Skip to main content

The Influence of Pharmaceutical Companies and Restoring Integrity to Psychiatric Research and Practice

  • Chapter
  • First Online:
Critical Psychiatry

Abstract

A growing concern across all areas of medicine is that commercial interests are undermining the medical profession’s culture and public health mission. The absence of biological markers for psychiatric conditions makes psychiatry more vulnerable to industry influence and, concomitantly, to overdiagnosis and overtreatment. Although we discuss conflicts of interest, we use the more robust framework of institutional corruption to understand the economies of influence and problematic incentive structures that have had a distorting effect on psychiatric research and practice. We provide specific examples of these distortions and discuss their implications (e.g., how the DSM-5 may have inadvertently functioned as a vehicle for high-profit patent extensions). Suggestions for how the profession can work to inoculate itself from commercial influences are offered.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

eBook
USD 16.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 16.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Notes

  1. 1.

    It should be emphasized that many trials were running before the DSM-5 was published. In other words, clinical trials were being run to test drugs for disorders that did not yet officially exist (e.g., binge eating disorder, mild neurocognitive disorder, disruptive mood dysregulation disorder, bereavement-related depression). Certainly, pharmaceutical companies would be delighted by the official inclusion of new DSM disorders; obtaining 3 more years of exclusivity for drugs capable of generating over US$1 billion in sales is a boon to industry.

References

  1. American Psychiatric Association. Practice guideline for the treatment of patients with major depressive disorder. 3rd ed. Washington, DC: American Psychiatric Publishing; 2010. https://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/mdd.pdf. Accessed 3 Feb 2018.

    Google Scholar 

  2. American Psychiatric Association. Practice guideline for the treatment of patients with major depressive disorder, reaffirmed; 2015. https://www.guidelinecentral.com/summaries/practice-guideline-for-the-treatment-of-patients-with-major-depressive-disorder-third-edition/#section-420. Accessed 17 July 2018.

  3. Andreasen NC. Brave new brain: conquering mental illness in the era of the genome. New York: Oxford University Press; 2001.

    Google Scholar 

  4. Appelbaum PS, Gold A. Psychiatrists’ relationships with industry: the principal-agent problem. Harv Rev Psychiatry. 2010;18(5):255–65. https://doi.org/10.3109/10673229.2010.507038.

    Article  PubMed  Google Scholar 

  5. Bachmann CJ, Aagaard L, Burcu M, Glaeske G, Kalverdijk LJ, Petersen I, et al. Trends and patterns of antidepressant use in children and adolescents from five western countries, 2005–2012. Eur Neuropsychopharmacol. 2016;26(3):411–9. https://doi.org/10.1016/j.euroneuro.2016.02.001.

    Article  CAS  PubMed  Google Scholar 

  6. Baldwin J. As much truth as one can bear. New York Times Book Review; 1962.

    Google Scholar 

  7. Batstra L, Frances A. Diagnostic inflation: causes and a suggested cure. J Nerv Ment Disord. 2012;200(6):474–9. https://doi.org/10.1097/NMD.0b013e318257c4a2.

    Article  Google Scholar 

  8. Pettypiece S. Bloomberg News; 2013. https://www.bloomberg.com/news/articles/2013-01-29/lilly-profit-beats-analyst-estimates-as-cymbalta-sales-climb. Accessed 22 Aug 2018.

  9. Boutron I, Dutton S, Ravaud P, Altman DG. Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. J Am Med Assoc. 2010;303(20):2058–64. https://doi.org/10.1001/jama.2010.651.

    Article  CAS  Google Scholar 

  10. Bracken P, Thomas P, Timimi S, Asen E, Behr G, et al. Psychiatry beyond the current paradigm. Br J Psychiatry. 2012;201(6):430–4.

    Article  PubMed  Google Scholar 

  11. Brauser, D. DSM-5 field trials generate mixed results; 2012. Retrieved from https://www.medscape.com/viewarticle/763519

  12. British Psychological Society. DSM 5: The future of psychiatric diagnosis; 2012. Retrieved from https://dxrevisionwatch.files.wordpress.com/2012/02/dsm-5-2012-bps-response.pdf

  13. Callaghan GM, Chacon C, Coles C, Botts J, Laraway S. An empirical evaluation of the diagnostic criteria for premenstrual dysphoric disorder: problems with sex specificity and validity [Article]. Women Ther. 2009;32(1):1–21. https://doi.org/10.1080/02703140802402396.

