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August 10, 2005

Direct-to-Consumer Advertising and Physician Prescribing—Reply

JAMA. 2005;294(6):678-679. doi:10.1001/jama.294.6.678-b

In Reply: Drs Miller and Wendler raise ethical concerns about our study. Because of space constraints within the article, we used the shorthand language quoted in their letter to describe our consent procedures. However, the actual situation was more complicated. Varying institutional review board (IRB) requirements and sensibilities led to the use of somewhat different language and procedures at each of the 4 study sites. For example, at 1 site, the physician recruiting script included the following statement: “The general hypothesis is that the way patients portray their symptoms and the context in which they present will influence how medical care is delivered. I’m afraid we can’t give you all the specifics now, because we don’t want to affect the results of the study. We will debrief everyone at the end.” Scripts at other sites included variations of this language, but all conveyed the same essential message.