Under the Influence: The Interplay among Industry, Publishing, and Drug Regulation

Accountability in Research
Lisa CosgroveAllen F Shaughnessy

Abstract

The relationships among academe, publishing, and industry can facilitate commercial bias in how drug efficacy and safety data are obtained, interpreted, and presented to regulatory bodies and prescribers. Through a critique of published and unpublished trials submitted to the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval of a new antidepressant, vortioxetine, we present a case study of the "ghost management" of the information delivery process. We argue that currently accepted practices undermine regulatory safeguards aimed at protecting the public from unsafe or ineffective medicines. The economies of influence that may intentionally and unintentionally produce evidence-biased-rather than evidence-based-medicine are identified. This is not a simple story of author financial conflicts of interest, but rather a complex tale of ghost management of the entire process of bringing a drug to market. This case study shows how weak regulatory policies allow for design choices and reporting strategies that can make marginal products look novel, more effective, and safer than they are, and how the selective and imbalanced reporting of clinical trial data in medical journals results in the marketi...Continue Reading

References

Jan 1, 1996·International Journal of Technology Assessment in Health Care·L A Bero, D Rennie
Dec 17, 2002·Accountability in Research·A E Shamoo
May 2, 2003·The British Journal of Psychiatry : the Journal of Mental Science·David Healy, Michael E Thase
Aug 5, 2003·BMJ : British Medical Journal·Allen F Shaughnessy, David C Slawson
Feb 5, 2005·Atencion primaria·V Baos Vicente
Jun 17, 2006·BMJ : British Medical Journal·Joel Lexchin, Donald W Light
Jan 18, 2008·The New England Journal of Medicine·Erick H TurnerRobert Rosenthal
Feb 27, 2008·Accountability in Research·Kevin C Elliott
Aug 1, 2008·Journal of Medical Ethics·M Doucet, S Sismondo
Sep 17, 2008·Accountability in Research·Leemon B McHenry, Jon N Jureidini
Apr 3, 2009·The American Journal of Psychiatry·Stephen R WisniewskiMadhukar H Trivedi
Apr 9, 2009·Accountability in Research·Patricia M TereskerzJonathan D Moreno
Oct 17, 2009·Social Studies of Science·Sergio Sismondo
Feb 4, 2010·PLoS Medicine·Jeffrey R Lacasse, Jonathan Leo
Sep 15, 2010·PLoS Medicine·Adriane J Fugh-Berman
Feb 3, 2011·Accountability in Research·Jon N Jureidini, Leemon B McHenry
Jul 20, 2011·The International Journal of Neuropsychopharmacology·Enric AlvarezFrancesc Artigas
Jan 3, 2012·European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology·David S BaldwinMarianne Dragheim
Apr 13, 2012·Journal of Psychopharmacology·Jean-Philippe BoulengerIoana Florea
Oct 25, 2012·JAMA : the Journal of the American Medical Association·Tiago V PereiraJohn P A Ioannidis
Dec 14, 2012·The Cochrane Database of Systematic Reviews·Andreas LundhLisa Bero
May 16, 2013·Accountability in Research·David B Resnik, Kevin C Elliott
Jul 19, 2013·PloS One·Adrienne ShnierKelly Holloway
Oct 4, 2013·The Journal of Law, Medicine & Ethics : a Journal of the American Society of Law, Medicine & Ethics·Lawrence Lessig
May 3, 2014·The International Journal of Neuropsychopharmacology·Roger S McIntyreChristina K Olsen
Oct 21, 2014·Journal of Evaluation in Clinical Practice·Lisa CosgroveJoel R Lexchin
Nov 19, 2014·CMAJ : Canadian Medical Association Journal = Journal De L'Association Medicale Canadienne·Yoon Kong Loke, Katharina Mattishent
Feb 3, 2015·Kennedy Institute of Ethics Journal·Kirstin Borgerson

❮ Previous
Next ❯

Citations

Oct 13, 2018·BMJ Evidence-based Medicine·Tom JeffersonLesley A Stewart
Apr 16, 2019·Current Medical Research and Opinion·Lisa M DeToraEllen Z Baum
Aug 31, 2019·Epidemiology·Triet H TranDavid S Egilman
Sep 6, 2019·History and Philosophy of the Life Sciences·Inmaculada de Melo-Martín
Apr 15, 2020·Journal of the Royal Society of Medicine·Tom Jefferson
Sep 24, 2021·Family Practice·Christian RuchonAllen F Shaughnessy
Nov 9, 2021·Community Mental Health Journal·Lisa CosgroveAllen F Shaughnessy

❮ Previous
Next ❯

Clinical Trials Mentioned

NCT00811252
NCT00672620
NCT00635219
NCT01140906
NCT01153009
NCT00839423
NCT01571453
NCT00672958
NCT00735709
NCT01179516

Software Mentioned

Review Manager

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.