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Biomedical politics / Kathi E. Hanna, editor ; Division of Health Sciences Policy, Committee to Study Biomedical Decision Making, Institute of Medicine.

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Format:
Book
Contributor:
Hanna, Kathi E.
Institute of Medicine (U.S.). Committee to Study Biomedical Decision Making.
Language:
English
Subjects (All):
Medical policy--Case studies.
Medical policy.
Health planning--Case studies.
Health planning.
Physical Description:
viii, 352 p.
Edition:
1st ed.
Place of Publication:
Washington, D.C. : National Academy Press, 1991.
Language Note:
English
Summary:
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.
Contents:
Biomedical Politics
Copyright
Preface
Acknowledgments
Contents
Introduction
References
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 National Institutes of Health
The Activists
CONCLUSIONS
NOTES
REFERENCES
Commentary
LEON EISENBERG
PETER F. CARPENTER
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
WILLIAM N. HUBBARD
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
APPENDIX A.
Where Was OSTP?
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?
PAUL BERG
ERNEST R. MAY
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
CARL W. GOTTSCHALK
STANLEY JOEL REISER
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
Human Fetal Tissue Transplantation Research Panel
ADDITIONAL BIBLIOGRAPHY
PATRICIA A. KING
WALTER HARRELSON
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
Participants in the International Conference on Recombinant DNA Molecules Asilomar Conference Center ...
Organizing Committee
Domestic Participants
Foreign Participants
Press Participants
DOROTHY NELKIN
PAUL SLOVIC
THE NATURE OF PERCEPTION
THE EFFECTS OF PERCEPTIONS
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
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
Appendix B Biographical Notes on Authors and Commentators
Index.
Notes:
Bibliographic Level Mode of Issuance: Monograph
Includes bibliographical references and index.
ISBN:
9786610203956
9781280203954
1280203951
9780309597579
0309597579
9780585155319
0585155313
OCLC:
923263800

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