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September 24, 2008

Off-Label Indications for Medication Use and the Published Literature—Reply

JAMA. 2008;300(12):1411-1412. doi:10.1001/jama.300.12.1411-c

In Reply: Our Commentary on off-label use drew attention to some of the limitations of the published literature about indications for medication use. The failure to publish null or unfavorable studies and the misrepresentation of efficacy findings in other published studies makes it difficult to determine the risk-benefit profile of some approved indications. The state of the literature is generally even more problematic for off-label indications. We agree with Ms Dresser that prohibiting sponsors from distributing peer-reviewed studies of off-label indications will not improve the state of the literature. The prohibition, which has been in place for many years, will simply minimize the opportunity for industry to select particularly favorable studies for dissemination and off-label promotion. With the availability of electronic journals and PubMed Central, physicians and patients are likely to be better informed if they conduct their own independent search for information about off-label indications than if they rely on industry's promotional efforts.

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