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

References

• Alvarez, E., V. Perez, M. Dragheim, H. Loft, and F. Artigas. 2012. A double-blind, randomized, placebo-controlled, active reference study of lu aa21004 in patients with major depressive disorder. The International Journal of Neuropsychopharmacology 15 (5):589–600. doi:10.1017/S1461145711001027.
   PubMed Web of Science ®Google Scholar
• Angell, M. 2004. The truth about the drug companies: How they deceive us and what to do about it. New York, NY: Random House.
   Google Scholar
• Avorn, J. 2005. Powerful medicines: The benefits, risks, and costs of prescription drugs, Revised Edition. New York, NY: Vintage Books.
   Google Scholar
• Baciu, A., K. Stratton, and S. P. Burke, editors. 2006. The future of drug safety: Protecting the health of the public. Washington, DC: Institute of Medicine, National Academies Press.
   Google Scholar
• Baldwin, D. S., H. Loft, and M. Dragheim. 2012. A randomised, double-blind, placebo controlled, duloxetine-referenced, fixed-dose study of three dosages of lu aa21004 in acute treatment of major depressive disorder (mdd). European Neuropsychopharmacology 22 (7):482–91. doi:10.1016/j.euroneuro.2011.11.008.
   PubMed Web of Science ®Google Scholar
• Bero, L. A., and D. Rennie. 1996. Influences on the quality of published drug studies. International Journal of Technology Assessment in Health Care 12 (2):209–37. doi:10.1017/S0266462300009582.
   PubMed Web of Science ®Google Scholar
• Borgerson, K. 2014. Redundant, secretive, and isolated: When are clinical trials scientifically valid? Kennedy Institute of Ethics Journal 24 (4):385–411. doi:10.1353/ken.2014.0029.
   PubMed Web of Science ®Google Scholar
• Boulenger, J. P., H. Loft, and I. Florea. 2012. A randomized clinical study of lu aa21004 in the prevention of relapse in patients with major depressive disorder. Journal of Psychopharmacology 26 (11):1408–16. doi:10.1177/0269881112441866.
   PubMed Web of Science ®Google Scholar
• Boulenger, J. P., H. Loft, and C. K. Olsen. 2014. Efficacy and safety of vortioxetine (lu aa21004), 15 and 20 mg/day: A randomized, double-blind, placebo-controlled, duloxetine-referenced study in the acute treatment of adult patients with major depressive disorder. International Clinical Psychopharmacology 29 (3):138–49. doi:10.1097/YIC.0000000000000018.
   PubMed Web of Science ®Google Scholar
• Center for Drug Evaluation and Research. (2012). Medical reviews (s). Application Number: 204447Orig1s000 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204447orig1s000medr.pdf (accessed March 1, 2016).
   Google Scholar
• Cosgrove, L., A. F. Shaughnessy, E. E. Wheeler, S. Krimsky, S. M. Peters, D. J. Freeman-Coppadge, and J. R. Lexchin. 2014. From caveat emptor to caveat venditor: Time to stop the influence of money on practice guideline development. Journal of Evaluation in Clinical Practice 20 (6):809–12. doi:10.1111/jep.12244.
   PubMed Web of Science ®Google Scholar
• Cosgrove, L., and S. Krimsky. 2012. A comparison of DSM- IV and DSM-5 panel members’ financial associations with industry: A pernicious problem persists. PLoS Med 9:e1001190. doi:10.1371/journal.pmed.1001190.
   PubMed Web of Science ®Google Scholar
• Doucet, M., and S. Sismondo. 2008. Evaluating solutions to sponsorship bias. Journal of Medical Ethics 34 (8):627–30. doi:10.1136/jme.2007.022467.
   PubMed Web of Science ®Google Scholar
• Elliott, C. 2004. Pharma goes to the laundry: Public relations and the business of medical education. The Hastings Center Report 34 (5):18–23. doi:10.2307/3527586.
   PubMed Web of Science ®Google Scholar
• Elliott, K. C. 2008. Scientific judgment and the limits of conflict-of-interest policies. Accountability in Research 15 (1):1–29. doi:10.1080/08989620701783725.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. 2014. Committee for Medicinal Products for Human Use. A Multinational, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Assess the Efficacy and Safety of Vortioxetine in Patients with Major Depressive Disorder. Described in: Brintellix (vortioxetine), Applicant: H. Lundbeck A/S Assessment Report for an initial marketing authorisation application. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002717/WC500159447.pdf (accessed March 1, 2016).
