Institutional research misconduct.

It is now more than 18 months since the UK’s General Medical Council found AndrewWakefield guilty of dishonesty and other serious professional misconduct; and it is nearly a year since the BMJ concluded that his now retracted Lancet paper linking the measles, mumps, and rubella (MMR) vaccine with autism and bowel disease was an “elaborate fraud.” 3 At that time, January 2011, we called on Wakefield’s former employer, University College London (UCL), to establish an inquiry into the scandal. Ten months on, no inquiry has been announced. Our coverage in January showed howWakefield manufactured the appearance of a link between the vaccine and regressive autismwhile employed by lawyers trying to build a case against the MMR vaccine, and while negotiating extraordinary commercial schemes that would succeed only if confidence in the vaccine was damaged. The articles, by investigative journalist Brian Deer, also showed that the conflicts of interest were not confined toWakefield. They drew in his then employer, the Royal Free hospital and medical school. Now part of University College London, the Royal Free issued public statements of support for national immunisation policy while privately holding business meetings with Wakefield over purported diagnostic kits, single vaccines, and autism products meant to be sold on the back of the vaccine crisis. Now we can report that it is not only Wakefield and UCL’s administrators who have a case to answer. This week we publish new information that puts the spotlight on Wakefield’s coauthors. Previously unpublished histopathology grading sheets apparently completed by Amar Dhillon, the senior pathologist on the paper, remove any remaining credibility from the claim that the Royal Free doctors had discovered a new inflammatory bowel disease associated withMMR.Alongwith UCL’s failings during and after Wakefield’s tenure, this evidence also raises wider concerns about the prevailing culture of Britain’s academic institutions. In 1997, Dhillon was asked to reassess intestinal biopsy specimens taken from children enrolled inWakefield’s research after the hospital’s histopathology service, under consultant and fellow coauthor Susan Davies, reported most of the children’s biopsies to be normal. His 62 A4 grading sheets were sent to the BMJ by David Lewis, a self employed environmental microbiologist. Lewis says he was given them by Wakefield after they met at a vaccine safety conference in January. In his accompanying letter, Lewis concludes that a non-expert pathologist such as Wakefield could have thought they showed that the children had non-specific colitis. The grading sheets are certainly interesting, but not for the reasons Lewis (or, it may be assumed, Wakefield, in giving them to him) intended. We sent them to two independent reviewers and supplied the data for comment to two further senior gastroenterologists. We also showed them to Brian Deer, the investigative journalist who over the past eight years has uncovered the secrets behind theMMR scare and who arguably knows more about this case than anyone apart fromWakefield. Our expert reviewers are in no doubt that Dhillon’s findings—like Davies’s before him—are almost all normal, or as near to normal that the changes they reported were likely to be physiological. 7 In an accompanying feature article, Deer explains what they add to our knowledge of theWakefield saga. The grading sheets, which we have made available on bmj.com in the public interest (web extra), present findings from the biopsies of 11 of the 12 children, scored on a scale of 0-3 for the appearance of various levels of inflammation. Each sheet has a box for indicating the presence and severity of Crohn’s disease or ulcerative colitis, or for indicating other findings: “infection,” “ischaemia,” “non-specific,” or “normal.” In all but one child, “non-specific” is ticked for at least one biopsy. Lewis also sent us slightly different grading sheets completed by another coauthor, Andrew Anthony, who was then a trainee pathologist. Anthony concluded that some of the children had “mild” or in one case “active” chronic colitis. But these sheets are dated either September 1998 or October 2001, so they were completed after the Lancet paper was published. Because of this we did not send them out for external review. Assuming that the sheets are what they appear to be (and we have supplied them to Dhillon, who has not demurred), it is