Statin Papers Stand: Expert Panel Endorses the BMJ's Stance on Retraction Request

Shelley Wood

August 01, 2014

LONDON, UK — An "independent panel" tasked with reviewing the decision[1] by the BMJ to correct, rather than retract, two statin articles has unanimously agreed with the journal's decision[2].

As previously reported by heartwire , the authors of two separate papers published in the BMJ back in October 2013 were asked to retract a statement in their respective articles relating to statin side effects[3,4].

A prominent cholesterol researcher, however, believed this did not go far enough and has asked the BMJ to retract the papers in their entirety.

Both papers—one of which was focused on low-risk patients taking statins—cited a figure from an earlier observational study that estimated statin side effects to occur in 18% to 20% of patients. A notice of correction now accompanies both papers online, acknowledging that "the article [cited in the BMJ papers] did not reflect necessary caveats and did not take sufficient account of the uncontrolled nature of the study."

Dr Rory Collins (Oxford University, UK), head of the Cholesterol Treatment Trialists' (CTT) collaboration, was the researcher who alerted BMJ to the error and had asked that both papers be retracted.

Speaking with heartwire Friday, 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."

"I think the BMJ has missed the opportunity to correct the scientific record, and the consequence may well be that patients and physicians will be misinformed."

 
Extending statins to healthy people is a topical issue of wide public interest, and we will continue to cover the debate from all sides.
 

Back in May, BMJ editor in chief Dr Fiona Godlee opted instead to refer the decision to a panel chaired by Dr Iona Heath, a former chair of the Royal College of General Practitioners and the BMJ ethics committee. Heath and colleagues, delivering their decision today, have endorsed Godlee's handling of the matter.

"The panel were unanimous in their decision that the two papers do not meet any of the criteria for retraction . . . strong and iconoclastic opinions are expected in opinion pieces and can enhance scientific debate," a statement reads[5].

Godlee, also quoted in the statement, says the fracas over the journal's handling of this figure has meant "a challenging time for the BMJ.

"I am very pleased the panel has taken the view that we acted appropriately. I echo the panel's call for the individual patient data from the statin trials be made available for independent scrutiny. Patients and their doctors need access to all relevant information to make informed decisions about their health. Extending statins to healthy people is a topical issue of wide public interest, and we will continue to cover the debate from all sides."

The BMJ statement notes that both articles, by Dr John Abramson (Harvard Medical School, Boston, MA) et al, and Dr Aseem Malhotra (Croydon University Hospital, London, UK), went through the journal's standard peer-review process. Both "questioned the value of extending the use of statins to healthy people at low risk of heart disease."

Collins, for his part, believes there are additional errors in the paper that the BMJ has not addressed, despite taking six months to address the statin-side-effects figure, including a separate figure citing myopathy rates of 5%. The correct number, says Collins, is 0.05%. Letters to the BMJ, including one from the Cochrane group, have pointed out this error, yet it still stands, Collins alleges.

"It's disappointing that the BMJ hasn't got to the bottom of this issue and has not had this [review] done properly and independently," Collins said.

The full report from Heath and colleagues has been published online at the BMJ.

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