Amanda's Absence

Should Vioxx Be Kept Off the Market?

Author:	Dan Johnson Biology Department Wake Forest University johnsoad@wfu.edu
Abstract:	When chronic pain forces a top student to withdraw from college, biology instructor Dr. Sharpe learns that medications (in this case, Vioxx) may be removed from the market for many reasons, including safety concerns. As the case unfolds, students learn how the FDA balances drug safety against medical needs. As written, the case is appropriate for a non-majors biology course. It could also be adapted for use in a more advanced course in cell biology, pharmacology, or biochemistry, or modified to explore statistical analysis, specific analytical methods used for risk/benefit analysis, or bioethical issues.
Objectives:	Describe in general terms the purpose and structure of a clinical trial. Explain how the decision is made to bring pharmaceutical drugs on and off the market. Describe or define in general terms the concept of risk/benefit analysis. Distinguish between relative risk and absolute risk.
Keywords:	Vioxx; clinical trial; Food and Drug Administration; FDA; drug approval; risk-benefit analysis; pharmaceutical; Merck; "Big Pharma"; bioethics
Topical Area:	Ethics, Regulatory issues
Educational Level:	Undergraduate lower division, Undergraduate upper division
Formats:	PDF
Type/Method:	Interrupted, Dilemma/Decision
Language:	English
Subject Headings:	Biology (General) Biochemistry Pharmacy / Pharmacology
Date Posted:	10/25/05
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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