Lancet MMR autism fraud

Public understanding of the claims sharply changed in February 2004 with revelations by The Sunday Times of an undisclosed conflict of interest on Wakefield's part in that, two years before the paper's publication, he had been approached by a lawyer, Richard Barr, who was looking for an expert witness to start a planned class action regarding alleged "vaccine damage". Barr hired Wakefield at £150 per hour, plus expenses, and only then did they recruit the twelve children,[39] actively seeking the parents of cases that might imply a connection between MMR and autism. Barr and Wakefield convinced the UK Legal Aid Board, a UK government organization to give financial support to people who could not afford access to justice, to assign £55,000 to fund the initial stage of the research. According to journalist Brian Deer, the project was intended to create evidence for the court case, but this only became publicly known six years after The Lancet report, with the newspaper's first disclosures.[40]

Based on Deer's evidence, The Lancet's editor-in-chief Richard Horton said Wakefield's paper should have never been published because its findings were "entirely flawed".[2] Although Wakefield maintained that the legal aid funding was for a separate, unpublished study[41] (a position later rejected by a panel of the UK General Medical Council), the editors of The Lancet judged that the funding source should have been disclosed to them.[42] Horton wrote, "It seems obvious now that had we appreciated the full context in which the work reported in the 1998 Lancet paper by Wakefield and colleagues was done, publication would not have taken place in the way that it did."[43] Several of Wakefield's co-researchers also strongly criticized the lack of disclosure.[2]

Among Deer's earliest reported allegations was that, contrary to a statement in the paper, Wakefield's research on the 12 children was conducted without any institutional review board authorization—a claim quickly denied in February 2004 by both the paper's authors and the Lancet.[44] The paper itself said, "Ethical approval and consent. Investigations were approved by the Ethical Practices Committee of the Royal Free Hospital NHS Trust, and parents gave informed consent." The dispute over this would remain unresolved, however, until settled in the English High Court in March 2012, where a senior judge vindicated Deer. Quoting the text, Justice Mitting ruled, "This statement was untrue and should not have been included in the paper."[45]

The Lancet and many other medical journals require papers to include the authors' conclusions about their research, known as the "interpretation". The summary of the 1998 Lancet paper ended as follows:[1]

Interpretation We identified associated gastrointestinal disease and developmental regression in a group of previously normal children, which was generally associated in time with possible environmental triggers.

In March 2004, immediately following the news of the conflict of interest allegations, ten of Wakefield's 12 coauthors retracted this interpretation,[46] while insisting that the possibility of a distinctive gastrointestinal condition in children with autism merited further investigation.[47] However, a separate study of children with gastrointestinal disturbances found no difference between those with autism spectrum disorders and those without, with respect to the presence of measles virus RNA in the bowel; it also found that gastrointestinal symptoms and the onset of autism were unrelated in time to the administration of MMR vaccine.[48]

Later in 2004, the newspaper's investigation also found that Wakefield had a further conflict of interest in the form of a patent for a single measles vaccines,[2][4] had manipulated evidence,[3] and had broken other ethical codes. The Lancet paper was partially retracted in 2004 and fully retracted in 2010, when Lancet's editor-in-chief Richard Horton described it as "utterly false" and said that the journal had been deceived.[49] Wakefield was found guilty by the General Medical Council of serious professional misconduct in May 2010 and was struck off the Medical Register, meaning he could no longer practise as a doctor in the UK.[50] In 2011, Deer provided further information on Wakefield's improper research practices to the British Medical Journal, which in a signed editorial described the original paper as fraudulent.[7][51]

Deer continued his reporting in a Channel 4 Dispatches television documentary, MMR: What They Didn't Tell You, broadcast on 18 November 2004. This documentary alleged that Wakefield had applied for patents on a single measles vaccine that claimed to be a potential rival of MMR, and that he knew of test results from his own laboratory at the Royal Free Hospital that contradicted his own claims.[4] Wakefield's patent application was also noted in Paul Offit's 2008 book, Autism's False Prophets.

In January 2005, Wakefield sued Channel 4, 20/20 Productions, and the investigative reporter Brian Deer, who presented the Dispatches programme. However, after two years of litigation, and the revelation of more than £400,000 in undisclosed payments by lawyers to Wakefield, he discontinued his action and paid all the defendants' costs.

