02/02/2010

The Lancet formally retracts Andrew Wakefield's 1998 MMR paper

LONDON, UK: The Lancet medical journal on February 2 finally retracted the paper that sparked a crisis in MMR vaccination across the UK, after the General Medical Council found that its lead author, Dr Andrew Wakefield, had been dishonest.

The Lancet's editor, Richard Horton, told the Guardian on February 2 that he realised as soon as he read the GMC findings that the paper, published in February 1998, had to be retracted. "It was utterly clear, without any ambiguity at all, that the statements in the paper were utterly false," he said. "I feel I was deceived."

Many in the scientific and medical community have been pressing for the paper, linking the MMR (measles, mumps and rubella) jab to bowel disease and autism, to be quashed. But Horton said he did not have the evidence to do so before the end of the GMC investigation on January 28.

In 2004, when concerns were first raised about the conduct of the study, the Lancet asked the Royal Free hospital, where Dr Wakefield and his fellow authors worked, to investigate.

But Professor Humphrey Hodgson, then vice dean of the Royal Free and University College school of medicine, wrote to the journal to say it had found no problems. "We are entirely satisfied that the investigations performed on children reported in the Lancet paper had been subjected to appropriate and rigorous ethical scrutiny," he said at that time.

The GMC last week disagreed. Children had been subjected to invasive procedures that were not warranted, a disciplinary panel ruled. They had undergone lumbar punctures and other tests solely for research purposes and without valid ethical approval.

Dr Wakefield "was dishonest", said Horton. "He deceived the journal." The Lancet had done what it could to establish that the research was valid, by having it peer-reviewed. But there is a limit, he said, to what peer-review can ascertain.

"Peer review is the best system we have got for checking accuracy and acceptability of work, but unless we went into the lab or examined every case record, we can't ever finally rule out some element of misconduct.

"The entire system depends upon trust. Most of the time we think it works well, but there will be a few instances – and when they happen they are huge instances – where the whole thing falls apart."

When journals have suspicions of fraud or misconduct, they have to refer them to the institution employing the scientists. "We rely on the processes within institutions to investigate allegations of fraud, and if they are found to be wanting, that is extremely disappointing," he said.

Dr Michael Fitzpatrick, GP and author of books on the MMR scare, said the retraction was "good news – only 10 years too late."

Dr David Elliman, consultant in community child health at Great Ormond Street hospital, said it was a very reasonable decision. "To be fair to the Lancet, they did publish a commentary at the time urging caution that wasn't picked up. I think the reality of the world today is that academic papers on major public health issues do not remain the property of academia. Therefore, it is incumbent on us all in science, in journals and in the media to be very certain of the strength of a study before rushing to publish, and to be aware of the potential effects."

The research sparked a massive drop in the number of children given the triple jab for measles, mumps and rubella.

The editors of the Lancet said it had become clear that several elements of the paper were 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.''

The fitness to practise panel ruled last week that Dr Wakefield ''showed a callous disregard'' for the suffering of children and subjected some youngsters to unnecessary tests.

Dr Wakefield ''abused his position of trust'' as he researched the possible link, it said. He also brought the medical profession ''into disrepute'' after he took blood samples from children at his son's birthday party in return for £5 payments.

He and two colleagues involved in the research, Professors John Walker-Smith and Simon Murch, face being struck off if they are found guilty of serious professional misconduct at a later date.

It ruled that Dr Wakefield ''failed in his duties as a responsible consultant'' and went against the interests of children in his care in conducting research. He further acted dishonestly and was misleading and irresponsible in the way he described the study.

It said Dr Wakefield, whose contract prevented him from carrying out clinical research on youngsters, had not acted in the children's best clinical interests. He ordered some youngsters to undergo unnecessary colonoscopies, lumbar punctures (spinal taps), barium meals, blood and urine tests and brain scans.Some of the tests were carried out by Professors Walker-Smith and Murch.

The GMC said the children did not meet the criteria for inclusion in the research and the doctors did not have ethical approval to investigate them.

The panel heard that Dr Wakefield later took blood from his son's friends at the birthday party and joked about it during a US presentation in March 1999.

Dr Wakefield was an honorary consultant in experimental gastroenterology at London's Royal Free Hospital at the time of his research.

A decision on serious professional misconduct and any sanctions are not expected for a matter of months.

Dr Wakefield said after the GMC hearing: ''The allegations against me and against my colleagues are both unfounded and unjust - I repeat unfounded and unjust - and I invite anyone to examine the contents of these proceedings and come to their own conclusion.''

Professor Adam Finn, a leading paediatrician based at the University of Bristol Medical School, said: "This is not before time. Let's hope this will do something to re-establish the good reputation of this excellent vaccine. And I hope the country can now draw a line under this particular health scare and move on to new opportunities for vaccination."

(Sources: The Guardian, The Daily Telegraph, BBC News Online, February 2, 2010)

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