DOCSLIB.ORG

Special Features Pharmacokinetics – Applications PHARMACEUTICAL PHYSICIAN MHRA Case Study Brapp Education Day 2015 Pphinal Pphunnybone

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Special Features Pharmacokinetics – Applications PHARMACEUTICAL PHYSICIAN MHRA Case Study Brapp Education Day 2015 Pphinal Pphunnybone IN THIS ISSUE: Special features Pharmacokinetics – Applications PHARMACEUTICAL PHYSICIAN MHRA Case Study BrAPP Education Day 2015 PPhinal PPHunnybone JANUARY 2016 VOLUME 26 | NO4 JOURNAL OF THE BRITISH ASSOCIATION OF PHARMACEUTICAL PHYSICIANS www.axess.co.uk Providing Pharmaceutical Physicians Medical Affairs – Permanent Medical Director EU Specialty Pharma Middlesex PP 6497 Regional Director EU/ Canada Oncology Global Pharma Hertfordshire PP 6434 Director Medical Affairs EMEA Oncology Global Pharma Surrey PP 6505 Medical Manager Epilepsy Global Pharma Hertfordshire PP 6385 Head of Medical Affairs IBD Global Pharma Buckinghamshire PP 6522 Country Medical Leader - Haematology Global Pharma – Line and cross functional leadership Hertfordshire PP 6418 Senior Medical Manager - Oncology Global Pharma – major brand Hertfordshire PP 6413 Senior Medical Manager - Haematology Global Pharma Hertfordshire PP 6468 Senior Medical Advisor – Respiratory/ Allergy Global Pharma West London PP 6419 Medical Advisor – Anti-infectives Global Pharma Surrey PP 6396 Medical Advisor – Respiratory/ Urology Global Pharma Buckinghamshire PP 6523 Pharmacovigilance – Permanent Medical Director Global Pharmacovigilance Specialty Pharma – Strategic / Line Management Middlesex PP 6339 Medical Director Pharmacovigilance Global Pharma – strategic role Central London PP 6323 Medical Director Pharmacovigilance- 6m Interim Contract Global Safety Lead for Established Products Central London PP 6510 Clinical Development – Permanent Medical Fellow/ Associate Director Clinical Development Early Development CRO – Unique Model Nottinghamshire PP 6483 Associate Director Clinical Development Specialty Pharma Middlesex PP 6407 Clinical Development Physician – Rheumatology Global Pharma Pharma PIII Hertfordshire PP 6447 Clinical Research Physician Early Development PI/II Southern UK PP 6293 Clinical Research Physician Early Development PI/II Nottinghamshire PP 6499 Senior/ Study Physician Early Development PI/II Manchester PP 6511 This is just a selection of the current assignments with our pharmaceutical clients. For a confidential discussion please telephone Beth Thomas-Stonier at AXESS Limited on 020 8560 2300. To apply please send your CV to [email protected] quoting the reference number. Visit our website www.axess.co.uk to register for jobs by e-mail – new roles that match your criteria e-mailed to you on the same day that they are posted. Resourcing Solutions for Medical Affairs, Regulatory Affairs and Clinical Development PHARMACEUTICAL PHYSICIAN Contents EDITORIAL 3 BOOK REVIEW 26 Vie d’Or SPECIAL FEATURE 4 Pharmacokinetics – an PPHUNNYBONE 29 overview Mission Complete Applications of Hugh Gibbons Pharmacokinetics Drs RMJ Ings and CW Vose JANUARY 2016 VOLUME 26 | NO4 SPECIAL FEATURE 14 MHRA Case Study: MSD melanoma treatment through the early access scheme (EAMS) PEOPLE 17 MEETING REPORT 18 BrAPP Education Day 2015 EDITOR: DR MADHU DAVIES [email protected] PROFESSIONAL DEVELOPMENT 25 EDITORIAL BOARD: Benefits of being a DR JANE BARRETT medical assessor at MHRA DR HUGH BOARDMAN DR DAVID FOWLER LIZ LANGLEY [email protected] Published 6 times per annum by BrAPP Royal Station Court, Station Road DESIGN: DANA KIDSON Twyford, Reading, Berkshire RG10 9NF. [email protected] Telephone +44 (0)118 934 1943 Fax +44 (0)118 932 0981 Email [email protected] www.brapp.org Call the BrAPP office for subscription information or to advertise in the journal. BrAPP grants editorial freedom to the editor of Pharmaceutical Physician. The views expressed in the journal are those of the authors and the editor may not comply with the views of BrAPP or the authors' own companies. © BrAPP ISSN 0960-6548 Taking the trial to the patient PatientPattient RecruitmentRecruitment SpecialistsSpecialists The Medical Research Reseaarch Network At the e MRN it’s it’s all about patients…patients… findingfinding them, treatingtreating them,them, keepingkeeping them. (MRN)(MRN) is a unique clinical trial EstablishedEstablisshed inin 2006,2006, thethe MRN is the worldsworldds leadingleading providerprovider ofof homehome healthcarehealthhcare forfor patientspatients inin clinicalclinical trial; taking the trial to the patientpatient makes participationparticipation more convenientconvenient and appealingappealing support ororganizationganization offeringoffering fforor ththee ppatientsatients and boosts recruitment rates considerably (from 60% uupwards).pwwards). This ease ooff nnursingursing focused ppatientatient recruitment pparticipationarticipation also sisignificantlygnificantly imimprovesproves ppatientatient retention, consistently aboaboveve 95%. & retentretentionion sosolutionslutions