Will the last person in Britain not on a statin please turn out the lights
Our clinical columnist Dr Malcolm Kendrick is back with a second provocative series challenging sacred cows – and he argues that NICE has been sucked in by the statin propaganda machine
So another three to four million adults in the UK are to be put on statins for the rest of their lives following the latest appraisal from NICE. I estimate the drug cost at £300 million a year, which is probably an underestimate.
But this £300 million does not include extras – for example, the six million consultations and the extra three million blood tests a year. Things are not going to stop here – it seems that universal treatment with a statin is on the horizon.
So surely these huge costs must be justified? Not so. The reality is that, except in the very small population of men with pre-existing CHD, not one life will be saved. No statin study ever has shown statins have an overall effect on mortality in women, or in men without CHD.
GP colleagues look at me as if I'm mad when I tell them this fact. But don't just take my word for it. The Therapeutics Initiative at the University of British Columbia – which has close links with the Cochrane Collaboration – analysed the use of statins in primary prevention, mainly in men. Their conclusions were as follows:
•If cardiovascular serious adverse events are viewed in isolation, 71 primary prevention patients with cardiovascular risk factors have to be treated with a statin for three to five years to prevent one myocardial infarction or stroke.
•This cardiovascular benefit is not reflected in two measures of overall health impact – total mortality and total serious adverse events. Therefore, statins have not been shown to provide an overall health benefit in primary prevention trials1.
And Dr Peter Jackson, in the UK, also looked at major statin trials. His conclusion, published in the British Journal of Clinical Pharmacology in 2001, was that statin use could be associated with an increase in mortality of 1 per cent in 10 years. The paper said: 'This would be sufficiently large to negate statins' beneficial effect on CHD mortality in patients with a CHD event risk less than 13 per cent over 10 years.'2
Not one day longer for men
In short, the vast majority of men will not live one day longer if they take a statin. And the picture is worse for women. The 4S study3, by far the most positive statin trial ever, found that two more women died on simvastatin than taking the placebo!
I was not alone in picking up the lack of impact on female mortality. GP Dr Arnold Jenkins wrote to the BMJ following the HPS study4: 'Imagine my delight when I heard of the large heart protection study showing clear benefits in the use of statins for women. On reading this study I was therefore disappointed to find the total mortality data for women missing. I now understand that the total mortality benefit for women did not reach significance and therefore was not published (Louise Bowman, personal communication, 2002)'5.
And going back to the University of British Columbia study again, this reported that while there were 10,990 women in the primary prevention trials (28 per cent of the total), only coronary events were reported for women. But when these were pooled they were not reduced by statin therapy, RR 0.98 [0.85-1.12]. They therefore concluded: 'The coronary benefit in primary prevention trials appears to be limited to men.'
The point about statins is that, if you look purely at cardiovascular events, there are benefits. But if we are going to put the entire adult population on statins, which is where we seem to be heading, we should look at the effect on overall mortality, not just prevention of CV events. At which point the picture changes dramatically.
Have GPs been picking up on these facts and standing up for their patients in avoiding the use of statins in primary prevention? Hardly.
Here we go again with BP
And we now seem to be moving in the same direction with blood pressure. A recent study published in the Department of Health research findings register came to the following conclusions: 'The report suggests the term hypertension should be avoided because it is not a disease and it implies another category (normotensives) who would not benefit from lowering blood pressure.
'Since blood pressure reduction using combinations of safe, well-established drugs is effective in preventing cardiovascular events, it is suggested that such preventive therapy might be considered more widely in people who are at risk of a heart attack or stroke regardless of initial blood pressure.'6
Translation...people with normal blood pressure should be treated with antihypertensives!
Study leader Dr Malcolm Law – who patented the concept of the polypill – commented that blood pressure was a poor predictor of cardiovascular events, and recommended a population approach to treat- ment.
'It is like cholesterol – it has come down and down until they say ''treat everyone''. They will do the same with this. It might seem strange to give it [BP-lowering treatment] to everyone, but we give vaccines to everyone.' (Pulse, 1 June, 2006)
As with the use of statins for raised cholesterol levels, if you look only at prevention of CV events, universal lowering of blood pressure may have some minor beneficial effects. But the effect on overall mortality is unknown and may even be negative.
Somehow, we seem to be slipping towards a world where there is no such thing as a normal cholesterol level, or a normal blood pressure level. Whatever the level, it should be treated.
But where is the evidence that this will do any good? And even if it did, would the marginal benefits outweigh the costs, the side-effects, the impact of every single adult in the UK taking drugs every single day for the rest of their lives? I doubt it.
Malcolm Kendrick is a salaried GP in south Manchester – he is a UK member of the International Network of Cholesterol Skeptics and developed the educational website for the European Society of Cardiology
Competing interests None declared
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2 Jackson PR et al. Statins for primary prevention: at what coronary risk is safety assured? Br J Clin Pharmacol. 2001;52:439-46.
3 Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4,444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet, 1994;344:1383-89
4 Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet 2002;360:7-22
5 Jenkins AJ. Might money spent on statins be better spent? BMJ 2003;327:933
6 Law M. Lowering blood pressure to prevent myocardial infarction and stroke: a new preventive strategy. Department of Health research findings register