By Martin Hewitt
In April AoA published the first part of a series revisiting Brian Deer’s claim in the British Medical Journal on 5 January 2011 [HERE] that the findings in the Wakefield et al paper 'Ileal-lymphoid-nodular hyperplasia' (Lancet, 1998; vol. 351, p.637) were fixed. It focused on the first claim that three of the nine children reported with regressive autism did not have an autism diagnosis [HERE].
Part two examines Deer‘s second claim that “Despite the paper claiming that all 12 children were “previously normal,” five had documented pre-existing developmental concerns”. This is done by examining the published UK General Medical Council transcripts of the fitness to practice hearing against Dr Andrew Wakefield and Professors John Walker-Smith and Simon Murch. We can then judge the accuracy, selectivity and interpretive license he applies to his evidence against Wakefield.
Deer identifies children 4, 8, 1 and 5 as examples of developmental concerns raised before MMR. The fifth child is child 11, a US citizen whose case was not examined by the GMC and therefore cannot be verified. We will examine statements he makes about each of the four children and then visit the transcript evidence to see if it supports his claims. Readers can see Deer's bullet-point claims in the BMJ paper. Each of Deer's quotes, including the endnotes, is given in italics. The validity of the claims is then tested against evidence from the GMC. All emphases below are added to the original.
CHILD 4 (born March 1987; measles vaccination April 1988; MMR February 1991)
Quote 1: “child 4...had developmental delays, and also facial dysmorphisms, noted before MMR vaccination...Wakefield played down problems, suggesting that early issues had resolved. ‘Child four was kept under review for the first year of life because of wide bridging of the nose,’ he reported in the paper. ‘He was discharged from follow-up as developmentally normal at age 1 year.’ But medical records, presented by the GMC, give a different picture for this child. Reports from his pre-MMR years were peppered with “concerns over his head and appearance,” “recurrent” diarrhoea, “developmental delay,” “general delay,” and restricted vocabulary.
62. Dr Steel. Letter to Dr Sendall. 19 May 1988. Day 6 and Day 36.
63. William Tapsell. GP records. Day 6.
64. Dr Jackson. Letter to health visitor. 1988. Day 6.
65. ENT surgeon. Day 36. “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’.”
Deer claims that developmental concerns were raised about child 4 before his MMR. If we take the facial dysmorphisms first, a letter from Dr Shabde (paediatric register) to the GP (General Practitioner), read at the hearing, says, “[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 between the 50th and 75th percentile. His general growth appears to be satisfactory with his weight just below the 50th centile” (Day 6, p.57).
The paper’s authors did not see Dr Shabde’s letter and relied on the GP referral letter and the case history they took. Nonetheless the Lancet paper reports accurately that, “Child 4 was kept under review for the first year of life because of wide bridging of the nose. He was discharged from follow-up as developmentally normal at age 1 year (Wakefield et al, 1998 see above, p.638).
What Deer does not reveal is that child 4 had measles vaccination at 15 months, prior to MMR in February 1991. This significant fact was referred to in the Lancet paper: “[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. 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 behaviour that she did link with the immunisation” (Wakefield et al (1998) see above, p.638). Deer’s endnotes 62 to 65 above refer to doctors’ comments on developmental problems after child 4’s measles vaccination in March 1988. To be pedantic one might say that the measles vaccination is not the MMR. But for completeness, the paper referred to both immunizations noting slowing development after the measles vaccination and striking delay after MMR. It was at the latter point that parents suspected post-MMR regression.
Quote 2. “And although before his referral to Wakefield his mother had inquired about vaccine damage compensation, his files include a report of a “very small deletion within the fragile X gene”.
66. Government vaccine damage payments unit. Request for information. 18 September 1995. Day 36.
67. Consultant geneticist letter. Day 6. “We are not sure whether this deletion is significant at all and certainly there is a very high possibility that it has nothing to do with [child 4’s] autism.”
Deer expressly refers in the body of his article to “very small deletion within the fragile X gene’ as a significant finding worth mentioning on early developmental delay. It is only when readers trawl down to endnote 67 that the finding is placed in context and its lack of relevance to developmental delay made clear.
CHILD 8 (born June 1993; MMR 27 January 1995)
Quote 1. “Child 8…was also described in the Lancet as having overcome problems recorded before vaccination. ‘The only girl . . . was noted to be a slow developer compared with her older sister,’ the paper said. ‘She was subsequently found to have coarctation of the aorta. After surgical repair of the aorta at the age of 14 months, she progressed rapidly, and learnt to talk. Speech was lost later.’….Her doctors put the coarctation side by side with the delay and dysmorphism, and noted of her vocabulary that, before MMR at 18 months, she vocalised only ‘two or three words.’”
