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July 4, 1990

The Role of Data Audits in Detecting Scientific Misconduct

Author Affiliations

Orlando, Fla

Orlando, Fla

JAMA. 1990;264(1):36-37. doi:10.1001/jama.1990.03450010039021

To the Editor.—  In the May 5, 1989, issue of JAMA, Drs Wyllie, Pippenger, and Rothner1 were castigated by Nightingale et al of the Food and Drug Administration,2 Robert Shulman of the Bolar Pharmaceutical Company,2 and by the Deputy Editor (West) of JAMA.3This rather harsh criticism followed the article by Wyllie et al in which a patient was described with a static encephalopathy and a seizure disorder. During an October 1985 hospital admission her seizures were under reasonable control with a combination of Klonopin and Mysoline (500 mg/d) with a blood level for primidone of 10.8 mg/L. She then began experiencing increased seizure activity with a drop in her primidone level to 5.1 mg/L and subsequently to 2.0 mg/L despite a dosage increase. The reason for the drop in her level was ultimately found to have been secondary to generic primidone substituted for Mysoline by