glgloballyobally fforor FForor tritrialal sites with resource constraintsconstraints,, the MRN also offersoffers a SSiteite NuNurserse SupportSupport service, pplacinglacing exexperiencedperienced research nurses and/and/oror coordinators into the sites to enensuresure enrollment and clinical trials. HeadqHeadquartereduartered in the rretentionetention tartargetsgets are metmet.. UK & now with a NNorthorth American DDuringuring the last 4 yyears,ears, MRN has beebeenn iinvolvednvolved iinn the coconductnduct of ooverver 111010 pprojectsroojects across a wwideide operaoperation,tion, ththee MRNN ooffers ffers SitSitee rrangeange ooff theratherapeuticpeutic areas, ranging frofromm comcomplexplex trials in oncologoncology,y, rherheumatology,umatology, enenzymezyme NNurseurse SSupportupport anandd Home TTrialrial rreplacementeplacement theratherapy,py, hematolohematologygy and otothershers requiringrequiring drudrugg administration of IV therapiestherapies and ototherher iinjectablesnjectables iinn tthehe hhome,ome, as wellwell as simplesimple bloodblood drawsdraws inin neurology,neuroloogy, antianti infectives,infectives, SSupportupport services acracrossoss the gglobe.lobe. rrespiratory,espiratory, renarenall & manmanyy otothers.hers. ShouldShould you wish to findfind out more aboutabout our services or discussdiscuss a specificspec project pleasepleasse contactact us.us TalonTalon House, PresleyPresley Way,Way, Milton Keynes,Keynes, BuckinghamshireBuckinghamshire MK8 0ES0ES E: [email protected]@stuar dding@@[email protected] T: +44 (0)1908(0)1908 261 153153 www.themrn.co.ukwww.themwww.t mrn.co.ukk STOCK MARKETS OPENED the year available at the regulatory agency. The with record falls around the world. But other showcases a recent Early Access the pundits predict a good year for us to Medicines Scheme and illustrates, in pharma/biotech with research and perhaps, how it could be utilised to the development productivity continuing at advantage of all stakeholders by your EDITORIAL pace. Has there ever been a better time company? to work in our industry? The recent BrAPP Annual Education Starting at the end of the journal- Hugh Day was a great success. Liz Langley Gibbons draws his series of has drafted a summary of the day for PPhunnybones to a close marking his those of you who were unable to attend 50 years in our industry. He has including a precis of the inaugural Anne witnessed change a-plenty and has Appleton lecture, given in memory of thrived on it developing one of the Anne, a relatively young PP and most interesting careers I have come enthusiastic BrAPP committee member, across yet. Over the 23 years during who passed away last year. which our paths have crossed, Hugh has demonstrated a hunger for Last but not least, Dr David Glover has development-both his own and for enjoyed a stellar career in pharma and others, contributing to the career his memoire is reviewed in this issue. trajectory of many tyro pharmaceutical As the reviewer notes “David argues physicians – an appetite for challenge that he may have enjoyed the heyday of and, above all, cheerful and intelligent the blossoming industry but for those us resilience. None of these attributes goes who remain and those of you to come it out of fashion and all remain essential behoves us to keep the banner flying. to the success of a PP today. I am sure This book may help you reflect on ways you will join me in thanking Hugh for to do that.” PPhunnybone and wishing him health and happiness. And on that positive note, I will end. Bob Ings and Colin Vose, who many of Here’s to a great 2016. you know from the BrAPP/ University of Cardiff Postgraduate Course in Dr Madhu Davies Pharmaceutical Medicine, draw their series on pharmacokinetics to a close with a useful article summarising the practical applications of a Dr Madhu Davies pharmacokinetic approach in drug development today. The series has been very well received by this journal’s readership and I am delighted that Bob and Colin have been prepared to put in so much time and effort to share their enthusiasm and understanding of the topic more widely. Those of you taking the Dip Pharm Med exam may usefully choose to incorporate the series into your revision… For the rest of us, a welcome reminder of things we thought we knew. Thank you, Bob and Colin. I also need to thank the MHRA for two items. The first is a timely piece on career development reminding readers of the diversity and value of the roles 3 January 2016 PHARMACEUTICAL PHYSICIAN volume 26 | No 4 SPECIAL FEATURE: Pharmacokinetics – an overview Applications of Pharmacokinetics By Drs R. M. J. Ings and C. W. Vose 1. INTRODUCTION • Understanding the effects of disease, THIS IS THE last of six articles aiming both that being treated and other to provide an overview and unrelated diseases such as renal and understanding
Load more

Recommended publications
  • 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]
  • 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).
