Skip to Content

Is That Pill You're Taking Safe?

A Case Study About the Drug Development Process


Author(s)

Janis Hammer
Animal Science
Animal Behavior Institute
support@animaledu.com

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.


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

Educational Level

Undergraduate lower division, Undergraduate upper division

Format

PDF

Type Methods

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

Language

English

Subject Headings

Biology (General)  |   Medicine (General)  |   Pharmacy / Pharmacology  |  


Date Posted

2/24/00

Teaching Notes

Case teaching notes are password-protected and access to them is limited to paid subscribed instructors. To become a paid subscriber, begin the process by registering.

Teaching notes are intended to help teachers select and adopt a case. They typically include a summary of the case, teaching objectives, information about the intended audience, details about how the case may be taught, and a list of references and resources.

Comments