File #2863: "2020_Book_InstitutionalCorruptionTheoryI.pdf"
Text
1|Preface|7
1|Acknowledgements|11
1|Contents|13
1|1 Introduction|17
2|1.1 Bad Pharma, Good Doctor?|19
2|1.2 Research Questions|20
2|1.3 Academic Relevance|22
3|1.3.1 A European Context|22
3|1.3.2 A Qualitative Approach|23
3|1.3.3 An Interdisciplinary Study|24
2|1.4 Structure|25
2|References|30
1|2 Undue Pharmaceutical Industry Influence in Medical Profession|33
2|2.1 Pharmaceutical Industry Criminality|34
2|2.2 Industry-Medicine Relationships and Corruption in the Healthcare Sector|36
2|2.3 Undue Industry Influence in the Medical Discourse|42
2|2.4 The Institutional Purpose of Medicine and the Changing Nature of Professional Control|46
2|2.5 From White Collar Crime to Institutional Corruption|52
2|References|57
1|3 Applying Institutional Corruption Theory to the Study of Undue Influence in Medicine|65
2|3.1 Sacrificing Homo-Rationale for Embeddedness|66
2|3.2 Principal-Agent Relationships Between Industry and Medicine|68
2|3.3 Structural Conflict of Interest and Institutional Corruption|72
2|3.4 Filling in the Gaps of Institutional Corruption Theory: Criticism, Compliment, and Claim|74
2|3.5 The Profession of Medicine: Trust, Autonomy, and Ethics|78
3|3.5.1 Medicine as a Profession: The Components of Autonomy and Authority|78
3|3.5.2 The Basis of Autonomy: A Culture of Ethics|81
2|3.6 Autonomy of Medical Knowledge and the Analytical Framework|83
2|References|84
1|4 The Methodological Audit Trail|88
2|4.1 The Netherlands and Hungary|90
2|4.2 Sampling|91
2|4.3 Access|95
2|4.4 Interviews|96
2|4.5 Data Collection, Retention, Codification, and Analysis|99
2|4.6 Conclusion|101
2|References|101
1|5 More Than a Manufacturer: The Role of Industry in Medicine|104
2|5.1 The Pharmaceutical Product Lifecycle|106
3|5.1.1 Basic Research, Drug Discovery, and Preclinical Research|108
3|5.1.2 Clinical Research|109
3|5.1.3 Medicines Regulatory Authority Review and Authorization|110
2|5.2 Good Science and Good Medicine: Adopting EBM in Medical Practice|112
3|5.2.1 Post-marketing Trials and Pharmaceutical Marketing|114
2|5.3 Industry Self-regulation and Codes of Ethical Pharmaceutical Marketing|118
3|5.3.1 Hungary|119
3|5.3.2 The Netherlands|120
2|5.4 Transparency and Disclosure Codes|120
2|5.5 Medical Association Codes of Ethics on Industry-Medicine Relationships|121
3|5.5.1 Hungary|121
3|5.5.2 The Netherlands|122
2|5.6 Conclusion|123
2|References|123
1|6 Institutional Corruption of Medical Knowledge Production|129
2|6.1 The Pharmaceutical Innovation Crisis and Its Consequences|131
2|6.2 Technology Transfer: The Birth of the Enterprising University|133
3|6.2.1 A “Spin” on the Commitments of Medical Science|136
2|6.3 How Much of Clinical Trials Are Funded by Industry?|141
2|6.4 Consequences of Industry-Funded Clinical Trials|146
2|6.5 Economic Pressures in Clinical Trials: CROs in R&D|151
2|6.6 Conclusion|154
2|References|155
1|7 Between Knowledge Production and Knowledge Interpretation|159
2|7.1 Science or Seeding?|160
2|7.2 Awareness, Attitude, and Action|162
2|7.3 Seeding Trials and the Erosion of Professional Trust|169
2|7.4 Attitudes of Regulators and “Tone at the Top”|170
2|7.5 Conclusion|176
2|References|177
1|8 Institutional Corruption of Medical Knowledge Interpretation|179
2|8.1 Evidenced Based Medicine|179
2|8.2 Evaluating EBM in the Field|184
2|8.3 Industry Influence in Medical Guidelines|186
