stackery n., – the art of confounding people about statins.
Just when you thought it was safe not to take your statins, another report hits the fan. Or rather three. The Oxford academic Sir Rory Collins, who does for statins what Viagra does for old men, has been banging on BMJ editor Dr Fiona Godlee’s back door – curiously he declined to provide an open letter for publication – demanding she retract two articles published in the journal recently. Both articles claimed, as part of their arguments, that statins had high rates of side-effects, affecting up to 20% of all patients taking the drugs. The gist was that not only were statins pretty useless for primary prevention of cardio-vascular disease (folk with no prior history of CVD: NNT’s in the high tens if not hundreds), they also caused unacceptably high rates of side-effects, some of which were serious. The implication, though not stated in such lurid terms, was that peddling statins to low-risk folk was little short of institutionalised quackery.
The ensuing bun-fight, which at its height had Collins claiming the row ‘was probably killing more people than had been harmed as a result of the paper on the MMR vaccine by Andrew Wakefield’ – a curious notion, to be sure – rumbled on until earlier this week, when Godlee threw a gobstopper into the ring. In an editorial ‘special’ published on Thursday, Godlee announced that both the journal and the authors of both articles have been ‘made aware’ – a curious notion, to be sure – that the 18-20% figure is ‘incorrect’, and that the side-effect rate statements have been withdrawn. Whether this limited pro tem retraction will be sufficient to stop Collins’ gob remains unclear – one rather suspects it won’t, given he has already called for both papers to be fully retracted. For her part, Godlee has promised an independent ‘no dog in the fight’ – a curious notion, to be sure – panel, chaired by the GPs’ national treasure Dr Iona Heath, to consider what happens next.
Dr No is still grappling with the ‘made aware’ wording – the phrase suggests passivity – but he is more confident saying that the assertion that the 18-20% figure is ‘incorrect’ is itself, strictly speaking, incorrect. Godlee herself notes that ‘the true incidence of adverse events from use of statins in people at low risk continues to be disputed’ – as indeed it does – and this comes about because we don’t actually know the true incidence. The BMJ articles lifted the rate from a retrospective cohort study that reported that 17.4% (inflated by the original authors to ‘nearly 18%’, then ‘≈20%’) of study subjects had a statin-related adverse event. But the study, being observational, lacked controls, making it impossible to tease out how many of the side effects either would have happened anyway, or were a nocebo (the opposite of placebo) response. Collins’ own view – considered by some to be compromised by a combination of drug company prizes and data coyness – is that the true statin related adverse event rate is nearer 1%. Twenty percent? One percent? They say close only counts in horseshoes and hand grenades – yet here we aren’t even getting close.
So, back in the real world, should low cardiovascular risk folk take statins? The benefits, though apparently real, are trivial (unless you are the rare happy punter who benefits): NNTs in the high tens or hundreds. The harms: we don’t know, beyond competing claims that suggest the true statin side effect rate may lie somewhere between one and twenty percent – a wide range, to be sure. What the actual rate is, we simply don’t yet know. Until we do, Dr No as ever gives greatest salience to primum non nocere. In the stackery vacuum surrounding low risk folk, the sensible course is no course: no statins for low risk folk.