The editorial comments: 'There are no trials of OTC statins for primary prevention of heart disease. There are no data on compliance with OTC statins, which for products that need to be taken daily longterm is a concern. Will those who buy simvastatin also stop smoking, lose weight, and do more exercise, or will they substitute drug use for lifestyle modification? Will pharmacists have the time to determine the individual's risk of coronary heart disease before selling the drug and also to give lifestyle advice? All these are unknowns, which is unfortunate for the UK public, who will be the guineapigs in this large-scale OTC experiment. Americans have escaped this role, with two applications for OTC statins (pravastatin 10 mg and lovastatin 10 mg) being rejected in 2000 because of insufficient evidence that either drug could be used safely and effectively in an OTC setting'.
Financial reasons are suggested as the driver behind the decision: 'In the absence of evidence of the overall mortality benefits of OTC simvastatin, it is difficult to avoid concluding that the motive behind the Government's decision is saving money. Statins are currently prescribed to about 1.8 million people in the UK, costing the NHS £700 million a year. With the NHS bill for statins predicted to be more than £2 billion a year by 2010, transferring costs to patients might seem timely. But privatising the prevention of heart disease will increase inequalities, with many unable to afford the likely £10-15 per month longterm. For the manufacturer, of course, the motive is clear. With simvastatin now off patent, creation of a new market (perhaps 8 million more people in the UK) will please shareholders'.
The editorial concludes: 'What is now needed is a surveillance system for OTC simvastatin. Evidence of benefit and risk must be collated in this primary-prevention setting, and used to decide on applications for increased doses of simvastatin or other statins to be available OTC. In the meantime the planned National Institute for Clinical Excellence appraisal of statins for prevention of coronary events due to be published in June, 2005, should be fast-tracked to provide updated guidance on statin prescribing. If the Government is serious about preventing heart disease, then privatisation of that prevention is not the answer. And if the UK public is to be used in an OTC experiment, then the evidence must be collected and used for the benefit of all.'
Lancet 2004; 363: 1659