An editorial in the Lancet noted that in 2004 the UK became the first country to make an over-the-counter (OTC) statin - simvastatin - available for those at moderate risk of coronary heart disease, despite no trials of OTC statins for primary heart disease having been undertaken, and in the absence of data on compliance with OTC statins (Anonymous, 2004).
Was it successful? Vamvakopoulos et al (2008) carried out a self-administered questionnaire survey of GPs, community pharmacists, and potentially eligible consumers eight months after the UK launch of OTC simvastatin. The survey found that OTC availability of statins was not considered a popular public health intervention by consumers and GPs because of a perception that the drugs would be prone to misuse, although ‘OTC availability was favoured by pharmacists, who saw this as empowering both for consumers and themselves’ Vamvakopoulos et al (2008). When Mainous et al (2010) evaluated the proportion of eligible individuals aged 20 years and over, using OTC statins, they found that ‘less than 1% of Great Britain's population were using OTC statins. Among those taking OTC statins, 71.5% were also taking prescribed lipid-lowering agents … [and] … Improving the use of statins by the target at-risk population remains an elusive goal (Mainous et al, 2010).
Elusive goal or not, the appeal of OTC statins remained attractive, with NHS chief executive Simon Stevens announcing in 2019 that ‘[h]igh dose statins could be made available directly from high street pharmacies as part of the NHS Long-Term Plan to cut heart disease and stroke’ (NHS England, 2019). This was endorsed by Chief Pharmaceutical Officer Dr Keith Ridge, who claimed: ‘Hundreds of thousands of people could benefit if industry committed more research and investment in bringing high-dose statins to the high street, and the NHS is going to be driving forward these efforts, as we save thousands of lives from deadly heart attacks and strokes as part of our Long-Term Plan.’
More recently, in an American study, Nissen et al (2021) investigated whether an at-home, web-based programme could determine consumers' eligibility for rosuvastatin (5 mg) without securing a doctor's prescription, reporting good agreement between consumers' self-selected decisions and a clinician's assessment. Nissen et al (2021) suggest that such an approach would enhance compliance and improve access to medication. However, Demasi and DuBroff (2021) counter by stating that Nissen et al (2021) ignored an effective therapy for heart disease prevention: a healthy lifestyle.
Demasi (2021) further argues that taking statins encourages patient complacency by promoting the notion that a pill confers protection against heart disease ‘at the expense of engaging in more protective lifestyle interventions such as regular exercise, not smoking, eating a Mediterranean-style diet and maintaining an ideal body weight.’ Demasi (2021) also notes that the web-based application used by Nissen et al (2021) is based on official guidance from the 2013 American College of Cardiology (ACC)/American Heart Association (AHA). This guidance, says Demasi (2021), is unreliable and she cites Nasir et al (2015) who, as part of the longitudinal Multi-Ethnic Study of Atherosclerosis (MESA), investigated 6814 men and women 45 to 84 years of age without clinical atherosclerotic cardiovascular disease (ASCVD) risk at enrolment. When applying the 2013 ACC/AHA cholesterol treatment guidelines, Nasir et al (2015) noted that nearly two-thirds of MESA participants 45 to 75 years of age without known ASCVD were eligible for statins, yet around half of these statin-eligible candidates had coronary artery calcium scores - an estimate of the burden of atherosclerosis - of zero.
There is a certain zeal with which many of those who favour the widespread use of statins seek to limit debate over their use, asserting instead that the science is settled. For example, in 2017 the lead author of Nissen et al (2021) penned an editorial suggesting that many of those who dare challenge the scientific edifice on which statin treatment is founded are ‘statin denialists’ belonging to ‘an internet-driven cult with deadly consequences’ (Nissen, 2017), and concluding that ‘[p]assive acceptance of harmful pseudoscience is not an option.’
Scientific progress depends on the honest exchange of evidence-based opinions. Statins are a one trillion-dollar industry (Kendrick, 2021), and perhaps this context should be borne in mind when the topic of OTC statin sales is debated.