The abortifacient RU-486 was born in the laboratory, but its history has been shaped by legislators, corporate marketing executives, and protesters on both sides of the abortion debate.
This volume explores how society decides what to do when discoveries such as RU-486 raise complex and emotional policy issues. Six case studies with insightful commentary offer a revealing look at the interplay of scientists, interest groups, the U.S. Congress, federal agencies, and the public in determining biomedical public policy—and suggest how decision making might become more reasoned and productive in the future.
The studies are fascinating and highly readable accounts of the personal interactions behind the headlines. They cover dideoxyinosine (ddI), RU-486, Medicare coverage for victims of chronic kidney failure, the human genome project, fetal tissue transplantation, and the 1975 Asilomar conference on recombinant DNA.
- Biomedical Politics
- Copyright
- Preface
- Acknowledgments
- Contents
- Introduction
- Unproven AIDS Therapies: The Food and Drug Administration and DDI
- THE DRUG REGULATION PROCESS
- The Drug Approval Process Today
- Speeding Up the Process: The "Bush Initiative"
- Prelicensing Availability
- PARALLEL TRACK
- PARALLEL TRACK: PROS AND CONS
- The Food and Drug Administration
- The Research Community
- The AIDS Activists
- Other Consumer Interests
- EARLY RELEASE OF DDI
- MOTIVATIONS
- Bristol-Myers
- The Food and Drug Administration
- The National Institutes of Health
- The Activists
- CONCLUSIONS
- NOTES
- REFERENCES
- Commentary
- Commentary
- A Political History of RU-486
- Introducing Contraceptives to the United States
- THE EARLY DEVELOPMENT OF RU-486
- COMMERCIAL INTEREST IN RU-486
- THE GROWING THREAT OF ANTI-ABORTION GROUPS
- CORPORATE PRESSURE FOR WITHDRAWAL
- THE RETURN OF RU-486
- THE CONTINUING OPPOSITION
- SUCCESS OF THE BOYCOTT THREAT
- THE FEMINIST AND MEDICAL COMMUNITY RESPONSE
- INTERNATIONAL RU-486 AVAILABILITY
- GETTING RU-486 TO THE UNITED STATES
- INDUSTRY CONSTRAINTS ON RU-486 DEVELOPMENT
- Market Share and Price
- FDA Review
- Product Liability
- Public Relations
- AMERICAN ACCESS TO RU-486 IN THE 1990S
- REFERENCES
- Commentary
- Commentary
- The Human Genome Project: The Formation of Federal Policies in the United States, 1986–1990
- TECHNICAL AND SCIENTIFIC BACKGROUND
- ORIGINS OF DEDICATED GENOME RESEARCH PROGRAMS
- THE DEPARTMENT OF ENERGY PLAN
- THE SCIENTIFIC COMMUNITY RESPONDS
- CALLS FOR EVALUATION
- THE NATIONAL INSTITUTES OF HEALTH AND CONGRESS RESPOND
- THE PROJECT IS FUNDED
- SOCIAL ISSUES EMERGE
- STILL, ORGANIZATIONAL ISSUES
- CONCLUSIONS
- APPENDIX A
- APPENDIX B
- Can the Genome Project Keep Its Promises?
- APPENDIX C
- Is Cost Wobble a Serious Problem?
- APPENDIX D
- What Is "Technically Feasible" in the Policy Context?
- REFERENCES
- Commentary
- Commentary
- Origins of the Medicare Kidney Disease Entitlement: The Social Security Amendments of 1972
- A HISTORICAL FOOTNOTE
- ANTECEDENTS TO THE 1972 LEGISLATION
- The Influence of the Gottschalk Report
- Setting the Legislative Stage
- THE SOCIAL SECURITY AMENDMENTS OF 1972, SECTION 299I
- The Legislative Process
- The Policy Context
- The Adoption of Section 299I
- Ways and Means: November and December 1971
- Senate Finance Committee: 1972
- The Joint House-Senate Conference Committee: 1972
- ESTIMATES OF COST
- SUMMARY AND CONCLUSIONS
- AFTERWORD
- APPENDIX
- Public Law 92-603, 92nd Congress, H.R. 1 October 30, 1972
- NOTES
- REFERENCES
- Commentary
- Commentary
- Deliberations of the Human Fetal Tissue Transplantation Research Panel
- BACKGROUND AND CONTEXT
- PROCESS
- THE MORAL STATUS OF THE FETUS AND THE MORALITY OF ABORTION
- COMPLICITY, COLLABORATION, AND COOPERATION IN MORAL EVIL
- INCREASE IN THE NUMBER OF ABORTIONS
- General Altruism
- Specific Altruism
- Incentives of Financial Gain
- SOCIETAL LEGITIMATION OF ABORTION DECISIONS AND PRACTICES
- DISPOSITIONAL AUTHORITY OVER FETAL REMAINS
- LIMITS ON DISCLOSURE OF INFORMATION AND DECISION MAKING
- OTHER ISSUES AND RECOMMENDATIONS
- OTHER DEVELOPMENTS AND PUBLIC POLICY RESPONSES
- CONCLUSION
- APPENDIX A
- APPENDIX B
- Human Fetal Tissue Transplantation Research Panel
- REFERENCES
- ADDITIONAL BIBLIOGRAPHY
- Commentary
- Commentary
- Asilomar and Recombinant DNA: The End of the Beginning
- THE COMING OF AGE OF MOLECULAR BIOLOGY
- Structure of DNA
- Fruit Flies, Corn, and Molds
- The Need for Germs
- An International Frontier
- SETTING THE STAGE: THE EXPERIMENT AND ITS EFFECTS
- Critique
- The Encounter
- The "First" Asilomar Conference
- EcoRI
- Scientific Exchange and Scrutiny
- THE 1973 GORDON CONFERENCE ON NUCLEIC ACIDS
- THE ACADEMY'S TURN
- THE ASILOMAR CONFERENCE
- Monday, February 24—Opening Day
- Tuesday, February 25—Getting Down to Guidelines
- Wednesday, February 26—Dissonance and Lessons in the Law
- Thursday, February 27—The Final Hours
- CONCLUSION
- NOTES
- APPENDIX
- Participants in the International Conference on Recombinant DNA Molecules Asilomar Conference Center ...
- Organizing Committee
- Domestic Participants
- Foreign Participants
- Press Participants
- Commentary
- Commentary
- PAUL SLOVIC
- THE NATURE OF PERCEPTION
- THE EFFECTS OF PERCEPTIONS
- REFERENCES
- Conclusions
- THEMES OF DECISION MAKING
- Pluralism and Democracy
- Incrementalism
- Chance, Fate, and Politics
- Precedents and the Slippery Slope
- Politics, Expertise, and Process
- QUESTIONS FOR RESEARCH
- How and Why Does an Issue Become Public, and What Is the Proper Response?
- What Are the Roles of Science Versus the Public in Risk Recognition, Perception, Assessment, and Management?
- What Are the Role and Impact of the Media in Publicizing and Defining the Debate?
- How Can We Evaluate and Predict the Impact of Single-Issue Politics?
- How Have the Ground Rules and Institutions Changed in Biomedical Decision Making?
- How Can Costs of Research and Treatment Be Estimated to Diminish Future Conflicts?
- When Is Consensual Decision Making the Most Desirable Approach?
- What Are the Domains of Politics and Science? Where Do They Overlap? What Is the Role of Expertise?
- Who Represents the Public?
- QUESTIONS FOR POLICY MAKERS
- REFERENCES
- Appendixes
- Appendix A The Public and the Expert in Biomedical Policy Controversies
- QUESTIONING THE EXPERTS: THE CHALLENGE FROM LAYMEN
- QUESTIONING THE EXPERTS: THE CHALLENGE FROM OFFICIALDOM
- THE EXPERT'S JOURNEY INTO PUBLIC DOMAIN
- CONCLUSION
- REFERENCES
- Appendix B Biographical Notes on Authors and Commentators
- Index
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