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