Educational Module: Drug-Induced Birth Defects

Using the currently topical issue of whether SSRI (Selective Serotonin Reuptake Inhibitor) anti-depressants cause birth defects, the module aims to provide students with a general understanding of the following: (1) human risk factor causation as determined by epidemiologic methods; (2) the limits of non-human toxicological evidence to the assessment of causality in humans; (3) the importance of pharmacovigilance for all medications; (4) special difficulties in identifying causes of human birth defects; (5) the importance of ruling out chance, bias, and confounding, in determining that an observed association is causal; and (6) the role of the systematic review and meta-analysis in synthesizing judgments of causality from complex datasets.

Teaching the materials in this module will require five classes of 90 to 120 minutes. For students coming from pharmacy or public health programs, less time may be needed to present the fundamental aspects of epidemiology.  For law students, more time might be required. The assigned readings will consume at least as much time out of the classroom, as in the classroom. 

This module is one of 9 modules developed by the Committee on Preparing the Next Generation of Policy Makers for Science-Based Decisions, an ad hoc committee under the auspices of the National Academies of Sciences, Engineering, and Medicine’s Committee on Science, Technology, and Law. The modules were developed for students of law, public policy, medicine, journalism and business, and are intended to provide early exposure to materials that elucidate the role that scientific information and scientific processes play in decision-making across diverse venues. Access all modules.