First to crack was “regressive autism,” the bedrock of his allegations. “Bear in mind that we are dealing with regressive autism in these children, not of classical autism where the child is not right from the beginning,” he later explained, for example, to a United States congressional committee.
But only one—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.
The paper did not reveal that two of this trio were brothers, living 60 miles south of the hospital. Both had histories of fits and bowel problems recorded before their MMR vaccinations. The elder, child 6, aged 4 years at admission, had Asperger’s syndrome, which is distinct from autism under DSM-IV, is not regressive, and was confirmed on discharge. His brother, child 7, was admitted at nearly 3 years of age without a diagnosis, and a post-discharge letter from senior paediatric registrar and Lancet coauthor David Casson summarised: “He is not thought to have features of autism.”
The third in the trio, child 12, was enrolled on the advice of the brothers’ mother—reported in media to be a JABS activist, and who had herself “only relatively recently” blamed the vaccine. Child 12 was aged 6 at admission and had previously been assessed for possible Asperger’s syndrome at Guy’s Hospital, London, by a renowned developmental paediatrician. She diagnosed “an impairment in respect of language”—an opinion left undisturbed by Berelowitz.
Mrs 12 was a GMC witness at its mammoth hearing, which between July 2007 and May 2010 ran for 217 days. She explained that the brothers’ mother had made her suspicious of MMR and had given her Barr’s and Wakefield’s names. Mrs 12 then approached them and filed a statement for legal aid before her son was referred.
“It was like a jigsaw puzzle—it suddenly seemed to fit into place,” she told the panel, describing how she concluded, four years after the boy was vaccinated, that MMR was to blame for his problems. “I had this perfectly normal child who, as I could see, for no apparent reason started to not be normal.”
The 12 children were admitted between July 1996 and February 1997, and others had connections not revealed in the paper, almost as striking as the trio’s. The parents of child 9 and child 10 were contacts of Mrs 2, who ran a group that campaigned against MMR. And child 4 and child 8 were admitted—without outpatient appointments—for ileocolonoscopy and other invasive procedures, from one Tyneside general practice, 280 miles from the Royal Free, after advice from anti-MMR campaigners.
Both child 4 and child 8 were among the eight whose parents were reported to have blamed the vaccine. But although the paper specified that all 12 children were “previously normal,” both had developmental delays, and also facial dysmorphisms, noted before MMR vaccination.
In the case of child 4, who received the vaccine at age 4 years, 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. 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,” and a note of the mother’s view that her concerns about his development had begun when he was 18 months old.
“In general, his mother thinks he developed normally initially and subsequently his problems worsened, and he lost some of his milestones, but he subsequently improved on a restrictive exclusion diet,” wrote his general practitioner, William Tapsfield, referring the boy, then aged 9, after a phone conversation with Wakefield. “The professionals who have known [child 4] since birth don’t entirely agree with this, however, and there is a suggestion that some of his problems may have started before vaccination.”
Similarly with child 8, who 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.”
But Wakefield was not a paediatrician. He was a former trainee gastrointestinal surgeon with a non-clinical medical school contract. And his interpretation differed from that of local consultants (including a developmental paediatrician and a geneticist) who had actually looked after the girl. 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.”
“[Child 8’s] mother has been to see me and said you need a referral letter from me in order to accept [child 8] into your investigation programme,” the general practitioner, Diana Jelley, wrote to Wakefield at referral, when the girl was aged 3 and a half years. “I would simply re-iterate . . . that both 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.”
The girl’s general practice notes also provide insight into the background to the 12 children’s referrals. After person(s) unknown told Mrs 8 that her daughter may have inflammatory bowel disease, Jelley wrote: “Mum taking her to Dr Wakefield, Royal Free Hospital for CT scans/gut biopsies ?Crohn’s—will need ref letter—Dr W to phone me. Funded through legal aid.”
The child was “pale”
The remaining five children served Wakefield’s claims no better. There was still no convincing MMR syndrome. Child 1, aged 3 years when he was referred to London, lived 100 miles from the Royal Free, and had an older brother who was diagnosed as autistic. Child 1’s recorded story began when he was aged 9 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 a hallmark presentation of classical autism, the emergence of which is often insidious. Indeed, a Royal Free history, by neurologist and coauthor Peter Harvey, noted “normal milestones” until “18 months or so.”
Child 1 was vaccinated at 12 months of age, however. Thus neither 9 nor 18 months helped Wakefield’s case. But 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.
“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.”
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.
So here—behind the paper—is how Wakefield evidenced his “syndrome” for the lawsuit, and built his platform to launch the vaccine scare.
“It is significant that this syndrome only appeared with the introduction of the polyvalent MMR vaccine in 1988 rather than with the monovalent measles vaccine introduced in 1968,” he claimed in one of a string of patents he filed for businesses to be spun from the research. “This indicates that MMR is responsible for this condition rather than just the measles virus.”
Three of the four remaining children were seen in outpatients on the same day—in November 1996. None of their families were reported in the paper as blaming the vaccine. 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. Child 9, aged 6, from Jersey, also had MMR at 16 months. His mother dated problems from 18-20 months. Child 10, aged 4, from south Wales, contracted a viral infection, which was suspected by parents and doctors to have caused his disorder, four months after his vaccination.
“Behavioural changes included repetitive behaviour, disinterest in play or head banging,” said a question and answer statement issued by the medical school, concerning the Lancet 12, on the day of the paper’s publication.
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, and 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.