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-Andre 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-Andre 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.
Summary:
"There is plenty of controversy surrounding pharmaceuticals, however 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 this sense of 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."-- Provided by publisher.
This resource is supported by the Institute of Museum and Library Services under the provisions of the Library Services and Technology Act as administered by State Library of Iowa.