The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance

International Journal of Risk and Safety in Medicine

Volumn 28, Issue 1, 2016, Pages 33-43

  Jureidini, Jon N ^a   Amsterdam, Jay D ^b   McHenry, Leemon B ^c  

^a UNIVERSITY OF ADELAIDE   (Australia)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c CALIFORNIA STATE UNIVERSITY   (United States)

Author keywords

Citalopram; depression; escitalopram; FDA; ghostwriting; key opinion leaders; psychiatric litigation; research misconduct; SSRI antidepressants

Indexed keywords

CITALOPRAM; ESCITALOPRAM; PLACEBO; ANTIDEPRESSANT AGENT;

ACADEMIC FAILURE; ACADEMIC MALFEASANCE; ADOLESCENT; ARTICLE; ASSESSMENT OF HUMANS; CHILD; CHILDREN DEPRESSION RATING SCALE REVISED; CONTROLLED STUDY; DATA ANALYSIS; DATA MISCHARACTERIZATION; DEPRESSION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; EFFECT SIZE; FOOD AND DRUG ADMINISTRATION; HUMAN; LAW SUIT; MAJOR DEPRESSION; MEDICAL DOCUMENTATION; MEDICAL GHOSTWRITING; MEDICAL LITERATURE; POST HOC ANALYSIS; RANDOMIZED CONTROLLED TRIAL; SAMPLE SIZE; SCHEDULE FOR AFFECTIVE DISORDERS AND SCHIZOPHRENIA; STATISTICAL SIGNIFICANCE; METHODOLOGY; PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); STANDARDS; STATISTICAL ANALYSIS;

ADOLESCENT; ANTIDEPRESSIVE AGENTS, SECOND-GENERATION; CHILD; CITALOPRAM; CLINICAL TRIALS, PHASE III AS TOPIC; DATA INTERPRETATION, STATISTICAL; DEPRESSION; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN;

EID: 84971434622     PISSN: 09246479     EISSN: 18786847     Source Type: Journal    
DOI: 10.3233/JRS-160671     Document Type: Article

References (34)