    Article  Google Scholar 

  14. Carey B. Panel to debate antidepressant warnings; 2006. Retrieved from http://www.nytimes.com/2006/12/13/us/13suicide.html

  15. Carlat D. Unhinged: the trouble with psychiatry – A doctor’s revelation about a profession in crisis. New York: First Free Press; 2010.

    Google Scholar 

  16. Chiu K, Grundy Q, Bero L. ‘Spin’ in published biomedical literature: a methodological systematic review. PLoS Biol. 2017;15(9):e2002173. https://doi.org/10.1371/journal.pbio.2002173.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  17. Cosgrove L, Krimsky S, Wheeler EE, Kaitz J, Greenspan SB, DiPentima NL. Tripartite conflicts of interest and high stakes patent extensions in the DSM-5. Psychother Psychosom. 2014;83(2):106–13. https://doi.org/10.1159/000357499.

    Article  PubMed  Google Scholar 

  18. Cosgrove L, Wheeler EE. Drug firms, the codification of diagnostic categories, and bias in clinical guidelines. J Law Med Ethics. 2013;41 https://doi.org/10.1111/jlme.12074.

    Article  Google Scholar 

  19. Cosgrove L, Vannoy S, Mintzes B, Shaughnessy AF. Under the influence: the interplay among industry, publishing, and drug regulation. Account Res. 2016;23(5):257–79. https://doi.org/10.1080/08989621.2016.1153971.

    Article  PubMed  Google Scholar 

  20. Cuijpers P, Karyotaki E, Weitz E, Andersson G, Hollon SD, van Straten A. The effects of psychotherapies for major depression in adults on remission, recovery and improvement: a meta-analysis. J Affect Disord. 2014;159:118–26. https://doi.org/10.1016/j.jad.2014.02.026.

    Article  PubMed  Google Scholar 

  21. Elliott C. Industry-funded bioethics and the limits of disclosure. In: Arnold DG, editor. Ethics and business of biomedicine. Cambridge: Cambridge University Press; 2009. p. 150–68.

    Google Scholar 

  22. Fontanarosa P, Bauchner H. (Editorial). Conflict of interest and medical journals [Theme issue]. J Am Med Assoc. 2017; 317(17). https://doi.org/10.1001/jama.2017.4563.

    Article  PubMed  Google Scholar 

  23. Fournier JC, DeRubeis RJ, Hollon SD, Dimidjian S, Amsterdam JD, Shelton RC, et al. Antidepressant drug effects and depression severity: a patient-level meta-analysis. J Am Med Assoc. 2010;303. https://doi.org/10.1001/jama.2009.1943.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  24. Frances A. DSM 5 is guide not bible – simply ignore its ten worst changes; 2012. Retrieved from https://www.psychologytoday.com/blog/dsm5-in-distress/201212/dsm-5-is-guide-not-bible-ignore-its-ten-worst-changes

  25. Gopal AA, Cosgrove L, Shuv-Ami I, Wheeler EE, Yerganian MJ, Bursztajn HJ. Dynamic informed consent processes vital for treatment with antidepressants. Int J Law Psychiatry. 2012;35(5–6):392–7. https://doi.org/10.1016/j.ijlp.2012.09.006.

    Article  PubMed  Google Scholar 

  26. Gupta H, Kumar S, Roy SK, Gaud RS. Patent protection strategies. J Pharm Bioallied Sci. 2010;2(1):2–7. https://doi.org/10.4103/0975-7406.62694.

    Article  PubMed  PubMed Central  Google Scholar 

  27. Hamm RM. Automatic thinking. In: Kattan MW, editor. Encyclopedia of medical decision making. Thousand Oaks: Sage Publications; 2009a. p. 45–9.

    Google Scholar 

  28. Hamm RM. Irrational persistence in belief. In: Kattan MW, editor. Encyclopedia of medical decision making. Thousand Oaks: Sage Publications; 2009b. p. 640–4.

    Google Scholar 

  29. Higgins JPT, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, et al. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. Br Med J. 2011;343 https://doi.org/10.1136/bmj.d5928.

