SECOND AFFIDAVIT OF ANDREW J. WAKEFIELD by Dr. Wakefield Justice Fund

CAUSE NO. D-1-GN-12-000003

DR. ANDREW J. WAKEFIELD, MB., BS. v.

THE BRITISH MEDICAL JOURNAL, a d/b/a of BMJ PUBLISHING GROUP LTD, also d/b/a BMJ GROUP, and BMJ, BRIAN DEER, individually, and DR. FIONA GODLEE, individually.

§ § § § § § § § § § §

Filed 12 July 19 P7:37 Amalia Rodriguez-Mendoza District Clerk Travis District D-1-GN-12-000003

IN THE DISTRICT COURT

FOR THE 250th JUDICIAL DISTRICT

TRAVIS COUNTY, TEXAS

SECOND AFFIDAVIT OF ANDREW J. WAKEFIELD Before me, the undersigned authority, on this day personally appeared ANDREW J. WAKEFIELD, known to me to be the person whose name is subscribed to this instrument, and having been by me duly sworn, upon his oath deposes and states as follows: 1. “My name is ANDREW J. WAKEFIELD, I am over the age of eighteen, of sound mind, and am fully competent and able to testify herein. Unless otherwise stated, I have personal knowledge of the facts set forth herein, and they are true and correct. 2. I am the Plaintiff in the above entitled lawsuit. 3. I, along with 12 other medical and scientific colleagues, am a co-author of an article titled Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children which was published in The Lancet in 1998 (hereinafter referred to as the “Lancet Paper,”) a true and correct copy of which is attached as Exhibit [1]. I worked with and am generally familiar with the medical and scientific research backgrounds and reputations of the other co-authors. The Lancet Paper was co-authored

by very experienced clinicians and clinical researchers who between them have published hundreds of original papers in major scientific and medical journals, invited medical articles, and textbooks in the field of pediatric gastroenterology. Some of them, including Prof. John Walker–Smith and Dr. Simon Murch, have a reputation of world leaders in this field. 4. The case report set forth in the Lancet Paper, involved a clinical review of a 12 children (herein collectively referred to as the “Lancet Children”) who after a period of documented normal development, subsequently developed behavioral anomalies followed by developmental regression with loss of acquired skills and developmental milestones. These children also received a diagnosis of a pervasive developmental disorder on the autism spectrum. Significantly, these children also developed chronic (longstanding) intestinal symptoms. The Lancet Children were referred by their family doctors or pediatricians to the Royal Free Hospital (“Royal Free”) in London, England, where both myself, Prof. Walker-Smith, and others worked. There, in accordance with their symptoms and under the clinical care of senior physicians, they underwent various gastroenterological, neurological, and developmental assessments and as well as a review of their developmental histories. See Exhibit 1, p. 637. 5. The Lancet Paper itself took the form of a case report or Case Series which is a series of anecdotal clinical cases involving patients presenting with similar clinical symptoms and findings. The first descriptions of novel diseases often start with a Case Series. The following excerpt may be helpful: “Case series studies describe the experience of a single patient or a group of patients with a similar diagnosis. These types of studies, in which typically an astute clinician identifies an unusual feature of a disease or a patient’s history, may lead to the formulation of a new hypothesis…At 2

that time an analytic study (most frequently using a case-control approach), can [then] be done to investigate possible causal factors.” Exhibit 2, Hennekens C and Buring J. 919870 Epidemiology in Medicine. Mayrent SL (ed) Philadelphia, PA. Lippincot, Williams and Wilkins. 6. Accordingly, the Lancet Paper described 12 children with a similar diagnosis: pervasive developmental disorder following a period of documented normal development, associated with intestinal pathology (colonic inflammation and/or swelling of the intestinal lymph glands (lymphoid nodular hyperplasia) with or without small intestinal inflammation). Concurrent bowel and brain pathology and the parental association with MMR in 8 of the 12 Lancet Children led to analytic studies that tested new hypotheses of causation. In its most simple terms the clinical findings revealed that the Lancet Children who were diagnosed with developmental disorders, such as autism, were also identified to have inflammatory intestinal disease, as the Lancet Paper states: “We have identified a chronic enterocolitis in children that may be related to neuropsychiatric dysfunction.” Ex. 1, p. 641.

7. Enterocolitis refers to inflammation in the small and large intestine. A review of the Lancet Children’s relevant medical histories is provided later in this declaration. In the majority of cases, the onset of behavioral symptoms and other reactions such as fever and seizures were identified by the parents and in some cases by the children’s doctors, as occurring soon after receipt of receiving the Measles, Mumps and Rubella (MMR) vaccine. 8. It is important to recognize that our investigations into a possible link between developmental disorders, bowel problems, and MMR vaccines were responsive to preexisting medical and parental concerns. Of the 3 brands of MMR introduced into the UK

in the late 1980’s, two-including the brand produced by what is now Glaxao SmithKline (“GSK”) had to be hastily withdrawn in 1992 because they caused meningitis in children at an unacceptably high rate. 1 These unsafe vaccines had been licensed in the face of specific advice to the contrary. Neither my colleagues nor I are anti-vaccine, rather we advocate for safe vaccines and rigorous surveillance for adverse events. 9. The Lancet Paper was not intended to - nor could it - test a hypothesis of causation i.e. that MMR was the cause in any child. Rather, the Lancet Paper could and did generate hypotheses that were subsequently tested in further detailed studies. 2 Accordingly, the Lancet Paper states: “We did not prove an association between measles, mumps, and rubella vaccine and the syndrome described.” 3 Id.

10. The Lancet Paper served merely to report the parental observations of this possible association and (principally in the Discussion section) assess the plausibility of such an association in the light of the published medical literature. Accordingly, the Lancet Paper clearly states: “Further investigations are needed to examine this syndrome and its possible relation to this vaccine.” 4 Id.

11. The potential significance of the findings are captured in a statement from Prof. John Walker-Smith, the senior clinician involved with publishing the Lancet Paper and (who I know to be one of the world's leading pediatric gastroenterologists) in a letter to Dr.

See Callous Disregard, Skyhorse Publishing NY Chapter 4, “The Whistleblower” pp65-76 Uhlmann V., Martin C, Shiels, Wakefield AJ, O.Leary JJ. Possible viral pathogenesis of a novel paediatric inflammatory bowel disease. Molecular Pathology 2002;55:84-90 3 Emphasis added 4 Emphasis added 2

David Salisbury at the Department of Health in London, England in 1997. That letter states: “On the issue of autism, I am completely astounded by the clinical features of these children with autism and bowel inflammation. Very often the gastrointestinal symptoms have been ignored by a succession of doctors and the findings on ileo-colonoscopy appear to be quite distinctive. There seems to me to be a whole new syndrome which is in urgent need of clarification.” Exhibit 3, GMC Transcripts, Day 26, p. 61. 12. Defendants, Brian Deer and the British Medical Journal (“BMJ”) have published a very different interpretation of the Lancet Paper in their article published January 5, 2011 in the British Medical Journal titled How the case against the MMR was fixed., (the “First Article”) A true and correct copy of the print version of the article (BMJ0000088) is attached as Exhibit 4. The publication’s subtitle states: “In the first part of a special BMJ series, Brian Deer exposes the bogus data behind claims that launched a worldwide scare over the measles, mumps and rubella vaccine and reveals how the appearance of a link with autism was manufactured at a London medical school.” Id. at p. 77. 13. I believe it is undisputed that in a radio broadcast from New York (which I believe was on or about January 25, 2011) Brian Deer said, “Wakefield has now been branded by the British Medical Journal a fraudster. They described his work as an elaborate fraud. He also went through the results manually altering test results and diagnoses and histories of the children so to create the appearance that there was a link between MMR and autism.” 5 Exhibit 5. 14. The Defendant’s position through the time the BMJ article was in preparation and publication appears to be rooted in Deer’s claim, despite being presented with evidence to the contrary, that my research interest in autism arose following my encounter with 5

Emphasis added

lawyer Richard Barr, a plaintiff’s attorney acting on behalf of vaccine damaged children. Deer states on his website that, the “research” published in the Lancet “began with a contract between Wakefield and the lawyers.” A true and correct copy is attached as Exhibit 6: Is “Wakefield cluster” a chance finding or a telltale clue to suspect research? From http://briandeer.com/wakefield/thirty-children.htm. 15. This false assertion is reiterated and emphasized by Defendant Godlee in a draft version of part 1 of the Secrets series: “Brian, I would like to add the following couple of sentences, as I don’t think it is yet sufficiently clear to the reader that it was the lawsuit that put Wakefield onto the autism side of things. I certainly hadn’t picked that up until you emphasized it when we met the other day.” Exhibit 7 (Defendants production, BMJ 008377). 16. Godlee’s and Deer’s assertions on this issue are demonstrably false. My clinical and research interest in autism and the beginning of my clinical research in this area followed on directly from a telephone call to my office at the Royal Free Medical School from the mother of Child 2 on May 19,1995, 7½ months prior to my first meeting with Richard Barr in January 1996. This was confirmed in my GMC testimony – testimony defendants had ready access to. Q. (To the witness) Dr Wakefield, I just want for our present purposes to look, please, at Child 2 and it is simply for reference purposes at this stage. We have heard evidence from Dr Wozencroft that Child 2 was referred to Professor Walker-Smith by letter dated 29 June 1995 and that the first outpatient appointment for Child 2 was on 1 August 1995. At that stage, June/July/August 1995, what was the impact of what Mrs 2, possibly others, had been saying to you on the development of the hypothesis as it stood in the earlier part of the year when The Lancet paper had been published? … A It was absolutely fundamental to the articulation of the hypothesis. Here is a mother, amongst other mothers, who had taken it upon themselves to 6

educate themselves about how the gut and the brain might be injured and interact to produce the condition that their child suffered from… As I have said before, the key to the formulation of medical hypothesis must come – must come – by necessity from the history and the examination of the patient and, if they do not, then there is no foundation for that hypothesis because that is where it will stake its roots and this is a classic example of that process, the iterative nature of science. Exhibit 8 GMC Transcripts Day 48/31

17. My encounter with Mrs. 2 is also described in my book Callous Disregard, chapter 2, pages 25-26, a true and exact copy of which is Exhibit 9. In addition, there is correspondence in the medical records of Child 2 that confirms this. See for example, a referral letter from Child 2’s psychiatrist, Dr. Wozencroft to Prof. Walker-Smith on June 26, 1995: “I write to ask you to see 2 and express an opinion on him. I know that his parents have contacted you and your colleague, Andrew Wakefield…” Exhibit 10 GMC Transcripts Day 76/45 (referencing Royal Free Hospital records page 197). 18. Mrs 2’s call to me and my subsequent dealings with Child 2 were concerned primarily with her child’s illness and my response to her plea for my help for her severely ill son. This help involved recommending a referral of Child 2 to Prof. Walker-Smith for clinical evaluation. In addition, this contact with Mrs. 2 triggered my research interest in autism and its potential relationship to intestinal disease. Child 2 was not involved in litigation for sometime afterwards and did not become a plaintiff in vaccine injury litigation as a client of Mr. Barr’s firm or any other lawyer until after Child 2 had eventually been diagnosed, treated, and discharged from inpatient care at the Royal Free on August 30, 1996. 19. Beyond May 1995 and in advance any meeting with Richard Barr or knowledge of vaccine injury litigation, I received a number of similar requests for help from other

parents, concerned about their sick children with autism. The possibility of an unmet clinical need and unanswered questions led my interest in this subject. My response was entirely in keeping with my duty and interests as a physician and clinical researcher.

UK Medical Referral Process and Medical Records 20. In order to understand the Lancet Paper better, it is important to understand the underlying data relied on by the authors. Since this matter is also the subject of allegations of fraud by Defendants, it is covered in some detail. The underlying data for the Lancet Paper is comprised of three categories of medical records: a) the child's history as documented from a general practitioner's (GP’s) referral letter to the Royal Free Hospital, b) prospective developmental records from Health Visitors, general practitioners and other healthcare professionals contained in what is known as the “Red Book,” or Personal Child Health Record, and c) clinical records as maintained by the various physicians at the Royal Free where the Lancet Children were seen. 21. First, with regard to the GP’s referral letters to Prof. Walker-Smith’s clinical service, it important to understand the process of clinical care and referral within the British National Health Service (NHS). As a former practicing medical physician in the United Kingdom, I am generally familiar with the processes and procedures commonly followed. Generally, a patient is first seen by their general practitioner or “GP”. The GP, if he or she feels it necessary, will refer the patient to a specialist (the majority of whom operate at a hospital). In order to do so, the GP typically writes a referral letter that, ideally, should describe the patient's relevant medical history, which is assimilated from the GP’s knowledge of the patient contained in the patient’s own medical records. Typically, as

with the case of the Lancet Children, the GP’s medical records do not transfer to the specialist/hospital with the referral letter. 22. The second type of record relied upon in the Lancet Paper was prospective developmental records or what is generally known in the United Kingdom (UK) as the “Red Book” or Personal Child Health Record (PCHR). The Red Book is provided to all parents or guardians at around the time of their child’s birth and is kept by them. It is generally taken to each visit to the child’s doctor, dentist, Child Health Clinic, and hospital, at which time relevant entries should be made by healthcare professionals involved. In addition, at regular, routine visits to the home by the Health Visitor (a nurse with specialized training in child development) a child’s developmental “milestones” (e.g. months starting using hands, forming words, laughing, walking, etc.) are prospectively assessed and documented in the Read Book through the early months and years of the child’s life. In addition a record of vaccinations the child has received are maintained in the Red Book. A true and accurate copy of a Red Book issued in the United Kingdom is attached as Exhibit 11. 6 The significance of the Red Book is that it contains prospectively collected information on a child’s health and development. In particular, review of the Red Book permits an assessment of whether early childhood development is within normal limits or not. The Red Book provides in pertinent part as follows: “This is your child's personal child health record. It is the main record of your child's health, growth and development..” Ex. 11, The Red Book at p. 4. “It is a very important book for you to keep. It is for you and the other people who care for your child to be able to see and write in. Please always bring it with you when you take your child to: The child health clinic, the dentist, the family doctor, the hospital accident and emergency 6

Available at http://www.healthforallchildren.co.uk/pro.epl?SHOP=HFAC4&DO=USERPAGE&PAGE=pchr09

department, the hospital outpatients department or if your child is admitted to hospital." Id 23. Parents of the Lancet Children were asked to bring their child's Read Book with them when they visited the Royal Free. A true and correct copy of a letter sent to a Lancet Parent is attached as Ex 12. 24. Third, the doctors at the Royal Free maintained their own medical records – largely clinician notes and correspondence – the work product of physicians at the Royal Free itself and referring doctors- and test results. These records and notes were stored centrally in the hospital’s Records Department, and were accessed for the purpose of clinical care of the Lancet Children and writing the Lancet Paper. These notes also contain valuable information as relayed to the doctors and clinicians at the Royal Free throughout their conversations and interviews with the Lancet Children’s parents. I know, based upon my direct involvement in working on the Lancet Paper, that all three types of records were relied upon by the authors, including myself, in support of the Lancet Paper, as is described in the Lancet Paper itself: Clinical investigations We took histories, including details of immunisations and exposure to infectious diseases, and assessed the children. In 11 cases the history was obtained by the senior clinician [Prof. Walker-Smith]. Neurological and psychiatric assessments were done by consultant staff [Dr. Harvey & Dr. Berelowitz] with [D]MS-4 (sic) criteria. Developmental histories included a review of prospective developmental records from parents, health visitors, and general practitioners. Four children did not undergo psychiatric assessment in hospital; all had been assessed professionally elsewhere, so these assessments were used as the basis for their behavioural diagnosis. Ex. 1, The Lancet Paper at p. 637. 25. Accordingly, in working on the Lancet Paper, I considered records from these sources that provide reference to a child’s developmental status to be relevant, including but not limited to the GP's referral letters to Prof. Walker-Smith, the “Red Books,” and other 10

information that the parents provided. Additionally, the clinician notes, including, but not limited to the gastrointestinal, neurological, and psychiatric examinations of the Lancet Children at the Royal Free Hospital, were relied upon. As will be demonstrated below, those records were accurately relied upon. 26. What were not in our possession at the time of writing the Lancet Paper are the original medical records held by the GP, documents that Deer has indicated he relies upon in making specific allegations against me. I refer to this as a “fallacy of access” by Deer, as illustrated below. In some cases, and these will be illustrated, the parents of the some Lancet Children had various documents that they had obtained from their children’s General Practice records, but, as stated previously, the practice in the UK is for the GP to summarize the patient’s medical history in a referral letter as opposed to sending the entire medical history of the patient to the specialist. Notwithstanding the fact that some of the GP’s records were not routinely supplied to us and used in the writing of the Lancet Paper I have now reviewed GP records which were subsequently made available and, as will be demonstrated with specifics below, they corroborate the factual content of the Lancet Paper.

Falsity of Defendant’s allegations 27. Defendants’ statements that I altered data are completely and wholly false. Defendant’s statement that “[I] also went through the results manually altering test results and diagnoses and histories of the children so to create the appearance that there was a link between MMR and autism” 7 Ex.5, p 3, line 10-25 is also completely and wholly false. At no time did I ever change or alter data relied upon in support of the Lancet Paper or 7

Emphasis added

for that matter any medical records, GP referral letters, Red Book data or clinician notes and records. Further, I do not have any knowledge that at any time any of the authors, doctors, nurses or staff involved in the study changed or altered same in the manner alleged by the Defendants. 28. More to the point, the medical records maintained by the GP which were not in our possession at the material time could not and have not been changed or altered by me or to my knowledge by any of the authors, doctors, nurses or staff involved in the study by the mere fact that we didn’t have them at the time.

Introduction: Inflammation of the colon and non-specific colitis” 29. Based upon my encounter with Mrs. 2 in May 1995 and other parents beyond that date, I wanted to investigate whether these autistic children had an underlying inflammatory disease of the intestine. I did not believe this hypothetical disease to be classical inflammatory bowel disease, for example, Crohn’s disease since this would be unlikely to have escaped prior medical attention. This is captured in a letter from Prof. Walker-Smith to Child 2’s GP, Dr. Cartmel, on June 28,1996: “I duly saw 2 in the clinic. As you know I first met Mrs 2. Via Dr Andy Wakefield who is concerned with measles immunization and possible Crohn’s disease. I think Crohn’s disease is unlikely. Dr Wakefield has the view that there may be some kind of other inflammation which may be a relevant factor in 2’s illness 8…” Exhibit 13, GMC Transcripts Day 39/25 (referencing Royal Free Hospital records pages 159-130, and General Practice records pages 164 and 323.)

Emphasis added

30. This statement accurately reflected my view at that time. Further evidence in support of an inflammatory intestinal disease in some children with autism was published in 1995; For example, Exhibit 14, Lucarelli et al. Food allergy and infantile autism. Panminerva Medica 1995;37:137-141, and 1996; For example, Exhibit 15, D’Eufemia et al, Abnormal intestinal permeability in children with autism. Acta Paediatrica. 1996;85:1076-1079. Thus, by early 1996 there was a theroretical (rather than hypothetical) basis for an inflammatory intestinal disease in children with autism and gastrointestinal symptoms. Colitis Based upon my training and years of experience in medicine, I am familiar with commonly used medical definitions and uses of the terms "colitis", "non-nonspecific colitis", "indeterminate colitis" and "enterocolitis". Colitis refers to inflammation of the colon or large intestine. Non-specific (or indeterminate) colitis is a diagnosis that is often made in the absence of clear diagnostic features under the microscope and in the patient’s clinical presentation of either Crohn’s disease or ulcerative colitis. Interpreted literally, the diagnosis of “colitis” means an increased number of inflammatory cells in the colon “[colitis]. 31. In accordance with the appropriate level of scientific rigor, it was this strict, literal definition that was applied to the interpretation of colonic biopsy slides from the Lancet Children. This, in addition to the further clinical assessment of the children, led to their final clinical diagnosis of non-specific colitis. This definition was applied throughout the histopathology analyses for the Lancet Paper and several subsequent peer reviewed publications. For the Lancet Children, the final diagnosis was made by the clinicians – not me – and was thoroughly and rigorously reviewed (see below) before being endorsed by the authors of the Lancet Paper.

Histopathology: The Allegations 32. Defendants allege that I altered data with the intent to find a “new syndrome” or disease. I have reviewed the interview of Brian Deer which aired on the Gary Null show on January 25, 2011. In that interview, Deer stated: “[Wakefield] went through the results, manually altering the test results.” On the second page of the BMJ First Article there is a “sidebar” or "highlight box” provided in which Defendants highlight what Mr. Deer testified in his deposition to be the components of the fraud they allege I committed. Exhibit 65, Jane Smith Deposition 56; 12-24 Under the heading “How the link was fixed,” he states that as a matter of “fact”: “In nine cases, unremarkable colonic histopathology results - noting no or minimal fluctuations in inflammatory cell populations - were changed after a medical school ‘research review’ to ‘non-specific colitis.’” The fact that allegations of changing the histopathology results by me are a major component of the alleged fraud is reinforced on Brian Deer's own website under the title “MMR: Faking the Link. Wakefield's Autistic Enterocolitis Under the Microscope,” a true and correct copy is attached as Exhibit 16. These statements about me and about the Lancet Paper are false. I did not change the histopathology results. In fact, as shown below, the histopathology results were arrived at after a rigorous process of analysis and were approved by the authors of the Lancet Paper prior to publication. 33. With regard to the pathology examination for the Lancet Children, I am personally familiar with the details of how the pathology examinations occurred.

Routine histopathology reporting

34. During the course of the providing clinical care for the Lancet Children and in order to establish the origins of their intestinal symptoms, biopsies of the lower intestine (colon and for most, terminal ileum also) were obtained by the pediatric gastroenterologists, from each of the Lancet Children . These biopsies were sent to the routine pathology laboratory for analysis by a routine on-call pathologist. Based on my years of medical training and experience, this is standard practice for biopsy materials taken from patients in the NHS. Based upon my employment by and position at the Royal Free Hospital, I was familiar with the qualifications of the on-call pathologist's at the Royal Free during the relevant time. The on-call pathologist at the Royal Free Hospital was neither a pediatric specialist nor routinely a gastrointestinal specialist.

Professor Walker-Smith’s “clinicopathological” review 35. As part of his routine clinical practice, I observed that Prof. Walker-Smith, who is a pediatric gastroenterologist with an expertise in intestinal pathology in children, would, on a weekly basis, review with his team of doctors, the tissue biopsies taken from his patients in the previous week in the company of a pathologist. I attended many of these meetings. At some stage during the clinical evaluation of the Lancet Children Dr. Susan Davies took over the role of liaison pathologist with the role of representing the Department of Histopathology at these meetings and reviewing the relevant biopsy slides. Dr. Davies was not – as Deer has erroneously referred to her the “lead pathologist on Wakefield’s project.” Exhibit 17. She did, however, report and/or review all of the biopsies in the Lancet Children prior to publication (see below).

36. In his testimony to the GMC, Professor Walker-Smith confirmed the purpose of his regular clinicopathological review in establishing a final diagnosis in his patients. “The next event, and a very important one, was the Friday clinicopathological meeting…This was a clinical meeting shared between and led by the histopathologists, as we have just been discussing this morning. It was entirely [routine clinical] service, but there were other observers sometimes who may be present at that meeting. At that meeting we would review the histology and the diagnosis and, at the end of the meeting, we should have a firm diagnosis for the child and the junior doctors would then have the opportunities to talk to the parents, because the parents were aware that we were having this meeting. The middle grade staff would have then gone from the meeting to the ward and discussed what was planned with the parent.” Exhibit 18, GMC Transcripts Day 73/51 37. I know, based on my training and experience that a principal reason for such a review is that a final diagnosis of intestinal disease should only be arrived at in the light of the full clinical picture, including a review of symptoms, physical, radiologic, endoscopic, and histopathologic findings. This is reinforced by Dr. Dhillon, the senior intestinal pathologist at the Royal Free Hospital and co-author of the Lancet Paper. Attached as Ex 19, is a copy of the Personal statement by Amar Dhillon in response to “Pathology reports solve “new bowel disease” riddle” (BMJ 2011;343:bmj.d6823). BMJ Nov 2011 , in which Dr. Dhillon states: Bowel disease is not diagnosed by gut mucosal histopathology in isolation:...I am of the opinion that the histological interpretation should never (or not very often) replace clinical judgment…A final diagnosis can only be made with the full clinical information and a biopsy specimen should be reported as diagnostic only if full supportive clinical information is available.” (Jenkins D et al. Guidelines for the initial biopsy diagnosis of suspected chronic idiopathic inflammatory bowel disease. The British Society of Gastroenterology Initiative. J Clin Pathol 50,93105;1997). Exhibit 19 Personal statement by Amar Dhillon in response to “Pathology reports solve “new bowel disease” riddle” (BMJ 2011;343:bmj.d6823). BMJ Nov 2011

38. The importance of the clinicopathological review in the assessment of intestinal disease, is emphasized by independent physicians as well. For example, see Ex 20, Haboubi NY, Schofield PF. Large bowel biopsies in colitis: a clinicopathological collaboration. Journal of the Royal Society of Medicine Volume 1994;87:16-17,

which states in pertinent part: “Most biopsies from patients with colitis have no pathognomonic diagnostic histological features; therefore they have to be interpreted with the full knowledge of the clinical endoscopic, radiological and laboratory data. (2) It is highly desirable to have regular clinicopathological meetings to establish a final diagnosis. (3) If we follow histological patterns only we find that different forms of colitis share similar patterns but on the other hand a single disease may have different patterns. 39. Significantly, at these meetings Prof. Walker-Smith and his team noted that the routine pathology service was overlooking evidence of inflammation in the children with autism. In his GMC testimony he commented on the inadequacy of the diagnostic histopathology service at the Royal Free Hospital compared with his previous hospital, St Bart’s as follows: “I was used to working with an expert team at Bart’s [St Bartholomew’s Hospital], but the team that I had at the Royal Free in histopathology did not have the same degree of expertise…” Exhibit 21, GMC Transcripts Day 74/46. 40. In reference to this intestinal pathology in the Lancet Children that was missed by the routine pathology service, Prof. Walker-Smith stated in his GMC testimony: “– but in those cases in which I departed, I saw with my own eyes these changes.” id.

Dr. Dhillon’s first review 41. In order to thoroughly analyze the Lancet Children’s biopsies systematically and ensure proper diagnosis, at Prof. Walker-Smith’s request, Dr. Paul Dhillon, a senior pathologist with a specialty in liver and intestinal pathology, conducted a review of all of the biopsy slides from 7 of the Lancet Children. Seven children had been through clinical evaluation by the point at which Prof. Walker-Smith had become sufficiently concerned about the inadequacy of the routine pathology service that he considered such an analysis necessary, particularly in light of an invitation to present his findings on these children at a upcoming meeting. Dr. Dhillon was chosen by Prof. Walker-Smith because he is an accomplished and respected physician and pathologist with several degrees including Medical Bachelor and Bachelor of Surgery (MB,BS), Fellow of the Royal College of Physicians (FRCP), Fellow of the Royal College of Pathologists (FRCPath), and had the appropriate expertise. In reference to the selection of Dr. Dhillon to undertake this analysis, Prof. Walker-Smith stated in his GMC testimony: “Dr Davies is a very good histopathologist and by the time I left she had the skills appropriate – but at that particular time Dr Dhillon had much more experience, as indeed I believe I myself had from my years of looking down a microscope twice a week with histopathologists.”Exhibit 22, GMC Transcripts, Day 74/46-47

42. In his testimony to the GMC, Prof. Walker-Smith accurately described the format of the review that he undertook with Dr. Dhillon. “What I asked him to do was if he would pull out the histology of the first seven children that we had investigated, autistic children, and would he gather together the slides of those children and look at them, without any of the clinical information being provided to him. I would then meet with him and we together would look together down the microscope at the histological findings,…” Exhibit 23, GMC Transcripts Day 74/39

43. In addition, at the GMC, Prof Walker-Smith was questioned about the advantages of conducting such a review, where all the biopsies from a group of children are reviewed at one time: Q. Just finally on that point, is there any benefit in seeing a series in one go of slides which may have the same sorts of features, as opposed to seeing them as one out of a list of ten or 12? A. Immense. You asked me earlier in the afternoon about the stocktaking thing, when we had this approval. I had not realised quite so clearly how similar these pathological features were until I, with my own eyes, actually saw these seven children, because of course they were diluted in the Friday clinic because the majority of the children actually would have Crohn's disease and ulcerative colitis. So it was a very valuable exercise to put all these children together. Exhibit 24, GMC Transcripts Day 74/4748

44. In order to add objectivity and rigor to his analysis and protect against bias in the interpretation of biopsies, Dr. Dhillon performed his review without knowing the clinical history and final diagnosis in any child. Significantly, Prof. Walker-Smith stated in his GMC testimony that, in the context of the first 7 cases that were reviewed by Dr. Dhillon, the process â&#x20AC;&#x153;was totally unrelated to Andy Wakefield.â&#x20AC;? 9 Exhibit 25, GMC Transcript Day 74/38. 45. The outcome of this review was that Dr. Dhillon and Prof. Walker-Smith agreed upon non-specific colitis in 7 children (children Nos. 1,2,3,4,5,6, and 9) and these results were compiled by Prof. Walker-Smith for a presentation to a scientific meeting at the Wellcome Trust, London, in December 1996. For the purpose of this presentation, Prof. Walker-Smith prepared a set of notes confirming his diagnoses, a true and correct copy of which are attached as Exhibit 26, Presentation notes of Prof. Walker-Smith from December 1996. 9

Emphasis added

46. At some stage before the Lancet Paper was completed, Dr. Dhillon’s findings were entered into scoring sheets, prepared by him, that documented the children’s histopathology in a formal, qualitative way (see below). Of these 7 children, the scoring sheets for children 3,4, and 5 had, for one or more biopsies in the colon biopsy series, a score of “1” in the category of “chronic inflammation” indicating “mild chronic inflammation.” In turn, this finding combined with the child’s clinical picture, was interpreted by Prof. Walker-Smith as showing “Indeterminate” AKA “non-specific colitis”. This diligent process led to a diagnosis of indeterminate or non-specific colitis in all 7 children (Nos. 1-6, and 9) examined in Dr. Dhillon’s first systematic review.

