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Around 40% of the adult population could be offered cholesterol-busting statins drugs by their doctors, under official guidance from the NHS medicines watchdog.
The National Institute for Health and Clinical Excellence (Nice) confirmed the draft recommendation it made in February, which sparked a row among doctors over alleged over-prescribing. Some critics accused Nice's guideline group of close ties with the pharmaceutical industry.
Prof Mark Baker, director of the centre for clinical practice at Nice, strongly defended both the decision to offer the drugs to people with a lower risk of heart disease than previously recommended and the independence of those working on the guideline. They had carried out their work "in the face of some completely unjustified attacks on their integrity," he said.
"I must remind you that nobody gets into our guidelines group if they have any significant vested interest, particularly a financial interest," he said at the launch of the guideline on tackling the risk of heart attacks and strokes. All the interests of the group members were declared, unlike those of some of the critics, he said. Appointees to the group are required to have had no financial involvement with pharmaceutical companies for at least the previous year.
Nice says GPs should first discuss lifestyle measures – a better diet and more exercise – with people who have a 10% risk of a heart attack or stroke in the next 10 years. They can then offer a statin if they think it appropriate. Previously, GPs were advised to intervene when their patient had a 20% risk.
An estimated 4.5 million more people will be eligible for statins, in addition to the 13 million currently eligible. Nice says half those patients will probably not be offered them or will refuse. Somewhere between five and 10 million are thought to be taking the drugs at present.
The drugs are now off-patent and therefore cheap. Nice says if 80% of the 4.5 million newly eligible take them, the cost to the NHS will be £52m, which is small in the context of the savings from heart attack and stroke treatment.
If two million – less than half – of the lower-risk group accept statins, Nice estimates that an extra 4,000 deaths from heart attacks will be saved, and 8,000 strokes and 14,000 non-fatal heart attacks prevented.
Critics of statins have contested their benefits in people at lower risk and raised concerns about side-effects. Baker rejected those arguments. The evidence from randomised, controlled trials of the drugs "show the same frequency and severity of symptoms in the statins and the placebo group," he said.
"Most of the side-effects attributed to the drugs but not necessarily caused by them are very common. The occurrence of things like muscle pain has little or nothing to do with whether people take statins."
One severe type of muscle pain had been reported, but it was very rare, he said. He thought that some patients and GPs had wrongly assumed the severe reaction was as common as the mild one.
Opposition to statins for the lower-risk group surfaced in the British Medical Journal last year. The journal has retracted statements in two papers it published. Independent experts have been asked by the BMJ's editor, Dr Fiona Godlee, to advise on whether the papers should be retracted, in response to a call from Professor Rory Collins, joint head of the clinical trials service unit at Oxford University.
Nice's guidance was welcomed by many senior scientists, but some pointed out the importance of trying to change people's lifestyle in preference to handing out drugs. "We should not simply use pharmaceuticals to treat the results of unhealthy conditions," said Sir Michael Marmot, director of the Institute of Health Equity at UCL. "Choosing healthy lifestyles is more difficult because our society promotes cheap unhealthy foods, low alcohol prices, and car use instead of walking or cycling."
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