Access to clinical trial information and the stockpiling of Tamiflu PDF Download

Author: Great Britain: National Audit Office
Publisher: Stationery Office
ISBN: 9780102981445
Category : Medical
Languages : en
Pages : 44

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Book Description
This review reports whether medicines regulators and NICE have access to the clinical trials evidence they require when licensing Tamiflu and other medicines for use in the NHS, and whether the Department of Health stockpiled Tamiflu for influenza pandemics on the basis of clinical evidence. The NAO has set out a number of recommendations: (i) NICE and the MHRA should work together, with the EMA where necessary, to ensure that arrangements are in place to allow NICE to access the evidence underlying regulatory decisions to avoid the necessity for duplicated effort by NICE; (ii) NICE should require manufacturers to give assurances that they have confirmed at a global level that the evidence submitted is complete; (iii) NICE should align its policies for the publication of information across single and multiple technology appraisals of medicines or treatments; (iv) When making decisions about the stockpiling of pandemic medicines, the Department and its agencies should concentrate on building up knowledge about the added value of stockpiling through reducing complications and deaths; (v) To reduce the risk of unnecessary write-offs, NHS England and Public Health England should ensure that all providers of antivirals in a pandemic have robust antiviral storage and quality control in place during a pandemic; (vi) The Department should review its guidance and methods for ensuring that those in need of Tamiflu receive it quickly enough for it to be of use.

Author: Great Britain: Parliament: House of Commons: Committee of Public Accounts
Publisher: The Stationery Office
ISBN: 9780215065971
Category : Business & Economics
Languages : en
Pages : 52

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Book Description
The report Access To Clinical Trial Information And The Stockpiling Of Tamiflu (HC 295) examines two separate but connected issues; the routine withholding of clinical trial information from doctors and researchers, and the effectiveness of stockpiling of Tamiflu during an influenza pandemic. The full results of clinical trials are being routinely and legally withheld from doctors and researchers by the manufacturers of medicines. The ability of doctors, researchers and patients to make informed decisions about treatments is being undermined. Regulators and the industry have recently made proposals to open up access, but these do not cover the issue of access to the results of trials in the past which bear on the efficacy and safety of medicines in use today. Research suggests that the probability of completed trials being published is roughly 50%. Trials which give a favorable verdict are about twice as likely to be published as trials giving unfavorable

Author: John Germov
Publisher: Routledge
ISBN: 1000247023
Category : Social Science
Languages : en
Pages : 580

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Book Description
From the future of work to the nature of our closest relationships, how do we understand the links between our personal troubles and wider public issues in society today? Now into its fourth edition, Public Sociology continues to highlight the relevance of a grounded sociological perspective to Australian social life, as well as encouraging students to apply a sociological gaze to their own lives and the communities in which they live. Public Sociology presents a wide range of topics in a user-friendly and accessible way, introducing key theories and research methods, and exploring core themes, including youth, families and intimate relationships, class and inequality and race and ethnic relations. All chapters have been extensively revised to bring them up to date in a fast-changing social world, reflecting the latest sociological debates in response to changing lifestyles and evolving political landscapes. In addition to updated statistics and research findings, an expanded glossary and the latest citations to the scholarly literature, the text features a completely new chapter on gender and sexualities with expanded discussion of LGBTIQ+. This new edition also explores contemporary issues ranging from the #MeToo movement to marriage equality, fake news and 'alt facts'. This is the essential sociological reference to help students make sense of a complex and challenging world. NEW TO THE FOURTH EDITION: * A new chapter on gender and sexualities and expanded discussion of intersectionality * Exploration of the latest social issues including #MeToo, rising inequality, and the 'post-truth' age * All chapters thoroughly revised and updated with the latest research * Updated book website with extra readings, YouTube clips, and case studies * A new feature, Visual Sociology, helps the reader analyse the power of visual messaging 'With a firm base in the richest traditions of the discipline and with a remarkably approachable format, this book offers an excellent introduction to a wide array of sociology's concerns, making it suitable for all Australian social science undergraduates.' Gary Wickham, Emeritus Professor of Sociology, Murdoch University 'A sophisticated yet accessible introduction to social identities, differences and inequalities, and social transformations.' Jo Lindsay, Professor in Sociology, Monash University 'Sweeping and lucid...communicates with ease and simplicity.' Toni Makkai, Emeritus Professor, College of Arts and Social Sciences, Australian National University

