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July 4, 1990

The Role of Data Audits in Detecting Scientific Misconduct-Reply

Author Affiliations

Department of Health and Human Services Rockville, Md

Department of Health and Human Services Rockville, Md

JAMA. 1990;264(1):37-38. doi:10.1001/jama.1990.03450010039024

In Reply.—  We are writing in response to Dr Rosenberg's letter regarding the case report by Wyllie et al.1 The information obtained from our investigation of this report does not substantiate the alleged bioinequivalency of the generic primidone and the brand-name product. In our letter of May 5, 1989,2 we summarized the final report of the Therapeutic Inequivalency Action Coordinating Committee. Aside from the two hospitalizations that were not mentioned by the authors (ie, August 1985, when the patient received the generic product, and January 1986, when she was given the brand-name product), and the fact that the patient had, on occasion, lost clinical benefit as well as therapeutic blood levels while receiving both the generic and brand-name products, our investigation revealed conflicting evidence regarding the actual product that the patient was receiving at the time points critical to the authors' conclusion. For example, although the admission history