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BMJ authors withdraw statements about adverse effects of statins

Academic papers that questioned the widespread use of cholesterol-reducing statins are to be the subject of an independent investigation for one of the UK’s most prestigious medical journals.

The British Medical Journal said it was setting up a panel of experts to decide whether it should completely retract two articles which claimed the drugs − taken by millions of Britons − caused harmful side effects and did not cut death rates.

The papers prompted a row, with one expert calling them “misleading”.

The authors, Dr John Abramson from Harvard Medical School and UK cardiologist Dr Aseem Malhotra, have already withdrawn statements from the articles after some figures they cited were found to be incorrect, the BMJ said.

“I have decided the right thing to do is to pass this decision to an independent panel”

Fiona Godlee

It admitted the errors had not been picked up by editors or experts who peer-reviewed them before publication in October.

Writing in the BMJ earlier this week, the journal’s editor-in-chief Dr Fiona Godlee said she wanted to alert readers, the media, and the public to the withdrawal of the 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”.

BMJ

Fiona Godlee

She added that their withdrawal raised the question of whether the whole articles should be pulled, saying: “However, as the editor responsible for publishing the articles, I have a vested interest in not retracting them unless the case of doing so is completely clear.

“So I have decided the right thing to do is to pass this decision to an independent panel,” she said.

She added: “Meanwhile, 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.”

Statins are currently offered to as many as seven million people in the UK who have a 20% risk of developing cardiovascular disease within 10 years.

In February, the National Institute for Health and Care Excellence called for the NHS to widen this to cover people with just a 10% risk following a study by Professor Rory Collins and a team at Oxford University.

Professor Collins criticised the papers by Dr Abramson and Dr Malhotra in March, saying they were misleading. It was he who requested the papers be withdrawn, the BMJ said.

University of Oxford

Rory Collins

The independent panel will be chaired by Iona Heath, a former chair of the Royal College of General Practitioners and a member of the BMJ’s ethics committee.

The journal said guidelines from 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 said Dr Abramson’s paper re-analysed data from the Cholesterol Treatment Trialists’ (CTT) Collaboration which showed treating people with a less than 20% risk of heart disease with statins made no difference to the death rate over the following 10 years.

This finding has not been challenged, but the paper also cited data from a separate “uncontrolled observational study” and “incorrectly concluded” that statin side-effects occur in 18-20% of patients.

The same mistake was made by Dr Malhotra in the same edition of the BMJ and it is these statements that have been withdrawn, the journal said.

Dr Godlee added: “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.”

The NHS estimates that statins save 7,000 lives a year in the UK.

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