Journal of Clinical Epidemiology
Volume 63, Issue 2 , Pages 117-125 , February 2010

The effect of study sponsorship on a systematically evaluated body of evidence of head-to-head trials was modest: secondary analysis of a systematic review

  • Gerald Gartlehner

      Affiliations

    • Department of Evidence-based Medicine and Clinical Epidemiology, Danube University, Krems, Austria
    • Corresponding Author InformationCorresponding author. Department of Evidence-based Medicine and Clinical Epidemiology, Danube University, Karl Dorrek-Straße 30, 3500 Krems, Austria. Tel.: +0043-2732-89327-2818; fax: +0043-2732-893-4810.
    • ,
  • Laura Morgan

      Affiliations

    • Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
    • ,
  • Patricia Thieda

      Affiliations

    • Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
    • ,
  • Anthony Fleg

      Affiliations

    • Department of Family and Community Medicine, University of New Mexico, Albuquerque, NM, USA

,Accepted 29 September 2008.

References 

  1. Shah RV, Albert TJ, Bruegel-Sanchez V, Vaccaro AR, Hilibrand AS, Grauer JN. Industry support and correlation to study outcome for papers published in Spine. Spine. 2005;30:1099–1104
  2. Lesser LI, Ebbeling CB, Goozner M, Wypij D, Ludwig DS. Relationship between funding source and conclusion among nutrition-related scientific articles. PLoS Med. 2007;4:e5
  3. Montgomery JH, Byerly M, Carmody T, Li B, Miller DR, Varghese F, et al. An analysis of the effect of funding source in randomized clinical trials of second generation antipsychotics for the treatment of schizophrenia. Control Clin Trials. 2004;25:598–612
  4. Brown A, Kraft D, Schmitz SM, Sharpless V, Martin C, Shah R, et al. Association of industry sponsorship to published outcomes in gastrointestinal clinical research. Clin Gastroenterol Hepatol. 2006;4:1445–1451
  5. 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;290:921–928
  6. Baker CB, Johnsrud MT, Crismon ML, Rosenheck RA, Woods SW. Quantitative analysis of sponsorship bias in economic studies of antidepressants. Br J Psychiatry. 2003;183:498–506
  7. Barnes DE, Bero LA. Why review articles on the health effects of passive smoking reach different conclusions. JAMA. 1998;279:1566–1570
  8. Bhandari M, Busse JW, Jackowski D, Montori VM, Schunemann H, Sprague S, et al. Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials. CMAJ. 2004;170:477–480
  9. Chard JA, Tallon D, Dieppe PA. Epidemiology of research into interventions for the treatment of osteoarthritis of the knee joint. Ann Rheum Dis. 2000;59:414–418
  10. Cho MK, Bero LA. The quality of drug studies published in symposium proceedings. Ann Intern Med. 1996;124:485–489
  11. Dieppe P, Chard J, Tallon D, Egger M. Funding clinical research. Lancet. 1999;353:1626
  12. Finucane TE, Boult CE. Association of funding and findings of pharmaceutical research at a meeting of a medical professional society. Am J Med. 2004;117:842–845
  13. Friedman LS, Richter ED. Relationship between conflicts of interest and research results. J Gen Intern Med. 2004;19:51–56
  14. Hartmann M, Knoth H, Schulz D, Knoth S. Industry-sponsored economic studies in oncology vs studies sponsored by nonprofit organisations. Br J Cancer. 2003;89:1405–1408
  15. Kemmeren JM, Algra A, Grobbee DE. Third generation oral contraceptives and risk of venous thrombosis: meta-analysis. BMJ. 2001;323:131–134
  16. Kjaergard LL, Als-Nielsen B. Association between competing interests and authors' conclusions: epidemiological study of randomised clinical trials published in the BMJ. BMJ. 2002;325:249
