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To the Editor: Although the observations of Dr Kesselheim and colleagues¹ are generally accurate, the authors oversimplified the issue and did not adequately consider all of the evidence. They largely grouped the material they reviewed into clinical trials and editorials. The former were appropriately given more weight in the authors' conclusions. However, case report material in some editorials as well as in articles that were not included² (such as reports of serious arrhythmic recurrences, proarrhythmic events, and deaths in association with formulation substitution of an antiarrhythmic drug) was ignored.

In addition, the systematic review did not consider the major concern of repeated formulation substitution over time among a branded agent and several of its generic congeners. Although each generic has to meet bioequivalence with the branded product for it to be released to the market, one generic does not have to meet the same equivalence standard to another. For example, . . . [Full Text of this Article]

James A. Reiffel, MD
jar2@columbia.edu
Department of Medicine
Columbia University Medical Center
New York, New York

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