On 4 September, NHS Chief Executive Simon Stevens announced that high-dose statins could be available from high street pharmacies as part of the NHS Long-Term Plan to cut heart disease and stroke (NHS England, 2019). According to NHS England (2019), it is clear that statins ‘have been shown to be effective, with minimal side-effects, and even a small reduction in cholesterol from these drugs is able to save lives’. This report cites British Heart Foundation-funded research presented at the recent European Society of Cardiology Conference in Paris, which showed ‘that the benefits of statins are potentially even higher than previously reported’. Following an NHS England and Improvement review, the Medicines and Healthcare products Regulatory Agency (MHRA) will rule on the proposal.
But the day before NHS England's announcement, the British Medical Journal reported that Norman Lamb MP, Chair of the parliamentary Science and Technology Committee, had asked the Department of Health and Social Care to conduct an independent review of the evidence on the effectiveness of statins and their possible side-effects (Mahase, 2019).
Were the MHRA to approve the provision of high-dose statins from high street pharmacies, it would be reasonable for patients to expect evidence-based advice on statins from pharmacists. But how solid is the evidence-base on which the case for prescribing statins rests? At its core lies the diet-heart hypothesis, introduced in 1952 by biologist Dr Ancel Keys (Teicholz, 2018), asserting that dietary saturated fat raises blood cholesterol concentrations, causing cardiovascular disease (CVD). This hypothesis is challenged by a growing body of evidence.
‘Fake medical news and fearmongering… plague the cardiovascular world through relentless attacks on statins’
To take three examples; first, in May this year, DuBroff and de Lorgeril (2019) considered 22 randomised controlled trials (RCTs) testing people's diet, lasting at least one year and reporting CV and/or mortality outcomes. 11 reported statistically significant serum cholesterol reductions, two reported a reduction in CV events, but none found a mortality benefit. Of the eight RCTs that replaced saturated fat with combinations of omega-3 and omega-6 polyunsaturated fats. Two RCTs reported increased mortality and/or CV events with cholesterol reduction'. Similarly, of 17 meta-analyses that evaluated the relationship of dietary fat, CVD and/or mortality, ‘most meta-analyses do not support the diet-heart hypothesis or the recommendation to replace saturated fat with polyunsaturated fat’ (DuBroff and de Lorgeril, 2019).
Second, following ‘a comprehensive review of the current literature’, Ravnskov et al (2019) showed that high concentrations of low-density lipoprotein cholesterol (LDL-C) – or so-called ‘bad cholesterol’ – ‘appear to be unrelated to the risk of CVD, both in familial hypercholesterolaemia individuals and in the general population and that the benefit from the use of cholesterol-lowering drugs is questionable’.
Third, in an epidemiological comparison of 42 European countries, Grasgruber et al (2016) found that instead of an association between CVD and dietary saturated fat, their results ‘agree with data accumulated from recent studies that link CVD risk with the high glycaemic index/load of carbohydrate-based diets. In the absence of any scientific evidence connecting saturated fat with CVDs, these findings show that current dietary recommendations regarding CVDs should be seriously reconsidered’.
Leaving aside the questionable evidence for the diet-heart hypothesis, pharmacists will be aware of the conflicting and well-documented claims as to the efficacy, or otherwise, of statins. Some health professionals deplore the fact that these disputes are often conducted under the media spotlight, with Navar (2019) noting that ‘fake medical news and fearmongering … plague the cardiovascular world through relentless attacks on statins’.
Given this fraught context, and the possibility that high-dose statins might soon be available on the high street, perhaps it is appropriate to step back for a more considered and discursive approach, such as that offered by Byrne et al (2019). They observe, for example, that whereas clinical guidelines recommend statin prescription based on a person's overall CVD risk, ‘this recommendation may, in reality, have little impact on professional or lay behaviour’ and that GPs may specifically focus on patients' cholesterol concentrations ‘as a reason to prescribe statins rather than the overall baseline risk of the person as recommended by clinical guidelines’, thereby medicalising a well person into someone at risk of illness.
Perhaps it is timely to pause for thought in relation to high-dose statin prescribing on the high street.