  17. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ. 2003;326:1167–1170
  18. Procyshyn RM, Chau A, Fortin P, Jenkins W. Prevalence and outcomes of pharmaceutical industry-sponsored clinical trials involving clozapine, risperidone, or olanzapine. Can J Psychiatry. 2004;49:601–606
  19. Rochon PA, Gurwitz JH, Simms RW, Fortin PR, Felson DT, Minaker KL, et al. A study of manufacturer-supported trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis. Arch Intern Med. 1994;154:157–163
  20. Stelfox HT, Chua G, O'Rourke K, Detsky AS. Conflict of interest in the debate over calcium-channel antagonists. N Engl J Med. 1998;338:101–106
  21. Thomas PS, Tan KS, Yates DH. Sponsorship, authorship, and accountability. Lancet. 2002;359:351
  22. Turner C, Spilich GJ. Research into smoking or nicotine and human cognitive performance: does the source of funding make a difference?. Addiction. 1997;92:1423–1426
  23. Wahlbeck K, Adams C. Beyond conflict of interest. Sponsored drug trials show more-favourable outcomes. BMJ. 1999;318:465
  24. Yaphe J, Edman R, Knishkowy B, Herman J. The association between funding by commercial interests and study outcome in randomized controlled drug trials. Fam Pract. 2001;18:565–568
  25. Kelly RE, Cohen LJ, Semple RJ, Bialer P, Lau A, Bodenheimer A, et al. Relationship between drug company funding and outcomes of clinical psychiatric research. Psychol Med. 2006;36:1647–1656
  26. Barden J, Derry S, McQuay HJ, Moore RA. Bias from industry trial funding? A framework, a suggested approach, and a negative result. Pain. 2006;121:207–218
  27. Davidson RA. Source of funding and outcome of clinical trials. J Gen Intern Med. 1986;1:155–158
  28. Montaner JS, O'Shaughnessy MV, Schechter MT. Industry-sponsored clinical research: a double-edged sword. Lancet. 2001;358:1893–1895
  29. 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
  30. Melander H, Ahlqvist-Rastad J, Meijer G, Beermann B. Evidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ. 2003;326:1171–1173
  31. Teutsch SM, Berger ML, Weinstein MC. Comparative effectiveness: asking the right questions, choosing the right method. Health Aff (Millwood). 2005;24:128–132
  32. Oregon Health and Science University (OHSU). Drug Effectiveness Review Project. Available at http://www.ohsu.edu/drugeffectiveness/description/index.htm, Accessed November 15, 2007.
  33. Agency for Healthcare Research and Quality (AHRQ). Available at: http://effectivehealthcare.ahrq.gov/repFiles/Antidepressants_Final_Report.pdf. Accessed August 26, 2009.
  34. Gartlehner G, Hansen RA, Thieda P, DeVeaugh-Geiss AM, Gaynes BN, Krebs EE, et al Comparative effectiveness of second-generation antidepressants in the pharmacologic treatment of adult depression. Comparative effectiveness review no. 7. (Prepared by RTI-UNC under contract no. 290-02-0016.) Rockville, MD: Agency for Healthcare Research and Quality. Available at: http://effectivehealthcare.ahrq.gov/repFiles/Antidepressants_Final_Report.pdf. Accessed August 26, 2009.
  35. Hansen RA, Gartlehner G, Lohr KN, Gaynes BN, Carey TS. Efficacy and safety of second-generation antidepressants in the treatment of major depressive disorder. Ann Intern Med. 2005;143:415–426
  36. Williams JW, Mulrow CD, Chiquette E, Noel PH, Augilar C, Cornell J. A systematic review of newer pharmacotherapies for depression in adults: evidence report summary. Ann Intern Med. 2000;132:743–7562000
  37. Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow CD, Teutsch SM, et al. Current methods of the US Preventive Services Task Force: a review of the process. Am J Prev Med. 2001;20(3 Suppl):21–35
