OTC Statins

OTC Statins

Could a popular cholesterol lowering medicine soon become available over the counter? Today, the FDA began hearings to consider Merck & Co.'s request to sell its 20-milligram Mevacor pill over the counter. Four years ago, the FDA rejected a similar request by Merck to take Mevacor over the counter over concerns over safe use without a doctor's follow-up. The question is, has that changed?

"I've been coming in every 4 to 5 months." Terry Umans-Gough is on a very low dose of the prescription cholesterol-lowering medicine Lipitor. While there's some effort involved in follow up with her doctor, including the need for blood tests, she says it's better than if she got the medicine over the counter. "It would be easier but it wouldn't be smarter. There's a difference." says Terry.

For Americans, is it the right choice to allow this class of medicines be available without a prescription? "I think the conversation and the guidance that I get with the doctor concomitant with the drug, is what benefits me, not simply just taking a drug over the counter." says Terrie. And now, Bristol Myer's Squibb wants to throw their hat into the ring and make its popular Statin Pravachol over the counter. Mevacor has already lost patent protection, and its sales have been significantly eroded by generic competitors.

Pravachol will lose U.S. patent protection in April 2006. The potential danger of statins is liver damage. Most patients who take a statin get a blood test at least once a year to follow liver enzyme numbers to make sure they're in the normal range. Dr. Robert Phillips, Chairman of the Department of Medicine at Lenox Hill Hospital, says, "High cholesterol is a chronic disease and it requires blood monitoring, and it require discussion with the physician about the medication that you are taking as well as the lifestyle and the kind of diet that you are on and the exercise that you are doing. The physician needs to be involved in the process."

Some experts say the 20 mg Mevacor dosage is so low it probably wouldn't be harmful but it also might not lower high cholesterol in many patients. But that is a problem in and of itself. Not knowing or following their cholesterol numbers it can give patients a false sense of security. Another problem: some insurance plans that pay for prescription drugs don't cover over-the-counter products.

On the other hand, given many patients are non-compliant with doctor visits, any treatment of cholesterol using a statin in the population might have a significant impact in lowering cardiovascular disease and death rates. So in spite of potential negatives, access to a statin over the counter might be a net positive for Americans.

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