Differences in reporting serious adverse events in industry sponsored clinical trial registries and journal articles on antidepressant and antipsychotic drugs: A cross-sectional study

BMJ Open

Volumn 4, Issue 7, 2014, Pages

  Hughes, Shannon ^a   Cohen, David ^b   Jaggi, Rachel ^c  

^a Department of Environmental and Radiological Health Sciences   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c UNIVERSITY OF UTAH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARIPIPRAZOLE; ATOMOXETINE; DULOXETINE; OLANZAPINE; SERTRALINE; ZIPRASIDONE; ANTIDEPRESSANT AGENT; NEUROLEPTIC AGENT;

ALCOHOLISM; ALZHEIMER DISEASE; ANXIETY DISORDER; ARTICLE; ATTENTION DEFICIT DISORDER; AUTISM; BIPOLAR DISORDER; BORDERLINE STATE; CLINICAL TRIAL (TOPIC); CROSS-SECTIONAL STUDY; DEPRESSION; DRUG INDUSTRY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; HUMAN; MANIA; MEDICAL LITERATURE; NATIONAL HEALTH ORGANIZATION; OUTCOME ASSESSMENT; PAIN; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHASE 4 CLINICAL TRIAL (TOPIC); POSTTRAUMATIC STRESS DISORDER; PSYCHOSIS; REGISTER; UNSPECIFIED SIDE EFFECT; COMPARATIVE STUDY; PUBLICATION; SEVERITY OF ILLNESS INDEX; STATISTICS AND NUMERICAL DATA;

ADVERSE DRUG REACTION REPORTING SYSTEMS; ANTIDEPRESSIVE AGENTS; ANTIPSYCHOTIC AGENTS; CLINICAL TRIALS AS TOPIC; CROSS-SECTIONAL STUDIES; DRUG INDUSTRY; HUMANS; PERIODICALS AS TOPIC; REGISTRIES; SEVERITY OF ILLNESS INDEX;

EID: 84904262560     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2014-005535     Document Type: Article

References (50)

