SECRETS OF THE MMR SCARE

HOW THE VACCINE CRISIS WAS MEANT TO MAKE MONEY In the second part of a special BMJ series, reveals a secret scheme to raise huge sums from a campaign, launched at a London medical school, that claimed links between MMR, , and bowel disease

ohn Walker-Smith, professor of paediat- to have received information she expected, and one. Previously the hospital had no children’s ric , hurried to Malcolm made it sound as if Walker-Smith was glad too. bowel service, but with him, it had a chance of ward on the sixth fl oor of the Royal Free “He skipped into that room like a " year old,” the best. Hospital, London, with what any doctor she told me. She remembered he said: “[Mrs "], The initiative to recruit him, however, had J would think was bad news. An ! year old you were right.” not come from management. It came from an boy, admitted for fi ve days of investiga- Brightly painted with murals, Malcolm ward academic researcher in the gastroenterology tions, had been provisionally diagnosed with was Walker-Smith’s. It came with his employ- department: a former trainee surgeon, Andrew Crohn’s disease. But when the child’s mother— ment contract. Exactly one year previously, Wakefield. # He wanted Walker-Smith, who here anonymised as “Mrs "”—years afterwards in September #$$%, he had been lured to the would bring access to children’s gastrointestinal recounted what happened, she seemed pleased Royal Free with many perks, of which this was tracts, to help him prove a personal theory. This

October 1988: September 1992: January 1994: A campaign February 1996: JABS solicitor, Richard The three in one The UK Departments group, JABS, is launched in Barr, retains Wakefield, at £150 an hour, , , of Health withdraw Wigan, Lancashire, alleging plus expenses, to support a speculative and rubella vaccine two brands of that MMR causes brain legal attack on MMR manufacturers. This is introduced to the MMR vaccine damage and other problems contract is not publicly disclosed UK after successful after research in children. Autism and July 1996: The first child is admitted to the use in the US since shows them to be inflammatory bowel disease Royal Free for research to try to show a link 1971. Previously, associated with a are not initially claimed with MMR. The research is commissioned single measles and raised incidence of by, and supported with £50 000 from, the rubella vaccines transient mumps UK Legal Aid Board, but this is not publicly were used, and there meningitis, March 1995: Andrew disclosed was no licensed although much Wakefield, a researcher September 1996: Wakefield and his mumps vaccine lower than with at the Royal Free medical mentor Roy Pounder meet medical school natural disease school, files for a patent managers to discuss market projections claiming that Crohn’s for a new business based on purportedly disease and ulcerative diagnosing Crohn’s disease from the colitis may be diagnosed by presence of measles virus detecting measles virus in bowel tissue and body fluids

Virginia Bottomley, the then September 1995: P a e d i a t r i c Conservative health secretary, gastroenterologist John in 1994 launching the multi- Walker-Smith moves with million pound MMR most of his team from Barts campaign with Professor Sir hospital, London, to set up a Kenneth Calman, chief medical service at the Royal Free officer for England at the time Roy Pounder, who was professor of gastroenterology at the Royal Free

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“You used to hear Wakefi eld’s people talking about how they would win the Nobel Prize”

was that Crohn’s disease was caused by persist- for the measles theory. Since February #$$,, (found to be constipation overfl ow) was the ing measles virus infections " —most notably, he seven months before child "’s admission, fi rst to have his ileum intubated. came to suggest, from vaccines. & Wakefield had been engaged by a lawyer C h i l d " also had autism, the fi rst signs of “You used to hear Wakefi eld’s people talk- named Richard Barr, who hoped to bring a which came on “a few months” after MMR ing about how they would win the Nobel Prize lawsuit against vaccine manufacturers. ) ! vaccination. #' His mother was referred to for this,” remembers Brent Taylor, the Royal Barr was a high street solicitor, and an expert Wakefi eld by the JABS organiser, and the boy Free’s head of community child health, who in home conveyancing, $ but also acted for an would not only be the lead test case in Barr’s frequently clashed with the pair. “The atmos- anti-vaccine group, JABS. And, through this eventual, failed, lawsuit but would feature phere here was extraordinary.” connection, the man nowadays popularly with ## other children in a now notorious, But instead of honours, the two men reaped dubbed the “MMR doctor” had found a supply retracted, Lancet paper linking the vaccine disgrace. In January and May "'#', the UK’s of research patients for Walker-Smith. with bowel and brain problems. ## found them guilty of “The following are signs to look for,” Barr He was admitted on Sunday # September a raft of charges over a project involving child wrote in a newsletter to his vaccine claim #$$, and endured a gruelling battery of inves- ".( W a k e f i e l d , n o w %(, was judged by a five clients, mostly media enlisted parents of tigations. ( These included magnetic resonance member panel to be guilty of some &' charges, children with brain disorders, giving a list of imaging of his brain, electroencephalography including four counts of dishonesty and #" of common Crohn’s disease symptoms. “If your and evoked potentials, radioactive Schilling causing children to be subjected to invasive child has suffered from all or any of these test, blood and urine tests, and lumbar punc- procedures that were clinically unjustified. symptoms could you please contact us, and ture—all specifi ed in an agreement with Barr. #" Walker-Smith, )(, was deemed irresponsible it may be appropriate to put you in touch with and unethical. ( Both were struck o ff the medi- Dr Wakefi eld.” A viral diagnostic cal register % , and have since fi led High Court The fi rst to be admitted—in July #$$,—was The following day, Monday, child " had an appeals. a & year old boy with autism. But, according ileo , which, in common with to his records, reviewed by the GMC panel, seven other children reported in the paper, Working on a lawsuit he was so constipated that, despite two the GMC panel would find was not clini- Their misconduct arose out of a fi shing expe- attempts, the endoscopist could not reach his cally warranted. Tuesday was Wakefield’s dition, in which Malcolm ward was the pond . So child ", who had diarrhoea ('th birthday. And on Wednesday, with the

