The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience
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Vyšlo v časopise:
The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience. PLoS Med 9(4): e32767. doi:10.1371/journal.pmed.1001201
Kategorie:
Policy Forum
prolekare.web.journal.doi_sk:
https://doi.org/10.1371/journal.pmed.1001201
Souhrn
article has not abstract
Zdroje
1. BrodyHLightDW 2011 The inverse benefit law: how drug marketing undermines patient safety and public health. Am J Public Health 101 3 399 404
2. SmithR 2005 Medical journals are an extension of the marketing arm of pharmaceutical companies. Plos Med 2 5 e138 doi:10.1371/journal.pmed.0020138
3. The New York Times 28 April 2009 Tamiflu (drug). The New York Times. Available: http://topics.nytimes.com/topics/news/health/diseasesconditionsandhealthtopics/tamiflu-drug/index.html. Accessed 6 March 2012
4. U.S. Department of Health and Human Services 2005 HHS pandemic influenza plan. Available: http://www.hhs.gov/pandemicflu/plan/pdf/HHSPandemicInfluenzaPlan.pdf. Accessed 6 March 2012
5. HarperSAFukudaKUyekiTMCoxNJBridgesCB 2004 Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 53 RR-6 1 40
6. Roche Products Pty Limited 2011 TAMIFLU® capsules: consumer medicine information. Available: http://www.roche-australia.com/fmfiles/re7229005/downloads/anti-virals/tamiflu-cmi.pdf. Accessed 6 March 2012
7. European Medicines Agency 2011 Summary of product characteristics (Tamiflu 30 mg hard capsule). Available: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000402/WC500033106.pdf. Accessed 5 February 2012
8. KaiserLWatCMillsTMahoneyPWardPHaydenF 2003 Impact of oseltamivir treatment on influenza-related lower respiratory tract complications and hospitalizations. Arch Intern Med 163 14 1667 1672
9. Hoffman-La Roche, Ltd. 2011 Product label. Tamiflu (oseltamivir phosphate) capsules and for oral suspension. Available: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021087s056_021246s039lbl.pdf. Accessed 6 March 2012
10. U.S. Food and Drug Administration 14 April 2000 NDA 21-087 TAMIFLU (oseltamivir phosphate) MACMIS ID#8675. Available: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM166329.pdf. Accessed 6 March 2012
11. JeffersonTJonesMADoshiPDel MarCBHeneghanCJ 2012 Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children. Cochrane Database Syst Rev 2012 1 CD008965
12. World Health Organization 2007 WHO interim protocol: rapid operations to contain the initial emergence of pandemic influenza. Available: http://www.who.int/influenza/resources/documents/RapidContProtOct15.pdf. Accessed 6 March 2012
13. JeffersonTDoshiPThompsonMHeneghanC 2011 Ensuring safe and effective drugs: who can do what it takes? BMJ 342 c7258
14. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 1996 Guideline for industry: structure and content of Clinical Study Reports (ICH E3). Available: http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm129456.pdf. Accessed 6 2012
15. LundhABarbateskovicMHróbjartssonAGøtzschePC 2010 Conflicts of interest at medical journals: the influence of industry-supported randomised trials on journal impact factors and revenue – cohort study. PLoS Med 7 10 e1000354 doi:10.1371/journal.pmed.1000354
16. JeffersonTJonesMADoshiPDel MarCBHeneghanCJ 2011 Cochrane Database Syst Rev Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children - a review of unpublished data. 2011 CD008965 Available: http://doi.wiley.com/10.1002/14651858
17. GøtzschePCJørgensenAW 2011 Opening up data at the European Medicines Agency. BMJ 342 d2686
18. Yale School of Medicine 2011 Yale University Open Data Access Project (YODA Project). Available: http://medicine.yale.edu/core/projects/yodap/index.aspx. Accessed 6 March 2012
19. EydingDLelgemannMGrouvenUHarterMKrompM 2010 Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials. BMJ 341 c4737
