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BioIndustry Ethics

1st Edition - June 10, 2005

Authors: David L. Finegold, Cecile M Bensimon, Abdallah S. Daar, Margaret L. Eaton, Beatrice Godard, Bartha Maria Knoppers, Jocelyn Mackie, Peter A. Singer

eBook ISBN:

9 7 8 - 0 - 0 8 - 0 4 9 2 5 1 - 3

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… Read more

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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.

RESEARCH TEAM
PREFACE
ACKNOWLEDGMENTS
Chapter 1: INTRODUCTION
- Publisher Summary
- ETHICAL ISSUES CONFRONTING BIOSCIENCE COMPANIES
- WHY SHOULD BIOSCIENCE FIRMS CARE ABOUT ETHICS?
- ETHICISTS AND THE BIOSCIENCE INDUSTRY
- A NEW APPROACH: BIOSCIENCE BUSINESS ETHICS
- STRUCTURE OF THE BOOK
Chapter 2: MERCK: STAYING THE COURSE
- Publisher Summary
- INTRODUCTION
- FOCUSING ON PATIENTS AND THE LONG TERM
- ETHICS RESOURCE CENTERS
- INTERNAL ETHICAL PRACTICES
- ASSESSING THE IMPACT
- BENEFITS OF AN ETHICAL APPROACH
- ETHICAL ISSUES
- DRUG PRICING, ACCESS, AND INTELLECTUAL PROPERTY
- CLINICAL TRIALS AND PUBLICATION OF RESULTS
- WHAT DRUGS TO DEVELOP
- CHALLENGES FOR THE FUTURE
Chapter 3: GENZYME: PUTTING PATIENTS FIRST
- Publisher Summary
- INTRODUCTION
- PUTTING THE PATIENT FIRST: GENZYME’S APPROACH TO ETHICAL ISSUES
- ETHICAL ISSUES
- DRUG PRICING, MARKETING, ACCESS
- CLINICAL TRIALS
- PERSONAL CONFLICTS OF INTEREST
- PRODUCT MIX
- ETHICAL MECHANISMS
- SUSTAINING THE GENZYME CULTURE
- CONCLUSION
Chapter 4: MILLENNIUM PHARMACEUTICALS, INC.: CREATING AND SUSTAINING CORPORATE VALUES
- Publisher Summary
- INTRODUCTION
- MILLENNIUM PHARMACEUTICALS INC.
- INSTITUTIONALIZING CORE VALUES AND ETHICS
- ETHICS EDUCATION PROGRAMS
- IMPACT OF INSTITUTIONALIZATION OF VALUES AND ETHICS
Chapter 5: MAXIM PHARMACEUTICALS (A): INTERNAL AND EXTERNAL DIALOGUES
- Publisher Summary
- AN UNUSUAL BIOTECH LEADER
- THE IMPACT OF BUSINESS ETHICS IN THE BIOSCIENCE INDUSTRY
- COMPANY HISTORY
- EMBEDDING CORE VALUES
- MECHANISMS FOR EMBEDDING CORE VALUES
- BUILDING A SUCCESSFUL GLOBAL BOARD
- ANNUAL STRATEGIC RETREAT
- DEALING WITH ETHICAL ISSUES
- MAXIM PHARMACEUTICALS (B)
Chapter 6: DIVERSA INC.: ETHICAL ISSUES IN BIOPROSPECTING PARTNERSHIPS
- Publisher Summary
- FROM BIOPIRACY TO BIOPROSPECTING
- THE COMPANY
- THE CONTEXT FOR BIOPROSPECTING PARTNERSHIPS
- DIVERSA’S BIODIVERSITY COLLABORATIONS
- PROCESS FOR ESTABLISHING AND IMPLEMENTING COLLABORATIVE AGREEMENTS
- ETHICAL DECISION MAKING
- TOWARD THE FUTURE
- DIVERSA INC. (B)
- DIVERSA INC. (C)
- DIVERSA INC. (D)
Chapter 7: PIPELINE BIOTECH A/S: COMPETING REGULATORY REGIMES FOR LABORATORY ANIMAL EXPERIMENTS
- Publisher Summary
- INTRODUCTION
- COMPANY HISTORY
- BUSINESS MODEL AND ETHICAL APPROACH
- EMPOWERING THE WORKFORCE
- ETHICAL ISSUES AT PIPELINE
- CONCLUSION
Chapter 8: TGN BIOTECH: A START-UP WITH ETHICAL ROOTS
- Publisher Summary
- WHAT NOW?
