerns?
A Thinking back, the three reasons I would normally have been approached to see a child on the gastroenterology ward would be a neurological problem, one or two of the autistic children and maybe a child who had developmental delay. One of the reasons I did not get further involved was that these children were out of borough children. They were not local Camden children. Although consultants had the freedom to see out of borough children, the other professionals such as speech therapy or psychology were not allowed to, so we could not actually properly assess them. I should also say that all of these children would have come through a local service such as we had in Camden to assess children with developmental delay or social communication disorders, autism, etc. So a diagnosis or an approach to a diagnosis should already have been made by the local multi-disciplinary team. Being asked to re-assess that actually was not terribly possible without extra manpower.

Q Were you clear as to whether you were actually being asked to confirm the diagnosis made by the local teams or to look and see whether you wanted to give a new diagnosis? Were you clear as to which you were actually being to do?
A I simply cannot remember. I am sorry. I just do not have that memory.

Q Would it have been possible for you to substitute a diagnosis? You have told us you would not have had the team back-up that you would have for a local child: was it possible to substitute a diagnosis simply on the basis of your own individual assessment?
A I think that would be very unsafe to do, both then and now.

Q Generally speaking, when you are assessing a child for a developmental disorder, how long does that assessment take?
A It varies considerably from child to child. It can take anything from half a day to a day, maybe two days, depending on how many people saw the child. I mean, I suppose if I were to say, the tertiary centres who see children with perhaps more complicated autism spectrum disorders generally take one to two days to complete the assessment. A local assessment would be perhaps a bit less than that. Some children are quick to assess; others are not, but it is a matter of several hours, at least, yes.

Q As far as making a short assessment on the ward is concerned, how reliable would you view the testimony of the parents if you are simply asking them what their perception of the developmental delay is?
A In those days, mostly one was doing it on a relatively informal history. Now we do it in a much more structured way with properly researched diagnostic interviews. In those days – well, I suppose any reported developmental story is open to distortion, depending on, you know, what the parents might want out of it or not. It is an issue that we certainly see in autism spectrum that we sometimes have difficulty with the reliability of the information that we are given, which is why a child has to be assessed, not just by interview but by several people and in different contexts.

Q What is your view of how the condition affects the parents? Do you find that parents with an autistic child find that difficult or easy to cope with?
A It depends on the degree of autism, but if one were to describe the most severe kinds of autism then it is a devastating diagnosis. It is almost flippant to say but the short lecture is we do not really know in detail what causes it; there are no effective treatments and it is a lifelong and devastatingly disabling condition in the most severe form.

Q You said one has to be conscious of the fact that there may be unreliability in relation to what the parents tell you. Can you just tell us what you mean by “unreliability”? You are not suggesting that they make it up are you?
A Well some years ago there was a circular from the National Autistic Society which was warning against the unreliability of some developmental histories, and certainly in the milder forms of autism a diagnostic label can be helpful in terms of what you get in order to help, in terms of an educational statement, in terms of extra therapy time and extra resource in the educational environment, so there is a sort of “wriggle room” about what one might be told, and, of course, if you are very knowledgeable and you are well read on the internet and in other ways, a history can be given that is very convincing.

Q You said that the multi-disciplinary aspect of having all the community therapists involved helps with that, how does it help if you are got psychologists, psychiatrists, speech therapists, etc., involved in the process of assessment?
A One of the terms for autism spectrum disorder is pervasive developmental disorder. The word “pervasive” is quite important because the child should be functioning in the same way in various contexts: nursery, home, school, in the hospital setting, in the child development centre. If the child’s behaviour varies considerably with the context then that is something that is important to know. What we are looking for in terms of using several people working in different places is whether this problem is indeed pervasive and therefore satisfies the diagnostic criteria for autism spectrum.

Q You have said you have had concerns because you could not do assessments in that kind of a way when you were asked to do these assessments on the gastroenterology ward: what did you do about that? You said you stopped seeing the children but did you expressly say you were going to stop or did you simply not see any more?
A Again I cannot remember a point where I might have said I was not. I think I just did not see them. I suppose it is worth saying that we had enough work to see our local referrals in the patch without seeing out of borough referrals, and I think if a proper diagnostic assessment was required then it should really have been part of the research protocol.

Q You know, and there is no secret about the fact that some of the children who were seen in the gastroenterology ward with autism were subsequently written up in The Lancet in 1998.
A Yes.

Q Are you able at all to say whether any of the children that you reviewed were ultimately part of that paper?
A No, I cannot say.

Q I am going to take you to the references that are made to you in three of the children’s records in a moment. If you look in front of you there is a laminated sheet which is called an “anonymisation key”, and just so you are aware, I am going to take you to the records of three children, and you can see their names there, in case it triggers anything for you: I am going to take you to the records for child 8, child 7 and child 6: 7 and 6 are in that order because that is the chronological order they were in when you had an involvement, and they were brothers. If you would look at the records for child 8, please, and you will need the Royal Free Hospital Records at page 18. This is a letter from Dr Berelowitz, who is a child psychiatrist, is that correct?
A That is correct.

Q This is a letter to Professor Walker-Smith and it is an assessment by Dr Berelowitz from a psychiatric point of view:

“Thank you for referring [child 8] to me.”

I am not going to take you all the way through it. It refers to the deterioration following MMR and at the bottom of the page:

“Now [she] has no language. However, she is affectionate and responsive and makes good eye contact. She certainly tried very hard to communicate …”

Then he says:

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

First of all, do you have any recollection of seeing that child?
A No recollection, and if I had seen the child there would be a written record in the notes.