1. Dickersin K, Rennie D. The evolution of trial registries and their use to assess the clinical trial enterprise. JAMA 2012;307:1861-4.
2. Turner E. Publication bias, with a focus on psychiatry: causes and solutions. CNS Drugs 2013;27:457-68.
3. Doshi P, Jefferson T, Del Mar C. The imperative to share clinical study reports: Recommendations from the Tamiflu experience. PLoS Med 2012;9:e1001201.
4. Doshi P, Jones M, Jefferson T. Rethinking credible evidence synthesis. BMJ 2012;344:d7898.
5. Structure and content of clinical study reports E3. 1995. http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/Efficacy/ E3/E3-Guideline.pdf
6. Guidance for industry and investigators: safety reporting requirements for INDs and BA/BE studies. 2012. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM227351.pdf
7. Reporting requirements of individual case safety reports (ICSRs) applicable to marketing authorisation holders during the interim period. 2013. http://www.ema.europa.eu/docs/en-GB/document-library/Regulatory-and-procedural- guideline/2012/05/WC500127657.pdf
8. Earley A, Lau J, Uhling K. Haphazard reporting of deaths in clinical trials: a review of cases of ClinicalTrials.gov records and matched publications - a cross-sectional study. BMJ Open 2013;3:e001963.
9. Riveros C, Dechartes A, Perrodeau E, et al. Timing and completeness of trial results posted at Clinicaltrials.gov and published in journals. PLoS Med 2013;10:e1001566.
10. Wieseler B, Wolfram N, McGauran N, et al. Completeness of reporting of patient-relevant clinical trial outcomes: comparison of unpublished clinical study reports with publicly available data. PLoS Med 2013;10:e1001526.
11. Thomas K. J&J. fined $1.2 billion in drug case. New York Times 2012 April 12, 2012. http://www.nytimes.com/2012/04/12/business/drug-giant-is- fined-1-2-billion-in-arkansas.html
12. Thomas K, Schmidt M. Glaxo agrees to pay $3 billion in fraud settlement. New York Times 2012. http://www.nytimes.com/2012/07/03/business/ glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?pagewanted=all
13. Almashat S, Wolfe S. Pharmaceutical industry criminal and civil penalties: An update. 2012; Available from: http://www.citizen.org/documents/ 2073.pdf (accessed 21 Oct 2013).
14. Top therapeutic classes by US spending. 2012. http://www.imshealth.com/ deployedfiles/ims/Global/Content/Corporate/Press%20Room/Top- Line%20Market%20Data%20&%20Trends/2011%20Top-line%20Market%20Data/ Top-Therapy-Classes-by-Sales.pdf (accessed 18 Jul 2012).
15. Top 20 global therapeutic classes, 2011. 2012. http://www.imshealth.com/ deployedfiles/ims/Global/Content/Corporate/Press%20Room/Top- Line%20Market%20Data%20&%20Trends/2011%20Top-line%20Market%20Data/ Top-20-Global-Therapeutic-Classes.pdf
16. Alexander G, Gallagher S, Mascola A, et al. Increasing off-label use of antipsychotic medications in the United States, 1995-2008. Pharmacoepidemiol Drug Saf 2011;20:177-84.
17. Mark T. For what diagnoses are psychotropic medications being prescribed? A nationally representative survey of physicians. CNS Drugs 2010;24:319-26.
18. PhRMA clinical study results database proposal. 2004. http://www.aei.org/files/2004/09/20/20040927-ClinicalStudyResultsDatabase.pdf (accessed 30 Aug 2008).
19. PASW Statistics, 18.0. Chicago: Predictive Analytics Software 2009.
20. De Deyn PP, Carrasco M, Deberdt W, et al. Olanzapine versus placebo in the treatment of psychosis with or without associated behavioral disturbances in patients with Alzheimer's disease. Int J Geriatr Psychiatry 2004;19:115-26. (Pubitemid 38247846)
21. Tran-Johnson T, Sack D, Marcus R, et al. Efficacy and safety of intramuscular aripiprazole in patients with acute agitation: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry 2007;68:111-19. (Pubitemid 46220132)
22. Veitch E. Silent takedown of the pharma trials database...and more. 2012. http://blogs.plos.org/speakingofmedicine/2012/03/23/silent-takedown-of-the- pharma-trials-database%E2%80%A6and-more/
23. Chan A-W, Hrobjartsson A, Haahr MT, et al. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 2004;291:2457-65. (Pubitemid 38669189)
24. Heres S, Davies J, Maino K, et al. Why olanzapine beats risperidone, risperidone beats quetiapine, and quetiapine beats olanzapine: an exploratory analysis of head-to-head comparison studies of second-generation antipsychotics. Amer J Psych 2006;163:185-94. (Pubitemid 44480836)
25. Ioannidis JPA, Lau J. Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. JAMA 2001;285:437-43. (Pubitemid 32097262)
26. Jones C, Handler L, Crowell K, et al. Non-publication of large randomized clinical trials: cross sectional analysis. BMJ 2013;347:f6104.
27. Wieseler B, Kerekes MF, Vervoelgyi V, et al. Impact of document type on reporting quality of clinical drug reports: a comparison of registry reports, clinical study reports, and journal publications. BMJ 2012;344:d8141.
28. Torjesen I. Europe's drug agency will publish clinical trial data for new products from 2014. BMJ 2012;345:e8061.
29. Doshi P, Dickersin K, Healy D, et al. Restoring invisible and abandoned trials: a call for people to publish findings. BMJ 2013;346:f2865.
30. Chan A-W, Song F, Vickers A, et al. Increasing value and reducing waste: addressing inaccessible research. Lancet 2014;383:257-66.
31. Goldacre B. Are clinical trial data shared sufficiently today? No. BMJ 2013;347:f1880.
32. Kirsch I, Moore TJ, Scoboria A, et al. The emperor' s new drugs: an analysis of antidepressant medication data submitted to the US Food and Drug Administration. Prev Treat 2002;5:23a.
33. Melander H, Ahlqvist-Rastad J, Meijer G, et al. Evidence-b(i)ased medicine - selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ 2003;326:1171-3. (Pubitemid 36649049)
34. Papanikolaou P, Churchill R, Wahlbeck K, et al. Safety reporting in randomized trials of mental health interventions. Amer J Psych 2004;161:1692-7. (Pubitemid 39201468)
35. Turner E, Matthews AM, Linardatos E, et al. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008;358:252-60.
36. Rodgers M, Brown J, Heirs M, et al. Reporting of industry funded study outcome data: comparison of confidential and publicized data on the safety and effectiveness of rhBMP-2 for spinal fusion. BMJ 2013;346:f3981.
37. Angell M. Industry-sponsored clinical research: a broken system. JAMA 2008;300:1069-71.
38. Relman A, Angell M. America's other drug problem. New Repub 2002;227:27-41.
39. Baker D. The benefits and savings from publicly funded clinical trials of prescription drugs. Int J Health Serv 2008;38:731-50.
40. Ross JS, Gross CP, Krumholz HM. Promoting transparency in pharmaceutical-sponsored research. Am J Public Health 2012;102:72-80.
41. Gotzsche PC. Deadly medicines and organized crime: how big pharma has corrupted healthcare. London: Radcliffe Publishing, 2013.
42. Peart K. Yale program's agreement with Johnson & Johnson allows broad access to clinical trial data. 2014. http://news.yale.edu/2014/01/30/yale- program-s-agreement-johnson-johnson-allows-broad-access-clinical-trial-data
43. Castellani J. Are clinical trial data shared sufficiently today? Yes. BMJ 2013;347:f1881.
44. Prasad S, Harpin V, Poole L, et al. A multi-centre, randomised, open-label study of atomoxetine compared with standard current therapy in UK children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Curr Med Res Opin 2007;23:379-94. (Pubitemid 46333386)
45. Meehan K, Zhang F, David S, et al. A double-blind, randomized comparison of the efficacy and safety of intramuscular injections of olanzapine, lorazepam, or placebo in treating acutely agitated patients diagnosed with bipolar mania. J Clin Psychopharmacol 2001;21:389-97. (Pubitemid 32673028)
46. Zimbroff D, Warrington L, Loebel A, et al. Comparison of ziprasidone and aripiprazole in acutely ill subjects with schizophrenia or schizoaffective disorder: a randomized, double-blind, 4-week study. Int Clin Psychopharmacol 2007;6:363-70. (Pubitemid 47530841)
47. Kratochvil C, Michelson D, Newcorn J, et al. High-dose atomoxetine treatment of ADHD in youths with limited response to standard doses. J Am Acad Child Adolesc Psychiatry 2007;46:1128-37. (Pubitemid 47295924)
48. Street J, Clark S, Gannon K, et al. Olanzapine treatment of psychotic and behavioral symptoms in patients with Alzheimers disease in nursing care facilities. Arch Gen Psychiatry 2000;57:968-76.
49. Kamijima K, Kuboki T, Kumano H, et al. A placebo-controlled, randomized withdrawal study of sertraline for panic disorder in Japan. Int Clin Psychopharmacol 2005;20:265-73. (Pubitemid 41192147)
50. Tohen M, Calabrese J, Sachs G, et al. Randomized, placebo-controlled trial of olanzapine as maintenance therapy in patients with bipolar I disorder responding to acute treatment with olanzapine. Am J Psychiatry 2006;163:247-56. (Pubitemid 44480844)