3|8.3.1 A Dutch Case Study of Industry Influence in Medical Guidelines|191
2|8.4 Key Opinion Leaders|198
3|8.4.1 KOL Status in Industry Endorsement|199
3|8.4.2 Influence by Proxy|201
2|8.5 Educating the Medical Profession|205
3|8.5.1 KOLs in CME|207
3|8.5.2 Paying the Piper|208
2|8.6 Conclusion|218
2|References|221
1|9 Institutional Corruption of Medical Knowledge Application|226
2|9.1 Too Much Information: Quantity Over Quality|227
2|9.2 The Stringency Smokescreen and Financial Dependency on CME Sponsorship|231
3|9.2.1 Hungarian Pharmaceutical Industry Self-regulation and Disclosure|232
3|9.2.2 Dutch Pharmaceutical Industry Self-regulation and Disclosure|233
2|9.3 Quantity Over Quality in Medical Education|234
3|9.3.1 Industry-Medicine Relationships and CME Sponsorship: Explanations from the Field|235
2|9.4 Industry Funding of CMEs: A Look into the Transparency Data|241
2|9.5 Favouring Specialists Over GPs|246
2|9.6 Doctors and Sales Representatives|250
2|9.7 Regulatory Loopholes in Transparency|255
3|9.7.1 Hiding Payments|257
3|9.7.2 Obfuscating Payments|260
2|9.8 Effects on Prescription Practices: Explanations from the Field|264
2|9.9 Conclusion|267
2|References|268
1|10 Reviewing Institutional Corruption in Medicine|273
2|10.1 Institutional Corruption in the Work Breakdown Structure|278
2|10.2 Institutional Corruption in Goal Motivation|279
2|10.3 Institutional Corruption in Formalization and Communication|281
2|10.4 Closing Remarks|282
2|References|283
1|Annex 1|284
2|World Medical Association Hippocratic Oath Declaration of Geneva 1948|284
1|Annex 2|285
1|Annex 3|288
1|Annex 4|291
2|Membership Positions of Specialist College Members and Corresponding Positions in Medical Associations|291
1|Index|297
1|Acknowledgements|11
1|Contents|13
1|1 Introduction|17
2|1.1 Bad Pharma, Good Doctor?|19
2|1.2 Research Questions|20
2|1.3 Academic Relevance|22
3|1.3.1 A European Context|22
3|1.3.2 A Qualitative Approach|23
3|1.3.3 An Interdisciplinary Study|24
2|1.4 Structure|25
2|References|30
1|2 Undue Pharmaceutical Industry Influence in Medical Profession|33
2|2.1 Pharmaceutical Industry Criminality|34
2|2.2 Industry-Medicine Relationships and Corruption in the Healthcare Sector|36
2|2.3 Undue Industry Influence in the Medical Discourse|42
2|2.4 The Institutional Purpose of Medicine and the Changing Nature of Professional Control|46
2|2.5 From White Collar Crime to Institutional Corruption|52
2|References|57
1|3 Applying Institutional Corruption Theory to the Study of Undue Influence in Medicine|65
2|3.1 Sacrificing Homo-Rationale for Embeddedness|66
2|3.2 Principal-Agent Relationships Between Industry and Medicine|68
2|3.3 Structural Conflict of Interest and Institutional Corruption|72
2|3.4 Filling in the Gaps of Institutional Corruption Theory: Criticism, Compliment, and Claim|74
2|3.5 The Profession of Medicine: Trust, Autonomy, and Ethics|78
3|3.5.1 Medicine as a Profession: The Components of Autonomy and Authority|78
3|3.5.2 The Basis of Autonomy: A Culture of Ethics|81
2|3.6 Autonomy of Medical Knowledge and the Analytical Framework|83
2|References|84
1|4 The Methodological Audit Trail|88
2|4.1 The Netherlands and Hungary|90
2|4.2 Sampling|91
2|4.3 Access|95
2|4.4 Interviews|96
2|4.5 Data Collection, Retention, Codification, and Analysis|99
2|4.6 Conclusion|101
2|References|101
1|5 More Than a Manufacturer: The Role of Industry in Medicine|104