Dr. Dhillon’s further review 47. At the point that we decided to report the 12 Lancet Children, I requested that Dr. Dhillon review and analyze the biopsy slides for all 12 Lancet Children. This is described in Dr. Dhillon’s statement to the GMC, a true and correct copy of which is provided as Exhibit 27, Dr. Dhillon’s statement to the GMC. Dr. Dhillon compared the Lancet Children’s biopsies with a control group comprised of colonic biopsy tissues from children who were developmentally normal and who did not have inflammation of the colon. The samples were coded and then mixed up so that the pathologists reviewing the slides did not know whether the slide came from a child with autism or a child who was developmentally normal. This process was intended ensure that there was no “observer bias” that might result from the interpretation of biopsies in light of the known diagnosis in the child. All biopsies were reviewed and scored in the same manner. This process is described by Dr. Dhillon in his sworn statement to the GMC as follows:

20. My appointment in the Medical School requires me to undertake research activities. Around 1997, I was asked by Dr Wakefield to review a series of slides of gut biopsies from patients from the paediatric gastroenterology department. …Biopsies would have been taken from different parts of the gut from each patient, and I would have looked at the whole series of biopsies for each patient. 21. For my research review of slides, I was not given any clinical details about the children who had provided the samples. I made microscopical observations and recorded these observations using the system described above. The observations were given to Dr Wakefield. 22. When I was asked to do this review of slides, I did not know what symptoms the children had. The review of the slides was straightforward and was a matter of saying whether there was inflammation or not as well as other relevant microscopical observations. Ex. 27

Dr. Dhillon’s scoring sheets

48. In undertaking his systematic research review of the biopsies, Dr. Dhillon entered his results into a scoring sheet, a true and correct copy of a completed example which is presented as Exhibit 28, Dr. Dhillon’s scoring sheet for Child 1. The purpose and interpretation of these scoring sheets is explained in the statement of Dr. Dhillon to the GMC as follows: 17. In quite a different way [to routine diagnostic histopathology], when a histopathologist provides systematic observations for research purposes, it is best practice to be unbiased and not to see the clinical details of the patient who has provided the sample. In the context of inflammatory bowel disease, the histopathologist might put more order into his observations and may say whether there is acute inflammation, chronic inflammation, ulceration, or architectural changes. He/she will also comment on the extent to which these things can be seen on the slide. Histopathologists sometimes record their observations as a “score” ranging 0-III, where ‘0’ could represent no inflammation, ‘I’ could represent mild inflammation, ‘II’ could represent moderate inflammation, and ‘III’ could represent severe inflammation. 10 18. I often use this type of scoring system when I am asked to undertake a systematic review for research purposes. I will look at each slide down the 10

Emphasis added

microscope and record the relevant features for each slide in a table. I may record a score for some of the relevant microscopical features in the table as well. 19. The different scores of 0-III representing for example, different degrees of inflammation, are not necessarily reproduced in a published research paper unless a specific referee requests it. Ex. 27, Dr. Dhillon’s statement to the GMC

49. The grades of inflammation described by Dr. Dhillon above - none, mild, moderate, or severe - were provided for different elements of the inflammatory process, and for each biopsy in the Lancet Children. This extract from Dr. Dhillon’s statement was included in my complaint about Deer’s reporting to the UK Press Complaints Commission and in my book Callous Disregard, both of which were available to the Defendants when they made their allegations of fraud. Moreover, details of Dr. Dhillon’s systematic research review were described by me at the GMC hearing. 50. On the basis of his initial analysis and his subsequent systematic research review Dr. Dhillon was included as a co-author on the paper. As a co-author he had access to drafts of the paper and was free to modify or edit those drafts as he saw fit, prior to publication. His research role and the basis of his authorship is confirmed in his statement to the GMC, Ex. 27 as follows: 23. The idea to publish the series of children described in the 1998 Lancet Paper had arisen probably in 1997. It was then that I learned more about the clinical syndrome which the children (included in the slide series which I had reviewed) apparently had. My clinical colleagues told me that this was a group of children with a syndrome that included gut problems, endoscopic changes and a particular histological appearance. These children had delayed or regressed development. The syndrome became more coherent to me when I saw a draft of the paper. 24. The paper contained histology paragraphs and a table which includes a column where the histological findings for the 12 children have been written up. I did not write the histology section of the paper and I cannot remember whether I made any amendments to the draft paper which would have been circulated to all of the authors. I do not know if any 22

other histopathologists undertook the same review exercise with the slides as me, and I did not see their observations. 25. The person who wrote the histological findings may have looked at the observations which I provided to Dr Wakefield. The person writing the research paper may have translated the Roman numeral scores which I may have used into something readable. For example, the term “lymphoid nodular hyperplasia” is synonymous with “increased or enlarged lymphoid follicles”, and this an aspect of chronic inflammation. 26. The paper was published in the Lancet in February 1998 and was entitled “Ileal-lymphoid nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children” (“the Lancet Paper”). I was named as one of the authors on this paper because of the blinded review of the series of slides which I undertook in a research capacity.

Biopsy scores and their interpretation in the first 7 and all 12 Lancet Children. 51. As set out above, the outcome of Dr. Dhillon’s and Prof. Walker-Smith’s initial analysis resulted in diagnoses of non-specific colitis in 7 children (children Nos. 1,2,3,4,5,6, and 9). It is relevant to the diagnoses in the remaining 5 of the Lancet 12 children (Nos. 7,8,10,11, and 12) that the scoring sheets for children 3,4, and 5 had, for at least one colonic biopsy, a score of “1” in the category of “Chronic inflammation” indicating “mild chronic inflammation.” In turn, in light of his clinical knowledge of the individual children, this was interpreted by Prof. Walker-Smith as showing non-specific colitis for each. True and correct copies of Dr. Dhillon’s scoring sheets for children 1,2,3,4,5,6, and 9 are attached as Exhibit 29. 52. Of the remaining 5 Lancet Children, children 8,10,11, and 12 had an identical score of “1” in the category of “Chronic inflammation” indicating “mild chronic inflammation”. This was interpreted in an identical manner for children 8,10,11, and 12 as it had been for children 3,4, and 5 above and was reported correctly in the Lancet as showing non-

specific colitis. True and correct copies of Dr. Dhillon’s scoring sheets for children 7,8,10,11 and 12 are attached as Exhibit 30.

Dr. Anthony’s systematic research review 53. A further level of scrutiny was applied to the interpretation on the Lancet Children’s intestinal biopsies. A second pathologist on the Lancet Paper team, Dr. Andrew Anthony, analyzed the tissues, also. A true and correct copy of Dr. Anthony’s statement to the GMC is provided as Exhibit 31, Statement of Dr. Andrew Anthony to the GMC. 54. Dr. Anthony confirmed his use of scoring sheets (slightly modified from those of Dr. Dhillon) in a systematic, research review of the biopsies that I instructed him to undertake. His statement to the GMC also confirms that Dr. Anthony reviewed the slides as part of his contribution to the Lancet Paper (see below). 55. Dr. Anthony was, at the material time, an experimental pathologist with postgraduate qualifications in both Science (Ph.D) and Medicine (MB,BS), with a published expertise in the earliest microscopic features of inflammatory intestinal disease. 11 He was ideally

Dhillon AP, Anthony A, Sim R, Wakefield AJ, Sankey EA, Hudson M, Allison MC, Pounder RE. Mucosal capillary thrombi in rectal biopsies. Histopathology 1992; 21: 127-133. Sankey EA, Dhillon AP, Anthony A, Wakefield AJ, Sim R, More L, Hudson M, Sawyerr AAM, Pounder RE. Early mucosal changes in Crohn's disease. Gut 1993; 34: 375-381 Anthony A, Dhillon AP, Nygård G, Hudson M, Piasecki C, Strong P, Trevethick MA, Clayton NM, Jordan CC, Pounder RE, Wakefield AJ. Early histological features of small intestinal injury induced by indomethacin. Alimentary Pharmacology &.Therapeutics.1993; 7: 29-39 Nygård G, Anthony A, Piasecki C, Trevethick MA, Hudson M, Dhillon AP, Pounder RE, Wakefield AJ. Acute indomethacin-induced jejunal injury in the rat: early morphological and biochemical changes. Gastroenterology 1994; 106: 567-575 Anthony A, Dhillon AP, Sim R, Pounder RE, Wakefield AJ. Dexamethasone promotes ulcer plugging in experimental enteritis. Alimentary Pharmacology & Therapeutics 1994; 8: 597-602

suited, therefore, to undertake this review. Dr. Anthony scored these biopsies in a manner very similar to that of Dr. Dhillon and his results confirmed those of Dr. Dhillon. The attached portion of a Microsoft Powerpoint presentation prepared by Dr. Anthony at the material time, illustrates the interpretation (numerical grading system) applied to the biopsies in the scoring sheet. Exhibit 32, See: Slides taken from Dr. Anthony’s Powerpoint presentation. 56. Applying a level of scientific rigor similar to that of Dr. Dhillon, Dr. Anthony also compared the Lancet Children biopsies to the control set comprised of colonic biopsies from children who were developmentally normal and who did not have inflammation of the colon. These controls were provided by the Department of Histopathology at St Bart’s Hospital. At my request, both of these doctors reviewed the tissue pathology of all 12 Lancet Children before the results were entered into the Lancet Paper. 57. During the course of writing the Lancet Paper I asked Dr. Anthony to write a “Methods” section for the histopathology, and the histological findings for the Lancet Paper and he did so. This is confirmed in his statement to the GMC as follows: “25. When the time came for the Lancet study to be written up, Dr Wakefield asked me to write a paragraph on the methodologies and the histological findings….” Ex. 31, Statement of Dr. Andrew Anthony to the GMC.

Anthony A, Dhillon AP, Sim R, Nygård G, Pounder RE, Wakefield AJ. Ulceration, fibrosis and diaphragm-like lesions in the caecum of rats treated with Indomethacin Alimentary Pharmacology & Therapeutics 1994; 8: 417-424. Nygård G, Anthony A, Khan K, Bounds SV, Dhillon AP, Pounder RE, Wakefield AJ. Intestinal site-dependent susceptibility to chronic indomethacin in the rat: a morphological and biochemical study. Alimentary Pharmacology & Therapeutics 1995; 9: 403-410 Anthony A, Dhillon AP, Thrasivoulou C, Pounder RE, Wakefield AJ. Pre-ulcerative villus contraction and microvascular occlusion induced by indomethacin in the rat jejunum: a detailed morphological study. Alimentary Pharmacology & Therapeutics. 1995;9:605-613 Anthony A, Dhillon AP, Fidler H, McFadden JJ, Billington O, Nygård G, Pounder RE, Wakefield AJ. Mycobacterial granulomatous inflammation in the ulcerated caecum of indomethacin-treated rats. International Journal of Experimental Pathology. 1995; 76: 149-155

58. Other than to shorten the text in line with the word-count limits imposed by the Lancet, Dr. Anthony’s text was unchanged and its meaning preserved in the final Lancet Paper.. Dr. Anthony’s statement continues: “26. My paragraph did not go into the Lancet paper word for word but was adapted by Dr Wakefield, although I could not say exactly how it was changed. I have been shown a copy of the Lancet paper, and while it does appear that I may have written something longer for the methodology than was published, as it is now 9 years since this happened, I cannot recall exactly.” id

Further review by Dr. Davies and others prior to publication of the Lancet Paper 59. Prior to publication of the Lancet Paper, a further level of scrutiny was applied to the interpretation of the histopathology in the Lancet Children’s biopsies. Dr. Davies, who had not been part of either Dr. Dhillon’s or Dr. Anthony’s systematic research reviews, and who was relatively unfamiliar at this stage with pediatric intestinal pathology, called a meeting to review the biopsy findings and the wording of the histopathology in a draft Lancet Paper. This meeting, which I personally attended, was also attended by Dr. Dhillon and Dr. Anthony as well as the pediatric gastroenterology team. The meeting was described in detail by Dr. Murch during his GMC testimony and was unchallenged. The team of pathologists reviewed the slides of the Lancet Children on a case by case basis and agreed that the wording in the Lancet Paper regarding the histology was reasonable and appropriate and could go forward for publication. In response to the question at the GMC hearing “What was the outcome of that meeting about the description of the histology?”, Dr. Murch accurately replied as follows: “That all the pathologists present when the slides were reviewed case by case agreed that the wording in the paper – we had a table of the histological findings, which I believe will be as seen in the paper here – they all agreed that the wording was reasonable. So I think that Dr Davies 26

was then satisfied that the paper could go forward for publication without change in the histological description. Exhibit 33, GMC Transcripts Day 113/44

60. Dr. Davies later commented upon the merits of such reviews in response to Deer writing in the BMJ, accompanied by a commentary Prof. Nicholas Wright, a histopathologist . “Nick Wright writes that there is nothing intrinsically wrong with such a review of the histopathology. I would state more strongly that ANY study of histopathology has more credence, with reduced inter- and intraobserver variation, when a systematic review, using defined structured criteria over a short time-frame, is performed.” Ex 17, Letter from Dr. Susan Davies to BMJ Rapid Responses.

Further use and independent validation of the scoring sheets after publication of the Lancet Paper. 61. The validity of the scoring sheets as part of the analytic process of investigating potentially novel or previously unreported intestinal pathology, is provided in a follow up paper to the Lancet Paper a copy of which is attached as Exhibit 34 entitled: Wakefield AJ et al, Enterocolitis in Children with Developmental Disorders. American Journal of Gastroenterology 2000,95:2285-2295, 12 62. This paper describes the process by which the tissue diagnosis was made, using the scoring sheet data, and presents as a figure in the paper, a copy of the table in the scoring

It is notable that this paper has also been retracted following the retraction of the Lancet Paper, precisely because it included the original 12 children reported in the Lancet. It was specifically retracted because of the questions regarding the “consecutive referral” of children in the Lancet Paper and finding that the was no ethical approval for the investigation of the Lancet Children. It was not retracted for any other reason. In the English High Court Justice Mitting’s rejected both of these findings made against Prof. Walker-Smith. I believe that the basis for retraction of the Lancet Paper was wrong and a demand for the reinstatement of both papers has been made.

sheet. This paper (unlike the Deer BMJ articles) was formally and independently (externally) peer reviewed prior to publication. I am aware of no issue on the part of the peer reviewers or the Journal’s editorial board over the use and interpretation of the scoring sheets data and the papers conclusions.

Summary 63. The histopathology diagnoses of non-specific colitis in the Lancet Children were arrived at after a rigorous, exacting process that involved two specialists in intestinal pathology, Dr. Dhillon and Dr. Anthony, a further senior pathologist, Dr. Davies, and a highly experienced team of pediatric gastroenterologists, before the findings were published in the Lancet Paper. At no stage have these experts and co-authors retracted their collective findings of non-specific colitis in these children. At no time were the pathology reports changed or altered by me as Defendants have alleged. 64. To further the point, while I do have first-hand knowledge of the manner in which Dr. Dhillon and Dr. Anthony reviewed and analyzed the biopsies of the Lancet Children, other than as an observer who was able to validate the process and participate in the assessments, I had no role in analyzing or recording the data in the scoring sheets – although I observed under the microscope the features that they identified and do not dispute the accuracy of their findings. For that reason, alone, Deer’s statements that I personally, changed or altered data, is all the more false. 65. In order to allege fraud, Deer compares the findings in the Lancet Children’s routine pathology reports generated for the most part by non-specialists with the findings reported in the Lancet Paper. The process by which the final diagnoses – those published

in the Lancet Paper – were arrived at, were readily available to the Defendants in the GMC Transcripts, my complaint to the Press Complaint’s Commission, Callous Disregard, and published papers. When challenged on the omission of the relevant information from these sources during his deposition, Deer commented: “Dr Dillon was asked to perform a subsequent review and at that point it all becomes very confusing and, dare I say, murky, because different -- there are now a multiplicity of different accounts as to what this second review was…” Exhibit 35, Deposition of B. Deer, June 26, 2012 at p. 82, 13-16.

The Lancet Paper: additional matters 66. Defendants have falsely asserted and accused me of altering data. Defendants state unequivocally that, “No case was free of misreporting or alteration. Taken together, the NHS records cannot be reconciled with what was published, to such devastating effect, in the journal (table)” (emphasis added). In a January 8, 2011 BMJ editorial authored by Defendant Godlee titled Wakefield’s Article Linking MMR Vaccine and Autism was Fraudulent, a true and correct copy of which is attached hereto as Exhibit 36, Godlee reiterates the same false statements: In a series of articles starting this week, and seven years after first looking into the MMR scare, journalist Brian Deer now shows the extent of Wakefield’s fraud and how it was perpetrated. Drawing on interviews, documents, and data made public at the GMC hearings, Deer shows how Wakefield altered numerous facts about the patients’ medical histories in order to support his claim to have identified a new syndrome. Exhibit 37 Godlee’s Editorial at p. 342-43.

67. Defendants have stated that they base these defamatory statements on information they claim to have reviewed in the transcripts [“GMC Transcripts”] of those proceedings, which the BMJ and its editorial staff allegedly relied upon in their alleged fact checking exercise. 29

68. Although the GMC proceedings did not concern the accuracy of the clinical data in the Lancet Paper (instead it mainly involved ethical issues related to, for example, whether the Lancet Paper was a research or clinical exercise), much of the testimony in the GMC proceedings discussed and referenced the Lancet Children’s medical histories. The transcripts of the GMC proceedings are thus helpful. The GMC transcripts cite from the National Health Service (NHS) records for each child. These included references to not only the Royal Free Hospital records, but also the GP records [“General Practice records”] and the local hospital records. Of the latter two sources, much was not in the possession of the Lancet Paper authors at the material time. Notwithstanding, based on my subsequent review of many of those documents, many of these records that were not in the authors’ possession at the time of writing the Lancet Paper, further prove the accuracy of the that paper and disprove the basis on which Defendants base their false and defamatory statements about me as shown child by child below. 69. The following section addresses for each Lancet Child, the Defendants’ specific contentions with their “citations,” the evidence in response to that allegation, including the nature of the citation, for example, whether it is a doctor's letter or a clinical note in the hospital; a statement of the relevant extract from that citation; the Exhibit number followed by the reference to the citation in the GMC transcript (if it was cited at the GMC) according to day and page number. Then the source of the citation in the medical record (labeled according to the numbering used in the GMC files for each child). For example: Ex 10 GMC Transcript Day 10/54 (reference to General Practice records page 32) not a true reference.

THE LANCET CHILDREN AND GENERAL MISSTATEMENTS In How the Case Against the MMR Vaccine was Fixed, Deer states the following: Multiple discrepancies The [Lancet] paper gave the impression that the authors had been scrupulous in documenting the patients’ cases… First to crack was regressive autism, the bedrock of [Wakefield’s] allegations, but only one child - Child 2 - clearly had regressive autism. No evidence of regression in Child 1 has come to light, except for a GP letter apparently repeating what the mother said when seeking referral to Wakefield's project. Exhibit 38 at p. 78-79 (emphasis added)(citing testimony of Prof. Sir Michael Rutter, a child psychiatrist, and a Prosecution expert at GMC proceeding). 70. Defendants’ statement that “only one child – Child 2 – clearly had regressive autism” is mischaracterization of a statement made by this expert witness for the GMC. A review of the GMC transcript cited by Deer reveals that Prof. Rutter did not so testify. Rather than testifying that only one child, Child 2, clearly had regressive autism, what, in fact, Prof. Rutter said was: “In some Lancet cases there is some evidence of regression. In Child 2’s case it is quite marked and repeated.” Exhibit 39, GMC Transcript Day 37/34. Clearly, Prof. Rutter is stating that there were multiple cases where regression had occurred among the Lancet Children, and that Child 2’s case was the clearest. 71. To further that point, Defendant Deer states that some of the children diagnosed with “regressive autism” – a phrase the Lancet Paper never used to describe the 12 Lancet Children – actually had Asperger’s syndrome which (in Deer’s non-medical opinion) is not autism . This is false and incorrect and Deer miss-cites the relevant diagnostic criteria. Deer is not a doctor. In fact, during the GMC proceedings three expert witnesses testified to the opposite. One was Professor Sir Michael Rutter, who according to Deer, is “widely regarded as the world’s most respected expert on

autistic disorders. Testifying on behalf of the GMC, Rutter testified: Asperger’s Syndrome as we have discussed, is a milder variety on the autism spectrum.” Ex. 40, At Day 36/62 E-F; see also Ex 41, at Day 36/32

72. Other medical experts at the GMC gave similar testimony. For example Dr. Victor Miller, a pediatric gastroenterologist and expert witness for Prof. Walker-Smith testified at the GMC proceeding as follows: Q: “As far as behavioural difficulties, just briefly, Doctor [Miller], there is a diagnosis of Asperger’s syndrome. You would expect a consultant paediatrican to know that that was at the mild end of autism, would you not? A: [Dr. Miller]: Yes.” Exhibit 42, GMC Transcript at Day 106/11. Another expert witness, Dr. Thomas, a pediatric neurologist, testified as follows: Q: “This is a child who arrived at the Royal Free with a diagnosis of possible Asperger’s syndrome, and…Asperger’s is recognized to be at the mildest end of the autistic spectrum, is it not? A: [Dr. Thomas]: Yes, that is correct.” Exhibit 43, GMC Transcripts at Day 108/7. 73. There is no dispute that Asperger’s is a developmental disorder included in the autism (adjective: “autistic”) spectrum. Mr. Deer asserts that “autism” and “Asperger’s syndrome” are separate diagnoses in the DSM-IV. However, Mr. Deer is incorrect. A review of DSM-IV indicates that it does not contain a category “Autism.” See Exhibit 44, Excerpt from the DSM-IV.“Autism” is a label that is commonly used generically by specialists and non-specialists alike [See for example Exhibit 45, The DSM-IV Source Book, Volume 3]. A summary of data accumulated during DSM-IV field trials has been provided by the American Psychiatric Association, that

concludes, in its DSM-IV Source Book, Vol. 3, that the validity of Asperger’s Disorder “…has not been well established” (APA 1997, pg. 7). This conclusion is also reflected in Exhibit 46, ICD 10, WHO, 1994, p. 286. Which describe Asperger’s syndrome as “…a disorder of uncertain nosological validity. Also see Exhibit 47, Szatmari, 1997, p. 44. Moreover, it is recognized in the medical community that there is considerable overlap between these conditions on the autism spectrum. 74. Had the authors used in the Lancet Paper the specific term “Autistic Disorder” - a specific diagnostic category in DSM-IV - this might have conveyed the more specific meaning. However we did not use that term; we used the term “autism” in the generic sense. 75. Evidence for the generic use of this term in the Lancet Paper is provided as an example. The first reference to the word “autism’ comes in the section labeled “Summary: Findings” (Ex Lancet Article pg. 1 para 3, lines 9 to 11). Here the authors provide reference to 9 children having “autism”, one having “disintegrative psychosis”, and two having possible “post-viral or vaccinal encephalitis”. . 1Id. 76. The second reference comes in Table Two where the authors refer to the children’s behavioral diagnosis. Here there are, in fact, 10 references that include the words “autism” or “autistic”. Eight of these refer to “Autism”, one refers to “Autism/ Disintegrative disorder” and one refers to “Autistic spectrum disorder”. Id.id 77. These initial references to autism/autistic indicate that the authors’ intention that the term ‘autism’ in and of itself refers only to a generic pervasive developmental disorder (PDD) presentation for the following reasons.

78. In the Lancet Summary: the authors refer to 9 cases of ‘autism’. Following this, in Table 2 there are 10 references to ‘autism’. This begs the question of where the extra ‘autism’ classification comes from. Scrutiny of Table Two makes it clear that the one child (Child 4) has an “?autism / ? disintegrative disorder” classification; this child is classified in the Summary – as having disintegrative disorder. This must be the case as there are no other children with disintegrative disorder in Table 2. This clearly means that the child in Table 2 who is classified as having “autistic spectrum disorder” (also a generic term) is included in the 9 children who, according to Summary: had “autism”. This demonstrates that the authors are using the term ‘autism’ to refer generically to autism spectrum disorders/PDDs. 79. Overall there is substantial evidence to support the assertion that the authors of the Lancet Paper used the term ‘autism’ to describe a general PDD presentation and not to indicate the presence or otherwise of a diagnostically valid and coded diagnostic entity such as “Autistic Disorder”. No reference was made to the precise diagnostic categories in DSM-IV. Had the authors intended to convey diagnostic precision there would have been reference at some point to either Childhood Autism, Autistic Disorder, Asperger’s Syndrome, Asperger’s Disorder, Atypical Autism and/or PDDNOS. The fact that we do not do this in any part of the paper is an additional indication that diagnostic precision was not intended. 80. Further, in a child with high functioning autism a diagnostic label of Asperger’s may be applied inappropriately when, in fact, scrutiny of the child’s developmental history reveals problems in speech and language development (see the discussion of Child 7

and Child 12 below) – something that should specifically preclude an Asperger’s syndrome diagnosis.

