Will Retracted Study Affect Autism Activism?

Finally: after almost a dozen years, scores of studies undercutting its conclusions, and a years-long disavowal by most of the authors, the infamous paper that first claimed a link between childhood vaccinations and autism has been formally retracted by The Lancet, the medical journal that published it in 1998.

Ten of the 13 authors had previously—in 2004—retracted the claim that the measles, mumps, and rubella (MMR) vaccine is linked to autism, but because the primary author, Andrew Wakefield, had not, the paper remained as part of the scientific literature, albeit with a big fat asterisk. The belated retraction was triggered not by a long-overdue recognition that the study was scientifically flawed, however, but by an official ruling that it had been conducted in violation of the standard ethical norms of scientific research.

To summarize, as I recounted in a story last year, the study claimed to have found severe intestinal inflammation in children who had just days before received the MMR. Because nine of the children also had autism, with symptoms appearing between one and 14 days after the vaccination, Wakefield concluded that the shot had damaged the children's intestines. According to his convoluted hypothesis, the measles part of the vaccine had caused serious inflammation of the gut, allowing harmful proteins to leak from there into the bloodstream and then to the brain, where they damaged neurons in a way that triggered autism.

That allegation unleashed more than a decade—and counting—of hysteria that childhood vaccines are behind the rising incidence of autism, which has soared from one in 300 in 2000 to just over one in 100 in the latest U.S. government count. Parents have refused to let their children be vaccinated, leading to an increase in the rate of measles.

The British panel investigating the MMR-autism study had a different focus, however. For years allegations of ethical improprieties have dogged Wakefield. An investigation by The Sunday Times of London revealed that some of the children in his study were clients of a lawyer working on a case against vaccine makers; Wakefield also received £55,000 from Britain's Legal Aid Board, which supports research related to lawsuits. Those revelations prompted Lancet editor Richard Horton to say, in 2004, "If we knew then what we know now, we certainly would not have published the part of the paper that related to MMR…There were fatal conflicts of interest."

A 2004 investigation into whether the study had broken any rules of ethical research cleared the scientists. Last month, however, Britain's General Medical Council completed a new two-and-a-half-year investigation into whether Wakefield & Co. followed proper research ethics in their study, and the answer was no. The 143-page decision (you can find a PDF of the report here) calls Wakefield's conduct "dishonest" and "misleading" in numerous respects. But the bottom line is that he misled The Lancet about how children came to be studied (that is, through the attorneys), that the ethical statement in the paper (denying any conflict of interest) was false, and that the hospital where the research was conducted had not approved it. Most damning, the GMC found that Wakefield "showed a callous disregard for the distress and pain that [he] knew or ought to have known the children involved might suffer," that he "abused [his] position of trust as a medical practitioner," and that he brought "the medical profession into disrepute."

The Lancet retraction will certainly not derail the anti-vaccine movement, or even—I'll bet a nickel—give it pause. The General Medical Council stated explicitly that "the Panel wish to make it clear that this case is not concerned with whether there is or might be any link between the MMR vaccination and autism." Ironically, its findings about "callous disregard" for children and bringing medicine "into disrepute" apply most forcefully to the storm Wakefield unleashed, not to the niceties of bioethics that he failed to observe.

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