CARDIOLOGY AND VASCULAR
PHARMACOLOGY
Merits and limitations of statins in low risk CVD
Publication of two articles prompts controversy about statin therapy
September 30, 2014
-
The publication of two articles by the BMJ in October 2013 prompted a controversy over claims about statin therapy made in the articles, as well as the publishing process of the articles. In response to a request for retraction of the articles, the BMJ set up an independent panel to consider both the question of retraction and also to review the processing of the papers.1
The first of the two articles, by Abramson et al,2 argued that cholesterol lowering guidelines should not be widened to include statin therapy for low risk individuals (five year risk <10%). The authors set out to reanalyse data from the Cholesterol Treatment Trialists (CTT) Collaboration. Their contention was that the benefits of statins in low risk people were less than has been claimed and the risks greater. In their conclusion, they said that side effects of statins occur in 18-20% of people. This figure was repeated in a second article published in the same issue of the BMJ by Malhotra,3 which suggested that saturated fat is not the main cause of cardiovascular disease.
The BMJ and the authors of both articles were made aware that the side-effects claim is incorrect, and corrections were published on May 15, 2014 withdrawing these statements. The corrections explain that, although the 18-20% figure was based on statements in the referenced observational study by Zhang et al – which said that “the rate of reported statin-related events to statins was nearly 18%,”4 – the BMJ articles did not reflect necessary caveats and did not take sufficient account of the uncontrolled nature of Zhang et al’s data.
The BMJ had been alerted to the error by Rory Collins, professor of medicine and epidemiology at Oxford University and head of the CTT collaboration whose data was reanalysed by Abramson et al. Prof Collins called for the retraction of both articles. The BMJ’s editor in chief Fiona Godlee then decided to pass the decision on whether to retract one or both of the articles to an independent panel.
The whole process that led to the correction and the independent panel reflects an ongoing vigorous debate on the merits and limitations of statins for those at low risk of cardiovascular disease.
The panel was unanimous in its decision that the two papers did not meet any of the criteria for retraction. The error did not compromise the principal arguments being made in either of the papers. These arguments involve interpretations of available evidence and were deemed to be within the range of reasonable opinion among those who are debating the appropriate use of statins.
References
- Report of the Independent Panel considering the retraction of two BMJ papers. http://journals.bmj.com/site/bmj/statins/Final%20report%20of%20the%20independent%20panel%20310714.pdf
- Abramson J, Rosenberg H, Jewell N et al. Should people at low risk of cardiovascular disease take a statin? BMJ 2013;347:f6123
- Malhotra A. Saturated fat is not the major issue. BMJ 2013;347:f6340
- Zhang H, Plutzky J, Skentzos S et al. Discontinuation of statins in routine care settings: a cohort study. Ann Intern Med 2013;158(7):526-34