Behavioral/developmental diagnoses in the Lancet Children 1. The role of Dr. Berelowitz 81. In connection with the examination of the Lancet Children and the Lancet Paper, Dr. Mark Berelowitz, the attending child and adolescent psychiatrist at the Royal Free Hospital, was brought in as a collaborating clinician and an expert in childhood developmental disorders and to advise on the developmental diagnoses in the Lancet Children. How Dr. Berelowitz applied the DSM-IV criteria to the Lancet Children that he saw is a matter for Dr. Berelowitz. 82. Dr. Berelowitz was entirely responsible for developmental diagnoses in the Lancet Children that he saw personally and was responsible for checking the paper in draft form to approve or modify its contents, including the diagnoses listed in Table 2 and the terminology used therein. I believed that he had done so because: (a) that was his obligation as a senior author and sole expert among the co-authors qualified in the relevant field and (b) he edited elements of the paper in various drafts, leading me to believe and entitling his co-authors to believe that he had executed his obligations diligently. Dr. Berelowitz’s proposed revisions to a draft Lancet Paper, none of which concerned the nosology or diagnoses in the individual Lancet Children, are referred to in the GMC proceedings. For example see the following: SMITH : Dealing first of all with Dr Berelowitz’s proposed amendments, you will recall that in August“ Dr Berelowitz wrote to Prof. WalkerSmith, copying the letter to Dr Wakefield and Prof. Murch, amongst 35

others, suggesting that there should be various changes to the draft paper. There were three matters which concerned him.” Exhibit 48, GMC Transcripts Day 128/12 83. Dr. Berelowitz confirmed in his GMC testimony that he had received and made comments upon the draft Lancet Paper. Q You say you commented on the draft, so you were provided with a draft copy, were you? A [Berlowitz] Yes. Q I will take you to your comments in a moment. Before I do so I just want to ask you some general questions. When you saw that draft, you could tell that there were 12 children involved, obviously? A Yes. Exhibit 49, GMC Transcripts Day 12/42

84. Finally, Dr. Berlowitz signed up to the final paper. As far as I am aware, he has never demurred from the diagnoses contained therein. Exhibit 50. 2. The generic use of autism and autism spectrum disorder as a diagnosis: additional comments 85. Autism is a spectrum disorder with high-functioning or “mild” autism (Asperger’s) at one end and severe autism with profound behavioral abnormalities and cognitive impairment at the other. Beyond the three experts cited above, this is reiterated multiple times in the GMC Transcripts. For example: SMITH [examining Child 12’s GP] …and Child 12 had by that stage had a formal diagnosis of autism. Q Yes. That is the Asperger’s, is it? A Yes. That is considered to be part of the autistic spectrum disorder. Exhibit 51, GMC Transcripts Day 7/24-25 GMC counsel [examining Dr Berelowitz] Q … it would be helpful if you could identify what you thought the probable diagnosis was. A. I was unsure about the diagnosis. I noted: language delay, 36

possible attention deficit disorder and the features of Asperger’s Syndrome – an autism spectrum disorder. Exhibit 52, GMC Transcripts Day 12/32 GMC counsel [opening remarks on Child 2] He was seen in September 1992 by a Prof. of Child Health at Southampton Hospital, who thought that the best label that might be attached to him was one of Asperger’s syndrome, which you will probably have heard of as a relatively mild form of autism.” Exhibit 53, GMC Transcripts Day 3/43 86. Child 2 provides an excellent example of how a normally developing child can regress to an Asperger’s syndrome presentation, confirmed by two experts. As his regression worsens or progresses, his place on the autism spectrum moves to “severe” autism. GMC counsel [opening remarks on Child 2] He was seen in September 1992 by a Prof. of Child Health at Southampton Hospital, who thought that the best label that might be attached to him was one of Asperger’s syndrome, which you will probably have heard of as a relatively mild form of autism.” 13 Id. “Then if we go over the page to page 17 there is a reference to Prof. Warner, who did not find any allergies, and suggested a diagnosis of Asperger's, and there is a reference to Dr Rolles. A few lines down, reference to “EEG”, and then is that “slow waves right temporal lobe”? A I believe so. Exhibit 54,GMC Transcripts Day 111/46 “Prof. Warner, Prof. of Child Health, wrote on 29 September 1992 that the best label for Child 2 was then, in 1992, Asperger’s syndrome.” Exhibit 55,GMC Transcripts Day 146/47

Emphasis added

87. Child 2’s history illustrates the fact that Asperger’s may be regressive and that it is continuous with more severe forms of autism rather than being a distinct disease entity, as acknowledged repeatedly in the GMC hearing. 88. In his Amended Anti-SLAPP motion, Deer belabors his opinion that “Asperger’s syndrome is neither a regressive developmental disorder, nor is it by definition, under the nosology claimed by the paper to be relied upon by Wakefield a “behavioral” or “developmental” diagnosis of autism. See Deer’s Amended Anti-SLAPP motion. Para 160 89. The Lancet Paper states: “Neurological and Psychiatric assessments were done by consultant staff (PH [Dr. Peter Harvey] and MB [Dr. Mark Berelowitz]) with HSMIV (sic) criteria.” Ex. 1. The paper does not claim to rely upon any “nosology.” Further, the paper does not claim that I relied on any “nosology” or on DSM-IV. My colleagues and I “relied upon” Dr. Berelowitz whose “assessments used DSM-IV criteria.” How he applied those criteria is a matter for Dr. Berelowitz.

Evidence relied upon by Deer in alleging alteration or misreporting of behavioral/ developmental diagnoses by me 90. To support his claim that I “altered” or “misreported” Child 6’s medical diagnoses Deer relies upon a 1999 text book, Pediatric Neurology, and in particular Chapter 36, Autism Spectrum Disorder, authored by Dr. Pauline Filipek, which discusses the features of Asperger’s syndrome (“Filipek Chapter”) Exhibit 56. As an initial matter, Dr. Filipek’s Chapter was published the year after the Lancet Article, and

therefore my co-authors and I could not have possibly relied upon the information contained in it. 91. But even if the Lancet authors could have reviewed Dr. Filipek’s analysis of Asperger’s syndrome, Dr. Filipek’s Chapter makes clear that, as of 1994 Asperger’s syndrome was considered a form of autism — it is one of six possible Autism Spectrum Disorder diagnoses set forth in the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (“DSM-IV”). Filipek Chapter at 607, Table 36-1. Dr. Filipek’s 1999 Article, The Screening and Diagnosis of Autism Spectrum Disorders (“Filipek Article”) (See Exhibit 57), confirms that as of 1994, Asperger’s syndrome was considered a form of “autism.” Compare Deer Article at 3 (“Asperger’s syndrome … is distinct from autism under DSM-IV”), with Filipek Article at 442, Table I (listing six possible diagnoses under the umbrella of “Autism Spectrum Disorders” as set forth in DSM-IV, including, among others, Asperger’s disorder). 92. Dr. Filipek’s Chapter goes on to explain that “[t]he diagnostic term [Asperger’s syndrome] was included for the first time in DSM-IV (American Psychiatric Association, 1994), and the criteria for the qualitative impairments in social interaction, and restrictive and repetitive patterns of behaviors and activities are identical to those for Autistic Disorder.” Filipek Chapter at 610; see also Filipek Article at 447 (same). She further explains that “[t]he validity of Asperger disorder as a definitive diagnostic entity separate from high-functioning (verbal) children with autism remains controversial,” Filipek Chapter at 611, and she opines that diagnosing those with Asperger’s syndrome instead with “a learning disability is not an 39

appropriate substitution for a diagnosis of autism, as all too often it does not account for the social deficits and restrictive, repetitive interests,â&#x20AC;? Filipek Article at 447. 93. It is notable that DSM-IV describes the differences between Asperger's and Autistic Disorder in one of the triad of autistic features, namely, language acquisition. In Asperger's syndrome, there should be no delay in acquisition of language. And the confusion that arises as a consequence of this is seen in the cases of at least two of the three children [Child 7 and Child 12] that Deer cites as not having a diagnosis of autism, who have received a diagnosis of Aspergerâ&#x20AC;&#x2122;s syndrome or possible Aspergerâ&#x20AC;&#x2122;s syndrome. 94. In summary, the expert opinion currently is that the validity of Asperger's disorder as a definitive diagnostic entity separate from higher-functioning [verbal] children with autism remains controversial. That was the state of the understanding of these conditions when the Lancet Paper was written and it remains a source of confusion to this day. In addition, there is nothing in Deer's citations that precludes regression in Asperger's syndrome. As for Asperger's being non-regressive, the 2006 chapter that he cites in the BMJ article does not mention regression or non-regression in relation to Asperger's. The DSM-IV states that there are no delays in early language acquisition in the Asperger's child. However, evidence of absence of early language delay does not preclude later regression. 95. Furthermore, when we come to examine the evidence for an autism diagnosis in Child 6, for example, it is evident that throughout his medical records different descriptions are used to represent, interchangeably, the same developmental diagnosis. 40

96. For example, there is a letter from the GP, Dr. Nalletamby, to me on September 8, 1996 which states: "Following our discussions over the phone the other day, 6 is a boy with autism syndrome 14..." Exhibit 58, GMC Transcripts 4/9 (referencing General Practice records page 125) 97. Further, there is a letter from Walker-Smith to me on October 4, 1996 which states: "This is a child who has been diagnosed with Asperger's syndrome." Id. (referencing Royal Free Hospital records (Additional) page 1). 98. Further, in a letter from Walker-Smith to Dr. Nalletamby on October 4, 1996 states: "...he certainly fits into the spectrum of a child diagnosed as autistic 15..." Id. (referencing General Practice records page 123). 99. Further, his Royal Free Hospital admission clerking note of October 25, 1996 states: "Autistic child 16 with recurrent gastrointestinal problems..." Exhibit 59, GMC Transcripts Day 99/2 (referencing Royal Free Hospital records (Additional) page 37). 100. In addition, there is a June 3, 1997 letter from Dr. Berelowitz to me, in which he expresses caution about the precise diagnosis: "Because of his mother's uncertainty about the timing of his developmental history, it is a little hard for me to be as confident as I would like to be about the diagnosis. However, it would seem that the most likely diagnosis is Asperger's syndrome. 17" Exhibit 60, GMC Transcripts Day 92/46 (referencing GMC Fitness to Practice (FTP) Bundle 2/605e).

Emphasis added Emphasis added 16 Emphasis added 17 Emphasis added 15

101. Finally, a March 11, 1997 letter from Dr. Nalletamby to Dr. Bennett, a pediatrician, requesting an opinion on his brother Child 7 states : “[Child 6], as you know, is autistic. 18” Exhibit 61, Transcripts Day 6/19 (referencing General Practice records pages 274-275) 102. Therefore, in circumstances where the terms: “Asperger’s”, “autism syndrome”, “autistic,” “likely Asperger’s,” and “autistic spectrum disorder” are used, the label of the generic term “autism” is appropriate in the description of a spectrum disorder, consistent with the statement of Prof. Rutter.

Significance of timing of behavior changes in relation to possible triggers 103. In our investigation in connection with the Lancet Paper we were interested in the onset of first behavioral symptom(s) following any parentally cited trigger. This was reported in Table 2 of the Lancet Paper. 104. In the paper we did not define this initial behavior(s) as “autistic behavior(s),” nor did we confine the initial behavioral change(s) to autistic behaviors. The reason for this is a simple one: as trained physicians I and many of my co-authors knew that behavioral changes such as aggression, inattention, change in sleep pattern, and self-injury, are often an early sign of brain damage in children; a behavior(s) associated with a possible environmental trigger that is capable of causing brain inflammation (encephalitis) or brain dysfunction (encephalopathy) may not necessarily be characteristically ‘autistic’ per se. Examples of some autistic behaviors are provided below. 18

In other words, non-specific behavioral

Emphasis added ASD varies widely in severity and symptoms and may go unrecognized, especially in mildly affected children or when it is masked by more debilitating handicaps. Very early behavioral indicators that require evaluation by an expert include:

changes may be an indication of brain injury that might lead to an autistic spectrum disorder. 105. This sequence of events – behavioral changes followed by developmental regression – is reported following measles encephalitis and other encephalitidies. As early as 1948, Greenbaum and Lurie reported that: “Encephalitis following acute viral or bacterial infections or cerebral trauma early in childhood may lead, in addition to structural cerebral changes, to behavioral and personality disturbances of such gravity as to prevent normal adjustment to life; this despite the fact that the intellect may be unimpaired.” See Exhibit 62, Greenbaum JV and Lurie LA, Encephalitis as a causative factor in behavioral disorders of children. J. Am. Med. Assn. 1948;136:923-930 106. Such prodromal behavioral changes are well documented in a rare measles encephalitis, subacute sclerosing panencephalitis (SSPE), where the classical presentation and progress of the condition has been well defined and subdivided into

• • • • •

poor social skills poor eye contact excessive lining up of toys or objects no smiling or social responsiveness. Hand-flapping and other repetitive behaviors

Later behavioral indicators include: • • • • • • •

impaired ability to make friends with peers impaired ability to initiate or sustain a conversation with others absence or impairment of imaginative and social play stereotyped, repetitive, or unusual use of language restricted patterns of interest that are abnormal in intensity or focus preoccupation with certain objects or subjects inflexible adherence to specific routines or rituals.

Adapted from http://www.ninds.nih.gov/disorders/autism/detail_autism.htm#198193082 (National Institute of Neurological Disease and Stroke)

four clinical stages. “In Stage I [the earliest phase of the disease] there is subtle intellectual and behavioural change....” See Exhibit 63, Chadwick DW et al. Measles virus and subacute neurological disease: an unusual presentation of measles inclusion body encephalitis. J. Neurol, Neurosurgery, Psychiat. 1982;45:680-684

The sequence of behavioral change and developmental regression in autism: 107. Werner and Dawson have published a study that not only validates the parents’ description of regression, but also makes the point that behavioral changes – changes that are not part of the core symptoms of autism – may pre-date onset of developmental regression. They noted that: “Parent interview data suggested that some children with regression displayed difficulties in regulatory behavior before the regression occurred.” Exhibit 64, Werner E and Dawson G. Validation of the Phenomenon of Autistic Regression Using Home Videotapes. Arch Gen Psychiatry. 2005;62:889-895

108. While this study post-dates the Lancet, it validates our position on the relationship between early behavioral symptoms and later developmental regression. The authors report that: “Regulatory behaviors included sleeping problems and oversensitivity to sensory stimulation, symptoms that are not part of DSM-IV criteria for autism but that might reflect subtle differences in neurological development [in those destined to regress into autism].” id.

109. I, and some of my co-authors, were aware at the time of the Lancet Paper that such behaviors might be significant. It was our intention in the Lancet Paper to describe the first behavioral symptoms recognized by the parents following the environmental trigger that they, themselves, had associated with their child’s deterioration. The authors were careful not to overstate the significance of this association. 110. It would be potentially inaccurate and therefore unjustified to interpret the words in the Lancet Paper “first behavioral symptom(s)” as either the “first symptom of autism” or “the first “behavioral symptom of regressive autism,” (or the time of the child’s autism diagnosis, See Exhibit 65, as the Defendants have done. (see Ex 65, Deposition of Dr. Jane Smith at p.p 71; 23-72; 6 para)

111. The following begins a child-by-child analysis which demonstrates that the statements made in the Lancet Paper were accurate and statements made by Defendants regarding the basis for their defamatory statements are false. [Child 1] 112. With regard to Child 1, Deer states in How the Case Against the MMR Vaccine was Fixed, that: “[n]o evidence of regression in Child 1 has come to light, except for a GP letter apparently repeating what the mother said when seeking referral to Wakefield's project.” Id. at p. 78-79. 113. First with regard to Deer’s statement regarding the allegedly unique reference to regression in the GP’s referral letter to Prof. Walker-Smith on May 17, 1996, Child 1’s GP clearly stated: “Child 1 initially developed normally, reaching all normal milestones until he was about 15 months old. He then regressed and has now been

diagnosed as autistic.” 20 Exhibit 66, GMC Transcripts Day 3/58 (referencing Royal Free Hospital Records pages 56-57). This letter alone supports the Lancet Paper’s findings and refutes Defendants’ assertions to the contrary. Notwithstanding and contrary to Deer’s statements, more evidence supports the same notion. 114. A letter from the Speech and Language Therapy Department of Yeoman's House to Mrs. Cassell of February 2, 1995 states “[Child 1’s] parents report that [Child 1] has lost the words he had developed 21 and now only rarely names things.” Exhibit 67, Royal Free Hospital records 61-62. 115. It is important to note here that both parents appeared to have reported that the child lost words, the words he had previously developed, and now only rarely names things, whereas Deer in his allegations cited a single, unique source, and that was from the mother. 116. Further, there is a Prof. Walker-Smith clinic note of June 20, 1996 where the mother has reported firsthand to Prof. Walker-Smith her concerns. It states: “At 18 months noticed slowed and then lost developmental landmarks.” Exhibit 68, GMC Transcripts Day 77/45 (referencing Royal Free Hospital records page 13). 117. There is an interview between the mother and Dr. David Casson, the pediatric gastroenterologist in the hospital - a clerking note of July 21, 1996 stating: “Till one year [forward arrow] appeared very bright - had 5 words e.g. brother [forward arrow] walked at 15 months. Noted that he had lost 'words' 22 and not progressing normally.” Exhibit 69, GMC Transcripts Day 77/53 (referencing Royal Free Hospital records pages 9-10). 20

Emphasis added Emphasis added 22 Emphasis added 21

118. There is a fifth source for evidence of regression, and that is from Dr. Peter Harvey, the consultant neurologist who saw this child and his mother on October 23, 1996 and states: “History as noted… after normal milestones a deterioration 23 from 18 months or so.” Exhibit 70, GMC Transcripts Day 36/6 (referencing Royal Free Hospital records page 19). 119. There is a sixth record of his regression, and this is the discharge summary from Dr. Casson to the GP on August 9, 1996: “1's developmental problems were first noted when he was 18 months. Mum noted that until one year of age, 1 appeared to be very bright and had apparently had five full words. Subsequently he had apparently lost his vocabulary. According to his mum, he has not progressed normally since then, especially with speech and comprehension.” And below in the same document: “It is not entirely clear whether his neurological condition in fact represents a neurological deterioration in view of lost milestones, 24 or whether it is a classic autistic picture.” Exhibit 71, GMC Transcripts Day 77/64-65 (referencing Royal Free Hospital records 49-51). 120. There is further evidence of regression in this child that is found in response to a vaccine damage payments unit questionnaire by Dr. Simon Murch on February 23, 2001. The question that is asked, "Please give details of the nature and severity of any antenatal, perinatal or developmental problems, including dates of onset.” Dr. Murch's answer was "Normal initial development with no known perinatal factors. Development slowed in second year of life with frank regression 25 around eighteen months." Exhibit 72, GMC Transcripts Day 118/51-52 (referencing Royal Free Hospital record 32).

Emphasis added Emphasis added. 25 Emphasis added 24

121. Deer’s statement is false. As cited above, that which Deer himself was privy to, contains multiple instances of evidence supporting the findings that Child 1 regressed in his development and was diagnosed as autistic. 122. Deer claims that Child 1’s first behavioral symptom did not occur within days of receiving the MMR vaccine. Instead, Deer claims that Child 1's developmental problems in fact may have occurred before the MMR vaccination: “Child 1's recorded story began when he was aged nine months, with a new patient note by general practitioner Andrea Barrow. One of the mother's concerns was that he could not hear properly - which might sound like the hallmark presentation of classical autism, the emergence of which is often insidious.” Ex. 73, BMJ First Art. at p. 80. 123. In Deer's Footnote 47 to his Web Extra tables, he also states, “The boy's medical records reveal a subtly different story, one familiar to mothers and fathers of autistic children. At the age of nine-and-a-half months, 10 weeks before his jab, his mother had become worried that he did not hear properly: the classic first symptom presented by sufferers of autism.” Exhibit 73, BMJ First Art. Online at FN 47. 124. What we see here are two examples of Deer seeking to link the child's apparent hearing problems with the insidious onset of autism occurring prior to MMR vaccination; however, also included in Deer's footnote is the following: "The child first presented to the GP at age nine months, with his mother concerned that he couldn't hear properly and with a discharge from one ear. Repeated hearing tests found no abnormality." id. 125. Deer however, fails to present in his article the full medical history associated apparently with a minor ear infection. According to the GP’s records as cited in the GMC Transcript, at 10 months (in medical nomenclature 10/12), the mother was reassured by

Child 1’s GP that the ear problem was minor: “New patient - recently posted from [redacted]. Mum worried re hearing/wax in ears/discharge left ear. Reassured.” Exhibit 74, GMC Transcripts Day 5/51 (referencing General Practice records page 6). 126. In other words, what Deer has omitted from the body of the BMJ article is that mother's concerns about her child’s ear ache were associated with discharge from his left ear, clearly suggesting an ear infection – which is not whatsoever related to autism. In summary, Deer’s basis that Child 1 showed signs of autism prior to his MMR is false and misleading. As the records clearly state, the child had what appears to be an ear infection, as is not uncommon in children. Additionally and as previously stated, the GP’s records were not available to the Lancet Paper authors. However, these records themselves further support the finding in the Lancet Paper and contradict Defendants’ assertions. 127. As explained above, the Lancet Paper was concerned with first onset of “behavioral symptoms” and not as Deer reports, the first signs of “developmental regression” which frequently occur subsequent to the first behavioral symptoms (see above). The Lancet Paper accurately states that Child 1’s first behavioral symptom occurred within “1 week” of his MMR when he was reported as having “delirium.” Ex.1, The Lancet Paper at p. 639. Deer went on to state that the “steps” took to falsify this data included: Step 1, to achieve this: two-and-a-half years after [Child 1] was vaccinated, Walker-Smith took an outpatient history. Although the mother apparently had no worries following her son’s vaccination, the Prof. elicited that the boy was ‘pale’ 7-10 days after the shot. He also elicited that the child possibly had a fever, and ‘may’ have been delirious, as well as pale… 49

Step 2: for the Lancet, Wakefield dropped the question marks, turning Walker-Smith's queries into assertions… Step 3, the former surgeon [Wakefield] reported ‘delirium’ as the first ‘behavioral symptom’ of regressive autism, with, Step 4, a time to onset of seven days. Ex. 73, BMJ Art. at. p. 80. 128. Deer asserts: "Child 1 is recorded (as a parentally-recalled fact) only to have been pale seven to 10 days after MMR." 129. However, in the medical records, a clinical note from Prof. John Walker-Smith on June 20, 1993, states: “After MMR - seven to 10 days later pale, ?fever ?delirious (out of it) for three days.” Exhibit 75, GMC Transcripts Day 77/45 (referencing Royal Free Hospital records pages 13 & 54). Crucially, as noted in the record, “(out of it)” is a “parentally-recalled fact” and a direct quote from the mother, and not the words of Prof. Walker-Smith. The child’s clinical status – “out of it for three days” – is the mother’s idiomatic description of her child’s reaction that was appropriately and reasonably interpreted by Prof. Walker-Smith as “delirium” in the Lancet Paper. 26 Deer omits this crucial “parentally recalled fact” in seeking to make his case for fraud. 130. In terms of the interval of “seven to 10 days after MMR” to this first behavioral symptom, Prof. Walker-Smith also noted in a later presentation note to the Wellcome Trust in December 1996, that Child 1 had an “[i]mmediate reaction to MMR with fever at one week. Rapid deterioration in behavior > autism.” Attached as Ex. 26 is a true 26

“Delerium” is appropriately interpreted as a behavior and reported in the medical literature as an adverse reaction to infection, vaccination and febrile episodes generally. Exhibit 77, Okumura A et al . Delirious behavior in children with influenza: its clinical features and EEG findings. Brain and Development 2005;27:271-274 Exhibit 78, Okumura A et al. Unconsciousness and delirious behavior in children with febrile seizures. Pediatric Neurology. 2004;30:316-319 Exhibit 79, Takanashi J. Two newly proposed infectious encephalitis/encephalopathy syndromes. Brain and Development. 2009;31;521-528

and correct copy of Prof. Walker-Smith’s note. When asked at the GMC about the significance of these notes, he described them as the “core facts” for the lecture. It is clear that he considered the mother’s reporting of these events key to Child 1’s subsequent deterioration. 131. Also available to Deer was further evidence of the onset of this child's problems at one week, and this comes from an article in a newspaper, the Daily Mail, of August 12, 1997, This article was provided to my lawyers from Mr. Deer’s lawyers in a document production in the U.K. defamation proceedings. In the article, Mrs. 1, referring first to her older son Aaron who also suffers from autism, states : "A week later after MMR he came down with what I can only describe as a meningitis-like illness. I found him lying motionless in his bed, his face was white as a sheet, and he was unable to eat. He was sick over and over again and there was nothing I could do to stop him crying. Nathan [Child 1] was a bouncing 10-pound baby who from an early age was bright and alert. Before he was one, he could say at least eight words, loved playing with building blocks and was always pointing out things of interest. I think he would have been an intellectual. It was only after Nathan was vaccinated and developed identical meningitis-like symptoms a week after the jab, like his brother, that I realized something wasn't right. When Nathan started following his brother on tiptoes, a sign of neurological damage, and had similar speech and communication problems, a warning light flashed in my head." See Exhibit 79, Daily Mail newspaper article, August 12, 1997

132. In summary, Child 1's initial behavioral symptom was determined by Prof. WalkerSmith and correctly described in the Lancet Paper as “delirium.” The onset of this symptom was seven to ten days post MMR vaccination. Child 2 133. Deer stated: "Child 2 was diagnosed with regressive autism, which, according to the Lancet Paper, started two weeks after his jab. However, this child's medical records, backed by numerous specialist assessments, said his problems 51

began three to five months later." See Amended Anti-SLAPP motion @ pp. 271-272, para 79.

134. The Lancet Paper did not report that Child 2 was diagnosed with “regressive autism.” The term "regressive autism" was used only once in the Lancet Paper, and this was in the Discussion section in relation to a statement made by another author of a separate paper whose description – “regressive autism” was a direct quote. Exhibit 80, Ex Gupta S. The Lancet Paper did not contain any description of the Lancet Children as having “regressive autism”. Thus, for Child 2, the Lancet Paper does not report that the condition – “regressive autism” started two weeks after his jab as Deer falsely alleges. What is described is the onset of his “first behavioral symptoms” two weeks after MMR. 135. The evidence in support of the description in the Lancet Article is found in the medical records available to the authors at the Royal Free Hospital. The first is a clinic note of Prof. Walker-Smith of August 1, 1995: "MMR injection at 15/12 [Referring to 15 months]. Went downhill ever since." Exhibit 81, GMC Transcript Day 76/47 (referencing Royal Free Hospital records page 25). 136. Further, there is a clinic note from Prof. Walker-Smith's on June 2, 1996: "MMR at 13 months (sic) 27. 2/52 [two weeks] later started head banging. 28 ?head pains, screaming through night. 29 Seemed generally sickly." Exhibit 82, GMC Transcripts Day 76/73 (referencing Royal Free Hospital records pages 15-18). 137. Further evidence comes from Dr. Casson's discharge summary to the GP on September 16, 1996: "Until 20 months of age, mum notes that he had a normal developmental

An error made by Prof. Walker-Smith and reproduced by Dr. Casson and in the Lancet Paper Table 2. Child two had MMR at 15 months 28 Emphasis added 29 Emphasis added

progress. He walked at one year and started using recognizable words at 13 months of age. He was growing well and feeding himself. Mum does recount that at 13 months (sic) of age he had had his MMR, and two weeks following this he had started with head banging behavior and screaming through the night." 30 Exhibit 83, GMC Transcripts Day 77/11 (referencing Royal Free Hospital record pages 127-129). 138. Further evidence is found in a letter from Dr. Berelowitz, consultant child psychiatrist, to Dr. Murch of September 30, 1996: "Mrs. 2 reiterated that 2 started head banging about two weeks after the MMR 31 and hasn't looked right since." Exhibit 84, GMC Transcripts Day 3/53 (referencing Royal Free Hospital record page 143). 139. There is an additional record submitted as Exhibit 26 from Prof. Walker-Smith's notes for the Wellcome Trust meeting of December 1996 where he states "MMR at 15 months - head banging two weeks later." 32 Exhibit 26 is a true and correct record of a document prepared by Prof. Walker-Smith that I relied upon in writing the Lancet Paper. Child 1’s “first behavioral symptom” did develop within days of MMR. 150.In respect of Child 2, Deer further alleged: "However, this child's medical records, backed by numerous specialist assessments, said his problems began three to five months later." 33 See amended Anti-SLAPP motion at pp. 271-271 para 79. Records were available to the authors of the Lancet Paper from earlier, independent “specialist assessments” since these were provided to us by Mrs. 2. For example, there is a letter from Prof. Warner, Professor of Child Health, Southampton General Hospital, to the GP, Dr. Cartmel, on September 29, 1992: "["Child 2] first began to have severe temper

Emphasis added Emphasis added 32 Emphasis added 33 Emphasis added 31

tantrums and overactivity from between 16 and 20 months of age. At that stage, he lost all his language which he had acquired, became very withdrawn and appeared to have totally glazed eyes." Exhibit 85, GMC Transcript Day 111/16 (referencing Royal Free Hospital records pages 188-189). 151.A second such record available to the authors of the Lancet Paper is an assessment at a specialist autism unit at Southampton General Hospital on February 26, 1993: "Between 15 and 20 months 34 he began to change. He became hyperactive, aggressive, demanded constant attention, had a glazed expression, was observed to lose some of his words (speech at one year mummy, daddy, James, ball, book, cat. Could also string two words together e.g. cat gone.) At approximately 20 months he lost all speech apart from juice." See Exhibit 86, GMC Transcripts Day 35/62 (referencing Royal Free Hospital record pages 228-242). See also Exhibit 87, Letter to Dr. Cartmel from Dr. Warner, dated September 29, 1992. 152.The previous examples of additional NHS records from specialists outside the Royal Free confirm that Child 2's first behavioral symptoms started zero to one month after MMR vaccination and not three to five months as asserted by Deer. Not only did Deer have an opportunity to review these documents in Child 2â&#x20AC;&#x2122;s Royal Free Hospital records during the earlier UK defamation proceedings, but also they were read into the record in the GMC proceedings, upon which all the Defendants claim to have relied.