  38. Centre for Reviews and Dissemination. Undertaking systematic reviews of research on effectiveness: CRD's guidance for those carrying out or commissioning reviews. CRD Report Number 4 (2nd edition). York, UK: York Publishing Services; 2001;
  39. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ. 2003;327:557–560
  40. Aberg-Wistedt A, Agren H, Ekselius L, Bengtsson F, Akerblad AC. Sertraline versus paroxetine in major depression: clinical outcome after six months of continuous therapy. J Clin Psychopharmacol. 2000;20:645–652
  41. Bennie EH, Mullin JM, Martindale JJ. A double-blind multicenter trial comparing sertraline and fluoxetine in outpatients with major depression. J Clin Psychiatry. 1995;56:229–237
  42. Boyer P, Danion JM, Bisserbe JC, Hotton JM, Troy S. Clinical and economic comparison of sertraline and fluoxetine in the treatment of depression. A 6-month double-blind study in a primary-care setting in France. Pharmacoeconomics. 1998;13(1 Pt 2):157–169
  43. Burke WJ, Gergel I, Bose A. Fixed-dose trial of the single isomer SSRI escitalopram in depressed outpatients. J Clin Psychiatry. 2002;63:331–336
  44. Cassano GB, Puca F, Scapicchio PL, Trabucchi M. Paroxetine and fluoxetine effects on mood and cognitive functions in depressed nondemented elderly patients. J Clin Psychiatry. 2002;63:396–402
  45. Chouinard G, Saxena B, Belanger MC, Ravindran A, Bakish D, Beauclair L, et al. A Canadian multicenter, double-blind study of paroxetine and fluoxetine in major depressive disorder. J Affect Disord. 1999;54:39–48
  46. Colonna L, Andersen HF, Reines EH. A randomized, double-blind, 24-week study of escitalopram (10mg/day) versus citalopram (20mg/day) in primary care patients with major depressive disorder. Curr Med Res Opin. 2005;21:1659–1668
  47. Dalery J, Honig A. Fluvoxamine versus fluoxetine in major depressive episode: a double-blind randomised comparison. Hum Psychopharmacol. 2003;18:379–384
  48. De Wilde J, Spiers R, Mertens C, Bartholome F, Schotte G, Leyman S. A double-blind, comparative, multicentre study comparing paroxetine with fluoxetine in depressed patients. Acta Psychiatr Scand. 1993;87:141–145
  49. Ekselius L, von Knorring L, Eberhard G. A double-blind multicenter trial comparing sertraline and citalopram in patients with major depression treated in general practice. Int Clin Psychopharmacol. 1997;12:323–331
  50. Fava M, Amsterdam JD, Deltito JA, Salzman C, Schwaller M, Dunner DL. A double-blind study of paroxetine, fluoxetine, and placebo in outpatients with major depression. Ann Clin Psychiatry. 1998;10:145–150
  51. Fava M, Judge R, Hoog SL, Nilsson ME, Koke SC. Fluoxetine versus sertraline and paroxetine in major depressive disorder: changes in weight with long-term treatment. J Clin Psychiatry. 2000;61:863–867
  52. Fava M, Hoog SL, Judge RA, Kopp JB, Nilsson ME, Gonzales JS. Acute efficacy of fluoxetine versus sertraline and paroxetine in major depressive disorder including effects of baseline insomnia. J Clin Psychopharmacol. 2002;22:137–147
  53. Gagiano CA. A double blind comparison of paroxetine and fluoxetine in patients with major depression. Br J Clin Res. 1993;4:145–152
  54. Haffmans PM, Timmerman L, Hoogduin CA. Efficacy and tolerability of citalopram in comparison with fluvoxamine in depressed outpatients: a double-blind, multicentre study. The LUCIFER Group. Int Clin Psychopharmacol. 1996;11:157–164
  55. Kasper S, de Swart H, Friis Andersen H. Escitalopram in the treatment of depressed elderly patients. Am J Geriatr Psychiatry. 2005;13:884–891
