A Bioethics Tool for the Implementation of Global Principles by the Pharmaceutical Industry Daniel J
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Coronavirus: Covid-19 Has Killed More People Than SARS and MERS Combined, Despite Lower Case Fatality Rate
BMJ 2020;368:m641 doi: 10.1136/bmj.m641 (Published 18 February 2020) Page 1 of 1 News BMJ: first published as 10.1136/bmj.m641 on 18 February 2020. Downloaded from NEWS Coronavirus: covid-19 has killed more people than SARS and MERS combined, despite lower case fatality rate Elisabeth Mahase The BMJ The novel coronavirus that has so far spread from China to 26 This comment came after the first case of covid-19 was countries around the world does not seem to be as “deadly as confirmed in Africa (in Egypt). Commenting on this milestone other coronaviruses including SARS and MERS,” the World in the outbreak, Trudie Lang, director of the Global Health Health Organization has said. Network at the University of Oxford, said it was “important but At a briefing on 17 February WHO’s director general, Tedros not unexpected.” She highlighted the fact that WHO had Adhanom Ghebreyesus, said that more than 80% of patients declared the outbreak a “public health emergency” to “support with covid-19 have a “mild disease and will recover” and that less well resourced nations in responding and preparing for it is fatal in 2% of reported cases. In comparison, the 2003 cases.” outbreak of severe acute respiratory syndrome (SARS) had a Lang praised the response of the Africa Centres for Disease case fatality rate of around 10% (8098 cases and 774 deaths), Control and Prevention, which is based in Ethiopia and supports http://www.bmj.com/ while Middle East respiratory syndrome (MERS) killed 34% countries with surveillance, emergency responses, and of people with the illness between 2012 and 2019 (2494 cases prevention of infectious disease. -
Annual Meeting
Volume 97 | Number 5 Volume VOLUME 97 NOVEMBER 2017 NUMBER 5 SUPPLEMENT SIXTY-SIXTH ANNUAL MEETING November 5–9, 2017 The Baltimore Convention Center | Baltimore, Maryland USA The American Journal of Tropical Medicine and Hygiene The American Journal of Tropical astmh.org ajtmh.org #TropMed17 Supplement to The American Journal of Tropical Medicine and Hygiene ASTMH FP Cover 17.indd 1-3 10/11/17 1:48 PM Welcome to TropMed17, our yearly assembly for stimulating research, clinical advances, special lectures, guests and bonus events. Our keynote speaker this year is Dr. Paul Farmer, Co-founder and Chief Strategist of Partners In Health (PIH). In addition, Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, will deliver a plenary session Thursday, November 9. Other highlighted speakers include Dr. Scott O’Neill, who will deliver the Fred L. Soper Lecture; Dr. Claudio F. Lanata, the Vincenzo Marcolongo Memorial Lecture; and Dr. Jane Cardosa, the Commemorative Fund Lecture. We are pleased to announce that this year’s offerings extend beyond communicating top-rated science to direct service to the global community and a number of novel events: • Get a Shot. Give a Shot.® Through Walgreens’ Get a Shot. Give a Shot.® campaign, you can not only receive your free flu shot, but also provide a lifesaving vaccine to a child in need via the UN Foundation’s Shot@Life campaign. • Under the Net. Walk in the shoes of a young girl living in a refugee camp through the virtual reality experience presented by UN Foundation’s Nothing But Nets campaign. -
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 -
Written Evidence Submitted by the BBC
Written evidence submitted by the BBC The DCMS Sub-committee on Online Harms and Disinformation Covid-19 Inquiry April 2020 Executive summary 1. The BBC is the leading public service broadcaster in the UK, with a mission to inform, educate and entertain. Our first public purpose is to provide impartial news and information to help people understand and engage with the world around them, and we deliver this across national, local and global news services.1 2. The Editorial Guidelines are the standards that underpin all our journalism, at all times, including during the Covid-19 pandemic. They apply to all our content, wherever and however it is received. Producing and upholding these Editorial Guidelines is an obligation across the BBC and all output made in accordance with these Editorial Guidelines fulfills our public purposes and meets and goes beyond the requirements of our regulator, Ofcom. 3. Coverage of Covid-19 is dominating the UK news across all platforms. And with a plethora of cross platform content, people are most likely to turn to the BBC’s TV, radio and online services for the latest news on the pandemic (82%)2, significantly more than any other source. 4. BBC News has attracted record audiences across platforms with our nations and regions, UK wide and international coverage highlighting the importance of impartial and accurate news at this time. 5. The BBC remains the UK’s primary source for news. In a world of fake news and disinformation online, audiences said they turn to the BBC for a reliable take on events and this reputation for accuracy and trust sends audiences to the BBC during breaking news and to verify facts.3 During the Covid-19 pandemic 83% of people trust coverage on BBC TV4; and audiences from the UK and around the world have come to BBC News in their millions to stay informed and seek trusted advice on how they can protect themselves and those most at risk. -
