Is there evidence for biased reporting of published adverse effects data in pharmaceutical industry-funded studies?

British Journal of Clinical Pharmacology

Volumn 66, Issue 6, 2008, Pages 767-773

  Golder, Su ^a   Loke, Yoon K ^b  

^a UNIVERSITY OF YORK   (United Kingdom)

^b UNIVERSITY OF EAST ANGLIA   (United Kingdom)

Author keywords

Adverse effects; Bias; Industry funding; Systematic review

Indexed keywords

ADVERSE DRUG REACTION; ARTICLE; DATA ANALYSIS; DATA BASE; DATA EXTRACTION; DRUG INDUSTRY; DRUG SAFETY; FUNDING; POST HOC ANALYSIS; PRIORITY JOURNAL; PUBLICATION; STATISTICAL SIGNIFICANCE; SYSTEMATIC REVIEW;

CLINICAL TRIALS AS TOPIC; DRUG INDUSTRY; DRUG TOXICITY; FEMALE; FINANCING, ORGANIZED; HUMANS; MALE; META-ANALYSIS AS TOPIC; PUBLICATION BIAS; RISK ASSESSMENT;

EID: 56549110284     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2008.03272.x     Document Type: Article

References (22)

1. Bero L, Oostvogel F, Bacchetti P, Lee K. Factors associated with findings of published trials of drug-drug comparisons: why some statins appear more efficacious than others. PLoS Med 2007 4 : e184.
2. Sismondo S. Pharmaceutical company funding and its consequences: a qualitative systematic review. Contemp Clin Trials 2008 29 : 109 13.
3. Vandenbroucke JP, Helmerhorst FM, Rosendaal FR. Competing interests and controversy about third generation oral contraceptives. BMJ 2000 320 : 381.
4. Chou R, Fu R, Carson S, Saha S, Helfand M. Empirical Evaluation of the Association between Methodological Shortcomings and Estimates of Adverse Events. Rockville, MD : Agency for Healthcare Research and Quality (AHRQ), 2006. Report No.: Technical Review 13.
5. Chou R, Fu R, Carson S, Saha S, Helfand M. Methodological shortcomings predicted lower harm estimates in one of two sets of studies of clinical interventions. J Clin Epidemiol 2007 60 : 18 28.
6. Kemmeren JM, Algra A, Grobbee DE. Third generation oral contraceptives and risk of venous thrombosis: meta-analysis. BMJ 2001 323 : 119 20.
7. Als-Nielsen B, Chen W, Gluud C, Kjaergard LL. Association of funding and authors' conclusions in randomized drug trials: a reflection of treatment benefit or adverse events? abstract] In: XI Cochrane Colloquium: Evidence, Health Care and Culture. 2003 October 26-31; Barcelona, Spain; 2003 2003 36.
8. Als-Nielsen B, Chen W, Gluud C, Kjaergard LL. Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events? JAMA 2003 290 : 921 8.
9. Juni P, Nartey L, Reichenbach S, Sterchi R, Dieppe PA, Egger M. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet 2004 364 : 2021 9.
10. Nieto A, Mazon A, Pamies R, Linana JJ, Amparo Lanuza A, Jiménez FO, Medina-Hernandez A, Nieto FJ. Adverse effects of inhaled corticosteroids in funded and nonfunded studies. Arch Intern Med 2007 167 : 2047 53.
11. Rochon PA, Gurwitz JH, Simms RW, Fortin PR, Felson DT, Minaker KL, Chalmers TC. A study of manufacturer-supported trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis. Arch Intern Med 1994 154 : 157 63.
12. Stelfox HT, Chua G, O'Rourke K, Detsky AS. Conflict of interest in the debate over calcium-channel antagonists. N Engl J Med 1998 338 : 101 6.
13. Dubben HH, Beck-Bornholdt HP. Systematic review of publication bias in studies on publication bias. BMJ 2005 331 : 433 4.
14. Ioannidis JP, Evans SJ, Gotzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D, CONSORT Group. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004 141 : 781 8.
15. Ross JS, Hill KP, Egilman DS, Krumholz HM. Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. JAMA 2008 299 : 1800 12.
16. Weinfurt K, Seils D, Tzeng J, Lin L, Schulman K, Califf R. Consistency of financial interest disclosures in the biomedical literature: the case of coronary stents. PLoS ONE 2008 3 : e2128. doi:10.1371/journal.pone.0002128.
17. 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 60.
18. Djulbegovic B, Lacevic M, Cantor A, Fields KK, Bennett CL, Adams JR, Kuderer NM, Lyman GH. The uncertainty principle and industry sponsored research. Lancet 2000 356 : 635 8.
19. Safer DJ. Design and reporting modifications in industry-sponsored comparative psychopharmacology trials Review J Nerv Ment Dis 2002 190 : 583 92.
20. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003 326 : 1167 70.
21. Chan AW, Hrobjartsson A, Haahr MT, Gotzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 2004 291 : 2457 65.
22. Higgins JPT, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions 5.0.0 updated February 2008 The Cochrane Collaboration, 2008.