February 1998: publishes a 12 January 2001: The Daily Mail and other patient case series by Wakefield and 12 newspapers launch campaigns backing others, proposing a link between MMR and Wakefield, working with JABS, after he a “new syndrome” of autism and bowel publishes a purported review of his evidence disease. At a press conference, he urges the and repeats his calls for single vaccines use of single vaccines instead of MMR Wakefield and his wife Carmel, after February 1998: Just days after the press whom the doctor named one of his conference, Wakefield and business partners health businesses Single vaccine patent filed by Wakefield meet Royal Free medical school managers to discuss a joint company to develop products February 1999: Unigenetics is June 1997: Claiming that the based on his MMR claims, including “a incorporated, with Wakefield measles virus in MMR causes replacement for attenuated viral vaccines” and a Dublin pathologist, problems, Wakefield files for John O’Leary, as directors. a patent on a “safer” single The company is awarded and for £800 000 by the Legal Aid October 2001: Wakefield is asked to leave products to treat both autism Board to perform tests on the Royal Free after failing to mount a large and inflammatory bowel samples from children seen scale controlled study to confirm or refute his disease. This, too, is not at Walker-Smith’s Royal Free claims about MMR publicly disclosed unit December 2001: Prime Minister December 1999: , is ambushed by new head of medicine at the Wakefield supporters, who medical school, challenges claim that his youngest son, Wakefield (centre) at the press conference to launch Wakefield about his Leo, did not have MMR. The the Lancet research business scheme and puts Blairs initially decline to him on notice that he must comment but much later deny replicate his research the claim

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news that the boy—still on the ward—might paper’s publication—had been paying the Arie Zuckerman, a virologist, was told that have Crohn’s disease, the doctor produced researcher undisclosed fees of £#%' an hour, the lawyer had off ered to pay the school for a a remarkable document. It was an ## page plus expenses. ! “clinical and scientifi c study,”#% and had sent draft of a scheme behind the vaccine scare, “The ability of the Company to commer- a fi rst instalment of £"% '''. ( This was held in now revealed for the fi rst time in full. cialise its candidate products,” the draft plan suspense while Zuckerman sought confi den- The document was headed “Inventor/ continued, “depends upon the extent to which tial ethical advice from the British Medical school/investor meeting #.” Based on a pat- reimbursement for the cost of such products Association, although Wakefi eld had already ent Wakefi eld had fi led in March #$$% claim- will be available from government health started spending it. ing that “Crohn’s disease or ulcerative colitis administration authorities, private health “Arising from recent widespread publicity may be diagnosed by detecting measles virus providers and, in the context of the molecular given to this research,” Zuckerman (who told in bowel tissue, bowel products or body fl u- diagnostic, the Legal Aid Board.” me he does not want to discuss these matters) ids,” #& it proposed starting a company that As it turned out later, child " did not have wrote of Wakefi eld’s already televised claims could reap huge returns from molecular viral Crohn’s disease, but three weeks after draft- about Crohn’s disease, “the Legal Aid Board diagnostic tests. It predicted a turnover from ing the plan, Wakefi eld met three others to has provided funding through a fi rm of solici- Britain and America of up to £)".%m a year. discuss it. One was his mentor, Roy Pounder, tors representing Crohn’s disease suff erers “In view of the unique services off ered by the Royal Free’s professor of gastroenterology and we have been asked to make an appoint- the Company and its technology, particularly and later vice president of the Royal College ment to the staff of the Medical School, spe- for the molecular diagnostic,” the document of . The others were Bryan Blatch, cifi cally to undertake a pilot study of selected noted, “the assays can command premium the medical school’s secretary, and Cengiz patients.” prices.” Tarhan, its fi nance offi cer. The BMA answered fully the following To help finance the scheme, Wakefield March, after its ethics committee had consid- looked to the government’s legal aid fund— Money from the lawyer ered the issue. It said that money could be meant to give poorer people access to jus- Discussions about the business continued accepted provided there was proper research tice. For the previous seven months, child " over the following years, but Wakefield’s oversight and transparency over funding and had been enrolled with Barr’s fi rm, #( which involvement with Barr was quickly noted. patient sources. since February #$$,—two years before the In October #$$,, the medical school’s dean, But the dean remained concerned and so

May 2002: Amid continuing January 2003: Vaccination February 2004: The Sunday media campaigns over MMR, among 2 year olds falls to Times reveals that the particularly by the Mail 78.9%: below the 92% the Legal Aid Board funded the and Telegraph groups, the Department of Health says Lancet r e s e a r c h a n d t h a t magazine i s s u e s is needed to maintain herd many of the children were a special edition, written in immunity. Figures in parts litigants. , collaboration with families of inner London are half the the journal’s editor, rejects that are suing vaccine national rates more serious charges manufacturers September 2003: T h e L e g a l Richard Horton, against the authors, later Lancet editor proved by the GMC Brian Deer questions Wakefield as part of the Channel Services Commission 4 Dispatches programme stops funding for Barr’s March 2004: Ten of the 1998 paper’s 13 lawsuit after barristers for authors, excluding Wakefield, retract its January 2005: Wakefield initiates libel lawsuits, the claimants report to the “interpretation” section, which claimed funded by the Medical Protection Society, commission that, on the an association in time between MMR, against , , and evidence, they cannot make enterocolitis, and regressive developmental Brian Deer over Deer’s website, claiming that all a case that MMR causes disorders allegations are false and defamatory autism November 2004: Channel 4’s Dispatches March 2005: Among much research rejecting reveals Wakefield’s single vaccine patent any link with developmental disorders and and that, despite Wakefield’s claims that the bowel disease, research is published showing culprit for the disorders is measles in MMR, that, after MMR was discontinued in Japan, the molecular tests in his laboratory found no incidence of autism diagnoses continued to rise trace of the virus October 2005: In the London High Court, Mr Justice Eady refuses an application from Wakefield to freeze his libel actions and orders him to proceed to trial of Deer’s allegations against his “honesty and professional integrity”

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bmj.com/podcasts ! Listen to Brian Deer explain the background to his MMR investigation in this week’s podcast at bmj.com/podcasts

made an arrangement with the hospital’s chief #$$!, and the scare was launched at a tele- panic, and distributed to broadcasters a "& executive, Martin Else, who managed a char- vised press conference, nobody was aware minute video news release showcasing Wake- ity called the Special Trustees. Else, now chief that Wakefield was receiving substantial fi eld’s claims. “There is su ffi cient anxiety in executive of the Royal College of Physicians personal payments from Barr. # But both the my own mind for the long term safety of the (who told me that he was “not aware of any medical school’s dean and the hospital’s chief polyvalent vaccine—that is, the MMR vaccina- signifi cant issue being raised”), agreed that executive knew that his research was part tion in combination—that I think it should be the charity could take Barr’s payment and funded through a lawyer. suspended in favour of the single vaccines,” hold it as a grant for Wakefi eld. So the legal The paper itself, meanwhile, included a he said, in one of four similar formulations on money (which eventually totalled £%' ''' funding statement, which Else later told me the videotape. #! and seed funded the business scheme) was he did not notice. “This study was supported The press conference and video boosted the moved from the medical school into a num- by the Special Trustees,” it said, with no men- commercial plans, which were moving for- bered hospital charity account and then paid tion of legal aid or Barr. ward behind the scenes. The following week, out for Wakefi eld’s research on the MMR vac- The lawyer, however, was forthright when Wakefi eld brought two associates to the school cine—back in the medical school. ( later asked. He said he paid for the Lancet for an already scheduled meeting with the “Further to our conversation regarding research. “I remember noting at the time that fi n a n c e o ffi cer Tarhan. One was the father of the establishment of a fund with the Special the funding acknowledgment wasn’t there,” child #' in the paper. The other was a venture Trustees for your income and expenditure he told me. “But it didn’t seem to be a big capitalist. And two days after the meeting, associated with the MMR research,” Else wrote deal, because it just wasn’t a big deal in those they submitted a #& page proposal to launch to Wakefi eld, “I can confi rm that a grant will days.”#) a joint business with the school. It would be be established for the purpose, given your focused on a new company, Imm unospecifi cs written confi rmation that there is no confl ict Behind the press conference Biotechnologies Ltd, aiming not only to pro- of interest involved.” #, Neither school nor hospital stood on the duce a diagnostic test, as proposed #! months Wakefield obliged, but the arrangement sidelines. They threw their weight behind earlier, but also “immunotherapeutics and raised issues about the two institutions’ Wakefi eld. In the build-up to the press con- vaccines.” involvement in the vaccine crisis. For when ference, they installed extra phone lines and Given the previous week’s publicity drive, the Lancet paper was published, in February answering machines to field the expected the vaccine plans were sensitive. But the

February 2009: The Sunday Times a l l e g e s January 2010: A panel that Wakefield “fixed” the appearance of a comprising three doctors link between MMR and autism. He denies and two lay members gives fraud and files a complaint with the UK Press findings of fact on the GMC’s Complaints Commission, which he later case, upholding dozens of abandons charges against Wakefield, April 2006: A s m e a s l e s January 2007: Two days after Walker-Smith, and Murch outbreaks are reported the payments from Barr February 2009: In the United States, three and sending all three across Britain, the first death are revealed, the Medical test case judgments for 5000 claims based forward for sentencing in the UK from the disease Protection Society stops on Wakefield’s theories are handed down in 14 years is reported—a funding for Wakefield’s libel in federal court, rejecting the allegation that February 2010: Six years MMR can cause autism. They are upheld on after the matters were raised 13 year old boy from the actions and agrees to pay EARLY REPORT appeal in August 2010 with the Lancet , t h e j o u r n a l Early report traveller community the defendants’ costs of Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children

A J Wakefield, S H Murch, A Anthony, J Linnell, D M Casson, M Malik, M Berelowitz, A P Dhillon, M A Thomson, P Harvey, A Valentine, S E Davies, J A Walker-Smith fully retracts the 1998 Summary Introduction We saw several children who, after a period of apparent Background We investigated a consecutive series of about £800 000 on top of its normality, lost acquired skills, including communication. children with chronic enterocolitis and regressive December 2006: T h e Sunday They all had gastrointestinal symptoms, including developmental disorder. abdominal pain, diarrhoea, and bloating and, in some Methods 12 children (mean age 6 years [range 3–10], 11 cases, food intolerance. We describe the clinical findings, boys) were referred to a paediatric gastroenterology unit and gastrointestinal features of these children. paper. Horton describes with a history of normal development followed by loss of acquired skills, including language, together with diarrhoea Patients and methods own legal bills and abdominal pain. Children underwent 12 children, consecutively referred to the department of paediatric gastroenterology with a history of a pervasive Times reveals Wakefield’s gastroenterological, neurological, and developmental developmental disorder with loss of acquired skills and intestinal assessment and review of developmental records. symptoms (diarrhoea, abdominal pain, bloating and food Ileocolonoscopy and biopsy sampling, magnetic-resonance intolerance), were investigated. All children were admitted to the imaging (MRI), electroencephalography (EEG), and lumbar ward for 1 week, accompanied by their parents. aspects of it as “utterly puncture were done under sedation. Barium follow-through radiography was done where possible. Biochemical, Clinical investigations haematological, and immunological profiles were We took histories, including details of immunisations and exposure to infectious diseases, and assessed the children. In 11 personal funding from examined. July 2007: At a fitness to cases the history was obtained by the senior clinician (JW-S). Findings Onset of behavioural symptoms was associated, Neurological and psychiatric assessments were done by 1 by the parents, with measles, mumps, and rubella consultant staff (PH, MB) with HMS-4 criteria. Developmental histories included a review of prospective developmental records vaccination in eight of the 12 children, with measles false” and says he “felt from parents, health visitors, and general practitioners. Four infection in one child, and otitis media in another. All 12 children did not undergo psychiatric assessment in hospital; all children had intestinal abnormalities, ranging from had been assessed professionally elsewhere, so these assessments Barr to support the lawsuit lymphoid nodular hyperplasia to aphthoid ulceration. were used as the basis for their behavioural diagnosis. Histology showed patchy chronic inflammation in the colon After bowel preparation, ileocolonoscopy was performed by practise hearing in London, SHM or MAT under sedation with midazolam and pethidine. in 11 children and reactive ileal lymphoid hyperplasia in Paired frozen and formalin-fixed mucosal biopsy samples were seven, but no granulomas. Behavioural disorders included taken from the terminal ileum; ascending, transverse, deceived” autism (nine), disintegrative psychosis (one), and possible descending, and sigmoid colons, and from the rectum. The postviral or vaccinal encephalitis (two). There were no procedure was recorded by video or still images, and were focal neurological abnormalities and MRI and EEG tests compared with images of the previous seven consecutive were normal. Abnormal laboratory results were significantly paediatric (four normal colonoscopies and three over MMR: £435 643 plus on children with ulcerative colitis), in which the raised urinary methylmalonic acid compared with age- the General Medical Council reported normal appearances in the terminal ileum. Barium matched controls (p=0·003), low haemoglobin in four follow-through radiography was possible in some cases. children, and a low serum IgA in four children. Also under sedation, cerebral magnetic-resonance imaging (MRI), electroencephalography (EEG) including visual, brain Interpretation We identified associated gastrointestinal stem auditory, and sensory evoked potentials (where compliance disease and developmental regression in a group of made these possible), and lumbar puncture were done. May 2010: After a 217 day previously normal children, which was generally associated expenses, from the legal aid in time with possible environmental triggers. Laboratory investigations opens its case alleging Thyroid function, serum long-chain fatty acids, and Lancet 1998; 351: 637–41 cerebrospinal-fluid lactate were measured to exclude known See Commentary page causes of childhood neurodegenerative disease. Urinary methylmalonic acid was measured in random urine samples from Inflammatory Bowel Disease Study Group, University Departments eight of the 12 children and 14 age-matched and sex-matched of Medicine and Histopathology (A J Wakefield FRCS, A Anthony MB, normal controls, by a modification of a technique described inquiry, the GMC panel J Linnell PhD, A P Dhillon MRCPath, S E Davies MRCPath) and the previously.2 Chromatograms were scanned digitally on fund. Some other Royal Free University Departments of Paediatric Gastroenterology computer, to analyse the methylmalonic-acid zones from cases serious professional (S H Murch MB, D M Casson MRCP, M Malik MRCP, and controls. Urinary methylmalonic-acid concentrations in M A Thomson FRCP, J A Walker-Smith FRCP,), Child and Adolescent patients and controls were compared by a two-sample t test. Psychiatry (M Berelowitz FRCPsych), Neurology (P Harvey FRCP), and Urinary creatinine was estimated by routine spectrophotometric Radiology (A Valentine FRCR), and School of assay. Medicine, London NW3 2QG, UK Children were screened for antiendomyseal antibodies and doctors were also paid orders Wakefield and Correspondence to: Dr A J Wakefield boys were screened for fragile-X if this had not been done misconduct by the Lancet THE LANCET • Vol 351 • February 28, 1998 637 paper’s three senior Walker-Smith to be erased authors, Wakefield, Walker- from the medical register, Smith, and endoscopist but notes that Murch had Simon Murch shown “insight” and finds him not guilty of serious professional misconduct