Child 2: additional matters 153. Deerâ&#x20AC;&#x2122;s BMJ article continued, "According to the paper, Child 2 had his first behavioral symptom two weeks, not six months, after MMR. This was derived from a Royal Free 34

Emphasis added

medical history taken by Mark Berelowitz. He saw the boy during the boy's admission at age eight after she had discussed her son's study with Wakefield." Deer asserted, "As I later discovered, each family in the project was involved in such discussions before they saw the hospital's clinicians. Wakefield phoned them at home and must have at least suggestively questioned them, potentially impacting on later history taking." Ex. 4 154. Deer goes further in para 177 of his affidavit to Anti-SLAPP Deer states: “Wakefield also admitted during the GMC hearing that he had contacted the parents of each of the children, 35 generally by phone, prior to their attendance at the hospital.” Ex. Deer B Declaration to Anti-SLAPP, March 9, 2012, para 177 155. Deer alleges, not only that I “phoned [the parents] at home” but also that in my GMC testimony, I “admitted” to contacting “the parents of each of the children.” He also appears to impute to me that I “must have at least suggestively questioned [parents]”, which Deer states as a matter of fact, in order to approximate the first behavioral symptoms to MMR exposure (evident from the fact that this assertion is made with reference to this specific matter in respect of Child 2 above). 156. As matters of fact, I did not “[phone] “each family” “at home,” nor did I admit as much in testimony. 157. Further, there is no basis whatsoever for Deer asserting that I "must have at least suggestively questioned them potentially impacting on later history taking." I did not initiate the contact with the parents of any of the Lancet Children. I did respond to parents of the Lancet Children who phoned me or wrote to me seeking help for their child. In my discussions with them, I never coached them on what they should or should

not say regarding their child's medical history or any aspect of their child's condition. Likewise, I did not question them suggestively regarding their child's medical history.

Child 3 158.In the case of Child No. 3, Defendants question whether this child had a diagnosis of “regressive autism” but do not appear to allege evidence of fraud in this respect. However, they do allege as evidence of fraud, that Child 3 did not have “non-specific colitis.” 36 They also take issue with the fact that this child's onset of first behavioral symptoms occurred within days of MMR. Turning first to whether this child had a diagnosis of “non-specific colitis”, Exhibit 88, Dr. Dhillon’s scoring sheet for Child 3 is a true and correct copy of Dr. Dhillon's scoring sheet for Child 3. This scoring sheet shows evidence of mild chronic inflammation id., consistent with a diagnosis of “nonspecific colitis.” In fact, the image of this child's colonic biopsy was used in the Lancet Paper and was described therein as showing a dense infiltration of the intestine with inflammatory cells (colitis). Attached as Exhibit 89, Dr. Anthony’s scoring sheet for Child 3 is a true and correct copy of the scoring sheet of Dr. Andrew Anthony for Child 3, which is set out in a similar way to that of Dr. Dhillon. This document reports a score of 1 for mild chronic inflammation throughout the colon (colitis). 159. As further evidence, there is a letter from Prof. Walker-Smith to Child 3’s GP, Dr. Shantha on December 31, 1996 where Prof Walker-Smith follows up after Child 3’s discharge from the Royal Free with his recommendation for treatment with antiinflammatory medication. It states: "Further critical analysis of histology results has led to an amendment to our discharge summary which I am now enclosing. Our final 36

“How the link was fixed.” Breakout box in BMJ article

diagnosis is indeterminate [AKA non-specific] ileo-colitis and lymphoid nodular hyperplasia." See Exhibit 90, GMC Transcript Day 5/35 (referencing Royal Free Hospital record page 25). 160. Finally, there is Prof. Walker-Smith’s presentation note on Child 3 for the December 1996 Wellcome Trust meeting in which he confirms the diagnosis of “Indeterminate colitis.” This diagnosis was made by Prof. Walker-Smith in consultation with Dr. Dhillon. Ex. 26 161. Deer has indicated that he disputes the fact that Child 3’s autism was associated with regression. 37 Deer continues by asserting, "As for a connection with MMR, there was only a suspicion." In fact, there was far more than a suspicion of a link with MMR in the case of Child 3. Evidence for both his regression and his parents’ association of this regression with MMR come from his NHS records. First, in a letter from Dr. Rosenbloom, a pediatric neurologist, to Dr. Verma, a GP, on October 6. 1994, he describes "acquired autistic problems." Exhibit 91, GMC Transcript Day 36/17 (referencing Local Hospital records page 207, also at General Practice records page 110). 162. There is further evidence of regression and an MMR link in a letter from the GP, Dr. Shantha, to Prof. Walker-Smith on February 19, 1996: "["Child 3] develop[ed] behavioral problems of autistic nature, severe constipation and learning difficulties after MMR vaccination. The batch incriminated was D1433, incidentally, which was the discontinued batch following adverse reactions." Exhibit 92, GMC Transcripts Day 41/13 (referencing Royal Free Hospital records page 38). 37

Ex. 38 at p. 78-79 (emphasis added)(citing Prof. Sir Michael Rutter testimony as a Prosecution expert at GMC proceeding). Defendants’ statement that “only one child – Child 2 – clearly had regressive autism”

163. There is further evidence of regression and a link with MMR in his NHS records in a clinic note by Prof. Walker-Smith of April 3, 1996. "Fine as a baby... Well until 14/12 [14 months] - MMR. On the second day 38 after the injection he developed fever, rash. Banging his head. 39 His behavior became abnormal thereafter - "flapping his hands." Stopped playing with his brothers." Exhibit 93, GMC Transcript Day 76/3 (referencing Royal Free Hospital record pages 9-10). 164. There is further evidence of his behavioral changes being linked to MMR vaccination in a letter from Prof. Walker-Smith following his interview with the parents of Child 3, responding to Dr. Shantha of April 4, 1996: "There is a clear history of the child being completely well until the age of 14 months when he had MMR. On the second day 40 after the injection he developed a fever and a rash, and since then his mother noticed dramatic changes in his behavior." 41 Exhibit 94, GMC Transcript Day 76/4 (referencing Royal Free Hospital records page 55). 165. Prof. Walker-Smith recites this history of deterioration in relation to MMR in a letter to me of April 4. 1996: "There is a clear history of this child having been perfectly well until the age of 14 months, and then the second day after the MMR injection there was a change in behavior which has persisted thereafter." Exhibit 95, GMC Transcript Day 76/5 (referencing Royal Free Hospital records page 40). 166. There is further reference to regression and a link to MMR in the discharge summary of Dr. Casson to Dr. Shantha of October 4, 1996: "…he had his MMR injection at 13

Emphasis added Emphasis added 40 Emphasis added 41 Emphasis added 39

(sic) 42 months of age and on the second day after injection he had a fever and rash. Overall mum considers that his developmental regression has progressed since this time." Exhibit 96, GMC Transcript Day 76/28 (referencing Royal Free Hospital records day 26 and in a revised discharge summary, Royal Free Hospital records day 41-43) 167. Prior to Child 3’s first encounter at the Royal Free, there is further evidence of regression and a link to MMR vaccination in other NHS records that were read into the GMC transcript. In a letter from Dr. Rosenbloom, a pediatric neurologist, to Dr. Balachandran of January 11, 1995 i.e. long before referral to the Royal Free Hospital: "His mother, who is pregnant, is devastated at the change in 3 that occurred at around 14 months of age. She says this coincided with MMR immunization, which she therefore blames." Exhibit 97, GMC Transcripts Day 5/31 (referencing Local Hospital records page 201). See also Exhibit 98, Letter to Dr. Balachandran from Dr. Rosenbloom, dated November 1, 1995. 168. Further, in a letter from Mr. and Mrs. 3 to Dr. Rosenbloom on August 17, 1994, the parental concerns are more a conviction than a “suspicion”, as described by Deer: “When 3 had his MMR, we were told that 3 may have a slight temperature, which he did... Within 3 days of the injection, 3 had started banging his head on his cot, rocking backwards and forwards on a chair or when sitting on the floor sometimes banging his head against the wall causing him to have nosebleeds." They continue, "We both feel that the MMR needle has made 3 the way he is today." Exhibit 99, (referencing GMC Transcripts Day 36/16 and also at Local Hospital records pages 183-185). 42

Child 3 received his MMR on March 1, 1991 according to two records in his GP records (Pages 49 and 50 in the GMC records. He was born on January 1, 1990, thus his MMR was given at 14 months of age.

169. There is further evidence of regression in other records available to the authors, including Prof. Walker-Smith's presentation notes to the Wellcome Trust in December 1996. "MMR at 14 months. Second day after, fever and rash, bangs his head and behavior abnormal thereafter." Attached as Ex. 26 is a true and exact copy of Prof. Walker-Smith's presentation notes that were relied upon in writing the Lancet Paper.

Child 4. 170.For Child 4, Deer alleges that Child 4 did not have a diagnosis of “non-specific colitis” and that onset of his first behavioral problem did not occur “within days of MMR” vaccination. As far as “regressive autism” goes, Deer appears to disagree but it is my understanding that he does not allege fraud. With respect to a finding of non-specific colitis, 43 Exhibit 100, Dr. Dhillon’s scoring sheet for Child 4 is presented as a true and correct copy of Dr. Dhillon's biopsy scoring sheet for Child 4, which documents mild chronic inflammation consistent with a diagnosis of colitis. Attached as Exhibit 101, Dr. Anthony’s scoring sheet for Child 4, is a true and correct copy of Dr. Anthony's biopsy scoring sheet for Child 4, where we see corroboration of Dr. Dhillon's findings with evidence of mild colitis. Further evidence of the confirmed finding of colitis in this child is found in Prof. Walker-Smith’s presentation notes to the Wellcome Trust where he states “Indeterminate colitis,” a term that is synonymous with non-specific colitis. Ex. 26 171. As further corroboration of this diagnosis, there is a letter from Prof. Walker-Smith to Child 4’s GP, Dr. Tapsfield, dated March 20, 1997 where he states: "In light of the histological findings of a colitis, I believe a therapeutic trial of mesalazine...may be 43

“How the link was fixed.” Breakout box in BMJ article

useful." Exhibit 102, GMC Transcript Day 6/72 (referencing Royal Free Hospital record page 20.).

Child 4’s Developmental history 172. Child 4 had a complex developmental history that, as can be seen below, was described accurately in the Lancet Paper. Deer alleges as part of the claim of fraud that: Child 4 is "one of five children with “prior developmental concerns.”…child 4...had developmental delays, and also facial dysmorphisms, noted before MMR vaccination...Wakefield played down problems 44 suggesting that early issues had resolved." Deer cites the Lancet Paper: "Child 4 was kept under review for the first year of life because of wide bridging of his nose...he was discharged from follow-up as developmentally normal at age one year."

173.Deer continues, "But medical records presented by the GMC give a different picture for this child." Exhibit [First article] at [page 79, column 3, para 2]. Child 4's complex developmental history falls into three phases: Phase 1 was of documented normal development, as described in the Lancet:

"Child 4 was kept under review for the first year of life because of wide bridging of his nose. He was discharged from follow-up as developmentally normal at age one year..." Ex.1, Page 638

174.Phase 2 of Child 4’s developmental history followed his single measles vaccine at 15 months of age and was characterized by developmental slowing:

Emphasis added

"Child 4 had received monovalent measles vaccine at 15 months, after which his development slowed (confirmed by professional assessors). No association was made with the vaccine at this time." id.

175. Phase 3, followed on from an MMR vaccine at 4 years of age and was characterized by marked, rapid regression into autism. The Lancet stated:

"He received a dose of measles, mumps and rubella vaccine at age 4.5 years, the day after which his mother described a striking deterioration in his behavior that she did link with the immunization." id.

176.These 3 phases of Child 4's complex development will now be examined in detail with respect to the documentary evidence. Evidence of Phase 1 (normal development) is found in an undated letter from Dr. Shabde, a pediatrician, to Dr. Sendall, a GP in the medical practice caring for Child 4: "Child 4 is nine months old and appears to be growing and developing normally." Exhibit 103, GMC Transcripts Day 6/57 (referencing General Practice records page 271). 177.Child 4â&#x20AC;&#x2122;s normal development to 18 months of age is captured in Dr. Casson's discharge summary from the Royal Free Hospital on October 16, 1996: "It is relevant to this admission that he was followed until [18] months of age at North Tyneside Hospital and on his discharge his development was normal." Exhibit 104, GMC Transcripts Day 78/22 (referencing Royal Free Hospital record page 21). 178.There is further evidence for normal development in Phase 1 in a referral letter from Dr. Shabde, a pediatrician, to Dr. Gibson, also a pediatrician, on March 25, 1991: "His developmental milestones were normal according to mother until he was 18 months of age. He crawled at 14 months of age and was walking by 18 months. He was said to be

saying at least six words by 18 months, but she felt that his comprehension was normal. She also mentioned that at 10 months of age he was able to build a tower of three to four bricks, but he is now lost as to what to do with them." Exhibit 105, GMC Transcripts Day 6/60 (referencing General Practice records page 240). 179.Evidence for Phase 2 (Developmental slowing or “plateauing’): developmental problems started for Child 4 at around 15 months of age. A letter from Dr. Steele, a pediatrician, to GP Dr. Sendall on May 19, 1988 captures the concerns first expressed by Dr. Steele when Child 4 was 16 months old, that is, one month after his single measles vaccine. "I feel we should see him one more time regarding his development..." Exhibit 106, GMC Transcripts Day 36/24 (referencing General Practice records page 269). 180.There is further expression of concern about Child 4’s development in the GP records on July 6, 1988, when he was just over 17 months of age: "Milestones slow." Exhibit 107, General Practice records for Child 4 [GMC numbering obscured in photocopy]. 181.Further evidence of developmental problems in Phase 2 is to be found in a letter from Dr. Jackson, senior medical officer in the Community Health Department, to Mrs. Letham, a health visitor, on November 18, 1988 at approximately 22 months of age: "Thank you for referring Child 4, who presents with developmental delay. His mother is recently aware of this..." Exhibit 108, GMC Transcripts Day 6/59 (referencing General Practice records page 266). 182.Further evidence of developmental problems in Phase 2 is found in a letter from Dr. Creswell, an ENT surgeon, to Dr. Jackson on February 24, 1989 where, having initially discussed Child 4’s sister, Dr. Creswell writes: “Obviously I am more concerned about

[Child 4’s] increasingly apparent general delay.” Exhibit 109, GMC Transcripts Day 36/24 (referencing General Practice records page 263). 183.Further evidence for developmental problems from 15 months of age come from a meeting of the pediatric Special Needs Team on July 5, 1989: "Problems: Developmental delay - possible regression...Words he previously used appropriately are no longer evident." Citing General Practice records page 257. Not cited in the GMC transcript. Records not available. 184.Further evidence of developmental problems in Phase 2 is to be found in a letter from GP Dr. Tapsfield to Dr. Wraith, a geneticist, on September 30, 1994: "Concern was expressed in November 1988 before he was two that he had poor language development... Delayed language development was therefore thought possibly related to a global delay in development..." Exhibit 110, General Practice records page 166 and Royal Free Hospital records pages 29-31. Not cited in the GMC transcript. 185.From the Royal Free records, there is further evidence of developmental problems in Phase 2. From Dr. Casson's admission clerking of September 29, 1996: "At 18/12 [18 months] noticed seemed to be losing words both vocally and understanding." Exhibit 111, GMC Transcripts Day 78/6 (referencing Royal Free Hospital records pages 510). 186.Further evidence of developmental delay in Phase 2 is found in Dr. Casson's admission clerking on September 29, 1996: "Play - seemed to progress til two-and-a-half years but subsequently plateaued. But play skills were back from three to four-and-a-half years of age.” Exhibit 112, GMC Transcripts Day 118/57 (referencing Royal Free Hospital records pages 5-10).

187.Phase 3 (marked developmental and behavioral regression) started after Child 4 received his MMR vaccine on February 19, 1991 at age four years. A GP note on February 31, 1991, i.e. 12 days after MMR states: "Still angry and miserable. Temps [temperatures] have settled. Vomited times one last week. A little diarrhea." Exhibit 113, General Practice records page 20; not cited in the GMC transcript. 188.Evidence for profound developmental and behavioral regression in Phase 3 comes from a referral letter from Dr. Meikle, an ENT surgeon, to Dr. Shabde on March 15, 1991, four weeks after MMR: "Mum is unsure of what is going on with Child 4...He exhibits very odd behavior...mother is certainly worried about the possibility of autism..." Citing General Practice records page 243. Not cited in GMC transcript. 189.Further evidence of profound developmental and behavioral regression in Phase 3 comes from an admission clerking note of Dr. Casson on September 29, 1996: "Had had MMR - 4/52 [four weeks] before those loss of skills...i.e. loss of concentration - very hyperactive - destructive play - head banging/kicking out... til then had been placid [arrow to] subsequently behavioral problems, also less affectionate, no eye contact, loss of communication. Also lost eating skills, i.e., holding cup/spoon..." Exhibit 114, Royal Free Hospital records pages 5-7. See also Exhibit 115, GMC Transcript Day 25/7677 (referencing Royal Free Hospital records pages 5-10). 190.Further evidence for profound developmental and behavioral regression in Phase 3 comes from Dr. Casson's discharge summary on October 16, 1996: "He had his measles immunization initially at 15 months and a second measles immunization at approximately 2.5 (sic) 45 years of age. Mum relates a change in his behavior from a period extending four weeks after the second measles immunization. His play skills did 45

Should read 4 years.

not develop further. He became extremely hyperactive and indulged in destructive play..." Exhibit 116, GMC Transcripts Day 36/22 (referencing Royal Free Hospital record day 21). 191.So how does Deer’s representation of Child 4's history contradict what was said in the Lancet Paper, rendering it “fraud”? Deer states: "Child 4 had developmental delays... noted before MMR vaccination." Further, in his relevant footnote 61, he states "Multiple concerns of the parents and doctors over Child 4's development are documented before he received MMR. These include 'developmental delay,' 'general delay' and 'restricted vocabulary.'” This does not contradict what is stated in the Lancet Paper and is misleading. What is omitted from Deer’s narrative is the documentary evidence cited at the GMC of Child 4’s early normal development, certainly for his first year of life. Specifically, Deer’s article quotes the Lancet paper: "Child 4 was kept under review for the first year of life because of wide bridging of his nose...he was discharged from follow-up as developmentally normal at age one year."

And then follows on with the statement: “But medical records, presented by the GMC, give a different picture for this child.

192.No they do not. Deer’s claim is entirely false. There is no record that refutes or contradicts the fact that he was discharged from follow up as developmentally normal at age one year. Deer deception continues: Reports from his pre-school years were peppered with concerns over… “developmental delay”, “general delay” and restricted vocabulary.

193.What is also omitted, misleadingly, from Deer’s BMJ narrative is the fact that all his citations for these developmental concerns, provided as footnotes below, 46 come from the period after Child 4 had received his single measles vaccine when, as reported accurately in the Lancet: "Child 4 had received monovalent measles vaccine at 15 months, after which his development slowed 47 (confirmed by professional assessors). No association was made with the vaccine at this time." Ex. 1, Page 638

194.Child 4's complex developmental history was reported accurately in the Lancet. By the construct of his narrative Deer omits crucial details and misrepresents what was written in the Lancet in order to achieve the impression of fraud when in fact there was none. 195.Furthermore, Deer goes on to state: "It was mother's stated impression that Child 4 regressed. This was not adopted by doctors..." 48 This is also false; at least three doctors at the Royal Free Hospital adopted the mother's story, reiterating it in the Lancet Paper. Further, in a letter from Dr. Tapsfield, the GP, to Dr. Wraith on September 30, 1994, he writes: "Mrs. 4 feels that he achieved certain milestones in the first year or two but which were then lost subsequently..." In the same context, Dr. Tapsfield concluded:"...she [Mrs 4] is Child 4's mother and knows him better than any of us, and therefore I think it is very important to acknowledge the possibility that she may well be 46

64. Dr Jackson. Letter to health visitor. 1988. Day 6. [22 months of age]. “So it seems that over the course of 1988 there had been a concern about developmental delay.” SOURCE, General Practitioner records page 266, GMC transcripts Day 6/58-59 65. ENT surgeon. Day 36. [28 months of age.] “At the age of two years and one month he apparently has a few single words only. He does not seem able to communicate his needs to his mother... Obviously I am more concerned about his increasingly apparent general delay. Mum was asking about this and although initially denying any problem, is obviously concealing quite deep seated worries about him being ‘backward’. SOURCE: General Practitioner records 263, GMC transcripts Day 36/24 47 48

Emphasis added Citation 59

right." Exhibit 117, GMC Transcripts Day 112/13-14 (referencing General Practice record page 166. This letter was also available to the Royal Free Hospital doctors at Royal Free Hospital records page 29).

Additional matters for Child 4: “facial dysmorphisms” 196.As a further example of Deer’s false reporting: for Child 4, there is a reference by Deer to “facial dysmorphisms,” 49 which Wakefield “played down.” He states: "Child 4...had developmental delays and also facial dysmorphisms, noted before MMR vaccination ...Wakefield played down problems, suggesting that early issues had resolved." Deer presents as fact, rather than possibility, that Child 4 had facial dysmorphisms and that I “played down” these problems. There is no evidence that was available to the Lancet authors at the material time that Child 4 did, in fact, have facial dysmorphisms. Dr. Casson's discharge summary of October 16, 1996 noted: "...[Child 4] was on the Special Care Baby Unit for two days in view of concern over possible 50 dysmorphisms. At this time chromosomes were analyzed, which were reported as normal. It is relevant to this admission that he was followed until 18 months of age at North Tyneside Hospital, and on discharge his developmental (sic) was normal.” Exhibit 118, GMC Transcripts Day 78/21-22 (referencing Royal Free Hospital records day 2). 197.Further, in a letter from Dr. Shabde, the pediatrician, to the GP (undated), "[Child 4] is nine months old and appears to be growing and developing normally. As you may recall, the main worry initially was his small head, which, in fact, is growing quite nicely

"Facial dysmorphisms" refer to structural abnormalities of cranio-facial development with features that frequently are seen in the presence of genetic disorders such as Down's Syndrome. 50 Emphasis added

between the 50th and 75th percentile." Exhibit 119, GMC Transcript Day 6/57 (referencing a letter from Dr. Shabde to Dr. Sendall ). 198.The Lancet Paper reported accurately that, "Child 4 was kept under review for the first year of life because of wide bridging of the nose [a possible dysmorphism]. He was discharged from follow-up as developmentally normal at age one year." Child 4's possible dysmorphism was acknowledged and not “played down” by me, nor did “medical records, presented by the GMC, give a different picture for this child,” as alleged by Deer.

Child 5. 199.For Child 5, Deer rejects the fact that he had “nonspecific colitis” and questions the diagnosis of “regressive autism,” although the latter does not appear to lead to an allegation of fraud. In respect of his intestinal pathology, See Exhibit 120 is a true and accurate copy of Dr. Dhillon’s scoring sheet for Child 5’s (transverse colon) biopsy. Following his review of the biopsy down the microscope the biopsy is scored by Dr. Dhillon as showing as “1” for mild chronic inflammation. See Exhibit 121 is a true and correct copy of a scoring sheet from Dr. Anthony confirming similar findings in Child 5, documented by him as chronic non-specific colitis and reactive lymphoid hyperplasia. Corroboration of these findings is provided by Prof. Walker-Smith’s letter to Dr. Shillam, the GP, on March 7, 1997: "Of more interest is that when his mother subsequently gave him Mesalazine there was a further symptomatic improvement with the disappearance of his abdominal pain and apparent general improvement in his behavior and well-being. As you know, we did find some evidence of microscopic

colitis and we have had several children who have now responded remarkably well to Mesalazine." Exhibit 122, GMC Transcripts Day 11/55 (referencing Royal Free Hospital records page 350). 200.Finally, confirmation of the systematic research review by Dr. Dhillon’s and Prof. Walker-Smith is found the latter’s presentation notes for the Wellcome Trust meeting in December 1996, documenting a diagnosis in Child 5 of “Indeterminate colitis” and annotated by him “?Crohn’s disease.” Ex. 26 is a true and exact copy of Prof. WalkerSmith’s presentation notes for Child 5. Child 5’s ileal lymphoid nodular hyperplasia was identified on barium follow-through X-ray examination (Exhibit 123, Royal Free Hospital Records, p. 7-10) rather than endoscopically, suggesting that the region of the ileum showing this change could not be seen adequately via the colonoscope (i.e. retrogradely), it could be seen by X-ray contrast imaging from above (antegradely) 201.With respect to whether he had developmental regression and a diagnosis of autism, there is documentary evidence bearing on his early development and the timing of initial concerns. Deer states: "Child 5...had received MMR at 16 months. The paper reported concerns at 18 months. But the medical records noted fits and parental worries at 11 months." Ex. 4

202.This is an example of Deer’s “fallacy of access” error. The medical records noting “parental worries” at 11 months were not in the possession of the Lancet authors at the time of writing the paper. The first reference to Child 5's behavioral and developmental regression that was in the possession of doctors at the Royal Free Hospital was the clinic record of Prof. Walker-Smith on November 8, 1996: "At 8/12 [eight months] good

developmental progress. At 18/12 [18 months] stopped speaking and stopped responding." Exhibit 124, GMC Transcripts Day 78/36 (referencing Royal Free Hospital records page 40-41). 203.Further corroborative evidence of Child 5’s normal early development is available in the Royal Free Hospital admission clerking notes on November 12, 1996: "Remained well for first 18 months. Achieved early milestones normal. Was walking by seven to nine months of age. Was saying three to four words but then stopped talking, started making growling noises, lost interest in surroundings..." Exhibit 125, GMC Transcripts Day 93/32 (referencing Royal Free Hospital records pages 38-39). 204.Evidence of behavioral and developmental problems starting at 18 months is also available in a letter from Dr. Berelowitz, the child psychiatrist, to me and Dr. Murch on December 4, 1996: "His mother reported that...[5] was born a healthy baby and he initially seemed to be advanced in his milestones. However, from 18 months he began to lose language, become less sociable and less responsive. Now he has few words, his play is not purposeful and his affection is muddled with aggression." Exhibit 126, GMC Transcripts Day 12/31 (referencing Royal Free Hospital records page 354). 205.The earliest contemporaneous record of “parental worries” in Child 5 was not in the possession of doctors at the Royal Free Hospital at the material time. It is contained in a letter from Dr. Sumitra, an audiologist, to Mrs. Head, a health visitor, in August of 1990 (date not available) when Child 5 was approximately 20 months of age i.e., after his MMR vaccination, referring earlier in the letter to five’s sister: "I am more concerned of (sic) 5, whose behavior is very difficult." Exhibit 127, GMC Transcript Day 11/35. (referencing General Practice record page 158).

206.In a subsequent reference to his developmental problems that was not in the possession of the Lancet authors at the material time, a letter from Dr. Williams, a clinical psychologist, to Dr. Wilkinson, a psychiatrist, on January 16, 1992 states: "At one year he had convulsions which led to a further hospital admission, but these appear to have been due to a high fever. From then on his parents noticed a difference in his behavior. He became very miserable and appeared to lose ground in his development after he had been to the hospital." Exhibit 128, GMC Transcripts Day 11/38 (referencing General Practice records day 138-40). 207.A letter from Dr. Wallis, a pediatrician, to GP Dr. Shillam on March 31, 1995, that was also not in the possession of Royal Free doctors states: "During a hospital admission at 11 months [for febrile convulsion, 26.11.89] mother had noticed some odd behavioral changes, but at this stage he seemed advanced with mobility and with speech, in that he was producing some words and waving bye-bye. By 18 months he was described as physically very able, but had stopped talking." Exhibit 129, General Practice records 123-6; not cited in the GMC transcript. 208.Evidence of Child 5's behavioral and development regression is seen in a letter from Dr. Richer, a pediatric psychologist, to Dr. Shillam on December 15, 1995: "Mr. and Mrs. 5 brought 5 to see me on the 13th of December to follow up progress... his behavior started to deteriorate in late October/early November and he has become much more overactive, skills have dropped away, including speech, and he has started hitting himself, scratching himself intensely, and sometimes hitting others in his distress." Ex. GMC Transcripts Day 11/40-4141 (referencing General Practice records pages 4-5).

209.All references to earlier "parental worries" before 18 months of age were from records not in the possession of the authors of the Lancet Paper. Records that were in the possession of the authors were faithfully reflected in the Lancet Paper.