Q I was going on to ask you, what was your usual practice in relation to ---
A If I saw a child there would be a signed record in the notes.

Q Can you help us at all: on the basis of the possible diagnosis he has come to of a post-vaccination encephalitis, are you able to help us as to why that might be something where you would have an involvement?
A I think when psychiatrists feel it is more organic than psychiatric they tend to reach for the neurological paediatrician, and that would have been the reasoning, I think.

Q Remembering we have lay members: when you say “organic rather than psychiatric”?
A Something that had happened to the brain in a medical sense rather than in a psychological sense.

Q And in this case there is a suggestion of a post-vaccination encephalitis, that would be actual physical brain damage, is that correct?
A Yes, I think that is the implication.

Q I am now going to ask you some general questions about these issues in a moment but I want to ask you about your individual role first of all. If you now go to the bundle for child 7 at page 7, we see at the bottom January 1997, “[ward round] professor”, do you see where I am?
A Yes.

Q “Colonoscopy today for barium meal and follow through, to see Dr Berelowitz re autism, MRI, EEG, Dr Lloyd-Evans re development”. Again, there is no other record that we can find: do you have any recollection of seeing that child?
A Again, I do not have a recollection and had I seen the child there would be a written record.

Q We see further up the same page there is a reference to “Impression: Funny turns and altered bowel habit” and “? Petty mal.” Can you help us with what that is a reference to? What is that querying?
A Petty mal is the old name for what is now described as childhood absence epilepsy.

Q Might that give some explanation as to why your involvement again was being, at least, mooted?
A It may well have been, yes, it is possible.

Q We have no reason to suppose that that was anything other than a tentative diagnosis but if it had been the diagnosis again it would have been neurological, organic, is that correct?
A Yes.

Q It says, “Dr Lloyd-Evans re developments”. What would it appear, would you think, from that that they were planning to ask you to do?
A They probably wanted an overview of the child’s developmental level. I notice in the middle of all this of course that a lot of investigations were going on and the child would not have been on the ward for some of that time. It is very possible that I never got to see some of these children because they were off having things done and it was difficult to fit them in.

Q But again would a developmental assessment have been something that you would have been comfortable with undertaking in those sorts of circumstances?
A No, not particularly. I really did not feel it was appropriate. if they had been seen by local services. to repeat that.

THE CHAIRMAN: Dr Lloyd-Evans, please keep your voice up because this is a large room.
A I just tended to take the view that developmental assessment really was the prerogative of the local child development service that the child had come from. Had they been local to us, we would have done a proper multi-disciplinary assessment.

Q Is it clear from that note, which seems to be dividing off a developmental assessment, or something about development, from you and seeing Dr Berelowitz in respect of autism, again? Would you have been clear as to exactly what yours and Dr Berelowitz’s respective roles would be from that?
A Looking at the written note here, it looks as though Dr Berelowitz was being asked to comment on autism and I was being asked to comment on the child’s general developmental level.

Q If you and/or Dr Berelowitz in conjunction had taken on an assessment, would that have been a satisfactory way of coming to any conclusions about what was actually wrong with this little boy?
A It would have gone part way to it but I think you would still need therapists; you would still need a clinical psychologist, in my view.

Q Could we go on to the last child where your name is in the records, which is Child 6, please, again, the Royal Free Hospital records? If we look at page 6, we see in the patient episode summary at the bottom there appears to be an outpatient appointment with you and that is much later than the period with which we have been concerned. That is now in 2000.
A Yes, I see that.

Q If we go on to page 318 of the GP records, this is a letter to the child’s GP, who we have been referring to as Dr N. It is from Professor Walker-Smith. It relates to child 6’s “quite severe headache which seems to have been worsening over the past year and is currently associated with dizziness.” Professor Walker-Smith says he could not –

“… detect no gross neurological signs … I have, in view of the family history of a sibling with autism and abnormal EEG, arranged for an EEG to be performed. I am also asking my colleague in the Department of Paediatric Neurology, Dr Andrew Lloyd-Evans, to review him.

I have made no plans to see him again in the clinic but I will be looking forward to hearing Dr Lloyd-Evans’ opinion.”

I will ask you about the sequence of the letters in a moment, Doctor, but if we go on to page 324, we see a letter from Dr N to you asking if you could make an appointment to see the child who –

“… has been suffering from severe headaches and behaviour disturbance and his mum is very concerned about him.”

Dr N says:

“Clinically I think he is suffering from severe headaches with no organic cause but I spoke to Dr Wakefield of the Royal Free who suggested I needed to consider diagnosis of sub-acute sclerosing panencephalitis in view of his other presence of measles vaccine virus in his gut. Apparently this has an insidious onset.

In view of his worsening symptoms of headache I would be grateful therefore if it would be possible for you to see him sooner.”

If we go on to 327, we see a letter to a consultant paediatrician at the Royal Alexandra Hospital in XXX. Just going down the letter, he said;

“I believe Dr Lloyd-Evans of the Royal Free rang you regarding this autistic boy who is suffering from recurrent moderately severe headaches….

He was seen by Professor Walker-Smith at the Royal Free who referred him to Dr Lloyd-Evans, who rang me rather irately saying he didn’t want referrals from our local children for general paediatric matters!

