Transparency and trust in the European pharmaceutical sector: outcomes from an experimental study

Journal of Risk Research

Volumn 19, Issue 9, 2016, Pages 1082-1103

  Löfstedt, Ragnar ^a   Way, Dominic ^a  

^a KING'S COLLEGE LONDON   (United Kingdom)

Author keywords

Europe; pharmaceuticals; risk communication; transparency

Indexed keywords

DECISION MAKING; DRUG PRODUCTS; TRANSPARENCY;

CONTEXTUALIZATION; EUROPE; FACE-TO-FACE INTERVIEW; FULL DISCLOSURES; OPEN-ENDED QUESTIONNAIRE; PHARMACEUTICAL SECTOR; REGULATORY DECISIONS; RISK COMMUNICATION;

SURVEYS;

EID: 84902701930     PISSN: 13669877     EISSN: 14664461     Source Type: Journal    
DOI: 10.1080/13669877.2014.919517     Document Type: Article

References (68)

1. E.Babbie, 2013. The Practice of Social Research. 13th ed. Cengage Learning:USA.
2. C.Ball, 2004. “What is Transparency?” Public Integrity 11:293–307.
3. F.Bouder, D.Way, and R.Löfstedt. forthcoming. Transparency in Europe:A Quantitative Study.
4. L.Brandeis, 1913. Other People’s Money:And How the Bankers Use It. New York, NY:The McClure.
5. G.Breakwell, 2007. The Psychology of Risk. Cambridge:Cambridge University Press.10.1017/CBO9780511819315
6. D.Cahoy, 2007. “Medical Product Information Incentives and the Transparency Paradox.” Indiana Law Journal 82:623–671.
7. S.Chakraborty, and R.E.Löfstedt. 2011. “Transparency Initiative by the FDA’s Center for Drug Evaluation and Research (CDER):Two Qualitative Studies of Public Perceptions.” European Journal of Risk Regulation 3:57–71.
8. C.Coglianese, 2009. “The Transparency President? The Obama Administration and Open Government.” Governance 22:529–544.10.1111/gove.2009.22.issue-4
9. C.Coglianese, H.Kilmartin, and E.Mendelson. 2008. Transparency and the Public Participation in the Rulemaking Process:A Non-Partisan Presidential Task Force Report. Philadelphia:University of Pennsylvania Law School.
10. R.Dawes, 1998. “Judgment and Choice.” In Handbook of Social Psychology, edited by D.Gilbert, S.Fiske and G.Lindzey, 497–548. New York:McGraw and Hill.
11. DG SANCO. 2011. Pharmaceuticals:Today, the EU Register of Clinical Trials is Launched Online. Accessed June 26, 2013. http://ec.europa.eu/health/files/clinicaltrials/ip-11-339_en.pdf
12. P.Doshi, T.Jefferson, and C.Del Mar. 2012. “The Imperative to Share Clinical Study Reports:Recommendations from the Tamiflu Experience.” PLoS Medicine 9:1–6.
13. H.G.Eichler, F.Pétavy, F.Pignatti, and G.Rasi. 2013. “Access to Patient-level Trial Data – A Boon to Drug Developers.” New England Journal of Medicine 369:1577–1579.10.1056/NEJMp1310771
14. A.Etzioni, 2010. “Is Transparency the Best Disinfectant?” Journal of Political Philosophy 18 (4):389–404.10.1111/jopp.2010.18.issue-4
15. EMA (European Medicines Agency). 2009. The EMA Transparency Draft for Public Consultation. London:EMA.
16. EMA (European Medicines Agency). 2010. “European Medicines Agency Policy on Access to Documents (Related to Medicinal Products for Human and Veterinary Use).” Policy, Vol. 43. London:EMA.
17. EMA (European Medicines Agency). 2012. Guideline on Good Pharmacovigilance Practices (GVP):Module I – Pharmacovigilance Systems and Their Quality Systems. London:EMA.
18. EMA (European Medicines Agency). 2013. Special Topics:Transparency. Accessed December 20, 2013. http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000526.jsp&mid=WC0b01ac0580050108
19. European Ombudsman. 2010. Case Decision of the European Ombudsman Closing His Inquiry into Complaint 2560/2007/BEH against the European Medicines Agency. Accessed September 17, 2013. http://www.ombudsman.europa.eu/en/cases/decision.faces/en/5459/html.bookmark
