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    Study: Americans Confused on Drug Benefits vs. Risks

    Researchers Find That Many in U.S. Have Poor Understanding of Drug Approval Process

    Improving Drug Choices continued...

    When the people were asked what they would do if their doctor suggested they take the drug only known to lower cholesterol, the group getting information plus advice did best. While 61% of those given information plus advice said they would request the drug known to reduce heart attacks, 58% of those only given information would. And just 49% of those given no information or advice did.

    Woloshin says the studies prove that ''the public need more information, not just numbers. They also need explanations."

    The explanations used in the two studies were just 23 and 37 words long, he says. He says the FDA could easily incorporate this information to accompany drugs.

    "If you read the whole package insert, you might get some of this information," he says. However, he points out that few patients do so.

    Patients Need More Information

    The study shows that just giving people information about drug benefits and harms isn't going to solve the problem, says Michael Steinman, MD, associate professor of medicine at San Francisco VA Medical Center. He wrote a commentary to accompany the study.

    People need to know what questions to ask, he says.

    Suppose there is a new cholesterol-lowering drug. "There are some important questions you would want to ask," he says. Among them:

    • Has the drug been shown to reduce strokes and heart attacks?
    • Does it reduce them more than the other choices?
    • Has the drug been around long enough that we have a good sense of its true benefits and harms?

    The latest, greatest drug is not always best, he says. As an example, he and Woloshin point to Vioxx. The anti-inflammatory drug had sales of $2.4 billion before being withdrawn in 2004 due to its link with heart attacks and strokes.

    Another expert, Michael Cohen, RPh, ScD, president of the Institute for Safe Medication Practices, thinks some of the study findings will be a surprise to consumers. "I would suspect that many consumers are unaware that not all adverse events can be detected during clinical trials."

    When a drug is approved and becomes more widely used, new side effects can surface, he says.

    Consumers can keep tabs on this information, he says. One option is by checking Medwatch, the FDA Safety Information and Adverse Event Reporting Program. The Institute for Safe Medication Practices also posts drug alerts on its consumer site,, Cohen says.

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