Drugs, Money and Misleading Evidence
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The Opportunities and Challenges of Pragmatic Point-Of-Care Randomised Trials Using Routinely Collected Electronic Records: Evaluations of Two Exemplar Trials
HEALTH TECHNOLOGY ASSESSMENT VOLUME 18 ISSUE 43 JULY 2014 ISSN 1366-5278 The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records: evaluations of two exemplar trials Tjeerd-Pieter van Staa, Lisa Dyson, Gerard McCann, Shivani Padmanabhan, Rabah Belatri, Ben Goldacre, Jackie Cassell, Munir Pirmohamed, David Torgerson, Sarah Ronaldson, Joy Adamson, Adel Taweel, Brendan Delaney, Samhar Mahmood, Simona Baracaia, Thomas Round, Robin Fox, Tommy Hunter, Martin Gulliford and Liam Smeeth DOI 10.3310/hta18430 The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records: evaluations of two exemplar trials Tjeerd-Pieter van Staa,1,2* Lisa Dyson,3 Gerard McCann,4 Shivani Padmanabhan,4 Rabah Belatri,4 Ben Goldacre,1 Jackie Cassell,5 Munir Pirmohamed,6 David Torgerson,3 Sarah Ronaldson,3 Joy Adamson,3 Adel Taweel,7 Brendan Delaney,7 Samhar Mahmood,7 Simona Baracaia,7 Thomas Round,7 Robin Fox,8 Tommy Hunter,9 Martin Gulliford10 and Liam Smeeth1 1Department of Non-Communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK 2Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands 3York Trials Unit, York University, York, UK 4Clinical Practice Research Datalink, Medicines and Healthcare products Regulatory Agency, London, UK 5Division of Primary Care and Public Health, Brighton and Sussex Medical School, University of Brighton, Brighton, UK 6The Wolfson Centre for -
Quine and Whitehead: Ontology and Methodology 3
McHENRY I QUINE AND WHITEHEAD: ONTOLOGY AND METHODOLOGY 3 philosophical scene as of late (e.g., deconstructionism, postmodem relativism), the and Whitehead: Ontology and gulf that separates Whitehead and analytical philosophy is not as great as it used to Quine 'be.3 Before I begin to explore the affinities, as well as some contrasts, between Methodology . Quine and Whitehead, a word of caution is in order. It is well known that Quine wrote his doctoral dissertation, "The Logic of Sequences: A Generalization of LeemonMcHenry Principia Mathematica," under Whitehead's direction.4 Quine also took two of Whitehead's seminars at Harvard,"Science and the Modem World" and "Cosmol I LEEMON McHENRY reaches philosophy at Loyola Marymount University, Los ogies Ancient and Modem," but he says that he "responded little to these courses" Angeles, CA 90045, E-mail: [email protected] and "took refuge in his relatively mathematical material on 'extensive abstrac tion. "'s Despite Quine's statement that he "retained a vivid sense of being in the presence of the great," he does not acknowledge any philosophical influence from · Introduction . the ph!losoph!es o!'W.V . Qu�e an d Whitehead. Rather, Camap and Russell are cited as the inspirations of Quine's The very idea· of a basis for comparing . , mcluding Qume himself. early development. A.N. Whitehead may be surprising to most philosophe� . philosophy two completely Both produced systems of thought that have taken m When Quine overlapped with Whitehead at Harvard, Whitehead was deeply at the forefron: of c�ntemp� involved in working out the details of his metaphysics of process--a philosophic different directions. -
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. -
Homeopathy Works, Then Obviously the Less You Use It, the Stronger It Gets
http://www.physics.smu.edu/pseudo "...for the purposes of popular discourse, it is not necessary for homeopaths to prove their case. It is merely necessary for them to create walls of obfuscation, and superficially plausible technical documents that support their case, in order to keep the dream alive in the imaginations of both the media and their defenders." --Ben Goldacre If homeopathy works, then obviously the less you use it, the stronger it gets. So the best way to apply homeopathy is to not use it at all. --Phil Plait http://www.physics.smu.edu/pseudo “Alternative Medicine” - Homeopathy - Supplementary Material for CFB3333/PHY3333 Professors John Cotton, Randy Scalise, and Stephen Sekula http://www.physics.smu.edu/pseudo ● FRINGE ● The land of wild ideas, mostly untested or untestable. Most of these will be discarded as useless. Only some of these will make it into the frontier. ● FRONTIER ● CORE Tested (somewhat or better) ideas that could still be wrong or require significant modification. ● CORE FRONTIER ● Very well-tested ideas that are unlikely to be overturned. They may FRINGE become parts of bigger ideas, but are very unlikely to be discarded. A Depiction of Science Thanks to Eugenie Scott http://www.physics.smu.edu/pseudo HOMEOPATHY A LOOK AT THE SCIENTIFIC EVIDENCE http://www.physics.smu.edu/pseudo Claim and Assessment ● Claim: homeopathic medicine can treat the diseases it claims to treat ● there are many more medicines than there have been scientific tests of those medicines, which should already tell you something. Homeopathy is like a hydra. ● Tests: ● Gold-standard medical testing: randomized, double/single-blinded, placebo-controlled, large-statistics trials http://www.physics.smu.edu/pseudo http://www.physics.smu.edu/pseudo ● Findings: ● 8 studies in the review fulfilled their review criteria ● Only about half of those were more akin to gold standard, and they tended to show no effect over placebo. -
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. -
Philip Mirowski, Never Let a Serious Crisis Go to Waste: How Neoliberalism Survived the Financial Meltdown, New York: Verso, 2013
Book Review Symposium Philip Mirowski, Never Let a Serious Crisis Go to Waste: How Neoliberalism Survived the Financial Meltdown, New York: Verso, 2013. ISBN: 9781781680797 (cloth); ISBN: 9781781683033 (ebook); ISBN: 9781781683026 (paper) Author’s response I want to thank Antipode and the four participants for lengthy reactions to my book Never Let a Serious Crisis Go to Waste. I think it is apparent it was written in a funk of distress; and the reviewers here invite me to step back from all that, and reflect on how it has been regarded by various readers who do not necessarily share my own particular chagrin nor my axes to grind. The experience has been salutary, and evokes a few short responses. One theme present to a greater or lesser extent in all the reviews is that, as Nick Gane puts it, I never tell the reader “what should happen next”; or, as Geoff Mann writes, “OK. So what now?”. I should confess I also get this a lot when I give talks concerning the subjects in the book. When that happens, I take the occasion to suggest that one of the primary lessons of the book directly informs my self-denying ordinance: the prohibition of offering any ‘remedies’ as conventional bullet points, like those which fill the last chapters of the torrent of crisis books which have fallen from the presses clonedead since 2008. When the Neoliberal Thought Collective (NTC) began to organize itself in the 1930s/40s, it found itself stranded in the intellectual wilderness, exiled from political power by Depression and war, and suffering internal disarray, much as the Left has experienced now. -
The American Philosophical Association EASTERN DIVISION ONE HUNDRED TENTH ANNUAL MEETING PROGRAM
The American Philosophical Association EASTERN DIVISION ONE HUNDRED TENTH ANNUAL MEETING PROGRAM BALTIMORE MARRIOTT WATERFRONT BALTIMORE, MARYLAND DECEMBER 27 – 30, 2013 Important Notices for Meeting Attendees SESSION LOCATIONS Please note: the locations of all individual sessions will be included in the paper program that you will receive when you pick up your registration materials at the meeting. To save on printing costs, the program will be available only online prior to the meeting; with the exception of plenary sessions, the online version does not include session locations. In addition, locations for sessions on the first evening (December 27) will be posted in the registration area. IMPORTANT INFORMATION ABOUT REGISTRATION Please note: it costs $40 less to register in advance than to register at the meeting. The advance registration rates are the same as last year, but the additional cost of registering at the meeting has increased. Online advance registration at www.apaonline.org is available until December 26. 1 Friday Evening, December 27: 6:30–9:30 p.m. FRIDAY, DECEMBER 27 EXECUTIVE COMMITTEE MEETING 1:00–6:00 p.m. REGISTRATION 3:00–10:00 p.m., registration desk (third floor) PLACEMENT INFORMATION Interviewers and candidates: 3:00–10:00 p.m., Dover A and B (third floor) Interview tables: Harborside Ballroom, Salons A, B, and C (fourth floor) FRIDAY EVENING, 6:30–9:30 P.M. MAIN PROGRAM SESSIONS I-A. Symposium: Ancient and Medieval Philosophy of Language THIS SESSION HAS BEEN CANCELLED. I-B. Symposium: German Idealism: Recent Revivals and Contemporary Relevance Chair: Jamie Lindsay (City University of New York–Graduate Center) Speakers: Robert Brandom (University of Pittsburgh) Axel Honneth (Columbia University) Commentator: Sally Sedgwick (University of Illinois–Chicago) I-C. -
