Zoe Harcombe walks through the BMJ green channel

Green ChannelLast week I pointed out Zoe Harcombe’s rather over the top reactions to the BMJ’s decision to retract misleading claims about statin side effects. She continued her crusade by writing a rapid response in the BMJ yesterday – which predictably references claims about the conflicts of Professor Rory Collins – and then urging her followers to inflate the ‘likes’ on the comment.

What is amazing about all this is not the content of her rapid response – or the fact she feels the need to validate the content through a show of popularity – but the declaration at the bottom, a requirement and indeed a term and condition for all authors submitting comments to the BMJ

Competing interests: None declared

Hmm, not sure about that.

I think its relevant for BMJ readers to know that you have written about statins fairly extensively, and are an open and prominent sceptic of their application. I think its relevant to declare that you are a member of the International Network of Cholesterol Sceptics, an organisation which state

Members of this group represent different views about the causation of atherosclerosis and cardiovascular disease..[…]…What we all oppose is that animal fat and high cholesterol play a role.

You know, maybe something along the lines of the below – submitted by Dr John Briffa under his comments on the article – would have been appropriate

 Competing interests: I am a paid author, journalist and speaker, and in my work regularly express views that question conventional wisdom regarding the cholesterol hypothesis and the appropriateness of mass medication with statins

Also I think its fair to point out that Zoe has a financial conflict that she has failed to declare, and I don’t think its covered adequately by describing herself as an ‘author’. Zoe sells diet and recipe books, and runs the Harcombe Diet Club, businesses which are based upon the promotion of low carb, high fat diet. She appears to makes a nice living from it.

The principles  of the diet which are emphasised – and are probably part of its success – are alternative to mainstream dietary advice:  it advocates the principle that saturated fat doesn’t raise cholesterol and that high cholesterol doesn’t cause CVD. Any acknowledgement that statins do reduce cholesterol and CVD would damage credibility – and potentially have negative financial consequences.

I think Zoe should be allowed to question whatever she wants, but I think she has a duty to inform BMJ readers of these facts. Bearing in mind the subject of her rapid response – the failure to declare conflicts of interest – this represents hypocrisy so delicious and thick, you could spread it on toast.

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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.