MMR SCARE

HOW THE CASE AGAINST THE MMR VACCINE WAS FIXED In the first part of a specialBMJ 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

hen I broke the news to the brain and bowel diseases. Child 11 was the closed £150 (€180; $230) an hour through a father of child 11, at first he did penultimate case. Norfolk solicitor named Richard Barr, he had not believe me. “Wa­kefield told Running his finger across the paper’s tables, been confidentially put on the payroll for two us my son was the 13th child over coffee in London, Mr 11 seemed reassured years before the paper was published, eventu- they saw,” he said, gazing for by his anonymised son’s age and other details. ally grossing him £435 643, plus expenses.4 Wthe first time at the now infamous research But then he pointed Curiously, however, paper which linked a purported new syndrome at table 2—headed “The regulator’s main focus Wakefield had already with the measles, mumps, and rubella (MMR) “neuropsychiatric was whether the research identified such a syn- vaccine.1 “There’s only 12 in this.” diag­nosis”—and for a drome before the That paper was published in the Lancet second time objected. was ethical. Mine was project that would on 28 February 1998. It was retracted on “That’s not true.” whether it was true” reputedly discover it. 2 February 2010.2 Authored by Andrew Wake- Child 11 was among “Children with enteri- field, John Walker-Smith and 11 others from the eight whose parents apparently blamed tis/disintegrative disorder [an expression he the Royal Free Hospital and School of Medi- MMR. The interval between his vaccination used for bowel inflammation and regressive cine, London, it reported on 12 developmen- and the first “behavioural symptom” was autism5 form part of a new syndrome,” he tally challenged children, and triggered a reported as 1 week. This symptom was said and Barr explained in a confidential grant decade long public health scare. to have appeared at age 15 months. But his application to the UK government’s Legal Aid “Onset of behavioural symptoms was associ- father, whom I had tracked down, said this Board,6 before any of the children were inves- ated by the parents with measles, mumps, and was wrong. tigated. “Nonetheless the evidence is undeni- rubella vaccination in eight of the 12 ­children,” “From the information you provided me on ably in favour of a specific vaccine induced began the paper’s “findings.” Adopting these our son, who I was shocked to hear had been ­pathology.” claims as fact, its results section included in their published study,” The two men also aimed to show a sudden added: “In these eight chil- he wrote to me, after we met again onset “temporal association”—strong ­evidence dren the average interval from in California, “the data clearly in product liability. “Dr Wakefield feels that if exposure to first behavioural appeared to be distorted.” we can show a clear time link between the symptoms was 6.3 days (range He backed his concerns with ­vaccination and onset of ­symptoms,” Barr told 1-14).” medical records, including a Royal the legal board, “we should be able to dispose Mr 11, an American engi- Free discharge summary. Although of the suggestion that it’s simply a chance neer, looked again at the the family lived 5000 miles from encounter.”7 paper: a five page case series the hospital, in February 1997 the boy But child 11’s case must have proved a dis- of 11 boys and one girl, aged (then aged 5) had been flown to London appointment. Records show his behavioural between 3 and 9 years. Nine and admitted for Wakefield’s project, the symptoms started too soon. “His developmen- children, it said, had diag- undisclosed goal of which was to help tal milestones were normal until 13 months noses of “regressive” autism, sue the vaccine’s manufacturers. of age,” notes the discharge summary. “In while all but one were the period 13-18 months he developed slow reported with “non-specific Wakefield’s “syndrome” speech patterns and repetitive hand move- colitis.” The “new ­syndrome” Unknown to Mr 11, Wakefield was ments. Over this period his parents remarked brought these working on a lawsuit,3 for which he on his slow gradual deterioration.” together, sought a bowel-brain “syndrome” as That put the first symptom two months l i n k i ng its centrepiece. Claiming an undis- ­earlier than reported in the Lancet, and a

