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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.

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.

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.