Industry-sponsored ghostwriting in clinical trial reporting: A case study

Accountability in Research

Volumn 15, Issue 3, 2008, Pages 152-167

  McHenry, Leemon B ^a   Jureidini, Jon N ^b  

^a CALIFORNIA STATE UNIVERSITY   (United States)

^b UNIVERSITY OF ADELAIDE   (Australia)

Author keywords

Central medical affairs team; Clinical trials; Conflict of interest; Final clinical report; Glaxosmithkline; Industry sponsored ghostwriting; Key opinion leader; Off label prescriptions; Paroxetine (paxil; Paxil team; Primary efficacy variables; Scientific therapeutics information; Secondary efficacy variables; Serious adverse events; Seroxat); Smithkline beecham

Indexed keywords

PAROXETINE; SEROTONIN UPTAKE INHIBITOR;

ARTICLE; CLINICAL TRIAL; DRUG INDUSTRY; ETHICS; FORGERY; LEGAL ASPECT; TREATMENT OUTCOME; WRITING;

AUTHORSHIP; CLINICAL TRIALS AS TOPIC; DRUG INDUSTRY; FRAUD; PAROXETINE; SEROTONIN UPTAKE INHIBITORS; TREATMENT OUTCOME; WRITING;

EID: 55449116862     PISSN: 08989621     EISSN: 15455815     Source Type: Journal    
DOI: 10.1080/08989620802194384     Document Type: Article

References (47)

