Dr Aseem Malhotra, up to his neck and still digging

You might expect an author who had just had a statement in the BMJ withdrawn for being incorrect might behave with just the tiniest degree of humility and contrition.

But not Aseem Malhotra – he’s not for turning on statin side effects – and he has come out fighting in an independent article and his twitter feed, the latter increasingly carrying the hallmarks of a man desperately covering his arse.

Lets just remind ourselves of the statement he agreed to retract from his article

A recent “real world” study of 150 000 patients who were taking statins showed “unacceptable” side effects—including myalgia, gastrointestinal upset, sleep and memory disturbance, and erectile dysfunction—in 20% of participants

The real world study in question was Zhang et al, and the BMJ article cites the following reasons for retraction

The BMJ articles did not reflect necessary caveats and did not take sufficient account of the uncontrolled nature of Zhang and colleagues’ data.

Its not clear whether this hasn’t sunk in yet, or if the perspective offered by being a front-line doctor allows Malhotra a special insight into why he can safely dismiss these concerns, but this morning in reaction he made the following statement.

Now the implied suggestion here – that this is about some minor error in the numbers that he had already addressed in an earlier rapid response – is extremely disingenuous.

The concerns were not just about the numbers, but about the nature of the study he relied upon, in particular his failure to mention important caveats in the article and his subsequent clarification. These are highlighted by the BMJ in the correction to the Abramson et al paper.

Zhang et al observed that the rate of statin related events found in their study (18%) was “substantially higher than the 5% to 10% usually described in randomized, placebo-controlled, clinical trials.” Two caveats must be considered. As Zhang et al point out, the rate of statin related events reported in their study was uncontrolled and therefore may be inflated because events attributed to statins might have occurred in a placebo group as well. In addition, although Zhang et al do not make this point, the 5-10% rate quoted by Zhang et al as having been observed in randomised trials was, in many cases, similar in both active and placebo groups. The exact rate of statin related adverse events in people at low risk of cardiovascular disease remains uncertain.

In addition, this statement from Malhotra is actually a very subtle slight of hand which moves the goal posts entirely – can you spot it? His original, now retracted claim, wasn’t simply that 17.4% of patients had a statin-related adverse event documented, it was that 20% had unacceptable side effects. These are entirely different claims!

To pretend his original contention still holds is embarrassing, and to again not mention the limitations is unforgivable, but I mean its not like the Zhang et al study flagged up any potential pitfalls is it?

Conclusion: Statin-related events are commonly reported and often lead to statin discontinuation. However, most patients who are rechallenged can tolerate statins long-term. This suggests that many of the statin-related events may have other causes, are tolerable, or may be specific to individual statins rather than the entire drug class.

Oh.

I think I’d better bulk order the popcorn.

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