Additional matters re Child 5: lack of parental association with MMR 210.Deer states: "Three of the four remaining children were seen in outpatients on the same day. None of their families were reported as blaming the vaccine...The parents of Child 5, 9 and 12 were also noted at the hospital as blaming the vaccine, but their stated beliefs were omitted from the journal." As a matter of fact, the parents’ “stated beliefs” at the material time – the period of their son’s deterioration – were not that MMR was the trigger for his child’s condition. They only came to this position “after the fact.” For example, the father of Child 5 actually read about the possible link between measles vaccines and gastrointestinal problems in an article in the newspaper the Daily Mail (see below). For this reason, it was not cited in the Lancet as part of this child's history. The parents' "stated beliefs" at the time of their interview with doctors at the Royal Free was not the issue. The issue was whether or not they made a link between MMR and their child’s deterioration at the time it occurred.. 211.In his amended Anti-SLAPP motion Deer cites a draft proforma – in effect a clinical database - designed by me and maintained electronically by a research nurse Jill Thomas. He cites this (and other children’s) proformas as being inconsistent with what is written in the Lancet Paper. He does so in respect of Child 5 specifically in support of his allegation that “the parents of Child 5 were among those who blamed MMR for the onset of their child’s autism.” See Amended Anti-SLAPP motion.

212.The documents Deer cites to are merely draft proformas, maintained by a research nurse, that had not been validated, I know from my work on this matter that the documents he cited were unverified drafts. Unvalidated draft proformas were not used as the basis for material in the Lancet Paper. Instead, we used original source documents such as those read into the record as can be found in the GMC transcripts. Deer now seems to claim that the authors should have relied upon unverified internal draft proforma documents rather than the original source documents referenced in the GMC transcripts (transcripts upon which the Defendants state they specifically relied.) To have preferred the content of these draft documents (for any child) over the original medical records that were actually relied upon in writing the Lancet Paper would have been highly questionable and we did not do so. 213.Deer also claims that the children were "recruited through anti-MMR campaigners." This child's father advised me that he read about the possible link in a newspaper article and came to the Royal Free in that way. To my knowledge he had no contact at all with JABS prior to coming to the Royal Free Hospital. Child 6. 214.Deer asserts, as evidence of fraud, that Child 6 did not suffer developmental regression, that he did not have a diagnosis of autism, and that his first behavioral symptoms did not begin within days of MMR vaccination. Deer states in the BMJ that, with respect to the issue of regression: "But only one child - Child 2 - clearly had regressive autism. Three of nine so described clearly did not. None of these three even had autism diagnoses either at admission or on discharge from the Royal Free." 51 Also, in the BMJ articles sidebar that highlights the main elements of the alleged fraud under the title â&#x20AC;&#x153;How the 51

Emphasis added

link was fixed,” Deer states as highlight number one: “Three of nine children reported with regressive autism did not have autism diagnoses at all.” 52 Child 6 is one of the three children that Deer refers to in these statements. 53 215.References to the basis for autism as a diagnosis in the Children generally and the specific evidence for this in the case of Child 6 have been dealt with above (paras X-Y: 97-102). For example, in a letter from Dr. Nalletamby to Dr. Bennett, a pediatrician, on March 11, 1997, requesting an opinion on his brother Child 7 Dr Nallentamby stated : “[Child 6], as you know, is autistic. 54” Exhibit 130, GMC Transcripts Day 6/19 (referencing General Practice records pages 274-275) 216.In his relevant footnote Deer continues: "Child 6 was admitted following a specialist assessment and a diagnosis of Asperger's syndrome, which is distinct from autism under the DSM-IV classification, stated in the paper to have been used for assessments, and is not recognized as a regressive disorder." In contrast with Deer’s assertion, "autism" is a generic term and describes a behavioral and developmental disorder on a spectrum of severity. Autism is not a diagnostic category in DSM-IV either distinct from Asperger’s syndrome or at all. The appropriate use of the term “autism” to reflect a spectrum of disorders that includes higher functioning individuals with Asperger’s syndrome or possible Asperger’s syndrome, comes from a physician acknowledged by Deer to be one of the world's experts on autism See Deer’s Declaration to Anti-SLAPP at p. 89. Para 259. Prof. Sir Michael Rutter, Prosecution expert for in the GMC: "Asperger's Syndrome, as we have discussed, is a milder variety on the autism spectrum." Exhibit 131, GMC Transcript Day 36/62. 52

Emphasis added See First Article at page 78. 54 Emphasis added 53

217.Deer’s allegation of fraud in respect of Child 6’s developmental diagnosis relies in part upon his argument that Asperger’s syndrome is not regressive. While the evidence he cites in support of this assertion does not, in fact, support his position, as discussed at length above, this assertion in respect of Child 6 does require that this boy did not regress i.e. that he did not lose acquired skills, in order to preserve his contention that this child had “Asperger’s which is distinct from autism under DSM-IV and is not regressive.” Ex. 4, page 3, para 8. 218.In support of his argument, Deer argues against regression in Child 6 by misrepresenting a number of facts. First is the GMC testimony of Rutter, which Deer references in asserting that: "Only one child [2] clearly had regressive autism." 219.Rather than testifying that only one child, Child 2, clearly had regressive autism, what, in fact, Rutter said was “In some [Lancet] cases there is some evidence of regression. In Child 2’s case it is quite marked and repeated.” Exhibit 132, GMC Transcript Day 37/34. Clearly, Prof. Rutter is stating that there were multiple cases where regression had occurred among the Lancet Children, and that Child 2’s case was the clearest. 220.Contrary to Deer’s assertion, however, Child 6 did exhibit behavioral and developmental regression, the first symptoms of which did start within days of MMR vaccination (see below). 221.In what appears to be a further allegation of fraud, Deer includes Child 6 among those five children where: "Despite the paper claiming that all 12 children were 'previously normal,' five had documented preexisting developmental concerns." As evidence for this he states, "Both [brothers 6 and 7] had histories of fits 55... recorded before their MMR 55

“Fit(s)” is a term used in common parlance in the UK to describe seizures, whether febrile, or petit mal and grand mal epilepsy.

vaccinations." This is a misrepresentation and is misleading In the case of Child 6 the medical records indicate that Child 6 had fits that were febrile seizures.. Fits that are febrile seizures are not uncommon and are not an indication of a developmental concern. As a trained physician and a former practicing physician in England, I was and remain familiar with febrile seizures and the terminology used by English physicians in describing febrile seizures. It was common during the relevant time frame for physicians and others to refer to febrile seizures as “fits”. It is clear from a review of the records for this child that the term "fits", as used here, is referring to a febrile seizure and not to a “developmental concern” or a symptom of autism. 222.Child 6's development is characterized by two distinct phases, first, normal early development, and second, regression into autism. Evidence for Phase 1 is seen in a letter from Dr. Dey, a pediatrician, to GP Dr. Lloyd on September 4, 1992: "He is holding objects, laughing and smiling...He is very well...he is definitely thriving." Exhibit 132, General Practice records page 90; GMC transcript not cited—not available. 223.Phase 2 is captured in a clinic note of Prof. Walker-Smith of October 2, 1996. "At 15/12 [15 months] - had MMR - behavior had changed within a week...Began to become aggressive, feeding poorly. Poor eye contact. Slipping back in development - two years. 56 Unexplained high temperatures, violent towards big brother." Exhibit 133, GMC Transcripts Day 102/43 (referencing Royal Free Hospital records (Additional) 57 pages 38 and 47).

Read as, for a period of 2 years. Much of Child 6’s Royal Free Hospital record was originally missing and was only provided to the GMC later as “Additional Records” 57

224.It is notable that Deer, himself, refers similarly to regression as: “slipping back in development” in an email exchange with Ms. Jacqueline Annis at the BMJ on January 4, 2011: “I mean it was the hallmark presentation of classical autism, not necessarily of regressive autism, the hallmark presentation of which is a child appearing to go backwards.” Exhibit 134, Bates papers BMJ 008439

225.Despite this, he alleges fraud in the context of describing Child 6 as having regressed. This evidence of regression alone would, according to Deer’s criteria for Asperger’s, rule out a diagnosis of Asperger’s for Child 6. 226.Further evidence of behavioral and developmental regression is found in the Royal Free Hospital admission clerking note of October 25,1996: "developed behavioral changes 58 responding differently and was extremely terrified a week after MMR immunization59...Since then he became aggressive. His eye controls are poor as well." Exhibit 135, GMC Transcripts Day 79/6 (referencing Royal Free Hospital records (Additional) page 37; also at FTP Bundle 2/605g). 60. 227.Further, in a letter from Dr. Casson to Dr. Bennett on May 19, 1997: "Mum gave a history in [6] of changes in social interaction following on immediately from MMR vaccination." Exhibit 136, GMC Transcripts Day 79/17 (referencing Royal Free Hospital records (Additional) page 17). 228.Further, in a letter from Dr. Berelowitz to me and to Dr. Murch of June 3, 1997 he states:"...He had his MMR at 15 months. He had a strong reaction to his last vaccine. A

Emphasis added Emphasis added 60 Further documentary records of Child 6 (and child 7) were entered in evidence by Prof. Walker-Smith. These were included in a Fitness To Practice (FTP) bundle. 59

week later he stopped breathing and was thought to have had a near cot-death. He then became aggressive, starting crying, poor concentration." Exhibit 137, GMC Transcripts Day 79/21 (referencing GMC FTP Bundle 2/605e). 229.There is clear evidence from the medical records of behavioral and developmental regression in Child 6 that started with behavioral abnormalities one week after his MMR vaccination.

Additional matters re Child 6: initial behavioral symptom 230.In what appears to be a further allegation of fraud, with respect to Child 6’s initial behavioral symptom described in the Lancet, Deer states: "Wakefield reported in the Lancet that the child [6] and his brother suffered 'gaze avoidance' immediately after MMR, but no such record was produced to the GMC of such a phenomenon." See Deer Web Extra Tables 73, at footnote 69 231.In contrast with Deer’s assertion, gaze avoidance - a classical symptom of autism - is captured in a clinic note from John Walker-Smith on October 2, 1996: "At 15/12 [15 months] - had MMR - behavior had changed within a week...Began to become aggressive, feeding poorly. Poor eye contact….” 61 Exhibit 138. GMC Transcripts Day 102/43 (referencing Royal Free Hospital records page 38). 232.Prof. Walker-Smith's reference to "poor eye contact" is synonymous with gaze avoidance, which is a well-described symptom of autism. 62 As a doctor who has

Emphasis added. 62 Exhibit 139, Baron- Cohen S. Social and pragmatic deficits in autism: Cognitive or affective? JOURNAL OF AUTISM AND DEVELOPMENTAL DISORDERS. 1988;18:379-402

Hutt C and C Ounsted - The biological significance of gaze aversion with particular reference to the syndrome of infantile autism. Behavioral Science 1966;11:346-356

practiced in this area for many years, I am familiar with the terminology used by many doctors in describing behavioral symptoms related to autism. "Poor eye contact" and "gaze avoidance" are commonly used interchangeably in the field.

Child 7 233.Child 7 is the younger brother of Child 6. Deer alleges fraud in respect of the diagnosis of "regressive autism" and the fact that in the Lancet Paper his onset of first behavioral symptoms is reported to have occurred within days of MMR vaccination. Deer also appears to include Child 7 among five children whom he claims had developmental concerns prior to MMR. 234.Deer states, "Despite the paper claiming that all children were 'previously normal,' five had documented preexisting developmental concerns." As evidence for prior developmental concerns in Child 7, he states, "Both [Brothers 6 and 7] had histories of fits recorded before their MMR vaccinations." As noted above, based on my medical training and years of experience as a practicing physician and my subsequent experience in medical research, I am familiar with the common practice among doctors in the UK to use the term "fits" to refer to seizures and I am familiar with the fact that such fits are not

Gaze aversion in autistic and normal children JM Richer… - Acta Psychiatrica Scandinavica, 1976 ... Kunner (1943) reported that the typical autistic child “never looked into anyone's face.” Hutt & Ounsted (1970) also observed this and argued that it was due to a specific and active avoidance of eye contact. They interpreted this “gaze aversion” as a “cut off” act (Chance (1962 ... Mirenda PL, Donnellan AM. Gaze behavior: A new look at an old problem … - Journal of Autism and …, 1983 ... GAZE BEHAVIOR: AUTISTIC CHILDREN One of the most immediately noticeable characteristics of autistic children is their lack or active avoidance of eye contact or eye-to-face gaze (Rutter, 1978; Wing, 1976; Wolff

& Chess, 1964). ...

considered a developmental concern. In the case of Child 7, the medical records available to me in the other co-authors of the Lancet Paper did not evidence pre-existing developmental concerns. 235.Child 7's development can be divided into two phases. Phase 1: normal early development. Evidence for this read into the GMC transcripts includes a letter from Dr. Trounce, a neurologist, to Child 7's GP, Dr. Mills, on March 8, 1995 when Child 7 was 13 months of age. This letter came after Child 7 suffered a possible seizure: “On the positive side, he appears to be developing normally, and there are no significant abnormal findings." Exhibit 140, GMC Transcripts Day 6/14 (referencing General Practice records page 334). 236.There is a further record of his early normal development to 20 months of age. This is a note in the GP records on October 12, 1995: "Development N [Normal] - 2 words together." Exhibit 141, General Practice records page 24; GMC Transcripts not cited. 237.Phase 2 of Child 7's development, including his developmental regression, is described in the Royal Free Hospital records, including, for example, a letter from Dr. Berelowitz to Dr. Murch of June 3, 1997: "MMR at 20 months, from then on he became quiet with a decrease in spontaneous speech...and poor language." Exhibit 142, GMC Transcripts Day 37/12 (referencing FTP Bundle, File 2/605g). 238.Deer also claims that Child 7 was “not diagnosed with autism before, during or after admission to the Royal Free.” See Ex. 73, Footnote 71 239. The record includes multiple documents evidencing Child 7's autism diagnosis. For example, a letter from Child 7's GP, Dr. Bennett, dated February 27, 1997 which states :

"[Child 7] who would appear to have autism or at least be within the autistic spectrum." Exhibit 144, GMC Transcripts Day 6/18 (referencing Local Hospital records page 71). 240.Another example is a letter from Dr. Hyde-Foster, dated July 6, 1998 which states: "His obsessive traits place him within the autistic spectrum somewhere between high functioning autism and Asperger's syndrome." Exhibit 145, General Practice record page 239; GMC Transcripts not cited. 241.Another autism diagnosis is found in Dr. Baird's report written by her assistant Dr. Soutter, a locum pediatrician, of September 30, 1998 which states: "As has been previously suggested, this pattern is that of an autistic disability...his problems are best described as being due to a Pervasive Developmental Disorder in the autistic spectrum." Exhibit 146, GMC Transcripts Day 6/23 (referencing General Practice records pages 216-223). 242.There is further evidence for Child 7's autism diagnosis after discharge from the Newcomen Center at Guy's Hospital on May 7, 1999: "We concluded then that he had a combination of autistic spectrum disorder and attention deficit hyperactivity disorder (ADHD)." Exhibit 147, General Practice records page 163; GMC transcripts not cited. 243.Moreover, autism is used as a generic term in the Lancet Paper for a disorder on a spectrum of severity. This is confirmed by, among other witnesses at the GMC hearing, the GMC's own expert on behalf of the prosecution, Prof. Sir Michael Rutter. "Asperger's Syndrome, as we have discussed, is a milder variety on the autistic spectrum." Exhibit 148, GMC Transcript Day 36/62.

244.Based on the foregoing evidence, and in contrast with Deerâ&#x20AC;&#x2122;s assertions, Child 7 did have evidence of normal early development, developmental regression and a diagnosis of autism.

Interval to First Behavioral Symptom in Child 7 Following MMR. 245.The first record of a reaction to and contemporaneous concern about MMR (received in November 1995) comes from an admission record to the Royal Alexandra Hospital on March 22, 1996 which states: "...Mum... continues to be anxious re.post effects of MMR vaccination." Exhibit 149, GMC Transcripts Day 6/25 (referencing Local Hospital record page 104). 246.There is further evidence for this concern in a letter from Prof. Walker Smith to the GP, Dr. Nalletamby, on January 15, 1997. "...there does seem to be a clear relationship between symptomology and MMR. He had the MMR rather later than usual at the age of 21 months. His mother tells me that 24 hours later he had a fit like episode and slept poorly thereafter and she attributes his change in behavior 63 to this event." Exhibit 150, GMC Transcripts Day 25/48 (referencing General Practice record pages 279-280 and also at Royal Free Hospital records pages 60-61. 247.Notably, in the admission clerking of Dr. Dickson at the Royal Free Hospital of January 26, 1997: "Had MMR late - parents unwilling to give [until approximately] 20 months." Exhibit 151, GMC Transcripts Day 79/32 (referencing Royal Free Hospital records page 6).

Emphasis added

248.Mrs. 7 advised that the delay in administration of MMR to Child 7 was a deliberate decision on her part in light of his older brother's reaction to this vaccine; i.e., she made a contemporaneous association of Child 6â&#x20AC;&#x2122;s problems with the MMR vaccine. Child 7â&#x20AC;&#x2122;s first behavioral symptoms started within days of his MMR.

Additional matters in Child 7: Initial Behavioral Symptom. 249.Deer alleges fraud in respect of the claim that Child 7's initial behavioral symptom included "gaze avoidance." He states, "Wakefield reported in the Lancet that the child, and his brother, suffered 'gaze avoidance' immediately after MMR, but no such record was produced to the GMC of such a phenomenon." See Deer Web Extra Table Ex 73, at footnote 69 Evidence for gaze avoidance comes from a letter from Dr. Berelowitz to Prof. Walker-Smith of June 3, 1997 which states: "...MMR at 20 months (sic) 64...from then on he became quiet with a decrease in spontaneous speech, less social engagement, eye contact 65 and poor language." Ex. 142 250.In addition, there is a clinic note from Prof. Walker-Smith of January 15, 1997. "Had MMR at 21 months...slept poorly. Contacted GP. Sleeping problem, poor eye control. 66 Query, autistic spectrum disorder." Exhibit 152, GMC Transcripts Day 79/27 (referencing Royal Free Hospital record page 11). 251.There are two references to eye problems in this child, including a direct reference to decrease in eye contact which, based on my years of experience , is often considered synonymous with gaze avoidance and is a feature of autistic spectrum disorder. 64

Child 7 was born on February 24, 1994 and had MMR in November 1995 at between 20 and 21 months of age. Emphasis added 66 Emphasis added 65

Child 8. 252.Deer states that Child 8, a girl, did not have a diagnosis of non-specific colitis and that her symptoms did not start within days of MMR. In addition, he states that Child 8 was not developmentally normal prior to MMR as was reported in the Lancet Paper. 253.In respect of her diagnosis of non-specific colitis, attached as See Exhibit 153, and is a true and correct copy of Dr. Dhillon's scoring sheet for Child 8 This exhibit contains a clear indication that he made a finding of inflammation in the rectum. That was interpreted by the Lancet authors including Prof. Walker-Smith as a diagnosis of nonspecific colitis. 254.In addition, in the discharge summary from Dr. Casson to Child 8's GP, Dr. Jelly, on November 27, 1997: "All pieces of colonic tissue demonstrated minimal inflammatory changes." Exhibit 154, GMC Transcripts Day 24/48-49 (referencing Royal Free Hospital record pages 15-16; also at General Practice records pages 76 -77). 255.There is a letter from me to Prof. Walker-Smith of January 15, 1998 following a spontaneous contact from the mother in light of her daughter's continuing severe intestinal symptoms. "Mother has phoned me to say that [8's] gastrointestinal symptoms are particularly severe at present. I note that she has changes typical of the syndrome, although (sic) they are mild...I think she would be an ideal candidate for mesalazine." Exhibit 155, GMC Transcripts Day 80/40 (referencing Royal Free Hospital records page 14). 256.Having then reviewed Child 8's report and tissue biopsies himself, Prof. Walker-Smith wrote to Dr. Jelly on April 14, 1998: "I understand that 8 continues to have 85

gastrointestinal symptoms. I do believe that it would be appropriate to give a therapeutic trial of the 5ASA derivative of Pentasa in a dose of 500 milligrams daily." Exhibit 156, GMC Transcripts Day 80/41 (referencing Royal Free Hospital record page 13). 257.Changes consistent with a diagnosis of non-specific colitis in Child 8 were confirmed by reference to Dr. Dhillon's scoring sheet and she was treated clinically as having nonspecific colitis by Prof. Walker-Smith.

â&#x20AC;&#x153;Preexisting developmental concernsâ&#x20AC;? and Onset of Behavioral Symptoms Within Days of MMR. 258.Deer states, "Despite the paper claiming that all 12 children were previously normal, five had documented preexisting developmental concerns." Deer appears to include Child 8 in these five children. In respect of Child 8, the Lancet said: "12 children...were referred to a pediatric gastroenterology unit with a history of normal development followed by loss of acquired skills, including language...". 1 at [page 637, column 1, para 2] And below: "We saw several children who after a period of apparent normality, lost acquired skills, including communication." id. 259.Deer went on to state, "Child 8 was not developmentally normal prior to MMR 67 and she showed 'behavior symptoms' before vaccination. The GP warned Wakefield at referral that the girl's hospital and primary care doctors had concerns about her some months before vaccination. She was globally delayed." See Ex. 74 Web Extra Table FN 77

Emphasis added

260.Child 8's development can be divided into three phases, and these are described in the Lancet. Phase 1 consisted of slow development that was nonetheless within normal limits according to an expert in child development. The Lancet Paper states: "The only girl (Child No. 8) was noted to be a slow developer compared with her older sister. She was subsequently found to have coarctation of the aorta." . 1 at p. 638, column 1, para 4. 261. Based on my medical training and years of experience as a practicing physician, I can say the following. Coarctation of the aorta is a narrowing of the main outflow from the heart. It occurs in children rarely and requires surgical correction. It is more than enough reason for impaired physical and cognitive development. 262. Phase 1 is captured in the Royal Free Hospital admission clerking of January 19, 1997 which states: "Developmentally 8 always a bit slow compared with her elder sister..." Exhibit 157, GMC Transcripts Day 103/2 (referencing Royal Free Hospital records pages 7-8, 10). 263. There is further evidence for Phase 1 in the referral from the junior doctor on the pediatric gastroenterology team at the Royal Free to Dr. Berelowitz on January 21, 1997 which states: "She has always been 'slow' compared to her elder sister, but she had a coarctation of the aorta, so it was attributed to that by her pediatrician.â&#x20AC;? Exhibit 158, GMC Transcripts Day 12/32-33 (referencing Royal Free Hospital record page 20). 264. There is further evidence for Phase 1 in a letter from Dr. Berelowitz to both Prof. WalkerSmith and myself of January 28, 1997 which states: "...mother noticed that 8 was developing more slowly than her sister when she was about 11 months old..." Exhibit 159, GMC Transcripts Day 37/3 (referencing Royal Free Hospital record pages 18-19).

265.There is further evidence for Phase 1 in a letter from Dr. Tapsfield, Child 8's GP, to Dr. Houlsby, a developmental pediatrician, on May 5, 1994 which states: "Her mother is expressing considerable concern about her health and development generally and in particular relating this to her performance compared to her older sister." Exhibit 160, GMC Transcripts Day 29/1 (referencing General Practice records page 164). 266.Most importantly, further evidence of Phase 1 is captured in Dr. Houlsby's response to Dr. Tapsfield of May 24, 1994 where it states : "...Child 8's mother was expressing concern about her health and development, particularly when compared with her older sister...My impression was that she is a child who is developing within normal limits (emphasis added) but in whom I thought I may have found congenital heart disease as an incidental finding." Exhibit 161, GMC Transcripts Day 29/2 (referencing General Practice records pages 162-163). 267.Phase 1 came to an end when Child 8's congenital heart defect was operated on at the age of 14 months on September 19, 1994. Her records document subsequent good progress. This is captured in the Lancet Article where it stated: "After surgical repair of the aorta at 14 months, she progressed rapidly and learned to talk." 1. Lancet Paper at p. 638, column 1, para 4. 268.Evidence for Phase 2 is captured in the Royal Free Hospital clinical admission clerking of January 19, 1997 which states: "By 18 months she was saying two to three words and walking." Exhibit 162, GMC Transcripts Day 42/18 (referencing Royal Free Hospital record pages 7-80). 269.There is further evidence for Child 8â&#x20AC;&#x2122;s developmental progress in Phase 2 in the referral from the junior doctor to Dr. Berelowitz at the Royal Free on January 21, 1997which

states: "At 18/12 [18 months] she was saying two to three words and walking." Ex [] GMC Transcripts Day 80/3932 (referencing Royal Free Hospital record page 20). 270.There is further evidence for Child 8’s normal developmental trajectory in Phase 2 in the second of four letters from Dr. Houlsby to Dr. Hunter, a pediatric cardiologist The documents indicate that on December 23, 1994. Dr. Houlsby saw Child 8 again at age 17 months and while her developmental assessment was limited by the fact that she was unwell, apparently with an upper respiratory infection, Dr. Houlsby stated: "I felt that her abilities although delayed on the average age of attainment were not outside the range of normal." 68 Exhibit 163, GMC Transcripts Day 29/3 (referring to General Practice record page 149). This is the second occasion on which this expert developmental pediatrician opined that Child 8’s developmental trajectory was within normal limits up to this point in time. Importantly, this assessment came just one month before Child 8’s MMR immunization. 271.There is further evidence for Child 8's developmental progress in Phase 2 in a letter from Dr. Hossain, a pediatric cardiologist, to Dr. Tapsfield of January 5,1995 which states: "Dr. Hunter [a pediatric cardiologist] is pleased with [8's] progress and is planning to review her in one year's time." Citing General Practice record pages 133-134; GMC transcript not cited. Exhibit not available. 272.There is further evidence for Child 8's developmental progress during Phase 2 in a letter from Dr. Meikle, an ENT surgeon, to Child 8’s GP on January 10, 1995. "I reviewed this young lady who I found to have glue ear when she was admitted for her repair of coarctation of the aorta. She seems to be getting along fine with no obvious hearing problem and she babbles appropriately for her age. She is starting to say some words 68

Emphasis added

now." Citing General Practice record page 148; GMC Transcripts not cited. Exhibit not available. 273.Phase 3 of Child 8's development is associated with developmental regression following her MMR on January 27,1995 at 18 months of age. The Lancet Paper, reported: "Speech was lost later," Ex 1, at p. 638, column 1, para 4. . 274.Evidence for Child 8’s developmental regression in Phase 3 is found in a GP record following her MMR Which states :"MMR Jan 95: [arrow to] grand mal convulsion Feb 95 two weeks after MMR. Never the same again...frequent diarrhea." Exhibit 164, GMC Transcript Day 29/5 (referencing General Practice records page 4 and page 25). 275.There is a further letter from Dr. Houlsby, the developmental pediatrician, to Dr. Shabde, a pediatrician, dated February 17, 1995, when Dr. Houlsby reviewed Child 8 just 3 weeks after her MMR vaccination. At this point, in contrast with his opinion on Child 8 just prior to MMR when he stated that developmentally, “her abilities….were not outside the range of normal” i.e. for a 17-18 month-old child, in this document he states that he now considered her to be "globally developmentally delayed functioning at about the one year level.” 69 Exhibit 165 GMC Transcripts Day 29/6 (referencing Royal Free Hospital Record pages 23-24 and also at General Practice records pages 131-132). 276.In other words, the medical records from the developmental pediatrician indicate that, in a matter of just one month, Child 8 went from functioning at around the 17-18 month developmental level back to around the one year level. This is clear evidence of regression. These serial observations were made by the same physician, an expert in child development.

