[ProCOR] OTC Statins: Implications of new UK policy
The UK government recently decided to make the cholesterol-lowering drug
simvastatin available over the counter (OTC) from July this year for people at moderate risk of cardiovascular disease. The Lancet just published an editorial entitled "OTC Statins: A Bad Decision for Public Health," which illuminates the emerging issue of making drugs available over the counter (OTC). This often precludes insurance coverage for the drug, placing the burden on the patient.
The push has also begun to bring cholesterol-lowering drugs to the mass market in the United States. The Associated Press reported this week that several American pharmaceutical firms who make the drugs known as statins have begun behind-the-scenes efforts to convince officials at the U.S. Food and Drug Administration to follow the UK's lead in allowing the drugs to be sold over the counter.
We at ProCOR are interested in your comments.
Brian Bilchik MD
Director, ProCOR
OTC Statins: A Bad Decision for Public Health
(Lancet 2004; 363: 1659)
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 guinea pigs 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."
"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 pounds a year. With the NHS bill for statins predicted to be more than 2 billion pounds 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 pounds per month long-term. 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."
"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."
c2004 The Lancet
simvastatin available over the counter (OTC) from July this year for people at moderate risk of cardiovascular disease. The Lancet just published an editorial entitled "OTC Statins: A Bad Decision for Public Health," which illuminates the emerging issue of making drugs available over the counter (OTC). This often precludes insurance coverage for the drug, placing the burden on the patient.
The push has also begun to bring cholesterol-lowering drugs to the mass market in the United States. The Associated Press reported this week that several American pharmaceutical firms who make the drugs known as statins have begun behind-the-scenes efforts to convince officials at the U.S. Food and Drug Administration to follow the UK's lead in allowing the drugs to be sold over the counter.
We at ProCOR are interested in your comments.
Brian Bilchik MD
Director, ProCOR
OTC Statins: A Bad Decision for Public Health
(Lancet 2004; 363: 1659)
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 guinea pigs 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."
"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 pounds a year. With the NHS bill for statins predicted to be more than 2 billion pounds 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 pounds per month long-term. 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."
"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."
c2004 The Lancet
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