71. Wheldon Houlsby [consultant paediatrician]. Letter to Neela Shabde [community paediatrician] 17 February 1995. Day 29. “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 10½ months I discovered that she had a coarctation, and referred her to the paediatric cardiologists. This was repaired surgically, and she is now well from this point of view. However concern about her development persists.”
72. For reference, according to Medline Plus, from the US National Library of Medicine and the National Institutes of Health, the typical 18 month old “Can say 10 or more words when asked”. According to the Early Identification of Developmental Delay and Disability project, funded by the state of California, at age 15 months, a child typically “uses 4-6 words”, and at 16-18 months “uses 7-20 words”.
73. Michael Rutter. Evidence to the panel. Day 37. “It is the kind of account that one often gets with an autism spectrum disorder. The fact that the child had only two to three words would make one uncertain as to whether this is a true bill or not, in that that is a very small amount of language to lose, but this is the kind of thing that one often sees so that the picture that comes out of all of these records is of a developmental problem that began early, involves language, involves some autistic-like features, quite a lot of hyperactivity, so that there does not seem much doubt that there was some sort of pervasive developmental disorder that could be regarded as falling on the autism spectrum at an earlier point.”
Endnote 71 refers to consultant paediatrician Dr Houlsby’s examination of child 8 after MMR and not ‘side by side with’ the earlier suspicion of coarctation of the aorta. This is what Dr Houlsby said about child 8 in May 1994 before MMR, at the first examination the previous year: 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. She has mild eczema.... My impression was that she is a child who is developing within normal limits, but in whom I thought I may have found congenital heart disease as an incidental finding. I have arranged an EEG which was of very poor quality but probably within normal limits … I am therefore referring her to the Paediatric Cardiologists for a further opinion.” (Letter from Dr Houlsby, consultant paediatrician, to Dr Tapsfield (another practice GP), 24 May 1994, Day 29, p.2). Writing to the paediatric cardiac surgeon on 23 December 1994, a month before MMR, Dr Houlsby reiterates his view that child 8’s abilities “were not outside the normal” (Day 29, p.3). In summary, the child is assessed as normal apart from congenital heart disease.
Deer’s quote from Houlsby’s letter of 17 February 1995 (endnote 71) refers to an examination that raised developmental concerns shortly after the MMR given on 27 January 1995. The transcripts record the following summary by the prosecuting counsel examining the GP Dr Jelley. Referring to the same letter from Dr Houlsby to Dr Shabde (the community paediatrician), counsel says: “’Dictated 17 February 1995’, so a matter of a few weeks after the MMR. [Dr Houlsby] says, ‘She was recently admitted to the ward [on 13 February 1995] following a febrile convulsion in association with gastroenteritis...When I reviewed her in clinic recently I confirmed that she is globally developmentally delayed, functioning at about a one year level... There were no neurological abnormalities other than the developmental delay’” (Day 29, p.6).
So Deer’s quote refers to the consultant’s record of his examination of child 8 following a febrile convulsion and gastroenteritis 2 weeks after MMR and requiring emergency hospital admission.
In endnotes 72 & 73, Deer refers to the number of words child 8 spoke by 18 months before MMR at 20 months, suggesting early delay in language acquisition. Professor Rutter, the prosecution's psychiatric expert witness, advises that the number of words lost based on the number of words acquired in the first year is too small for an assessment of significant loss. However, contrary to his advice, he goes on to suggest that the loss of two or three words may be typical of developmental problems and autism. But no reference to the child’s vocabulary of “two or three words” is given in the GP’s examination on Day 29. Rutter’s reference to ‘two or three words’ is unreferenced and a “this is the kind of thing that one often sees” generalisation.
Several references are made in doctors’ letters to the mother's saying that child 8 had several words before her MMR immunisation which were subsequently no longer used. For example, the GP says to the hearing, "Several months later her mum said she had been looking at a video when Child 8 had a little bit of speech before the vaccination and she felt that that had reduced post-vaccination" (Day 29, p.4).
Quote 2. “[B]oth the hospital and members of the primary care team involved with [child 8] had significant concerns about her development some months before she had her MMR.”
74. Diana Jelley. Referral letter to Wakefield. 3 October 1996. Day 29
Again Deer persists with his claim that child 8’s developmental problems began before MMR. He refers to the GP’s referral letter to Dr Wakefield which, though claiming concerns prior to MMR, in fact referred to Dr Houlsby’s letter of 17 February 1995 (see above) noting child 8’s condition after the MMR, namely gastroenteritis and convulsions. But again other parts of the hearing transcripts cast doubt on Deer’s claim. For example, the prosecuting counsel asks Dr Jelley, GP: “What was the mother of Child 8’s perception of Child 8’s reaction to the vaccine? Answer: I felt that the mother was concerned fairly soon after the vaccine – I think I saw her at home on a home visit shortly after the vaccination – she had had a kind of feverish reaction to it. There obviously was no suggestion of delay at that point..." (In fact, Dr Houlsby's letter of 17 February 1995 referred to her being "globally developmentally delayed"). The examination continues: Question: In terms of the more immediate reaction to the vaccine, you say that mum reported a fever. Answer: Yes. I remember seeing her at home and then I think she was admitted with a febrile convulsion shortly afterwards” (Day 29, p.4).
