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BMJ withdraw statements about statin safety

Independent panel will decide if two articles should be retracted

Mark Gould

Thursday, 15 May 2014

Dr Iona Heath, former chairwoman of the Royal College of General Practitioners and of the BMJ’s ethics committee will chair an independent inquiry to decide whether two articles raising concerns about the higher than reported adverse effects of statins should be retracted.

The move comes as the authors of two articles, published in the BMJ last year, withdrew statements about the adverse effects of statins.

In an editorial* in the BMJ today, editor-in-chief Dr Fiona Godlee alerted readers, the media and the public to the withdrawal of these statements “so that patients who could benefit from statins are not wrongly deterred from starting or continuing treatment because of exaggerated concerns over side effects.”

In October last year, BMJ articles by John Abramson and colleagues questioned the evidence behind new proposals to extend the routine use of statins to people at low risk of cardiovascular disease.

The authors re-analysed data from the Cholesterol Treatment Trialists’ (CTT) Collaboration. This showed no mortality benefit associated with treatment of people with a less than 20% risk of developing cardiovascular disease over the next 10 years. This has not been challenged.

However, they also cited data from a separate uncontrolled observational study and incorrectly concluded that statin side effects occur in 18-20% of patients. This incorrect statement was repeated in another article published in the same week in the BMJ by Aseem Malhotra – and is the statement the authors have now withdrawn.

Sir Rory Collins, professor of medicine and epidemiology at Oxford University and head of the CTT Collaboration whose data were re-analysed by Abramson and colleagues alerted the BMJ to the error in the uncontrolled observational study. Sir Rory told the BBC Radio 4 Today programme that he drew this problem to the attention of Dr Godlee but that nothing was done to correct it so that it was repeated a number of times. "It's big error overestimating by more than 20 times the adverse effects of statins," he said.

Dr Godlee said this error was due to a misreading of data from one observational study, and was not picked up by the peer reviewers or editors. “The BMJ and the authors of both these articles have now been made aware that this figure is incorrect, and corrections have been published withdrawing these statements.”

She explains that writing, peer reviewing, and editing are human processes subject to error, “which is why we must be, and are, ready to correct things when they are found to be wrong.”

Professor Collins has requested retraction of both articles, but Dr Godlee questions whether the error is sufficient for retraction, “given that the incorrect statements were in each case secondary to the article’s primary focus.”

Guidelines of the International Committee on Publication Ethics state that journals should consider retracting a publication if there is clear evidence that the findings are unreliable, either as a result of misconduct or honest error.

The BMJ says full details of the panel and processes will be published shortly, and all submissions to the panel will be placed in the public domain on the BMJ website. Dr Godlee has asked Dr Heath to chair the independent review and says she is committed to implementing the panel’s recommendations in full.

Meanwhile, she says: “The BMJ will continue to debate the important questions raised in both these articles: whether the use of statins should be extended to a vastly wider population of people at low risk of cardiovascular disease; and the role of saturated fat in heart disease.”

* Fiona Godlee. Adverse effects of statins. BMJ 2014; 348 doi: 10.1136/bmj.g3306

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