Is That Pill You're Taking Safe?

By Janis Hammer

Abstract

This dilemma cased is based on the actual development, FDA approval, and market withdrawal of dexfenfluramine, a drug used in the late 1990s in combination with phentermine for weight loss. The case is set up as a mock trial, with students taking the role of jury, defense (representing the drug company), and the prosecution (representing the central character Sally, who has developed cardiac valvular disease). Developed for a senior-level, small animal science class, the case would be applicable to any science major, and particularly those students who may go on to graduate school or work in research in any of the biomedical fields.

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Date Posted

02/24/2000

Overview

Objectives

Introduce the prescription drug approval process from initial development to post market evaluation; including animal testing, clinical trials, and market approval.
Research and present information to the class in a trial based setting.
Understand the concept of health risk/benefit analysis.
Consider the social/moral implications of the potential risks.
Develop critical thinking skills with a dilemma based case.

Keywords

Drug development; drug approval process; drug testing; substance use; Food and Drug Administration; FDA; fen-phen; dexfenfluramine; fenfluramine; phetermine; weight loss drug; pulmonary hypertension; cardiac valvular disease; thalidomide; bioethics

Subject Headings

Biology (General)

Medicine (General)

Pharmacy / Pharmacology

EDUCATIONAL LEVEL

Undergraduate lower division, Undergraduate upper division

FORMAT

PDF

TOPICAL AREAS

Ethics, Legal issues, Policy issues, Regulatory issues, Social issues

LANGUAGE

English

TYPE/METHODS

Dilemma/Decision, Trial, Role-Play, Student Presentations

Teaching Notes & Answer Key

Teaching Notes

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Answer Key

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