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Schering-Plough and Concerns about Vytorin®

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Abstract

Clinical tests showed cholesterol drug Vytorin® was not living up to the claims of the producers, Schering-Plough and Merck. Consumers could receive a virtually equivalent drug for one-third of the cost. The problem facing Schering-Plough was to find the best methods to reach its stakeholders and ensure them that their concerns will be addressed in a timely and effective manner. This case has health, financial, and legal ramifications for stakeholders.

This case was prepared for inclusion in SAGE Business Cases primarily as a basis for classroom discussion or self-study, and is not meant to illustrate either effective or ineffective management styles. Nothing herein shall be deemed to be an endorsement of any kind. This case is for scholarly, educational, or personal use only within your university, and cannot be forwarded outside the university or used for other commercial purposes.

2023 Sage Publications, Inc. All Rights Reserved

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Resources

Exhibit 1: FDA Approval Process

Step

Details

1.

Synthesis and Purification
  • Screening compounds for bodily effect

2.

Short-term Animal Testing
  • 2 or more species are tested
  • Measures blood absorption, chemical breakdown, toxicity, and rate of excretion

3.

Long-term Animal Testing
  • Ranges from a few weeks to several years
  • Tests for causation of cancer and birth defects
  • Results submitted to FDA for approval to proceed with human clinical testing

4.

Institutional Review Boards
  • Monitor process of acquiring test patients for clinical studies
  • Ensures participants are fully informed and have given their written consent

5.

Phase I Clinical Studies
  • Normally conducted in healthy volunteers
  • Goal is sufficient information on metabolic and pharmacologic effects, as well as potential side effects and early evidence on effectiveness
  • Number of patients ranges from 20-80

6.

Phase II Clinical Studies
  • Conducted to obtain preliminary results on effectiveness of drug for a particular indication of a disease or condition
  • Normally involves several hundred people

7.

Phase III Clinical Studies
  • Conducted to obtain additional effectiveness evidence and to evaluate benefit-risk relationship
  • Results can be extrapolated to the general population, as studies include several hundred to several thousand people

This case was prepared for inclusion in SAGE Business Cases primarily as a basis for classroom discussion or self-study, and is not meant to illustrate either effective or ineffective management styles. Nothing herein shall be deemed to be an endorsement of any kind. This case is for scholarly, educational, or personal use only within your university, and cannot be forwarded outside the university or used for other commercial purposes.

2023 Sage Publications, Inc. All Rights Reserved

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