Histories of Medical Lobbying’
‘Histories of medical lobbying’ The lobbying of government ministers by medical professionals is a live issue. In Britain and around the world medical practitioners have become active in the pursuit of legislative change. In the UK, the AllTrials campaign co-founded by the physician-researcher Ben Goldacre continues to exert pressure on parliamentarians in a bid to force greater transparency in the publication of clinical trial results. Meanwhile, the California Medical Association advocates the legalisation of the recreational use of marijuana, and doctors in Australia refuse to release child refugees from hospital into detention centres damaging to their mental health. It was precisely the lobbying of medical humanitarians such as Médecins sans Frontières in France that effected a change in the law there in 1998, permitting undocumented immigrants with life-threatening conditions to remain in the country for medical treatment. Each of these examples represents an organised attempt on the part of medical professionals to change government policy on matters related to public health – in other words, lobbying. Yet a recent announcement by the UK cabinet office suggests that henceforth recipients of public funding will be banned from directly lobbying government ministers in the hope of changing public policy. When questioned in parliament David Cameron stated that charities should be devoting themselves to ‘good causes’ rather than ‘lobbying ministers’. Unless some qualification is forthcoming, medical researchers too will be proscribed from carrying out such activity. This insinuates that lobbying is in some way outside the proper remit of researchers, medical or otherwise. Yet even a cursory glance at the history of the medical profession’s engagement with public health reveals a longstanding and significant engagement with the political process. -
“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. -
Academic Publishing and Scientific Integrity: Case Studies of Editorial Interference by Taylor & Francis
Kahr et al. Journal of Scientific Practice and Integrity. 1(1). DOI: 10.35122/jospi.2019.848394 Research Article | Commentary Academic Publishing and Scientific Integrity: Case Studies of Editorial Interference by Taylor & Francis Bart Kahr,i Leemon B. McHenry,ii Mark D. Hollingsworthiii Abstract Editorial independence is a bedrock principle of academic publishing. The growing domination of academic publishing by large, for-profit corporations threatens this independence. There is alarming evidence that large companies too often serve their own business interests and those of powerful clients rather than serving the scientific community and the general public. This evidence includes the publication of infelicitous commercial science and concealing scientific misconduct. We present two case studies in which the UK-based publisher Taylor & Francis interfered in the editorial process by blocking publication of legitimate criticism that had been reviewed and approved for publication by its specialized editors. The integrity of science depends in part on the transparency and intellectual honesty of all stakeholders. The widely- acknowledged inadequacies of English libel law are reviewed as context for some of Taylor & Francis’s fearful decisions. Introduction the editorial independence of the editor, and it should not interfere in the assessment, selection, or editing Editorial independence, the license of editors to approve of journal articles. The relationship between the a contribution for publication free from the influence of editor and the publisher, sponsoring society, or journal owners, advertisers, or media company directors, is a owner should be based on trust and respect.1 bedrock of journalism and academic publishing. This position has been adopted by COPE, the Committee Independence is intended to ensure public access to true on Publication Ethics, an advisory body for its member stories and investigations.