    Article  PubMed  PubMed Central  Google Scholar 

  30. Jakobsen JC, Katakam KK, Schou A, Hellmuth SG, Stallknecht SE, Leth-Møller K, et al. Selective serotonin reuptake inhibitors versus placebo in patients with major depressive disorder. A systematic review with meta-analysis and trial sequential analysis. BMC Psychiatry. 2017;17(1):58. https://doi.org/10.1186/s12888-016-1173-2.

    Article  PubMed  PubMed Central  Google Scholar 

  31. Jones RG, Ornstein C. Matching industry payments to Medicare prescribing patterns: an analysis. ProPublica; 2016. Retrieved from https://static.propublica.org/projects/d4d/20160317-matching-industry-payments.pdf?22

  32. Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, Kokkotou E, Singer JP, et al. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One. 2010;5(12):e15591. https://doi.org/10.1371/journal.pone.0015591.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  33. Keller MB, Ryan ND, Strober M, Klein RG, Kutcher SP, Birmaher B, et al. Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry. 2001;40(7):762–72. https://doi.org/10.1097/00004583-200107000-00010.

    Article  CAS  PubMed  Google Scholar 

  34. Keshavarz H, Fitzpatrick-Lewis D, Streiner DL, Maureen R, Ali U, Shannon HS, et al. Screening for depression: a systematic review and meta-analysis. CMAJ Open. 2013;1(4):E159–67. https://doi.org/10.9778/cmajo.20130030.

    Article  PubMed  PubMed Central  Google Scholar 

  35. Khan A, Brown WA. Antidepressants versus placebo in major depression: an overview. World Psychiatry. 2015;14(3):294–300. https://doi.org/10.1002/wps.20241.

    Article  PubMed  PubMed Central  Google Scholar 

  36. Kirsch I, Deacon BJ, Huedo-Medina TB, Scoboria A, Moore TJ, Johnson BT. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the food and drug administration. [Comparative study meta-analysis]. PLoS Med. 2008;5(2):e45. https://doi.org/10.1371/journal.pmed.0050045.

    Article  PubMed  PubMed Central  Google Scholar 

  37. Le Noury J, Nardo JM, Healy D, Jureidini J, Raven M, Tufanaru C, Abi-Jaoude E. Restoring study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. Br Med J. 2015;351. https://doi.org/10.1136/bmj.h4320.

  38. Lenzer J. FDA panel urges “black box” warning for antidepressants. Br Med J. 2004;329(7468):702. https://doi.org/10.1136/bmj.329.7468.702.

    Article  Google Scholar 

  39. Lessig L. Republic, lost: how money corrupts congress – and a plan to stop it. New York: Hachette Book Group; 2011.

    Google Scholar 

  40. Lessig L. America, compromised. Chicago: University of Chicago Press; 2018.

    Book  Google Scholar 

  41. Lieberthal AS, Carroll AE, Chonmaitree T, Ganiats TG, Hoberman A, Jackson MA, et al. The diagnosis and management of acute otitis media. Pediatrics. 2013;131(3):e964–99. https://doi.org/10.1542/peds.2012-3488.

    Article  PubMed  Google Scholar 

  42. Lindsley CW. 2013 trends and statistics for prescription medications in the United States: CNS highest ranked and record number of prescriptions dispensed. ACS Chem Neurosci. 2015a;6(3):356–7. https://doi.org/10.1021/acschemneuro.5b00049.

    Article  CAS  PubMed  Google Scholar 

  43. Lindsley CW. 2014 prescription medications in the United States: tremendous growth, specialty/orphan drug expansion, and dispensed prescriptions continue to increase. ACS Chem Neurosci. 2015b;6(6):811–2. https://doi.org/10.1021/acschemneuro.5b00148.

    Article  CAS  PubMed  Google Scholar 

  44. Mahableshwarkar AR, Jacobsen PL, Serenko M, Chen Y, Trivedi MH. A randomized, double-blind, placebo-controlled study of the efficacy and safety of 2 doses of vortioxetine in adults with major depressive disorder. J Clin Psychiatry. 2015;76(5):583–91. https://doi.org/10.4088/JCP.14 m09337.

    Article  PubMed  Google Scholar 

  45. Mangin D, Heath I, Jamoulle M. Beyond diagnosis: rising to the multimorbidity challenge. BMJ. 2012;344:e3526. https://doi.org/10.1136/bmj.e3526.

