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Examining Product Risk in Context: The Case of Zomepirac-Reply

Dennis Ross-Degnan, ScD; Stephen B. Soumerai, ScD; Eric Fortess, ScD, MPH; Jerry H. Gurwitz, MD
JAMA. 1994;272(16):1252. doi:10.1001/jama.1994.03520160036027.
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In Reply.  —Dr Spielberg suggests that the manufacturer's warning letter to physicians regarding the risk of zomepirac was worded ambiguously to soften its impact. He states that this was an important factor in the failure to affect prescribing habits.We are not as sanguine, however, about the effectiveness of even more accurate and persuasive printed informational materials, used alone, in changing physician behavior. Data from four large and well-controlled trials strongly indicate that while mailed drug information may increase knowledge temporarily, it generally has little or no effect on prescribing behavior, unless it is supplemented by face-to-face communications, or heavy reporting of toxic effects by television, radio, and other media.1Dr Musa's letter implies that because the withdrawal of a new agent may lead to a return to the use of older, suboptimal therapies (that would have continued without introduction of the new drug), there is "no net effect."


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