20. B.Fischhoff, 2013. “The Sciences of Science Communication.” Proceedings of the National Academy of Sciences 110:14031–14109.
21. B.Fischhoff, N.T.Brewer, and J.S.Downs. 2011. Communicating Risks and Benefits:An Evidenced-Based User’s Guide. Silver Spring, MD:US Department of Health and Human Services, Food and Drug Administration.
22. R.Fisher, 1993. “Social Desirability Bias and the Validity of Indirect Questioning.” Journal of Consumer Research 20:303–315.10.1086/jcr.1993.20.issue-2
23. A.M.Florini, 1999. “Does the Invisible Hand Need a Transparent Glove? The Politics of Transparency.” Paper in Annual World Bank Conference on Development Economics, Washington, DC.
24. F.Godlee, 2012. “Clinical Trial Data for All Drugs in Current Use.” British Medical Journal 345:1–2.
25. B.Goldacre, 2012. Bad Pharma:How Drug Companies Mislead Doctors and Harm Patients. London:Harper Collins.
26. B.Goldacre, 2013. “Are Clinical Trial Data Shared Sufficiently Today? No” British Medical Journal 347:1–3.
27. P.Gøtzsche, and A.Jorgensen. 2011. “Opening up Data at the European Medicines Agency.” British Medical Journal 342:d2686.
28. C.Grassley, 2004. Opening Statement of US Senator Chuck Grassley of Iowa at the Hearing:FDA, Merck and Vioxx:Putting Patient Safety First. November 18.
29. C.Grassley, 2007. Floor Statement of U.S. Senator Chuck Grassley of Iowa. FDA legislation, July 26.
30. S.Grimmelikhuijsen, 2010. “Transparency of Public Decision-Making:Toward Trust in Local Government.” Policy and the Internet 2:5–35.
31. T.Groves, and F.Godlee. 2013. “The European Medicines Agency’s Plans for Sharing Data from Clinical Trials.” British Medical Journal 346:1–2.10.1136/bmj.f2961
32. M.Hamburg, and J.Sharfstein. 2009. “The FDA as a Public Health Agency.” New England Journal of Medicine 360:2493–2495.10.1056/NEJMp0903764
33. T.Hampton, 2011. “European Drug Agency under Fire.” Journal of the American Medical Association 306:593–595.10.1001/jama.2011.1102
34. T.Hampton, 2012. “European Drug Agency Works to Improve Transparency, but Skepticism Remains.” Journal of the American Medical Association 308:850–851.10.1001/2012.jama.10451
35. D.Heald, 2006. “Varieties of Transparency.” In Transparency:The Key to Better Governance?, edited by C.Hood and D.Heald, 25–43. Oxford:Oxford University Press.
36. C.Hood, 2006. “Transparency in Historical Perspective.” In Transparency:The Key to Better Governance?, edited by C.Hood and D.Heald, 1–24. Oxford:Oxford University Press.10.5871/bacad/9780197263839.001.0001
37. C.Hood, 2007. “What Happens When Transparency Meets Blame Avoidance?” Public Management Review 9 (2):191–210.10.1080/14719030701340275
38. C.Hood, and D.Heald. 2006. Transparency:The Key to Better Governance? Oxford:Oxford University Press.10.5871/bacad/9780197263839.001.0001
39. House of Commons. 2003. Improving Science Delivery:The Food Standards Agency. London:The Stationery Office.
40. IOM (Institute of Medicine). 2006. The Future of Drug Safety:Promoting and Protecting the Health of the Public. Washington DC:National Academy of Sciences.
41. Irish Medicines Board. 2010. Consumer Views on Sourcing Information on Medicines:National Survey. Accessed September 17, 2013. http://www.lenus.ie/hse/handle/10147/96670
42. A.Jack, 2013. “Big Pharma, Big Data.” Financial times, April 5, 9.
43. R.E.Kasperson, O.Renn, P.Slovic, H.S.Brown, J.Emel, R.Goble, J.X.Kasperson, and S.Ratick. 1988. “The Social Amplification of Risk:A Conceptual Framework.” Risk Analysis 8:177–187.10.1111/risk.1988.8.issue-2
44. M.E.Kraft, M.Stephan, and T.Abel. 2011. Coming Clean. Cambridge:The MIT Press.10.7551/mitpress/9780262014953.001.0001