    Article  PubMed  Google Scholar 

  46. McHenry LB, Jureidini JN. Industry-sponsored ghostwriting in clinical trial reporting: a case study. Account Res. 2008;15(3):152–67. https://doi.org/10.1080/08989620802194384.

    Article  PubMed  Google Scholar 

  47. Mittal M, Harrison DL, Miller MJ, Brahm NC. National antidepressant prescribing in children and adolescents with mental health disorders after an FDA boxed warning. Res Soc Adm Pharm. 2014;10(5):781–90. https://doi.org/10.1016/j.sapharm.2013.11.001.

    Article  Google Scholar 

  48. Meeker AS, Herink MC, Haxby DG, Hartung DM. The safety and efficacy of vortioxetine for acute treatment of major depressive disorder: a systematic review and meta-analysis. Syst Rev. 2015;4:21. https://doi.org/10.1186/s13643-015-0001-y.

    Article  PubMed  PubMed Central  Google Scholar 

  49. Mitchell J, Trangle M, Degnan B, Gabert T, Haight B, Kessler D, Mack N, Mallen E, Novak H, Rossmiller D, Setterlund L, Somers K, Valentino N, Vincent S. Institute for Clinical Systems Improvement. Adult depression in primary care; 2013. Retrieved from http://pcptoolkit.beaconhealthoptions.com/wp-content/uploads/2016/02/ICSI_Depression.pdf

  50. Moynihan R. Caution! Diagnosis creep. Aust Prescr. 2016;39(2):30–1. https://doi.org/10.18773/austprescr.2016.021.

    Article  PubMed  PubMed Central  Google Scholar 

  51. Moynihan R, Cassels A. Selling sickness: how the world’s biggest pharmaceutical companies are turning us all into patients. New York: Nation Books; 2005.

    Google Scholar 

  52. Moynihan R, Doust J, Henry D. Preventing overdiagnosis: how to stop harming the healthy. Br Med J. 2012;344:e3502. https://doi.org/10.1136/bmj.e3502.

    Article  Google Scholar 

  53. National Institute for Health and Care Excellence. Depression in adults: recognition and management. Clinical guideline [CG90]; 2016. Retrieved from https://www.nice.org.uk/guidance/cg90/resources

  54. Pae CU, Wang SM, Han C, Lee SJ, Patkar AA, Masand PS, et al. Vortioxetine: a meta-analysis of 12 short-term, randomized, placebo-controlled clinical trials for the treatment of major depressive disorder. J Psychiatry Neurosci. 2015;40(3):174–86.

    Article  PubMed  PubMed Central  Google Scholar 

  55. Pigott HE, Leventhal AM, Alter GS, Boren JJ. Efficacy and effectiveness of antidepressants: current status of research. Psychother Psychosom. 2010;79(5):267–79. https://doi.org/10.1159/000318293.

    Article  PubMed  Google Scholar 

  56. Pūras D. Report of the special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health; 2017. Retrieved from http://www.un.org/en/ga/search/view_doc.asp?symbol=A/72/137

  57. Quanstrum KH, Hayward RA. Lessons from the mammography wars. N Engl J Med. 2010;363:1076–9.

    Article  CAS  PubMed  Google Scholar 

  58. Regier D. In Elias, M, USA Today: conflicts of interest bedevil psychiatric drug research; 2009. Retrieved from http://www.usatoday.com/news/health/2009-06-02-psychiatry-drugs-conflicts_N.htm

  59. Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatr. 2006;163(11):1905–17. https://doi.org/10.1176/ajp.2006.163.11.1905.

    Article  PubMed  Google Scholar 

  60. Schwartz LM, Woloshin S. Low “T” as in “template”: how to sell disease. JAMA Intern Med. 2013;173(15):1460–2. https://doi.org/10.1001/jamainternmed.2013.7579.

    Article  PubMed  Google Scholar 

  61. Sismondo S. Key opinion leaders and the corruption of medical knowledge: what the Sunshine Act will and won’t cast light on. J Law Med Ethics. 2013;41(3):635–43. https://doi.org/10.1111/jlme.12073.

    Article  PubMed  Google Scholar 

  62. Sox H. Conflict of interest in practice guidelines panels. JAMA. 2017;317(17):1739–40. https://doi.org/10.1001/jama.2017.2701.

