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Last week the National Institute for Health and Clinical Excellence (Nice) recommended nearly tripling the number of people in England prescribed statins — from 1.8 million to 5.1 million.
The extra 3.3 million people would have nothing wrong with them. When bodies as miserly as Nice recommend dosing the apparently healthy with drugs that could add as much as £80 million a year to the NHS drug budget, you can be sure something unusual is going on.
Anointed by Nice and blessed by almost every specialist in heart disease, statins have taken on the mantle of miracle drugs, saving lives with few side effects. But if whole swaths of the over-fifties are to be encouraged to swallow them, it is important that this judgment is right.
Statins raise a host of questions. If they are really such remarkable performers, why has it taken so long for their merits to emerge? And if they have such potent effects on heart health, how can we be sure they do not have some hidden side effects that will emerge to trouble us years down the road?
The data are certainly impressive. Trials show that in people with heart disease, statins cut death rates from all causes by 21 per cent, deaths from heart disease by 28 per cent, and further non-fatal heart attacks by 31 per cent.
In those without clinical evidence of heart disease, the results are more equivocal. One study showed that death rates were reduced by 17 per cent, but this was on the edge of statistical significance.
Another, more modest, way of looking at it is to say that if 95 apparently healthy people are treated over three years with statins, one death or heart attack would be avoided. From an individual’s perspective, the benefits do not appear overwhelming.
But from a public health perspective, the picture looks very different. If Nice’s target of 3.3 million new statin-users is achieved, 10,000 deaths or heart attacks might be prevented every year: a very significant number.
But if statins are so good, why has it taken 20 years to prove it? These are not new drugs: they are, indeed, old enough for some to be out of patent and to be produced very cheaply as generics. Others have dropped their prices to match.
This goes a long way towards explaining the enthusiasm of Nice and the Department of Health for the widespread prescription of statins. Here we have “new” drugs that are actually old, and therefore cheap.
Statins first emerged from the laboratories in the late 1970s and early 1980s. Relatively few people then were convinced that lowering cholesterol levels would have much effect on heart disease, but a few companies nevertheless launched programmes of research. Among them was Merck, which assigned a biochemist called Alfred Alberts to the job when he joined the firm in 1975. Alberts had little idea where to start, but as an inspired guess gathered a few fungal extracts that had been rejected by a Merck laboratory in Spain as antibiotics, and tested them against the enzyme that makes cholesterol.
The first 17 failed, but the eighteenth was so effective that the chemist responsible thought she had made a mistake. She hadn’t: it really did work. An active extract that became Mevacor, the first successful statin, was produced in 1978.
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