Heart Choices

A cholesterol drug study suggests that consumers have been lured into overspending.

IT'S NO WONDER medical costs are skyrocketing: Companies such as Merck and Schering-Plough have been brilliantly marketing a drug that hasn't been shown to improve health.

The two manufacturers released the results of a cholesterol study last month that compared Zocor, a generic cholesterol treatment, with Vytorin, a drug that combines Zocor with another drug called Zetia. Despite Vytorin's massive marketing campaign, the drug looks to be no more effective at reducing artery plaque than Zocor alone, even though Vytorin is three times as expensive as generic Zocor.

The study results have led to much confusion among patients. Despite the rumors, Vytorin is not known to be dangerous; it's just no better than the cheaper alternative, except perhaps for patients who are not responding well to Zocor (or other similar drugs, called "statins") alone.

What explains this belated revelation? The Food and Drug Administration approved Vytorin and Zetia for reducing LDL (the "bad") cholesterol, and they do in fact reduce LDL cholesterol more than statins alone do. However, lower LDL cholesterol itself is not the final goal; the goal is to lower the risk of heart disease and stroke. Only with the new study has it become known that Vytorin and Zetia are probably not superior to statins in improving health. Although another study looking directly at their effects on heart disease and stroke is underway, it looks as if consumers may have been throwing away their money.

The FDA could take some steps to prevent similar waste. When approving drugs, it could make public statements to clarify whether a drug is more effective than similar drugs and whether it should be used first or as a last resort. FDA officials say this type of information is sometimes included in drug labels, but drug companies often bury it.

For drugs that are the first in a new class, as Vytorin was, the FDA could also request post-approval tests to show that the medicines do improve health. Merck and Schering-Plough initiated the Vytorin efficacy study voluntarily. But had they not undertaken a study to directly compare their drug with a competing drug, and had a congressional investigation not scared the companies into releasing the embarrassing results, patients would be none the wiser.

For many drugs, a dollar spent on marketing goes further than a dollar spent on additional testing. That's why the FDA should either give the drug companies incentives to conduct the tests or require more testing that would protect consumers.