Late last year, the American College of Cardiology and the American Heart Association (ACC/AHA) published joint guidance, which recommended lowering the risk threshold at which statins are offered for primary prevention of cardiovascular disease. The National Institute for Health and Care Excellence (NICE) later issued similar guidance in the UK.
In October 2013, The BMJ published an Analysis article that questioned the evidence behind the new guidance. The article quoted data from an observational study, which suggested that side effects of statins occur in 18-20% of people. This figure was repeated in another article published in the same week. The BMJ and the authors of both articles were made aware that this figure was incorrect, and corrections were published withdrawing these statements.
In response to calls to retract the two papers, Fiona Godlee, The BMJ’s editor in chief, passed the decision to an independent review panel, as she explained in an Editorial: “As the editor responsible for publishing the articles, I have a vested interest in not retracting them unless the case for doing so is completely clear. So I have decided that the right thing to do is to pass this decision to an independent 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.”
After a two month review, the panel have published their report. They have concluded that there are no grounds for retraction and that The BMJ’s handling of the two articles was appropriate.
Like many of you, I’ve been following the process with interest. As an editor, it’s been interesting to read how openly the report describes the review process and conclusions. Indeed, according to Retraction Watch: “This is the most detailed justification for a journal’s decision not to retract a paper that we’ve seen in a long time, perhaps ever.”
As a GP and a prescriber of statins, this outcome doesn’t really change the current day-to-day challenges around shared decision making with patients. We do our best to help patients make informed decisions, taking their values and preferences into account, and acting on the best available evidence. But it’s hard to do that when there is widely publicised uncertainty around the harms of a treatment. A recent Editorial by Ben Goldacre and Liam Smeeth in The BMJ says:
“When we offer a preventive drug to such large numbers of healthy people, we are a long way from the doctor treating a sick patient. In some respects, we are less like doctors and more like a life insurance sales team: offering occasional, possibly life changing, benefits, many years from now, in exchange for small ongoing inconvenience and cost . . . This persisting uncertainty about the precise risks and benefits of statins is a serious barrier to informed patient choice.”
And the way forward? “Mass prescription for modest individual benefit is new. Truly informed choice will require more than good intentions. We will need better data, from bigger trials, and better risk communication than for conventional medical treatment.”
In the final paragraph of the statins review, the review panel add their voices to the call for more data: “The panel strongly believes that the current debates on the appropriate use of statins would be elevated and usefully informed by making available the individual patient level data that underpin the relevant studies.”
The debate will no doubt continue. And, until we have better evidence, so will the uncertainty around prescribing statins at a lower risk threshold for primary prevention of cardiovascular disease.
Navjoyt Ladher is a clinical editor, The BMJ.