Making Medicines Affordable: a National Imperative

Total Page:16

File Type:pdf, Size:1020Kb

Making Medicines Affordable: a National Imperative THE NATIONAL ACADEMIES PRESS This PDF is available at http://nap.edu/24946 SHARE Making Medicines Affordable: A National Imperative DETAILS 234 pages | 6 x 9 | PAPERBACK ISBN 978-0-309-46805-3 | DOI 10.17226/24946 CONTRIBUTORS GET THIS BOOK Norman R. Augustine, Guru Madhavan, and Sharyl J. Nass, Editors; Committee on Ensuring Patient Access to Affordable Drug Therapies; Board on Health Care Services; Health and Medicine Division; National Academies of Sciences, FIND RELATED TITLES Engineering, and Medicine Visit the National Academies Press at NAP.edu and login or register to get: – Access to free PDF downloads of thousands of scientific reports – 10% off the price of print titles – Email or social media notifications of new titles related to your interests – Special offers and discounts Distribution, posting, or copying of this PDF is strictly prohibited without written permission of the National Academies Press. (Request Permission) Unless otherwise indicated, all materials in this PDF are copyrighted by the National Academy of Sciences. Copyright © National Academy of Sciences. All rights reserved. Making Medicines Affordable: A National Imperative Norman R. Augustine, Guru Madhavan, and Sharyl J. Nass, Editors Committee on Ensuring Patient Access to Affordable Drug Therapies Board on Health Care Services Health and Medicine Division A Consensus Study Report of Copyright National Academy of Sciences. All rights reserved. Making Medicines Affordable: A National Imperative THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001 This activity was supported by grants from the American College of Physicians, Breast Cancer Research Foundation, Burroughs Wellcome Fund, California Health Care Foundation, The Commonwealth Fund, Laura and John Arnold Foundation, Milbank Memorial Fund, and the Presidents’ Committee of the National Academies of Sciences, Engineering, and Medicine. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization that provided support for the project. International Standard Book Number-13: 978-0-309-46805-3 International Standard Book Number-10: 0-309-46805-1 Digital Object Identifier: https://doi.org/10.17226/24946 Library of Congress Control Number: 2018931964 Additional copies of this publication are available for sale from the National Acad- emies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624- 6242 or (202) 334-3313; www.nap.edu. Copyright 2018 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2018. Making medicines affordable: A national imperative. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/24946. Copyright National Academy of Sciences. All rights reserved. Making Medicines Affordable: A National Imperative The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president. The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary con- tributions to engineering. Dr. C. D. Mote, Jr., is president. The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president. The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine. Learn more about the National Academies of Sciences, Engineering, and Medi- cine at www.nationalacademies.org. Copyright National Academy of Sciences. All rights reserved. Making Medicines Affordable: A National Imperative Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typi- cally include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task. Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opin- ions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies. For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo. Copyright National Academy of Sciences. All rights reserved. Making Medicines Affordable: A National Imperative In memory of Henri Termeer 1946–2017 v Copyright National Academy of Sciences. All rights reserved. Making Medicines Affordable: A National Imperative Copyright National Academy of Sciences. All rights reserved. Making Medicines Affordable: A National Imperative COMMITTEE ON ENSURING PATIENT ACCESS TO AFFORDABLE DRUG THERAPIES NORMAN AUGUSTINE (Chair), Former Chairman and CEO, Lockheed Martin Corporation JEFF BINGAMAN, Former U.S. Senator, New Mexico RENA CONTI, Associate Professor, Department of Pediatrics and the Department of Public Health Sciences, The University of Chicago