Lancet retracts Wakefield’s MMR paper

The Lancet has retracted the 12 year old paper that sparked an international crisis of confidence in the safety of the measles, mumps, and rubella (MMR) vaccine when its lead author suggested a link between the vaccine and autism.

Andrew Wakefield was found guilty by the General Medical Council last week of dishonesty and flouting ethics protocols.

The UK regulator held that Dr Wakefield abused his position, subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated, carried out research that breached the conditions of ethics committee approval, and brought the medical profession into disrepute.

In a statement published online (www.thelancet.com) the editors of the Lancet said: “Following the judgment of the UK General Medical Council’s Fitness to Practise Panel on Jan 28, 2010, it has become clear that several elements of the 1998 paper by Wakefield et al are incorrect, contrary to the findings of an earlier investigation.

“In particular, the claims in the original paper that children were ‘consecutively referred’ and that investigations were ‘approved’ by the local ethics committee have been proven to be false. Therefore we fully retract this paper from the published record.”

Evan Harris, a Liberal Democrat MP and doctor, who had called for the retraction, said: “The whole thing is flawed. You should not publish or leave in the literature papers which are unethical.”

His call was echoed in the BMJ this week by Trisha Greenhalgh, professor of primary health care at University College London, who says: “The Lancet’s editor, Richard Horton, is no doubt familiar with the guidelines of the Committee on Publication Ethics (http://publicationethics.org/guidelines), which recommend that a journal should formally retract a paper if its findings are subsequently shown to be unreliable as a result of either misconduct or honest error or if the work turns out to have been conducted unethically” (Observations, BMJ 2010;340:c644, doi:10.1136/bmj.c644).

One of the biggest public health scares in UK history was triggered by Dr Wakefield’s study of 12 children, published in the Lancet in 1998 (351:637-41, doi:10.1016/S0140-6736(97)11096-0). Although the paper conceded that it had not found a definite link between the vaccine and autism, Dr Wakefield, then a consultant gastroenterologist, caused a furore when he suggested during a press conference at the Royal Free Hospital in north London, where he worked at the time, that single vaccines for measles, mumps, and rubella might be preferable to a triple vaccine.

The take-up of the MMR vaccine plummeted and has still not fully recovered, whereas the number of cases of measles has soared.

Dr Wakefield, 52, failed to disclose to the Lancet that his research had received funding from the Legal Aid Board through a solicitor who hoped to mount a legal action against the manufacturer and that he had also filed a patent application for a new vaccine.

His failure to mention these conflicts of interest was contrary to his duties as senior author of the Lancet paper, the GMC panel found, and he had dishonestly represented that the children in the study, several of whom were litigants in the legal action, had come through GPs or paediatricians by the standard route.

Ten of the paper’s 13 authors later retracted the “interpretation” of the data (BMJ 2004;328:602, doi:10.1136/BMJ.328.7440.602-c). But Peter Harvey, one of the two who, with Dr Wakefield, did not sign the retraction, told the BMJ: “I stand by that original paper, and I see no reason to retract it. I saw no reason to retract it then, and I see no reason now.” Dr Harvey, a neurologist, said that the GMC findings represented “the establishment baying for blood—they want a sacrificial lamb.”

Subsequent research has found no evidence of a link between the vaccine and autism. Dr Wakefield left the Royal Free Hospital by mutual agreement and is now executive director of Thoughtful House Center for Children in Austin, Texas, which studies developmental disorders.

Backed by a throng of supporters, including parents of autistic children, he insisted outside the hearing in central London that the GMC panel’s findings were “unfounded and unjust.”

After a hearing lasting 148 days over two and a half years—the longest in the GMC’s history—he was also found guilty of a “callous disregard” for the distress and pain of children who had blood samples taken from them at his son’s birthday party and were paid £5 (€6; $8) each.

The panel also ruled that two of his former colleagues at the Royal Free who were coauthors of the Lancet paper—the retired professor of paediatric gastroenterology John Walker-Smith, 73, and Simon Murch, 53, now professor of paediatrics and child health at Warwick Medical School—had carried out investigations that were not in the interests of children and that did not have proper ethics approval.

Decisions on whether they and Dr Wakefield were guilty of serious professional misconduct and whether they should be struck off the medical register or receive a lesser sanction will be taken at the final session of the marathon hearing, which starts in April.