45. R.E.Löfstedt, 2004. “Risk Communication and Management in the Twenty-First Century.” International Public Management Journal 7:335–346.
46. R.E.Löfstedt, and F.Bouder. 2014. “New Transparency Policies:Risk Communication’s Doom?” In Effective Risk Communication, edited by J.Arvai and L.RiversIII, 73–90. Oxon and New York:Earthscan from Routledge.
47. R.E.Löfstedt, F.Bouder, and S.Chakraborty. 2012. “Risk Communication and Transparency:A Quantitative Study.” Journal of Health Communication 18 (4):391–396.
48. R.E.Löfstedt, 2007. “The Impact of the Cox-2 Inhibitor Issue on Perceptions of the Pharmaceutical Industry:Content Analysis and Communication Implications.” Journal of Health Communication 12 (5):471–491.10.1080/10810730701438724
49. R.E.Löfstedt, 2010. “Risk Communication:The Avandia Case, a Pilot Study.” Expert Review of Clinical Pharmacology 3:31–41.10.1586/ecp.09.49
50. R.E.Löfstedt, 2013. “Transparency at the EMA:More Evidence is Needed.” Therapeutic Innovation & Regulatory Science 47 (3):299–300.10.1177/2168479012469946
51. A.Meijer, 2009. “Understanding Modern Transparency.” International Review of Administrative Sciences 75 (2):255–269.10.1177/0020852309104175
52. A.Meijer, 2013. “Understanding the Complex Dynamics of Transparency.” Public Administration Review 73 (3):429–439.10.1111/puar.2013.73.issue-3
53. P.Norris, 2001. Digital Divide. Cambridge:Cambridge University Press.10.1017/CBO9781139164887
54. O.O’Neill, 2006. “Transparency and the Ethics of Communication.” In Transparency:The Key to Better Governance?, edited by C.Hood and D.Heald, 75–90. Oxford:Oxford University Press.
55. B.Obama, 2009. Memorandum for the Heads of Executive Departments and Agencies:Transparency and Open Government. Accessed May 17, 2013. http://www.whitehouse.gov/the_press_office/Freedom_of_Information_Act/
56. N.Pidgeon, R.E.Kasperson, and P.Slovic. 2003. The Social Amplification of Risk. Cambridge:Cambridge University Press.10.1017/CBO9780511550461
57. C.Pollitt, and G.Bouckaert. 2011. Public Management Reform:A Comparative Analysis. Oxford:Oxford University Press.
58. G.Rasi, 2013. “Clinical Data:Time for New Approach.” Financial Times, April 30, 10.
59. H.Schutz, and P.Wiedemann. 2000. “Hazardous Incident Information for the Public:Is It Useful?” Australasian Journal of Disaster and Trauma Studies 2:1174–4707.
60. P.Slovic, 1987. “Perception of Risk.” Science 236 (4799):280–285.10.1126/science.3563507
61. P.Slovic, 2000. The Perception of Risk. London:Earthscan.
62. R.Smith, 2004. “Transparency:A Modern Essential.” British Medical Journal 328:1136.
63. H.Tsoukas, 1997. “The Tyranny of Light.” Futures 29:827–843.10.1016/S0016-3287(97)00035-9
64. UK FSA (UK Food Standards Agency). 2003. Consumer Attitudes Survey 2002. London:FSA.
65. US FDA (US Food and Drug Administration). 2010. FDA Transparency Initiative:Draft Proposals for Public Comment regarding Disclosure Policies of the US Food and Drug Administration. Rockville, MD:US FDA.
66. S.S.Vedula, T.Li, and K.Dickersin. 2013. “Differences in Reporting of Analyses in Internal Company Documents versus Published Trial Reports:Comparisons in Industry-Sponsored Trials in off-Label Uses of Gabapentin.” PloS Medicine. 1–13.
67. WHO (World Health Organization). 2002. The Importance of Pharmacovigilance:Safety Monitoring of Medicinal Products. Genève:WHO.
68. D.Zarin, 2009. Comments given at the US FDA’s Risk Communication Advisory Committee. Rockville, MD:US Food & Drug Administration. Accessed December 20, 2013. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/RiskCommunicationAdvisoryCommittee/UCM199226.pdf