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. -
Agenda, WHO Ebola Research and Development Summit
WHO Ebola Research and Development Summit Geneva, 11 – 12 May 2015 WHO Executive Board Room Agenda Rapporteur: Elisabeth Heseltine Monday 11 May 2015 8:00-9:00 Registration Session 1: Introduction Chair: John Mackenzie (Curtin University, Australia) 9:00-9:15 Welcome: Margaret Chan, Director-General, World Health Organization (WHO) and Objectives of meeting, expected outcomes: Marie-Paule Kieny, Assistant-Director General, Health Systems and Innovation (WHO) 9:15-9:35 Keynote lecture: The Ebola response/getting to zero (20 min), Bruce Aylward (WHO) 9:35-10:15 Country perspectives on R&D during the Ebola epidemic (10 min each) • Wiltshire Johnson (Pharmacy Board, Sierra Leone) • Stephen Kennedy (Ministry of Health, Liberia) • Mandy Kader Konde (CEFORPAG, Guinea) Discussion (10 min) 10:15-10:45 Coffee break SESSION 2: Main lessons learnt on R&D in the 2014-15 EVD outbreak in West Africa. Main challenges, and factors that facilitated implementation of research activities in the affected countries Chair: Nicole Lurie (HHS/ASPR, USA) 10:45-11:30 What were the known facts, pipelines and major challenges to Ebola R&D when the international emergency was declared in August 2014, and what has been achieved since then? This presentation and discussion will identify crucial knowledge gaps at the start of the outbreak, e.g., in immunopathogenesis, appropriate animal models, use of in vitro data, natural history of disease ; and map out the current (May 2015) achievements in filling these gaps. Peter Jahrling (NIH/NIAID, USA): Addressing knowledge -
“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 -
Wet News Water Special Interest Group Newsletter
Wet News Water Special Interest Group Newsletter Issue 81, May 2020 WATER SPECIAL INTEREST GROUP Water Water Special Interest Group Special Interest Group News from the IChemE Water Special Interest Group Wet News Water Special Interest Group Newsletter Issue 81, May 2020 Editor: Paul Curtis, email: [email protected] or [email protected] Contents Editorial 1 Backwashings 1 From the Chair - Composting Toilets & Everything the Water Industry is doing on Covid-19 2 Secretary's Report 5 AGM 6 Unflushables 2030? Mapping Change Points for Intervention for Sewer Blockages: Workshop Proceedings 27 & 28 January 2020 6 European Biosolids & Organic Resources Conference & Exhibition, 19 & 20 November 2019 8 Water & Sustainability 9 Wanted: Book Reviewers 9 WATER SPECIAL INTEREST GROUP C0490_17 www.icheme.org/water Water Water Special Interest Group Special Interest Group EDITORIAL I turn on my computer and try to remember what day it is, as one day seems to merge into another – always the same home environment but with different calls on Skype, Teams or conference calls. Sometimes I get a moment from the incessant meetings to catch up on emails or important tasks such as editing this newsletter! The world is in turmoil and the challenges of COVID-19 affect how we, at the @one Alliance (Anglian Water’s Capital Delivery Team) engage with site teams, operations teams and managing a design team working from home, whilst managing home schooling and all the usual demands of life! Little different, I am sure, from most of our readers…….the Summer weather is enticing and looking out the window I see signs of things returning to some sort of normality. -
RESEARCH and DEVELOPMENT GOALS for COVID-19 in AFRICA the African Academy of Sciences Priority Setting Exercise CONTENTS
UPDATE – RESEARCH AND DEVELOPMENT GOALS FOR COVID-19 IN AFRICA The African Academy of Sciences Priority Setting Exercise CONTENTS Introduction ...............................................................................................................................................................3 Aim ............................................................................................................................................................................4 Methods ....................................................................................................................................................................5 Data Analysis .............................................................................................................................................................6 Results ......................................................................................................................................................................7 A. Quantitative Data ..............................................................................................................................................7 1. Virus natural history, transmission and diagnostics .......................................................................................................... 8 2. Animal and environmental research on the virus origin, and management measures at the human-animal interface ........ 9 3. Epidemiology studies ...................................................................................................................................................