    Article  PubMed  Google Scholar 

  63. Spitzer RL, Williams JB, Endicott J. Standards for DSM-5 reliability. Am J Psychiatr. 2012;169(5):537.; author reply 537–538. https://doi.org/10.1176/appi.ajp.2012.12010083.

    Article  PubMed  Google Scholar 

  64. Trivedi MH, Rush AJ, Wisniewski SR, Nierenberg AA, Warden D, Ritz L, et al. Evaluation of outcomes with citalopram for depression using measurement-based care in STAR*D: implications for clinical practice. Am J Psychiatr. 2006;163(1):28–40. https://doi.org/10.1176/appi.ajp.163.1.28.

    Article  PubMed  Google Scholar 

  65. Thompson DF. Two concepts of corruption. Edmond J. Safra working papers, no. 16; 2013. Retrieved from https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2304419

  66. Thompson DF. Understanding financial conflicts of interest. N Engl J Med. 1993;329(8):573–6. https://doi.org/10.1056/nejm199308193290812.

    Article  CAS  PubMed  Google Scholar 

  67. 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 https://doi.org/10.1056/NEJMsa065779.

    Article  CAS  PubMed  Google Scholar 

  68. UK NSC depression screening recommendation; 2015. Retrieved from https://legacyscreening.phe.org.uk/depression

  69. United States Preventive Services Task Force. Screening for depression in adults: US Preventive Services Task Force recommendation statement. J Am Med Assoc. 2016;315:380–7. Retrieved from https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/depression-in-adults-screening1#copyright-and-source-information

    Article  Google Scholar 

  70. Van Weel-Baumgarten EM, Van Gelderen MG, Grundmeijer HGLM, Light-Strunk E, Van Marwijk HWJ, Van Rijswijk HCAM, et al. NHG-Standard depression (second revision). Huisarts Act. 2012; 252–259. Retrieved from: https://www.nhg.org/standaarden/volledig/nhg-standaard-depressie-tweede-herziening.

  71. Woloshin S, Schwartz LM. Giving legs to restless legs: a case study of how the media helps make people sick. PLoS Med. 2006;3(4):e170. https://doi.org/10.1371/journal.pmed.0030170.

    Article  PubMed  PubMed Central  Google Scholar 

  72. Whiteford HA, Harris MG, McKeon G, Baxter A, Pennell C, Barendregt JJ, Wang J. Estimating remission from untreated major depression: a systematic review and meta-analysis. Psychol Med. 2013;43(8):1569–85. https://doi.org/10.1017/S0033291712001717.

    Article  CAS  PubMed  Google Scholar 

  73. Wilson M. DSM-III and the transformation of American psychiatry: a history. Am J Psychiatr. 1993;150(3):399–410. https://doi.org/10.1176/ajp.150.3.399.

    Article  CAS  PubMed  Google Scholar 

  74. Yank V, Rennie D, Bero LA. Financial ties and concordance between results and conclusions in meta-analyses: retrospective cohort study. Br Med J. 2007;335(7631):1202–5. https://doi.org/10.1136/bmj.39376.447211.BE.

    Article  Google Scholar 

  75. Yavchitz A, Boutron I, Bafeta A, Marroun I, Charles P, Mantz J, et al. Misrepresentation of randomized controlled trials in press releases and news coverage: a cohort study. PLoS Med. 2012;9(9):e1001308. https://doi.org/10.1371/journal.pmed.1001308.

    Article  PubMed  PubMed Central  Google Scholar 

  76. Yavchitz A, Ravaud P, Altman DG, Moher D, Hrobjartsson A, Lasserson T, et al. A new classification of spin in systematic reviews and meta-analyses was developed and ranked according to the severity. J Clin Epidemiol. 2016;75:56–65. https://doi.org/10.1016/j.jclinepi.2016.01.020.

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Lisa Cosgrove .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2019 Springer Nature Switzerland AG

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Cosgrove, L., Vaswani, A. (2019). The Influence of Pharmaceutical Companies and Restoring Integrity to Psychiatric Research and Practice. In: Steingard, S. (eds) Critical Psychiatry. Springer, Cham. https://doi.org/10.1007/978-3-030-02732-2_3

Download citation

  • DOI: https://doi.org/10.1007/978-3-030-02732-2_3

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-030-02731-5

  • Online ISBN: 978-3-030-02732-2

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics