Вся правда о лекарствах. Мировой заговор фармкомпаний

52. This is one of many stories for which I recommend delving into the horrible details, if you’re interested. A good place to start here is Prof David Colquhoun’s blog on the topic, with many links http://www.dcscience.net/?p=193 and this BMJ piece written by a lawyer, to keep the lawyers reading this book happy: Dyer C. Aubrey Blumsohn: Academic who took on industry. BMJ. 2009 Dec 15;339(dec15 1):b5293-b5293.

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]. Available from: http://www.mhra.gov.uk/Howweregulate/ 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. http://www.ombudsman.europa.eu/ cases/decision.faces/en/5459/html.bookmark.

75. UK drug regulator destroys all the evidence after 15 years/ BMI[Internet]. Available from http://www.bmj.com/ rapid-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 story behind 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.1001201 http://bit.ly/HIbwqO