Statistics and Data Science Seminar
Robert Gibbons
University of Chicago
Statistical Issues in Drug Safety: The curious case of Antidepressants, Anticonvulsants, ...., and Suicide
Abstract: In 2003, the U.S. FDA, MHRA in the U.K., and European union released
public health advisories for a possible causal link between
antidepressant treatment and suicide in children and adolescents ages
18 and under. This led the U.S. FDA to issue a black box warning for
antidepressant treatment of childhood depression in 2004, which was
later extended to include young adults (18-24) in 2006. Following
these warnings, rather than observing the anticipated decrease in
youth suicide rates, record increases in youth suicide rates were
observed in both the U.S. and Europe. In this presentation, we
review the data and statistical methodology that led to the public
health advisories and black box warning, and the data that led to the
record increases in youth suicide rates and discuss their possible
relationship. New statistical and experimental design approaches to
post-marketing drug safety surveillance are developed, discussed and
illustrated.
Wednesday March 30, 2011 at 3:00 PM in SEO 636