1. Armstrong, D. (2006). Medical reviews face criticism over lapses. Wall Street Journal, B1, July 19.
2. British Broadcasting Corporation (BBC) (2007). British Broadcasting Company, Panorama: Secrets of the Drug Trials. January 29, 2007. Available at: http://news.bbc.co.uk/1/hi/programmes/panorama/6317137.stm. Last accessed March 2008.
3. Boylan, K., Romero, S., and Birhmaher, B. (2007). Psychopharmacologic treatment of pediatric major depressive disorder. Psychopharmacology, 191: 27-38.
4. Cohen, D., Gerardin, P., Mazet, P., et al. (2004). Pharmacological treatment of adolescent major depression. Journal of Child and Adolescent Psychopharmacology,14: 19-31.
5. Holden, C (2006). Scientific publishing: The undisclosed background of a paper on a depression treatment. Science, 313: 598-59.
6. International Committee of Medical Journal Editors (ICMJE). (2001). Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Updated October 2001. Available at: www.icmje.org/. Last accessed March 2008.
7. Jureidini, J.N., McHenry, L.B., and Mansfield, P.R. (2008). Clinical trials and drug promotion: Selective reporting of Study 329. International Journal of Risk & Safety in Medicine, 20: 73-81.
8. Jureidini, J.N. (2007). Comparison of First to Final Draft. Available at: http://www.healthyskepticism.org/documents/documents/firsttofinaldraft.doc. Last accessed March 2008.
9. Jureidini, J.N., and Jureidini, E.S. (2008). 226 Papers/Letters that cite the Keller et al.'s report of Glaxo Smith Kline's Study 329 of antidepressants for adolescents. vailable at: http://www.healthyskepticism.org/documents/documents/Keller01Citations.doc. Last accessed June 2008.
10. Jureidini, J., and Tonkin, A. (2003). Paroxetine in major depression, Journal of the American Academy of Child and Adolescent Psychiatry, 42: 514.
11. Keller, M.B., Ryan, N.D., Strober, M., Klein, R.G., Kutcher, S.P., Birmaher, B., Hagino, O.R., Koplewicz, H., Carlsson, G.A., Clarke, G.N., Emslie, G.J., Feinberg, D., Geller, B., Kusumakar, V., Papatheodorou, G., Sack, W.H., Sweeney, M., Wagner, K.D., Weller, E., Winters, N.C., Oakes, R., and McCafferty, J.P. (2001). Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial. Journal of the American Academy of Child and Adolescent Psychiatry, 40: 762-772.
12. Keller, M. (2006). Keller Deposition. Beverly Smith vs. SmithKline Beecham, 09/06/2006.
13. Laden, S. (2007). Laden Deposition, Beverly Smith vs SmithKline Beecham, 15/03/2007.
14. McCafferty, J. (2006). McCafferty Deposition. Beverly Smith vs SmithKline Beecham, 08/23/2006.
15. Moffatt, B., and Elliott, C. (2007). Ghost marketing: pharmaceutical companies and ghostwritten journal articles. Perspectives in Biology and Medicine, 50: 18-31.
16. Moreno, C., Arango, C., Parellada, M., Shaffer, D., and Bird, H. (2007). Antidepressants in child and adolescent depression: Where are the bugs? Acta Psychiatrica Scandinavica, 115: 184-195.
17. Ngai, S., Gold, J., Gill, S., and Rochon, P. (2005). Haunted manuscripts: Ghost authorship in the medical literature. Accountability in Research, 12: 103-114.
18. Ryan, N. (1993) Investigator Agreement, Paroxetine 29060/329, Dec 13, 1993, RYAN000512-18. Available at: http://www.healthyskepticism.org/documents/documents/Ryan.invest.agr.pdf. Last accessed March 2008.
19. Ryan, N. (2006). Ryan Deposition. Beverly Smith vs SmithKline Beecham, 10/04/2006.
20. Shoaf, T.L. (2004). Pediatric psychopharmacology for the major psychiatric disorders found in the residential treatment setting. Child and Adolescent Psychiatric Clinics of North America, 13: 327-345.
21. SmithKline Beecham (SKB). (1992). Adolescent Unipolar Major Depression: Multisite Psychopharmacology Study. Draft of December 5, 1992, PAR000754956. Available at: http://www.healthyskepticism.org/documents/documents/19921205KellerProposal.pdf. Last accessed March 2008.
22. SmithKline Beecham (SKB). (1998a). Seroxat/Paxil adolescent depression position piece on the Phase III clinical studies, October 1998, PAR003019178. Available at: http://www.healthyskepticism.org/documents/documents/19981014PositionPiece.pdf. Last accessed March 2008.
23. SmithKline Beecham (SKB). (1998b). A Multi-Center, Double-Blind, Placebo Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression--Acute Phase. Final Clinical Report. SB Document Number: BRL-029060/RSD-100TW9/1/CPMS-329. 24 November 1998. Available at: http://www.gsk.com/media/paroxetine/depression_329_full.pdf. Last accessed March 2008.
24. SmithKline Beecham (SKB). (1998c). Laden, S. and Romankiewicz, R. Adolescent Depression. Study 329. Proposal for a Journal Article. 03/04/1998, PAR001373269-80. Available at: http://www.healthyskepticism.org/documents/documents/19980403STIContract.pdf. Last accessed March 2008.