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bmj.com/blogs ! Brian Deer: Piltdown medicine—The missing link between MMR and autism ! Liz Wager: Does the Wakefield et al case mean we should demand public access to raw data?

school had long known of this ambition. First testing in support of therapeutic regimes come political and legal pressures brought to bear, surfacing in Wakefield’s #$$% patent for a on stream.” the demand for a diagnostic able to discrimi- diagnostic test for Crohn’s disease, it had been Carmel was registered in the Irish Republic, nate between wild type and vaccine derived fleshed out in #$$), eight months before the where Wakefield would also become a director measles strains will be enormous.” press conference, in a patent for a “safer” of another business. This was Unigenetics Ltd, single measles shot.#$ incorporated in February #$$$ with a Dublin Keeping it secret The revised business plan was ambitious pathologist, John O’Leary. After Wakefield To facilitate negotiations, letters and draft and detailed, aiming to raise £".#m from submitted a confidential report to the Legal contracts went back and forth to the Royal investors. It spanned the detection of Crohn’s Aid Board,"( Unigenetics was awarded—with- Free. A principal document was finished in the disease, the treatment of autism, and “a out checks—£!'' ''' of taxpayers’ money"# autumn of #$$$, naming Wakefield, Pounder, replacement for attenuated viral vaccines.” to perform polymerase chain reaction tests on Carmel, Immunospecifics Biotechnologies The methods for the molecular test for bowel tissue and blood samples from children (IB Ltd), the medical school, Freemedic, an Crohn’s disease were newish. But those for passing through Malcolm ward. American foundation called Neuro Immuno the treatment and vaccines were dated. They The key players in Carmel were the same as Therapeutics, and its head, Hugh Fudenberg, relied on transfer factor, a largely abandoned in the first company, Immunospecifics, with an immunologist. fringe technology to move immune cells from their planned equity now set out. Wakefield “Royal Free and Immuno entered into the person to person."' would get &)%, and the father of child #' Letter Agreement (as defined in this Agree- Nevertheless, the school remained inter- ""."%. The venture capitalist would get #!%, ment),” began a typically meaty clause. ested, and a two year courtship ensued. Even Pounder ##.)%, and O’Leary ##.#%. “Under its terms Royal Free was to assign to as the vaccine scare escalated, triggering a Some would also be awarded extra money Immuno the intellectual property rights sub- deluge of referrals to Walker-Smith, staff at in advance, in proposed “executive and non- sisting in the Inventions. In consideration of Freemedic, the commercial arm of what was executive staff costs.” Wakefield was set to this assignment Immuno was to pay £#' ''' now the merged Royal Free and University get £(' ''' a year,"% in addition to his legal to Royal Free, and was to grant Freemedic College Medical School, poured over contracts earnings and medical school salary, with an an option, over shares representing #'% of and plans. annual travel budget of £%' ''' for the busi- Immuno’s issued share capital.” Trading was to be fronted by Carmel ness. All of this went forward between the par- Healthcare Ltd—named after Wakefield’s Here was another striking conflict of inter- ties in secret. Another document aimed to gag wife. Firmly rooted in Barr’s lawsuit, which est, but Wakefield had long made clear his the school. “RFUCMS and Freemedic agree eventually paid Wakefield £(&% ,(&, plus expectations. “The Company will endeavour to maintain all information about IB Ltd, its expenses,"# the business was to be launched to ensure that the principal members of its business plan, fund raising proposals etc pro- off the back of the vaccine scare, diagnosing a management and scientific team are suitably vided by IB Ltd . . . as confidential and will purported—and still unsubstantiated""—“new incentivised by the allocation of Equity and not disclose the same to any third party and syndrome.” This, Wakefield claimed, com- stock options,” he had written in September will restrict access thereto to the Directors and prised both brain and bowel diseases, which, #$$,, when child " was still on the ward. senior personnel.” after Crohn’s disease was not found in any of Carmel was to be based at the Coombe This latter document was never signed, and the Lancet children, he dubbed “autistic ente- Women’s Hospital, Dublin, where legal aid strictly therefore of no effect. But University rocolitis.”"& money paid for a laboratory. A College London (UCL) honoured its spirit, “It is estimated that the ini- prospectus described a public ensuring that the scheme went unreported. tial market for the diagnostic relations effort aimed at two “tar- And when I was tipped off about Wakefield’s will be litigation driven testing get” audiences: “parent groups business arrangements, the college fought me of patients with AE [autistic and lawyers representing affected for three years under the freedom of informa- enterocolitis] from both the individuals” and “major pharma- tion act to keep its involvement hidden. UK and the USA,” said a &% ceutical companies.” “UCL is coming to the conclusion,” the page “private and confiden- “Once the work of Professor college told the hospital in a February "''% tial” prospectus, which was O’Leary and Dr Wakefield is published, email, “that many of our docs on file fall passed to me by a recipient. It either late in #$$$ or early in "''', into the exemption under section &, of the was aimed at raising an initial which will provide unequivocal evi- Act whereby to disclose information ‘would £)'' ''' from investors and dence for the presence of the vaccine or would be likely to prejudice the free and forecast extraordinary rev- derived measles virus in biopsy frank provision of advice; the free and frank enues. “It is estimated that by samples,” the prospectus said, “the exchange of views for the purposes of delib- year &, income from this test- public and political pressure for a eration or the effective conduct of public ing could be about £& &'' ''' thorough, wide ranging investiga- affairs.’” rising to about tion into the aetiology of the bowel Refusals were authorised by UCL’s provost, £"! ''' ''' conditions will be overwhelming. Malcolm Grant, a professor of environmental as diagnostic “As a consequence of the public, law. Only when Richard Thomas, at the time