   Google Scholar
• Fugh-Berman, A. J. 2010. The haunting of medical journals: How ghostwriting sold “hrt”. PLoS Med 7 (9):e1000335. doi:10.1371/journal.pmed.1000335.
   PubMed Web of Science ®Google Scholar
• Garland, E. J. 2004. Facing the evidence: Antidepressant treatment in children and adolescents. Cmaj 170 (4):489–91.
   PubMed Web of Science ®Google Scholar
• Goldacre, B. 2013. Bad pharma: How drug companies mislead doctors and harm patients. First American edition. New York, NY: Faber and Faber, Inc., an affiliate of Farrar, Straus and Giroux.
   Google Scholar
• Goodrx.com (2015) Brintellix. http://www.goodrx.com/brintellix ( accessed 16 February 2015).
   Google Scholar
• Healy, D., and D. Cattell. 2003. Interface between authorship, industry and science in the domain of therapeutics. The British Journal of Psychiatry: The Journal of Mental Science 182:18322–27.
   Google Scholar
• Hedgecoe, A. 2014. A deviation from standard design? Clinical trials, research ethics committees, and the regulatory co-construction of organizational deviance. Social Studies of Science 44 (1):59–81. doi:10.1177/0306312713506141.
   Web of Science ®Google Scholar
• Henigsberg, N., A. R. Mahableshwarkar, P. Jacobsen, Y. Chen, and M. E. Thase. 2012. A randomized, double-blind, placebo-controlled 8-week trial of the efficacy and tolerability of multiple doses of lu aa21004 in adults with major depressive disorder. The Journal of Clinical Psychiatry 73 (7):953–59. doi:10.4088/JCP.11m07470.
   PubMed Web of Science ®Google Scholar
• Heres, S., J. Davis, K. Maino, E. Jetzinger, W. Kissling, and S. Leucht. 2006. Why olanzapine beats risperidone, risperidone beats quetiapine, and quetiapine beats olanzapine: An exploratory analysis of head-to-head comparison studies of second-generation antipsychotics. American Journal of Psychiatry 163 (2):185–94. doi:10.1176/appi.ajp.163.2.185.
   PubMed Web of Science ®Google Scholar
• Higgins, J. P. T., and S. Green; Cochrane Collaboration. 2008. Cochrane handbook for systematic reviews of interventions Cochrane book series. Chichester, England; Hoboken, NJ: Wiley-Blackwell.
   Google Scholar
• Higgins, J. P. T., and S. Green (eds.). 2011. Cochrane handbook for systematic reviews of interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, www.cochrane-handbook.org.
   Google Scholar
• Jacobsen, P. L., A. R. Mahableshwarkar, M. Serenko, S. Chan, and M. H. Trivedi. 2015. A randomized, double-blind, placebo-controlled study of the efficacy and safety of vortioxetine 10 mg and 20 mg in adults with major depressive disorder. The Journal of Clinical Psychiatry 76 (5):575–82. doi:10.4088/JCP.14m09335.
   PubMed Web of Science ®Google Scholar
• Jain, R., A. R. Mahableshwarkar, P. L. Jacobsen, Y. Chen, and M. E. Thase. 2013. A randomized, double-blind, placebo-controlled 6-wk trial of the efficacy and tolerability of 5 mg vortioxetine in adults with major depressive disorder. The International Journal of Neuropsychopharmacology 16 (2):313–21. doi:10.1017/S1461145712000727.
   PubMed Web of Science ®Google Scholar
• Jureidini, J. N., and L. B. McHenry. 2011. Conflicted medical journals and the failure of trust. Accountability in Research 18 (1):45–54. doi:10.1080/08989621.2011.542683.
   PubMed Web of Science ®Google Scholar
• Katona, C., T. Hansen, and C. K. Olsen. 2012. A randomized, double-blind, placebo-controlled, duloxetine-referenced, fixed-dose study comparing the efficacy and safety of lu aa21004 in elderly patients with major depressive disorder. International Clinical Psychopharmacology 27 (4):215–23. doi:10.1097/YIC.0b013e3283542457.
   PubMed Web of Science ®Google Scholar
• Kesselheim, A. S., B. Wang, D. M. Studdert, and J. Avorn. 2012. Conflict of interest reporting by authors involved in promotion of off-label drug use: An analysis of journal disclosures. PLoS Med 9 (8):e1001280. doi:10.1371/journal.pmed.1001280.
