| |
| |
Acknowledgments | |
| |
| |
Preface | |
| |
| |
| |
Introduction | |
| |
| |
| |
Introduction | |
| |
| |
Why study bioscience business ethics? | |
| |
| |
Benefits of addressing ethical and social issues | |
| |
| |
Tour of the book and suggestions for use of the material | |
| |
| |
| |
Ethics and Industry Overview | |
| |
| |
| |
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 | |
| |
| |
| |
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 | |
| |
| |
| |
Research Ethics | |
| |
| |
Human research | |
| |
| |
Animal research | |
| |
| |
| |
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 | |
| |
| |
| |
Case Studies | |
| |
| |
| |
Research Collaborations Between Academia and Industry | |
| |
| |
Benefits and risks 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 | |
| |
| |
| |
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 | |
| |
| |
| |
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 | |
| |
| |
| |
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 | |
| |
| |
| |
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 | |
| |
| |
| |
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 | |
| |
| |
| |
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 | |
| |
| |
| |
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 | |