Economics and industry do not mean ethical conduct in clinical trials

Journal of Pharmaceutical Policy and Practice

Volumn 6, Issue 1, 2013, Pages

  Lexchin, Joel ^a  

^a YORK UNIVERSITY   (Canada)

Author keywords

Clinical trials; Developing countries; Ethics; Ghost writing; Pharmaceutical industry; Seeding trials; Withholding data

Indexed keywords

CLINICAL TRIAL (TOPIC); COMPARATIVE EFFECTIVENESS; DEVELOPING COUNTRY; DRUG EFFICACY; DRUG INDUSTRY; DRUG SAFETY; EVIDENCE BASED MEDICINE; HEALTH ECONOMICS; MEDICAL DOCUMENTATION; MEDICAL ETHICS; MEDICAL INFORMATION; MEDICAL LITERATURE; NOTE; PUBLICATION; RISK BENEFIT ANALYSIS;

EID: 84904764510     PISSN: None     EISSN: 20523211     Source Type: Journal    
DOI: 10.1186/2052-3211-6-11     Document Type: Note

References (22)

1. Moses HI, Dorsey ER, Matheson DHM, Thier SO. Financial anatomy of biomedical research. JAMA 2005, 294:1333-1342. 10.1001/jama.294.11.1333, 16174691.
2. Hersh AL, Stefanick ML, Stafford RS. National use of postmenopausal hormone therapy: annual trends and response to recent evidence. JAMA 2004, 291:47-53. 10.1001/jama.291.1.47, 14709575.
3. Lundh A, Sismondo S, Lexchin J, Busuioc O, Bero L. Industry sponsorship and research outcome. Cochrane Database Syst Rev 2012, MR000033. 000010.001002/14651858.MR14000033.pub14651852.
4. Rising K, Bacchetti P, Bero L. Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. PLoS Med 2008, 5:e217. 10.1371/journal.pmed.0050217, 2586350, 19067477.
5. Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008, 358:252-260. 10.1056/NEJMsa065779, 18199864.
6. WMA Declaration of Helsinki - ethical principles for medical research involving human subjects http://www.wma.net/en/30publications/10policies/b3/.
7. Stephens J. As drug testing spreads, profits and lives hang in balance. Washington Post 2000, A1.
8. Howden D. Pfizer to pay £50m after deaths of Nigerian children in drug trial experiment. The Independent 2009, 20-21.
9. Schipper I, Weyzig F. Ethics for drug testing in low and middle income countries: considerations for European market authorisation 2008, Amsterdam: SOMO.
10. Psaty B, Rennie D. Stopping medical research to save money: a broken pact with researchers and patients. JAMA 2003, 289:2128-2131.
11. Kahn J, Cherng D, Mayer K, Murray H, Lagakos S. Evaluation of HIV-1 Immunogen, an immunologic modifier, administered to patients infected with HIV having 300 to 549 x 106/L CD4 cell counts: a randomized controlled trial. JAMA 2000, 284:2193-2202. 10.1001/jama.284.17.2193, 11056590.
12. Doshi P. Neuraminidase inhibitors: the story behind the Cochrane review. BMJ 2009, 339:1348-1351.
13. Wislar J, Flanagin A, Fontanarosa P, DeAngelis C. Honorary and ghost authorship in high impact biomedical journals: a cross sectional survey. BMJ 2011, 343:d6128. 10.1136/bmj.d6128, 3202014, 22028479.
14. Gøtzsche P, Hróbjartsson A, Johansen H, Haahr M, Altman D, Chan A-W. Ghost authorship in industry-initiated randomised trials. PLoS Med 2007, 4:e19. 10.1371/journal.pmed.0040019, 1769411, 17227134.
15. Amsterdam J, McHenry L. The paroxetine 352 bipolar trial: a study in medical ghostwriting. Int J Risk Saf Med 2012, 24:221-231.
16. Post-marketing observational studies: my experience in the drug industry. BMJ 2012, 344:e3990.
17. Gale E. Post-marketing studies of new insulins: sales or science?. BMJ 2012, 344:e3974. 10.1136/bmj.e3974, 22692652.
18. Bero L, Rennie D. Influences on the quality of published drug studies. Int J Technol Assess Health Care 1996, 12:209-237. 10.1017/S0266462300009582, 8707496.
19. Evans D. Big pharma's crime spree. Bloomberg Markets 2009, 72-86.
20. Tobbell D. Pills, power, and policy: the struggle for drug reform in cold war America and its consequences 2012, Berkeley: University of California Press.
21. Angell M. The truth about the drug companies: how they deceive us and what to do about it 2004, New York: Random House.
22. Lewis T, Reichman J, So A. The case for public funding and public oversight of clinical trials. Economists' Voice 2007, 4:1-4.