February 18, 1983

Association Between Salicylates and Reye's Syndrome

Author Affiliations

Glenbrook Laboratories New York
Sterling-Winthrop Research Institute Rensselaer, NY

JAMA. 1983;249(7):883-884. doi:10.1001/jama.1983.03330310019013

To the Editor.—  The report by Halpin et al in The Journal (1982;248:687) presented conclusions on salicylate use in children with viral illnesses that are not founded on comprehensive appraisals of the "raw" data for potential biases—specifically protopathic and product confusion biases.With respect to protopathic bias, the Food and Drug Administration Reye's Syndrome (RS) Working Group, stated "the temporal relationship between the use of a drug and the occurrence of the event must be considered in order to eliminate the bias that may result in estimation of a measure of association," and "it was considered critical that the use of aspirin must have been before the onset of Reye's Syndrome to be considered true exposure" (unpublished data, May 1982). This principle, when violated, results in protopathic bias.1In this regard, of all recent RS surveys, only the second-year Ohio study by Halpin et al contains the critical data