Contrary to Deer’s claim that child 8 had developmental delay before MMR, the following GP note records the concerns raised by the post-MMR convulsions: “MMR Jan 95: -> Grand mal convulsion Feb 95 2 weeks after MMR (no letter). Never the same again. Frequent diarrhoea, not infected but no tests done. Eats well and gains weight” (GP note, May 1994, Day 29, p.5).
The Lancet paper accurately records this in Table 2, stating under column headed ‘Interval from exposure to first behavioural symptom’, “2 weeks”, and under ‘Features associated with exposure’, “Fever, convulsion, rash & diarrhoea”, so corroborating the GP’s account.
CHILD 1 (born January 1993; MMR 19 January 1994)
Quote 1: “One of the mother’s concerns was that he could not hear properly—which might sound like a hallmark presentation of classical autism, the emergence of which is often insidious.”
Despite Deer’s suggestion of a hallmark presentation of classic autism evidenced in the child's earliest months, the GP’s record says differently: "4.11.93...Mum worried re hearing/wax in ears/? Discharge left ear…Reassured.” (Day 5, p.52). In other words, Deer is referring to the common childhood condition. The ‘hallmark’ was not an indication of a more insidious condition.
However, 13 months after MMR child 1 did see an audiologist who reported that “’Mrs 1 reported that Child 1 has around three meaningful words but his comprehension appears to be delayed....We are satisfied that Child 1’s hearing is adequate for normal development of speech and have discharged him from this clinic. (Day 5, p.53)”. After more than a year following MMR, this ‘hallmark presentation’ had now become a sign of developmental regression.
Quote 2: “Child 1 was vaccinated at 12 months of age, however...in the Lancet, the ‘first behavioural symptom’ was reported ‘1 week’ after the injection, holding the evidence for the lawsuit on track. Step 1 to achieve this: two and a half years after the child was vaccinated, Walker-Smith took an outpatient history. Although the mother apparently had no worries following her son’s vaccination, the professor 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.(81) “It’s difficult to associate a clear historical link with the MMR and the answer to autism,” Walker-Smith wrote to the general practitioner, with a similar letter to Wakefield, “although [Mrs 1] does believe that [child 1] had an illness 7-10 days after MMR when he was pale, ?fever, ?delirious, but wasn’t actually seen by a doctor.”
80. Anthea Barrow. Referral letter. 17 May 1996. “Mr & Mrs 1’s most recent concern is that the MMR vaccination given to their son may be responsible for the autism.” Day 5.
81. John Walker-Smith. Letter to Wakefield. 21 June 1996. Day 36.
82. John Walker-Smith. Letter Andrea Barrow. 21 June 1996. Day 77. Day 102.
Here, as elsewhere, Deer seems to assume that arriving at a diagnosis of autism is straightforward for parents and for doctors, ignoring the often lengthy retrospective process of arriving at a definitive diagnosis. He uses his simplified understanding of the diagnostic process to construct a narrative of Dr Wakefield ‘fixing’ the Lancet data in steps one to four. However the evidence shows otherwise. Professor Walker-Smith’s case history accurately records the parents’ belief that child 1 had a fever and was delirious seven to ten days after MMR. This information is entered in Table 2 of the paper, which states “1 week” under ‘Interval from exposure to first behavioural symptom’. The next column shows the ‘features associated with exposure’ as “Fever/delirium”.
Quote 3: “Step 2: for the Lancet, Wakefield dropped the question marks, turning Walker-Smith’s queries into assertions. And, although Royal Free admission and discharge records refer to ‘classical’ autism, step 3, the former surgeon reported ‘delirium’ as the first ‘behavioural symptom’ of regressive autism, with, step 4, a ‘time to onset’ of 7 days’.”
Walker-Smith’s use of question marks in his record of the parents’ statement reflects the passage of time between the first signs of regression following MMR and his examination of child 1 two and a half years later at the Royal Free, by which time autism had been expressly mooted. In compiling Table 2, summarising the case histories which members of the research team (but not Wakefield) took from parents, Wakefield distilled the essential points and removed Walker-Smith’s annotations. There was nothing underhand ‒ as Deer suggests ‒ in tabulating the bare information given by parents: the Lancet’s 'Early Report' paper summarises the information gleaned from the case histories and other clinical data.