- TGN BIOTECH
- TGN’S MARKET
- SEMENESIS™
- WHY PIGS AND WHY SEMEN?
- THE ETHICAL ISSUES
- MECHANISMS FOR A TRANSPARENT PROCESS
- FUTURE POSSIBILITIES
- WHAT NEXT?
Chapter 9: INTERLEUKIN GENETICS AND ALTICOR: AN UNLIKELY PARTNERSHIP
- Publisher Summary
- INTRODUCTION
- COMPANY ORIGINS
- EXPLORING THE ETHICS OF GENETIC TESTING
- FAILED EFFORTS TO BUILD A PERSONALIZED MEDICINE BUSINESS
- PUTTING ETHICS EXPERTS IN CHARGE
- APPROACH TO ETHICAL ISSUES
- PROPOSED ALTICOR DEAL
- INTERLEUKIN GENETICS AND ALTICOR: AN UNUSUAL PARTNERSHIP
- CREATING AN ETHICAL APPROACH TO NUTRIGENOMICS
Chapter 10: SCIONA LTD.: A PIONEER IN NUTRIGENOMICS: THE PATH TO CONSUMER ACCEPTANCE
- Publisher Summary
- INTRODUCTION
- BACKGROUND
- PRODUCT LAUNCH
- ETHICAL CONSIDERATIONS
- THE CASE FOR ETHICS
- APPLICATION TO THE HUMAN GENETICS COMMISSION
- PUBLIC OPPOSITION
- RESULTS
- THE HGC RECOMMENDATIONS
- TOWARD THE FUTURE
Chapter 11: AFFYMETRIX, INC.: USING CORPORATE ETHICS ADVICE
- Publisher Summary
- INTRODUCTION
- DNA CHIP TECHNOLOGY
- APPLICATIONS OF DNA CHIPS
- COMPANY HISTORY
- AFFYMETRIX ETHICS ADVISORY COMMITTEE FORMATION
- OPERATION OF THE ETHICS COMMITTEE
- ADVICE PROVIDED BY THE ETHICS ADVISORY COMMITTEE
- THE FUTURE OF ETHICS AT AFFYMETRIX
- CONCLUSION
Chapter 12: PHARMASNPS INC.: CREATING AN ETHICS ADVISORY BOARD
- Publisher Summary
- INTRODUCTION
- THE COMPANY
- HOW A PHARMACOGENOMICS STUDY WORKS
- CREATING AND IMPLEMENTING AN EAB
- THE EAB PROCESS
- ROLE OF THE COMPANY
- EAB-COMPANY RELATIONSHIP
- EXAMPLES OF ETHICAL ISSUES
- LESSONS LEARNED
- CONCLUSION
- CASE (B): POSTSCRIPT
Chapter 13: MONSANTO COMPANY: BIO-AGRICULTURE PIONEER
- Publisher Summary
- A LIGHTNING ROD FOR ETHICAL CONTROVERSIES
- THE POLARIZED DEBATE
- MONSANTO UNDER ATTACK
- MONSANTO COMPANY (B)
- THE NEW MONSANTO
- THE IMPACT OF THE PLEDGE ON MONSANTO
- THE IMPACT OF THE PLEDGE EXTERNALLY
- A MORE NUANCED PUBLIC DEBATE
- MEASURING THE EFFECTIVENESS OF THE PLEDGE
- TOWARD THE FUTURE
Chapter 14: NOVO NORDISK: THE TRIPLE BOTTOM LINE
- Publisher Summary
- INTRODUCTION
- THE COMPANY
- MAKING THE CASE FOR ACTING RESPONSIBLY
- THE TRIPLE BOTTOM LINE
- SOCIALLY RESPONSIBLE: PEOPLE WHOSE HEALTHCARE NEEDS WE SERVE
- SOCIALLY RESPONSIBLE: LOCAL COMMUNITIES AND GLOBAL COMMUNITY
Chapter 15: CONCLUSION: LESSONS FOR COMPANIES AND FUTURE ISSUES
- Publisher Summary
- WHAT ETHICAL ISSUES DO BIOSCIENCE COMPANIES FACE?
- ISSUE 1: FINANCIAL PRESSURES
- ISSUE 2: DEVELOPING CUTTING-EDGE TECHNOLOGIES
- ISSUE 3: RESEARCH ETHICS
- ISSUE 4: REGULATORY GUIDELINES INSUFFICIENT
- ISSUE 5: MARKETING AND DELIVERY OF PRODUCTS
- ISSUE 6: VALUE, PRICING, AND ACCESS TO PRODUCTS
- ISSUE 7: DOING BUSINESS GLOBALLY
- ISSUE 8: CONFLICTS OF INTEREST
- ISSUE 9: CORPORATE AND SOCIAL RESPONSIBILITY
- ISSUE 10: BUSINESS ETHICS AND GOOD GOVERNANCE
- BUILDING AN ETHICAL DECISION MAKING PROCESS
- KEY FUTURE TRENDS
- CONCLUSION
INDEX