Drug-Induced Birth Defects
Exploring the Intersection of Regulation, Medicine, Science,
and Law An Educational Module
Nathan A. Schachtman
Lecturer in Law
Columbia Law School
This module is intended for the advanced undergraduate student or graduate student in a professional or graduate study of law, public policy, pharmacy, hospital pharmacy administration, drug development, and probably other areas as well. It does not pre-suppose any prior knowledge, and the materials can be sampled at different levels of sophistication.
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:
human risk factor causation as determined by epidemiologic methods, as seen through the case study of sertraline and cardiac birth defects;
the limits of non-human toxicological evidence to the assessment of causality in humans;
the importance of pharmacovigilance for all medications, but especially for the determination of harms to embryos and fetuses;
special difficulties in identifying causes of human birth defects;
the importance of ruling out chance, bias, and confounding, and other relevant considerations, in determining that an observed association is causal; and
the role of the systematic review and meta-analysis in synthesizing judgments of causality from complex datasets.
There are other subsidiary goals embedded within these higher level goals, such as learning to read and evaluate the data from an epidemiologic study, recognizing the varying degree of rigor and validity of studies, and understanding the difficulties in synthesizing a judgment of causation from multiple studies with discordant results.
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. Classes will involve directed discussions as well as lecture material.
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