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Is That Pill You're Taking Safe?

A Case Study About the Drug Development Process



Author:

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
Topical Area: Ethics, Legal issues, Policy issues, Regulatory issues, Social issues
Educational Level: Undergraduate lower division, Undergraduate upper division
Formats: PDF
Type/Method: Dilemma/Decision, Trial, Role-Play, Student Presentations
Language: English
Subject Headings: Biology (General)   Medicine (General)   Pharmacy / Pharmacology  
Date Posted: 2/24/00
Date Modified: N/A
Copyright: Copyright held by the National Center for Case Study Teaching in Science, University at Buffalo, State University of New York. Please see our usage guidelines, which outline our policy concerning permissible reproduction of this work.

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