Cholesterol Drugs FDA is right; let doctors make the call

Posted: January 20, 2005

Suffering from a cold, aches and pains, or heartburn? Head for the over-the-counter section of the local pharmacy. But if your blood cholesterol numbers are sky-high, better see your family doctor.

That's always been the best medical advice, since out-of-kilter cholesterol levels can put patients at risk of heart attack and stroke. So it was good to see a U.S. Food and Drug Administration advisory panel affirm that advice. The panel of experts voted, 20-3, Friday to reject a request to legalize nonprescription sales of the Merck & Co. statin Mevacor.

The panel's recommendation - which the full FDA should endorse and adopt as its ruling - upholds an important tenet of drug safety: When there's a risk patients could be harmed by misuse of a drug, it makes perfect sense to require the drug be administered under a doctor's care.

With statins, it's a case of weighing such risks against the undisputed benefits that these medicines could offer to millions of Americans.

Drugmakers Merck and Johnson & Johnson, who formed a joint marketing venture to market over-the-counter products, note the potential of statins to help as many as 20 million people with problem cholesterol levels.

Not only would pill prices be lower with OTC status, but a study by the drug companies showed many consumers eager to try statins.

That study, however, also demonstrated why the FDA advisory panel was right to quash the Mevacor proposal. In a mock sales test, only 10 percent of the likely drug buyers were people for whom the statin was warranted. Some would-be purchasers were too young - women of child-bearing age, for instance, who could be at risk if pregnant. Others had healthy cholesterol levels and didn't need the drug at all.

Even for patients who should be taking statins, there's good reason to administer them under a physician's supervision due to potential, if rare, side-effects. Regular blood tests are advisable, as well as counseling on possible muscle problems due to stronger statin dosages.

Handsome profits from selling statins over-the-counter guarantee that drugmakers will be back again before the FDA seeking this change. When that happens, FDA officials need to remember the current outcry over the agency's inadequate scrutiny of risks from a variety of painkillers.

Meanwhile, boomers, have that cholesterol checked - by a doctor.

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