Adverse impact on public health of misleading information about statin safety

There is a serious cost to public health of misrepresenting the evidence about the safety and efficacy of statin therapy. Following publication in the British Medical Journal of misleading claims that statins cause side-effects in about one-fifth of patients, the independent Picker Institute conducted in-depth focus groups and surveys with patients, general practitioners, and cardiologists on behalf of the British Heart Foundation. It found that the related media coverage was linked to increased reticence among doctors to discuss and prescribe statins, and reduced compliance by the patients (including those with pre-existing cardiovascular disease) due to raised concerns about perceived side-effects.

Extensive evidence exists that statin therapy is being substantially under-used by people at high risk of heart attacks and strokes.¹ In a number of studies conducted in Europe, America and other countries,^2-5 statins are being taken by only about half to two-thirds of people who have previously had heart attacks or strokes (with lower rates in Eastern Europe and lower income populations), and only about one-quarter to one-third of people who have not yet had a heart attack or stroke but are at high risk of having one over the next 5-10 years.

Evidence is also now emerging about the adverse impact of misleading information about the safety of statin therapy. For example, a study in Denmark found that negative statin-related news stories were repeatedly followed by average proportional increases of about 10% in the likelihood of stopping statin therapy.⁶ Although it is difficult to be sure that the news coverage causes the change in statin use, the finding that reductions in statin use occurred repeatedly after adverse media coverage provides support for it being causal.

In Australia, it was estimated that about 60,000 fewer Australians at high risk of heart attacks and strokes had statin therapy dispensed during the year after broadcast of a TV programme that misrepresented the evidence about statins (and so was subsequently withdrawn).⁷ The researchers estimated that, as a result, about 1,500-3,000 people will have potentially fatal heart attacks and strokes during the next 5 years that would otherwise have been avoided.

Similarly, in the UK, it has been estimated that more than 200,000 patients stopped taking their statin therapy for secondary and primary prevention after the misleading claims were published in the BMJ.⁵ The researchers estimate that this could result in about 2,000-6,000 people having heart attacks and strokes in the next decade that would have been avoided.

The initial aims of the CTT Collaboration were to obtain and analyse individual patient data on heart attacks, strokes, revascularization procedures, deaths and cancers only, since the individual trials were considered large enough to detect or rule out any clinically significant effects on other types of health outcome. However, in order to help address concerns that have been raised about possible side-effects of statin therapy, data are being sought on all of the adverse events recorded in the large randomized trials of long-term statin therapy.

Results from analyses of these additional data will become available during the next year.

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Adverse impact on public health of misleading information about statin safety