Author: Great Britain: Parliament: House of Commons: Science and Technology Committee
Publisher: The Stationery Office
ISBN: 9780215062321
Category : Medical
Languages : en
Pages : 210

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Book Description
Many of the trials taking place today are unregistered and unpublished, meaning that the information that they generate remains invisible to both the scientific community and the public. This undermines public trust, slowing the pace of medical advancement and potentially putting patients at risk. All trials conducted on NHS treatments-and all other trials receiving public funding-should be prospectively registered and their results published in a scientific journal. While the focus should be on implementing this change for future trials, the Government must also do what it can to ensure that historic trials are registered and published, particularly where they have been publically funded. The Government should also take steps to facilitate greater sharing of the raw data generated during a trial in a responsible and controlled way, with the knowledge and consent of patients. The report also draws attention to the recent fall in the number of trials taking place in the UK. It finds that the need for multiple governance approvals from participating NHS organisations remained the biggest barrier to setting up a UK trial, but that lack of public awareness was also a key issue. Recruiting participants can also be a challenge. The report calls on the Government to take its recommendations into account in ongoing discussions regarding the revision of European clinical trials legislation and in its response to the European Medicines Agency's consultation on the release of clinical trial data, which closes at the end of this month

Author: Stefan Elbe
Publisher: JHU Press
ISBN: 1421425580
Category : Business & Economics
Languages : en
Pages : 281

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Book Description
Encapsulating security : pharmaceutical defenses against biological danger -- Discovering a virus's achilles heel : flu fighting at molecular scale -- The pill always wins: Gilead Sciences, Roche and the birth of Tamiflu -- What a difference a day makes : the margin call for regulatory agencies -- Virtual blockbuster : bird flu and the pandemic of preparedness planning -- In the eye of the storm : global access, generics and intellectual property -- 'Ode to Tamiflu' : side effects, teenage 'suicides' and corporate liabilities -- Data backlash : Roche and Cochrane square up over clinical trial data -- 'To boldly go ... ' : pharmaceutical enterprises and global health security -- Epilogue : pharmaceuticals, security and molecular life

Author: Donald W. Light
Publisher: Springer
ISBN: 1137374330
Category : Social Science
Languages : en
Pages : 289

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Book Description
Drawing on key concepts in sociology and management, this history describes a remarkable institute that has elevated medical research and worked out solutions to the troubling practices of commercial pharmaceutical research. Good Pharma is the answer to Goldacre's Bad Pharma: ethical research without commercial distortions.

Author: Timothy Garton Ash
Publisher: Yale University Press
ISBN: 0300161360
Category : Political Science
Languages : en
Pages : 701

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Book Description
Never in human history was there such a chance for freedom of expression. If we have Internet access, any one of us can publish almost anything we like and potentially reach an audience of millions. Never was there a time when the evils of unlimited speech flowed so easily across frontiers: violent intimidation, gross violations of privacy, tidal waves of abuse. A pastor burns a Koran in Florida and UN officials die in Afghanistan. Drawing on a lifetime of writing about dictatorships and dissidents, Timothy Garton Ash argues that in this connected world that he calls cosmopolis, the way to combine freedom and diversity is to have more but also better free speech. Across all cultural divides we must strive to agree on how we disagree. He draws on a thirteen-language global online project—freespeechdebate.com—conducted out of Oxford University and devoted to doing just that. With vivid examples, from his personal experience of China's Orwellian censorship apparatus to the controversy around Charlie Hebdo to a very English court case involving food writer Nigella Lawson, he proposes a framework for civilized conflict in a world where we are all becoming neighbors.