Emphasis added

277.There is further evidence for Child 8’s developmental regression in Phase 3 from the Royal Free Hospital admission clerking note of January 19, 1997 which states: "Had MMR at 18 months. Within two weeks of it she had diarrheal illness and a temp and had a febrile convulsion, she remained in hospital for five days. After that she deteriorated dramatically." 70 Exhibit 166, GMC Transcripts Day 80/27 (referencing Royal Free Hospital Record pages 7-8, 10). 278.There is further evidence for Child 8’s developmental regression in Phase 3, found in the referral letter from the junior doctor on the pediatric gastroenterology team at the Royal Free Hospital to Dr. Berelowitz of January 21, 1997 which states: "However, since then (post MMR) she has deteriorated dramatically." Exhibit 167, GMC Transcripts Day 80/31 (referencing Royal Free Hospital Record page 20). 279.Further evidence for Child 8’s developmental regression in Phase 3 is found in a letter from Dr. Berelowitz to Prof. Walker-Smith dated January 28, 1997, which states: "Mother reports that following the MMR there was a catastrophic deterioration in 8's level of functioning. She lost all language, became docile, with poor coordination and was, from her mother's point of view, a different person." Exhibit 168, GMC Transcripts Day 12/34, also Exhibit 169, GMC Transcripts Day 80/33 (referencing Royal Free Hospital record pages 18-19. 280.Further evidence for Child 8’s developmental regression in Phase 3 is found in a letter from Dr. Meikle, an ENT surgeon, to Child 8’s GP on November 28, 1995 referring to Child 8's difficulties following her MMR immunization, stating: "...Mum dates the deterioration in her speech development back to the difficulty she had after the MMR immunization, and I am sure that this is a more complex problem than just the glue ear..." 70

Emphasis added

Exhibit 170, GMC Transcripts Day 29/8 (referencing General Practice Record page 136). 281.Further evidence for Child 8’s developmental regression in Phase 3 is found in a letter from Dr. Meikle to Dr. Jelly, the GP, on January 10, 1996 which states : "...Mum feels the setback occurred at the time of the bad reaction to the MMR immunization..." Citing General Practice record page 130; GMC transcript not cited. STET. 282.Further evidence for Child 8’s developmental regression in Phase 3 is found in the minutes of the pediatric Special Needs Team meeting held on June 5, 1996 Which state: "...Mother was concerned that she had noticed a definite regression of [8's] skills since her MMR injection!.." Exhibit 171, GMC Transcripts Day 37/6 (referencing General Practice records page 122). 283.Further evidence for Child 8’s developmental regression in Phase 3 is found in a letter from Dr. Clydesdale, a clinical psychologist, to Dr. Houston, a pediatrician, dated September 10, 1996 which states: "Mother 8 had videoed 8 prior to and following the onset of her difficulty [which she thinks may be attributable to her MMR injection] and certainly from observation there did seem to be some evidence of language having developed early but which had subsequently been lost." Citing Local Hospital record pages 50-51; GMC transcript not cited. Exhibit not available. 284.Finally, there is a letter from Dr. Houlsby to Dr. Tapsfield on 13.9.96: "Her mother showed me a video of her progress over the years. In summary, at the age of 18 months she appeared to vocalize having two or three recognizable words. One year later there appears to be no vocalization, and she displays some behavioral features suggesting hyperacusis."" Exhibit 172, GMC Transcript Day 37/7. (referencing Local Hospital

records pages 47-48 and at Royal Free Hospital Record pages 33-34). Hyperacusis is a term that refers to hypersensitivity to sound leading to sound aversion. Hyperacusis is a common feature of Autism. 285.In order to create the impression of fraud, i.e. the allegation that I deliberately misrepresented Child 8's developmental problems prior to MMR, Deer cites in his first article Dr. Houlsby's letter of February 17, 1995 to Dr. Shabde, written a matter of weeks after MMR: "I was asked to see Child 8 last year when there was concern about her development generally. When I saw her in clinic at the age of 10-and-a-half months, I discovered that she had a coarctation, and referred her to pediatric cardiologists. This was repaired surgically, and she is now well from this point of view. However, concern about her development persists." See First Article (online version) FN 71 286.But crucially, Deer omits important elements of Child 8’s developmental chronology For example, Dr. Houlsby's letter on May 1, 1994 before she received MMR whch states : "Child 8 sits very stably. She does not crawl or roll. Her mother is now happy with her general health. She is vocal. She is beginning to manipulate small objects appropriately... My impression was that she is a child who is developing within normal limits 71 but in whom I thought I may have found congenital heart disease as an incidental finding." 287.Secondly, Deer omits Dr. Houlsby's letter of December 23, 1994 immediately prior to Child 8's MMR where he confirms that: "I felt that her abilities, although delayed on the average age of attainment, were not outside the range of normal." 72 288.Finally, he omits Dr. Houlsby’s letter February 17, 1995 when just 3 weeks after MMR she has lost 5-6 months of development and is “globally developmentally delayed.” 71 72

Emphasis added Emphasis added

289.Instead, in footnote 77 of his Web Extra tables Deer writes: “The GP warned Wakefield at referral that the girl’s hospital and primary care doctors had concerns about her for some months before vaccination. She was “globally delayed.” Ex. 73 Footnote 77 290.Deer places two facts back to back that are quite separate in time (one occurring before MMR vaccination, and one after) and presents them as one. This is grossly misleading. 291.It is evident from this chronology that Child 8 did have a "history of normal development followed by loss of acquired skills," as reported in the Lancet Paper. Child 8's complex developmental history was reported accurately in the Lancet Paper. The records show that Child 8’s behavioral symptoms did start within days of MMR vaccination. Additional matters in Child 8: Facial Dysmorphisms. 292.Deer presents as fact that Child 8 was among "eight whose parents were reported to have blamed the MMR. But although the paper specified that all three were previously normal both had developmental delays and also facial dysmorphisms, noted before MMR vaccination." 293.For Child 8, possible facial dysmorphisms are referred to in a letter from Dr. Tapsfield to Dr. Houlsby on May 5, 1994 which states: "She has a slightly high forehead, but I understand that this is probably a familial characteristic." Exhibit 173, GMC Transcript Day 29/2 (referencing General Practice record day 164). 294.There is also a letter from Dr. Hunter to Dr. Houlsby on November 23, 1994 which states: "[Child 8] has a somewhat bossed forehead and deep set eyes which we think probably resembles the facial appearance of the paternal side of the family. Nonetheless, it is a slightly unusually shaped head and in association with the moderate amount of delay I

think it merits some developmental follow-up." Exhibit 174, GMC Transcripts Day 29/3 (referencing General Practice record days 150-151). 295.There is one further reference to possible facial dysmorphisms in a letter from Dr. Houlsby to Dr. Shabde of February 17, 1995 which states: "Her appearance is somewhat unusual with a bossed forehead and deep set eyes, but I could find no other dysmorphic features. Ex. 165 GMC Transcripts Day 29/6 (referencing General Practice record page 131). 296.Deer presents facial dysmorphisms in Child 8 as fact without any alternative explanation that her facial features likely reflect a familial trait.. The lancet authors saw no evidence that any possible facial dysmorphisms in Child 8 related to any developmental delay or to autism.

Child 9 297.In the case of Child 9, Deer rejects the diagnosis of regressive autism, asserting that only one child clearly had regressive autism, and alleges fraud with respect to the diagnosis of nonspecific colitis in this child. Attached as Exhibit 175 is a true and exact copy of Dr. Dhillon's scoring sheet for Child 9’s colonic biopsies and Exhibit 176 is a true and correct copy of Dr. Anthony’s scoring sheets of same. These record evidence of marked chronic inflammation consistent with chronic non-specific colitis. 298.In addition, a letter from Prof. Walker-Smith to the child's community pediatrician, Dr Spratt, dated December 31, 1996, confirms Professor Walker-Smith’s clinical diagnosis, stating: "Histologically there was an increase in chronic inflammatory cells throughout the colon with a moderate increase in intraepithelial lymphocytes. Our diagnosis is of an 95

indeterminate colitis with lymphoid nodular hyperplasia. A therapeutic trial of Mesalazine [Asacol] may be worthwhile." Exhibit 177, GMC Transcripts Day 25/57 (referencing Royal Free Hospital records day 33). 299. Evidence of Child 9’s developmental regression is found in a letter from Dr. Cavanagh, pediatric neurologist, to pediatrician Dr. Spratt in February, 1995 which states: "It does seem that there was a regression in the second year of life." Exhibit 178, Local Hospital Record pages 213-215; GMC Transcripts not cited. 300.There is further evidence of Child 9’s developmental regression in a clinic note of Prof. Walker-Smith on November 8, 1996 which states: "Developed well. At age of two years was playing with other children. Stopped playing ball with father... Could not climb stairs - slipping back." Exhibit 179, GMC Transcripts Day 80/53 (referencing Royal Free Hospital record page 36). 301.As noted above, in the discussion of Child 6, Deer told the BMJ that the hallmark presentation of regressive autism is “a child appearing to go backwards”. Slipping back would certainly seem to qualify.

302.Despite this, Deer alleges that only one child – Child 2 – clearly had regressive autism. 303.Further evidence for Child 9’s developmental regression comes from the Royal Free Hospital admission clerking note on November 18, 1996 which states: "First word 6 months, 14 months put words together. Around 18 to 20 months regressed (progressively) (speech)." Exhibit 180, GMC Transcripts Day 81/1-2. (referencing Royal Free Hospital record pages 9 -11). 304.Further evidence for Child 9’s developmental regression is captured by Dr. Malik in his discharge summary of January 14, 1997 which states: "At 18 to 20 months he started to 96

regressing (sic) mentally." Ex 181 GMC Transcript Day 4/14 (referencing Royal Free Hospital record pages 31-32). 305.It is notable at this stage that the mother of Child 9 was one of the four sets of parents who did not volunteer an association with MMR immunization. Evidence for absence of parental concern in this respect is found in a clinic note from Prof. Walker-Smith of November 8, 1996: "MMR 30/10/91 16/12 [16 months] no obvious reaction." Ex. 179 (referencing Royal Free Hospital record pages 17-18). 306.Dr. Malik in his discharge summary of January 14, 1997, which is a recitation of the clinical history obtained from the mother earlier during his hospital admission and not based upon an interview between Dr. Malick and the parents, states: "At 18 to 20 months...he started...regressing mentally. His mother links that with MMR which was given at 16 months of age." In fact, there is no record of the mother ever having made this association contemporaneously, i.e. during the period of her childâ&#x20AC;&#x2122;s deterioration, in the Royal Free Hospital records. Exhibit 181, GMC Transcript Day 4/14 (referencing Royal Free Hospital record pages 31-32). 307.With respect to his autistic spectrum disorder/autism diagnosis, there is a clinic note from Prof. Walker-Smith dated November 8, 1996 which states: "Educational psychologist saw him in August '93 - autistic -..." Ex. 178 (referencing Royal Free Hospital record days 17-18). 308.There is further evidence for an autism diagnosis in Child 9 in a document from Ms. Brown, an educational psychologist, to pediatrician Dr. Spratt dated July 2, 1993, which states: "Although you have expressed some reservations about a diagnosis of autism, I do now feel that this description would be both accurate and helpful for the parents..." Citing

General Practice records pages 151-2; GMC Transcripts not cited. Exhibit not available. 309.Further evidence for his developmental diagnosis is present in a letter dated November 2, 1994 from Dr. Spratt to Dr. Cavanagh, a pediatric neurologist, which states: "...the firm diagnosis of autism reached by Chris Rolles and his colleague..." Exhibit 182, GMC Transcripts Day 107/52 (referencing General Practice records pages 123-124). 319. Finally, there is evidence of this diagnosis from Dr. Malik's discharge summary of January 14, 1997 which states : "Autistic spectrum." Exhibit 183, GMC Transcripts Day 81/13 (referencing Royal Free Hospital record pages 31-32). 320. Why, for this child, autistic spectrum disorder was provided as his diagnosis in Table 2 instead of autism, I cannot say. This was the responsibility of Dr. Berelowitz as the expert in childhood developmental disorders. Both terms, "autism" and "autistic spectrum disorder," are synonymous and interchangeable, as has been seen throughout the diagnoses in these children. Child 10. 321. For Child 10, Deer alleges that the diagnosis of non-specific colitis was fraudulent. asAttached as Exhibit 184 is a true and correctcorrect copy of a scoring sheet in the format of those designed and used by Dr. Dhillon, but apparently completed by Dr. Anthony, which confirms the presence of mild chronic inflammation in Child 10â&#x20AC;&#x2122;s colonic biopsies throughout the colon, Attached as Exhibit 185 is a true and correct copy of the scoring sheet from Dr. Anthony for Child 10, annotations on which confirm mild chronic colitis consistent with his diagnosis of non-specific colitis in the Lancet Paper.

322. In addition, there is a discharge summary from Dr. Casson, a pediatric gastroenterologist, to Dr. Hopkins on March 17, 1997 which states: "Biopsies...demonstrated normal crypt architecture but with a mild, increased distribution of chronic inflammatory cells throughout the colon. There are also decreased goblet cells and focal abnormalities of the epithelium. (Treatment Mesalazine).” Exhibit 186, GMC Transcripts Day 25/61 (referencing Royal Free Hospital records pages 23-27). 323. These documents support the diagnosis of “non-specific colitis” for Child 10. Child 11. 324. Child 11's case did not form part of the GMC hearing since he came from the United States. His clinical records from the Royal Free have not been available to the Plaintiff at any time during the course of these proceedings. In the Lancet Paper was written more than 15 years ago and I do not have perfect recall of all the facts relating to same. Consequently, without the relevant medical records, I am at a disadvantage. However, even without access to the medical files, certain information is clear based upon correspondence from Child 11’s father which Deer attached as exhibits 48 and 49 to his Amended Declaration. 325. Attached as Exhibit 187 to this Declaration (Exhibit 48 to Deer’s Amended declaration) is a letter I received from Child 11’s father, Mr. 11, dated January 7, 1997, requesting investigation for his son at the Royal Free Hospital. It states in part: "My son [Child 11] at age 15 months was immunized with the Merck MMR vaccine...His condition slowly deteriorated over time, and was diagnosed as being autistic on his birthday at age 3. The onset of his autistic like behaviors began around 18 months."

326. With respect to timing of Child 11’s regression, Deer states, "Despite the paper claiming that all 12 children were 'previously normal' five had documented preexisting developmental concerns." In the BMJ paper, Deer refers to this in the context of Child 11. Deer states in the First Article: "But Child 11's case must have proved a disappointment. Records show his behavioral symptoms started too soon. “His developmental milestones were normal until 13 months of age,” notes the discharge summary. “In the period 13 to 18 months he developed slow speech patterns and repetitive hand movements. Over this period, his parents remarked on his slow gradual deterioration.”" First Article at page 77, column 3, para 4-5 and page 78, column 1, para 1. 327. Deer goes on to say, "This put the first symptom two months earlier than reported in the Lancet, and a month before the boy received the MMR vaccination." id. Id. 328. In fact, the referral letter to the Royal Free (Ex 187) and the clear unambiguous history from the father was that Child 11 had undergone developmental regression following a period of normal development and only after receiving his MMR immunization at 15 months. I do not have a copy of the discharge summary for Child 11 but, if the discharge summary says what Deer claims it says, it is clear that there is an error in the discharge summary with respect to the reference to "13 months." This error was confirmed by Mr. 11 in correspondence to journalist Daniel Olmstead and Brian Deer which was attached to Deer's Amended Declaration as Exhibit 49 and which for the Court's convenience is attached hereto as Exhibit 188 . In that correspondence, Mr. 11 states: "One of the incorrect statements in my son's discharge report was that autistic symptoms were seen from 13-18 months, while the vaccination was at 15 months. This is clearly inaccurate as his symptoms began several months after the MMR, as reflected in my initial correspondence to the Royal 100

Free …”. [Remember that Deer quotes the Discharge Summary as stating “In the period 13 to 18 months he developed slow speech patterns and repetitive hand movements. Over this period, his parents remarked on his slow gradual deterioration.” First Article at page 77, column 3, para 4] Thus it appears that Mr. 11 is saying that the “autistic behaviors” described – slow repetitive hand movements and slow speech patterns – did not start at 13 months. Mr. 11 also states in that letter "My son's autistic behaviors 73 did NOT begin a week after the administration of the vaccine, in fact they began several months afterwards, with several medical complications occurring in between." As in his initial January 7, 1997 letter to me at the Royal Free, Mr. 11 with absolutely clear that Child 11 received the MMR at the age of 15 months. Id. 329. When the two letters from Mr. 11 are compared to the comments about Child 11 in Table 2 of the Lancet Article, it can be seen that the letters confirm several of the comments about Child 11 in that Table 2. First, it is clear that Child 11 had a diagnosis of autism as reflected in Table 2. Second, the January 7, 1997 referral letter confirms that the exposure identified by the parents or Dr. was MMR. Third, the correspondence confirms that child 11 experienced recurrent viral pneumonia, as indicated in Table 2. Fourth, that letter indicates that child 11 was suffering from "indeterminate inflammatory bowel disease." Fifth, the correspondence confirms that Child 11 received his MMR at the age of 15 months and Table 2 indicates that 15 months was the "age at onset of first symptom." If indeed the interval from exposure to first behavioral symptom was one week as reported in Table 2, the age at onset of first symptom would accurately be described as 15 months, as indicated in Table 2. Ex 1, page 639. With respect to the “interval from exposure to first behavioral

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symptom” this was described as one week in Table 2 of the Lancet Paper. The Lancet paper used the term “behavioral symptoms” not “autistic symptoms” or “autistic behavior”. Mr. 11 in his communication with Deer and his attached correspondence explicitly stated that his child's “autistic behaviors” did not start until 18 months. Neither I nor to my knowledge any of my co-authors have ever contended in the Lancet Paper or otherwise that Child 11’s “autistic behaviors” started one week after his MMR. 330. What we described was interval to the onset of the first “behavioral symptom” after the exposure to MMR (and other items the parent or doctor associated), and these may have been behaviors quite distinct from those that are characteristically associated with autism e.g., sleeplessness. If a child experienced a change in behavior after exposure (such as, for example sleeplessness) the authors reported the interval to that behavioral change. In the absence of Child 11's Royal Free Hospital records or any other contemporaneous record, it is not possible for me at this point to say exactly what the symptoms were that were reported for Child 11 and were the basis for the reference to “1 week” in Table 2 the Lancet Article. I can say, however, that some behavioral symptom was reported to have occurred in a one week time period or the statement would not have been made in Table 2. If the symptom reported was not a symptom that the parents would have recognized as a possible precursor to autism or would not have associated themselves with autism, there would be nothing inconsistent in what is stated in Table 2 and in the Mr. 11’s report that his son’s “autistic behaviors” (e.g, hand flapping) started later. 331. Deer also takes issue with the diagnosis of non-specific colitis. Since Child 11's records were not in evidence at the GMC hearings, we do not have Dr. Dhillon's scoring sheet regarding this child, and, therefore, this must remain an open question, but, as noted in Mr. 102

11’s January 7, 1997 correspondence, at least one other doctor, Dr. Richard Kunin - a doctor wholly independent from the Royal Free, diagnosed Child 11 with indeterminate inflammatory bowel disease. Child 12. 332. For Child 12, Deer alleges fraud with respect to the diagnoses of "regressive autism" and non-specific colitis. 333. With respect to the issue of non-specfic colitis in Child 12, I attach as Ex 189 a true and correct copy of a scoring sheet in the form generated by Dr. Dhillon but completed by Dr. Anthony, possibly in the company of Dr. Dhillon, and as Ex 190 a true and exact copy of Dr. Anthony's own scoring sheet. Based upon the scoring system described above both confirm the presence of mild inflammation consistent with a diagnosis of chronic nonspecific colitis. 334.The diagnosis is confirmed in a letter dated April 25, 1997 from Prof. Walker-Smith to Child 12’s GP, Dr. Stuart, which states: "We have had quite a remarkable success with the use of sulphasalazine or 5ASA [aminosalicylate] derivatives in children with autism and evidence of lymphoid nodular hyperplasia and nonspecific colitis as we found in Child 12." 74 Exhibit 188, GMC Transcripts Day 4/25 (referencing General Practice records page 110). “Regressive Autism.”

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335. In the First Article Deer states: "But only one child - Child 2 - clearly had regressive autism. Three of nine so described clearly did not. None of these three even had autism diagnoses, either at admission or on discharge from the Royal Free." Ex. 4 First Article at page 79, column 1, para 3. 336. Child 12 is included by Deer in these three children. Specifically with respect to Child 12 Deer states: "No autism diagnosis was made, and no evidence adduced that this child suffered developmental regression." Ex. 73, Footnote 91 337. Deer went on to say that: "The diagnosis at admission was 'an impairment in respect of language,' given by Gillian Baird at the specialist developmental unit at Guy's Hospital, London." Id. Ex. 73 338. Also, in his the First Article’s sidebar that highlights the main elements of the alleged fraud under the title “How the link was fixed,” Deer states as highlight number one and as a matter of “fact”: “Three of nine children reported with regressive autism did not have autism diagnoses at all.” 75 Ex. 4, page 78 339. Child 12's development can be divided into two phases. Phase 1 consists of normal early development. Evidence for a lack of any developmental concerns about Child 12 is be found in Dr. Stuart's September 23, 1996 referral letter to Prof. Walker-Smith of which states: "His early years were unremarkable..." Exhibit 189, GMC Transcripts Day 28/20 130/29 (referencing General Practice records page 124). 340. There is further evidence for normal development in Prof. Walker-Smith's clinic note of October 18, 1996 which states: "Appeared to be toilet trained aged three years." Exhibit 75

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190, GMC Transcripts Day 103/30 (referencing Royal Free Hospital records page1213). Based upon my medical education and training and years of experience that as a practicing physician and medical researcher I know that toilet training is generally considered by physicians to be a major “self-help” milestone in children. 341. There is further evidence for Child 12’s normal early development in Phase 1 in the Royal Free Hospital admission clerking note of Dr. Davey of January 6, 1997 which states: "Development normal until age 16 months...Clean and dry by three years." Exhibit 191, GMC Transcripts Day 106/21-22 (referencing Royal Free Hospital record page 19). 342. Further evidence for Child 12’s normal early development is found in the discharge summary from Dr. Casson dated January 22, 1997which states: "[12] had been followed by pediatricians locally because of poor Apgar's scores. Nevertheless, his development was recorded as normal until the age of 16 months..." Exhibit 192, GMC Transcripts Day 4/24 (referencing Royal Free Hospital record page 32-33). 343. With respect to Child 12’s toileting skills, Dr. Casson continues: "In regard to gastrointestinal symptoms he was noted to be clean and dry by the age of three years." id.; in other words, Child 12 was not urinating or defecating in his pants or pyjamas. 344. Phase 2 of Child 12's developmental trajectory is characterized by developmental regression. This is captured in a September 23, 1993 letter from Child 12’s GP Dr. Stuart, to Prof. Walker-Smith: "[which states: "12] did not present to my surgery until March of this year when Mrs. 12 came along to discuss his soiling habit." Exhibit 193, GMC Transcripts Day 103/29 (referencing General Practice Record page 124).

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345. Based upon my medical training in years of experience as a practicing physician in the UK, I know that “soiling” is a term commonly used in medicine in the UK to refer to secondary incontinence or defecating in one’s pants. s based upon that training experience I also know that oiling secondary incontinence following the attainment of fecal continence is considered by physicians to be a loss of a self-help skill and clear evidence of regression in the absence of any other explanation (see below). 346. Child 12’s regression is also captured in Prof. Walker-Smith's clinic note of October 18, 1996 which states: "Soils - not had diarrhea." Ex. 190 (referencing Royal Free Hospital record pages 12-13). 347. Further evidence of Child 12’s regression “adduced” at the GMC hearing is captured also in the Royal Free Hospital clerking note of Dr. Davey of January 6, 1997 which states: "Had MMR at 15 months. Noticed loss of language skills, stopped playing, progressively deteriorated." Ex. 191 (referencing Royal Free Hospital record day 19). 348. Below this Dr. Davey makes reference to Child 12’s secondary incontinence. "Clean and dry by three years. Then starts soiling sometime later. Now soils up to times 8 per day. Doesn't realize he needs to open his bowels and doesn't realize he is soiled." id. 349. Further evidence for Child 12's developmental regression “adduced” at the GMC is found in the discharge summary of Dr. Casson dated January 22,1997 which states: "Subsequent to [16 months] his parents noticed a loss of language skills. He was also noted to stop playing and hi s behavior has progressively deteriorated..." Ex 192, (referencing Royal Free Hospital records pages 32-33).

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350. Dr. Casson continues, "...subsequent to [three years] his soiling started and he is presently soiling up to 8 times a day. He does not realize he has opened his bowels and that he has soiled." Ex. 192 351. Contrary to Deer's assertion, evidence of Child 12’s developmental regression was clearly "adduced" at the GMC hearing. This evidence includes references to Child 12’s secondary incontinence, loss of language skills, loss of play skills and progressive deterioration. 352. Deer also alleges fraud with respect to Child 12’s autism diagnosis "at admission." Further, in the first sidebar of his BMJ article, under the title “How the link was fixed, Child 12 is among those children that Deer states as a matter of “fact”, “did not have [an] autism diagnos[is] at all.” Ex. 4 Page 342 353. Evidence for autism diagnosis in Child 12 is captured in the Royal Free admission record of Dr. Davey of January 6, 1997 which states: "Admitted for investigation of autism and bowel problems… PC [presenting complaint] Autism - 'autism spectrum.'"" Ex. 191 (referencing Royal Free Hospital record page 19). 354. Further evidence that, at the time of admission, Child 12 had an autism diagnosis is found in a letter from Dr. Ing, a child psychiatrist, to Dr. Hyde-Foster (a community pediatrician) on July 1, 1996 where he states: "...His mother has recognized that he has been different in some ways since 18 months old...[...He is recognized to have delay in language]......I would agree with the possibility that 12 has Asperger's syndrome." Exhibit 194, GMC Transcripts Day 7/16-17 (referencing General Practice records pages 127-128).

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355. It is notable that Dr. Ing raises the possibility that Child 12 has Asperger's syndrome, but this diagnosis is inconsistent with this doctor’s prior acknowledgment that 12 has a delay in language. The latter symptom is not consistent with an Asperger's syndrome diagnosis. 356. Dr. Ing recognizes this in an addendum to his letter dated September 11, 1996; writing to Dr. Wade on October 11, 1996 he states: “Such language impairment would preclude 12 as qualifying for a diagnosis of Asperger’s syndrome. Equally, he does not quite fall into the category of classical autism, but might best be diagnosed as having an autistic spectrum disorder.

Exhibit 195, letter from Dr. Ing to Dr. Wade, dated October 11, 1996.

357. There is further evidence for an autism diagnosis "at admission" found in the GP records on July 19, 1996: “diagnosis "autism."” Exhibit 196, GMC Transcripts Day 7/18 (referencing General Practice record page 11). 358. Further evidence for an autism diagnosis in Child 12 at admission is found in Prof. WalkerSmith's clinic note of October 18, 1996: "School doctor referred to educational psychologist - five-and-a-half years autistic spectrum... Dr. Richard Lynn - seen Prof. Cox at Guy's [hospital] -? Asperger's syndrome." Exhibit 197, GMC Transcripts Day 82/8, (referencing Royal Free Hospital record pages 12-13). 359. In addition, there is evidence of an autism diagnosis for Child 12 in a letter from Prof. Walker-Smith to me of October 21, 1996, "It is interesting to see this child who really has the features of autism..." Exhibit 198, GMC Transcripts Day 93/54 (referencing Royal Free Hospital record page 66). 360. There is further evidence of an autism diagnosis in a letter from Prof. Walker-Smith to Dr. Stuart on October 21, 1996: "Thank you for referring Child 12, certainly he seems to fit the

Emphasis added.

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spectrum of autism." Exhibit 199, GMC Transcripts Day 103/31 (referencing General Practice record page 116 and also at Royal Free Hospital record page 67). 361. There is also evidence of an autism diagnosis in a clinical note from Dr. Berelowitz of January 10, 1997. "Seen Tony Cox - severe language problem. Not quite Asperger's but does have autistic spectrum disorder. 77 Diagnosis - language delay;? ADD; A[autism]? Asperger's." Ex. 158 (referencing Royal Free Hospital records page 18). Berelowitz appears to have picked up on, appropriately, the inconsistency of language delay and a diagnosis of Asperger’s syndrome in Child 12. 362. Finally, there is evidence of an autism diagnosis in the discharge summary from Dr. Casson to Dr. Stuart on January 22, 1997, "Part of the autistic spectrum ?Asperger's." Exhibit 200, GMC Transcripts Day 24/46 (referencing Royal Free Hospital records pages 32-33. 363. In his footnote 91 of his Web Extra tables Deer also states that "Michael Rutter for the GMC said in evidence to the Fitness to Practice panel that there was 'no evidence that I could identify' in any of the child's examined records indicating any significant regressive element in his disorder." Ex. 73, FN 91 364. This opinion falls under the “fallacy of access” argument; it is offered after the fact by a physician who, whatever his experience, is limited by the fact that he has never seen or examined Child 12, nor interviewed his mother. It is also somewhat surprising given prior published opinions offered by the same physician. Child 12 clearly had secondary fecal incontinence i.e. loss of a major self-help skill In the absence of fecal impaction of the rectum and overflow diarrhea, which Child 12 did not have, fecal incontinence is a clear sign of developmental regression. Prof. Rutter's himself in published papers has identified loss of bowel and bladder control as evidence of developmental regression. Exhibit 201, 77

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Rutter M and Schopler E (1988), Autism and Pervasive Developmental Disorder. Chapter 13, Pages 408-434 in Rutter M, Tuma AH, Lann IS (Eds). Assessment and Diagnosis in Child Psychopathology, David Fulton, London.