   Google Scholar
• Koenig, F., J. Slattery, T. Groves, T. Lang, Y. Benjamini, S. Day, P. Bauer, and M. Posch. 2015. Sharing clinical trial data on patient level: Opportunities and challenges. Biometrical Journal. Biometrische Zeitschrift 57 (1):8–26. doi:10.1002/bimj.v57.1.
   PubMed Web of Science ®Google Scholar
• Kousar, S., Z. A. Wafai, M. A. Wani, T. R. Jan, and K. I. Andrabi. 2015. Clinical relevance of genetic polymorphism in CYP2C9 gene to pharmacodynamics and pharmacokinetics of phenytoin in epileptic patients: Validatory pharmacogenomic approach to pharmacovigilance. International Journal of Clinical Pharmacology and Therapeutics 53 (7):504–16. doi:10.5414/CP202112.
   PubMed Web of Science ®Google Scholar
• Krimsky, S. 2003. Science in the private interest: Has the lure of profits corrupted biomedical research? Lanham, MD: Rowman & Littlefield Publishers.
   Google Scholar
• Krimsky, S. 2013. Do financial conflicts of interest bias research?: An inquiry into the “funding effect” hypothesis. Science, Technology & Human Values 38 (4):566–87. doi:10.1177/0162243912456271.
   Web of Science ®Google Scholar
• Lacasse, J. R., and J. Leo. 2010. Ghostwriting at elite academic medical centers in the united states. PLoS Med 7 (2):e1000230. doi:10.1371/journal.pmed.1000230.
   Google Scholar
• Le Noury, J., J. M. Nardo, D. Healy, J. Jureidini, M. Raven, C. Tufanaru, and E. Abi-Jaoude. 2015. Restoring study 329: Efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. Bmj 351:h4320.
   PubMed Web of Science ®Google Scholar
• Lessig, L. 2013. Foreword: “Institutional corruption” defined. The Journal of Law, Medicine & Ethics: A Journal of the American Society of Law, Medicine & Ethics 41 (3):553–55. doi:10.1111/jlme.12063.
   PubMed Web of Science ®Google Scholar
• Lexchin, J., and D. W. Light. 2006. Commercial influence and the content of medical journals. Bmj 332 (7555):1444–47. doi:10.1136/bmj.332.7555.1444.
   PubMed Web of Science ®Google Scholar
• Loke, Y. K., and K. Mattishent. 2015. If nothing happens, is everything all right? Distinguishing genuine reassurance from a false sense of security. Cmaj 187 (1):15–16. doi:10.1503/cmaj.141344.
   PubMed Web of Science ®Google Scholar
• Lundh, A., S. Sismondo, J. Lexchin, O. A. Busuioc, and L. Bero. 2012. Industry sponsorship and research outcome. Cochrane Database Syst Rev 12:MR000033.
   PubMed Web of Science ®Google Scholar
• Mahableshwarkar, A. R., P. L. Jacobsen, and Y. Chen. 2013. A randomized, double-blind trial of 2.5 mg and 5 mg vortioxetine (lu aa21004) versus placebo for 8 weeks in adults with major depressive disorder. Current Medical Research and Opinion 29 (3):217–26. doi:10.1185/03007995.2012.761600.
   PubMed Web of Science ®Google Scholar
• Mahableshwarkar, A. R., P. L. Jacobsen, Y. Chen, M. Serenko, and M. H. Trivedi. 2015. A randomized, double-blind, duloxetine-referenced study comparing efficacy and tolerability of 2 fixed doses of vortioxetine in the acute treatment of adults with mdd. Psychopharmacology (Berl) 232 (12):2061–70. doi:10.1007/s00213-014-3839-0.
   PubMed Web of Science ®Google Scholar
• Mahableshwarkar, A. R., P. L. Jacobsen, M. Serenko, Y. Chen, and M. H. Trivedi. 2015b. A randomized, double-blind, placebo-controlled study of the efficacy and safety of 2 doses of vortioxetine in adults with major depressive disorder. The Journal of Clinical Psychiatry 76 (5):1–478. doi:10.4088/JCP.14m09337.
   Web of Science ®Google Scholar
• McHenry, L. B., and J. N. Jureidini. 2008. Industry-sponsored ghostwriting in clinical trial reporting: A case study. Accountability in Research 15 (3):152–67. doi:10.1080/08989620802194384.
