BMJ authors take back inaccurate statin safety statements
Last October, the BMJ published a paper by a group of researchers from the United States and Canada questioning the use of statins in patients considered at low risk of cardiovascular disease.
The article has been cited eight times since then, according to Thomson Scientific’s Web of Knowledge. It mentioned data from another study that reported a high rate of side effects in patients who used the drugs, between 18% and 20% — suggesting that those who received little or no benefit from the therapy could be more more likely to suffer harm than good.
But that citation turns out to have been flawed — prompting the journal to take the unusual step of removing those “statements” from the article and another it published about the issue that has been cited six times. And in an editorial, BMJ editor Fiona Godlee said she has asked a panel of experts to review the original paper to determine if it ought to be retracted completely:
As editor, I have a vested interest in not retracting the articles unless the case for doing so is completely clear. So I have passed this decision to an independent panel. …
This editorial aims to alert 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.
According to a BMJ release about the matter:
In October last year, The BMJ published an article by John Abramson and colleagues that 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 showing that statin side effects occur in 18-20% of patients. This 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in another article published in the same week in The BMJ by Aseem Malhotra – and is the statement the authors have now withdrawn.
This error was due to a misreading of data from one observational study, and was not picked up by the peer reviewers or editors, explains Dr Godlee. “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.”
According to Godlee’s editorial, the journal was alerted to the problematic data by Rory Collins, an Oxford University researcher who led the CCT Collaboration which Abramson’s group reanalyzed. Collins, Godlee says, has requested that both the Abramson paper and the Malhotra article be retracted, not corrected.
Godlee, in an artful but appropriate punt, says:
I have decided that the right thing to do is to pass this decision to an independent panel. Iona Heath, former chairwoman of the Royal College of General Practitioners and of The BMJ’s ethics committee, has agreed to chair the panel, whose members will include people with no “dog in this fight,” but with expertise in clinical trial and observational study methodology, and in designing and implementing editorial policies on retraction. Full details of the panel and processes will be published shortly. I have asked that all submissions to the panel be placed in the public domain on bmj.com, and I have committed to implementing the panel’s recommendations in full.