2|5.1 The Pharmaceutical Product Lifecycle|106
3|5.1.1 Basic Research, Drug Discovery, and Preclinical Research|108
3|5.1.2 Clinical Research|109
3|5.1.3 Medicines Regulatory Authority Review and Authorization|110
2|5.2 Good Science and Good Medicine: Adopting EBM in Medical Practice|112
3|5.2.1 Post-marketing Trials and Pharmaceutical Marketing|114
2|5.3 Industry Self-regulation and Codes of Ethical Pharmaceutical Marketing|118
3|5.3.1 Hungary|119
3|5.3.2 The Netherlands|120
2|5.4 Transparency and Disclosure Codes|120
2|5.5 Medical Association Codes of Ethics on Industry-Medicine Relationships|121
3|5.5.1 Hungary|121
3|5.5.2 The Netherlands|122
2|5.6 Conclusion|123
2|References|123
1|6 Institutional Corruption of Medical Knowledge Production|129
2|6.1 The Pharmaceutical Innovation Crisis and Its Consequences|131
2|6.2 Technology Transfer: The Birth of the Enterprising University|133
3|6.2.1 A “Spin” on the Commitments of Medical Science|136
2|6.3 How Much of Clinical Trials Are Funded by Industry?|141
2|6.4 Consequences of Industry-Funded Clinical Trials|146
2|6.5 Economic Pressures in Clinical Trials: CROs in R&D|151
2|6.6 Conclusion|154
2|References|155
1|7 Between Knowledge Production and Knowledge Interpretation|159
2|7.1 Science or Seeding?|160
2|7.2 Awareness, Attitude, and Action|162
2|7.3 Seeding Trials and the Erosion of Professional Trust|169
2|7.4 Attitudes of Regulators and “Tone at the Top”|170
2|7.5 Conclusion|176
2|References|177
1|8 Institutional Corruption of Medical Knowledge Interpretation|179
2|8.1 Evidenced Based Medicine|179
2|8.2 Evaluating EBM in the Field|184
2|8.3 Industry Influence in Medical Guidelines|186
3|8.3.1 A Dutch Case Study of Industry Influence in Medical Guidelines|191
2|8.4 Key Opinion Leaders|198
3|8.4.1 KOL Status in Industry Endorsement|199
3|8.4.2 Influence by Proxy|201
2|8.5 Educating the Medical Profession|205
3|8.5.1 KOLs in CME|207
3|8.5.2 Paying the Piper|208
2|8.6 Conclusion|218
2|References|221
1|9 Institutional Corruption of Medical Knowledge Application|226
2|9.1 Too Much Information: Quantity Over Quality|227
2|9.2 The Stringency Smokescreen and Financial Dependency on CME Sponsorship|231
3|9.2.1 Hungarian Pharmaceutical Industry Self-regulation and Disclosure|232
3|9.2.2 Dutch Pharmaceutical Industry Self-regulation and Disclosure|233
2|9.3 Quantity Over Quality in Medical Education|234
3|9.3.1 Industry-Medicine Relationships and CME Sponsorship: Explanations from the Field|235
2|9.4 Industry Funding of CMEs: A Look into the Transparency Data|241
2|9.5 Favouring Specialists Over GPs|246
2|9.6 Doctors and Sales Representatives|250
2|9.7 Regulatory Loopholes in Transparency|255
3|9.7.1 Hiding Payments|257
3|9.7.2 Obfuscating Payments|260
2|9.8 Effects on Prescription Practices: Explanations from the Field|264
2|9.9 Conclusion|267
2|References|268
1|10 Reviewing Institutional Corruption in Medicine|273
2|10.1 Institutional Corruption in the Work Breakdown Structure|278
2|10.2 Institutional Corruption in Goal Motivation|279
2|10.3 Institutional Corruption in Formalization and Communication|281
2|10.4 Closing Remarks|282
2|References|283
1|Annex 1|284
2|World Medical Association Hippocratic Oath Declaration of Geneva 1948|284
1|Annex 2|285
1|Annex 3|288
1|Annex 4|291
2|Membership Positions of Specialist College Members and Corresponding Positions in Medical Associations|291
1|Index|297