Suchergebnisse

Introduction / Katherine Fierlbeck, Janice Graham, and Matthew Herder -- Transparency, Pharmaceuticals, and the Problem of Policy Change / Katherine Fierlbeck -- Data Transparency and Pharmaceutical Regulation in Europe: Road to Damascus, or Room without a View? / Courtney Davis, Shai Mulinari, and Tom Jefferson -- The FDA and Health Canada: Similar Origins, yet Divergent Paths and Approaches to Transparency / Margaret E. McCarthy and Joseph S. Ross -- 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 -- The Limits of Transparency and the Role of Essential Medicines / Nav Persaud -- Speak No Secrets: (Non)transparency in Health Canada's Communications about Pharmaceutical Regulation / Joel Lexchin -- The Political Economy of Influence: Ghost-Management in the Pharmaceutical Sector / Marc-André Gagnon -- Data Transparency and Rare Disease: Privacy versus Public Interest? / Kanksha Mahadevia Ghimire and Trudo Lemmens -- The European Registration of the Pandemic Influenza Vaccine Pandemrix: A Case Study of the Consequences of Poor Clinical Data Transparency / Tom Jefferson -- The Road Forward: How Researchers Can Sustain an Ethical and Transparent Health System / Rita Banzi -- Conclusion / Katherine Fierlbeck, Janice Graham, and Matthew Herder.

"Through twelve ethnographic case studies, The Social Life of Standards reveals how standards - political and technical tools for organizing society - are developed, applied, subverted, contested, and reassembled by local communities interacting with norms often created by others. Contributors explore standards at work across different countries and contexts, such as Ebola biomedical safety precautions in Senegal, Colombian farmers contesting politicized seed regulations, and the application of Indigenous standards to Canadian environmental assessments. They emphasize the uncomfortable fit between the often messy and inconsistent implementation of standards in the real world and the monolithic, non-negotiable criteria presupposed by external forces. Overt conflict arises when standards misrepresent important local (or global) realities. How do communities actively challenge and re-create standards that do not meet their needs? The Social Life of Standards provides an important anthropological perspective on the articulation of standards. The goal is to arrive at a more reflexive process that offers progressive engagement at the local level. Ultimately, we need an effective balance between evidence-based science, the social contexts that inform more useful and appropriate standards, and the inherent potential for activism."--