Consumers Union Opposes Over-the-Counter Choles... (who do not have heart disease and may ha...)

Consumers Union Opposes Over-the-Counter Cholesterol Drug

Date:12/11/2007

who do not have heart disease and may have only marginally elevated cholesterol or normal cholesterol levels.

-- The risk of minor muscle pains with statin drugs, and when those muscle pains warrant a doctor visit to assess the blood levels of a certain enzyme (creatine kinase). Studies indicate patients may be confused about those risks.

"The outcome of the safety review we've requested is probably more likely to reassure doctors and the public about the safety of statins. But the reality is, we just don't know until the analysis is done," Findlay said.

Consumers Union opposes Merck's application for an OTC version of Mevacor (lovastatin) for the following main reasons:

(1) Elevated LDL ("bad") cholesterol and/or low HDL ("good") cholesterol can not be self-diagnosed. This requires a blood test and a doctor's interpretation of the test results in the context of a person's medical history and health status. Even if Merck and its partner in this venture, GlaxoSmithKline, were to require that OTC Mevacor only be sold to people who have a blood test and whose doctors have recommended a statin, the availability of OTC Mevacor opens up too much risk that the drug would be obtained by those who have not had a blood test nor had visited a doctor.

(2) Many people with high cholesterol levels have other risk factors for heart disease, heart attack and stroke, and may be taking other drugs on a long-term regular basis that require close medical management. The availability of OTC Mevacor could undermine this process by leading people to self-manage and self-medicate with an OTC statin.

(3) Many people diagnosed with high cholesterol have only marginally elevated LDL levels and can bring their cholesterol into normal range with dietary and lifestyle changes. The availability of a more easily obtained OTC statin may work against such lifestyle changes and lead many consumers to choose the "easy pill route," without fully balanc
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