Table of Contents for Ethics and the Business of Bioscience
Acknowledgements
Preface
Part I. INTRODUCTION
1.
Introduction
Why study bioscience business ethics?
Benefits of addressing ethical and social issues
Tour of the book and suggestions for use of the material
Part II. ETHICS AND INDUSTRY OVERVIEW
2.
Ethics and Business Activity
Benefits of incorporating ethics into business decision making
Moral systems
Utilitarianism
Kantian ethics, rights, and duties
Justice and fairness
Formal and material principles of justice
Distributive justice
Compensatory justice
Method for ethics analysis and decision making
3.
Ethics Analysis Applied to Monsanto and the Labeling of rbST
Case Study: Monsanto and the labeling of rbST
Analysis of case study
Facts
Utilitarian analysis
Rights analysis
Justice
Ethical reasoning conclusions
4.
Research Ethics
Human Research
Animal Research
5.
Industry Regulation and the Product Approval Process
Striking a balance between speed and safety
Stages of FDA product review
Clinical trials process
Medical device regulation
Part III. CASE STUDIES
6.
Research Collaborations Between Academia and Industry
Benefits and risk of collaboration
Assessing the impact of university-industry research relationships
Changes in industry-academic relationships and the federal response
Case Study: Novartis-U.C. Berkeley research collaboration
7.
Industry-Sponsored Clinical Research and the Use of Placebo Controls
Placebo Controls
Ethical issues in placebo-controlled studies
Changing views on placebo controls
International debates
Case Study: Genzyme Tissue Repair and the NeuroCell-PD clinical trials
8.
Mitigation of Harm to Subjects Injured in Clinical Research
History of attempts to develop compensation policies
Industry research practice
Tentative responses and renewed calls for mandatory compensation programs
Case Study: Adiana, Inc., and the development of a female sterilization device
9.
Conducting Clinical Research in Developing Countries
HIV transmission research in Haiti
AZT studies in pregnant African and Thai women
HIV transmission trial in Uganda
Cardiac drug trials in Argentina
Case Study: VaxGen, Inc., fighting the AIDS epidemic
10.
Anticipating and Managing Postmarket Problems
Medical and social uncertainties associated with marketing medical products
Uncertainty about product safety and efficacy
Product misuse
Public acceptance
Evolving medical information
Case Study: Myriad and OncorMed and the marketing of the first genetic tests for breast cancer susceptibility
11.
Access to Medical Products
AIDS activists and the Food and Drug Administration
Early access: Compassionate use, treatment INDs, and parallel track programs
Personal use import exemption
Accelerated drug approval
Pharmaceutical companies and drug pricing
Case Study: Merck's U.S. managed distribution program for the HIV drug Crixivan
12.
Advertising Prescription Drugs Directly to Patients
Development and enforcement of FDA's DTC broadcast ad guidelines
Cost effectiveness of DTC prescription drug advertising
DTC prescription drug advertising expenditures
Medical community reactions to DTC prescription drug advertising
Case Study: Zeneca's direct-to-consumer advertising of Nolvadex
13.
Using Corporate Ethics Advice
Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts
Affymetrix, Inc., Santa Clara, California
The Institute for Genomic Research, Rockville, Maryland
DNA Sciences, Mountain View, California
Advanced Cell Technologies, Worcester, Massachusetts
Case Study: Geron Corporation and the role of ethics advice
Index
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