Immunity and Impunity: Corruption in the State-Pharma Nexus
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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. -
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 -
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. -
Transparency in the Time of Constant Change
PhUSE 2014 Paper RG02 Transparency in the Time of Constant Change Todd Case, Biogen Idec, Cambridge MA, USA ABSTRACT The time has come, after years of hard work, to submit your application to the regulatory agency for review and possible approval! What a relief to be able to finally hand off all of your hard work and, wait a minute, ensure that all data can be reproducible?!? While CDISC has been widely adopted and its SDTM and AdAM models widely implemented, there is still the need to understand the process of ensuring that all the data is a reflection of how it was originally collected, which in some cases can be very challenging. This paper will discuss some more trending ways of both creating and presenting data in ways that ensure it is consumable and can be understood not only for analysis/submission purposes but also that post-approval it is transparent and that everyone who has a vested stake can review the data in an appropriate way. INTRODUCTION With the publication of Bad Pharma: How Medicine is Broken , and How We Can Fix it, by Dr. Ben Goldacre in 2013 a bright spotlight was shone on the data behind/supporting clinical trials. A large part of his thesis is that pharmaceutical companies exaggerate the efficacy of successful trials and that, in addition to drug companies, regulators , physicians (who are educated by the drug companies) and even patient groups have failed to protect us. Another rather striking revelation was that a clinical trial with positive results is twice more likely to be published than one with negative results (although it should be noted that this specifically is related to results – the protocol is always provided). -
Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients by Ben Goldacre
RCSIsmjbook review Bad Pharma: How drug companies mislead doctors and harm patients by Ben Goldacre Reviewed by Eoin Kelleher, RCSI medical student Paperback: 448 pages Publisher: Fourth Estate, London Published 2012 ISBN: 978-0-00-735074-2 Dr Ben Goldacre earned his reputation for his 2008 book Bad to affect doctors’ prescribing habits (although most doctors claim Science and his column in the Guardian newspaper of the same that their own practices have never been affected, just those of their name. In both he provides an entertaining, accessible and colleagues). Even journals, which are considered to be an unbiased well-researched exposé of poor scientific practices. Compared to source of medical knowledge, are not free from this – journal articles his first book, which played charlatans such as Gillian McKeith are regularly ghost-written by employees of drug companies and an and homoeopathists for laughs, Bad Pharma is a much more eminent academic is invited to put their name to it; this appears in sombre read. However, as a piece of investigative journalism, and the journal, again without disclosure. a resource for students, doctors and patients, it is invaluable. Drugs are tested by the people who Food for thought Goldacre opens by making a claim that: “Drugs are tested by the manufacture them, in poorly designed people who manufacture them, in poorly designed trials, on trials, on hopelessly small numbers of hopelessly small numbers of weird, unrepresentative patients, and unrepresentative patients, and analysed analysed using techniques which are flawed by design, in such a way that exaggerate the benefits of treatments. -
Drugs, Money and Misleading Evidence
Books & arts tallying up the inequalities. She recruited colleagues to gather much more data. The culmination was a landmark 1999 study on gender bias in MIT’s school of science (see go.nature.com/2ngyiyd), which reverber- ated across US higher education and forced many administrators to confront entrenched discrimination. Yet Hopkins would rather have spent that time doing science, she relates. The third story comes from Jane Willenbring, a geoscientist who in 2016 filed a formal com- plaint accusing her PhD adviser, David March- ant, of routinely abusing her during fieldwork in Antarctica years before. Marchant, who has denied the allegations, was sacked from his post at Boston University in April 2019 after an inves- tigation. Picture a Scientist brings Willenbring together with Adam Lewis, who was also a grad- uate student during that Antarctic field season and witnessed many of the events. Their conver- sations are a stark reminder of how quickly and how shockingly the filters that should govern work interactions can drop off, especially in UPRISING, LLC Biologist Nancy Hopkins campaigned for equal treatment at work for female scientists. remote environments. Lewis tells Willenbring he didn’t realize at the time that she had been as they admit on camera. scientists. Its two other protagonists are white bothered, because she did not show it. “A ton The iceberg analogy for sexual harassment is women with their own compelling stories. of feathers is still a ton,” she says. apt. It holds that only a fraction of harassment — Biologist Nancy Hopkins was shocked In stark contrast, the film shows us obvious things such as sexual assault and sex- when Francis Crick once put his hands on Willenbring, now at the Scripps Institution of ual coercion — rises into public consciousness her breasts as she worked in the laboratory. -
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. -
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. -
“The Hidden Manipulation: the Influence of Pharmaceutical Companies on Physicians and Researchers” by Shivankar Vajinepalli
“The Hidden Manipulation: The Influence of Pharmaceutical Companies on Physicians and Researchers” By Shivankar Vajinepalli The Undergraduate Research Writing Conference • 2020 • Rutgers, The State University of New Jersey The Hidden Manipulation: The Influence of Pharmaceutical Companies on Physicians and Researchers Shivankar Vajinepalli Professor Kathleen Wilford Research in Disciplines: Science, Medicine, and Society 2 May 2019 Vajinepalli 1 Abstract Pharmaceutical companies spend a significant amount of money on physician advertising and industry sponsored research. Involvement from pharmaceutical companies in these areas can divert the focus away from patient safety and causes changes in prescribing behavior and can cause the “funding effect.” Therefore, it can be concluded that industry involvement in research and physician marketing does negatively impact patient safety, and the relationship between physicians, researchers and the industry should not be eliminated, but more strictly regulated. When physicians are visited by pharmaceutical sales representatives (PSR), their prescribing habits are negatively affected. PSRs also do not provide accurate information to physicians about medications, and therefore physician advertising should be more strictly regulated to protect patients. Possible solutions such as providing federally funded PSRs and licensing PSRs to improve the quality of information they provide should be implemented not to eliminate, but to control physician advertising. Industry presence in research causes bias in designing and publishing research studies. The funding effect causes industry funded research to report greater benefits and safety of the medications being studied. Bias in research and lack of laws regulating disclosures of conflicts of interests also raise questions about the authenticity of studies published in medical journals. Since research cannot continue without the funding from pharmaceutical companies, they should continue to fund research, but strict ethical regulations should be followed. -
Presentation
ISSUE PANEL 1: PRAGMATIC CLINICAL TRIALS TO ESTIMATE TREATMENT EFFECTS: ARE THEY WORTH THE EFFORT? Presented by the ISPOR Statistical Methods in HEOR Special Interest Group Monday, 6 November 2017 Panelists . Rita M. Kristy, MS, Senior Director, Medical Affairs Statistics, Astellas Pharma Global Development, Northbrook, IL, USA . Helene Karcher, PhD, Managing Vice-President, Analytica Laser, Basel, Switzerland . Christoph Gerlinger, PD, Dr, Senior Director, Pharmaceuticals Statistics, Bayer AG, Berlin, and Gynecology and Obstetrics, University of Saarland, Homburg, Germany . Keith R. Abrams, PhD, CStat, Professor of Medical Statistics, NIHR Senior Investigator Emeritus & Head, Biostatistics Research Group, Department of Health Sciences, University of Leicester, Leicester, UK 2 1 What is a pragmatic clinical trial? . Can this intervention work under ideal conditions (explanatory) vs. Does the intervention work under usual conditions (pragmatic) 3 PRECIS-2 Criteria . Pragmatic-Explanatory Continuum Indicator Summary 2 . Developed and validated to improve issues with the original PRECIS . 9 domains scored from very explanatory to very pragmatic 4 2 PRECIS-2 Wheel The PRagmatic-Explanatory Continuum Indicator Summary 2 (PRECIS-2) wheel. Adapted from BMJ 2015;350:h2147 5 Examples of PRECIS-2 wheel Little P, Moore M, Kelly J, Williamson I, Leydon G, McDermmott L, Mullee M, Stuart B: Ibuprofen, paracetamol, and steam for patients with respiratory tract infections in primary care: pragmatic randomised factorial trial. BMJ 2013, 347:f6041. 6 3 -
A Bioethics Tool for the Implementation of Global Principles by the Pharmaceutical Industry Daniel J
Duquesne University Duquesne Scholarship Collection Electronic Theses and Dissertations Fall 1-1-2017 A Bioethics Tool for the Implementation of Global Principles by the Pharmaceutical Industry Daniel J. Hurst Duquesne University Follow this and additional works at: https://dsc.duq.edu/etd Part of the Bioethics and Medical Ethics Commons Recommended Citation Hurst, D. J. (2017). A Bioethics Tool for the Implementation of Global Principles by the Pharmaceutical Industry (Doctoral dissertation, Duquesne University). Retrieved from https://dsc.duq.edu/etd/193 This One-year Embargo is brought to you for free and open access by Duquesne Scholarship Collection. It has been accepted for inclusion in Electronic Theses and Dissertations by an authorized administrator of Duquesne Scholarship Collection. For more information, please contact [email protected]. A BIOETHICS TOOL FOR THE IMPLEMENTATION OF GLOBAL PRINCIPLES BY THE PHARMACEUTICAL INDUSTRY A Dissertation Submitted to the McAnulty College and Graduate School of Liberal Arts Duquesne University In partial fulfillment of the requirements for the degree of Doctor of Philosophy By Daniel J. Hurst, ThM, MDiv December 2017 Copyright by Daniel J. Hurst 2017 A BIOETHICS TOOL FOR THE IMPLEMENTATION OF GLOBAL PRINCIPLES BY THE PHARMACEUTICAL INDUSTRY By Daniel J. Hurst Approved August 31, 2017 ________________________________ ________________________________ Henk ten Have, MD, PhD Gerard Magill, PhD Director, Center for Healthcare Ethics The Vernon F. Gallagher Chair Professor of Healthcare Ethics -
For Big Pharma: Like the Show’S Biggest Fans
Life Science Compliance Update U.S. Edition further scrutiny into the pharmaceutical industry. Big The Media Has Been All pharma couldn’t catch a break in the media as millions Over “Bad Pharma,” But of viewers tuned in to hear “Last Week Tonight” host John Oliver lambast pharmaceutical marketing practices Has the Department of to doctors.4 Oliver digs up clips from a 2001 GSK sales meeting where reps are told they’ll make an “ungodly Justice Followed Suit? sum of money selling Advair,” he spends some time on good-looking but unqualified sales reps, free lunches, Senator Elizabeth Warren (D-Mass) made a splash in the and even throws in an Open Payments database critique, news earlier this year when she introduced the Medical noting, “the only way a four cent meal makes sense is if Innovation Act,1 which would that doctor is a mouse!” institute a so-called “swear jar” for pharmaceutical companies.2 Based on conversations at The Act requires drug companies A “swear jar” conferences over the last month, that want to settle alleged compliance officers seemed violations with the government like the show’s biggest fans. for big pharma: to also pay one percent of the Many of the marketing schemes profits for each “blockbuster the Medical Innovation Act would Oliver references would be drug” with more than $1 billion tack on additional punishment unimaginable now, and the in annual sales that can be video clips demonstrate how far traced to government research for companies looking to settle the industry has come since the support.