Торговец смертью: Торговец смертью. Большие гонки. Плейбой и его убийца
Шрифт:
53. Wendler D, Krohmal B, Emanuel EJ, Grady C, for the ESPRIT Group. Why Patients Continue to Participate in Clinical Research. Arch Intern Med. 2008 Jun 23;168(12):1294-9.
54. McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006;7:9.
55. Simes RJ. Publication bias: the case for an international registry of clinical trials. Journal of Clinical Oncology. 1986 Oct 1;4(10):1529–1541.
56. Clarke M, Clarke L, Clarke T. Yes Sir, no Sir, not much difference Sir. JRSM. 2007 Dec 1;100(12):571–572.
57. Chalmers Iain. Underreporting Research Is Scientific Misconduct. JAMA: The Journal of the American Medical Association. 1990 Mar 9;263(10):1405–1408.
58. Chalmers I. From optimism to disillusion about commitment to transparency in the medico-industrial complex. JRSM. 2006 Jul 1;99(7):337–341.
59. Their delegation was led by Frank Wells: his textbook on fraud is fantastic. I tell you this because you should understand that these are not all bad people with inherently secretive natures.
60. Sykes R. Being a modern pharmaceutical company. BMJ. 1998 Oct 31;317(7167):1172-80.
61. http://www.bmj.com/content/339/bmj.b4330.
62. De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. The Lancet. 2004 Sep 11;364(9438):911-2.
63. Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P. Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials. JAMA. 2009 Sep 2;302(9):977-84.
64. Wieseler B, McGauran N, Kaiser T. Still waiting for functional EU Clinical Trials Register. BMJ. 2011 Jun 20;342(jun202):d3834d3834.
65. Prayle AP, Hurley MN, Smyth AR. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ. 2012;344:d7373.
66. A good (but brief) overview of how to try and get info from nonacademic sources is here: Chan A-W. Out of sight but not out of mind: how to search for unpublished clinical trial evidence. BMJ. 2012 Jan 3;344(jan03 2):d8013-d8013.
67. You can read the letters and the report online. It’s a gripping read, with many interesting and nefarious details, so I highly recommend doing so: Medicines and Healthcare products Regulatory Agency (MHRA) www. mhra. gov. u. GSK investigation concludes [Internet]. [cited 2012 Apr 29]. Availablefrom:Medicines/Medicinesregulatorynews/CON014153
68. This was SmithKline Beecham, before they merged with GlaxoWellcome and became GSK.
69. Strech D, Littmann J. Lack of proportionality. Seven specifications of public interest that override post-approval commercial interests on limited access to clinical data. Trials. 2012 Jul 2;13(1):100.
70. Lenzer J, Brownlee S. Antidepressants: an untold story? BMJ 2008;336:532-4.
71. Wood AJ. Progress and deficiencies in the registration of clinical trials. N Engl J Med. 2009;360(8):824-830
72. O’Connor AB. The need for improved access to FDA reviews. JAMA: The Journal of the American Medical Association. 2009;302(2):191.
73. http://www.prescrire.org/editoriaux/EDI33693.pdf
74. Decision of the European Ombudsman closing his inquiry into complaint 2560/2007/BEH against the European Medicines Agency. November 2010.cases/decision.faces/en/5459/html.bookmark.
75. UK drug regulator destroys all the evidence after 15 years/ BMI[Internet]. Available fromrapid-response/2011/11/03/uk-drug-regulator-destroys-allevidence-after-15-years.
76. You might be unsurprised to hear that no large drug company has ever been prosecuted under the safety monitoring regulations in the UK.
77. This story is spread over various publications by the Cochrane team, and the account here is taken from their work, published responses from Roche, and discussions with the Cochrane team. The best place to get the early half of this story is this paper: Doshi P. Neuraminidase inhibitors the storybehind the Cochrane review. BMJ. 2009;339. And for the second half, I recommend this open-access paper: Doshi P, Jefferson T, Del Mar C (2012) The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience. PLoS Med 9(4): e1001201. doi:10.1371/journal.pmed.1001201http://bit.ly/HIbwqO
78. This is a fascinating and messy new area. The paper below gives a good summary of the importance of analysing full trial programmes, and the discrepancies found on Tamiflu between papers and Clinical Study Reports: Jefferson T, Doshi P, Thompson M, Heneghan C, Group CARI. Ensuring safe and effective drugs: who can do what it takes? BMJ. 2011 Jan 11;342(jan11 1):c7258-c7258.
79. This is all from: Jefferson T, Doshi P, Thompson M, Heneghan C, Group CARI. Ensuring safe and effective drugs: who can do what it takes? BMJ. 2011 Jan 11;342(jan11 1):c7258-c7258.
80. Tom Jefferson, Lecture on Tamiflu, BMJ Evidence 2011, London.
81. Tramer MR, Reynolds DJ, Moore RA, McQuay HJ. Impact of covert duplicate publication on meta-analysis: a case study. BMJ. 1997 Sep 13;315(7109):635-40.
82. Doshi P, Jefferson T, Del Mar C (2012) The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience. PLoS Med 9(4): e1001201. doi:10.1371/journal.pmed.1001201 http://bit.ly/HIbwqO
83. Cohen D (2009) Complications: tracking down the data on oseltamivir. BMJ 339: b5387.
84. If you’re interested in this story, the links to primary documents are all here: Diabetes drug ‘victory’ is really an ugly story about incompetence. Ben Goldacre, The Guardian. 2010 Jul 17 [cited 2012 May 2]; Available from:2010/07/pharmaco-epidemiology-would-be-fascinatingenougheven-if-society-didnt-manage-it-really-really-badly/
85. Nissen SE. Setting the record straight. JAMA. 2010 Mar 24; 303(12):1194-5
86. Eichler H-G, Abadie E, Breckenridge A, Leufkens H, Rasi G. Open Clinical Trial Data for All? A View from Regulators. PLoS Med. 2012 Apr 10;9(4):e100i202.