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Statins are no universal panacea

It is time for a major rethink of statin prescribing.

It is time for a major rethink of statin prescribing.

Somehow these drugs have reached the status of universal panacea. Not only are they hailed as preventing heart disease and stroke, it is now claimed they will cut the risk of Alzheimer's, MS and bowel cancer – to name but three.

Side-effects are dismissed as being so uncommon as to be almost irrelevant. We have to ask, where is this all coming from? Analyses of statins (by non-pharmaceutical company supported groups) find the following. In primary prevention, in men, statins reduce the risk of dying of CVD. However, serious adverse events and death rates are unchanged.

In women, neither CVD nor overall mortality is affected in either primary or secondary prevention trials. The Heart Protection Study, hailed throughout the world, found a non-significant reduction in overall mortality in women – who were deliberately chosen as being in the highest risk groups.In only one group, men with pre-existing heart disease, have statins been found to reduce both CVD and overall mortality. However, five men would have to take statins for 50 years to prevent one CVD 'event'. Average life expectancy may be increased by about nine months from taking a statin for 30 years.

With regard to side-effects, it seems extraordinary no post-marketing surveillance has been done on drugs to be taken by 14 million people each year. So we have no idea, as per rofecoxib, what is really happening with regard to the prevalence of side-effects – serious or otherwise – in the wider community.

The US Food and Drug Administration, however, has reports of 416 deaths directly attributable to simvastatin between 1997 and 2004. Adverse event reporting has been found to detect 1-5% of the true number of events in a population. Personally, I have come across 20 clear-cut cases of statin-related adverse events in the last six months (since I started keeping a record). Perhaps most worrying is the drive to achieve ever-lower LDL levels based on new 'evidence'.

The reality is no trial on statins has shown additional benefits from greater LDL lowering – despite claims to the contrary. There is no doubt that attempts to force cholesterol level below 4mmol/l in more and more patients will result in far more side-effects, up to and including death. I look on with open-mouthed horror at this apparently unstoppable drive to put the majority of adults in the UK on (what I consider to be) highly toxic medication for the rest of their lives.

From Dr Malcolm Kendrick, Cheshire, author of The Great Cholesterol ConIt is time for a major rethink of statin prescribing (News, 14 June).

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