Ethics and the Business of Bioscience
Margaret L. Eaton

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Table of Contents for Ethics and the Business of Bioscience

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