STACIE DUSETZINA, Assistant Professor, Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill MARTHA GAINES, Director, Center for Patient Partnerships; Distinguished Clinical Professor of Law, University of Wisconsin Law School REBEKAH GEE, Secretary, Louisiana Department of Health VICTORIA HALE, Founder and Former CEO, OneWorld Health and Medicines360 MICHELLE MELLO, Professor of Law, Stanford Law School; Professor of Health Research and Policy, Stanford University School of Medicine ELISEO PÉREZ-STABLE, Director, National Institute on Minority Health and Health Disparities, National Institutes of Health CHARLES PHELPS, University Professor and Provost Emeritus, University of Rochester MICHAEL ROSENBLATT, Chief Medical Officer, Flagship Pioneering; Former Chief Medical Officer and Executive Vice President, Merck & Co., Inc. DIANE ROWLAND, Executive Vice President, Henry J. Kaiser Family Foundation; Executive Director, Kaiser Commission on Medicaid and the Uninsured VINOD SAHNEY, Distinguished University Professor of Industrial Engineering and Operations Research, Northeastern University; Former Senior Vice President, Blue Cross Blue Shield of Massachusetts and Henry Ford Health System PETER SANDS, Research Fellow, Mossavar-Rahmani Center for Business and Government, Harvard John F. Kennedy School of Government; Research Fellow, Harvard Global Health Institute; Former CEO, Standard Chartered Bank PLC vii Copyright National Academy of Sciences. All rights reserved. Making Medicines Affordable: A National Imperative HENRI TERMEER,1 Former Chairman, President, and CEO, Genzyme Corporation REED TUCKSON, Managing Director, Tuckson Health Connections, LLC; Former Executive Vice President and Chief of Medical Affairs, UnitedHealth Group ALAN WEIL, Editor-in-Chief, Health Affairs; Vice President for Public Policy, Project HOPE Staff GURU MADHAVAN, Project Director FRANCIS AMANKWAH, Associate Program Officer SYLARA MARIE CRUZ, Senior Program Assistant DANIEL BEARSS, Senior Research Librarian REBECCA MORGAN, Senior Research Librarian PATRICK BURKE, Senior Financial Officer SHARYL NASS, Director, Board on Health Care Services Fellows and Consultants JENNIE KWON, National Academy of Medicine Anniversary Fellow in Osteopathic Medicine; Assistant Professor, Washington University School of Medicine STEPHEN MERRILL, Technical Consultant; Executive Director, Center for Innovation Policy and Senior Fellow in Innovation and Entrepreneurship, Duke University School of Law ROBERT POOL, Editorial Consultant BRENDAN SALONER, National Academy of Medicine Greenwall Fellow in Bioethics; Assistant Professor, Johns Hopkins Bloomberg School of Public Health JONATHAN WATANABE, National Academy of Medicine Anniversary Fellow in Pharmacy; Associate Professor, University of California, San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences Executive Assistant to the Committee Chair LAURA AHLBERG, Lockheed Martin Corporation 1 Deceased May 2017. NOTE: See Appendix F, Disclosure of Conflicts of Interest. viii Copyright National Academy of Sciences. All rights reserved. Making Medicines Affordable: A National Imperative Reviewers his Consensus Study Report was reviewed
Recommended publications
  • Big Pharma Takes It
    A Public Eye Report – March 2021 Big Pharma takes it all How pharmaceutical corporations profiteer from their privileges – even in a global health crisis like COVID-19 1 COVID-19, SHOWCASE OF A PERVERTED BUSINESS MODEL 3 2 BIG PHARMA’S 10 STRATEGIES FOR CASHING IN 7 2.1 – Determine R & D priorities by potential profits alone 9 2.2 – Abuse patents to lock up knowledge, inflate prices and limit supply 10 2.3 – Direct the system towards the needs of high-income countries 13 2.4 – Avoid public accountability 16 2.5 – Design clinical trials for self-interest 18 2.6 – Socialise risks, privatise profits 20 2.7 – Embrace public investment, reject public returns 22 2.8 – Impose unjustifiable, unchallengeable prices 24 2.9 – Financialise innovation 29 2.10 – Lobby pervasively 31 3 SWITZERLAND IS ‘PHARMALAND’ 33 4 CONCLUSION: WHAT COVID-19 SHOWS US 37 5 TIME TO ACT: OUR DEMANDS 39 Endnotes 42 IMPRINT Big Pharma takes it all: How pharmaceutical corporations profiteer from their privileges – even in a global health crisis like COVID-19. A Public Eye Report, March 2021, 52 pages. | Authors Patrick Durisch, Gabriela Hertig | Contributors Christa Luginbühl, Oliver Classen | Edition Mary Louise Rapaud | Publishers Romeo Regenass, Ariane Bahri | Layout Karin Hutter, karinhutter.com | Icons opak.cc | Cover picture © Tang Ming Tung/Getty Images PUBLIC EYE Dienerstrasse 12, Postfach, CH-8021 Zurich | +41 (0)44 2 777 999 | [email protected] Avenue Charles-Dickens 4, CH-1006 Lausanne | +41 (0)21 620 03 03 | [email protected] Donations IBAN CH64 0900 0000 1001 0813 5, Public Eye | publiceye.ch 1 ��-19, showcase of a perverted business model Monty Rakusen/Keystone © 4 BIG PHARMA TAKES IT ALL “No one is safe until everybody is safe”, “leave no one behind” are mantras that have been oft repeated by state leaders and the World Health Organization (WHO) since the coronavirus pandemic turned our world upside down in spring, 2020.
    [Show full text]
  • The Pharma Barons: Corporate Law's Dangerous New Race to the Bottom in the Pharmaceutical Industry
    Michigan Business & Entrepreneurial Law Review Volume 8 Issue 1 2018 The Pharma Barons: Corporate Law's Dangerous New Race to the Bottom in the Pharmaceutical Industry Eugene McCarthy University of Illinois Follow this and additional works at: https://repository.law.umich.edu/mbelr Part of the Business Organizations Law Commons, Consumer Protection Law Commons, Food and Drug Law Commons, and the Rule of Law Commons Recommended Citation Eugene McCarthy, The Pharma Barons: Corporate Law's Dangerous New Race to the Bottom in the Pharmaceutical Industry, 8 MICH. BUS. & ENTREPRENEURIAL L. REV. 29 (2018). Available at: https://repository.law.umich.edu/mbelr/vol8/iss1/3 This Article is brought to you for free and open access by the Journals at University of Michigan Law School Scholarship Repository. It has been accepted for inclusion in Michigan Business & Entrepreneurial Law Review by an authorized editor of University of Michigan Law School Scholarship Repository. For more information, please contact [email protected]. THE PHARMA BARONS: CORPORATE LAW’S DANGEROUS NEW RACE TO THE BOTTOM IN THE PHARMACEUTICAL INDUSTRY Eugene McCarthy* INTRODUCTION......................................................................................... 29 I. THE RACE TO THE BOTTOM AND THE RISE OF THE ROBBER BARONS ..................................................................................... 32 A. Revising the Corporate Codes............................................ 32 B. The Emergence of Nineteenth-Century Lobbying ............. 37 C. The Robber
    [Show full text]
  • JEMH Vol4 No1 Sept
    ARTICLE SPECIAL THEME ISSUE ARTICLE Privatization of Knowledge and the Creation of Biomedical Conflicts of Interest Leemon B. McHenry Department of Philosophy, California State University, Northridge Jon N. Jureidini Discipline of Psychiatry, University of Adelaide, South Australia rather than to what is meaningful, so that fi ndings that are Abstract likely to be clinical and meaningful are rejected because they fail to reach statistical signifi cance whereas others that appear Scientifi c and ethical misconduct have increased at an clinically trivial are accepted (Ziliak and McCloskey, 2007). Th e alarming rate as a result of the privatization of knowledge. disenchantment with the psychoanalytic paradigm of psychiatry What began as an eff ort to stimulate entrepreneurship led to a massive investment in psychopharmacology and other and increase discovery in biomedical research by physical interventions. A concession now to the limited benefi t strengthening the ties between industry and academics that psychopharmacology off ers would come at great cost to the has led to an erosion of confi dence in the reporting of profession. A vested interest in protecting the new paradigm of research results. Inherent tensions between profi t-directed neurological models of psychiatric disorders reaches beyond the inquiry and knowledge-directed inquiry are instantiated quest for a secure scientifi c foundation. in psychopharmacology, especially in the co-option of academic activity to corporate objectives. The eff ects of To the vulnerability created by personal bias and questionable these tensions are visible in research agendas, publication methodology we must add the dangers of pervasive fi nancial practices, postgraduate education, academic-industry confl icts of interest, of which we investigate the root cause in this partnerships and product promotion.
    [Show full text]
  • Pharmaceutical Price Regulation
    Pharmaceutical Price Regulation Pharmaceutical Price Regulation Public Perceptions, Economic Realities, and Empirical Evidence John A. Vernon and Joseph H. Golec The AEI Press Publisher for the American Enterprise Institute WASHINGTON, D.C. Distributed to the Trade by National Book Network, 15200 NBN Way, Blue Ridge Summit, PA 17214. To order call toll free 1-800-462-6420 or 1-717-794-3800. For all other inquiries please contact the AEI Press, 1150 Seventeenth Street, N.W., Washington, D.C. 20036 or call 1-800-862-5801. Library of Congress Cataloging-in-Publication Data Vernon, John A. Pharmaceutical price regulation : public perceptions, economic realities, and empirical evidence / John A. Vernon and Joseph H. Golec. p. ; cm. Includes bibliographical references. ISBN-13: 978-0-8447-4277-9 ISBN-10: 0-8447-4277-5 1. Pharmaceutical industry—Government policy—United States. 2. Drugs—Prices—Law and legislation—United States. I. Golec, Joseph. II. Title. HD9666.6.V47 2008 338.4'361510973--dc22 2008049681 12 11 10 09 1 2 3 4 5 © 2008 by the American Enterprise Institute for Public Policy Research, Washington, D.C. All rights reserved. No part of this publication may be used or reproduced in any manner whatsoever without permission in writing from the American Enterprise Institute except in the case of brief quotations embodied in news articles, critical articles, or reviews. The views expressed in the publications of the American Enterprise Institute are those of the authors and do not necessarily reflect the views of the staff, advisory panels, officers, or trustees of AEI. Printed in the United States of America Contents LIST OF ILLUSTRATIONS vii INTRODUCTION 1 1.
    [Show full text]
  • The Big Pharma Conspiracy Theory
    The Big Pharma conspiracy theory Correspondence to: Robert Blaskiewicz Department of English Robert Blaskiewicz University of Wisconsin- Eau Claire, Eau Claire, WI University of Wisconsin-Eau Claire, Eau Claire, WI, USA USA [email protected] Abstract This essay outlines the broad themes of the conspi- pharmaceutical industry; rather it is the pharma- racy theory that pharmaceutical companies, regula- ceutical industry as they imagine it. In these tors, politicians, and others are secretly working in stories, ‘Big Pharma’ is shorthand for an abstract consort against the public interest. This so-called entity comprised of corporations, regulators, Big Pharma conspiracy theory shares a number of NGOs, politicians, and often physicians, all with a features with other conspiracy narratives, but some finger in the trillion-dollar prescription pharma- features make this particular subgenre of conspiracy ceutical pie. Eliding all of these separate entities theory especially intractable and dangerous. into a monolithic agent of evil allows the conspiracy theorist to mistakenly ignore the complex and con- Keywords: Conspiracy theory, Pharmaceutical flicting interests that they represent. This agent is, companies, Paranoia, Vaccines as are all antagonists in conspiratorial narratives, improbably powerful, competent, and craven, and it allows the conspiracy theorist to cast himself in The so-called Big Pharma conspiracy theory shares a the role of crusader and defender of a way of life, number of features with all other conspiracy the- a Manichean dichotomy that was identified in ories. First, it shares the same basic plot: a relatively Richard Hofstadter’s classic treatise on America’s small number of people are working in secret recurring conspiracism, ‘The Paranoid Style in against the public good.
    [Show full text]
  • "Beware the Drug Companies, How They Deceive Us: 'Criticizing Big Pharma'", Global Research
    Kohls, Gary G., "Beware the Drug Companies, How they Deceive Us: 'Criticizing Big Pharma'", Global Research. Centre for Research on Globalization (CRG), Québec, Canadá, 16 de febrero de 2015. Consultado en: https://www.globalresearch.ca/beware-the-drug-companies-how-the-deceive-us-criticizing- big-pharma/5431517 Fecha de consulta: 10/10/2019 . Beware the Drug Companies, How they Deceive Us: “Criticizing Big Pharma” Pertinent Quotes from Marcia Angell, MD and Author Helen Epstein Note: Dr Marcia Angell was fired from her long-held job as executive editor of the once prestigious New England Journal of Medicine because of an editorial that she wrote criticizing the pharmaceutical industry, criticisms that she elaborated on in her book, “The Truth About the Drug Companies: How They Deceive Us and What to Do About It”. Here are some quotes from Dr Angell’s writings and/or interviews. Some of them were published at Jon Rappoport’s website: https://jonrappoport.wordpress.com/2011/05/09/faking-medical-reality/ “…Similar conflicts of interest and biases exist in virtually every field of medicine, particularly those that rely heavily on drugs or devices. It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.” — Marcia Angell, M, author of “The Truth About the Drug Companies: How They Deceive Us and What to Do About It” “Consider the clinical trials by which drugs are tested on human subjects.
    [Show full text]
  • Immunity and Impunity: Corruption in the State-Pharma Nexus
    www.crimejusticejournal.com IJCJ&SD 2017 6(4): 86‐99 ISSN 2202–8005 Immunity and Impunity: Corruption in the State‐Pharma Nexus Paddy Rawlinson Western Sydney University, Australia Abstract Critical criminology repeatedly has drawn attention to the state‐corporate nexus as a site of corruption and other forms of criminality, a scenario exacerbated by the intensification of neoliberalism in areas such as health. The state‐pharmaceutical relationship, which increasingly influences health policy, is no exception. That is especially so when pharmaceutical products such as vaccines, a burgeoning sector of the industry, are mandated in direct violation of the principle of informed consent. Such policies have provoked suspicion and dissent as critics question the integrity of the state‐pharma alliance and its impact on vaccine safety. However, rather than encouraging open debate, draconian modes of governance have been implemented to repress and silence any form of criticism, thereby protecting the activities of the state and pharmaceutical industry from independent scrutiny. The article examines this relationship in the context of recent legislation in Australia to intensify its mandatory regime around vaccines. It argues that attempts to undermine freedom of speech, and to systematically excoriate those who criticise or dissent from mandatory vaccine programs, function as a corrupting process and, by extension, serve to provoke the notion that corruption does indeed exist within the state‐pharma alliance. Keywords State‐corporate harm; mandated vaccines; informed consent; neoliberalism. Please cite this article as: Rawlinson P (2017) Immunity and impunity: Corruption in the state‐pharma nexus. International Journal for Crime, Justice and Social Democracy 6(4): 86‐99.
    [Show full text]
  • Doctor's Dependency on Big Pharma Larissa Tiller
    The Business, Entrepreneurship & Tax Law Review Volume 2 | Issue 2 Article 12 2018 Getting Their iF x: Doctor's Dependency on Big Pharma Larissa Tiller Follow this and additional works at: https://scholarship.law.missouri.edu/betr Part of the Business Organizations Law Commons, Entrepreneurial and Small Business Operations Commons, and the Tax Law Commons Recommended Citation Larissa Tiller, Getting Their Fix: Doctor's Dependency on Big Pharma, 2 Bus. Entrepreneurship & Tax L. Rev. 492 (2018). Available at: https://scholarship.law.missouri.edu/betr/vol2/iss2/12 This Comment is brought to you for free and open access by the Law Journals at University of Missouri School of Law Scholarship Repository. It has been accepted for inclusion in The usineB ss, Entrepreneurship & Tax Law Review by an authorized editor of University of Missouri School of Law Scholarship Repository. Tiller: Getting Their Fix: Doctor's Dependency on Big Pharma Getting Their Fix: Doctor’s Dependency on Big Pharma Larissa Tiller* ABSTRACT Section 6002 of the Affordable Care Act, also known as the “Sunshine Act,” was intended to stop corrupt practices within the medical community by requiring phar- maceutical and medical device manufacturers to disclose all transfers of value of a certain amount made between them and physicians. This article suggests that the better solution to stopping corrupt practices is to ban some transfers all together. * B.A., Columbia College, Columbia, Missouri 2015; J.D. Candidate, University of Missouri School of Law, 2019. Special thanks to Benjamin Kweskin for his helpful feedback and editorial input on this article. Published by University of Missouri School of Law Scholarship Repository, 2018 1 The Business, Entrepreneurship & Tax Law Review, Vol.
    [Show full text]
  • Big Pharma Wields Its Power with the Help of Government Regulation
    Emory Corporate Governance and Accountability Review Volume 5 Issue 2 2018 Thick as Thieves? Big Pharma Wields Its Power with the Help of Government Regulation Leslie E. Sekerka Lauren Benishek Follow this and additional works at: https://scholarlycommons.law.emory.edu/ecgar Recommended Citation Leslie E. Sekerka & Lauren Benishek, Thick as Thieves? Big Pharma Wields Its Power with the Help of Government Regulation, 5 Emory Corp. Governance & Accountability Rev. 113 (2018). Available at: https://scholarlycommons.law.emory.edu/ecgar/vol5/iss2/4 This Essay is brought to you for free and open access by the Journals at Emory Law Scholarly Commons. It has been accepted for inclusion in Emory Corporate Governance and Accountability Review by an authorized editor of Emory Law Scholarly Commons. For more information, please contact [email protected]. SEKERKA_BENISHEK GALLEYFINAL 5/10/2018 12:23 PM THICK AS THIEVES? BIG PHARMA WIELDS ITS POWER WITH THE HELP OF GOVERNMENT REGULATION† Leslie E. Sekerka∗ Lauren Benishek∗∗ INTRODUCTION Americans are barraged by an endless flow of ads that claim to remedy medical maladies with prescribed drugs. The commercials depict productive and happy lives, with suggestive associations that human flourishing can be achieved via pharmaceutical intervention. The appeals are accompanied by an exhaustive inventory of potentially negative life-altering side effects. As ads end with this depiction of relational bliss through drug use, viewers hear a fast- paced listing of monotone non-segmented disclaimers,
    [Show full text]
  • Industry-Corrupted Psychiatric Trials1
    Psychiatr. Pol. 2017; 51(6): 993–1008 PL ISSN 0033-2674 (PRINT), ISSN 2391-5854 (ONLINE) www.psychiatriapolska.pl DOI: https://doi.org/10.12740/PP/80136 Industry-corrupted psychiatric trials1 Jay D. Amsterdam1, Leemon B. McHenry 2, Jon N. Jureidini3 1Depression Research Unit, Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania 2Department of Philosophy, California State University, Northridge, California 3Critical and Ethical Mental Health Research Group, Robinson Research Institute, University of Adelaide, Australia Summary The goal of this paper is to expose the research misconduct of pharmaceutical industry- sponsored clinical trials via three short case studies of corrupted psychiatric trials that were conducted in the United States. We discuss the common elements that enable the misrepre- sentation of clinical