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the UK’s information commissioner, travelled medical board over his prescription and use of “possible causal link”"$ and, given a Wakefield to the college’s offices and later served a for- controlled drugs.") When I interviewed him in presentation, promised a storm like the press mal notice, did they release the documents August "''( for a Channel ( documentary,#! conference two years before. into my hands. he claimed to cure autism with transfer factor, Meanwhile, he nurtured relationships, with Among the more striking were those which he said he rolled out like pizza “three drug industry support, including front of the through which the school could deny any molecules deep” on his North Carolina kitchen plane overseas travel. “Please find enclosed involvement in the scheme. “That is to say if table. a cheque for £"!),.)' from Axcan Pharma Freemedic choose not to be associated with “And where does that come from?” I asked. Inc, a refund of my airfare with regard to the company in the first instance they may “From my bone marrow.” my Canadian trip,” he told the special trus- not wish to exercise their options until they “From your own personal bone marrow?” tees, for example, as he put final touches to are ready to be associated at some time in “Yeah.” the scheme. He was also then negotiating a the future,” Tarhan wrote to child #'’s father Another hidden flaw, which Johnson & Johnson consul- in July #$$$, as they divided the notional would emerge only later, was “The 1998 Lancet tancy&' and had longstanding spoils. “We have discussed the reasons for the Dublin measles tests— research had been connections with Merck and this before.” over which vaccine lawsuits SmithKline Beecham. Another letter— to Wakefield— in Novem- in Britain and America would a sham. Trying to ber #$$$ said: “Therefore neither Freemedic founder. These tests were pro- replicate it with The scheme unravels nor the School are in any way involved with moted as detecting persistent But as the Carmel plans were Carmel until such options are formally exer- virus from past MMR vaccina- greater numbers finalised, Wakefield’s for- cised and shares are taken up.” tions. But blood from Walker- would have been tunes reversed. On the brink Smith’s patients, analysed by of his business launch, it Why investors might have paused O’Leary, failed to give consist- hopeless” foundered. But for all the preparations, ready for presen- ent results. The unravelling began tation to investors, one critical issue for the For instance, child " had all the elements after the arrival in the school of a new head of apparent inventions was not broached—that for Wakefield’s theory: regressive autism, medicine: Mark Pepys. A fellow of the Royal the company’s ambitious products might not bowel problems (actually diagnosed as a Society and a specialist in amyloid diseases, work. food intolerance"!), and a mother who blamed he brought huge grants and was now the Investment analysts told me that the late MMR. He was vaccinated at #% months of age school’s biggest name. He was astounded to #$$'s was a prime time to raise cash from in November #$!$. A blood test for the virus find Wakefield being feted. “I said I wouldn’t optimists. “Money flowing into the City post- ## years later was negative. Then, two years transfer my unit if he was there,” Pepys told deregulation had driven the start-up of a load after that, another result from the boy was me. “And you know what they did? They pro- of inexperienced investment schemes in bio- positive. Then, two months after that, one moted him.” tech,” one pointed out. “Very few venture was negative. With Chris Llewellyn-Smith, a theoretical capitalists have the technical knowledge.” physicist and at that time UCL’s provost, Pepys Investors might have been encouraged Preparing for the launch struck in December #$$$, barely two months by the mounting vaccine scare and by the In advance of such results, Wakefield relied after starting at the Royal Free. Wakefield was Lancet’s backing for Wakefield.", But there on what he called a series of “impending” summoned from the hospital’s Hampstead were curious fundamentals in the secret papers. “A variety of topics were discussed in campus to the college’s central London head- scheme which the best informed investors the meeting with reference to the forthcom- quarters. He was challenged over the scheme, might have noticed. ing publication of the paper in Nature (date then on the verge of fruition, and was given a Firstly, transfer factor, for the proposed to be confirmed),” said a confidential Carmel two page letter. treatments and vaccines, had long been aban- “communications programme,” for example, “We remain concerned about a possible doned by industry. Proposed in the #$('s as passed to me by someone present. serious between your a bespoke blood product remedy, it was all The launch was scheduled for March "''', academic employment by UCL, and your but killed by impractical cost, risk of infec- with an attention grabbing stunt three months involvement with Carmel,” it said, in part. tion, and lack of evidence or standards. Later earlier. No Nature paper appeared, and “This concern arose originally because the reformulated as a treated milk pill, as in pro- Wakefield’s platform was to be a London meet- company’s business plan appears to depend posals such as Wakefield’s—which relied on ing of the Pathological Society of Great Britain on premature, scientifically unjustified pub- the colostrum of pregnant goats—experts sug- and Ireland. There, with O’Leary and Pounder lication of results, which do not conform to gest that it is therapeutically inert. Today, it is (who both declined to comment on my find- the rigorous academic and scientific standards promoted on the internet as a cure all. ings), he planned to present research claiming that are generally expected.” Secondly, there was Hugh Fudenberg, a breakthrough. Based on alleged gut biopsy This marked the end of any commercial the American immunologist with his Neuro samples from Walker-Smith’s patients—#' deals with Wakefield, and the beginning of his Immuno Therapeutics foundation. He was with autism and three with Crohn’s disease end at the Royal Free. When eventually ousted under sanction at the time from his local —tested at the Dublin laboratory, it claimed a from his job, he said, “I have been asked to go

