Wakefield Sues BMJ Editor for Defamation

Wow. Author of the a now-discredited Lancet article which started a vaccine scare by falsely linking MMR vaccination to autism onset, Andrew Wakefield is suing BMJ's editor, Fiona Godlee, and British investigative journalist Brian Deer, for defamation of his character. The complaint, filed in Travis County, Texas, is here. It focuses fairly narrowly on statements by Godlee and Deer to the effect that Wakefield manipulated or falsified data in the study.

The UK's General Medical Council, after the longest hearing in its history, found Wakefield guilty of serious professional misconduct in connection with the conduct of the research underlying the article, and erased him from its rolls. But they didn't specifically find that he altered data in the study; their main complaint about the article itself was that it mischaracterized the children under study--especially the means by which, and purpose for which, they were recruited. The GMC's findings spoke mainly to other forms of research and clinical misconduct. To review, the GMC found that Wakefield violated the limits of his appointment as an Honorary Consultant in a "breach of trust of patients and employers alike," and mismanaged funds, and failed to disclose "matters which could legitimately give rise to a perception of a conflict of interest," and conducted research on vulnerable children without required ethics review, and concealed that fact, and repeatedly breached "fundamental principles of research medicine," and acted contrary to the clinical interests of 9 of the 12 children mentioned in the article, and violated his duties as a senior author, and failed to correct his mistakes when given the chance, and made "dishonest and irresponsible" statements to the GMC board itself.

Of course, the fact that Wakefield was unprofessional in a bunch of different ways doesn't mean that he was unprofessional in all of the ways that Godlee or Deer have, at one time or another, alleged. It's just possible that one or the other of them has said something factually wrong by accusing Wakefield of some specific kind of scumbaggery that he didn't actually engage in. If so, may the damages found be very, very small.

Because the damage caused by Wakefield hasn't been small. The publicity around his unethical research likely caused children to die of completely preventable childhood diseases, and is certainly still causing misguided parents to fail to vaccinate their children. It is depressing to note that here, the Autism Action Network is already trumpeting Wakefield's suit against Deer and a woman whom they call "Fiona Godley." Their view is that Wakefield and his co-author John Walker-Smith "had their medical licenses suspended for their refusal to recant their hypothesis." They don't mention the actual GMC findings against Wakefield, nor those against Walker-Smith (which you can read here), nor the fact that in 2004, six years before the GMC acted, Walker-Smith and nine of Wakefield's other co-authors specifically retracted the portion of the paper that posited a link of MMR with autism.

Human Subjects Protection, Unintended Consequences Edition

The New York Times has a story here (oddly printed in the Arts section) dealing with some unintended consequences of the proposed changes to the Common Rule, which protects human subjects of research. One of the major proposed changes (which I earlier mentioned here) is to implement HIPAA-like privacy and security standards to protect the data gathered in human-subjects research. The idea is to relieve IRBs from having to consider "informational risks" when they evaluate studies (risks related to subjects' having their personal data leaked out into the world). The Times article notes that the actual HIPAA standards prevent data collected for one purpose from being released to researchers for another. This means that studies-about-studies (like the recent work of Susan Reverby, which uncovered unethical US research in Guatemala) could be much more difficult to conduct. Jerry Menikoff of OHRP has said that the government will work on the problem, based on the comments received from historians and social scientists. This is an example of a good feature of our administrative law system: federal regulations are always released in draft form with a comment period, precisely so that problems like this can be pointed out by interested parties and addressed before the rules become final. The rub is that regulators are not as responsive to comments as we'd sometimes like them to be. But in this case, researchers have in Jerry Menikoff a former academic bioethicist with real expertise in this area. He'll take all the comments seriously.