   PubMed Web of Science ®Google Scholar
• McIntyre, R. S., S. Lophaven, and C. K. Olsen. 2014. A randomized, double-blind, placebo-controlled study of vortioxetine on cognitive function in depressed adults. The International Journal of Neuropsychopharmacology 17 (10):1557–67. doi:10.1017/S1461145714000546.
   PubMed Web of Science ®Google Scholar
• Meeker, A. S., M. C. Herink, D. G. Haxby, and D. M. Hartung. 2015. The safety and efficacy of vortioxetine for acute treatment of major depressive disorder: A systematic review and meta-analysis. Systematic Reviews 4:21. doi:10.1186/s13643-015-0001-y.
   PubMed Web of Science ®Google Scholar
• Pae, C. U., S. M. Wang, C. Han, S. J. Lee, A. A. Patkar, P. S. Masand, and A. Serretti. 2015. Vortioxetine: A meta-analysis of 12 short-term, randomized, placebo-controlled clinical trials for the treatment of major depressive disorder. Journal of Psychiatry & Neuroscience: JPN 40 (3):174–86. doi:10.1503/jpn.140120.
   PubMed Web of Science ®Google Scholar
• Pereira, T. V., R. I. Horwitz, and J. P. Ioannidis. 2012. Empirical evaluation of very large treatment effects of medical interventions. Jama 308 (16):1676–84. doi:10.1001/jama.2012.13444.
   PubMed Web of Science ®Google Scholar
• Resnik, D. B., and K. C. Elliott. 2013. Taking financial relationships into account when assessing research. Accountability in Research 20 (3):184–205. doi:10.1080/08989621.2013.788383.
   PubMed Web of Science ®Google Scholar
• Shamoo, A. E. 2001. Adverse events reporting–the tip of an iceberg. Accountability In Research 8 (3):197–218. doi:10.1080/08989620108573974.
   PubMedGoogle Scholar
• Shaughnessy, A. F., and D. C. Slawson. 2003. What happened to the valid POEMs? A survey of review articles on the treatment of type 2 diabetes. BMJ: British Medical Journal (International Edition) 327 (7409):266. doi:10.1136/bmj.327.7409.266.
   PubMed Web of Science ®Google Scholar
• Shnier, A., J. Lexchin, B. Mintzes, A. Jutel, and K. Holloway. 2013. Too few, too weak: Conflict of interest policies at Canadian medical schools. PLoS One 8 (7):e68633. doi:10.1371/journal.pone.0068633.
   PubMed Web of Science ®Google Scholar
• Sismondo, S. 2009. Ghosts in the machine: Publication planning in the medical sciences. Social Studies of Science 39 (2):171–98. doi:10.1177/0306312708101047.
   PubMed Web of Science ®Google Scholar
• Smith, R. 2005. Medical journals are an extension of the marketing arm of pharmaceutical companies. PLoS Medicine 2 (5):e138. doi:10.1371/journal.pmed.0020138.
   PubMed Web of Science ®Google Scholar
• Tereskerz, P. M., A. B. Hamric, T. M. Guterbock, and J. D. Moreno. 2009. Prevalence of industry support and its relationship to research integrity. Accountability in Research 16 (2):78–105. doi:10.1080/08989620902854945.
   PubMed Web of Science ®Google Scholar
• Turner, E. H., A. M. Matthews, E. Linardatos, R. A. Tell, and R. Rosenthal. 2008. Selective publication of antidepressant trials and its influence on apparent efficacy. The New England Journal of Medicine 358 (3):252–60. doi:10.1056/NEJMsa065779.
   PubMed Web of Science ®Google Scholar
• Wang G., M. Gislum, G. Fillipov, and S. Montgomery. 2015. Comparison of vortioxetine versus venlafaxine XR in adults in Asia with major depressive disorder: A randomized, double-blind study. Current Medical Research & Opinion 31 (4):785–794.
   PubMed Web of Science ®Google Scholar
• Wisniewski, S. R., A. J. Rush, A. A. Nierenberg, B. N. Gaynes, D. Warden, J. F. Luther, P. J. McGrath, P. W. Lavori, M. E. Thase, M. Fava, and M. H. Trivedi. 2009. Can phase iii trial results of antidepressant medications be generalized to clinical practice? A star*d report. American Journal of Psychiatry 166 (5):599–607. doi:10.1176/appi.ajp.2008.08071027.
   PubMed Web of Science ®Google Scholar