Regulating the cancer-inducing potential of non-steroidal anti-inflammatory drugs: Some lessons from the 1970s and 1980s

This article systematically examines government regulation of medicines in the U.K. and the U.S. with specific reference to carcinogenic risk assessment. By taking four non-steroidal anti-inflammatory drugs (NSAIDs) as case studies, it is argued that there have been inconsistencies between regulatory practice and the scientific standards supposed to have been upheld by drug regulatory agencies. Moreover, those inconsistencies are shown to form a trend over time which suggests an erosion and neglect of regulatory rigour during the 1980 s. This takes the form of awarding the benefit of the many scientific doubts in carcinogenicity testing to manufacturers rather than to patients. (C) 1998 Elsevier Science Ltd. All rights reserved.