  56. Kiev A, Feiger A. A double-blind comparison of fluvoxamine and paroxetine in the treatment of depressed outpatients. J Clin Psychiatry. 1997;58:146–152
  57. Kroenke K, West SL, Swindle R, Gilsenan A, Eckert GJ, Dolor R, et al. Similar effectiveness of paroxetine, fluoxetine, and sertraline in primary care: a randomized trial. JAMA. 2001;286:2947–2955
  58. Lepola UM, Loft H, Reines EH. Escitalopram (10-20mg/day) is effective and well tolerated in a placebo-controlled study in depression in primary care. Int Clin Psychopharmacol. 2003;18:211–217
  59. Moore N, Verdoux H, Fantino B. Prospective, multicentre, randomized, double-blind study of the efficacy of escitalopram versus citalopram in outpatient treatment of major depressive disorder. Int Clin Psychopharmacol. 2005;20:131–137
  60. Nemeroff CB, Ninan PT, Ballenger J, Lydiard RB, Feighner J, Patterson WM, et al. Double-blind multicenter comparison of fluvoxamine versus sertraline in the treatment of depressed outpatients. Depression. 1995;3:163–169
  61. Newhouse PA, Krishnan KR, Doraiswamy PM, Richter EM, Batzar ED, Clary CM. A double-blind comparison of sertraline and fluoxetine in depressed elderly outpatients. J Clin Psychiatry. 2000;61:559–568
  62. Patris M, Bouchard JM, Bougerol T, Charbonnier JF, Chevalier JF, Clerc G, et al. Citalopram versus fluoxetine: a double-blind, controlled, multicentre, phase III trial in patients with unipolar major depression treated in general practice. Int Clin Psychopharmacol. 1996;11:129–136
  63. Rapaport M, Coccaro E, Sheline Y, Perse T, Holland P, Fabre L, et al. A comparison of fluvoxamine and fluoxetine in the treatment of major depression. J Clin Psychopharmacol. 1996;16:373–378
  64. Rossini D, Serretti A, Franchini L, Mandelli L, Smeraldi E, De Ronchi D, et al. Sertraline versus fluvoxamine in the treatment of elderly patients with major depression: a double-blind, randomized trial. J Clin Psychopharmacol. 2005;25:471–475
  65. Schone W, Ludwig M. A double-blind study of paroxetine compared with fluoxetine in geriatric patients with major depression. J Clin Psychopharmacol. 1993;13(6 Suppl 2):34S–39S
  66. Sechter D, Troy S, Paternetti S, Boyer P. A double-blind comparison of sertraline and fluoxetine in the treatment of major depressive episode in outpatients. Eur Psychiatry. 1999;14:41–48
  67. Tignol J. A double-blind, randomized, fluoxetine-controlled, multicenter study of paroxetine in the treatment of depression. J Clin Psychopharmacol. 1993;13(6 Suppl 2):18S–22S
  68. Van Moffaert M, Bartholome F, Cosyns P, De Nayer AR. A controlled comparison of sertraline and fluoxetine in acute and continuation treatment of major depression. Human Psychopharmacol. 1995;10:393–405
  69. LaRosa JC, He J, Vupputuri S. Effect of statins on risk of coronary disease: a meta-analysis of randomized controlled trials. JAMA. 1999;282:2340–2346
  70. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet. 2002;360:7–22
  71. Rosenheck RA, Leslie DL, Sindelar J, Miller EA, Lin H, Stroup TS, et al. Cost-effectiveness of second-generation antipsychotics and perphenazine in a randomized trial of treatment for chronic schizophrenia. Am J Psychiatry. 2006;163:2080–2089
  72. DeAngelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Med J Aust. 2004;181:293–294

 Conflict of interest: None of the authors has any conflict of interest with respect to the topic of this manuscript. All authors had full access to the data of this study.

PII: S0895-4356(09)00231-5

doi: 10.1016/j.jclinepi.2008.09.019

Journal of Clinical Epidemiology
Volume 63, Issue 2 , Pages 117-125 , February 2010

Article Tools

* Image Usage & Resolution