In 2006, Deer reported in The Sunday Times that Wakefield had been paid £435,643, plus expenses, by British trial lawyers attempting to prove that the vaccine was dangerous, with the undisclosed payments beginning two years before the Lancet paper's publication.[5] This funding came from the UK legal aid fund, a fund intended to provide legal services to the poor.[13]

Despite The Sunday Times disclosures, Wakefield continued to find support. Melanie Phillips, an influential columnist with the Daily Mail, called the reporting of Wakefield's contract with the solicitor Richard Barr "a smear whose timing should raise a few eyebrows," and Ben Goldacre, a doctor and writer, defended the 1998 Lancet report. Writing in The Guardian in September 2005, he argued: "The paper always was and still remains a perfectly good small case series report, but it was systematically misrepresented as being more than that, by media that are incapable of interpreting and reporting scientific data."[52]

Three years later, as Wakefield appeared at a General Medical Council hearing charged with "serious professional misconduct", Goldacre stepped up his support: "Journalists have convinced themselves that his £435,643 fee from legal aid proves that his research was flawed. I will now defend the heretic Dr Andrew Wakefield. The media are fingering the wrong man, and they know who should really take the blame: in MMR, journalists and editors have constructed their greatest hoax to date."[53]

According to Deer writing in the BMJ, the General Medical Council hearing was also criticized by Richard Horton, the Lancet editor: "My own view is that the GMC is no place to continue this debate. But the process has started and it will be impossible to stop."[54]

Despite ongoing disagreement[55] from Goldacre and others, The Sunday Times continued the investigation, and on 8 February 2009, Brian Deer reported that Wakefield had "fixed" results and "manipulated" patient data in the Lancet, creating the appearance of a link with autism.[3] Wakefield falsely denied these allegations,[56] and even filed a complaint with the Press Complaints Commission (PCC)[57] over this article on 13 March 2009. The complaint was expanded by a 20 March 2009 addendum by Wakefield's publicist.[58] In July 2009, the PCC stated that it was staying any investigation regarding the Times article, pending the conclusion of the GMC investigation.[59] In the event, Wakefield did not pursue his complaint, which Deer published with a statement that he and The Sunday Times rejected it as "false and disingenuous in all material respects", and that the action had been suspended by the PCC in February 2010.[60]

Responding to the first Sunday Times reports, the General Medical Council (GMC), which is responsible for licensing doctors and supervising medical ethics in the UK, launched an investigation into the affair.[61] The GMC brought the case itself, not citing any specific complaints, claiming that an investigation was in the public interest. The then-secretary of state for health, John Reid, called for a GMC investigation, which Wakefield himself welcomed.[62] During a debate in the House of Commons, on 15 Mar 2004, Dr. Evan Harris,[63] a Liberal Democrat MP, called for a judicial inquiry into the ethical aspects of the case, even suggesting it might be conducted by the CPS.[64] In June 2006 the GMC confirmed that they would hold a disciplinary hearing of Wakefield.

The GMC's Fitness to Practise Panel first met on 16 July 2007[65] to consider the cases of Wakefield, Professor John Angus Walker-Smith, and Professor Simon Harry Murch.[66] All faced charges of serious professional misconduct. The GMC examined, among other ethical points, whether Wakefield and his colleagues obtained the required approvals for the tests they performed on the children; the data-manipulation charges reported in the Times, which surfaced after the case was prepared, were not at question in the hearings.[67] The GMC stressed that it would not be assessing the validity of competing scientific theories on MMR and autism. The GMC alleged that the trio acted unethically and dishonestly in preparing the research into the MMR vaccine. They denied the allegations.[68] The case proceeded in front of a GMC Fitness to Practise panel of three medical and two lay members.[69]

On 28 January 2010, the GMC panel delivered its decision on the facts of the case, finding four counts of dishonesty and 12 involving the abuse of developmentally disabled children. Wakefield was found to have acted "dishonestly and irresponsibly" and to have acted with "callous disregard" for the children involved in his study, conducting unnecessary and invasive tests.[70][71] The panel found that the trial was improperly conducted without the approval of an independent ethics committee,[72] and that Wakefield had multiple undeclared conflicts of interest.[73]

On 24 May 2010, the GMC panel ordered that he be struck off the medical register.[74] John Walker-Smith was also found guilty of serious professional misconduct and struck off the medical register, but that decision was reversed on appeal to the High Court in 2012, because the GMC panel had failed to decide whether Walker-Smith actually thought he was doing research in the guise of clinical investigation and treatment. The High Court criticised "a number of" wrong conclusions by the disciplinary panel and its "inadequate and superficial reasoning".[75] Simon Murch was found not guilty.[74]

In response to the GMC investigation and findings, the editors of The Lancet announced on 2 February 2010 that they "fully retract this paper from the published record".[76] The Lancet's editor-in-chief Richard Horton described it as "utterly false" and said that the journal had been deceived.[49]

The Hansard text for 16 March 2010 reported[77] Lord McColl asking the Government whether it had plans to recover legal aid money paid to the experts in connection with the measles, mumps and rubella/measles and rubella vaccine litigation. Lord Bach, Ministry of Justice dismissed this possibility.

