Background
In October 2013 the BMJ published two articles in the same issue: an Analysis article by Abramson et al1 arguing that cholesterol lowering guidelines should not be widened to include statin therapy for low risk individuals (five year risk <10%) and an Observations article by Malhotra2 suggesting that saturated fat is not the main cause of cardiovascular disease. The Abramson et al article1 questioned the balance
of risk and benefit presented in the recently updated Cochrane review3 and the 2012 Cholesterol Treatment Trialists’ (CTT) Collaboration meta-analysis4 (on which the updates to the 2013 Cochrane review3 are largely based). Both articles quoted an article by Zhang et al5 to claim that the rate of side effects with statins was around 20%. This was an error. In fact, Zhang et al5 referred to “statin-related clinical events that may be interpreted as adverse reactions by patients or their clinicians”. As Zhang et al themselves pointed out in a rapid response6, “implicit in this definition is the recognition that the causative association between each identified event and statin use was unknown.”
This error of interpretation was first suggested in a rapid response from Takhar7 immediately after publication of the Abramson et al article1 and subsequently clarified by Zhang et al themselves in a letter published in June 2014. 8 Numerous rapid responses were posted, reflecting a vigorous debate on the merits and limitations of statins for those at low risk of cardiovascular disease.
On 30 October 2013, a few days after publication, Professor Sir Rory Collins, professor of medicine and epidemiology at the Clinical Trial Service Unit at Oxford University and an author on the meta-analysis by the Cholesterol Treatment Trialists’ (CTT) Collaboration published in the Lancet in 20124, sent an email to the editor of the BMJ, Dr Fiona Godlee, stating that the BMJ seemed to have taken a stand against statins and that there was a danger that misrepresentation of the evidence in the BMJ could cause harm. He discussed this in person with Fiona Godlee in December 2013 and talked her through a set of slides (later submitted to the panel with additional annotations, SP16a). At that meeting Fiona Godlee invited Rory Collins to write an article presenting evidence on the benefits and harms of statins: “Although your article would be a response to the two articles, and to Abramson et al in particular, it would be helpful if you could use the opportunity to set your piece in the wider context of the evidence on the benefits and harms of statins.” (See SP13, email 2 December). Following this discussion Rory Collins submitted a number of written, but not-for-publication, criticisms to Fiona Godlee, focussed mainly on the Abramson et al paper, and was again invited to write an article in response. At the time of this report he had not yet done so in the form of a submitted article.
In another letter to Fiona Godlee, marked ‘not for publication’ and dated 28 April 2014, Rory Collins called for retraction of both papers, writing: “What the BMJ needs to do is withdraw these seriously damaging claims explicitly and unreservedly with a clear explanation of why they are so wrong and what is likely be correct, and to demonstrate that it is serious about rectifying the damage that it has caused by retracting both of these papers.” He emphasised the seriousness of his concerns, describing: “the need to rectify the harm that has been caused –perhaps resulting in large numbers of unnecessary deaths, heart attacks and strokes among patients at elevated risk – by misleading doctors and the public with gross over-estimates of the rates of side-effects with statins.” (SP20)
On 15 May 2014, corrections were posted for both articles, withdrawing the statement that side effects of statins occur in about 18-20% of patients9 10. “The authors withdraw this statement. Although it was based on statements in the referenced observational study by Zhang and colleagues, that ’the rate of reported statin-related events to statins was nearly 18%’, the article did not reflect necessary caveats and did not take sufficient account of the uncontrolled nature of the study.” The corrections were highlighted in an editorial11 by Fiona Godlee on 15 May 2014.
In response to the request for retraction, Fiona Godlee set up an independent panel to consider the question of retraction and to review the processing of the papers: (http://www.bmj.com/content/independent-statins-review-terms-of-reference).
Full PDF here: http://journals.bmj.com/
Commenting in a Medscape article Collins who along with fellow members of The Cholesterol Treatment Trialists' (CTT) Collaboration has close links to Big Pharma had this to say:
"Collins said he was "not surprised" by the panel's conclusions, pointing out that the entire panel was invited by the BMJ editor, all but one of the panel members have close links to the BMJ, and three of the seven members have written "papers about the hazards of statins that are not supported by the evidence."Graham
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