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HOW THE LINK WAS FIXED The Lancet paper was a case series of 12 child patients; it reported a proposed “new syndrome” of enterocolitis and regressive autism and associated this with MMR as an “apparent precipitating event.” But in fact: month before the boy • Three of nine children reported with regressive I travelled to the ad­mission, at age 8, after she had discussed her had MMR. And this was autism did not have autism diagnoses at all. family home, 80 miles son’s story with Wakefield.10 not the only anomaly Only one child clearly had regressive autism northeast of London, As I later discovered, each family in the project to catch the father’s • Despite the paper claiming that all 12 children to hear about child was involved in such discussions before they were “previously normal,” five had documented eye. What the paper 2 from his mother. saw the hospital’s clinicians. Wakefield phoned pre-existing developmental concerns reported as a “behav- That was in Septem- them at home, and must have at least sugges- • Some children were reported to have ioural symptom” was experienced first behavioural symptoms within ber 2003, when the tively questioned them, potentially impacting noted in records as a days of MMR, but the records documented lawsuit fell apart after on later history taking. But I knew little of such chest infection. these as starting some months after vaccination counsel representing things then, and shared my confusion with “Please let me • In nine cases, unremarkable colonic 1500 families said Walker-Smith, who I met shortly after Mrs 2. know if Andrew W has histopathology results—noting no or minimal that, on the evidence, “There is no case in the paper that is consist- his doctor’s license fluctuations in inflammatory cell populations— Barr’s autism claims ent with the case history [Mrs 2] has given me,” revoked,” wrote Mr 11, were changed after a medical school “research would fail.15 By that I told him. “There just isn’t one.” who is convinced that review” to “non-specific colitis” time, Mrs 2 had seen “Well that could be true,” the former professor many vaccines and • The parents of eight children were reported her son’s medical of paediatric gastroenterology replied, disarm- as blaming MMR, but 11 families made this environmental pollut- records and expert ingly. He knew the case well, having admitted allegation at the hospital. The exclusion of ants may be responsi- three allegations—all giving times to onset reports, written for her the boy for the project and written reports for 16 ble for childhood brain of problems in months—helped to create the case at trial. Barr, who paid him £23 000. disorders. “His misrep- appearance of a 14 day temporal link Her concerns about “Well, so either what she is telling me is not resentation of my son • Patients were recruited through anti-MMR MMR had been noted accurate, or the paper’s not accurate.” in his research paper campaigners, and the study was commissioned by her general prac- “Well I can’t really comment,” he said. “You is inexcusable. His and funded for planned litigation titioner when her son really touch on an area which I don’t think motives for this I may was 6 years old. But should be debated like this. And I think these never know.” she told me the boy’s troubles began after his parents are wrong to discuss such details, where The father need not have worried. My inves- vaccination, which he received at 15 months. you could be put in a position of having a lot of tigation of the MMR issue exposed the frauds “He’d scream all night, and he started head medical details and then try to match it with this, behind Wakefield’s research. Triggering the banging, which he’d never done before,” she because it is a confidential matter.” longest ever UK General Medical Council fit- explained. It was not merely medically confidential, it was ness to practise hearing, and forcing the Lancet “When did that begin, do you think?” I asked. also legally protected: a double screen against to retract the paper, last May it led to Wakefield “That began after a couple of months, a few public scrutiny. But responding to my first MMR and Walker-Smith being struck off the medical months afterward, but it was still, it was con- reports in the Sunday Times, in Fe­bruary 2004,17 register.8‑10 cerning me enough, I remember going back.” the GMC decided to investigate the cases and Wakefield, now 54, who called no witnesses, “Sorry. I don’t want to be, like, massively per- re­quisitioned the children’s records. was branded “dishonest,” “unethical,” and “cal- nickety, but was it a few months, or a couple of The regulator’s main focus was whether the lous.”8‑10 Walker-Smith, now 74, the senior clini- months?” research was ethical. Mine was whether it was cian in the project, was found to have presided “It was more like a few months because he’d true. So as a five member disciplinary panel over “high risk” 11 research without clinical indi- had this, kind of, you know, slide down. He trawled through the records, with five Queen’s cation or ethical approval. The developmentally wasn’t right. He wasn’t right. Before he started.” counsel and three defendant doctors, I com- challenged children of often vulnerable parents “Not quicker than two months, but not longer pared them with what was published in the were discovered to have been treated like the doc- than how many months? What are we talking journal.18 tors’ guinea pigs.10 about here?” “From memory, about six months, I think.” Multiple discrepancies Lawsuit test case The next day, she complained to my editors. The paper gave the impression that the authors But Mr 11 was not the first parent with a child in She said my methods “seemed more akin to had been scrupulous in documenting the the study whom I interviewed during my inves- the gutter press.” But I was perplexed by her patients’ cases. “Children underwent gastro- tigation. That was Mrs 2: the first of the parents story, since there was no case in the Lancet that enterological, neurological, and developmen- to approach Wakefield. She was sent to him by matched her careful account. tal assessment and review of developmental an anti-vaccine campaign called JABS. Her son According to the paper, child 2 had his “first records,” it explained, specifying that Diagnos- had regressive autism,12 longstanding problems behavioural symptom” two weeks, not six tic and Statistical Manual of Mental Disorders IV with diarrhoea,13 and was the prime example of months, after MMR. This was derived from a (DSM-IV) criteria were used for neuropsychiatric the purported bowel and brain syndrome—still Royal Free medical history (citing “head bang- diagnoses. “Developmental histories included unsubstantiated 14 years later.14 This boy would ing” and “screaming” as the start) taken by Mark a review of prospective developmental records appear in countless media reports, and was one Berelowitz, a child psychiatrist and a coauthor from parents, health visitors, and general of the four “best” cases in Barr’s lawsuit. of the paper. He saw Mrs 2 during the boy’s pr­actitioners.”

78 BMJ | 8 JANUARY 2011 | VOLUME 342 MMR SCARE STEVEPARSONS/PAARCHIVE/PA MMR vaccine Journalist Brian Deer Andrew Wakefield Coauthor John Walker-Smith

