Statins for all?

“Give statins to all over-50s. Even the healthy should take heart drug, says British expert.” This headline heralded a few days of intense media publicity, focusing on a talk given by the UK epidemiologist Rory Collins at the European Society of Cardiology congress in Munich. The Daily Mail continued in the same vein: “Currently statins only given to around eight million high-risk patients; But Professor Sir Rory Collins says healthy people can also benefit; He said evidence from 130 000 patients shows they’re safe.”1

The Geoffrey Rose lecture on population science, which Collins had delivered, is an annual event at the congress. It was publicised by means of a press notice that said that “Collins’s lecture this morning will hold out the promise of even more rapid demonstration of the benefits of adding newer cholesterol-lowering agents to the statins.”2 The Mail continued: “Prof Collins, 57, went to his GP a fortnight ago to ask about taking statins despite a relatively low cholesterol level, and was dismayed to learn she could not get high risk patients to take them because of fears about side effects.” The article stated that the “drugs cut the risks of heart attacks, strokes and operations to unblock arteries by one third or more.” Collins was quoted as saying that “these drugs are remarkably safe, but the problem is that high risk patients are getting the message that these drugs have side effects.”3

The Daily Mail report gave no absolute figures on the benefits of statins, and neither did the Daily Telegraph, which instead said, “Statins fear is ‘putting patients health at risk.’” The Telegraph said that Collins disagreed with claims that statins could cause sleep disturbances, memory loss, sexual dysfunction, depression, lung disease, and diabetes. “The only side effect proven by experiments is a very low risk of myopathy,” it reported Collins as saying, “which is easily outweighed by the benefit of taking the drug.” It went on: “Current guidelines on statin use should be scrapped and patients encouraged to begin using the medication earlier.”3 The Telegraph also stated that the UK Medicines and Healthcare Products Regulatory Agency listed many of these symptoms as side effects but that this year “the American FDA [Food and Drug Administration] changed its list of side effects to include memory loss and confusion.”

Coverage of the story reached Australia and the United States.4 5 The news reports were followed by comment. The Daily Mail’s columnist Robert Lefever, a retired general practitioner, wrote that Collins’s research was “vitally important and very persuasive” but that many drugs are “wildly overprescribed,” concluding that when it came to himself, with no family history of heart disease, no raised blood pressure, and no raised cholesterol, he would not take statins: “These drugs may well work wonders, but do we really want to encourage a culture of drug dependency where vital health factors (such as diet and exercise) are ignored?”6

Other GPs raised similar concerns. David Bailey, chairman of the BMA’s Welsh General Practitioners Committee, was pictured on www.walesonline.co.uk reading the Drugs and Therapeutics Bulletin, and said, “If I was low risk to start with it would only lower your risk by a tiny amount . . . I think the side effects have been downplayed.”7 Mark Porter, medical correspondent of the Times, tweeted, “Interesting how everyone focuses in on statins and forgets patients. Do any of them look after people on statins?”

The apparent disconnect between epidemiological research and frontline primary care may have its origins in a 2011 Cochrane review that found that “widespread use of statins in people at low risk of cardiovascular events—below a 1% annual all-cause mortality risk or an annual CVD [cardiovascular disease] rate of below 2% . . . is not supported by the existing evidence.”8 As for side effects, Collins’s own placebo controlled studies to investigate statin induced myopathy or adverse liver effects found that the risk of myopathy was less than 0.1% during five years’ treatment with 40 mg simvastatin a day and that there was no evidence of association with hepatitis.9 Analysis of primary care data published in 2010 showed that statins did not increase the prevalence of many disorders, including dementia and rheumatoid arthritis; however, there was an association with acute renal failure, myopathy, liver dysfunction, and cataract.10

However, this research did not specifically examine so called “minor” side effects, which can have a profound effect on patients’ wellbeing. Other research has found side effects to be common. For example, a consumer panel of over 10 000 current and former statin users found that muscular side effects were reported in 60% of former and 25% of current users.11 A French study reported that 104 (10%) of 1074 patients taking statins had muscular symptoms, which in turn led to 30% of these symptomatic patients stopping the treatment.12 The additional problem for primary care doctors is that even rare side effects become common when millions of low risk patients are treated with statins.

As for evidence that high risk patients are deciding not to take statins because of a perceived risk of side effects, this seems to be based on anecdote, and my own anecdote is also that many patients decline to take statins, saying that the side effects are unacceptable. The arguments for giving statins to a whole population need to be made equally in forms of absolute risk; we must be fair about potential side effects, including the association with diabetes13; and crucially we must also be clear that improving population health should not simply be made the work of drug companies.