    [Show full text]
  • 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.
    [Show full text]
  • 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.
    [Show full text]
  • “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.
    [Show full text]
  • 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
    [Show full text]
  • 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
    [Show full text]
  • 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.
    [Show full text]
  • 'Ignore Our Drug Prices', Greece Tells Europe
    December 21st 2012 No 3630 scripintelligence.com ‘Ignore our drug prices’, Greece Please expect your tells Europe next copy of Scrip Intelligence 11 January 2013. Triple-negative salvage for Eisai’s down-not-out eribulin? National pricing and reimbursement and EUCOPE, which represent pharmaceutical authorities in Europe should not use Greek companies in Europe, have complained that Encouraged by promising signs of activity, medicine prices to set their own prices, the wealthier countries are referencing prices in particularly in certain patient subsets, in Greek health ministry has said on its website. lower-income countries, including Greece. For the earlier line treatment of advanced “The current Greek pricing system is based example, Germany now uses Greek prices in the breast cancer, Eisai is stressing that it on the exceptional and harsh economic, procedure for fixing drug prices if negotiations remains committed to developing its novel social and medical factors that are specific between health insurers and companies fail microtubule dynamics inhibitor Halaven to Greece. The Greek ministry of health asks following the early benefit assessment. (eribulin mesylate) in this setting. competent authorities in other countries Firms are taking a hit. In 2011, a 10% price But additional studies will be needed to not to refer to those prices in their national cut in Greece lost firms €299 million there better elucidate the drug’s benefits as part of pricing and reimbursement decision-making and €799 million in European countries that a more focused strategy following the overall process,” says the announcement. reference Greece in some way, according to negative results from the comparative Study Companies will be hoping that national Global Insights.
    [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]
  • 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]
  • Clinical Trials to Enhance Drug Safety and Efficacy Assessment
    Layout: T. Robjohns (University of Sheffield) Printed by: Print & Design Solutions, University of Sheffield in silico Clinical Trials: How Computer Simulation will Transform the Biomedical Industry General Index General Index. Reading Guide. Executive Summary. ...8 Chapter I. In silico clinical trials: A layperson’s introduction ...9-12 Chapter II. Avicenna roadmap: Motivation and process ...13-22 II.1. Engineering a new industry...14 II.2. The Avicenna consensus process...16 Chapter III. The industrial need for in silico clinical trials ...23-28 III.1. Pharma and devices: Development pipelines...24 III.2. Modelling and simulation in the current industrial practice...24 III.3. Identifying the ‘issues’...25 III.4. Drivers and barriers for in silico clinical trials...26 III.5. A special barrier: The biological empiricism...27 Chapter IV. The socioeconomic need for in silico clinical trials ...29-46 IV.1. The cultural resistances...30 IV.2. Socioeconomic issues...31 IV.3. Ethical issues...44 Chapter V. In silico clinical trials: Use cases for medical devices ...47-54 V.1. Modernising the development of high-risk medical devices...48 V.2. In silico clinical trials: Current practice...51 V.3. In silico clinical trials: Best practice...52 V.4. Use of in silico clinical trials for medical devices...52 Chapter VI. In silico clinical trials: Use cases for pharmaceuticals ...55-62 VI.1. Modernising the development of pharmaceuticals...56 VI.2. In silico clinical trials: Current practice...59 VI.3. In silico clinical trials: Best practice...59 Chapter VII. In silico clinical trials: Horizontal challenges and emerging technologies ...63-68 VII.1.
    [Show full text]