There is plenty of controversy surrounding pharmaceuticals, but it cannot be denied that the pharmaceutical industry is both socially beneficial and profitable. Regulators are expected to ensure that the economic success of the industry does not come at the expense of public safety, yet they 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 the 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.
Table of Contents:
1. Introduction
Katherine Fierlbeck, Janice Graham, and Matthew Herder
2. Transparency, Pharmaceuticals, and the Problem of Policy Change
Katherine Fierlbeck
3. Data Transparency and Pharmaceutical Regulation in Europe: Road to Damascus, or Room without a View?
Courtney Davis, Shai Mulinari, and Tom Jefferson
4. FDA and Health Canada: Similar Origins, yet Divergent Paths and Approaches to Transparency
Margaret McCarthy and Joe Ross
5. Clinical Trial Data Transparency in Canada: Mapping the Progress from Laggard to Leader
Marc-André Gagnon, Matthew Herder, Janice Graham, Katherine Fierlbeck, and Anna Danyliuk
6. How Clinical Study Information Transparency Can Fail to Serve Its Purpose, and How the Essential Medicines Concept Can Help
Nav Persaud
7. Speak No Secrets: (Non)transparency in Health Canada’s Communications about Pharmaceutical Regulation
Joel Lexchin
8. Economic Ghost-Management in the Pharmaceutical Sector
Marc-Andre Gagnon
9. 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 Lemmens
10. The European Registration of the Pandemic Influenza Vaccine Pandemrix: A Case Study of the Consequences of Poor Clinical Data Transparency
Tom Jefferson
11. Sharing Data and Ideas for Good Health: How Researchers Can Sustain an Ethical and Transparent Health System
Rita Banzi
12. Conclusion
Katherine Fierlbeck, Janice Graham, and Matthew Herder
About the Author :
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.
Review :
"A superb evaluation of accountability in the pharmaceutical sector. Fierlbeck, Graham, Herder, and the contributors offer an authoritative and insightful assessment of the limited transparency that prevents us from seeing what is really happening as new drugs are assessed and approved. The authors compare international approaches that offer perspectives on how we can keep our trust in the safety of medicines and the stakeholders involved in regulatory processes."
--Mary E. Wiktorowicz, Professor of Global Health Governance and Policy and Associate Director of the Dahdaleh Institute for Global Health Research, York University
" Transparency, Power, and Influence in the Pharmaceutical Industry is thoroughly researched, extremely well documented, and well written. The contributors are superbly acquainted with the literature on the subjects they write about, and I know many of them encounter their world as both public-interest academics and advocates, people who pursue studies in the public interest and carry out their academic work in the spirit of making the world a more just place."
--Alan Cassels, Drug Policy Researcher, University of Victoria