BMJ | 15 JANUARY 2011 | VOLUME 342 141 SECRETS OF THE MMR SCARE

bmj.com ! Feature: Wakefield’s “autistic enterocolitis” under the microscope (BMJ 2010;340:c1127) ! News: Wakefield is struck off for the “serious and wide-ranging findings against him” (BMJ 2010;340:c2803) ! News: Lancet retracts Wakefield’s MMR paper (BMJ 2010;340:c696) ! Observations: After Wakefield—the real questions that need addressing (BMJ 2010;340:c2829) ! Observations: Reflections on investigating Wakefield (BMJ 2010;340:c672)

because my research results are unpopular.”&# I wasn’t supposed to say anything critical of 11 Wakefield AJ, Murch SH, Anthony A, Linnell, Casson DM, Malik M, et al. Ileal lymphoid nodular And in response to my investigation, he would him to anybody, for ever after.” hyperplasia, non-specific colitis, and pervasive allege sinister conspiracies to stop him reveal- Wakefield would never perform the developmental disorder in children. Lancet ing what he claimed were vaccine secrets.&" && research anywhere, or prove his measles 1998;351:637-41 [retracted]. 12 Barr R, Wakefield A. Proposed protocol and costing But the paperwork does not show this. theory. His vaccine plans—predictably—went proposals for testing a selected number of MR and Despite all that had happened, UCL volun- nowhere. And when I put these matters to MMR vaccinated children, and attached technical specification. Submitted to the Legal Aid Board, 6 teered to support his work. It offered him him, he and his lawyers acknowledged receipt June 1996. continuation on the staff, or a year’s paid but offered no further response. 13 Diagnosing Crohn’s disease or ulcerative colitis by absence, to test his MMR theories. He was Public fears over the vaccine had yet to detection of measles virus. UK patent application 2 300 259 A. UK Patent Office. Priority date 28 March promised help for a study of #%' children (to reach their peak. My investigation would 1995. Publication date 30 October 1996. try to replicate his Lancet claims from just not begin for two years. But Wakefield would 14 Langdon-Down G. Law: A shot in the dark. Independent 1996 Nov 27. #") and, in return for withdrawing from the never again hold an academic post, and the 15 Deer B. Revealed: MMR research scandal. Sunday January London conference, he would be secret scheme behind the scare was no more. Times 2004 Feb 22. www.timesonline.co.uk/tol/ given the intellectual property free. life_and_style/health/article1027636.ece. 16 Martin Else. Letter to . 30 June “Good scientific practice,” the provost’s Brian Deer journalist, London, UK briandeer.com 1997. Published at Deer B. How lawyers paid for start of MMR scare; letters refute Andrew Wakefield’s story. letter stressed, “now demands that you and Funding: Brian Deer’s investigation was funded by the http://briandeer.com/wakefield/wakefield-deal.htm. others seek to confirm or refute robustly, Sunday Times of London and the Channel 4 television 17 Deer B. Interview with Richard Barr, 14 January 2004. reliably, and above all reproducibly, the pos- network. Reports by Deer in the BMJ were commissioned [Audio extract of follow-up.] http://briandeer.com/ and paid for by the journal. No other funding was received, audio/richard-barr.mp3. sible causal relationships between MMR vac- apart from legal costs paid to Deer by the Medical 18 Deer B. MMR—what they didn’t tell you. Channel 4 cination and autism/“autistic enterocolitis”/ Protection Society on behalf of Andrew Wakefield. Nov 18, 2004. inflammatory bowel disease that you have 19 Deer B. Revealed: the first Wakefield MMR patent Competing interests: The author has completed the claim describes “safer measles vaccine.” http:// postulated.” unified competing interest form at www.icmje.org/coi_ briandeer.com/wakefield/vaccine-patent.htm. At the time, Wakefield agreed. Then his disclosure.pdf (available from him on request) and declares 20 Lawrence HS, Valentine FT. Transfer factor and other mediators of cellular immunity. Am J Pathol employer waited. It prompted, waited longer, no financial relationships with any organisation that might have an interest in this work; BD’s investigation led to the 1970;60:437-52. and prompted again. “Three months have GMC proceedings referred to in this report, including the 21 Deer B. Revealed: undisclosed payments to Andrew Wakefield at the heart of vaccine alarm. http:// elapsed,” Llewellyn-Smith wrote to him in charges. He made many submissions of information, but briandeer.com/wakefield/legal-aid.htm. March "''', asking for “a progress report on was not a party or witness in the case, nor involved in its 22 Buie T, Campbell DB, Fuchs GJ, Furata GT, Levy the study proposed” and “not to make any conduct. J, VandeWater J, et al. Evaluation, diagnosis, Provenance and peer review: Commissioned; not and treatment of gastrointestinal disorders in public statements” in the meantime. individuals with ASDs: a consensus report. Pediatrics externally peer reviewed. But the study did not happen. The #$$! 