Department of Statistics Seminar
North Carolina State
University
presents
Dr. Sally Morton
morton at rti dot org
RTI International
Ephedra: A Case Study of Statistics, Policy, and Politics
ABSTRACT
In February 2004, the U.S. Food and Drug Administration
(FDA) prohibited the sale of dietary supplements containing ephedrine alkaloids
(ephedra), stating that such supplements present an unreasonable risk of
illness or injury. The Dietary Supplement Health and Education Act (DSHEA) of
1994 governs dietary supplement regulation in the United States. DSHEA places the
burden of proof for safety on the government rather than on the manufacturer,
and thus differs significantly from regulations that govern the marketing of drugs.
Part of the evidence the FDA used in reaching its decision was a systematic
review of the efficacy and safety of ephedra conducted by the Southern
California Evidence-Based Practice Center. In addition to a meta-analysis of
controlled trial data, the review contained an evaluation of observational case
report data, a study design that has limited inferential abilities regarding
cause and effect.
How did the FDA decide what data were relevant to its
decision? How did the FDA argument for the ban differ from a decision based
solely on statistical hypothesis testing? This talk will address these
questions by describing the systematic review approach, the evidence presented,
the interpretation of that evidence by those on both sides of the argument, and
the process by which the decision was made.
Friday, October 6, 2006
3:35 - 4:35 pm
206 Cox Hall
Refreshments will be served on the
second floor of Dabney Hall (left of Room 222) at
3:00 pm.