Lancet MMR autism fraud

The Lancet MMR autism fraud centred on the publication in 1998 of a research paper titled Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children in The Lancet. The paper, authored by Andrew Wakefield and eleven coauthors, claimed to link the MMR vaccine to colitis and autism spectrum disorders.[1] Events surrounding the research study and the publication of its findings led to Wakefield being struck off the medical register. The paper was retracted in 2010.[2]

Lancet MMR autism fraud
ClaimsA link between the measles, mumps and rubella vaccination and regressive autistic spectrum disorder
Year proposed1998
Original proponentsAndrew Wakefield
Pseudoscientific concepts
This article is part of a series on
Alternative and pseudo‑medicine
Conspiracy theories (list)

Characterised as "perhaps the most damaging medical hoax of the 20th Century",[3] it led to a sharp drop in vaccination rates in the UK and Ireland. Promotion of the claimed link, which continues in anti-vaccination propaganda despite being refuted,[4][5] led to an increase in the incidence of measles and mumps, resulting in deaths and serious permanent injuries.[6][7] Following the initial claims in 1998, multiple large epidemiological studies were undertaken. Reviews of the evidence by the Centers for Disease Control and Prevention,[8] the American Academy of Pediatrics, the Institute of Medicine of the US National Academy of Sciences,[9] the UK National Health Service,[10] and the Cochrane Library[11] all found no link between the MMR vaccine and autism.[12] Physicians, medical journals, and editors[18] have described Wakefield's actions as fraudulent and tied them to epidemics and deaths.[19][20]

An investigation by journalist Brian Deer found that Wakefield had multiple undeclared conflicts of interest,[21][22] had manipulated evidence,[23] 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.[24] 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.[25] 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.[26][27] The scientific consensus is that there is no link between the MMR vaccine and autism and that the vaccine's benefits greatly outweigh its risks.

1998 The Lancet paper

In February 1998, a group led by Andrew Wakefield published a fraudulent paper in the respected British medical journal The Lancet, supported by a press conference at the Royal Free Hospital in London.[28][29] This paper reported on twelve children with developmental disorders referred to the Royal Free Hospital. The parents or physicians of eight of these children were said to have linked the start of behavioral symptoms to MMR vaccination. The paper described a collection of bowel symptoms, endoscopy findings and biopsy findings that were said to be evidence of a possible novel syndrome that Wakefield would later call autistic enterocolitis, and recommended further study into the possible link between the condition and the MMR vaccine. The paper suggested that the connection between autism and the gastrointestinal pathologies was real, but said it did not prove an association between the MMR vaccine and autism.[1]

At the press conference before the paper's publication, later criticized as "science by press conference",[28] Wakefield said that he thought it prudent to use single vaccines instead of the MMR triple vaccine until this could be ruled out as an environmental trigger; parents of eight of the twelve children studied were said to have blamed the MMR vaccine, saying that symptoms of autism had set in within days of vaccination at approximately 14 months. Wakefield said, "I can't support the continued use of these three vaccines given in combination until this issue has been resolved."[30] In a video news release issued by the hospital to broadcasters in advance of the press conference, he called for MMR to be "suspended in favour of the single vaccines".[31] In a BBC interview Wakefield's mentor Roy Pounder, who was not a coauthor, "admitted the study was controversial". He added: "In hindsight it may be a better solution to give the vaccinations separately,... When the vaccinations were given individually there was no problem."[32] These suggestions were not supported by Wakefield's coauthors nor by any scientific evidence.[33]

The initial press coverage of the story was limited. The Guardian and the Independent reported it on their front pages, while the Daily Mail only gave the story a minor mention in the middle of the paper, and the Sun did not cover it.[34]

Public controversy

The controversy began to gain momentum in 2001 and 2002, after Wakefield published papers suggesting that the immunisation programme was not safe. These were a review paper with no new evidence, published in a minor journal, and two papers on laboratory work that he said showed that measles virus had been found in tissue samples taken from children who had autism and bowel problems. There was wide media coverage including distressing anecdotal evidence from parents, and political coverage attacking the health service and government peaked with unmet demands that Prime minister Tony Blair reveal whether his infant son, Leo, had been given the vaccine. It was the biggest science story of 2002, with 1257 articles mostly written by non-expert commentators. In the period January to September 2002, 32% of the stories written about MMR mentioned Leo Blair, as opposed to only 25% that mentioned Wakefield. Less than a third of the stories mentioned the overwhelming evidence that MMR is safe.[34] The paper, press conference and video sparked a major health scare in the United Kingdom. As a result of the scare, full confidence in MMR fell from 59% to 41% after publication of the Wakefield research. In 2001, 26% of family doctors felt the government had failed to prove there was no link between MMR and autism and bowel disease.[35] In his book Bad Science, Ben Goldacre describes the MMR vaccine scare as one of the "three all-time classic bogus science stories" by the British newspapers (the other two are the Arpad Pusztai affair about genetically modified crops, and Chris Malyszewicz and the MRSA hoax).[36]

Confidence in the MMR vaccine increased as it became clearer that Wakefield's claims were unsupported by scientific evidence. A 2003 survey of 366 family doctors in the UK reported that 77% of them would advise giving the MMR vaccine to a child with a close family history of autism, and that 3% of them thought that autism could sometimes be caused by the MMR vaccine.[37] A similar survey in 2004 found that these percentages changed to 82% and at most 2%, respectively, and that confidence in MMR had been increasing over the previous two years.[38]