25. SmithKline Beecham (SKB). (1998d). Keller et al. Draft I, 12/18/1998, PAR004368103. Available at: http://www.healthyskepticism.org/documents/documents/DraftI.pdf. Last accessed March 2008.
26. SmithKline Beecham (SKB). (1999a). Comments from 3 JAMA Reviewers, October 22, 1999, PAR000757500-08. Available at: http://www.healthyskepticism.org/documents/documents/19991022JAMAreviews.pdf. Last accessed March 2008.
27. SmithKline Beecham (SKB). (1999b). A Multi-Center, Double-Blind, Placebo Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression, Protocol Number 29060/329, 1993, RYAN002807-45. Available at: www.healthyskepticism.org/documents/Protocol329.pdf. Last accessed March 2008.
28. SmithKline Beecham (SKB). (1999c). Oakes to McCafferty, 05/03/1999, PAR008977374. Available at: http://www.healthyskepticism.org/documents/documents/990305OakestoMcC.pdf. Last accessed March 2008.
29. SmithKline Beecham (SKB). (1999d). McCafferty to Laden, 07/19/1999, PAR008957942. Available at: http://www.healthyskepticism.org/documents/documents/19990719McCaffertytoLaden.pdf. Last accessed March 2008.
30. SmithKline Beecham (SKB). (1999e). Keller to Laden, 02/11/1999, PAR000212926. Available at: http://www.healthyskepticism.org/documents/documents/19990211KellertoLaden_000.pdf. Last accessed March 2008.
31. SmithKline Beecham (SKB). (1999f). Klein to B. Ryan, 04/15/1999, PAR000757612. Available at: http://www.healthyskepticism.org/documents/documents/19990415KleintoBRyan.pdf. Last accessed March 2008.
32. SmithKline Beecham (SKB). (1999g). Clarke to Ryan and Strober, 03/30/1999, PAR000757619. Available at: http://www.healthyskepticism.org/documents/documents/19990330ClarketoRyan.pdf. Last accessed March 2008.
33. SmithKline Beecham (SKB). (2000a). Laden to McCafferty, 04/26/2000, PAR000756969. Available at: http://www.healthyskepticism.org/documents/documents/20000426LadentoMcCafferty.pdf. Last accessed March 2008.
34. SmithKline Beecham (SKB). (2000b). Response to JAACAP Reviewers, November 3, 2000, PAR008947745-48. Available at: http://www.healthyskepticism.org/documents/documents/responsetoJAACAPReviews.pdf. Last accessed March 2008.
35. SmithKline Beecham (SKB). (2000c). Scientific Therapeutics Information Release Form 11/06/2000, PAR008947744. Available at: http://www.healthyskepticism.org/documents/documents/STIRelease.pdf. Last accessed March 2008.
36. SmithKline Beecham (SKB). (2000d). Reviewer comments on paper submitted to JAACAP. Available at: http://www.healthyskepticism.org/documents/documents/JAACAPReviews_000.pdf. Last accessed March 2008.
37. SmithKline Beecham (SKB). (2001a). Response to Queries from Mina Dulcan, 01/05/2001, PAR008965031-32. Available at: http://www.healthyskepticism.org/documents/documents/ResponsestoDulcan.pdf. Last accessed March 2008.
38. SmithKline Beecham (SKB). (2001b). Pretre to Keller, 02/06/2001, PAR000757621. Available at: http://www.healthyskepticism.org/documents/documents/20010206PretretoKeller.pdf. Last accessed March 2008.
39. SmithKline Beecham (SKB). (2001c). Laden to Brand et al., 01/11/2001, PAR008409833. Available at: http://www.healthyskepticism.org/documents/documents/20010111LadentoBrand.pdf. Last accessed March 2008.
40. SmithKline Beecham (SKB). (2001d). Battin to Laden, 04/25/2001, PAR012136791-92. Available at: http://www.healthyskepticism.org/documents/documents/010425BattintoLaden.pdf. Last accessed March 2008.
41. SmithKline Beecham (SKB). (2001e). White to Hood, 03/05/2001, PAR012140677-78. Available at: http://www.healthyskepticism.org/documents/documents/20010305WhitetoHood.pdf. Last accessed March 2008.
42. SmithKline Beecham (SKB). (2001f). Laden to McCafferty, 08/07/2001, PAR001380128. Available at: http://www.healthyskepticism.org/documents/documents/20010807LadentoMcCafferty.pdf. Last accessed March 2008.
43. SmithKline Beecham (SKB). (2001g). Zachary Hawkins to All Sales Representatives Selling Paxil, 08/16/2001, PAR000651577-78. Available at: http://www.healthyskepticism.org/documents/documents/20010816Hawkinstoreps.pdf. Last accessed March 2008.
44. SmithKline Beecham (SKB). (2002). GSK to Dear Dr, 02/21/2002, PAR001986877-92. Available at: http://www.healthyskepticism.org/documents/documents/2002MedQuery.pdf. Last accessed March 2008.
45. Steele, M.M. and Doey, T. (2007). Suicidal behaviour in children and adolescents, Part 2: Treatment and prevention. Canadian Journal of Psychiatry, 52:35S-45S.
46. Scientific Therapeutics Information, Inc. (STI). (2006). Scientific Therapeutics Information, Inc. Website. Available at: www.stimedinfo.com. Last accessed March 2008.
47. Strober, M. (2007). Strober Deposition. Beverly Smith vs. SmithKline Beecham, 11/04/2007.