BioIndustry Ethics
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Table of contents
- Contentsv
- Research Teamvii
- Prefaceix
- Acknowledgmentsxi
- 1 Introduction1
- ETHICAL ISSUES CONFRONTING BIOSCIENCE COMPANIES2
- WHY SHOULD BIOSCIENCE FIRMS CARE ABOUT ETHICS?4
- ETHICISTS AND THE BIOSCIENCE INDUSTRY8
- A NEW APPROACH: BIOSCIENCE BUSINESS ETHICS12
- STRUCTURE OF THE BOOK14
- 2 Merck: Staying the Course19
- INTRODUCTION19
- FOCUSING ON PATIENTS AND THE LONG TERM21
- ETHICS RESOURCE CENTERS29
- INTERNAL ETHICAL PRACTICES30
- ASSESSING THE IMPACT36
- BENEFITS OF AN ETHICAL APPROACH38
- ETHICAL ISSUES41
- DRUG PRICING, ACCESS, AND INTELLECTUAL PROPERTY45
- CLINICAL TRIALS AND PUBLICATION OF RESULTS47
- WHAT DRUGS TO DEVELOP50
- CHALLENGES FOR THE FUTURE51
- 3 Genzyme: Putting Patients First55
- INTRODUCTION55
- PUTTING THE PATIENT FIRST: GENZYMEÌS APPROACH TO ETHICAL ISSUES58
- ETHICAL ISSUES59
- ETHICAL MECHANISMS65
- SUSTAINING THE GENZYME CULTURE69
- CONCLUSION71
- 4 Millennium pharmaceuticals, Inc.: Creating and Sustaining Corporate Values73
- INTRODUCTION73
- MILLENNIUM PHARMACEUTICALS INC.74
- INSTITUTIONALIZING CORE VALUES AND ETHICS80
- ETHICS EDUCATION PROGRAMS87
- IMPACT OF INSTITUTIONALIZATION OF VALUES AND ETHICS95
- PRESERVING A FOCUS ON CORE VALUES104
- THE FUTURE105
- 5 Maxim Pharmaceuticals (A): Internal and External Dialogues111
- AN UNUSUAL BIOTECH LEADER111
- THE IMPACT OF BUSINESS ETHICS IN THE BIOSCIENCE INDUSTRY112
- COMPANY HISTORY114
- EMBEDDING CORE VALUES115
- MECHANISMS FOR EMBEDDING CORE VALUES116
- BUILDING A SUCCESSFUL GLOBAL BOARD117
- ANNUAL STRATEGIC RETREAT119
- DEALING WITH ETHICAL ISSUES122
- MAXIM PHARMACEUTICALS (B)125
- 6 Diversa Inc.: Ethical Issues in Bioprospecting Partnerships127
- FROM BIOPIRACY TO BIOPROSPECTING127
- THE COMPANY129
- THE CONTEXT FOR BIOPROSPECTING PARTNERSHIPS133
- DIVERSAÌS BIODIVERSITY COLLABORATIONS133
- PROCESS FOR ESTABLISHING AND IMPLEMENTING COLLABORATIVE AGREEMENTS135
- ETHICAL DECISION MAKING137
- TOWARD THE FUTURE140
- DIVERSA INC. (B)142
- DIVERSA INC. (C)147
- DIVERSA INC. (D)150
- 7 Pipeline Biotech A/S: Competing Regulatory Regimes for Laboratory Animal Experiments153
- INTRODUCTION153
- COMPANY HISTORY155
- BUSINESS MODEL AND ETHICAL APPROACH157
- EMPOWERING THE WORKFORCE159
- ETHICAL ISSUES AT PIPELINE163
- CONCLUSION166
- 8 TGN Biotech: A Start-Up with Ethical Roots167
- WHAT NOW?168
- TGN BIOTECH168
- TGNÌS MARKET169
- SEMENESISTM171
- WHY PIGS AND WHY SEMEN?171
- THE ETHICAL ISSUES172
- MECHANISMS FOR A TRANSPARENT PROCESS175
- FUTURE POSSIBILITIES181
- WHAT NEXT?182
- 9 Interleukin Genetics and Alticor: An Unlikely Partnership183
- INTRODUCTION183
- COMPANY ORIGINS186
- EXPLORING THE ETHICS OF GENETIC TESTING188
- FAILED EFFORTS TO BUILD A PERSONALIZED MEDICINE BUSINESS189
- PUTTING ETHICS EXPERTS IN CHARGE190
- APPROACH TO ETHICAL ISSUES194
- PROPOSED ALTICOR DEAL196
- INTERLEUKIN GENETICS AND ALTICOR: AN UNUSUAL PARTNERSHIP197