A factor in the controversy is that only the combined vaccine is available through the UK National Health Service. As of 2010 there are no single vaccines for measles, mumps and rubella licensed for use in the UK.[39] Prime Minister Tony Blair gave support to the programme, arguing that the vaccine was safe enough for his own son, Leo,[40] but refusing on privacy grounds to state whether Leo had received the vaccine; in contrast, the subsequent Prime Minister, Gordon Brown, explicitly confirmed that his son has been immunised.[41] Cherie Blair confirmed that Leo had been given the MMR vaccination when promoting her autobiography.[34][42]

Administration of the combined vaccine instead of separate vaccines decreases the risk of children catching the disease while waiting for full immunisation coverage.[43] The combined vaccine's two injections results in less pain and distress to the child than the six injections required by separate vaccines, and the extra clinic visits required by separate vaccinations increases the likelihood of some being delayed or missed altogether;[43][44] vaccination uptake significantly increased in the UK when MMR was introduced in 1988.[43] Health professionals have heavily criticized media coverage of the controversy for triggering a decline in vaccination rates.[45] There is no scientific basis for preferring separate vaccines, or for using any particular interval between separate vaccines.[46]

John Walker-Smith, a coauthor of Wakefield's report and a supporter of the MMR vaccine, wrote in 2002 that epidemiology has shown that MMR is safe in most children, but observed that epidemiology is a blunt tool and studies can miss at-risk groups that have a real link between MMR and autism.[47] However, if a rare subtype of autism were reliably identified by clinical or pathological characteristics, epidemiological research could address the question whether MMR causes that autism subtype.[48] There is no scientific evidence that MMR causes damage to the infant immune system, and there is much evidence to the contrary.[46]

In 2001, Berelowitz, one of the co-authors of the paper, said "I am certainly not aware of any convincing evidence for the hypothesis of a link between MMR and autism".[49] The Canadian Paediatric Society,[50] the Centers for Disease Control and Prevention,[8] the Institute of Medicine of the National Academy of Sciences, [9] and the UK National Health Service[10] have all concluded that there is no link between the MMR vaccine and autism, and a 2011 journal article described the vaccine–autism connection as "the most damaging medical hoax of the last 100 years".[12]

Developing scandal

Conflict of interest

In February 2004, after a four-month investigation, reporter Brian Deer wrote in The Sunday Times of London that, prior to submitting his paper to The Lancet, Wakefield had received £55,000 from Legal Aid Board solicitors seeking evidence to use against vaccine manufacturers, that several of the parents quoted as saying that MMR had damaged their children were also litigants, and that Wakefield did not inform colleagues or medical authorities of the conflict of interest. When the editors of The Lancet learned about this, they said that based on Deer's evidence, Wakefield's paper should have never been published because its findings were "entirely flawed".[21] Although Wakefield maintained that the legal aid funding was for a separate, unpublished study[51] (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.[52] Richard Horton, the editor-in-chief, 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."[53] Several of Wakefield's co-researchers also strongly criticized the lack of disclosure.[21]

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 vaccine that was a rival of the MMR vaccine, and that he knew of test results from his own laboratory at the Royal Free Hospital that contradicted his own claims.[22] 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.[54] This funding came from the UK legal aid fund, a fund intended to provide legal services to the poor.[30]

Retraction of an interpretation

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:

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.[1]

In March 2004, immediately following the news of the conflict of interest allegations, ten of Wakefield's 12 coauthors retracted this interpretation,[55] while insisting that the possibility of a distinctive gastrointestinal condition in children with autism merited further investigation.[56] 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.[57]

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.[24]

Manipulation of data

On 8 February 2009, Brian Deer reported in The Sunday Times that Wakefield had "fixed" results and "manipulated" patient data in his 1998 paper, creating the appearance of a link with autism.[23] Wakefield denied these allegations,[58] and even filed a complaint with the Press Complaints Commission (PCC)[59] over this article on 13 March 2009. The complaint was expanded by a 20 March 2009 addendum by Wakefield's publicist.[60] In July 2009, the PCC stated that it was staying any investigation regarding the Times article, pending the conclusion of the GMC investigation.[61] 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.[62]

General Medical Council investigation

The General Medical Council (GMC), which is responsible for licensing doctors and supervising medical ethics in the UK, investigated the affair.[63] 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.[64] During a debate in the House of Commons, on 15 Mar 2004, Dr. Evan Harris,[65] 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.[66] 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[67] to consider the cases of Dr. Wakefield, Professor John Angus Walker-Smith, and Professor Simon Harry Murch.[68] 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.[69] The GMC stressed that it would not be assessing the validity of competing scientific theories on MMR and autism. The General Medical Council alleged that the trio acted unethically and dishonestly in preparing the research into the MMR vaccine. They denied the allegations.[70] The case proceeded in front of a GMC Fitness to Practise panel of three medical and two lay members.[71]

On 28 January 2010, the GMC panel delivered its decision on the facts of the case: 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.[72][73] The panel found that the trial was improperly conducted without the approval of an independent ethics committee,[74] and that Wakefield had multiple undeclared conflicts of interest.[75]

Full retraction and fraud allegations

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 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 24 May 2010, the GMC panel found Wakefield guilty of serious professional misconduct on four counts of dishonesty and 12 involving the abuse of developmentally challenged children, and ordered that he be struck off the medical register.[80] 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".[81] Simon Murch was found not guilty.[80]

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.[82] Continuing BMJ series on 11 January 2011,[83] Deer said that based upon documents he obtained under freedom of information legislation,[84] 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".[85] 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.[84] 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".[86] 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".[86]

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See also

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