Many Mistakenly Believe FDA OKs Only Safe, Effective Drugs

Consumer explanations about safety, efficacy of drugs help public make better decisions

WEDNESDAY, Sept. 14 (HealthDay News) -- A considerable proportion of the U.S. public mistakenly believes that the U.S. Food and Drug Administration approves only effective and safe drugs, but providing consumer explanations can lead to better drug choices, according to a study published in the Sept. 12 issue of the Archives of Internal Medicine.

Lisa M. Schwartz, M.D., and Steven Woloshin, M.D., from the White River Junction VA Medical Center in Vermont, investigated the U.S. public's understanding of FDA drug approvals, and tested how drug explanations influence consumer choices in an Internet-based trial of 2,944 participants who received one of three explanations on a pair of cholesterol drugs (approvals based on surrogate [lower cholesterol] and patient [reduced myocardial infarction] outcome, respectively) and a pair of heartburn drugs (one newly approved and one approved eight years earlier). Controls received no explanations, the nondirective group received explanations alone, and the directive group received explanations plus advice. Patient choices (the cholesterol drug to reduce myocardial infarctions and the older heartburn drug) were primary outcomes.

The investigators found that 39 and 25 percent of the participants mistakenly believed only "extremely effective" drugs and drugs without serious side effects, respectively, are approved by the FDA. The explanations received influenced patient choice: the cholesterol drug that reduced myocardial infarctions was chosen by 71 percent each in the directive and nondirective groups and 59 percent of the controls. The older heartburn drug was chosen by 53 percent each in the directive and nondirective groups and 34 percent of the controls.

"Our findings show that simple explanations (ones that are brief enough even for television advertisements) help consumers make better decisions," the authors write.

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