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Journal's statin articles to be investigated Statins: BMJ investigates claims over side-effects
(35 minutes later)
Articles published by the British Medical Journal suggesting that statins may be harmful are to be investigated. The British Medical Journal is investigating whether two articles claiming cholesterol-reducing statins may be unsafe should be retracted.
The journal will set up an expert panel to decide if it should retract two articles saying the cholesterol-reducing drugs had harmful side-effects. The authors of two studies it published in October have withdrawn figures suggesting up to 20% of users would suffer harmful side-effects such as liver disease and kidney problems.
The papers were criticised when they were published in October. About 7m people in the UK at risk of heart disease are prescribed statins.
Statins are offered to seven million people in the UK who have a 20% chance of heart disease in the next decade. But experts fear the articles will have discouraged people from taking them.
The BMJ said Dr John Abramson from Harvard Medical School and UK cardiologist Dr Aseem Malhotra had already withdrawn statements from the articles after some figures proved to be incorrect. Peer reviewed
Its expert panel will decide whether to completely retract the articles. Writing in the latest edition of the British Medical Journal (BMJ), editor-in-chief Dr Fiona Godlee said it was publicising the withdrawal of the side-effects figures "so that patients who could benefit from statins are not wrongly deterred from starting or continuing treatment because of exaggerated concerns over side effects".
Errors were not picked up at the time by the journal's editors or the experts who peer-reviewed the work, the BMJ said. In the UK statins are offered people who have a 20% chance of heart disease in the next decade and studies have also examined whether more people should be offered the drugs to prevent heart problems.
The journal said Dr Abramson's paper cited data from an "uncontrolled observational study" and "incorrectly concluded" that statin side-effects occur in 18-20% of patients. In October the influential British Medical Journal (BMJ) published papers by Harvard Medical School's Dr John Abramson and UK cardiologist Dr Aseem Malhotra which claimed that side-effects occur in 18-20% of statin users.
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 said this figure was based on data from an "uncontrolled observational study" and was incorrect. However, it had not been picked up by the journal's editors or the experts who peer-reviewed the work.
BMJ editor Dr Fiona 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 journal has now set up an independent expert panel to decide whether it needs to completely retract the articles.
'Exaggerated concern' Dr Godlee told BBC Radio 4's Today programme she had established the panel because as editor she had an interest in not immediately retracting the work unless the case against them was clear.
Dr Godlee said she did not want patients who could benefit from statins to be "wrongly deterred from starting or continuing treatment because of exaggerated concern over side-effects". 'Very low risk'
She said she had established the panel because as editor she had an interest in not immediately retracting the work unless the case against them was clear. Medical researcher Prof Sir Rory Collins, who raised doubts over the two studies in March, said the BMJ articles had "overestimated the side-affects of statin therapy by more than 20 times".
The BMJ would continue to debate "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," she added. He told the Today programme this was likely to have encouraged people to either stop taking statins or not to start treatments in the first place.
Asked if he believed statins were safe to take, Sir Rory said trials of more than 100,000 patients showed there was "a very very low risk of muscle problems" and a "small increase in diabetes".
"These are far outweighed in the high-risk patients and indeed even in the patients at lower risk... by reductions in the risks of heart attacks and strokes," he said.
Medical experts have long debated whether the use of statins should be extended to people with a "low-risk" of heart disease.
A study by the University of Oxford in March 2012 concluded that people with a low-risk of heart problems would benefit from statins.
Dr Godlee said the BMJ would continue to debate "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".
The independent panel will be chaired by Dr Iona Heath, a former chairwoman of the Royal College of General Practitioners and a member of the BMJ's ethics committee.The independent panel will be chaired by Dr Iona Heath, a former chairwoman of the Royal College of General Practitioners and a member of the BMJ's ethics committee.
Have you been prescribed statins? Did you choose to stop taking them due to the research? If you are willing to be interviewed, please email haveyoursay@bbc.co.uk with your experiences using the subject line 'statins'. Please include your contact details, and if you are happy to feature on the BBC News website, a photograph of yourself.Have you been prescribed statins? Did you choose to stop taking them due to the research? If you are willing to be interviewed, please email haveyoursay@bbc.co.uk with your experiences using the subject line 'statins'. Please include your contact details, and if you are happy to feature on the BBC News website, a photograph of yourself.