I do see his point to some degree and looking at [child 6] he does seem to have had some behaviour change lately and seems much more anxious than normal …
A neurology referral seemed a little excessive to me at the time but Andrew Wakefield, who is the researcher into MMR gut disorders, spoke to me about him and suggested I needed to exclude sub-acute sclerosing panencephalitis.

That seems rather dramatic to me but I am not an expert and therefore agree that he needs to be reviewed by someone who knows about these things.

I am not sure why the referral should be made to you but Dr Lloyd-Evans told me that he had spoken to you and that you would be expecting it. I would be grateful therefore if you could see him with regard in particular to his headaches which are causing behavioural problems.”

Looking at that sequence of letters, Doctor, first of all, do you recall that correspondence?
A Strangely enough, I do.

Q Did you in fact see the child?
A No, I did not see the child.

Q Can you tell us what it is that made you deflect the referral in effect to Dr Livesey of the Royal Alexandra?
A I really could not see the point in dragging the child up to London when there are perfectly good paediatric services in XXX and Anne Livesey I knew and knew she was a very competent paediatrician and could do the job perfectly well in XXX.

Q If a child needed neurological investigations of some kind, i.e. as opposed to simply an assessment, was there anything extra that they could be offered by you at the Royal Free that they could not get in their local hospital?
A No, and the local hospital would have access to tertiary neurology, should they so wish it. I am not sure which one relates to XXX, but they would either refer up to London or somewhere else if they felt it was necessary.

Q It says you rang rather irately. What were your views, and you may not have had any? Did you understand why it was that this child was being sent to you at all?
A I think there was a tendency to keep things in-house, and certainly there were referrals between departments. I just took the view a child should have local services wherever possible and they should not have to travel for straightforward problems.

Q As far as the diagnosis that Dr Wakefield was suggesting, first of all you had better tell us, if you would not mind, in brief terms, what it is.
A Sub-acute sclerosing panencephalitis is a late reactivation of the measles virus in the central nervous system. It is a particularly unpleasant, relentlessly progressive neurological deterioration, which results in death within a matter of few months to a year or so.

Q Have you ever seen a child with it?
A I have seen one UK child with it, possibly in about 1980. We certainly see the occasional child from the developing world who has not been immunised and who has had measles, but in the UK for indigenous children, it is by and large gone.

Q You say it affects the brain and leads to death within a year. Is it progressive within a year?
A Yes, there is a progressive deterioration.

Q I think it is a condition, because we have heard reference to it before and we may later on in this case, that is often referred to as SSPE. Is that correct?
A Yes.

Q Can you see any reason why it should have been a possibility in this little boy with headaches that that sort of diagnosis should ---
A In short, no.

Q I just want to ask you, Doctor, about the involvement of Dr Harvey and Dr Berelowitz and so you can put away the individual children’s records now. Could you turn very briefly, so that you know why I am asking the questions, in FTP1 to page 200? This is the application that was made in respect of a research project relating to children with gastrointestinal symptoms and autism. I just want to ask you some questions about the two collaborating departments. We see on page 200 a Dr Peter Harvey in the Department of Neurology and Dr Berelowitz in the Department of Child Health (Psychiatry). If you would go on to 213, that is the first page of the protocol, the scientific study, that was submitted. On 214 under “Responsibilities”, Dr Mark Berelowitz (Consultant Psychiatrist) and "Responsibilities Confirmation and characterisation of features of disintegrative disorder.”

Then underneath that, Dr Harvey, consultant neurologist and responsibilities for neurological assessment and investigations. I just want to ask you a few questions about the respective specialisms and how they tie together. Dr Harvey: what was his specialism in the hospital?
A He is a consultant adult neurologist.

Q At that time, did adult neurologists see children?
A Yes, they did. There were very few paediatric neurologists and they needed to see children on that basis.

Q Would you expect an adult neurologist to be involved when there is an assessment of autism as part of the study?
A Not if it is assessing autism per se, no.

Q Even in 1996?
A An adult neurologist would have no experience of childhood autism, in my view.

Q As far as Dr Berelowitz was concerned, he was a consultant child psychiatrist.
A Yes.

Q We have heard him give evidence. In 1996 in the Royal Free, how did his role compare with yours, in general terms? Was there an overlap?
A Certainly with certain conditions such as autism and with attention deficit hyperactivity disorder, for example, and children who had more psychiatric and psychological issues, they would tend to go to his end of the department and the more straightforward ones would stay with mine.

Q I want to ask you about a few conditions that are relevant to this study and the first is, if you go back to page 201, you will see the title refers to disintegrative disorder.
A Yes.

Q How common a condition is disintegrative disorder in your personal experience?
A If we are talking about a regressive presentation of autism, not very common. I cannot put a figure on it because I am sure that you are aware that the epidemiology for autism in general does not have robust data.

Q I was asking you from a personal point of view, really.
A It is not very common.

Q When you say if you are talking about a regressive form of autism, do you recognise disintegrative disorder, or I think it is called Heller’s Disease, as a particular syndrome?
A No. I think it is a slightly old-fashioned concept now. We do get children who present with what I would describe as an encephalopathic presentation, by which I mean they give a strong impression that there is something organic wrong with the brain that has made them lose skills, particularly language and maybe other skills. Some of them have seizures. They require thorough neurological investigation. That is not the case for the majority of children presenting with social communication disorders and autism.

Q When you say a “thorough neurological investigation”, what would that include amongst the tests that you did?
A It would involve brain imaging, preferably MRI, an EEG recording, blood, urine and spinal fluid tests.