- CREATING AN ETHICAL APPROACH TO NUTRIGENOMICS198
- 10 Sciona Ltd.: A Pioneer in Nutrigenomics: The Path to Consumer Acceptance201
- INTRODUCTION201
- BACKGROUND202
- PRODUCT LAUNCH203
- ETHICAL CONSIDERATIONS204
- THE CASE FOR ETHICS205
- APPLICATION TO THE HUMAN GENETICS COMMISSION209
- PUBLIC OPPOSITION209
- RESULTS215
- THE HGC RECOMMENDATIONS216
- TOWARD THE FUTURE218
- 11 Affymetrix, Inc.: Using Corporate Ethics Advice219
- INTRODUCTION219
- DNA CHIP TECHNOLOGY219
- APPLICATIONS OF DNA CHIPS220
- COMPANY HISTORY221
- AFFYMETRIX ETHICS ADVISORY COMMITTEE FORMATION223
- OPERATION OF THE ETHICS COMMITTEE234
- ADVICE PROVIDED BY THE ETHICS ADVISORY COMMITTEE241
- THE FUTURE OF ETHICS AT AFFYMETRIX247
- CONCLUSION249
- 12 PharmaSNPs Inc.: Creating an Ethics Advisory Board251
- INTRODUCTION251
- THE COMPANY252
- HOW A PHARMACOGENOMICS STUDY WORKS253
- CREATING AND IMPLEMENTING AN EAB254
- THE EAB PROCESS256
- ROLE OF THE COMPANY258
- EAB-COMPANY RELATIONSHIP258
- EXAMPLES OF ETHICAL ISSUES260
- LESSONS LEARNED263
- CONCLUSION265
- CASE (B): POSTSCRIPT265
- 13 Monsanto Company: Bio- Agriculture Pioneer267
- A LIGHTNING ROD FOR ETHICAL CONTROVERSIES267
- THE POLARIZED DEBATE273
- MONSANTO UNDER ATTACK276
- MONSANTO COMPANY (B)281
- THE NEW MONSANTO286
- THE IMPACT OF THE PLEDGE ON MONSANTO294
- THE IMPACT OF THE PLEDGE EXTERNALLY295
- A MORE NUANCED PUBLIC DEBATE296
- MEASURING THE EFFECTIVENESS OF THE PLEDGE297
- TOWARD THE FUTURE299
- 14 Novo Nordisk: The Triple Bottom Line301
- INTRODUCTION301
- THE COMPANY302
- MAKING THE CASE FOR ACTING RESPONSIBLY305
- THE TRIPLE BOTTOM LINE309
- FUTURE CHALLENGES328
- 15 Conclusion: Lessons for Companies and Future Issues331
- WHAT ETHICAL ISSUES DO BIOSCIENCE COMPANIES FACE?331
- ISSUE 1: FINANCIAL PRESSURES332
- ISSUE 2: DEVELOPING CUTTING-EDGE TECHNOLOGIES333
- ISSUE 3: RESEARCH ETHICS333
- ISSUE 4: REGULATORY GUIDELINES INSUFFICIENT334
- ISSUE 5: MARKETING AND DELIVERY OF PRODUCTS335
- ISSUE 6: VALUE, PRICING, AND ACCESS TO PRODUCTS336
- ISSUE 7: DOING BUSINESS GLOBALLY337
- ISSUE 8: CONFLICTS OF INTEREST338
- ISSUE 9: CORPORATE AND SOCIAL RESPONSIBILITY339
- ISSUE 10: BUSINESS ETHICS AND GOOD GOVERNANCE340
- BUILDING AN ETHICAL DECISION MAKING PROCESS340
- KEY FUTURE TRENDS348
- CONCLUSION354
- Index355
This book is the first systematic, detailed treatment of the approaches to ethical issues taken by biotech and pharmaceutical companies. The application of genetic/genomic technologies raises a whole spectrum of ethical questions affecting global health that must be addressed. Topics covered in this comprehensive survey include considerations for bioprospecting in transgenics, genomics, drug discovery, and nutrigenomics, as well as how to improve stakeholder relations, design ethical clinical trials, avoid conflicts of interest, and establish ethics advisory boards. The expert authors represent multiple disciplines including law, medicine, bioinformatics, pharmaceutics, business, and ethics.