Transparency, Power, and Influence in the Pharmaceutical Industry: Policy Gain or Confidence Game?
© 2021
There is plenty of controversy surrounding pharmaceuticals, but it cannot be denied that it is both a socially beneficial and profit-making industry. Regulators are expected to ensure that the economic success of the pharmaceutical industry does not come at the expense of public safety, yet regulators have also assumed a cooperative role by providing advice on regulation and by targeting unmet medical needs. Concerns over regulatory standards, conflicts of interest, and the manipulation of information on drug safety and effectiveness have led to public mistrust and a greater need for transparency between pharmaceutical industry and government regulators.
Transparency, Power, and Influence in the Pharmaceutical Industry evaluates the progress made in holding the pharmaceutical industry responsible for creating transparency in the industry, from development to market. The contributors to this volume examine the various mechanisms introduced to make the regulatory process more informative and situate these efforts within the larger project of enhancing the safety of drugs, vaccines, and other products.
Product Details
- World Rights
- Page Count: 304 pages
- Dimensions: 6.0in x 1.0in x 9.0in
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Author Information
Katherine Fierlbeck is the McCulloch Professor of Political Science at Dalhousie University, with a cross-appointment as professor of Community Health and Epidemiology.
Janice Graham is a professor of Paediatrics (infectious diseases) and Medical Anthropology, and the University Research Professor at Dalhousie University.
Matthew Herder is the director of the Health Law Institute and an associate professor of Medicine and Law at Dalhousie University. -
Table of contents
1. Introduction
Katherine Fierlbeck, Janice Graham, and Matthew Herder2. Transparency, Pharmaceuticals, and the Problem of Policy Change
Katherine Fierlbeck3. Data Transparency and Pharmaceutical Regulation in Europe: Road to Damascus, or Room without a View?
Courtney Davis, Shai Mulinari, and Tom Jefferson4. FDA and Health Canada: Similar Origins, yet Divergent Paths and Approaches to Transparency
Margaret McCarthy and Joe Ross5. Clinical Trial Data Transparency in Canada: Mapping the Progress from Laggard to Leader
Marc-André Gagnon, Matthew Herder, Janice Graham, Katherine Fierlbeck, and Anna Danyliuk6. How Clinical Study Information Transparency Can Fail to Serve Its Purpose, and How the Essential Medicines Concept Can Help
Nav Persaud7. Speak No Secrets: (Non)transparency in Health Canada’s Communications about Pharmaceutical Regulation
Joel Lexchin8. Economic Ghost-Management in the Pharmaceutical Sector
Marc-Andre Gagnon9. Balancing the Privacy Rights of Research Participants with the Public Interest in Clinical Drug Trials Data in the Context of Rare Diseases
Kanksha Mahadevia Ghimire and Trudo Lemmens10. The European Registration of the Pandemic Influenza Vaccine Pandemrix: A Case Study of the Consequences of Poor Clinical Data Transparency
Tom Jefferson11. Sharing Data and Ideas for Good Health: How Researchers Can Sustain an Ethical and Transparent Health System
Rita Banzi12. Conclusion
Katherine Fierlbeck, Janice Graham, and Matthew Herder
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Subjects and Courses
