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Renowned journal retracts controversial autism/vaccine paper

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    Renowned journal retracts controversial autism/vaccine paper

    The following is interesting from several viewpoints. First, journals rarely retract papers. This is only the 9th retraction in several hundred year history of Lancet and 12 years after the paper was published in 1998. Second, ten of the 13 authors of the paper withdrew from the interpretation section of the paper. Third, investigations revealed a sordid story of not just failure of Wakefield to obtain permission from the Institutional Review Board to do the study and mischaracterization of the data but his failure to report that he had been paid £400,000 to do this study by lawyers who were preparing a lawsuit against vaccine manufacturers.

    Some background on this remarkable case is summarized in Wikipedia [source][/source]. In addition to not having permission from the IRB and falsely stating that he did and that the patients were consecutively referred, the panel that investigated the case concluded.
    • There were inconsistencies between the claimed autism start dates and the medical records of the children.
    • The children were subjected to unnecessary medical procedures, including ileocolonoscopy and lumbar puncture. One of the patients suffered life-threatening complications.
    • Conflict of interest has been alleged. Specifically, Wakefield apparently recruited some of the patients through a lawyer who was preparing lawsuits against vaccine manufacturers and he had been paid £400,000 for the work, something that he never disclosed in the paper. In addition, he had filed a patent for a single measles vaccine before the paper was published and he omitted mentioning in the paper that he did not find measles virus in the children.

    Renowned journal retracts controversial autism/vaccine paper
    By Kayt Sukel
    About Kayt Sukel
    February 10, 2010
    On Feb. 2, renowned medical journal The Lancet retracted a controversial 1998 paper that hypothesized a link between the measles, mumps, and rubella (MMR) vaccine and autism. Citing ethics violations by the lead author, Andrew Wakefield, the journal’s decision set off a global media firestorm. Many scientists argue the paper’s retraction definitely debunks the premise that vaccines play any role in the development of autism. But advocacy groups, as well as many parents of children who have autism, argue that Wakefield’s work still has merit—and questions about why autism rates have risen so dramatically over the past few decades still need to be answered.

    The retracted study

    Wakefield was the lead researcher on the paper, “Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive development disorder in children,” published in the Feb. 28, 1998, issue of The Lancet. It was a series of 12 case studies of children who were referred to a pediatric gastroenterology unit with both gastro-intestinal issues and autistic symptoms.

    “It wasn’t a study, per se,” says Paul Offit, the director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. “He looked at children believed to have intestinal abnormalities and hypothesized that maybe after they received their MMR vaccine, they developed the intestinal problems and that may have led to the autism. He raised a hypothesis but, in that paper, he didn’t study a thing.”

    Soon after the paper was published, the General Medical Council (GMC), the organization responsible for regulation of doctors and proper medical practice standards in the United Kingdom, received a complaint about the work.

    “The GMC can look into a doctor’s registration when any concerns are raised by a member of the public, a newspaper, a journal, or even an institution,” says Lisa Crack, a spokesperson for the organization. The GMC investigation of the complaint culminated in a panel hearing that lasted 148 days. According to Crack, it’s the longest hearing in GMC’s history. The panel found Wakefield did not receive proper approvals from a governing research ethics committee and that he was biased in his selection of participants.

    Based on the GMC’s findings, editors of The Lancet decided to retract the paper, releasing the following statement:

    "It has become clear that several elements of the 1998 paper by Wakefield et al. are incorrect, contrary to the findings of an earlier investigation. In particular, the claims in the original paper that children were 'consecutively referred' and that investigations were 'approved' by the local ethics committee have been proven to be false. Therefore we fully retract this paper from the published record."

    Tony Kirby, press officer for the journal, said there would be no further comment on this decision, but did say such a decision is not unprecedented.The Lancet has retracted more than a dozen papers in its history, including one in October 2009.

    Precedents notwithstanding, Offit argues The Lancet’s decision sends a strong message to the research community. “Bad science gets published all the time. Rarely does a journal retract a paper, they usually just let the bad science die in the face of irreproducibility,” he says. “But in this case, not only was the paper incorrect, it was fraudulently incorrect.”