2010;125(suppl 1):s1-18. Lancet research had been a sham.#' Trying to 1 Walker-Smith JA, Enduring memories. The Memoir 23 Deer B. Wakefield’s “autistic enterocolitis” under the Club, 2003. microscope. BMJ 2010;340:838-41. replicate it with greater numbers would have 2 Wakefield AJ, Pittilo RM, Sim R, Cosby SL, Stephenson 24 Wakefield AJ. Developmental disorders in children been hopeless. JR, Dhillon AP, Pounder RE. Evidence of persistent and measles, mumps, rubella (MMR) vaccine. Interim report to the Legal Aid Board. January 1999. Wakefield, however, shrugged off his non- measles virus infection in Crohn’s disease. J Med Virol 1993;39:345-53. 25 Tarhan C. Letter to Andrew Wakefield. 11 November compliance as arising from some fault of the 3 Thompson NP, Montgomery SM, Pounder RE, 1999. school’s. “It is clear that academic freedom is Wakefield AJ. Is measles vaccination a risk factor for 26 Horton R. Second opinion. Granta Books, 2003. inflammatory bowel disease? Lancet 1995;345:1071- 27 Deer B. Royal Free’s autism pill partner, Hugh essential, and cannot be traded,” he eventu- 4. Fudenberg, wasn’t fit to prescribe. http://briandeer. ally responded in September "'''. “It is the 4 General Medical Council. Fitness to practise panel. com/wakefield/hugh-fudenberg.htm. 28 Walker-Smith JA, Davies SE, Murch SH, Wakefield unanimous decision of my collaborators and Findings of fact, 28 January 2010. www.gmc-uk. org/static/documents/content/Wakefield__Smith_ AJ. Ileo-caecal lymphoid nodular hyperplasia non- co-workers that it is only appropriate that Murch.pdf. specific ileo-colitis with regressive behavioural we define our research objectives, we enact 5 GMC. Andrew Wakefield: determination of serious disorder and food intolerance: a case study. J Pediatr professional misconduct 24 May 2010. www.gmc-uk. Gastroenterol Nutr 1997;25(suppl 1):S48. the studies as appropriately reviewed and org/Wakefield_SPM_and_SANCTION.pdf_32595267. 29 Uhlmann V, Martin C, Shiels O, O’Donovan M, approved, and we decide as and when we pdf. Bermingham N, Ring M, et al. Measles virus (MV) in reactive lympho-nodular hyperplasia and ileo-colitis deem the work suitable for submission for 6 GMC. John Walker-Smith: determination of serious professional misconduct 24 May 2010. www.gmc-uk. of children. Pathological Society of Great Britain and peer review.” org/Professor_Walker_Smith_SPM.pdf_32595970. Ireland. 180th meeting, 18-21 January 2000. J Pathol 2000;190(suppl):33A. This was a step too far, and in October "''# pdf. 7 MMR and MR Vaccine Litigation Sayers and others v 30 Wakefield A. Letter to Mark Pepys, 12 October 1999. Wakefield was shown the door. As I under- Smithkline Beecham plc and others - [2007] All ER 31 Profile: Dr Andrew Wakefield. BBC News 2010 Jan 27. stand it, he got two years’ money, a statement (D) 30 (Jun). http://news.bbc.co.uk/1/hi/health/3513365.stm. 32 Deer B. Vaccine victim: Andrew Wakefield invents a clearing him of misconduct, the intellectual 8 Deer B. MMR doctor given legal aid thousands. Sunday Times 2006 Dec 31. www.timesonline.co.uk/ bizarre conspiracy [video]. http://briandeer.com/ solved/tall-story.htm. property for £#', uncollected, and a gag on tol/news/uk/article1265373.ece. 33 Profile: Andrew Wakefield , the man at the centre 9 Barr R, Barr A. The Which? way to buy, sell and move Royal Free comment. “We paid him to go of the MMR scare. Times 2010 May 24. www. house. Consumers’ Association, 1993. timesonline.co.uk/tol/news/uk/article7135099.ece. away,” Pepys told me. “And, of course, one 10 Deer B. How the case against the MMR vaccine was of the conditions of him going away was that fixed. BMJ 2011;342:c5347. Cite this as: BMJ 2011;342:c5258

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