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Public Often Unaware of a Drug's Safety Record -- Or Lack of One

Date:9/13/2011

FDA-approval, the authors of the current study noted.

Against that backdrop, Woloshin and Schwartz conducted a pair of Internet-based studies involving nearly 3,000 American adults.

At the outset, almost 40 percent said they thought the FDA only approved "extremely effective" drugs, while one-quarter believed FDA approval means no serious side effects.

The first trial involved offering patients two cholesterol drug choices: one shown only to reduce cholesterol, and a second shown to directly lower heart attack risk. The second trial involved two heartburn drugs, a new one, and one in use for eight years.

Participants in each case were divided into three groups, with each group receiving different degrees of information about drug safety and effectiveness.

Those given the most information ultimately made better drug choices, the study found.

About 60 percent of those uninformed about the cholesterol drug options chose the one shown to reduce heart attacks. But that figure rose to 70 percent among those told of the distinctions and among those instructed to ask for the drug shown to affect cardiac risk.

Results were similar in the heartburn drug group. While just one-third of those given no information chose the older drug option, that figure rose to 53 percent among those told that one was old and one was new, and among those informed that less is known about the safety profile of newer drugs.

"So what we have here," said Woloshin, "is not just a question of focusing people's attention on the potential harm side of drugs, but also on whether or not a new drug really works. Is there really a benefit here? Is this drug worth it? These are the questions we think patients need to be asking."

Dr. Michael Carome, deputy director of Public Citizen's Health Research Group in Washington, D.C., also believes in encouraging consumers to view the medications they're prescribed with a more critical eye.

"Patients need
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