Andrew Wakefield - Fraud and Conflict of Interest Allegations

Fraud and Conflict of Interest Allegations

In February 2009, The Sunday Times reported that a further investigation by the newspaper had revealed that Wakefield "changed and misreported results in his research, creating the appearance of a possible link with autism", citing evidence obtained by the newspaper from medical records and interviews with witnesses, and supported by evidence presented to the GMC.

In April 2010, Deer expanded on laboratory aspects of his findings in a report in the BMJ, recounting how normal clinical histopathology results (obtained from the Royal Free hospital) had been subjected to wholesale changes, from normal to abnormal, in the medical school and published in The Lancet. On 2 January 2011, Deer provided two tables comparing the data on the twelve children, showing the original hospital data and the data with the wholesale changes as used in the 1998 Lancet article.

On 5 January 2011, BMJ published an article by Brian Deer entitled "How the case against the MMR vaccine was fixed". Deer, funded by The Sunday Times of London and Channel 4 television network, said that, based on examination of the medical records of the 12 children in the original study, his research had found:

"The Lancet paper was a case series of 12 child patients; it reported a proposed “new syndrome” of enterocolitis and regressive autism and associated this with MMR as an “apparent precipitating event.” But in fact:

"Three of nine children reported with regressive autism did not have autism diagnosed at all. Only one child clearly had regressive autism;

"Despite the paper claiming that all 12 children were “previously normal,” five had documented pre-existing developmental concerns;

"Some children were reported to have experienced first behavioural symptoms within days of MMR, but the records documented these as starting some months after vaccination;

"In nine cases, unremarkable colonic histopathology results—noting no or minimal fluctuations in inflammatory cell populations—were changed after a medical school “research review” to “non-specific colitis”;

"The parents of eight children were reported as blaming MMR, but 11 families made this allegation at the hospital. The exclusion of three allegations — all giving times to onset of problems in months — helped to create the appearance of a 14 day temporal link;

"Patients were recruited through anti-MMR campaigners, and the study was commissioned and funded for planned litigation."

In an accompanying editorial, BMJ editors said:

Clear evidence of falsification of data should now close the door on this damaging vaccine scare ... Who perpetrated this fraud? There is no doubt that it was Wakefield. Is it possible that he was wrong, but not dishonest: that he was so incompetent that he was unable to fairly describe the project, or to report even one of the 12 children's cases accurately? No. A great deal of thought and effort must have gone into drafting the paper to achieve the results he wanted: the discrepancies all led in one direction; misreporting was gross. Moreover, although the scale of the GMC's 217 day hearing precluded additional charges focused directly on the fraud, the panel found him guilty of dishonesty concerning the study's admissions criteria, its funding by the Legal Aid Board, and his statements about it afterwards.

In a BMJ follow-up article on 11 January 2011, Deer said that based upon documents he obtained under Freedom of information legislation, Wakefield—in partnership with the father of one of the boys in the study—had planned to launch a venture on the back of an MMR vaccination scare that would profit from new medical tests and "litigation driven testing". The Washington Post reported that Deer said that Wakefield predicted he "could make more than $43 million a year from diagnostic kits" for the new condition, autistic enterocolitis. According to Deer's report in BMJ, the ventures, Immunospecifics Biotechnologies Ltd and Carmel Healthcare Ltd—named after Wakefield’s wife—failed after Wakefield's superiors at University College London's medical school gave him a two-page letter that said:

"We remain concerned about a possible serious conflict of interest between your academic employment by UCL, and your involvement with Carmel ... This concern arose originally because the company's business plan appears to depend on premature, scientifically unjustified publication of results, which do not conform to the rigorous academic and scientific standards that are generally expected."

WebMD reported on Deer's BMJ report, saying that the $43 million predicted yearly profits would come from marketing kits for "diagnosing patients with autism" and that "the initial market for the diagnostic will be litigation-driven testing of patients with AE from both the UK and the US". According to WebMD, the BMJ article also claimed that Carmel Healthcare Ltd would succeed in marketing products and developing a replacement vaccine if "public confidence in the MMR vaccine was damaged".

In October 2012, research published in PNAS, the Proceedings of the National Academy of Sciences, identified Wakefield's 1998 paper as the most cited retracted scientific paper, with 758 citations, and gave the "reason for retraction" as "fraud".