On 28 February 1998, a fraudulent research paper primarily authored by the English physician Andrew Wakefield, along with twelve other coauthors (titled "Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children"), was published in The Lancet, a British medical journal. The paper falsely claimed causative links between the measles, mumps, and rubella (MMR) vaccine and colitis, and between colitis and autism. The fraud involved data bias and manipulation, and two undisclosed conflicts of interest. It was exposed in a lengthy Sunday Times investigation by reporter Brian Deer, resulting in the paper's retraction in February 2010 and Wakefield's being discredited and struck off the UK medical register three months later. In the paper, Wakefield fabricated evidence to suggest a new "syndrome" existed, which he called "autistic enterocolitis". Wakefield had been employed by a lawyer representing parents in lawsuits against vaccine producers, and had reportedly earned up to US$43 million per year selling diagnostic kits for the non-existent syndrome he claimed to have discovered. He also held a patent to a rival measles vaccine at the time.
The scientific consensus on vaccines and autism is that there is no connection between MMR (or any other vaccine) and autism.
1998 The Lancet paper In February 1998, a group led by Andrew Wakefield published a paper in the British medical journal The Lancet, supported by a press conference at the Royal Free Hospital in London, where the research was carried out. This paper reported on twelve children with developmental disorders referred to the hospital and described a constellation of bowel symptoms, as well as endoscopy and biopsy findings, that were said to be evidence of a new "syndrome" that Wakefield would later call "autistic enterocolitis". The paper described MMR vaccination as the "apparent precipitating event", tabulated the parents of eight of the twelve children as linking their developmental symptoms with MMR vaccination, suggested the connection between autism and the gastrointestinal pathologies was "real", and called for further research. Nevertheless, the paper admitted that the research did not "prove" an association between the MMR vaccine and autism.
At a press conference accompanying the paper's publication, later criticized as "science by press conference", 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. Wakefield said, "I can't support the continued use of these three vaccines given in combination until this issue has been resolved." In a video news release issued by the hospital to broadcasters in advance of the press conference, he called for MMR vaccine to be "suspended in favour of the single vaccines". 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." These suggestions were supported neither by Wakefield's coauthors nor any scientific evidence.
British television coverage of the press conference was intense, but press interest was mixed. 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.
Controversy over MMR
Multiple subsequent studies failed to find any link between the MMR vaccine, colitis, and autism. In March 1998, a panel of 37 scientific experts set up by the Medical Research Council, headed by Professor Sir John Pattison found "no evidence to indicate any link" between the MMR vaccine and colitis or autism in children.Official letter
Public concern over Wakefield's claims of a possible link between MMR and autism gained momentum in 2001 and 2002, after he published further 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. 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, autism, and bowel disease. 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).
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. 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.
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. Prime Minister Tony Blair gave support to the programme, arguing that the vaccine was safe enough for his own son, Leo, 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.Nic Fleming My son has had MMR jab, says Brown (in dig at Blair) Telegraph 7 February 2006 Cherie Blair confirmed that Leo had been given the MMR vaccination when promoting her autobiography.
The government stressed that administration of the combined vaccine instead of separate vaccines decreases the risk of children catching the disease while waiting for full immunisation coverage. 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;MMR vs three separate vaccines: vaccination uptake significantly increased in the UK when MMR was introduced in 1988. Health professionals have heavily criticized media coverage of the controversy for triggering a decline in vaccination rates. No scientific basis has been found for preferring separate vaccines, or for using any particular interval between them.
In 2001, Mark 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". The Canadian Paediatric Society, Also published in . the Centers for Disease Control and Prevention, the Institute of Medicine of the National Academy of Sciences, and the UK National Health Service 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".
Newspaper investigation
Conflict of interest 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 Richard Barr, a lawyer of Justice, Awareness and Basic Support, 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, 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.
Based on Deer's evidence, the Lancet editor-in-chief Richard Horton said Wakefield's paper should have never been published because its findings were "entirely flawed".The Sunday Times 2004: Although Wakefield maintained that the legal aid funding was for a separate, unpublished study (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. 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." Several of Wakefield's co-researchers also strongly criticized the lack of disclosure.
No ethical approval 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. 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."
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:
In March 2004, immediately following the news of the conflict of interest allegations, ten of Wakefield's 12 coauthors retracted this interpretation, while insisting that the possibility of a distinctive gastrointestinal condition in children with autism merited further investigation. 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.