The editors of a prestigious medical journal are declaring that a British study, since retracted by its publisher, that claimed to have found a link between autism and the measles, mumps and rubella vaccine was "an elaborate fraud" based on the "falsification of data."
In an explosive series of articles that began publication Monday, the British Medical Journal declares that there is "no doubt" that lead researcher Andrew Wakefield manipulated and even falsified his data to show a link between the vaccine and both autism and bowel disease. The study, published in the medical journal Lancet in 1998 and retracted last February, spurred millions of parents around the world to opt not to get the shot for their children.
In the years since the study's publication, measles outbreaks have occurred across Europe and North America. In 2006, a 13-year-old boy was the first recorded measles death in Britain in 14 years. In 2008, measles was declared endemic in England and Wales for the first time in more than a decade.
In an editorial, BMJ editor Dr. Fiona Godlee, deputy editor Jane Smith and associate editor Harvey Marcovitch said "the MMR scare was based not on bad science but on a deliberate fraud" and that "clear evidence of falsification of data should now close the door on this damaging vaccine scare."
Parental worries about the vaccine have endured despite the medical community's swift and vocal criticism of the study. Experts pointed out that the small sample size -- only 12 children were included in the study -- was insufficient to produce data of statistical significance. They also expressed concern about subject selection bias, and the lack of a control group.
In 2004, the Lancet issued a partial retraction of the study, citing Wakefield's "fatal conflict of interest." Two years before the journal published his study, Wakefield began working as a paid consultant to lawyers looking for evidence with which to sue makers of the vaccine, on behalf of parents of autistic children. The journal said that at the time the study was published it was unaware of Wakefield's work with the lawyers.
In the editorial, the editors point out that in the decade after the study was first published, other research has failed to find a link between the MMR vaccine and autism.
"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," they write. "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."
The BMJ articles dissecting Wakefield's research are written by investigative journalist Brian Deer, based on years of research into Wakefield's study. It was his first article questioning the research in 2004 that spurred Britain's General Medical Council (GMC), which licenses doctors, to launch its own investigation into Wakefield and his work.
In the article published Monday, Deer uses interviews with parents, documents and data from the GMC's investigation to show:
- how Wakefield altered patients' medical histories, including changing the dates parents reported their child's autism-like symptoms to fall closely after they received the MMR vaccine
- that some of the children included in the study did not have autism, and others had shown signs of developmental delays before receiving the vaccine
- that diagnoses of several children were changed to report the presence of bowel disease
- that patients were recruited via an anti-vaccine group called JABS and referred by a lawyer working on the planned lawsuit against the vaccine maker
In an interview with Â鶹´«Ã½, Deer said Wakefield's study has left a number of victims in its wake.
"There are the parents, who feel guilt if they have children with autism and think they caused it, the parents who stress over whether to give the vaccine, and the children who die of vaccine preventable illnesses," he said.
Last May, the GMC found Wakefield guilty of serious professional misconduct and stripped him of his U.K. medical licence. But Wakefield continues to tout the veracity of his research and, until last year, worked at an autism research centre he founded in Texas. He has also enjoyed the support of actress Jenny McCarthy, who has written extensively about her search for a cure for her son's autism and who claims Wakefield is the victim of a smear campaign.
But 10 of the study's co-authors have renounced its findings. The GMC investigation found that they were unaware of much of what Wakefield was doing and concluded that Wakefield alone wrote the final draft. However, the BMJ editors say "they all failed in their duties as authors," and point out that the satisfaction of attaching one's name to a study "must never detract from the responsibility to ensure that one has been neither party to nor duped by a fraud."
The editors are calling for investigations into Wakefield's other studies "to decide whether any others should be retracted."
Dr. Matthew Stanbrook of the Canadian Medical Association Journal says incidents where studies are so damningly discredited are rare, but admitted that the research and publishing process relies heavily on trust. While having studies peer reviewed to ensure they were conducted following the most stringent of standards "will pick up things," Stanbrook said it is impossible to completely prevent episodes of fraud.
In this case, Stanbrook says, the takeaway message for the public is "the MMR vaccine is absolutely safe.
"There is no link whatsoever, no scientific link between this vaccine and autism," Stanbrook told Â鶹´«Ã½. "That was a fraud fabricated by one man and there should be no concern among the general public that this vaccine causes autism."
Meanwhile, vaccination rates across the U.K. are only slowly recovering. While they are higher than the 80 per cent low hit in 2003-2004, they are still below the 95 per cent level recommended by the World Health Organization to ensure what it calls "herd immunity."
"The Lancet paper has of course been retracted, but for far narrower misconduct than is now apparent," the editors write. The retraction statement leaves "the door open for those who want to continue to believe that the science, flawed though it always was, still stands. We hope that declaring the paper a fraud will close that door for good."