trial results including ghostwriting for medical journals, the role of key opinion leaders as co-conspirators with the pharmaceutical industry and the complicity of top medical journals in failing to uphold standards of science and peer review. We conclude that the corruption of industry-sponsored clinical trials is one of the major obstacles facing evidence-based medicine. Key words: antidepressants, citalopram, clinical trials, depression, ghostwriting, key opi- nion leaders, paroxetine, research misconduct, selective reporting Introduction As former editor of the New England Journal of Medicine, Marcia Angell reported in 2008: Over the past 2 decades, the pharmaceutical
    [Show full text]
  • The Firepower of the EU Pharmaceutical Lobby and Implications for Public Health 1
    Policy prescriptions the firepower of the EU pharmaceutical lobby and implications for public health 1. Table of contents Table of contents Table of contents 2 Executive summary 3 Introduction 4 1. Speaking ‘Pharmish’: the industry paradigm 5 2. Pharmaceutical industry firepower: Lobby expenditure, meetings and expertise 8 2.1. Pharmaceutical companies 10 2.2. Pharmaceutical industry trade associations 15 2.3. Lobby consultancies hired by the pharmaceutical industry 19 3. Spotlight on EFPIA: Heart of the EU pharmaceutical lobbying machine 22 3.1. The pharmaceutical industry’s European powerhouse 22 3.2. EFPIA lobby meetings with the European Commission 23 3.3. Innovative Medicines Initiative (IMI): The public-private-partnership made in heaven for EFPIA 25 4. Commission TTIPs its hat to big pharma 27 4.1. Pharma’s stake in TTIP, and why it matters 27 4.2. A front row seat for pharma in TTIP negotiations under Barroso Commission 29 4.3. The Juncker Commission: Keeping pharma close on TTIP 30 5. Conclusion 33 Appendix 34 Notes 35 Published by Corporate Europe Observatory (CEO), September 2015. Research and writing: Rachel Tansey Editing: Katharine Ainger Design: Stijn Vanhandsaeme (nestor.coop) Infographics: Ophelia Van Campenhout (nordicmaterial.com) Cover picture: iStock.com/cikailja Acknowledgements: We would like to thank Olivier Hoedeman, Martin Pigeon, Teresa Alves, Yannis Natsis, Peter Gøtzsche, Dorota Sienkiewicz, Pia Eberhardt and others for insightful input, comments and support. Contents of the report may be quoted or reproduced for non-commercial purposes, provided that the source of information is acknowledged. Erratum: The infographic on p. 11 was updated on 04/09/2015 to correct an error.
    [Show full text]
  • Big Pharma's Shameful Secret
    Bloomberg Markets Special Report TK Month 2005 COVER STORY BIG PHARMA’S SHAMEFUL SECRET Every year, drug companies spend $14 billion to test experimental substances on humans. Across the U.S., the centers that do the testing—and the regulators who watch them—allow scores of people to be injured or killed. PHOTOGRAPH BY BRIAN SMITH B l o o m b e r g M a r ke t s December 2005 37 By David Evans, Michael Smith and Liz Willen ‚Oscar Cabanerio has been waiting in an experimental America, drawn to this five-story test center in a con verted drug testing center in Miami since 7:30 a.m. The 41-year- Holiday Inn motel. Inside, the brown paint and linoleum BIG PHARMA’S old undocumented immigrant says he’s desperate for cash is gouged and scuffed. A bathroom with chipped white to send his wife and four children in Venezuela. More than tiles reeks of urine; its floor is covered with muddy foot- 70 people have crowded into reception rooms furnished prints and used paper towels. The volunteers, who are with rows of attached blue plastic seats. Cabanerio is one supposed to be healthy, wait for the chance to get paid for of many regulars who gather at SFBC International Inc.’s ingesting chemicals that may make them sick. They are SHAMEFUL test center, which, with 675 beds, is the largest for-profit testing the compounds the world’s largest pharmaceutical drug testing center in North America. companies hope to develop into best-selling medicines. Most of the people lining up at SFBC to rent their bod- Cabanerio, who has a mechanical drafting degree from SECRET ies to medical researchers are poor immigrants from Latin a technical school, says he left Venezuela because he lost SFBC’s building in Miami, a former Holiday Inn, houses the largest for-profit drug testing center in the U.S.
    [Show full text]