Re: How the case against the MMR vaccine was fixed
In January this year, National Whistleblowers Center director, Stephen Kohn, spoke at a vaccine safety conference in Jamaica, where Andrew Wakefield discussed his research.(1) I was invited as an observer. My responsibilities include investigating “institutional research misconduct” in which government, industry, and academic institutions use false allegations of research misconduct to suppress research (www.researchmisconduct.org).
During the conference, the news broke of Brian Deer’s BMJ article on the MMR controversy(2) and the BMJ’s conclusion that Wakefield was guilty of research fraud.(3) Wakefield allowed me to review his personal files concerning the Lancet article. Among them were copies of histopathological grading sheets, which Wakefield told me had been created and filled in by two of his coauthors, pathologists Amar Dhillon and Andrew Anthony (see bmj.com). Wakefield said that the grading sheets related to all but one of the 12 children. Wakefield told me that the General Medical Council had passed the grading sheets on to him along with other documents collated for its investigation. The twelfth child, as a US citizen, was not subject to the GMC’s investigations.
Dhillon’s grading sheets comprised check boxes for the pathologist to indicate the presence and severity of Crohn’s disease or ulcerative colitis, plus a list of other headings: “infection,” “ischaemia,” “non-specific,” and “normal.” In one case Dhillon left the boxes blank. For the remaining 10 children, he checked either “non-specific” or “normal,” with “non-specific” being checked for at least one of each child’s biopsies. Using a slightly different form, Anthony noted mild or active chronic colitis in six children. However, his forms are dated either September 1998 or October 2001 so were completed after the Lancet paper was published.
Wakefield’s files also included a report by Professor Ian Booth, the GMC’s expert paediatric gastroenterologist.(4) Booth had compared routine pathology reports from the Royal Free Hospital with table 1 of the Lancet article and found that on-duty pathologists had indicated that most of the children’s biopsies were normal. He reported to the GMC that the “altered” diagnoses in the Lancet article suggested “an exaggerated view of the histology,” and concluded that “scientific fraud” could not be ruled out.
Four years later, Deer concluded: “These changes—from normal to abnormal, or from healthy to diseased—had also raised concern in the mind of at least one of the paper’s authors [histopathologist Susan Davies].” (5) Davies, as Deer noted, testified at the GMC’s hearings that her concerns were allayed when she discussed them with Dhillon and others.
As a research microbiologist involved with the collection and examination of colonic biopsy samples, I do not believe that Dr. Wakefield intentionally misinterpreted the grading sheets as evidence of “non-specific colitis.” Dhillon indicated “non-specific” in a box associated, in some cases, with other forms of colitis. In addition, if Anthony’s grading sheets are similar to ones he completed for the Lancet article, they suggest that he diagnosed “colitis” in a number of the children.
1 Vaccine safety: evaluating the science. Jamaica, West Indies. 3-8 January 2011. www.vaccinesafetyconference.com/index.html
2 Deer B. How the case against the MMR vaccine was fixed. BMJ 2011;342:c5347.
3 Godlee F, Smith J, Marcovitch H. Wakefield’s article linking MMR vaccine and autism was fraudulent. BMJ 2011;342:c7452.
4 Booth I. GMC Fitness To Practise Panel (Misconduct). Wakefield, Walker-Smith, Murch. Second addendum to overview statement, 8 November 2006.
5 Deer B. Wakefield’s “autistic enterocolitis” under the microscope. BMJ 2010;340:c1127.