Q And the spinal fluid tests would be as a result of undertaking a lumbar puncture; is that correct?
A Yes.

Q That is what you would regard as appropriate if a child presented with the sort of condition that has been referred to as disintegrative disorder with a regressive form of autism.
A Yes.

Q With a neurological component; is that correct?
A Yes.

Q You said that this is a rare condition, doctor. I am only asking from your personal experience rather than generalised figures, but how many children with this sort of disorder have you seen in the last year? Is it possible for you to help us on that?
A I think none in the last year and, in the year before that, maybe one. At most, I would say one or two a year in a district service.

Q You said that you would undertake invasive investigations such as a lumbar puncture. What is it about that particular condition that makes a lumbar puncture an appropriate investigation?
A You are looking at conditions that can cause acute neurological deterioration. These include infections, particularly viral infections, neuro-metabolic disorders, that kind of thing, so, biochemical imbalances that come out in childhood.

Q Is there a possibility for confusion at least for parents between a child who is autistic and apparently has had an element of regression in that autism and the conditions you are talking about, the condition with a neurological component about it?
A I think that there is scope for confusion. Many autistic children present between the ages of two and three and what sometimes is taken to be a regression is perhaps better described as a failure to progress and, in particular, the skill that fails to progress is spoken language. The nervous system tends to work in a rather hierarchical way and it expects certain more basic functions, maybe such as a few single words to develop before they join up and join up into longer sentences. What can sometimes happen is that when the basic level of single words is not superseded by the right kind of language development, the single words go. This is not a regression in an accurate sense, it is a failure to progress with normal language development and social development, but it can look like a loss of skills but in fact it is not.

Q You have told us that you would expect some thorough investigations of the type you have enumerated in a child who had a truly regressive disorder with a possibly organic component. How does that differ from the tests that you would regard as appropriate in a child with autism?
A This has actually changed over the last ten years or so. Now, with the national plan for autism, the national guidelines suggest that we do not image them and we do not do EEGs unless there is a good reason for doing it. Most of them presenting in early life would simply have chromosomes, a test for a condition called Fragile X and, in boys, you might do a test called creatine kinase which is a test for muscular dystrophy. Sometimes boys with muscular dystrophy present with failure to develop language properly. Ten or 11 years ago, it was much more common to investigate more and that would include sometimes brain imaging; sometimes an EEG. With both of those tests, it became clear over time that they tended to produce a ragbag of not particularly relevant findings which confused people and that led to the recommendations not to do them unless there was a clear clinical indication which would not be part of the assessment of autism. In terms of the blood tests, it was more common to look at metabolic tests such as aminoacids or organic acids in those days. Some people were keen on looking for lead and various other things. Again, the national recommendations now do not uphold those investigations unless there are very specific reasons for doing them.

Q What about lumbar puncture in 1996? In general terms, would you regard that as being a necessary investigation or appropriate investigation for autism?
A I would say at that stage it was a necessary or an appropriate investigation.

THE CHAIRMAN: Did you say “not unnecessary”?
A Not a necessary or appropriate investigation.

MS SMITH: One last condition, doctor. We know that ultimately when these children were written up the title of the paper refers to them suffering from a pervasive developmental disorder.
A Yes.

Q I simply want to ask you, in 1996/1997, what would be the investigations that you would do for a child with a pervasive developmental disorder?
A We are really looking at autism spectrum. The terms have never been absolutely clear apart from for PDD and autism in the international classifications of disease, the ICD10 or the DSM4. Autism spectrum is a clinical construct; it does not exist in the international research classifications. Terminology has always been a problem with autism. People would interchange PDD, autism, autism spectrum. In fact, the diagnostic tools that we now use are much clearer about autism and autism spectrum. The problem is that a lot of the literature and the tools and the classifications are research based, they are not clinically based and there is a problem with that divide. So, PDD would merge into autism; it would be the same territory.

Q One further matter that I am reminded of. I took you to the ethical committee application that was made in respect of the project on these children which starts at page 200. Do you have any recollection of whether or not you saw that document at around the time that you were being asked to see some children?
A It is very likely that I did and I have no recollection and I did not keep records. So, I do not know.

Q We can see that you have not signed it and you have no recollection of being asked ---
A I imagine that I was off the map at that stage and I was not wishing to be involved.

Q You mean off the map because you had given the indication that you have described to us, that you did not wish to be involved?
A I think my reluctance probably precluded me.

MS SMITH: Thank you very much. That concludes my examination-in-chief.

THE CHAIRMAN: Thank you, Ms Smith. It is now very close to 11.05, so we will now adjourn. (To the witness) Dr Lloyd-Evans, I remind you that you are still under oath and still in the middle of giving evidence, so, please, make sure that, during this interval, you do not discuss this case with anyone including the lawyers. I am sure that someone will supply you with a drink.

We will now adjourn and resume at 11.25.

(The Panel adjourned for a short while)

THE CHAIRMAN: Ms Smith, you had completed your examination in chief?

MS SMITH: Yes, I had.

THE CHAIRMAN: Dr Lloyd-Evans, as I said earlier, it will now be the opportunity for the representatives of the three practitioners to cross-examine you on the evidence. Mr Coonan?

MR COONAN: Sir, I have no questions, thank you.

THE CHAIRMAN: Mr Miller is acting on behalf of Professor Walker-Smith.

Cross-examined by MR MILLER

Q Dr Lloyd-Evans, I hope I do not disappoint you, but I only have a couple of things I want to ask you about, just about the structure of the Royal Free at the time. There is a combination of the medical school and the hospital?
A Yes.

Q And we have seen some evidence of departments within the hospital, whether it was within the medical school I do not know but was there a paediatric department -?
A Yes.

Q --- at the Royal Free?
A Yes.

Q And were you part of that department?
A Yes.

Q And there was a neurology department or a neurological department?
A Yes. A large adult neurology department.

Q Which would include neurologists, including Dr Harvey?
A Yes.

Q And perhaps neuro-radiologists – I do not know.
A The neuro-radiologists would have been part of the radiology department, not of the neurology department.

Q Anyway, you were part of the paediatric department. Remind us: the Royal Free has a district level, a catchment area, for its own patients?
A Yes.

Q And you were part of a team which would be involved in the diagnosis of children, within that area, with developmental problems?
A That is correct.

Q At a district level, so a child in Camden might be referred to the child development centre ---?
A Yes.

Q --- with “query”, development problems, and then a multi-disciplinary team would over time make the primary diagnosis of autism or autism spectrum?
A Yes.

Q And it is in that context that you say, “If you are going to be doing that, it is going to take quite a lot of time because each of those specialists have to come in, not simply your own involvement, but the speech therapists, psychologists, would also be making their assessments?
A Yes, that is right.

Q And that would result in a patient from Camden, or the parents, being given some sort of diagnosis?
A Yes.

Q Which might assist in school placement and assistance in school later on?
A They would get a diagnosis. They would get a treatment plan. They would have involvement from the various professionals, etc.

Q And I think you said that it certainly will help in the context of a statement of special educational needs, therapy and educational assistance when they are in school
A Yes.

Q We are all talking about Camden patients ---?
A Yes.

Q --- who you are seeing in that context?
A Yes.

Q I think another aspect of your role was as a paediatrician. I think you said you did acute cases, but that would be a child with a paediatric problem being admitted to, or referred to, the Royal Free?
A Yes.

Q Nothing to do with autism. That might be just another paediatric problem?
A Yes. The department was an integrated hospital and community department. There was no divide really where we saw the children.

MR MILLER: Thank you, Dr Lloyd-Evans.


MR HOPKINS: No thank you.


MS SMITH: I have no re-examination thank you, sir.

THE CHAIRMAN: Dr Lloyd-Evans, if there any questions from any of the Panel members, then I will introduce them to you. Dr Webster is a medical member.

Questioned by THE PANEL

DR WEBSTER: Good morning. Can you tell us what the system was at the Royal Free for internal referrals?
A It varied. One might be called by an SHO, a senior house officer, or a written referral might be made. It depends whether the child was an inpatient or an outpatient. Normally one of the trainees would be asking you to go and see the child if it was an inpatient.

Q I am talking about the inpatients. In many hospitals, there is a form that has to be filled in and sent.
A No. We did not have a form.

Q There was no form?
A No.

Q If you were asked one way or another to see a patient but decided not to go, is that appropriate to just not go?
A I suspect, if you are asking whether I was asked and did not go, I probably did go, but as I said earlier, maybe the child was busy being investigated somewhere, or was so sedated after the investigation you could not actually see them. So it is a question of fitting in with what one is being asked to do in and around everything else.

Q If you went, and you got out the notes, and the patient was not there, would you write in the notes ---
A No.

Q That the patient was not available?
A No.

Q You would write nothing at all in the notes?
A Right.

Q When you felt you could not do the assessments because of lack of time and staff resources in general, did you let Dr Wakefield know that was your opinion?
A I really do not remember. I am sorry.

DR WEBSTER: Thank you.

THE CHAIRMAN: Mrs Dean, a lay member.

MRS DEAN: I wonder if you could help me? We have heard the expression in evidence and in papers here of “late onset autism”. Is that an expression you recognise and, if it is, could you give me some understanding of what that might be?
A I do not recognise that as a condition. Children with autism can present at different ages. Particularly the higher functioning children may not present until they are at least in primary education where it becomes clear that they do not quite fit in. They do not socialise and a problem begins to be apparent. The high functioning children can quite often function perfectly happily in the pre-school environment and as increasing socialisation and pressures to be social are brought to bear on them, they find it hard to respond to that and therefore children can present even into adolescence for a diagnostic assessment. The severely affected children all present pre-school because the problem is so marked, but the milder children may certainly present years later. The problem, if one assesses them and the interviews include a retrospective component, will normally have been there always, looking back – but hindsight is always easier. I do not think it emerges suddenly when you are ten, or something like that. It becomes apparent when you are ten in some children, but it was always there.

Q Thank you. That is helpful. There is just one other thing I wanted to ask you about. You have explained that persistent development disorder ---
A Pervasive.

Q Pervasive – sorry. --- is, as you put it, in the same territory as autism?
A Yes.

Q Which I understand. Would you say that disintegrative disorder was the same territory as autism?
A No.

Q Very clearly not?
A It is an acute neurological deterioration which makes people worried and makes them reach for investigations or makes us reach for the tertiary neurologists who will investigate them. So no, it is a different presentation.

Q Was that quite clearly understood some ten or eleven years ago?
A I think it probably was fairly clearly understood. I just do not think it is as clearly understood now, because autism has really come of age in the last ten years and the interest is much higher than it used to be.

MRS DEAN: Thank you very much.

THE CHAIRMAN: Dr Moodley is a medical member.

DR MOODLEY: I just want to ask you about SSPE. You were about it in child 6. Does SSPE have a characteristic EEG?
A Yes, it does, and I cannot really pull it out of my head instantly, but it does have EEG abnormalities, yes.

Q So if the child has had an EEG one should be able to pick it up from there?
A Might be able to pick up from there. One would want the specific clinical presentation as well. EEGs on their own are sometimes not easy to interpret.


THE CHAIRMAN: Dr Lloyd-Evans, I have a couple of small question for you. I think the first question is on the line of the question by my colleague, Dr Webster. I know you mentioned that for internal reference there was no form in existence, at least at that particular time, at the Royal Free?
A That is right.

Q How did you actually get to hear that you are being expected to go and see someone?
A It would be something like, someone would ring my secretary and she would tell me that I was wanted.

Q Would she make a note of it on any document?
A I had a message book. I always had a message book so it might well have been in that but quite frankly the message books from ten or eleven years ago would not have been kept.

Q I appreciate that, but I am just trying to understand the process.
A Yes. It would not have been an unclear process. People would have been able to contact me. They could even have paged me. There is always the corridor consultation, where people say, “We have so-and-so on the ward. Would you come and see them.”

Q So would it be much more like word of mouth rather than any formal process of referral?
A There was no formal piece of paper so the message would come through a variety of routes; they might page, they might leave a message with my secretary. Email was not quite so popular in those days. My secretary would make sure I knew if somebody was after me. That was quite clear.

Q I think your response was that you would visit the child if a request was made – that you would always visit?
A I do recall going to the gastro ward and seeing I do not know how many children – not very many – with this particular project. If I did not record something I am speculating that a child was not in a state to be looked at because they were too sleepy, or they were off being investigated. Quite frankly, it is trying to fit everything into the day. They would only be there for a short period of time anyway.

Q What we do not want is speculation.
A Sure.

Q But what we do want to know from you is the practice as you would recollect it was at that particular stage – your practice in those circumstances?
A If I was asked, I would go, and if I did not record anything, something precluded my delivering what I was being asked.

Q If you did not record on the documents, would you know whether somebody else recorded whether a message has been passed on and you would visit on a Wednesday afternoon?
A There would be ---

Q Or the ward sister, or ---
A I do not think there would be any mechanism of knowing, really, what happened there.

Q How would you actually be able to justify if somebody in Professor Walker-Smith’s department asked you a question, “I asked you to go and see that child. What have you done?”
A I just never recorded if I did not have something to say.

Q All right. My second question is this. I think you mentioned in your evidence, was it the Autistic Society? Did you say that there was a ---
A National Autistic Society.

Q Was there a newsletter, did you say?
A They put out some years ago now, and I do not remember which year, a sheet of A4 – and I remember it was yellow – and it was about what we now call “factitious and induced illness”. It is about, to be blunt, faking it. It was to say, “Just be aware that some parents are fabricating” – whether on purpose or by accident I cannot say – “but just be aware that in diagnostic interviews they can be biased in a particular direction.” And that is true of any retrospective interview technique, where you are relying on recollection. It is all open to modification.

Q You said, “some time ago”. Would you be able to state whether it was before 1996 or after 1996?
A No. I think it was definitely after. Definitely after.

Q That particular newsletter was of no relevance at the time in question?
A Oh no; it is much later. Much later.

THE CHAIRMAN: I think those are all the questions that the Panel have. The Panel does not have any more questions, but the Council might, so I am going to ask first of all Ms Smith.

MS SMITH: Thank you, no, sir.


MR COONAN: No, thank you, sir.


MR MILLER: No, sir.

THE CHAIRMAN: And Mr Hopkins?

MR HOPKINS: No, thank you.

THE CHAIRMAN: Can I thank you, Dr Lloyd-Evans, for coming this morning and giving us the benefit of your evidence. You are now released.

(The witness withdrew)

THE CHAIRMAN: Ms Smith, who is the next witness?

MS SMITH: Sir, I indicated to you on Friday that I proposed to make an application to read the evidence of the next witness. That is because he is unavailable because he is unfit to be here. We do have a medical report in respect of him. It is Mr Phipps, who was the assistant finance officer at the Royal Free at the relevant time. I am pleased to say that application is unopposed in fact, but nonetheless I think if I may I would like to hand round the medical report that has been obtained on him so you see why he cannot attend. It can be C7.

THE CHAIRMAN: Yes. (Document marked and distributed)

MR COONAN: Could I just mention one thing before Ms Smith reads the statement. She is absolutely right: the application to read this statement is unopposed. We have had the advantage of seeing the medical certificate which you have just received and in the light of that, we therefore do not oppose it because the material is clearly admissible. I do, though, just make this observation. Had Mr Phipps been here, there would have been questions that we would wish to have asked him. I say no more about it at this stage. It affects Dr Wakefield directly, but I shall be making observations about it in due course. In terms of the principle of admissibility, there is no opposition to it.

THE CHAIRMAN: I take it you are speaking on behalf of your colleagues?

MR COONAN: No, I am not. I am speaking only on behalf of Dr Wakefield.

THE CHAIRMAN: I am sorry, I misunderstood. Mr Miller?

MR MILLER: This evidence does not affect my client at all. It is only in relation to Dr Wakefield, so we have no views about it one way or the other.


MR HOPKINS: The same but just for the sake of completeness I would be grateful for a copy of C7 when there is another copy available.

MS SMITH: Sir, in fact Mr Mellor is going to read Mr Phipps’ statement to you. I understand it is customary for you to have a copy of the statement.

THE CHAIRMAN: I was going to ask exactly that, if that is possible and there is no objection from the defence teams, perhaps we could have a copy. (Same handed and marked as C8). Just for clarification could I ask, I know what the situation with Mr Phipps was in June 2007. The hearing is obviously likely to continue at least until 19 September. Is there any possible that, in view of the observations made by Mr Coonan, Mr Phipps could give evidence at a later stage in the hearing?

MS SMITH: My understanding is that his medical condition is such that it is felt that he should not give evidence. Obviously, he was not asked about a specific date so we could certainly make further inquiries. You will appreciate, we will be going on to the experts but in view of what Mr Coonan said, if he wishes us to pursue it, or indeed you do, we are certainly very happy to do so but certainly our understanding was that it was a continuing situation, and you will see he has had a triple whammy in respect of medical conditions from which he suffers, so I would not anticipate that a month is going to make a difference, but I am very happy for those instructing me to inquire and we will let you know, and, of course, we could read the statement and then if the situation changes we can let you know and have him here.

THE CHAIRMAN: Thank you. Mr Coonan?

MR COONAN: Yes, I agree with Ms Smith, we read this as indicating that not only is he unfit as of 25 June but that that unfitness will last longer and looking at the nature of the health problems he has it would be perhaps surprising if he was in a better position within a fairly short time of today, so unless something very, very significant happens we read it as being well within the relevant statute.

THE CHAIRMAN: Thank you. I think I will leave it to one of you to resolve this in one way or the other, whichever process you want to employ. For the time being we are happy for Mr Mellor to read the statement of Mr Phipps.

MR MELLOR: That is correct, sir. Before I read the statement, I should mention there are five documents exhibited by Mr Phipps to his statement. All five of those have already been read into the transcript by Ms Smith during the evidence of Mr Else last Thursday. In those circumstances and having discussed the matter with the learned Legal Assessor I do not propose to re-read all those documents back into the transcript for a second time. What I do propose to do is give you the bundle references, allow everyone time to turn up the relevant pages, remind themselves of the contents and I will also give you the transcript reference for each document as well. If you are happy with me to proceed with that course I will do so.

THE CHAIRMAN: That is very helpful, thank you.

MR MELLOR: All the five documents are in the first three Panel bundles, FPT1, 2 and 3. Sir, the statement is dated 11 July 2007. It is the statement of Russ Phipps:

“I, Russ Phipps will say as follows:

I was the Assistant Director of Finance at the Royal Free Hampstead NHS Trust (‘the Trust’) from 1 April 1991 to 31 March 2006.

Part of this role involves the financial administration of the Special Trustees. The Special Trustees are a charitable wing of the Trust and I assist in managing their financial affairs.

It is common to set up individual accounts for consultants or separate departments at the hospital.

Account G106 was set up for the Gastroenterology Department at the Royal Free in 1994. The main signatories of this account were Dr Andrew Wakefield and AP Dhillon. I attached as exhibit RP1 a Memorandum dated 13 January 1994, which effectively established this fund.”

Pausing there, sir, the memorandum is in bundle 1, page 43, and it appears in the transcript on Day 19/3H to 4C. The Panel will see at page 43 in bundle 1 the memorandum is headed “The Special Trustees of the Royal Free Hospital” and is dated 13 January 1994. Returning to the statement:

“The prefix ‘G’ in G106 stands for ‘grant.’

A fund would often be opened if someone had a cheque to put into a fund or might imminently have a cheque. The Special Trustees effectively own these funds.

The Special Trustees operate a computer system where all cheques are submitted onto the system and all payments out are also recorded.

The central ledger generated by the Royal Free Hospital computer systems cannot be located prior before 1998. One reason for this might be that the Royal Free Hospital changed its computer systems in 1999/2000. In 1996 there was a computer system in place and some of the data from that computer system was transferred to a new computer system in late 1999. However, this transferred material only dated back to 1998.

A decision was made to destroy all of the pre-1998 data and it appears that none of it was backed up on the hard drive. I have checked with the systems people at the Royal Free who have confirmed that none of the data pre-1998 from the central Special Trustees ledger could be retrieved or recreated. This clearly includes any data or ledger for account G106 pre 1998.

I have been asked to confirm that all attempts were made to recreate the central Special Trustees ledger and that of account G106 prior to 1998. I can confirm that we looked for the data but could not find anything. This search included hard copy documents and computerised data.

I have seen a letter dated the 4 September 1996 sent by Martin Else to Dr Wakefield (copied to me) which informs Dr Wakefield that the Special Trustees will fund the salary of Ms Rosalind Sim to support the project for a period of two years. From my subsequent inspection of documents the source of funding was a Special Trustees general fund and not funding from account G106. I attach as exhibit RP2 a Memorandum which explains that for a two year period, Ms Sim’s salary costs were charged directly to the Special Trustees own unrestricted or general funds and not to Dr Wakefield’s fund number 106.”

That document is in bundle 3, page 1137, and it is referred to in the transcript again on Day 19/7G to 8E. Returning to the statement:

“I have received a letter dated 23 May 1997 sent by Dr Wakefield to me in which Dr Wakefield requests that the Legal Aid Board funds are transferred to the Special Trustees account which was currently paying the salary of Ros Sim. I attach this letter as exhibit RP3.”

That document is in bundle 2 at page 471, and was read into the transcript on Day 19/9F to 10H. Returning to the statement:

“I passed this letter on to Martin Else because Dr Wakefield had mentioned in the letter a problem with the medical school. There had been at that time many problems regarding the duplication of roles between the medical school and the Trust.

I also passed this letter onto Martin Else because I wanted to check that it was acceptable to put these funds into the Special Trustee’s account. Martin Else was a member of the medical school board and so it was important that he knew what was being requested so that he was not embarrassed at a later date. I did not speak to Professor Arie Zuckerman, the Dean of the medical school, about the request from Dr Wakefield. I had never heard of the Legal Aid Board at that time and I did not know that it was publicly funded.

I have previously reviewed the original copy of a letter dated 4 September 1996 sent by Martin Else to Dr Wakefield and copied to me. This contained an annotated note by Martin Else which said, ‘Ross Phipps. Ok, can you arrange?’ I took this to mean that the funds could be provided from the Special Trustee’s general account and I then arranged it. It was my understanding the Legal Aid Board money was going into account G106 not into the general Special Trustees’ account, I attach as exhibit RP4 a copy of the letter dated 4 September 1996 which is the same letter that I have reviewed previously save that he annotated note is missing.

That letter is in bundle 1, page 192, and was read into the transcript on Day 19/5C to 5G. Returning to the statement:

“I have reviewed a letter sent by me to Mr Tarhan dated 24 July 1997 in which I confirmed that Mr Tarhan should transfer the total amount of funds in question to the Special Trustees and that he should quote the reference G106. I attach this letter as exhibit RP5.”

That letter is in bundle 2 at page 495, and was read into the transcript on Day 19/15C to E. Returning to the statement:

“The Legal Aid Board funds had gone into account G106.

The Special Trustees’ accounts did not distinguish between Legal Aid Board funding and any other when the funds were submitted into account G106. There is no way of accounting for how Legal Aid Board funds were spent in financial terms. Any withdrawals from G106 would go out from the balance and would not be labelled as specifically Legal Aid Board funds.

I have been asked to confirm whether account G106 was set up for Dr Wakefield’s research generally or specifically for project 172-96. Account G106 was set up for Dr Wakefield’s research generally. I do not recognise the reference to project 172-96.

I have been asked to confirm whether it is unusual for the Trust to seek reimbursement from Special Trustees accounts, and where one could look for confirmation as to whether the Special Trustees had reimbursed the Trust over the period 1996-98.

It is not unusual for the Trust to seek reimbursement from the Special Trustees accounts by invoice. Because of the time elapsed and the computer system changes, I do not believe it is possible to establish now what reimbursements took place between 1996 and 1998.

Copies of the part of the Special Trustees’ ledger which relate to fund 106 were supplied to me sometime before June 2005 for the years 1998/99, 1999/2000, 2000/2001 and 2001/2002. I have reviewed all these entries and cannot see any reimbursements at all to the Trust.

I understand that my statement may be used in evidence for the purpose of hearing before the General Medical Council’s Fitness to Practise Panel, and for the purposes of any appeal, including an appeal by the Council for the Regulation of Health Care Professionals.

I believe that the facts stated in this witness statement are true.”

It is signed Russ Phipps, and, as I said previously, is dated 11 July 2007.

THE LEGAL ASSESSOR: Mr Coonan, that statement that has just been read, in the event that this case should ever finish and I have to advise the Panel on matters of law, I will have to draw a distinction between that and the statement – I am just looking for it – of Dr Jones, because that was read and the contents of that were accepted as true, is that right? This has been read because the witness is unavailable through ill-health and the contents are not necessarily accepted as true?

MR COONAN: Yes. IN due course I hope that I may make appropriate observations to yourself, to the Panel, on that topic for the assistance in due course of your directions.

THE LEGAL ASSESSOR: Thank you very much.

THE CHAIRMAN: Thank you. Ms Smith?

MS SMITH: Sir, the position is that I have no other witnesses available for today. I am trying to think of the best way forward: you indicated to us at an earlier stage that some time for reading would be very helpful to you, and it does seem to me that this short gap before tomorrow morning might be one opportunity for that.

THE CHAIRMAN: I think that is what I would be advising my Panel members, to try to spend some of the time this afternoon doing some reading.

MS SMITH: I apologise, I should say, for the fact that there is a gap in the witnesses, but you will appreciate that it is almost impossible for us to predict exactly how long the defence are going to be with a witness.

THE CHAIRMAN: We fully appreciate and understand the practical difficulties and also asking witnesses to be here that you consider to be necessary but eventually are considered not to be unnecessary because of the time when they could not be reached.

MS SMITH: Sir, there is quite a lot of time from now on and there are one or two short matters which I am wondering whether we could usefully deal with in front of the Panel. I am not really in a position to say any more than that until I have spoken to the Defence about it. I was wondering whether you would very kindly rise for, say, half an hour while we all consider whether there is anything that it would be useful to do for a short time this afternoon. If there is not, then you could perhaps use the afternoon in reading. If there is, it will only be short so that you will in any event have some considerable time. Could we have a short time to consider the position?

THE CHAIRMAN: May I suggest that, when we are able to resume, you could give us some references to what you would wish to draw to the attention of the Panel and on which they should be spending time reading. We will probably try to read the transcripts and some of the other documents. If you have a view on that, we would not mind you expressing it. The same request goes to the three Defence counsel as well.

MS SMITH: Thank you for that, sir.

(The Panel adjourned until Tuesday 14 August 2007 at 09.30 am)

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