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'.