BMJ  Withdraws Statement on Statin-Related Adverse Events, but Papers Stand, Pending Review

May 15, 2014

LONDON, UK — The authors of a research paper critical of statins have withdrawn a statement on the percentage of patients who experience treatment-related adverse events, according to BMJ[1].

The paper, with first author Dr John Abramson (Harvard Medical School, Boston, MA), questioned whether people at low risk of cardiovascular disease should be taking the lipid-lowering medications[2]. Specifically, they wrote that the side effects of statins, which include muscle symptoms, a risk of diabetes, liver inflammation, cataracts, decreased energy, sexual dysfunction, and fatigue, occur in approximately 18% to 20% of people treated with the drugs.

This figure, which was also cited in another BMJ paper by Dr Aseem Malhotra (Croydon University Hospital, London, UK) on the role of saturated fats in heart disease, turns out to be based on reported statin-related adverse events in an observational study[3], according to a new BMJ editorial. In reporting that nearly one in five patients develop side effects, Abramson and colleagues failed to take into account necessary caveats and the uncontrolled, observational nature of that study. In a correction amended to the paper, the actual percentage of patients who discontinued statin therapy because of adverse events is closer to 9%.

The researchers also conducted an analysis of the Cholesterol Treatment Trialists' (CTT) collaboration data and reported that statins failed to reduce all-cause mortality among people with a less than 20% risk of cardiovascular disease over the next 10 years. This statement, the main finding of the Abramson et al paper, has not been challenged by BMJ.

As a result of the incorrect reporting of statin-related adverse events, which was not picked up in the peer-review process, Abramson et al and Malhotra are withdrawing the statement. The papers, as of right now, have not been retracted, mainly because the reported 18% to 20% adverse-event figure is not the main finding of the Abramson or Malhotra articles.

Instead, BMJ editor in chief Dr Fiona Godlee has passed that decision to an independent panel that will advise the journal on what to do next. The panel, chaired by Dr Iona Heath, a former chair of the Royal College of General Practitioners and the BMJ ethics committee, will include experts in clinical-trial/observational-study methodology and will post their recommendations in the public domain when a decision is reached.

Dr Rory Collins (Oxford University, UK), the head of the CTT collaboration, alerted BMJ to the error and has asked that both papers be retracted.

In the meantime, by withdrawing the adverse-event statement by Abramson et al and Malhotra, Godlee hopes to alert readers, patients, and the media to the error. The goal is so that individuals who could benefit from the drugs "are not wrongly deterred from starting or continuing treatment because of exaggerated concerns over side effects," according to Godlee.


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