Cited triggers and parental reporting of an association with MMR vaccination The Summary section of the Lancet Paper states: “Onset of behavioral symptoms was associated, by the parents, with measles, mumps, and rubella vaccination in 8 of the 12 children, with measles infection in one child [Child 10] and otitis media in another [Child 9].” Ex. 1, page 637, col 1, para 3.

Further, in the Results section of the paper it states: “In eight children, the onset of behavioral problems had been linked, either by the physician or by the child’s physician, with measles, mumps, and rubella vaccination.” id.,, page 638, col 1, para 5.

365. Deer claims that the omission of three further children from this group [Child 5, Child 9, and Child 12] constitutes fraud. He states in the First Article: “Another discrepancy to emerge during the GMC hearing concerned the number of families who blamed MMR. The paper said that eight (1,2,3,4,6,7,8,11) linked developmental issues with the vaccine. But the total in the records was actually 11. The parents of child 5, 9 and 12 were also noted at the hospital as blaming the vaccine. But their stated beliefs were omitted from the journal.” 366. The Lancet paper was concerned with reporting accurately, the parent’s narrative of their child’s illness. The Lancet Paper specifically refers to historical instances where MMR “was associated” and “had been linked” to a possible environmental trigger, including MMR.

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367. Once again, the original purpose of the paper is subverted in Deer’s reconfiguration and reanalysis. He writes: "Three of the four remaining children were seen in outpatients on the same day. None of their families were reported as blaming the vaccine...The parents of Child 5, 9 and 12 were also noted at the hospital as blaming the vaccine, but their stated believes were omitted from the journal." Ex. 4, page 80, column 3, para 2 368. In the following section I will explain, with reference to the medical records and GMC Transcripts, those historical instances where MMR “was associated” and “had been linked” to MMR vaccination. 369. The omission of those parents who simply blamed the MMR vaccine has, in Deer’s opinion, an ulterior motive. Deer alleges fraud and asserts that the reason for the omission of these three children was a deliberate act on my part, intended to “sharpen the time link for a lawsuit.” This is not true. There was no such motive. There were very valid reasons for treating such narratives differently. 370. It is important to understand how we came to describe in the Lancet Paper the parental association with environmental triggers, including, but not limited to, MMR vaccine. This was included for children in whom an environmental exposure formed part of the child's historical narrative. 371. If a child’s parents made the association later in time and not on their own because, for example, they had read about the issue in a newspaper article, their association was not included. To have included those who only came to this position more recently and "secondhand" would have clearly biased the Lancet Paper’s reporting in favor of an association with, for example, MMR vaccine as the perceived trigger.

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372. Deer states: "With concerns logged from 11 of 12 families, the maximum time given to the onset of alleged symptoms was a (forensically unhelpful) four months." First Article Ex 4, page 81, column 1, para 4. 373. There are several questions that arise out of Deer's analysis. One, why does Deer choose 11 of 12 families when there were only 11 families represented in the Lancet Paper (Children 6 and 7 were brothers)? 374. Deer continues, "But in a version of the paper circulated from the Royal Free six months before publication, reported concerns fell to nine of 12 families but with a still unhelpful maximum of 56 days." Id.4 In fact the “56 days” refers to something quite different; it is the maximum interval for those children whose parents cited a possible environmental trigger, including MMR, measles disease, and otitis media – not MMR alone. 375. "Reported concerns" did not “fall” to nine children. Concerns in relation to MMR were always confined to those children for whom MMR was cited as part of the historical narrative. 376. In order to understand the misrepresentation by Deer and subsequently Defendant Godlee in this context, it is important to undertake a mundane comparison of the draft version referred to by Deer and Godlee, with the final Lancet Paper itself. This draft version of the paper was produced in August 1997 just prior to submission to the Lancet. It stated "Onset of behavioral symptoms was associated, by the parents, with MMR vaccination by nine of the 12 children, and with measles infection in one child and otitis media in another." These are the 11 children for whom parents cited a “possible precipitating event.”

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377. The draft paper of August 1997 continues: "Table 3 summarizes...the timing of onset of behavioral features in relation to the â&#x20AC;&#x153;possible precipitating eventâ&#x20AC;? reported by the parents..." Exhibit 202, Draft Lancet paper downloaded from briandeer.com of August 1997 entitled The Wakefield Paper: 1997 378. It continues, "In those [11] children in whom a precipitating event was reported by the parents, the average interval from exposure to first behavioral symptom was 14 days (range one to 56 days)". id. Lancet Paper at [] 379. During revision of the paper, as is often the case during drafting and redrafting of a scientific manuscript, it emerged that, in fact, in the case of eight children rather than nine, the parents had made the association with MMR. The final paper focused upon the interval for those citing MMR as the precipitating exposure. 380. Deer states, "Finally [in the Lancet Paper as published] Wakefield settled on eight of 12 families with a maximum interval to alleged symptoms of 14 days. Between the latter two versions, revisions also slashed the mean time to alleged symptoms - from 14 to 6.3 days." Ex. 4 First Article at page 81, column 1, para 5. 381. The precise wording of the final Lancet Paper is crucial. "Onset of behavioral symptoms was associated, by the parents, with the measles, mumps and rubella vaccine in eight of the 12 children, and with measles infection in one child and otitis media in another." Lancet paper Ex.1 at page 637, column 1, para 3. 382. The Lancet Paper continued, "In eight children, the onset of behavioral problems had been linked by the parents or by the child's physician with measles, mumps and rubella vaccination. Five had had an early adverse reaction to immunization (rash, fever, delirium,

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and, in three cases, convulsions). In these eight children, 78 the average interval from exposure to first behavioral symptoms was 6.3 days (range one to 14)." 383. On his website, the origin of Deer's false assertions is to be found. Deer presents a table, a true and correct copy of which was downloaded from his website and is attached as Exhibit 203. Deer provides a “comparison” of the aforementioned draft and final Lancet Papers. Column 1 of Deer’s table is headed: "Average interval reported between MMR shot and onset of behavioral symptoms." In Column 2, for the draft paper of August 1997, Deer writes “14 days” with a range provided in the row below of “1-56 days,”, “and in Column 3 for the final version of the Lancet Paper of February 1998 writes “6.3 days” with a range provided in the row below of “1-14 days.” 384. Deer has altered the facts to fit his case for fraud. He has compared the interval of 14 days in the August '97 draft and 6.5 days in the February 1998 paper between two fundamentally different groups of children, while claiming that they are the same. 385. In the first instance (the August ’97 draft), they are 11 children with a possible "precipitating event" and in the second (the published Lancet Paper) they are specifically those eight children for whom the precipitating event was cited as "MMR." These facts are explicit in the respective texts from August '97 and February '98. In his table Deer altered the text from the draft Lancet Paper from "precipitating event" to "MMR shot" in order to fit his case for fraud. Ex 203 386. Godlee recited these false allegations at a presentation to the US National Institutes of Health [NIH] on June 9, 2011, where she cited Deer's false analysis as evidence that I had fraudulently manipulated the time interval data in order to create a legally compelling case

Emphasis added

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She further suggested that for this manipulation I should face criminal charges. Exhibit 204, Transcript of Defendant Godlee’s presentation to the US NIH on June 9, 2011 387. I will now present the evidence from the medical records of the Lancet Children with respect to the issue of whether MMR vaccination as a possible trigger for a child’s symptoms formed part of their medical narrative inasmuch as the parent(s) made an association with MMR at the time of their child’s deterioration. 388. In his affidavit to Anti-SLAPP motion, Deer cites a statement made by me, giving the reasoning behind the Lancet Paper’s reference to some parents having cited MMR as a possible trigger and the exclusion of other parents: "Parents of eight of the 12 children made the link between MMR vaccination and onset of symptoms contemporaneously. Other parents made the link retrospectively; that is, some years later. I went on to define what is meant by "contemporaneous.” "We reported on those eight who had made the link at the time of their child's deterioration and excluded those who made the link later." I then provided the reason for having done so: "In order to remove any bias associated with recall that may have been prompted by, for example, media coverage." 389. I will now illustrate the distinction between those parents who made the association contemporaneously with their child’s (or children’s) deterioration and those who did not report this to us. Child 1. 390. The first reference to an association with MMR for Child 1 comes from the GP referral letter, Dr. Barrow, to Prof. Walker-Smith on May 17, 1995. "Mr. and Mrs. 1's most recent concern is that the MMR vaccination given to their son may be responsible for the autism." Ex. 66 (referencing General Practice record pages 123-124) The fact that it was recently 115

expressed to the GP does not mean that his had not been a longstanding concern of the parents (see below) 391. Further evidence is found in a clinic note from Prof. Walker-Smith dated June 20, 1996 in which Mrs. 1 reports a sequence of events that she associated historically with the onset of her child’s problems: "After MMR 79 7 to 10 days later, pale, ?fever, ?delirious (out of it) for three days." Ex. 68 GMC Transcript Day 77/45. (referencing Royal Free Hospital record day 13. 392. A further record highlighting the mother’s reported sequence of events includes a letter from Prof. Walker-Smith to me dated June 211996 which states: "I saw this interesting child with autism which began some weeks following MMR, although there was 7 to 10 days after the MMR at the age of one a brief illness during which he was pale, possibly had a fever and his mother said he may have been delirious." Exhibit 205, GMC Transcripts Day 3/60 (referencing General Practice records page 137 and Royal Free Hospital records page 53) 393. There is a further reference to parental association of MMR with their child’s developmental problems in the discharge summary of Dr. Casson dated August 9, 1996 which staes: "He is up to date with his immunizations, including his MMR at 12 months of age. There is obvious parental concern that this has had some bearing on his subsequent condition." Exhibit 206, GMC Transcripts Day 3/62 (referencing General Practice records pages 128-130 and also at Royal Free Hospital records pages 49-51). 394. There is a further non-clinical record, Prof. Walker-Smith's presentation notes to the Wellcome Trust research meeting of December 1996 in which he stated : "I wish today to present some preliminary details concerning seven children, all boys, who appear to have 79

Emphasis added

116

enterocolitis and a disintegrative disorder probably following MMR. I shall now briefly present their case history." In reference to Child 1, he wrote, "Immediate reaction to MMR at one year. Rapid deterioration in behavior arrow to autism." Exhibit 26 395. It was clearly the perception of the mother and Royal Free doctors, therefore, that MMR vaccination formed part of this child's narrative and that this had been part of the mother's concerns for some time. 396. This is corroborated by the evidence of Child 1's GP, Dr. Barrow, at the General Medical Council hearing. "Q. What view did Mrs. 1 have at that stage as to the development of Child 1? Was she accepting that there was developmental delay or autism or not? A. [Dr. Barrow, GP] She felt that the child developed completely normally until he had his MMR and that he did have a few words but then he subsequently lost them." Ex GMC Transcript Day 5/55. 397. This was further confirmed in Dr. Barrow’s statement to the General Medical Counsel, presented as Exhibit 207, on p. 3 para 18, where she states: “It had been [Mrs.2’s] anxiety all along that the MMR vaccine had caused her son’s problems. This had been long before Child [2’s] referral to the Royal Free Hospital. 398. Once again, Deer maintains that the Lancet Children were a "preselected group of complainants against the MMR vaccine" and that there were three exclusions from the paper - in Deer's words, "parents who made the same allegations." According to Deer, the purported purposes of their deliberate omission on my part were to: "Remove the appearance of a preselected group" of "complainants against the MMR" and "greatly sharpen the temporal link" between MMR and onset of symptoms. See Deer's affidavit to Anti-SLAPP para 94-99, Pages 31-32.

117

399. In support of this assertion with respect to Child 1, he states, "The GP writing to the Royal Free more than two years after the boy was vaccinated described the parents' association with MMR as their 'most recent concern as to the possible cause of his autism.'" See Deer Declaration in support of Anti-SLAPP, para 99, Page 32. 400. Deer's error in respect of Child 1 is the assumption that "most recent concern" expressed to the GP means that this is the first time this concern had been expressed. Deer’s error is illustrated by an article in the UK’s Daily Mail newspaper on August 12, 1997 that was, in fact, provided by Deer himself in his disclosures to the discontinued U.K. defamation proceedings. Quoting the mother, the ’97 article states: "It was only two years ago that the boys were diagnosed as autistic and that was after months of being told by various people that there was no link with MMR." (emphasis added) Ex. 79 401. The records reflect that Child 1 was born on January 14, 1993 and that he received his MMR one year later on January 19,1994. The Daily Mail article was written on August 12, 1997. The boys were diagnosed 2 years before the article was published i.e. in 1995, at which point mother states that she had been discussing an association with MMR for some months before. This puts her concerns long before the GP's May 17, 1997 letter cited by Deer. This information was in Deer’s possession. 402.With respect to Child 1, it is clear from the documentary record and the testimony of the child’s GP that mother was expressing concerns about her child's deterioration up to and beyond the middle of 1995, well within the time frame that she was concerned about a link with MMR.

118

403. In Deer's Anti-SLAPP affidavit, he cites my explanation for the inclusion and exclusion criteria as an “anomaly” and that based upon this anomaly, "…Wakefield knows that parents' recollections can be unreliable. Thus he knows that the entire premise of this project and his campaign against MMR is on his own account of this matter untenable.'" See Deer’s Declaration in Support of Anti-SLAPP para 100, page 32. 404.Once again, Deer is entirely wrong. In fact, the parents who did not make an association between MMR and their child’s deterioration contemporaneously, not only told us of this fact but reported faithfully how it was that they had become aware of the MMR association. In the case of Child 5 and Child 10, the parents advised us that they only became aware of a possible MMR association after reading a newspaper article. The parent of Child 12 told us she only became aware of a possible association with MMR after speaking with the parent of two vaccine damaged children who brought the issue to the parent’s attention.. We had no reason to doubt the reliability of their recollections. Child 2. 405. Evidence for the contemporaneous concerns of Child 2's mother about MMR vaccine and her child's developmental problems is reflected in an August 1, 1995 clinic note of Prof. Walker-Smith which states: “MMR injection at 15 months. Went downhill ever since." Ex. 81 406. There is further evidence in an October 31, 1995letter from Dr. Beattie, a pediatric gastroenterologist, to Child 2’s GP, copied to Prof. Walker-Smith, which states: "Mother...also feels that he had problems subsequent to MMR." Royal Free Hospital records pages 202-203; GMC Transcripts not cited.

119

407. There is further evidence in a Royal Free Hospital clinic note dated September 2,1996 which states : "Had MMR at 13 months [sic] two weeks later started head banging. ? head pains. Screaming through the night. Seemed generally sickly." Ex. 82 408. There is further evidence in a September 9, 1996 clinical note from Dr. Harvey which states: "History as noted. Head banging after MMR inoculation followed by [physical-]intellectual decline." Exhibit 208, GMC Transcripts Day 35/60 (referencing Royal Free Hospital records pages 13-14) 409. The records provide ample evidence of mother of Child 2â&#x20AC;&#x2122;s contemporaneous concerns about the MMR starting very soon after his exposure. Child 3. 410. For Child 3, evidence of contemporaneous concerns related to MMR vaccination are found in a February 19, 1996 letter from the GP, Dr. Shanta, to Prof. Walker-Smith which states: "Child 3 developed behavior problems of autistic nature, severe constipation and learning difficulties after MMR vaccination. The batch incriminated was D1433, incidentally, which was the discontinued batch following adverse reactions." Ex. 92 411. There is further evidence in Prof. Walker-Smith's April 3, 1996 clinic note which states: "Fine as a baby. Had whooping cough immunization at four months and then two. Well until 14 months - MMR. On second day after the injection, he developed fever, rash. Banging his head. His behavior became abnormal thereafter - 'flapping his hands.' Stopped playing with his brothers." Exhibit 93 412. There is further evidence in an April 4, 1996 letter from Prof. Walker-Smith to Dr. Shantha in which Professor Walker-Smith writes: "There is a clear history of the child being completely well until the age of 14 months when he had MMR. On the second day after the 120

injection, he developed a fever and a rash and since then his mother noticed dramatic change in his behavior." Ex. 94 413. Prof. Walker-Smith reiterated this in a letter to me dated April 4, 1996 which states: "There is a clear history of this child having been perfectly well until the age of 14 months, and then the second day after the MMR injection there was a change in behavior which has persisted thereafter..." Ex. 95 414. There is further evidence in a January 11, 1995 letter from Dr. Rosenbloom, the pediatric neurologist, to Dr. Balachandran which states: "His mother, who is pregnant, is devastated at the change in Kevin that occurred at around 14 months of age. She says this coincided with MMR immunization, which she therefore blames." Ex. 97 415. There is further evidence in an August 17, 1994 letter from Mr. and Mrs. 3 to Dr. Rosenbloom which states: "When 3 had his MMR we were told that 3 might have a slight temperature, which he did...Within three days of the injection, 3 had started banging his head on his cot, rocking backwards and forwards on a chair or when sitting on the floor, sometimes banging his head against the wall causing him to have nosebleeds." They continue, "We feel that the MMR needle has made 3 the way he is today." Ex. 99. 416. Therefore, in the case of Child 3, there is clear historical evidence of a longstanding parental association of the child's problems with exposure to MMR vaccine. Child 4. 417. Evidence for a contemporaneous parental association with MMR in the case of Child 4 is found in Dr. Casson's Royal Free Hospital clerking note of September 29, 1996 which states: "Had had MMR at four weeks before those loss of skills... i.e., loss of concentration - very hyperactive - destructive play - banging head/kicking out... till then he had been

121

placid, subsequently behavioral problems, also less affectionate, no eye contact, loss of communication. Also lost eating skills, i.e., holding cup/spoon..." Ex. 112 418. There is further evidence of early problems after MMR in a note from the GP in February, just 12 days after his MMR, "Still angry and miserable. Temps have settled. Vomited times one last week. A little diarrhea." Ex. 113 419. There is further evidence from March 15, 1991, that is, within four weeks of MMR in a referral letter from Dr. Meikle to Dr. Shabde which states: "Mum is unsure of what is going on with Child 4...He exhibits very odd behavior...mother is certainly worried about the possibility of autism..." Citing General Practice records page 243; GMC transcript not cited. Exhibit not available. 420. In the case of Child 4, the record reflects a historical association between MMR exposure and contemporaneous concerns expressed about his behavior and development.

Child 5. 421. Child 5 is a child where the parents did not make an association contemporaneously between the MMR vaccine their child's deterioration. They confirmed that they had read about a possible association in a newspaper article, and that led to them seeking a referral to the Royal Free Exhibit 210. 422. I have found no reference to the parents contemporaneously or historically associating their childâ&#x20AC;&#x2122;s problems with MMR vaccination. 423. There is documentary evidence in a letter from Dr. Shillam to Prof. Walker-Smith dated October 1, 1996, that the parents of Child 5 did not link their childâ&#x20AC;&#x2122;s illness to MMR contemporaneously with the vaccine but rather made the potential association years later.

122

The letter from Dr. Shillam to Prof. Walker-Smith states: "Parents are concerned about an association they have read in the Daily Mail 80 between MMR, enteritis and possible brain damage. Child received MMR on 10.4.90." Ex. 210 424. For Child 5, there is clear evidence of how they came to learn of the MMR association, and this was not something that they had made contemporaneously with their child's deterioration. 425. Deer cites what he claims to be the clinical record of Dr. Peter Harvey, a neurologist and co-author of the Lancet Paper, in support of his (Deer’s) allegation of fraud as follows: “No doubt about relationship with MMR at onset. No doubt about normal earlier development …Parents have no doubt about the relationship with MMR.” 81 Ex. 4 First Article – online version - Footnote 92 426. In fact, Dr Harvey’s clinical note is materially different from that cited in Deer’s footnote 92 The actual document, a true and correct copy of which is attached as Ex 211 states: “Parents have:- (1) no doubt about MMR relation to onset (2) no doubt about normal earlier development (3) Videos of his post-MMR / autism behavior.” Exhibit 211, Royal Free Hospital record page 36 and 39. 427. Deer’s footnote is also materially different from the GMC Transcript that reads: “Parents have (1) No doubt about the relationship to MMR or onset (2) No doubt of normal earlier development” – Exhibit 212, GMC Transcripts Day 36/46 428. Deer altered Dr. Harvey’s statement by changing the phrase “to onset” to the phrase “at onset”, falsely indicating that the parents made the association at onset. In addition Deer

80 81

Emphasis added Emphasis added

123

added a line - “Parents have no doubt about the relationship with MMR”- that Dr. Harvey did not write and that did not appear in the cited GMC Transcripts. 429. Nonetheless, at the time they attended the Royal Free Hospital years after their child had the MMR, having read the article in the newspaper that brought their attention to the possible link between MMR and autism, the parents of Child 5 may well have had “no doubt” in their minds that the MMR vaccine was connected with the onset of their child’s condition. This does not merit their inclusion among those parents who made the link contemporaneously with their child’s deterioration. 430. Further evidence that Child 5’s parents only made the link after they had read about measles vaccines and intestinal disease in a newspaper article, is the fact that after this disclosure they initiated a claim for vaccine-injury related financial support from the Department of Social Security. Exhibit 213, GMC Transcripts Day 11/50 (referencing). 431. Deer also cites Dr. Casson: “His parents feel that the onset of his neurodevelopmental symptoms stems from the period two months after having had the MMR vaccination which he received on 10 April 1990. A few months subsequent to this he started losing skills.” Ex. 4 footnote 92. 432. Once again, when they came to the Royal Free and were interviewed by Dr. Casson, the parents may well have been of this opinion. However, there is nothing in Dr. Casson’s note that indicates when the parents came to this belief or that the parent’s statement reflected their contemporaneous view at the time of Child 5’s deterioration. Child 6. 433. Evidence for a contemporaneous parental association with MMR in the case of Child 6 is found in an October 2, 1996 clinic note from Prof. Walker-Smith which states: "At 15 124

months had MMR. Behavior had changed within a week. Began to become aggressive, feeding poorly, poor eye contact, slipping back in development - two years. Unexplained high temperatures, violent towards big brother." Ex. 138 There is further evidence in an October 4, 1996 letter from Prof. Walker-Smith to me which states: "...had a measles rash week before MMR at the age of 15 months but the doctors proceeded with the MMR injection. He had behavior changes within a week..." Exhibit 214, GMC Transcripts Day 41/39 (referencing General Practice records page 123 and also at Royal Free Hospital records (Additional) page 6). 434. There further evidence in his Royal Free Hospital admission clerking note dated October 25, 1996which states: "...developed behavioral changes, responding differently and was extremely terrified a week after MMR immunization... since then he became aggressive. His eye controls are poor as well." Ex. 135 435. There is further evidence in a May 19, 1997 letter from Dr. Casson to Dr. Bennett which states: "Mum have a history in 6 of changes in social interaction following on immediately from MMR vaccination." Ex. 136 436. There is further evidence in a letter dated June 3, 1997from Dr. Berelowitz to me and to Dr. Murch which states: "He had his MMR at 15 months. He had a strong reaction to his last vaccine. A week later he stopped breathing and was thought to have had a near cotdeath. He then became aggressive, starting crying with poor concentration." Ex. 137 437. In the case of Child 6, there is a clear historical association between MMR exposure and contemporaneous concerns expressed about his behavior and development. Child 7.

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438. The records reflect that Child 7's MMR vaccination was delayed to 21 months in light of the problems that had occurred in Child 6, his older brother. The medical records show that Child 7 was admitted to the Royal Alexandra Hospital On March 22, 1996 . Evidence of his motherâ&#x20AC;&#x2122;s contemporaneous concerns are found in the nursing evaluation sheet of this hospital admission which states: "...Mum...continues to be anxious re.post effects of MMR vaccination." Ex. 149 439. There is further evidence in a January 15,1997 letter from Prof. Walker-Smith to Dr. Nalletamby which states: "There does seem to be a clear relationship between symptomology and MMR. He had the MMR rather later than usual at the age of 21 months. His mother tells me that 24 hours later he had a fit like episode and slept poorly thereafter, and she attributes his change in behavior to this event." Ex. 150 There is further evidence found in a June 3, 1997 letter from Dr. Berelowitz to Prof. Walker-Smith which states "...MMR at 20 months...from then on he became quiet with a decrease in spontaneous speech, less social engagement, eye contact and poor language." Ex. 142 440. There is further evidence in a January 15,1997 clinic note from Prof. Walker-Smith which states: "Had MMR at 21 months. 24 hours after MMR he had a fit - slept poorly, contacted GP." Ex. 152 441. In the case of Child 7, there is a clear historical association between MMR exposure and contemporaneous concerns expressed about his behavior and development. Child 8. 442. Evidence for contemporaneous parental concerns about Child 8â&#x20AC;&#x2122;s reaction following MMR is found in an undated GP record that followed MMR. That record states: "MMR

126

Jan 95. Led to grand mal convulsion February '95 two weeks after MMR. Never the same again and frequent diarrhea." Ex. 164. 443. There is further evidence in a November 28, 1995 letter from Dr. Meikle, Child 8â&#x20AC;&#x2122;s ENT surgeon, to Child 8â&#x20AC;&#x2122;s GP which states: "...Mum dates the deterioration in her speech development back to the difficulty she had after the MMR immunization, and I am sure that this is a more complex problem than just the glue ear..." Citing GMC Transcripts Day 28/8 (referencing General Practice records page 136). 444.

There is further evidence in a January 10, 1996 letter from Dr. Meikle to Dr. Jelley, the GP, which states: "...Mum feels the setback occurred at the time of the bad reaction to the MMR immunization..." Citing General Practice record page 130; GMC transcript not cited.

445.

There is further evidence in the minutes of a Special Needs Team meeting held on June 5, 1996. "...Mother was concerned that she noticed a definite regression of 8's skills since her MMR injection!..." Ex 171 GMC Transcripts Day 37/6. (referencing General Practice records page 122).

446.

A July 31, 1996 letter from Dr. Katherine Bushby to Dr. Tapsfield regarding Child 8 states:: "Much of our discussion recently centered around mother's concerns that her problems stemmed from her MMR vaccination at 19 months..." Ex 215 GMC Transcripts Day 29/9 (referencing Royal Free Hospital record pages 26-27).

447.

There is further evidence found in the Royal Free Hospital admission clerking note of January 19, 1997which states: "Had MMR at 18 months. Within two weeks of it she had diarrheal illness and temperature and had a febrile convulsion. She remained in the

127

hospital for five days. After that she deteriorated dramatically." Ex. 166 (referencing Royal Free Hospital records pages 7-8). 448. There is further evidence in a January 28, 1997 letter from Dr. Berelowitz to Prof. WalkerSmith which states: "Mother reports that following the MMR there was a catastrophic deterioration in 8's level of functioning. She lost all language, became docile, with poor coordination and was, from her mother's point of view, a different person." Ex. 169 449.

There is further evidence in a letter from Doctor Michael, the ENT sugeron to the GP November, 28, 1995. “…Mum dates the deterioration in her speech development back to the difficulty she had after the MMR immunization, and I am sure that this is a more complex problem that just the blue ear…” 170 Citing Exhibit not available.. 171Exhibit 215, GMC Transcripts Day 29/9 (referencing to Royal Free Hospital record pages 2627) There is further evidence in the inutes of the Special Needs Team Meeting held on June, 5 1996. “…Mother was concerned that she noticed a definite regression of 8’s skills since her MMR injection!...” Ex 171, GMC transcripts Day 37/6 (referencing general practice records pp. 122). There is a letter from Doctor Katherine Bushby to Doctor Tapsfield dated July 31, 1996; “much of our discussion recently centered around mothers concerns that her problems stemmed from her MMR vaccination at 19 months (sick)...” Ex 215 (referencing Royal Free Hospital pages 23-27)

450.

In the case of Child 8, there is a clear historical association between MMR exposure and contemporaneous concerns expressed about his behavior and development. Child 9.

128

451.

Child 9 is one of those Lancet Children where the mother did not cite an association with MMR to the doctors at the Royal Free Hospital but, instead cited an association with recurrent otitis media (middle ear infection).

452.

Evidence for a lack of associon with MMR is found in a November 8, 1996 clinic note from Prof. Walker-Smith which states: "MMR 30.10.91. At 16 months no obvious reaction." Ex. 179 Child 9’s Royal Free Hospital admission clerking note on November 18, 1996 states: "Around 18 to 20 months regressed (progressively) (speech)." On a separate line it quotes "MMR at 16 months of age." No association between these two events is documented in the admission clerking, that is, a direct interview with the parent. There is reference to concerns about recurrent viral illness and upper respiratory tract infections noted in this same clerking admission. Ex. 180

453.

There is an error in the discharge summary of Dr. Malik dated January 14, 1997, sent to pediatrician Dr. Spratt. The discharge summary is not based upon a direct interview with the parent but upon a recitation of the antecedent clinical records. "At 18 to 20 months of age he started to regressing (sic) mentally. His mother links for that (sic) with MMR which was given at 16 months of age." Ex. 181

454.

Dr. Malik is technically wrong. He generated his discharge summary from, for example, the admission clerking, which does not contain evidence that mother made the association between MMR and her son's behavioral/developmental problems.

455.

Deer cites the evidence from Child 9’s pediatrician, Dr. Spratt, who received Dr. Malik’s erroneous discharge summary. This was read into the GMC Transcripts on Day 23: “The letter also informed me that [child 9]’s mother linked his mental regression at age 18-20 months to MMR, which he was given at 16 months of age.” GMC Transcripts Day 23/7

129

456.

Pre-dating this, however, is a December 31, 1996 letter from Dr. Spratt, to Prof. WalkerSmith, indicating it reflects Dr. Sprattâ&#x20AC;&#x2122;s own understanding of the situation as the childâ&#x20AC;&#x2122;s pediatrician of many years, stating: "For my part I have no evidence to link the little boy's history of severe developmental delay and learning difficulties with a significant gastrointestinal history - nor indeed, for that matter, with receipt of immunizing agents in his first two years of life." Exhibit 216, GMC Transcripts Day 81/12 (referencing Royal Free Hospital record pages 29-30).

457.

Also, in the witness statement of pediatrician Dr. Spratt, read into the GMC transcript (he did not attend the hearing due to ill health), he stated: "In my view, Child 9 had had a minimally symptomatic colitis, and for local logistical reasons I was sure that this child's MMR inoculation, reportedly at 16 months of age, could not have caused any significant concern at the time. 82 In a small [island] community, with only one pediatrician (until December 1996), I would have been almost bound to be informed. I am and was very reluctant to believe that Child 9 could have been a vaccine-damaged child." Exhibit 217, GMC Transcripts Day 23/8.

458.

Deer fails to refer to this important statement from a doctor who has known Child 9 all of his life.

459.

There is a further citation, also unreferenced by Deer, from the GMC Transcripts where Prof. Walker-Smith is cross-examined with respect to a letter from Dr. Spratt to Professor Walker-Smith dated February 23, 2004. Quoting the letter, the transcript reads: Q.Then he said, and this is the part I do want to ask you about, on page 10, 'I do not recall any more enlightening conversations with Mr. and Mrs. 9 before your introductory note, and I am not aware that there has been any mention of his MMR history preceding his referral to the Royal Free Hospital, nor indeed until quite a long time later.

Emphasis added

130

A. Yes." Exhibit 218, GMC Transcripts Day 97/39.

460.

An association by the parents was not reported for Child 9, because we did not find reliable evidence available to us (or to his pediatrician) at the material time that MMR exposure formed any part of the narrative of this child's behavioral and developmental decline. Child 10.

461.

Child 10's parents cited a natural measles infection that preceded his MMR as the precipitating environmental factor that they believed led to his developmental regression.

462.

There is a March 14, 1995 letter from Dr. Hodges to Dr. Thomas which states: "It would appear that the family were quite happy with Child 10's progress up until June 1994. At that time he developed pyrexial illness and a rash. He was unwell for about a week and it was following this that the mum describes him as going into a shell. All speech and communication stopped and he seemed to regress as far as play was concerned." Exhibit 219, GMC Transcripts Day 5/3 (referencing General Practice record page 110 and also at Royal Free Hospital records page 136).

463.

Further evidence is found in an April 3, 1995 clinical referral letter to Prof. Sibert which states:"…there had already been a consultation with Dr. Hodges, who thought that the problem might be associated with an episode of measles that the child had contracted.” Exhibit 220, GMC Transcripts Day 5/4 (referencing General Practitioner Record page 115).

464.

There is further evidence in a March 14, 1995 letter from Dr. Hodges, a pediatrician, to Child 10’s GP Dr. Thomas which states: "Following his episode of measles, Child 10 appeared to lose any eye contact, he went into a world of his own, lost interest in toys and

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books and ceased almost all interaction with other people." Exhibit 221, GMC Transcripts Day 5/5 (referencing General Practice Record page 110 and also at Royal Free Hospital record page 136). 465.

There is further evidence in an August 3, 1995 letter from Dr. Wallace, a pediatric neurologist, to Dr. Davis, a pediatrician: "[which states: "It seems that 10's strange behavior started after he had had an illness which was considered likely to have been measles and which occurred in June 1994]...... ..Subsequently a measles titre has been shown to be 64 (in May 1995) and therefore this illness was listlessness, a fever and a rash is now considered to have been measles rather than rubella." Exhibit 222, GMC Transcripts Day 113/27 (referencing General Practice Records pages 46-48 and also at Royal Free Hospital records pages 46-48).

466.

There is further evidence in the Royal free Hospital discharge summary from Dr. Casson to Dr. Hopkins of March 17, 1997 which stated: "Mum reports that he was well until 16 months of age when he had a viral infection which was diagnosed by a GP as some form of measles. The exact history of the episode is somewhat confused...Nevertheless, a measles antibody titre was noted to be quite elevated." Ex. 181. For Child 10, MMR was not considered by his parents to be a trigger for his behavioral/developmental problems. Rather, an infection with what appeared to be natural measles was considered to be the triggering event.

Child 11 467.

For Child 11, there is a letter from Mr. 11 to me at the Royal Free dated January 7, 1997 which states: "My son [Child 11] at age 15 months was immunized with the Merck MMR 132

vaccine...His condition slowly deteriorated over time and was diagnosed as being autistic on his birthday at age three. The onset of his autistic behaviors began around 18 months." Ex. 187. In the case of Child 11, there is a clear historical association between MMR exposure and contemporaneous concerns expressed about his behavior and development. A parental link with MMR was made long before his contact with me in January 1997.

Child 12 468.

Child 12 is one of those for whom there is no historical association with the MMR vaccine. The mother indicated to me that she came to learn of the possible association from the mother of Child 6 and Child 7 at a “mother and baby” group meeting.

469.

Child 12 received his MMR on March 6, 1992 at 16 months. Child 12 had had the same GP, Dr. Stuart, from birth. His good health as a young child is evidenced by the fact that there are no entries in his GP records or elsewhere until July 29, 1994, at 44 months of age, when his mother reported gastrointestinal problems. See Exhibit 223, GMC Transcripts Day 7/15 (referencing General Practice records 13/15).

470.

Nowhere, in the multiple medical records that follow over the intervening two years up to July 19, 1996, is there mention of any parental concern that MMR had anything whatsoever to do with their son’s developmental and behavioral problems. Mrs. 12 made contact with me only after the issue of MMR, gastrointestinal problems, and developmental disorders had been brought to her attention by the mother of Child 6 and Child 7. I followed up this contact with a letter on July 19, 1996.

471.

Mrs. 12. Contacted the GP the day of my letter, probably faxed to her on July 19, 1996 that mentions MMR for the first time. The GP’s notes state “…mother anxious re MMR and 133

autism…” “Exhibit 224, GMC Transcripts Day 64/6 (referencing General Practice records page 11. 472.

There is a letter from Dr. Stuart, Child 12's GP, to me on September 23, 1996 in which she discusses his developmental and behavioral problems and MMR quite separately. She makes no link between them at all. See Exhibit 225, GMC Transcripts Day 82/7 (referencing General Practice records page 124 and also at Royal Free Hospital record page 69).

473.

There is a clinic note of Prof. Walker-Smith on October 18, 1996 in which he reports that after Child 12 had his MMR in March 1992 he suffered a “swollen” [arm] and “red rash” immediately afterwards. This was followed by a red rash, fever and misery, from which he had recovered two weeks later. There is no mention of a parental link between MMR and Child 12’s developmental problems. Exhibit 226, GMC Transcripts Day 82/9 (referencing Royal Free Hospital records pages 12-13).

474.

There is an admission clerking note from Dr. Davey of January 6, 1997 that provides only a chronological reference to the relationship between MMR and behavioral changes for which the mother claimed no association. "Development normal until age 16 months. Had MMR at 15 months. Initially noticed loss of language skills, stopped playing, progressively deteriorated." Ex. 191 (referencing Royal Free Hospital records day 19).

475.

In summary, Deer’s allegations regarding the description and inclusion of 8 children in the group whose parents made an MMR association are wrong. Deer’s impugning to me an ulterior motive for the inclusion of certain children and the exclusion of others, is also wrong. Deer’s citations to the relevant records in support of his assertions are highly selective and in at least one instance, cited incorrectly.

134

Additional matters Prof. Walker-Smith and Dr. Murch’s knowledge of Lancet children in 1997 and 2004.

476. The Defendants publically allege that my co-authors did not know the identities of the Lancet Children. Deer states: “But despite signing up to claim credit for a paper in the Lancet, his coauthors Walker-Smith and Murch did not even know which case was which.” Ex. 4; 342:82, column 1, para 4.

477. Deer’s allegation clearly refers to my co-author’s state of knowledge (or lack of it) at the time of their having signed up to the Lancet Paper in 1997. Defendant Godlee’s accompanying editorial reiterates this assertion:

“Firstly for the coauthors. The GMC panel was clear that it was Wakefield alone who wrote the final version of the paper. His coauthors seem to have been unaware of what he was doing under cover of their names and reputations. As the GMC panel heard, they did not even know which child was which in the paper’s patient anonymised text and tables.” Ex. 37

478. Defendant Godlee concurs with the substance and meaning of Deer’s stated position that my co-authors did not know which child was which at the time the Lancet Paper was written and submitted for publication. The facts are misrepresented by both Defendants and the true facts are materially and demonstrably different than those presented by Defendants. 479. The Lancet Paper was written in 1997 and published in the Lancet in 1998, after going through a review process. Six years later, in February of 2004, Brian Deer made certain allegations against us. At that point in time, Prof. Walker-Smith's had already retired. When Deer made his allegations in 2004 (six years after the articles written), Prof. Walker 135

Smith, Professor Murch, and I scrambled to try to find relevant records relating to the project in order to respond on an extremely tight deadline. Deer had advised Richard Horton of allegations Deer was going to make against the Lancet. Richard Horton asked us to gather information for a prompt response. When Prof. Walker-Smith refers in his GMC testimony to a time when he was unaware of the identities of the Lancet Children he is not referring to 1997 when the paper was written and submitted for publication, as alleged by Defendants. Rather, he was referring to the time in February 2004, over six years later, when Deer made allegations against us and we were looking for documents in order to respond with. At that time, when Prof. Walker-Smith could not specifically remember the identities of the Lancet Children, he found it necessary to consult a biopsy log, maintained in his previous department at the Royal Free Hospital. He did so in order to reassure himself that the Lancet Children were, in fact, the first 12 “consecutively referred” children to be investigated in the Department of Pediatric Gastroenterology at the Royal Free Hospital. In his testimony Prof. Walker-Smith states: “One of [Deer’s] allegations, or interpretation of the allegations that Richard Horton relayed to us, is that we had been guilty of cherry picking in that phrase. By that, it was implied that Dr Wakefield had just picked out the children with autism and bowel problems who had abnormal endoscopic findings. That was a charge about which it was very difficult to find precise facts to refute the charge that it was consecutive. I had been long retired and not au fait with these children, but I did remember, of course, that I had seen seven of the first consecutive seven children for review by Dr Dhillon, 83 and how would I find out of the subsequent five, whether they were the next consecutive children. We had no numbers at the time. It was all done under duress and in haste. I did not know the identification of The Lancet numbers at all. 84 Child 9 we guessed was the child from XXX. We wanted to address the issue, was there cherry picking? I do not know whether it was my idea or somebody else, I knew 83 84

Emphasis added Emphasis added

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that they were the twelve consecutive children, but Dr Horton said to me, “It is no good, John, if you just know it is the 12, what is the objective evidence?” Someone in the group suggested that we should look at the log book for biopsies coming in to the department in the Department of Pediatric Gastroenterology, bearing in mind that I had been long retired. Someone directed me to this particular book which was for the period, as you see there, 4/9/95 to 21/7/1997, and the idea we had was that if I looked in that book and we saw that amongst all the biopsies being done, the 12 Lancet children... Assuming that “autism” was written in the title, I looked through that book and we found that the first twelve children who had been biopsied were The Lancet 12 and that was the task that I took…” Exhibit 227, Prof. Walker-Smith, Cross-examination GMC Transcripts Day 97/36 And:

“The background was that when I originally said to Richard Horton that I denied these allegations, he said, “What is the evidence for that?” I was obviously aware from the study with Dr Dhillon that the first seven children in The Lancet were indeed the first seven consecutively seen, but what about the remaining five? I wanted to independently verify, particularly dealing with the allegation that Andy Wakefield had cherry-picked. I do not know who it was, but someone suggested that we had this log book, which we had from the days of Queen Elizabeth Hospital. All biopsies that were taken by members of the all departments were logged in and this was kept in the laboratory. Obviously I had been retired for a number of years and I did not know where the log book was. Somebody in the department obviously assisted me to find the book. This seemed to be an independent verification, if one could look through in that period and find that these twelve children were the twelve children consecutively seen with autism and ileo-colonoscopy. Exhibit 228, Ex Prof. Walker-Smith, Crossexamination GMC Transcripts Day 99/24 And:

Q You had access to it for the purpose of writing this statement? A This book? Q Yes. A Yes, I mean, I do not remember who actually … I had not been in the department for a long time, I had been retired for four years --137

Q I appreciate that. A --- and somebody in the department after this had been suggested said, “Well, there’s the book and you can look at it”, which I did. Q The statement says that you reviewed it --A I did. Q --- in order to confirm that they were the first 12 children consecutively referred in the way which you have described. A Yes, I obviously, as I said before, have memory of the first seven but I did not remember the subsequent five. 85 Q You are saying that the review of the book leads you to confirm what was said in the paper. A Exactly. Q Is that what you looked at? A That is what I looked at, yes, albeit done with some haste but that is what I believed to be the case. Exhibit 229, Ex Prof. Walker-Smith, Cross-examination GMC Transcripts Day 99/25 480. Prof. Walker-Smith is clearly referring to his lack of memory of the identities of these children when confronted with Deer’s allegations in 2004, a time when he was retired, six years after the paper was written. 481. In direct continuity to Deer’s BMJ statement: “But despite signing up to claim credit for a paper in the Lancet, his co-authors Walker-Smith and Murch did not even know which case was which.” Deer writes (quoting Prof. Walker-Smith)…“”When I signed that paper, I signed with good intent,” he told the GMC panel. Walker-Smith said he “trusted” Dr Wakefield.” 482. First, …“”When I signed that paper, I signed with good intent,” comes from JWS’ crossexamination about ethics approval 172-96 and has nothing whatsoever to do with signing up to the Lancet Paper. For example, see: Q Professor Walker-Smith, when you say you say you were satisfied, you felt that you had acted ethically at all times --A Yes. 85

Emphasis added

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Q --- that is not really the issue is it? This is a matter we have previously touched on but this is a representation that you had ethics committee approval. A When I signed that paper I signed in good intent and that is what I did at the time. Q If, as I suggest must be the case, this is a reference to the ethics committee approval under 172/96, if it is a reference to that approval, I think you would agree that some of these children were investigated before approval for that project, as a matter of fact. Exhibit 230, GMC Transcripts Day 97/30

483. Compounding his deception Deer’s cited reference to “trust” is found in various places in the transcripts e.g. Q You have said quite often that you trusted Dr Wakefield. A I did. Q Do you still trust him? A I think I trust Dr Wakefield but clearly there was a parting of the ways to some extent after the press briefing. He knows that and I told him that I thought it was a great mistake and he knows that view. There was an increasing divergence of views between us. Throughout I made recommendations to him which he did not follow, and that is fair enough because he was not academically accountable to me, but there was a divergence of view. I am not distancing myself from him at all. Exhibit 231, GMC Transcripts Day 100/31 484. But there are no references to ‘trust’ relating to his signing of the paper or his knowledge of the identities of the Lancet children. This is a further deliberate attempt by Deer to mislead.

Admission criteria to the Royal Free Hospital for the Lancet Children 485. Deer further alleges that the Lancet Children were selected because of their parental beliefs that MMR had caused their child's problem. In his BMJ article he states: "The frequency of these beliefs should not have surprised Wakefield, retained as he was to support a lawsuit... two years before the paper was published - the lawyer touted the doctor in a confidential 139

newsletter to his clients... Clients and contacts were quickly referred. Thus, an association between autism, digestive diseases and worries about MMR... was bound to be found by the Royal Free's clinicians because this is how the children were selected. “ Ex. 4 486. Deer alleges in his affidavit to anti-SLAPP Para 175: “The paper’s first ‘finding’ that the “onset of behavioral symptoms was associated by the parent with measles, mumps, and rubella vaccination” was a manufactured artifact of Wakefield’s concealed recruitment strategy – drawing upon Mr. Barr’s clients and contacts, and parents listed by vaccine campaign groups – and was no kind of “finding” at all. An honest researcher would have declared what he knew: that the association between developmental disorders, bowel issues and concern over MMR was not discovered at all. As the transcript shows (Ex. 28), it was the essential terms of admission.” Deer’s affidavit to anti-SLAPP

487. I will deal, first, with the selection and admission of children. Deer cites my GMC crossexamination where I refer to the issue of selection bias in a self-referred group. The term “self-referred” means simply that the parents have sought us out and initiated the clinical referral. Since these parents became aware of my interest in (1) GI disease and (2) vaccine links to GI disease, and (3) the possible association of these factors with developmental disorders, any of these elements in their own child’s experience might have motivated their self-referral. This bias therefore operates through the parents. As I stated in my GMC testimony: “The patients, children, are self-referred based upon their symptoms and their history. That contains the three key elements of an environmental exposure, gastrointestinal symptoms, and developmental regression.”

488. In contrast, from the Royal Free Hospital doctors’ perspective, these were clinical cases for whom there were no formal admission criteria, as such. In order to be seen by Professor 140

Walker-Smith, a child merely needed to be referred with GI symptoms. In order to be included in the Lancet series, a child needed only to have GI symptoms meriting colonoscopy, and a developmental disorder. There was absolutely no requirement for any perceived triggering of symptoms by MMR. This is self-evident from the cases of Child 5, 9, 10, and 12 and in the next 18 children seen (and reported to the British Society of Gastroenterology), only parents of three of those children made a link with MMR. See Exhibit 232, Abstract of presentation to the British Society of Gastroenterology. Deer’s assertion that: “…concern over MMR….was the essential term[s] of admission.” is patently false. It was in no way a condition of admission. 489. In order to assert the above, and for his argument to have any logical basis, Deer has to allege elsewhere that parents of 11 of the 12 children had linked their child’s problems with MMR but that this was deliberately omitted from the paper. “The paper’s first ‘finding’ that the “onset of behavioral symptoms was associated by the parent with measles, mumps, and rubella vaccination” was a manufactured artifact of Wakefield’s concealed recruitment strategy – drawing upon Mr. Barr’s clients and contacts, and parents listed by vaccine campaign groups -…” Deer’s affidavit to anti-SLAPP

490. There was no “recruitment” of these children in the sense suggested by Deer. I did not initiate the contact with any of the Lancet children, or Lancet children’s parents. I merely responded to parental requests for help for their seriously ill children. It was completely independent of Barr, as far as we were and are aware. None of the children were Barr’s clients, at the point of their referral to the Royal Free. There was absolutely no “concealed recruitment strategy” or strategy that “[drew] upon Mr. Barr’s clients.”

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491. I was found by the GMC to have played an “active involvement in the referral process” of Child 2, Child 9, Child 5, and Child 12. Deer picks up on this in para. 129, page 44 of his affidavit. “Concern over MMR,” that according to Deer was an “essential term of their admission,” was not the case for Child 5, Child 9, or Child 12. The circumstances of Child 2’s contact have been described previously. Since I originally referred this child to the clinical care of Prof. Walker-Smith at another hospital, when he had no interest in MMR, this criterion could have played no part in my decision to refer. Thus, any residual logic in Deer’s arguments falls apart. 492. In para 176. Deer embellishes his allegations. He refers to the “unscrupulous concealment of this device” [of drawing on Mr. Barr’s clients and contacts, and parents listed by vaccine campaign groups and making a link with MMR an essential term of admission). Through this device he alleges the Lancet Paper “…laundered into medical literature, as apparent facts, numerous primed, pre-agreed, but poorly-substantiated and often vague, memories and assertions, often not backed by contemporaneous medical records.” Deer’s Declaration in support of anti-SLAPP para 176

493. It is notable that in Deer now appears to present as fact, the priming and pre-agreeing that refers in the next paragraph to my apparently having phoned all of the parents at home. 494. In addition, the fact that some parents had been in contact with JABS – the support and campaign group that vexes Deer (for example see below) – was known to Prof. WalkerSmith at the time. He was averse to any involvement in litigation at that stage, but clearly did not feel that there was any “unscrupulous concealment of this device” or that there was any device at all that needed to be disclosed.

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Retraction of an Interpretation in the Lancet Paper. 495. Subsequent to Deer's disclosures to Richard Horton, the Lancet's editor, in February 2004, some of my colleagues issued the retraction of an interpretation of the Lancet Paper. 496. Deer has commented upon this retraction in Declaration in support of the Anti-SLAPP: "But as revealed in an exchange during this interview he [Wakefield] would not recognize the most basic facts. Daily Bell: We've already touched on it, but please explain in detail why the initial paper was disavowed by the Lancet. Wakefield: No, the paper did not make that claim that MMR was the cause of autism. However, it did raise the possibility that vaccines may be associated with autism. But you cannot retract a possibility. A possibility exists. It remains a possibility and therefore to retract it is illogical done purely as a political expedient." Deer Declaration in support of Anti-SLAPP para 146, Page 50. 497. The facts of the retraction are very straightforward. The interpretation provided by the Lancet was as follows: "We identified associated gastrointestinal disease and associated developmental regression in a group of previously normal children, which was generally associated in time with possible environmental triggers." Ex 1 498. The â&#x20AC;&#x153;retractionâ&#x20AC;? stated: "We wish to make it clear that in this paper no causal link was established between the MMR vaccine and autism as the data were insufficient. However, the possibility of such a link was raised and consequent events have had major implications for public health. In view of this, we consider now is the appropriate time that we should together formally retract the interpretation placed upon these findings in the paper, according to precedent." Ex 1, the Lancet Paper 2004;363:750.

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499. Therefore, it was the possibility that the authors of the â&#x20AC;&#x153;retractionâ&#x20AC;? sought to retract, and that possibility is that MMR was a trigger for the disorder in some cases. This is confirmed by Dr. Horton in his statement to the Lancet concerning the retraction of an interpretation. "This week, The Lancet prints a partial retraction - a retraction of an interpretation - from the majority of the authors of a paper published in February 1998 by Andrew Wakefield and colleagues. Wakefield and one other co-author, Peter Harvey, have not signed this retraction statement. We hope to publish their response very shortly. The original report made clear that the authors 'did not prove an association' between measles, mumps and rubella [MMR] vaccine and a newly described syndrome of bowel disease and autism. But the authors did raise the possibility of a link on the basis of parental and medical histories, and they suggested that 'further investigations are needed to examine this syndrome and its possible relation to this vaccine." This interpretation of their data, together with a suggestion made by Wakefield during a separate press conference held at the Royal Free Hospital that there was a case for splitting the MMR vaccine into its component parts, triggered a collapse in confidence in the U.K.'s MMR vaccination program. It is the interpretation expressed about a connection between the vaccine and the new syndrome that is now being retracted. Today's retraction comes after debate following the release of new information two weeks ago about the circumstances surrounding the publication of this work." Ex

Retraction of an Interpretation, Lancet 2004;363:1207. 500. Deer's response in his Anti-SLAPP was that no "possibility" was retracted. Rather, after discovering the circumstances under which Wakefield had been working for a lawyer and the covert involvement of litigants and campaign groups and the recruitment of children, the authors no longer stood by their conclusions. Deer is wrong for the reasons set out above. In addition, it is a fact that the authors make no mention of the other factors raised by Deer in their retraction. More important, they stand by their conclusions as to the finding of bowel disease in these children. The retraction states in pertinent part: â&#x20AC;&#x153;The main thrust of this paper was the fist description of an unexpected intestinal lesion in the children reported. Further evidence has been forthcoming in studies from the Royal Free Centre for Paediatric Gastroenterology and other groups to support and extend thses findings. 144

While much uncertainty remains about the nature of these changes, we believe it important that such work continues, as autistic children can potentially be helped by recognition and treatment of gastrointestinal problems.”

Right of reply 501. At no time in advance of publication was I offered sight of Deer’s article in the BMJ’s “Secrets” series, nor was I offered sight of the accompanying editorial or Editor’s Choice article. 502. At no time in advance of publication were my comments sought on, nor was I offered a right of reply to, either Deer’s article in the BMJ’s “Secrets” series, or the accompanying editorials. 503. Following publication, on I wrote to Dr. Godlee by email requesting a right of reply. I was not offered a full opportunity to reply. Instated I was offered a derisory opportunity to respond online on the BMJ Rapid Responses page on their website. I declined this offer as not being in any way commensurate with the attacks upon me in the published articles.

Prior litigation: 504. In 2004 and beyond Deer was involved in writing and broadcasting defamatory statements about me in the UK’s Sunday Times and on Channel 4 Television. These contained false and misleading information about me. After receiving advice of counsel, I initiated defamation proceedings against Deer and others in good faith and the claims were valid. The cases were certainly not filed for the purposes of publicity or harassment, nor were they filed to chill legitimate criticism or comment. They were filed to stop false defamatory statements. I was very keen to pursue what were valid claims. Ultimately, faced with

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fighting the GMC case concurrently, I had neither the time nor the financial resources to pursue the defamation cases and to defend against the GMC proceedings all at the same time. One suit was stayed. I sought a stay of the other one. When the judge denied the stay, I was faced with the prospect of fighting on three fronts at the same time. Consequently, I voluntarily dismissed the defamation proceedings in order to focus upon the GMC. It was a voluntary dismissal and no court threw the cases out. Money from patent 505. Defendants suggest in their papers filed with this Court that I had a hidden agenda of seeking personal wealth from my work in connection with a patent application related to Transfer Factor. This is simply not true. First, any patent rights were to be assigned to the Royal Free Medical School. Second, I had advised the Royal Free Medical School, in writing, of my intent that all inventor profit go to a charity for the care of individuals with gastrointestinal diseases and autism and that I and the other inventors would make no money from the patent whatsoever. This is confirmed in an attendance note made by lawyers for the GMC (Field Fisher Waterhouse) when they interviewed Mr. Chengiz Tarhan, the Medical School Finance Director during my time at the Royal Free Medical School. Ex 233, attendance note, Chengiz Tarhan. On page 6 it states:

â&#x20AC;&#x153;However, CT (Chengiz Tarhan) pointed to a letter from him to Dr. Wakefield dated 26 June 1998 where CT confirmed Dr Wakefieldâ&#x20AC;&#x2122;s wishes that all the inventor profit from the Transfer Factor patent was to go to a charity and that the inventors would make no money for themselves whatsoever.â&#x20AC;?

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Further, Affiant sayeth not. Signed this 19th Day of July, 2012.

________________________ ANDREW J. WAKEFIELD STATE OF TEXAS ยง ยง TRAVIS COUNTY ยง

Before me on this day personally appeared Andrew J. Wakefield, known to me to be the person whose name is subscribed to the foregoing instrument.

SUBSCRIBED and SWORN TO BEFORE ME on this _________ day of July 2012, to certify which witness my hand and seal of office.

________________________ Notary Public, State of Texas

147

Further,Affrant sayethnot. Signedthis 19thDay of July,2012.

ANDREW J. WAKEFIELD

STATEOFTEXAS $

TRAVISCOLINTY $

Before me on this day personally appearedAndrew J. Wakefield, known to me to be the person whose name is subscribedto the foregoing instrument.

SUBSCRIBEDand SWORNTO BEFOREME on this h 1 f certift which witnessmy handandsealof office.

KAYE. GENIRY NotarvPublic,Stateof Texas ExPircs My Gommieslo,n

Aprll20,2016

147

day of iuty 20t2,to