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March 11, 1983

Scientific Uncertainties in the Studies of Salicylate Use and Reye's Syndrome

Author Affiliations

From the Department of Epidemiology, School of Public Health, University of North Carolina, Chapel Hill (Drs Daniels, Greenberg, and Ibrahim); and the Division of Pediatric Cardiology, Children's Hospital Medical Center, Cincinnati (Dr Daniels).

JAMA. 1983;249(10):1311-1316. doi:10.1001/jama.1983.03330340053031

IN 1963, R. D. K. Reye and coworkers1 first reported a syndrome of acute encephalopathy associated with the fatty degeneration of the viscera. After almost two decades of research, the etiology of this condition, now designated as "Reye's syndrome," remains obscure. Several recent studies2-6 have implicated salicylates as a causal factor in Reye's syndrome. Based on these investigations, the Surgeon General of the United States issued an advisory against salicylate use for children with influenza or chickenpox.7 In addition, the American Public Health Association and the Public Citizen Health Research Group advocated that warning labels should be required on products containing salicylates.8

A closer examination of the salicylate-Reye's syndrome studies discloses several questions about the validity of these investigations. In reviewing these studies, the Committee on Infectious Diseases of the American Academy of Pediatrics enumerated a number of potential biases that may have occurred in these studies,