FDA Panel Considering Over-the-Coun... (ttee will reject the idea. I have te...)

FDA Panel Considering Over-the-Counter Statin

Date:12/13/2007

ttee will reject the idea.

"I have testified against this twice, and I know we will oppose it now," said Dr. Sidney M. Wolfe, director of the Health Research Group of Public Citizen.

To answer these objections, Merck said that its package would promote using Mevacor as part of an overall program and under a physician's advice.

"The people who would be the candidates for over-the-counter Mevacor are people who have had blood tests and know they have elevated cholesterol that should be treated," said Merck spokesman Ron Rodgers.

Rodgers noted the packaging says that patients should have a cholesterol test before using the drug. "The materials supporting over-the-counter Mevacor encourage consumers to get tested on a periodic basis for side effects and cholesterol monitoring," he said.

Merck thinks that even though patients should be under a doctor's care, buying Mevacor over the counter will make it more likely that they will get and use the drug, Rodgers said.

While nothing prevents consumers from taking Mevacor without tests and monitoring, "Merck's package encourages people to get tests and follow a healthy lifestyle," Rodgers said.

Gotto agreed that as long as people follow the program that Merck has developed, use of OTC statins could bring real gains for patients. "I am a believer in the health benefits of statins, and used according to this program they will prevent a lot of cardiac events," he said.

The U.S. National Center for Health Statistics released a survey this week that found, for the first time since the survey began in 1960, the average total cholesterol level among American adults is in the ideal range. The average level in 2005-2006 was 199, according to the survey of about 4,500 people 20 and older. A level of 200 or less is desirable.

The growing use of cholesterol-lowering drugs such as statins by middle-aged and older people is believed to be a big reason
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