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Editors at The Lancet said they might never have published the study by Andrew Wakefield in 1998 if they had known that he was also paid £55,000 as part of a legal action against the vaccine’s manufacturers.
They said the payment was a potential conflict of interest that should have been declared to their editorial board. They also criticised Dr Wakefield for failing to tell them that children used in The Lancet study were planning to sue the manufacturers of the vaccine.
Last night Richard Horton, Editor of The Lancet, said: “If we had known the conflict of interest Dr Wakefield had in this work it would have been rejected. As the father of a three-year-old who has had MMR, I regret the adverse impact this paper has had.”
Mr Horton told the BBC News: “If we had known then what we know now, we certainly would not have published the part of the paper that related to MMR. I believe there remains validity in the connection between bowel disease and autism, but I do not believe the MMR connection.”
In the wake of the report, parents in their thousands opted not to have their children vaccinated with the triple measles, mumps and rubella vaccine. In early 1995, 92.5 per cent of children under two were having the triple jab. Today it stands at 79 per cent.
In 1997 there were 117 cases of measles but by 2002 the number of cases had risen to more than 300. By last September 360 cases had already been reported for 2003.
The Lancet’s statement came after it received serious allegations about the ethics of the study, published in 1998. The allegations, by a journalist, claimed that Dr Wakefield failed to disclose £55,000 in fees that he received from the Legal Aid Board.
This was paid to conduct a pilot project investigating the grounds for pursuing legal action on behalf of parents of allegedly vaccine-damaged children. Some of the children who were reported in The Lancet study were also part of the Legal Aid Board-funded study.
The Lancet found those complaints proved but it dismissed other allegations made in the complaint. These were that ethical approval was not obtained for the 1998 study, and that the children described in that study had been “cherry-picked” to make the argument seem more plausible.
But they did find that Dr Wakefield had not been open about the potential conflict of interest in the work. “We regret that aspects of funding for parallel and related work and the existence of ongoing litigation that had been known during clinical evaluation of the children reported in the 1998 Lancet paper were not disclosed to editors,” they wrote. “We also regret that the overlap between children in the Lancet paper and in the Legal Aid Board-funded pilot project was not revealed to us.”
In a long statment issued last night, Dr Wakefield did not address the conflict of interest question raised by The Lancet but denied misrepresentation. “My colleagues and I have acted at all times in the best medical interests of these children and will continue to do so. Whether parents perceived an association with MMR vaccine or not, whether parents had approached lawyers with the intent to seek legal redress, or whether children were in receipt of legal aid funding or not, had no bearing on their selection for clinical investigation or inclusion in the Lancet report.”
Humphrey Hodgson, the Vice-Dean of the the Royal Free and University College Medical School, where Dr Wakefield’s research was carried out, denied that the study did not have ethical approval.
The investigation had been “properly submitted to and fully discussed” by the ethics committee at the Royal Free Hospital, he said in a statement.
But he conceded: “Had the advice of the institutions been sought at the time concerning conflict of interest, they would undoubtedly have advised that any potential conflict of interest should be declared, so that others could judge whether such conflicts were real.”
Jeff Bradstreet, the medical director of the International Child Development Resource Centre in Florida, where Dr Wakefield now works, said that the criticisms reported to The Lancet were part of a smear campaign to discredit the MMR research.
“I think it’s a witchhunt,” said Dr Bradstreet, the father of an autistic child, who has presented conferences around the world with Dr Wakefield.
“It is so outrageous. I have known Andy for about four years and he is the most ethical individual I have ever met.”
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