Tuesday Dec. 11, 2007
(Washington, D.C.) – Consumers Union is urging the FDA to reject Merck’s latest application to sell an over-the-counter version of the cholesterol-lowering medicine Mevacor, primarily because high cholesterol can’t be self-diagnosed, many people with elevated cholesterol can bring it under control with diet and lifestyle changes, and statins are potent drugs that can have serious side effects.
Two FDA advisory panels meet in joint session Thursday to consider Merck’s application. The pharmaceutical company was overwhelmingly turned down in January 2005 by a previous FDA committee for virtually the same OTC application.
Consumers Union sent a letter on Nov. 16, 2007, to FDA Commissioner Andrew von Eschenbach requesting that the agency initiate a formal review within 18 months of the adverse events caused by, and long-term safety of, statin drugs in various populations. CU is publicly releasing that letter today which can be downloaded here.
“Statins are among the most widely prescribed and studied drugs in the U.S, and by all accounts they are highly beneficial,” said Steven Findlay, managing editor of the Consumer Reports Best Buy Drugs project. “But there are still things we need to better understand about their benefits and risks.”
“In the context of Merck’s application, it is timely for the FDA to take a close look at the research on these medicines, with special attention to changes in the patterns of their use in recent years,” Findlay added.
Among the issues:
• The safety of statins over the long-term at the higher doses used more commonly today, especially among people who do not have diagnosed heart disease or multiple risk factors for heart disease.
• The benefits versus risks of statins over the long-term in people 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 balancing the risks of side effects.
(4) Statins are potent drugs that carry the risk of minor and serious side effects. It is unclear whether their benefits would outweigh their risks for some populations of people who might be induced to obtain an OTC statin.
(5) An OTC version of Mevacor is unlikely to yield significant savings to consumers over prescription generic lovastatin, which is generally available for under $30 and is a $4 drug at Wal-Mart and Target.
“There is simply too much potential for inappropriate, wasteful, or excessive use of OTC Mevacor without proper and useful medical supervision,” Findlay said.
In its letter to the FDA, Consumers Union points out that one in 10 adults over age 20, and one in four over age 65, currently take a cholesterol-lowering statin – about 20 million people. That number could grow to between 25 and 30 million by 2010 as more prescriptions are being written for people whose primary diagnosis is not high cholesterol or heart disease but conditions (such as diabetes and kidney disease) that put them at risk for heart disease. In some cases, such patients don’t even have high cholesterol.
The letter also cites a recent study suggesting that some doctors may have grown complacent about the adverse effects of statins. A study published in the August 2007 journal of Drug Safety found that 47 percent of doctors dismissed patients complaints of muscle weakness and pain as being associated with their statin use, even though those symptoms are well-documented side effects of statins.
The Consumer Reports Best Buy Drug free, consumer-friendly report on statins’ effectiveness, safety and affordability is available at http://www.CRBestBuyDrugs.org.
Susan Herold, Steve Findlay, 202-462-6262