20. HalperinRM 1979 FDA disclosure of safety and effectiveness data: a legal and policy analysis. Duke Law Journal 1979 1 286 326
21. KesselheimASMelloMM 2007 Confidentiality laws and secrecy in medical research: improving public access to data on drug safety. Health Aff (Millwood) 26 2 483 491
22. European Medicines Agency 2010 Output of the European Medicines Agency policy on access to documents related to medicinal products for human and veterinary use. Available: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/11/WC500099472.pdf. Accessed 6 March 2012
23. PottA 2011 EMA's response to articles. BMJ 342 d3838
24. JeffersonTJonesMDoshiPDel MarC 2009 Neuraminidase inhibitors for preventing and treating influenza in healthy adults: systematic review and meta-analysis. BMJ 339 b5106
25. SmithJ on behalf of Roche 2009 Point-by-point response from Roche to BMJ questions. BMJ 339 b5374
26. AbrahamJ 1995 Science, politics and the pharmaceutical industry: controversy and bias in drug regulation. First edition. Routledge
27. CohenD 2010 Rosiglitazone: what went wrong? BMJ 341 c4848
28. RosenCJ 2007 The rosiglitazone story—lessons from an FDA advisory committee meeting. N Engl J Med 357 9 844 846
29. RichterBBandeira-EchtlerEBergerhoffKClarCEbrahimSH 2007 Rosiglitazone for type 2 diabetes mellitus. Cochrane Database Syst Rev 2007 3 CD006063
30. NissenSEWolskiK 2007 Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 356 24 2457 2471
31. LenzerJ 2003 Whistleblower charges drug company with deceptive practices. BMJ 326 7390 620
32. KesselheimASMelloMMStuddertDM 2011 Strategies and practices in off-label marketing of pharmaceuticals: a retrospective analysis of whistleblower complaints. PLoS Med 8 e1000431 doi:10.1371/journal.pmed.1000431
33. SteinmanMABeroLAChrenM-MLandefeldCS 2006 Narrative review: the promotion of gabapentin: an analysis of internal industry documents. Ann Intern Med 145 4 284 293
34. LenzerJ 2004 Pfizer pleads guilty, but drug sales continue to soar. BMJ 328 7450 1217
35. SteinmanMAHarperGMChrenM-MLandefeldCSBeroLA 2007 Characteristics and impact of drug detailing for gabapentin. PLoS Med 4 4 e134 doi:10.1371/journal.pmed.0040134
36. BombardierCLaineLReicinAShapiroDBurgos-VargasR 2000 Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 343 21 1520 1528
37. CurfmanGDMorrisseySDrazenJM 2005 Expression of concern: Bombardier et al., “Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis,” N Engl J Med 2000; 343:1520–8. N Engl J Med 353 26 2813 2814
38. WilsonD 22 November 2011 Merck to pay $950 million over Vioxx]. The New York Times. Available: https://www.nytimes.com/2011/11/23/business/merck-agrees-to-pay-950-million-in-vioxx-case.html. Accessed 6 March 2012
39. TopolEJ 2004 Failing the public health–rofecoxib, Merck, and the FDA. N Engl J Med 351 17 1707 1709
40. DoshiP 2009 Neuraminidase inhibitors–the story behind the Cochrane review. BMJ 339 b5164
41. GodleeF 2009 We want raw data, now. BMJ 339 b5405
42. MelvilleNA 20 January 2012 Tamiflu data called inconsistent, underreported. Available: http://www.medscape.com/viewarticle/757226 [requires free registration]
43. DutkowskiRSmithJRDaviesBE 2010 Safety and pharmacokinetics of oseltamivir at standard and high dosages. Int J Antimicrob Agents 35 5 461 467
44. CohenD 2009 Complications: tracking down the data on oseltamivir. BMJ 339 b5387
45. WelliverRMontoASCarewiczOSchattemanEHassmanM 2001 Effectiveness of oseltamivir in preventing influenza in household contacts: a randomized controlled trial. JAMA 285 6 748 754
46. Gilead Sciences 1999 Roche announces new data on recently approved Tamiflu™, first pill to treat the most common strains of influenza (A & B). Available: http://www.gilead.com/pr_942082531. Accessed 6 March 2012
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