In an April 2010 report in The BMJ, Deer expanded on the laboratory aspects of his findings recounting how normal clinical histopathology results generated by the Royal Free Hospital were later changed in the medical school to abnormal results, published in The Lancet.[78] Deer wrote an article in The BMJ casting doubt on the "autistic enterocolitis" that Wakefield claimed to have discovered.[78] In the same edition, Deirdre Kelly, President of the European Society of Pediatric Gastroenterology and Nutrition and the Editor of the Journal of Pediatric Gastroenterology and Nutrition expressed some concern about The BMJ publishing this article while the GMC proceedings were underway.[79]

On 5 January 2011, The BMJ published the first of a series of articles by Brian Deer, detailing how Wakefield and his colleagues had faked some of the data behind the 1998 Lancet article. By looking at the records and interviewing the parents, Deer found that for all 12 children in the Wakefield study, diagnoses had been tweaked or dates changed to fit the article's conclusion.[39] Continuing BMJ series on 11 January 2011,[80] Deer said that based upon documents he obtained under freedom of information legislation,[81] Wakefield—in partnership with the father of one of the boys in the study—had planned to launch a venture on the back of an MMR vaccination scare that would profit from new medical tests and "litigation driven testing".[82] The Washington Post reported that Deer said that Wakefield predicted he "could make more than $43 million a year from diagnostic kits" for the new condition, autistic enterocolitis.[81] WebMD reported on Deer's BMJ report, saying that the $43 million predicted yearly profits would come from marketing kits for "diagnosing patients with autism" and "the initial market for the diagnostic will be litigation-driven testing of patients with AE [autistic enterocolitis, an unproven condition concocted by Wakefield] from both the UK and the USA".[83] According to WebMD, the BMJ article also claimed that the venture would succeed in marketing products and developing a replacement vaccine if "public confidence in the MMR vaccine was damaged".[83]

In an editorial accompanying Deer's 2011 series, The BMJ said, "it has taken the diligent scepticism of one man, standing outside medicine and science, to show that the paper was in fact an elaborate fraud," and asked:

Who perpetrated this fraud? There is no doubt that it was Wakefield. Is it possible that he was wrong, but not dishonest: that he was so incompetent that he was unable to fairly describe the project, or to report even one of the 12 children's cases accurately? No. A great deal of thought and effort must have gone into drafting the paper to achieve the results he wanted: the discrepancies all led in one direction; misreporting was gross. Moreover, although the scale of the GMC's 217 day hearing precluded additional charges focused directly on the fraud, the panel found him guilty of dishonesty concerning the study's admissions criteria, its funding by the Legal Aid Board, and his statements about it afterwards.[7][51]

Summarizing findings as of January 2011 in The BMJ, Deer set out the following analysis of the cases reported in the study:[39]

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:

• Three of nine children reported with regressive autism did not have autism diagnosed at all. Only one child clearly had regressive autism.
• Despite the paper claiming that all 12 children were "previously normal," five had documented pre-existing developmental concerns.
• Some children were reported to have experienced first behavioural symptoms within days of MMR, but the records documented these as starting some months after vaccination.
• In nine cases, unremarkable colonic histopathology results—noting no or minimal fluctuations in inflammatory cell populations—were changed after a medical school "research review" to "non-specific colitis."
• The parents of eight children were reported as blaming MMR, but 11 families made this allegation at the hospital. The exclusion of three allegations—all giving times to onset of problems in months—helped to create the appearance of a 14 day temporal link.
• Patients were recruited through anti-MMR campaigners, and the study was commissioned and funded for planned litigation.

In subsequent disclosures from the investigation, Deer obtained copies of unpublished gastrointestinal pathology reports on the children in the Lancet study that Wakefield had claimed showed "non-specific colitis" and "autistic enterocolitis". But expert analyses of these reports found bowel biopsies from the children to be overwhelmingly normal and with no evidence of any enterocolitis at all.[84]

In September 2020, Johns Hopkins University Press published Deer's account of the fraud in his book The Doctor Who Fooled the World: Science, Deception, and the War on Vaccines. The book includes reporting of parents whose children were among the twelve recruited by Wakefield in The Lancet study. One described the paper as "fraudulent" while another complained of "outright fabrication".[85]