The behavioural symptom ‘delirium’ accurately describes the symptom parents noted at about 1 week without knowing that their child would eventually be diagnosed as autistic.
Deer questions child 1’s diagnosis of regressive autism and bowel disease. However his admission to the Royal Free was for clinical investigations based on symptoms not diagnoses. The GP enclosed some consultant letters with her referral letter. Indeed, the GMC transcripts reveal the following records after MMR and prior to referral to the Royal Free, supporting the case for regressive autism and bowel symptoms:
The GP notes for 26 October 1994, written when child 1 had his 21-month check, 9 months after MMR and 19 months before his referral to the Royal Free, say, ‘“Little co-operation with psychomotor assessment. Will not obey. Tantrums when denied. Does not seem to understand or express speech very much. (cf probs with older brother). Discuss with health visitor for check audio. Re-assess in early 95. Long chat with mum” (Day 5, p.52). So the early signs of developmental illness were evident to the GP within months of MMR and long before the child’s referral to the Royal Free.
Quote 4: “So here—behind the paper—is how Wakefield evidenced his ‘syndrome’ for the lawsuit, and built his platform to launch the vaccine scare.
To construct his case that Wakefield fabricated the evidence, Deer must impute a motive as to why he would risk his reputation, namely that Wakefield wanted to discover a new syndrome to support the case of disabled children litigating against MMR manufacturers for vaccine damage. The discovery of a new syndrome is central to Deer’s case. However, he uses the term ‘syndrome’ (ie an association between two or more previously unrelated symptoms, namely autism and bowel disease) in two confusing ways: as a “brain-bowel syndrome” and as an “MMR syndrome”. But the evidence doesn’t serve Deer’s case. There is no reference in the Lancet paper to a “new syndrome” linking autism and bowel disease. All the references are to a hypothetical syndrome qualified, as befits a small initial case series paper, as follows:
CHILD 5 (born 10 December 1988; MMR 10 April 1990)
Quote 1: “Child 5, from Berkshire, aged 7 at admission, 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.”
86. Child 5 was born on 10 December 1988 and received MMR on 10 April 1990.
87. Geoffrey Shillam. GP records. 24 November 1989. Day 11.
88. Dr Williams. Letter to Dr Wilkinson. January 1992. Day 11, Day 36 “At one year he had convulsions which led to a further hospital admission but these appear to have been due to a high fever. From then on his parents noticed a difference in his development and feel that these febrile epileptic seizures continue to the present day... At 10 months of age he was saying mummy and daddy but then became very miserable and appeared to lose ground in his development after he had been in hospital.”
The Lancet paper Table 2 says under ‘Exposure identified by parent or doctor’: ‘none’. Therefore there was no evidence to fabricate. Deer suggests this is another case where there is no link between MMR and autism, but in this case the paper does not report a link.
Based on Dr William’s letter (see endnote 88) of January 1992 and written 21 months after MMR, Deer suggests that febrile convulsions and high fever at 10 months are evidence that concerns were raised prior to MMR. However, once again the transcripts for Day 11 show that for child 5 (as for all 11 children) autism and bowel symptoms were identified after MMR – and so this child was included in the Lancet 12:
We have focused on Deer’s second claim that “the paper specified that all 12 children were “previously normal,” but that five had documented pre-existing developmental concerns.
He selects those parts of the transcripts that support the case for Wakefield fixing the data and ignores other parts that undermine the case. He ignores letters, reports and witness statements that show the children developing normally before the MMR. For example, he ignores accounts of child 4’s normal development at nine months (apart from the coarctation), and child 8’s normal development at 11 months. He does not mention child 4’s measles vaccination several years before his MMR. He misses the significance of child 8’s convulsions and gastroenteritis immediately after MMR. He sets down false trails that lead nowhere, such as child 4’s fragile X gene or child 1’s hearing before MMR. He confuses a syndrome associating autism and bowel disease ‒ presented as part of the case series paper ‒ with the ‘MMR syndrome’. He oversimplifies the everyday complexities and uncertainties doctors and parents grapple with in reaching an autism diagnosis.
Yet, contrary to Deer’s claim, the above documentary evidence from the GMC hearing points to the possibility that the children underwent developmental regression, in the form of autism and bowel disease, after MMR and not before. On balance a more extensive reading of the GMC transcripts than he provides upholds rather than undermines the findings of the Lancet paper.
Martin Hewitt, PhD is a former UK social policy academic whose research focused on the politics of health and welfare. He has written several books, chapters for edited books and journal papers. Until recently he managed social policy and pensions work at the Institute of Actuaries in London. He has a teenage autistic son.