1. Whittington, CJ, Kendall T, Fonagy P, et al. Selective serotonin reuptake inhibitors in childhood depression: Systematic review of published versus unpublished data. Lancet. 2004;363:1341-5.
2. Hammad TA, Laughren TP, Racoosin JA. Suicide rates in short-term randomized controlled trials of newer antidepressants. J Clin Psychopharmacol. 2006;26(2):203-7.
3. Wijlaars LP, Nazareth I, Petersen I. Trends in depression and antidepressant prescribing in children and adolescents: A cohort study in The Health Improvement Network (THIN). PLoS One. 2012;7(3):e33181. doi: 10.1371/journal. pone.0033181. Epub 2012 Mar 13.
4. Turner EH. Publication bias, with a focus on psychiatry: Causes and solutions. CNS Drugs. 2013;27(6):457-68. doi: 10.1007/s40263-013-0067-9
5. Jureidini J, McHenry L, Mansfield P. Clinical trials and drug promotion: Selective reporting of study 329. Int J Risk Saf Med. 2008;20(1-2):73-81.
6. Healy, D., Cattell, D. Interface between authorship, industry and science in the domain of therapeutics. Br J Psychiatry. 2003;183:22-7.
7. 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. BMJ. 2015;351:h4320.
8. Keller MB, Ryan ND, Strober M, 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.
9. Horton R. The dawn of McScience. NY Rev Books. 51(4):7-9.
10. Wagner KD, Robb AS, Findling RL, Jin J, Gutierrez MM, Heydorn WE. A randomized, placebo-controlled trial of citalopram for the treatment of major depression in children and adolescents. Am J Psych. 2004;161(6):1079-83.
11. Email with attached info to Grassley on Citalopram and Escitalopram Studies in Pediatric Patients. 2004 September 15. http://industrydocuments.library.ucsf.edu/drug/docs/lkmf0220. Accessed February 2015.
12. Forest Research Institute. Study Protocol for MD-18. 1999 September 01. http://industrydocuments.library. ucsf.edu/drug/docs/gpmf0220. Accessed February 2015.
13. E-mail by Forest Staff re Peds Manuscript dated 4/17/02. http://industrydocuments.library.ucsf.edu/drug/docs/hymf0220. Accessed February 2015.
14. E-mail re: Pediatric data dated 10/15/01. http://industrydocuments.library.ucsf.edu/drug/docs/pymf0220. Accessed February 2015.
15. E-mail re: Pediatric data dated 10/16/01. http://industrydocuments.library.ucsf.edu/drug/docs/tymf0220. Accessed February 2015.
16. E-mail re: Pediatric Manuscript dated 12/17/01. http://industrydocuments.library.ucsf.edu/drug/docs/yymf0220. Accessed February 2015.
17. Ghostwritten Wagner study published in American Journal of Psychiatry dated 6/24/04. http:industrydocuments. library.ucsf.edu/drug/docs/qkmf0220. Accessed February 2015.
18. Senate Committee on Finance-Lexapro Marketing Plan Documents. http://industrydocuments.library.ucsf.edu/wpcontent/uploads/2015/01/celexa-lexapro-grassley-baucus-documents-unsealed.pdf. Accessed February 2015.
19. Freedman R, Roy MD. Editor's note. Am J Psych. 2009;166(8):942-3.
20. Wagner KD, Robb AS, Findling RL, Jin J, Wagner and colleagues reply. Am J Psych. 2005;162(4):819.
21. von Knorring AL, Olsson GI, Thomsen PH, Lemming OM, Hulten A. A randomized, double-blind, placebo-controlled study of citalopram in adolescents with depression. J Clin Psychopharm. 2006;26(3):311-5.
22. Email re: study 94404 Headline results. 2001 July 16. http://industrydocuments.library.ucsf.edu/drug/docs/nkmf0220. Accessed February 2015.
23. Jureidini, Jon. Declaration of Dr. Jon Jureidini. 2012 November 15. http://industrydocuments.library.ucsf.edu/drug/docs/znmf0220. Accessed February 2015.
24. Forest Research Institute. Study Report for Protocol No. CIT-MD-18. April 8, 2002. http://industrydocuments.library. ucsf.edu/drug/docs/jpmf0220.pdf. Accessed February 2015.
25. Martin A, Gilliam WS, Bostic JQ, Rey JM. Letter to the editor. Child psychopharmacology, effect sizes, and the big bang. Am J Psych. 2005;162(4):817.
26. Mathews M, Adetunji B, Mathews J, Basil B, George V, Mathews M, Budur K, Abraham S. Child psychopharmacology, effect sizes, and the big bang. Am J Psych. 2005;162(4):818.
27. Jureidini J, Doecke C, Mansfield P, Haby M, Menkes D, Tonkin A. Efficacy and safety of antidepressants for children and adolescents. BMJ. 2004;328:879-83.
28. International Committee of Medical Journal Editors. http://www.icmje.org. Accessed February 2015.
29. Forest Laboratories. Results of Escitalopram and Celexa ™ Studies Presented at Major Scientific Conference. http://www.prnewswire.com/news-releases/results-of-escitalopram-and-celexatm-studies-presented-at-majorscientific-conference-74591942.html. Accessed February 2015.
30. Carandang C, Jabbal R, MacBride A, Elbe D.Areviewof escitalopram and citalopram in child and adolescent depression. J Can Acad Child Adolesc Psych. 2011;20(4):323.
31. Newman M. The rules of retraction. BMJ. 2010;341:1246-8.
32. Amsterdam JD, McHenry L. The paroxetine 352 bipolar trial: A study in medical ghostwriting. Int J Risk Saf Med. 2012;24(4):221-31.
33. Nemeroff CB, Evans DL, Gyulai L, Sachs GS, Bowden CL, Gergel IP, Oakes R, Pitts CD. Double-blind, placebocontrolled comparison of imipramine and paroxetine in the treatment of bipolar depression. Am J Psychiatry. 2001;158(6):906-12.
34. Steinman MA, Bero LA, Chren MM, Landefeld CS. Narrative review: The promotion of gabapentin: An analysis of internal industry documents. Ann Inter Med. 2006;145:284-93.