When the details were dissected before Mrs 12 was a GMC witness at its mammoth In the case of child 4, who received the vac- the panel, however, multiple discrepancies hearing, which between July 2007 and May cine at 4 years, Wakefield played down prob- emerged. A syndrome necessarily requires at 2010 ran for 217 days. She explained that lems, suggesting that early issues had resolved. least some consistency, but, as the records were the brothers’ mother had made her suspicious “Child four was kept under review for the first laid out, Wakefield’s crumbled. of MMR and gave her Barr’s and Wakefield’s year of life because of wide bridging of the First to crack was “regressive autism,” the names. Mrs 12 approached them and filed nose,” he reported in the paper. “He was dis- bedrock of his allegations.3 “Bear in mind that a statement for legal aid before her son was charged from follow-up as developmentally we are dealing with regressive autism in these referred. normal at age 1 year.” children, not of classical autism where the “It was like a jigsaw puzzle—it suddenly But medical records, presented by the GMC, child is not right from the beginning,” he later seemed to fit into place,” she told the panel, give a different picture for this child. Reports explained, for example, to a United States con- describing how she concluded, four years after from his pre-MMR years were peppered with gressional co­mmittee.19 the boy was vaccinated, that MMR was to blame “concerns over his head and appearance,” But only one—child 2—clearly had regressive for his problems. “I had this perfectly normal “recurrent” diarrhoea, “developmental delay,” autism.20 Three of nine so described clearly did child who, as I could see, for no apparent reason “general delay,” and restricted vocabulary. not. None of these three even had autism diag- started to not be normal.” And although before his referral to Wakefield noses, either at admission or on discharge from The 12 children were admitted between July his mother had inquired about vaccine dam- the Royal Free. 1996 and February 1997, and others had con- age compensation, his files include a report The paper did not reveal that two of this nections not revealed in the paper, almost as of a “very small deletion within the fragile X trio were brothers, living 60 miles south of the striking as the trio’s. The parents of child 9 and gene,” and a note of the mother’s view that her hospital. Both had histories of fits and bowel child 10 were contacts of Mrs 2, who ran a group concerns about his development began when problems recorded before they received MMR. that campaigned against MMR. And child 4 and he was 18 months old. The elder, child 6, aged 4 years at admission, child 8 were admitted—without “In general, his mother had Asperger’s syndrome,21 which is distinct outpatient appointments10—for thinks he developed normally from autism under DSM-IV, is not regressive,22 ileocolonoscopy and other inva- initially and subsequently and was confirmed on discharge.10 His brother, sive procedures, from one Tyne- his problems worsened, and child 7, was admitted at nearly 3 years of age side general practice, 280 miles he lost some of his mile- without a diagnosis,10 and a post-discharge let- from the Royal Free, after advice stones, but he subsequently ter from senior paediatric registrar and Lancet from anti-MMR ca­mpaigners. improved on a restrictive coauthor David Casson summarised: “He is not exclusion diet,” wrote his thought to have features of autism.” Pre-existing problems general practitioner, William The third of this trio, child 12, was enrolled Both child 4 and child 8 were Tapsfield, referring the boy, then on the advice of the brothers’ mother— among the eight whose parents aged 9, after a phone conversation reported in media as a JABS activist, who had were reported to have blamed the with Wakefield. “The profession- herself “only relatively recently” blamed the vaccine. But although the paper als who have known [child 4] vaccine. Child 12 was aged 6 at admission specified that all 12 children since birth don’t entirely agree and had p­reviously been assessed for possi- were “previously normal,” both with this, however, and there ble ­Asperger’s syndrome at Guy’s ­Hospital, had developmental delays, and is a suggestion that some of London, by a renowned developmental also facial dysmor- his problems may have started ­paediatrician. She diagnosed “an ­impairment phisms, noted before vaccination.” in respect of language”—an opinion left before MMR Similarly with child 8, who ­undisturbed by Berelowitz.10 vaccination. was also described in the Lancet

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bmj.com archive ЖЖFeature: Wakefield’s “autistic enterocolitis” under the microscope BMJ( 2010;340:c1127) ЖЖNews: Wakefield is struck off for the “serious and wide-ranging findings against him”BMJ ( 2010;340:c2803) ЖЖNews: Lancet retracts Wakefield’s MMR paper BMJ( 2010;340:c696)

as having overcome problems recorded before This boy was vaccinated at 12 months of age, po­lyvalent MMR vaccine in 1988 rather than MMR. “The only girl . . . was noted to be a slow however. Thus neither 9 nor 18 months helped with the monovalent measles vaccine intro- developer compared with her older sister,” Wakefield’s case. But in theLancet , the “first duced in 1968,” he claimed in one of a string the paper said. “She was subsequently found behavioural symptom” was reported to have of patents he filed for businesses to be spun to have coarctation of the aorta. After surgical occurred “1 week” after the injection, holding from the research.23 “This indicates that MMR repair of the aorta at the age of 14 months, she the evidence for the lawsuit on track. is responsible for this condition rather than just progressed rapidly, and learnt to talk. Speech Step 1 to achieve this: two and a half years the measles virus.” was lost later.” after the child was vaccinated, Walker-Smith Three of the four remaining children were But Wakefield was not a paediatrician. He took an outpatient history. Although the mother seen in outpatients on the same day—in was a former trainee gastrointestinal surgeon apparently had no worries following her son’s November 1996. None of their families were with a non-clinical medical school contract.10 vaccination, the professor elicited that the boy reported in the paper as blaming the vaccine. And his interpretation differed from that of was “pale” 7-10 days after the shot. He also elic- Child 5, from Berkshire, aged 7 at admission, local consultants (including a developmental ited that the child “possibly” had a fever, and had received MMR at 16 months. The paper paediatrician and a geneticist) who had actually “may” have been delirious, as well as pale. reported concerns at 18 months, but the medi- looked after the girl. Her doctors put the coarc­ “It’s difficult to associate a clear historical cal records noted fits and parental worries at tation side by side with the developmental delay link with the MMR and the answer to autism,” 11 months. Child 9, aged 6, from Jersey, also and dysmorphism, and noted of her vocabulary Walker-Smith wrote to the general practitioner, had MMR at 16 months. His mother dated that, before MMR at 18 months, she “vocalised” with a similar letter to Wakefield, “although problems from 18-20 months. Child 10, aged 4, only “two or three words.” [Mrs 1] does believe that [child 1] had an illness from south Wales, contracted a viral infection, “[Child 8’s] mother has been to see me 7-10 days after MMR when he was pale, ?fever, which was suspected by parents and doctors and said you need a referral letter from me in ?delirious, but wasn’t actually seen by a doctor.” to have caused his disorder, four months after order to accept [child 8] into your investigation Step 2: for the Lancet Wakefield dropped his vaccination. p­rogramme,” the general practitioner, Diana the question marks, turning Walker-Smith’s “Behavioural changes included repetitive J­elley, wrote to Wakefield at referral, when the queries into assertions. And, although Royal behaviour, disinterest in play or head banging,” girl was aged 3 and a half years. “I would simply Free admission and discharge records refer to said a question and answer statement issued by re-iterate . . . that both the hospital and members “classical” autism, step 3, the former surgeon the medical school, concerning the Lancet 12, of the primary care team involved with [child 8] reported “delirium” as the first “behavioural on the day of the paper’s publication. had significant concerns about her development symptom” of regressive autism, with, step 4, a Another discrepancy to emerge during the some months before she had her MMR.” “time to onset” of 7 days. GMC hearing concerned the number of fami- The girl’s general practice notes also provide So here—behind the paper—is how Wakefield lies who blamed MMR. The paper said that insight into the background to the 12 children’s evidenced his “syndrome” for the lawsuit, and eight families (1, 2, 3, 4, 6, 7, 8, and 11) linked referrals. After person(s) unknown told Mrs 8 built his platform to launch the scare. developmental issues with the vaccine. But the that her daughter may have inflammatory bowel “It is significant that this syndrome total in the records was actually 11. The par- disease, Jelley wrote: “Mum taking her to Dr only appeared with the introduction of the ents of child 5, 9, and 12 were also noted at the Wakefield, Royal Free hospital for CT scans/gut biopsies ?Crohn’s—will need ref letter—Dr Wake- Comparison of three features of the 12 children in the Lancet paper with features apparent in the NHS field to phone me. Funded through legal aid.” records, including those from the Royal Free hospital First symptoms days The child was “pale” Regressive autism Non-specific colitis after MMR All three features The remaining five children served Wakefield’s Child No Lancet Records* Lancet Records† Lancet Records‡ Lancet Records 1 Yes ? Yes Yes Yes No Yes No claims no better. There was still no convincing 2 Yes Yes Yes Yes Yes No Yes No MMR syndrome. 3 Yes ? Yes No Yes ? Yes No Child 1, aged 3 years when he was referred 4 Yes ? Yes No Yes No Yes No to London, lived 100 miles from the Royal Free 5 Yes ? Yes No No No No No and had an older brother who was diagnosed 6 Yes No Yes Yes Yes ? Yes No as autistic. Child 1’s recorded story began 7 Yes No No No Yes No No No when he was aged 9 months, with a “new 8 No No Yes No Yes No No No patient” note by general practitioner Andrea 9 No No Yes No No No No No Barrow. One of the mother’s concerns was 10 No No Yes No No No No No that her son could not hear properly—which 11 Yes ? Yes No Yes No Yes No might sound like a hallmark presentation of 12 Yes No Yes No No No No No classical autism, the emergence of which is Total 9/12 ?6/12 11/12 3/12 8/12 ?2/12 6/12 0/12 See supplementary data on bmj.com for a version of this table with detailed footnotes. often insidious. Indeed, a Royal Free history, *Regressive developmental disorder—autism. by neurologist and coauthor Peter Harvey, noted †Royal Free hospital pathology service. “normal milestones” until “18 months or so.” ‡First behavioural symptoms ≤14 days after MMR.

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hospital as blaming the vaccine, but their stated Wakefield on the advice of “He would start head­ beliefs were omitted from the journal. JABS27—told me that her butting, kicking, breaking son had become aggres- anything in the house. Case selection sive towards a brother, and Then he would go to the The frequency of these beliefs should not records say that his vocab- toilet and release it.” have surprised Wakefield, retained as he was ulary had not developed. For the Royal Free team, to support a lawsuit. In the month that Barr “We both felt that the however, when reporting engaged him—two years before the paper was MMR needle had made on these patients, such published—the lawyer touted the doctor in a [child 3] go the way he is motility symptoms30 were confidential newsletter to his MMR clients and today,” the parents wrote sidelined in the hunt for contacts. “He has deeply depressing views about to a local paediatric neu- Wakefield’s syndrome. In the effect of vaccines on the nation’s children,” rologist, Lewis Rosen- almost all the children, Barr said.24 “He is also anxious to arrange for bloom, 18 months before they noted commonly tests to be carried out on any children . . . who their son’s referral to Lon- swollen glands in the are showing symptoms of possible Crohn’s don. They told him they t­erminal ileum, and what disease. The following are signs to look for. If wanted “justice” from the was reported as “non- your child has suffered from all or any of these vaccine’s manufacturer specific colitis.”31 32 In symptoms could you please contact us, and it and that they had been fact, as I revealed in the may be appropriate to put you in touch with Dr turned down for legal aid. No case was free BMJ last April,33 the hos- Wakefield.” “Although it is said that pital’s pathology service The listed symptoms included pain, weight the MMR has never been of misreporting or found the children’s colons loss, fever, and mouth ulcers. Clients and con- proven to make children to alteration. Taken to be largely normal, but a tacts were quickly referred. Thus, an association be autistic, we believe that medical school “review” between autism, digestive issues, and worries the injection has made together, the NHS changed the results. about MMR—the evidence that launched the [child 3] to be mentally records cannot be In this evolution of the vaccine scare—was bound to be found by the delayed, which in turn gut pathology to what was Royal Free’s clinicians because this was how may have triggered off the reconciled with what published in the Lancet, the children were selected. autism.” child 3’s case was a prime Moreover, through the omission from the I visited this family was published, to example. After ileocolonos- paper of some parents’ beliefs that the vac- twice. Their affected son such devastating copy (which GMC prosecu- cine was to blame, the time link for the lawsuit was now a teenager and a tion and defence experts sharpened. With concerns logged from 11 of 12 challenge both to himself effect agreed was not clinically families, the maximum time given to the onset and to others. His mother indicated), the hospital’s of alleged symptoms was a (forensically unhelp- said his diagnosis was originally “severe learn- pathologists found all colonic samples to be ful) four months. But in a version of the paper ing difficulties with autistic tendencies,” but that “within normal histological limits.” But three circulated at the Royal Free six months before she had fought to get it changed to autism. months after the boy was discharged, Walker- publication, reported concerns fell to nine of 12 As for a connection with MMR, there was only Smith recalled the records and changed the diag- families but with a still unhelpful maximum of suspicion. I don’t think his family was sure, nosis to “indeterminate ileocolitis.”34 56 days.25 Finally, Wakefield settled on 8 of 12 one way or the other. When I asked why they “I think, sadly, this was the first child who was families, with a maximum interval to alleged took him to the Royal Free, his father replied: referred, and the long-term help we were able to symptoms of 14 days. “We were just vulnerable, we were looking for give in terms of dealing with constipation was Between the latter two versions, revisions also answers.” not there,” he told the GMC panel. “However, we slashed the mean time to alleged symptoms— What was unquestionably true was that child had excluded Crohn’s disease and we had done from 14 to 6.3 days. “In these children the mean 3 had serious bowel trouble: intractable, life- our best to try and help this child, but in the end interval from exposure to the MMR vaccine to the long, constipation. This was the most consistent we did not.” development of the first behavioural symptom feature among the 12 children’s symptoms and So that is the Lancet 12: the foundation of the was six days, indicating a strong temporal asso- signs28 but, being the opposite of an expected vaccine scare. No case was free of misreporting ciation,” he emphasised, in a patent for, among finding in inflammatory bowel disease,29 was or alteration. Taken together, the NHS records other things, his own measles vaccine,26 eight nowhere mentioned in the paper. This young cannot be reconciled with what was published, months before the Lancet paper. man’s symptoms were so severe that he was to such devastating effect, in the journal (table). This leaves child 3. He was 6½ and lived on dosed at his special school, his mother said, with Wakefield, however, denies wrongdoing, Merseyside: 200 miles from the hospital. He up to five packets of laxative a day. in any respect whatsoever.35 He says he never received MMR at 14 months, with the first con- “You always knew when his stomach was claimed the children had regressive autism, cerns recorded in his GP notes 15 months after hard,” she told me, in terms echoed over the nor that he said they were previously normal. that. His mother— who 4 years later contacted years by many parents involved with Wa­kefield. He never misreported or changed any findings

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bmj.com archive ЖЖObservations: After Wakefield—the real questions that need addressing BMJ( 2010;340:c2829) ЖЖObservations: Reflections on investigating WakefieldBMJ ( 2010;340:c672)

in the study, and never patented a mother caught their mood 11 British Paediatric Association. Guidelines for the ethical conduct of medical research involving children. Bull Med vaccine for measles. None of the in a recent Dateline NBC Ethics 1992;80:13-20. children were Barr’s clients before television investigation, 12 Thomas N. Evidence to the panel. Day 107. 13 Cartmel R. Evidence to the panel. Day 14. referral to the hospital, and he never featuring the story of the 14 Buie T, Campbell DB, Fuchs GJ, Furata GT, Levy J, received huge payments from the doctor and me. “I don’t VandeWater J, et al. Evaluation, diagnosis, and treatment of gastrointestinal disorders in individuals with ASDs: a lawyer. There were no conflicts of know where we would be consensus report. Pediatrics 2010;125(suppl 1): s1-18. interest. He is the victim of a con- without him.”39 15 Lord Justice May. Judgment in the court of appeal, London. R spiracy.36 37 He never linked autism on the application of “H” v the Legal Services Commission. Brian Deer journalist, London, UK 28 February 2006. with MMR. Funding: Brian Deer’s investigation, which 16 Deer B. Revealed: Undisclosed payments to Andrew “Mr Deer’s implications of fraud led to the General Medical Council inquiry, Wakefield at the heart of vaccine alarm. http://briandeer. com/wakefield/legal-aid.htm. against me are claims that a trained was funded by the Sunday Times of London 17 Deer B. Revealed: MMR research scandal. Sunday Times and the Channel 4 television network. physician and researcher of good 2004 Feb 22. www.timesonline.co.uk/tol/life_and_style/ Reports by Deer in the BMJ were health/article1027636.ece\\ standing had suddenly decided commissioned and paid for by the 18 Deer B. MMR doctor fixed data on autism. Sunday Times he was going to fake data for his journal. No other funding was received, 2009 Feb 8. www.timesonline.co.uk/tol/life_and_style/ apart from legal costs paid to Deer by health/article5683671.ece. own enrichment,” he said in a now the Medical Protection Society on behalf 19 Wakefield A. Evidence to the House of Representatives abandoned complaint against of Andrew Wakefield. committee on government reform. 25-6 April 2001. 20 Rutter M. Evidence to the panel. Day 37. Day 39. me to the UK Press Competing interests: The author 21 Walker-Smith J. Letter to Andrew Wakefield, 4 October 1996. Complaints has completed the unified competing Day 41. Commission. interest form at www.icmje.org/coi_ 22 Filipek PA. Autistic spectrum disorders. In: Swaiman KF, disclosure.pdf (available on request Ashwal S, eds. Pediatric Neurology, Principles and Practice. “ T h e o t h e r from him) and declares no support 3rd ed. Mosby, 1999. authors generated from any organisation for the submitted work; no 23 Patent Office. Pharmaceutical composition for regressive financial relationships with any organisation that might have behavioural disease. UK patent GB 2 325 856 A. Priority and ‘prepared’ all the data that was reported in date 6 June 1997. Publication date 9 December 1998. an interest in the submitted work in the previous three years; the Lancet. I merely put their completed data in 24 Dawbarns. Newsletter. February 1996. BD’s investigation led to the GMC proceedings referred to in 25 Deer B. It’s all change as MMR paper reveals key differences tables and narrative form for the purpose of sub- this report, including the charges. He made many submissions from published Lancet study. http://briandeer.com/mmr/ mission for publication.” of information but was not a party or witness in the case, nor lancet-versions.htm. involved in its conduct. 26 Patent Office. Filing receipt. 6 June 1997, published at Deer But, despite signing up to claim credit for B. Revealed: the first Wakefield MMR patent describes Provenance and peer review: Commissioned; externally peer a paper in the Lancet, his co-authors Walker- “safer measles vaccine”. http://briandeer.com/wakefield/ reviewed. Smith and Murch did not even know which case vaccine-patent.htm. 1 Wakefield AJ, Murch SH, Anthony A, Linnell, Casson DM, 27 Walker-Smith J. Letter to Ajjegowda Shantha. 4 April 1996. was which. Walker-Smith said he had “trusted” Malik M, et al. Ileal lymphoid nodular hyperplasia, non- 28 Murch S, Thomson M, Walker-Smith J. Author’s reply [letter]. Wakefield. “When I signed that paper, I signed specific colitis, and pervasive developmental disorder in Lancet 1998;351:908. children. Lancet 1998;351:637-41 [retracted]. 29 Squires RH, Colletti RB. Indications for pediatric with good intent,” he told the GMC panel. 2 Editors of the Lancet. Retraction: ileal lymphoid gastrointestinal endoscopy: a medical position statement Denying any wrongdoing, he argued that the nodular hyperplasia, non-specific colitis, and of the North American Society for Pediatric Gastroenterology pervasive developmental disorder in children. Lancet and Nutrition. J Pediatr Gastroenterol Nutr 1996;23:107-10. published report was not even about MMR, but 2010;375:445. 30 Afzal N, Murch S, Thirrupathy K, Berger L, Fagbemi A, merely described a new “clinico-pathological 3 MMR and MR vaccine litigation: Sayers and others v Heuschkel R. Constipation with acquired megarectum in Smithkline Beecham plc and others - [2007] All ER (D) children with autism. Pediatrics 2003;112:939-42. entity”. He said that the admissions to the 30 (Jun). 31 Deer B. Wakefield MMR-autism sign was recognized for Royal Free were “entirely related to gastroen- 4 Deer B. MMR doctor given legal aid thousands. Sunday years: as benign finding in children. http://briandeer.com/ Times 2006 December 31. www.timesonline.co.uk/tol/ wakefield/ileal-hyperplasia.htm. terological illness” and how the children were news/uk/article1265373.ece/. 32 Turunen S, Karttonen TJ, Kokkonen J. Lymphoid nodular sourced was “irrelevant” and “immaterial.” His 5 Wakefield A. Introduction to the rationale, aims and hyperplasia and cow’s milk hypersensitivity in children with potential therapeutic implications of the investigation chronic constipation. J Pediatrics 2004;145:606-11. lawyers said that he was appealing against the of children with disintegrative disorder (regressive 33 Deer B. Wakefield’s “autistic enterocolitis” under the panel’s decision and on these grounds they had autism; Heller’s disease and intestinal symptomatology.” microscope. BMJ 2010;340:c1127. advised him not to respond to my questions. (Document issued by Wakefield and mailed to doctors 34 Walker-Smith J. Letter to Ajjegowda Shantha, with revised and parents who approached the Royal Free, dated 3 discharge summary. 31 December 1996. The journal, meanwhile, took 12 years to February 1997.) 35 Wakefield A. Complaint to the Press Complaints retract the paper, by which time its mischief had 6 Barr R, Wakefield A. Proposed protocol and costing Commission. March 2009 (suspended on 10 February 2010 proposals for testing a selected number of MR and on grounds of non-pursuit by the complainant). http:// been exported. As parents’ confidence slowly MMR vaccinated children (and attached specification). briandeer.com/solved/wakefield-complaint.pdf. returned in Britain, the scare took off around Submitted to the Legal Aid Board 6 June 1996. [GMC 36 Deer B. Vaccine victim: Andrew Wakefield invents a bizarre fitness to practise panel hearing in the case of Wakefield, conspiracy [video]. http://briandeer.com/solved/tall-story. the world, unleashing fear, guilt, and infectious Walker-Smith and Murch. Day 11]. htm. diseases—and fuelling suspicion of vaccines in 7 Richard Barr. Letter to the Legal Aid Board. 22 November 37 Profile: Andrew Wakefield , the man at the centre of the 1996. Day 11. MMR scare. Times 2010 May 24. www.timesonline.co.uk/ general. In addition to measles outbreaks, other 8 General Medical Council. Dr Andrew Wakefield: tol/news/uk/article7135099.ece. infections are resurgent, with Mr 11’s home state determinations on serious professional misconduct and 38 California Department of Public Health. Pertussis report. sanctions. 24 May 2010. Wakefield: www.gmc-uk.org/ 15 December 2010. http://www.cdph.ca.gov/programs/ of California last summer seeing 10 babies dead Wakefield_SPM_and_SANCTION.pdf_32595267.pdf. immunize/Documents/PertussisReport2010-12-15.pdf. from whooping cough, in the worst outbreak 9 General Medical Council. Professor John Walker-Smith: 39 NBC News. A dose of controversy. Dateline NBC, with Matt 38 determinations on serious professional misconduct and Lauer. 30 August 2009, repeated and updated 30 May since 1958. Wakefield, nevertheless, now sanctions, 24 May 2010.www.gmc-uk.org/Professor_ 2010. apparently self employed and professionally Walker_Smith_SPM.pdf_32595970.pdf. The version of this article on bmj.com contains full footnotes. 10 General Medical Council. Fitness to practise panel. Cite this as: BMJ 2011;342:c5347 ruined, remains championed by a sad rump of Findings of fact. 28 January 2010. www.gmc-uk.org/static/ disciples. “Dr Wakefield is a hero,” is how one documents/content/Wakefield__Smith_Murch.pdf. See EDITORIAL , p 64

82 BMJ | 8 JANUARY 2011 | VOLUME 342 MEDICAL EDUCATION Learning without patients How far can medical simulation replace clinical experience? Toby Reynolds LOUIEPSIHOYOS/SCIENCE FACTION/CORBIS and Ming-Li Kong report A device that simulates injection of fluid in the spinal cord

edicine has traditionally recommended that simulation be integrated into chief medical officer’s report notes how trainee approached the problem of the British postgraduate training.2 pilots are able to use the technology to recreate learning curve by supervising difficult situations and how established pilots trainees’ first attempts at new Sleepy start must also fly regular simulator flights. But one of tasks and otherwise relying on Simulation in medicine has its roots in anaes- the key elements in the aviation industry’s remark- Mthem to call for help when they feel overwhelmed. thesia. The first computer controlled manikin able reduction in air crashes in the second half of But a growing movement within medical educa- simulator, SimOne, was developed in the 1960s the 20th century was the introduction of manda- tion argues that a better approach is to practise by an anaesthetist and an engineer. They subse- tory training in teamwork and human behavioural new skills in a realistic simulated environment quently published a trial showing its effectiveness factors.5 before they are needed in a critical situation. in teaching anaesthetic trainees.3 “Other performance critical industries such as “The huge benefit of simulation is that it shifts However, SimOne was expensive and proved to aviation, energy, and the military have made great the steep and dangerous part of the learning curve be a little ahead of its time. Only one was built, and strides in improving quality and safety by adopting away from patients,” says Ian Curran, consultant activity in the field slowed until the 1980s, when a systems based approach to human factors and anaesthetist and clinical director of the Simulation separate groups interested in improving teamwork crisis management,” says Dr Curran. “Healthcare Technology-enhanced Learning Initiative (STeLI), and preventing anaesthetic errors again took up has much to learn from their insights.” a workforce development project funded by the the idea, recalls Jeffrey Cooper, a biomedical Roger Kneebone, reader in surgical education UK National Health Service’s London Deanery. engineer and professor of anaesthesia at Harvard at London’s Imperial College, says that there is an “There always has to be a first time with a real ­Medical School. important distinction to be drawn between physi- patient so we must do all we can to ensure that Professor Cooper was involved in awarding cal simulators and the broader concept of simula- these early encounters with real patients are as funding for some of this early work, which resulted tion, which tries to create a recognisable clinical safe as possible.” in the parallel development of two computer con- environment in which trainees can learn. Simulation ranges from task trainer models trolled realistic manikin simulators, both of which “The discourse has been dominated by simula- that teach a particular skill in isolation to full formed the basis for commercially produced tors, by machines, by kit, which has taken away immersion in a replicated environment with man- models. Task trainer simulators are also becom- sometimes from the bigger picture,” he says. ikins that mimic the physiological responses of ing more sophisticated, with models produced for He notes that simulation has so far mostly real patients and are able to develop, for example, learning interventional cardiology, endoscopy, and evolved for specific job roles, such as surgery or laryngeal oedema, pupillary dilation, or cyanosis. laparoscopic surgery, among others. anaesthesia. He believes it needs to balance devel- Use of simulation is growing worldwide. A oping specialty specific skills with teaching differ- database maintained by the Bristol Medical Wider environment ent professionals to work better together. Simulation Centre lists more than 1500 dedi- Regulatory bodies and healthcare commissioners This, Dr Kneebone says, requires a level of real- cated manikin simulation facilities.1 In Israel, are starting to agree that using simulation, particu- ism and sophistication in the environment, not just for example, internship doctors are required to larly full immersion techniques, is better for both a manikin. You need to be able to make people feel attend a five day workshop simulating a variety training and patient safety. A World Health Organi- that they are really doing what is being simulated, of challenging scenarios. It has a simulation zation patient safety guide for medical schools also he says. “In the surgeon’s case that involves hav- based exam for anaesthetists, and certification made extensive reference to simulation.4 Realistic ing organs and an operation that seem realistic, a exams for paramedics and all advanced nursing replication of clinical situations not only helps situation that doesn’t require a superhuman level specialties also include simulation. In the United teach technical skills but can also give important of suspension of disbelief in order to get into it.” States, anaesthetists who gained board certifica- insights into how individuals and teams behave Some simulation centres are complete replicas tion after 2000 are now required to do a day of and communicate, areas that have been repeatedly or real clinical environments. But Dr Kneebone simulation training for recertification. And last identified as common sources of clinical errors. notes that a fully simulated operating theatre may year the UK government’s chief medical officer Simulators are widely used in aviation, and the cost up to a million pounds. The high costs limit

BMJ | 8 JANUARY 2011 | VOLUME 342 83 MEDICAL EDUCATION

bmj.com archive ЖЖResearch: Effect of virtual reality training on laparoscopic surgery (BMJ 2009;338:b1802) ЖЖEditorial: Surgical training using simulation (BMJ 2009;338:b1001)

access and make it harder for training to match the but rather to push it to its ultimate application— “As clinicians and educators we need to decide realities of clinical work. mandatory courses, screening, licensing, and cer- what it is that is most important for people to learn Dr Kneebone’s work on simulation has included tification,” he says. and use simulation to construct environments that the development of a portable simulated operating “We want to make it part of the routine account- allow people to learn those things.” theatre6 that does not try to replicate the real thing able training of health professionals on the verti- Nonetheless, it looks as if simulation can reduce but instead includes those elements that trainees cal axis, from screening into medical school up to the amount of time needed to be spent under need to see, hear, or feel in order to engage with the heads of departments.” supervision and is set to play an important part the simulation. He adds that simulation brings a new way to in healthcare education in the future, Professor It can be used, for example, to manage a patient approach training, not just a new technology, with Cooper says. from arrival in the emergency department with a courses concentrating on hands-on application “In the medical education world it is starting traumatic injury to com- rather than accumula- to be felt that simulation is a tool for developing pletion of an emergency “Simulation is a tool for tion of knowledge in better educators, not just for safety, but to educate laparotomy. The surgi- developing better educators, isolation from the envi- healthcare providers better and faster . . . and it is cal models have been ronment in which it will clearly doing that,” he says. made using technology not just for safety, but to be used. “You talk to an anaesthesia resident and ask from the film industry to educate healthcare providers Professor Cooper them if they would take care of a patient without ensure the latex organs also sees simulation a pulse oximeter. That is the way we will think are as realistic as pos- better and faster . . . and it is techniques changing about simulation in the not too distant future,” sible. clearly doing that” healthcare education he adds. Dr Kneebone hopes more widely. He thinks Toby Reynolds FY2 doctor, Royal London Hospital, London, projects like the operating theatre, funded by that reduced access to clinical learning for nurses UK [email protected] STeLI, will create a middle ground between the and allied health professions such as emergency Ming-Li Kong specialist registrar in anaesthesia and intensive care medicine, Royal London Hospital, London, UK use of task trainers to learn isolated skills and the medical technicians (EMT) will be a powerful Competing interests: All authors have completed the unified expense of full scale simulation. driver moving simulation training forward. competing interest form at www.icmje.org/coi_disclosure.pdf “It is harder and harder for an EMT to get prac- (available on request from the corresponding author) and declare Efficient training tise in an operating room intubating because the no support from any organisation for the submitted work; M-LK was a fellow in medical education funded by the London Deanery There is evidence that simulation works. For risk is greater, there are more and more insurance from 2008-9; and no other relationships or activities that could instance, doctors with simulation training per- issues, but the more sophisticated the simulators appear to have influenced the submitted work. formed better in managing both simulated respi- get, the cheaper and faster it is for him or her to Provenance and peer review: Commissioned; not ratory arrest7 and, more importantly, actual cardiac learn everything outside of working on a patient,” externally peer reviewed. arrest.8 So now one of the main questions is not he says. 1 Bristol Medical Simulation Centre. World simulation centre database. www.bmsc.co.uk/sim_database/ whether simulation is a good idea but how to best “They can get good enough that the first time centres_europe.htm. integrate it into clinical training. they do it on a patient they need much less super- 2 Donaldson L. Annual report of the chief medical officer: on the state of public health 2008. 2009. www.dh.gov. Making training more efficient is a key chal- vised training,” he adds. uk/en/Publicationsandstatistics/Publications/ lenge in the UK, where the European Working “I don’t think there is any question that all of AnnualReports/DH_096206. Time Directive has cut clinical hours and limited these forms of simulation will become deeply inte- 3 Abrahamson S, Denson JS, Wolf RM. Effectiveness of a simulator in training anesthesiology residents. J Med Educ the scope for achieving competence through clini- grated into the process of training all healthcare 1969;44:515-9. cal experience alone. practitioners.” 4 WHO. WHO patient safety curriculum guide for medical schools. 2009. http://whqlibdoc.who.int/ “The more traditional experiential and per- Advocates agree that simulation training can- publications/2009/9789241598316_eng.pdf. haps less efficient methods of learning need to not entirely replace clinical experience. 5 Johnson D. Blunders will never cease. BMJ 2001;322:563. 6 Kneebone R, Arora S, King D, Bello F, Sevdalis N, Kassab be reviewed,” says Dr Curran. “It is clear that “I think simulation can only ever be an adjunct E, et al. Distributed simulation—accessible immersive every training hour needs to pack its educational to clinical practice,” says Dr Kneebone. One area training. Med Teach 2010;32:65-70. punch.” he notes that is difficult to recreate is how people 7 Kory PD, Eisen LA, Adachi M, Ribaudo VA, Rosenthal ME, Mayo PH. Initial airway management skills of senior Amitai Ziv, founder and director of Israel’s MSR respond when real disasters happen. Another dif- residents: simulation training compared with traditional simulation centre, has overseen the integration ficulty is the sheer complexity of the human body, training. Chest 2007;132:1927-31. 8 Wayne DB, Didwania A, Feinglass J, Fudala MJ, Barsuk JH, of simulation training into a variety of national particularly for simulating surgery. McGaghie WC. Simulation-based education improves courses and exams for many healthcare profes- “There are clearly limitations that affect the quality of care during cardiac arrest team responses at an academic teaching hospital: a case-control study. Chest sions. simulation of human beings that you don’t get in 2008;133:56-61. Dr Ziv is a former military pilot and was shocked aircraft cockpits or other more restricted environ- Cite this as: BMJ 2010;341:c6260 by how aviation training was much more struc- ments where you can control everything,” he says. tured and accountable than that in medicine. He “There is something about the complexity and the bmj.com/video sees a wider role for simulation in medicine, such contingency of real life clinical practice that defies ЖЖWatch a video that follows trainee surgeon as in selecting candidates for medical training, as copying.” Sofie Leisby as she learns about laparoscopic already happens in two of Israel’s medical schools. “We do need to look critically and conceptually surgery, from practising in virtual reality to a “Our vision was not only to train on simulators at what simulation can do and can’t do,” he adds. real life procedure, at bmj.com/video

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