Author: Katherine Fierlbeck
Publisher: University of Toronto Press
ISBN: 1487529066
Category : Medical
Languages : en
Pages : 303

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Book Description
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.

Author: Dag K.J.E. von Lubitz
Publisher: CRC Press
ISBN: 1351691260
Category : Social Science
Languages : en
Pages : 458

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Book Description
The ongoing COVID-19 disaster―and the universal realization of the inevitability of even worse pandemics in the future―has resulted in a wealth of books, scientific papers, and journalistic analyses of the politics, medicine, and human suffering. The Nature of Pandemics is not an outcrop of COVID-19 publication frenzy. Conceived in the period between the outbreaks of SARS and Ebola, the book addresses the critical, but commonly overlooked issues that limit readiness, recognition, and rapid response to emerging biodisasters. The book is unique in its approach to pandemics. It offers a holistic view of the nature of pandemics as a phenomenon, and of the challenges involved in mounting an organized, concerted response to a worldwide lethal bioevent. Most healthcare professionals at national and international levels recognize the danger; the political efforts to establish consistently effective countermeasures are sporadic and dissonant when they do occur. The slow and politically safe approach, the failure to react quickly, and unhesitatingly mobilize all resources, remain the paramount obstacles to the effective containment of a pandemic. The individual chapters of the book are written by internationally respected experts from Africa, Europe, and North and South America. The contributing authors represent a cross-section of professions involved in counter-pandemic activities: some operate at the highest levels of national and international institutions, others work as clinicians specializing in infectious diseases, scientists, experts in public health, law and its enforcement, or military aspects of pandemics. Their contributions, often highly personal and perhaps even controversial—supported by their involvement in the "front-line" challenges of pandemic containment and mitigation—provide a rare combination of first-hand knowledge of the current "state of the art" and recommendations for the implementation of best practices. The Nature of Pandemics offers multifaceted insight into problems that, if ignored initially, come to mar all subsequent response and mitigation efforts. The content spans solutions to developing readiness and mobilizing response as much to the current pandemic as to the future ones. Addressing government-generated roadblocks to response, military and security issues, global supply chain infrastructure, communications, information technology, ethical dilemmas posed by vacillating quality of care—and the inevitable mass fatalities—together with the confused interaction of global health organizations and response agencies, the book examines the panoply of complexities not only at the center of a pandemic outbreak but also at its equally critical and deadly periphery.

Author: Christopher Hodges
Publisher: Bloomsbury Publishing
ISBN: 1782255834
Category : Law
Languages : en
Pages : 768

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Book Description
This book examines the theories and practice of how to control corporate behaviour through legal techniques. The principal theories examined are deterrence, economic rational acting, responsive regulation, and the findings of behavioural psychology. Leading examples of the various approaches are given in order to illustrate the models: private enforcement of law through litigation in the USA, public enforcement of competition law by the European Commission, and the recent reform of policies on public enforcement of regulatory law in the United Kingdom. Noting that behavioural psychology has as yet had only limited application in legal and regulatory theory, the book then analyses various European regulatory structures where behavioural techniques can be seen or could be applied. Sectors examined include financial services, civil aviation, pharmaceuticals, and workplace health & safety. Key findings are that 'enforcement' has to focus on identifying the causes of non-compliance, so as to be able to support improved performance, rather than be based on fear motivating complete compliance. Systems in which reporting is essential for safety only function with a no-blame culture. The book concludes by proposing an holistic model for maximising compliance within large organisations, combining public regulatory and criminal controls with internal corporate systems and external influences by stakeholders, held together by a unified core of ethical principles. Hence, the book proposes a new theory of ethical regulation. This title is included in Bloomsbury Professional's International Arbitration online service.