Mevacor, The FDA, and Consumers
You remember the news about the over-the-counter statins right? A bizarre concept indeed! In case you need reminding, here’s some of the article from HealthDay News. Steven Reinberg reported:
For the third time in seven years, a U.S. Food and Drug Administration advisory panel has been asked to recommend making Merck & Co.'s statin drug Mevacor available over the counter.Now, let’s ignore the fact that Dr. Fuhrman thinks taking statins are a bad idea. How would the average person know when to take these? I mean it’s not like popping a Tylenol! The FDA seems to agree...kind of; FDA Weighs Cholesterol Drug Mevacor. Here’s a bit:
But with groups such as the American Medical Association, Public Citizen and Consumers Union lined up against it, experts think Merck's proposal is likely to be rejected once again when the panel meets on Thursday.
"The third time is not the charm," said Dr. Steven E. Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic. "It's time to move on."
Merck's proposal is being presented to a joint meeting of the FDA's Nonprescription Drugs Advisory Committee and its Endocrinology and Metabolic Drugs Advisory Committee. The FDA does not have to follow the advice of its advisory panels, but it usually does.
The government is questioning if too many of the wrong people will take cholesterol-lowering Mevacor if it's sold without a prescription, days before Merck & Co. makes its third try to move the drug over the counter.What do you think? “If consumers used it as directed.” I’m not sure consumers can be trusted. How many people do you know who take handfuls of Tylenol every time they have a headache?
Merck says selling a low dose of this long-used medication on drugstore shelves, next to the aspirin, could get millions of people at moderate risk of heart disease important treatment that they otherwise may miss.
A preliminary Food and Drug Administration review released Tuesday agreed that nonprescription Mevacor would be "a reasonably safe and effective" option — if consumers used it as directed.
But when Merck tested if consumers could judge who was a proper Mevacor candidate, only 20 percent answered all the questions completely correctly — 50 percent if researchers counted people who said they'd check some things with their doctor before purchasing, concluded FDA's lead medical reviewer.
