دانلود کتاب Debating Modern Medical Technologies

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Cover
Title
Copyright
Contents
Acknowledgments
Chapter 1: Evidence, Politics, and Medical Care Technology
Chapter 2: Evolving Public- and Private-Payer Approaches to Evidence and Health Technology Assessment
Evidence and the Influence of Scientific Medicine
From Cost Crisis to Value for Money
Expanding the Federal Government’s Role in Health Technology Assessment
Political Attacks on Health Services Research
Renewed Enthusiasm for Comparative Effectiveness Research
Medicare’s Renewed Interest in Evidence of Effectiveness
Evidence of Value for Private Payers
Conclusion
Chapter 3: Mammography Screening: Vested Interests and Polarization
Breast Cancer Trends in the United States
Breast Cancer Advocacy and the Role of Mammography Screening
Mammography Screening
Concerns About Underuse and Overuse of Screening
The 2009 Mammography Screening Recommendations
The Problem with Disinvestment
Mammography and the Limited Focus of Breast Cancer Advocacy
The Limits and Politics of Weighting Risks
Obamacare, Rationing, and Hyperpartisanship
Conclusion
Chapter 4: When Medicare Said No for Amyloid PET Imaging
Imaging the Brain for Amyloid Plaque
Asking for CMS Coverage
CMS Decision-Making and Coverage Criteria
Coverage Criteria and the NCD Approach
The CED Pathway
The NCD for Amyloid PET Imaging
Advocacy Positions Regarding Amyloid PET Coverage
The NCD Outcome
Responses to the Final Decision
The IDEAS Study
Conclusion
Chapter 5: Placing a Value on Cure: Lessons from the New Generation of Hepatitis C Drugs
Incidence and Consequences of Hepatitis C
What Is Hepatitis C?
How Many People Are Infected with Hepatitis C?
What Are the Characteristics of People Who Are Infected?
Evolution of Hepatitis C Treatment
Public- and Private-Payer Coverage Policies
Implications for Health Care Spending
The Advocacy Campaign for Expanded Access
A Response to Stigmatized Patients?
Role of the Courts
Price Negotiation and Competition
Lessons from the New Generation of Hepatitis C Drugs
Drug Company Responses to Price Complaints
How to Evaluate Value in the Context of Cure?
Loss of Innovation
Conclusion
Chapter 6: Avastin and the Politics of Accelerated Approval
The Challenge of Treating Advanced Breast Cancer
Drug Regulation in the United States: From Caveat Emptor to Accelerated Approval
Progressive Era Reforms
The Food, Drug, and Cosmetic Act of 1938
The 1962 Kefauver-Harris Drug Amendments
Expedited Approval and Expanded Access
Conditional Approval to Use Avastin for Treating Advanced Breast Cancer
Reversing Course
June 2011 FDA Hearing
Conclusions: Avastin and the Push for Faster Approval
Chapter 7: The Path to the Clinic for Stem Cell and Other Regenerative Medicine Interventions
FDA Regulation of Cellular Products
The 2001 Rule
FDA’s Initial Enforcement Actions
FDA Clarifies the Regulatory Approach
Stem Cells and Right-to-Try Laws
Right-to-Try in the States
Right-to-Try in Congress
Regenerative Medicine and the 21st Century Cures Act
Conflicting Interest Group Positions
From REGROW to the Cures Act
The New Political and Regulatory Landscape
Gottlieb’s First Steps
FDA’s New Policy Framework
Conclusion
Chapter 8: Conclusion: The 21st Century Cures Act and the Future of Health Technology Assessment
The Importance of Framing in Scientific Disputes
Who Should Have the Power to Decide?
Complex Coalitions and Competition among Powerful Interest Groups
Paying for Technology and Disagreements about Public Priorities
Final Reflections
Public Engagement
Access to Postapproval Data
Public and Private Payer Transparency
Looking Forward
Notes
Bibliography
Index
About the Authors