Вся правда о лекарствах. Мировой заговор фармкомпаний

38. Hazell L, Shakir SAW. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29(5):385-96.

39. L. Harmark and A. C. Grootheest, ‘Pharmacovigilance: methods, recent developments and future perspectives,’ European Journal of Clinical Pharmacology 64, no. 8 (June 4, 2008): 743–752.

40. FDA warns Pfizer for not reporting side effects Reuters [Internet]. [cited 2012 May 8]. Available from: http://www.reuters.com/ article/2010/06/10/us-pfizer-fda-idUSTRE6586PE20100610

41. Healy D: Let them eat Prozac. New York: New York University Press; 2004. Furukawa TA: All clinical trials must be reported in detail and made publicly available. BMJ 2004, 329:626. Via Gotzsche PC. Why we need easy access to all data from all clinical trials and how to accomplish it. Trials. 2011 Nov 23;12(1):249.

42. Serena Frau et al., ‘Risk Management Plans: are they a tool for improving drug safety?’ European Journal of Clinical Pharmacology 66, no. 8 (June 25, 2010): 785–790.

43. Giezen TJ, Mantel-Teeuwisse AK, Straus SMJM, Egberts TCG, Blackburn S, Persson I, et al. Evaluation of postauthorization safety studies in the first cohort of EU Risk Management Plans at time of regulatory approval. Drug Saf. 2009;32(12):1175-87.

44. Andrew Herxheimer, ‘Looking at EU pharmacovigilance,’ European Journal of Clinical Pharmacology 67, no. 11 (November 2011): 1201–1202.

45. Schwartz LM, Woloshin S. Communicating Uncertainties About Prescription Drugs to the Public: A National Randomized Trial. Arch Intern Med. 2011 Sep 12;171(16):1463-8.

46. EMA Press Office, 2 February 2012, EMA/30803/2012

47. Garattini S, Bertele’ V. Anything new in EU pharmacovigilance? Eur. J. Clin. Pharmacol. 2011 Nov;67(11):1199-200.

48. Garattini S, Bertele’ V (2010) Rosiglitazone and the need for a new drug safety agency. Br Med J 341:c5506. doi:10.1136/bmj.c5506

49. http://www.nap.edu/catalog.php?record_id=11750#orgs

50. http://www.iom.edu/Reports/2006/The-Future-of-Drug-SafetyPromoting-and-Protecting-the-Health-of-the-Public.aspx

51. Carpenter D. Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA. Princeton University Press; 2010.

52. European Journal of Clinical Pharmacology 2011 10.1007/ s00228-011-1052-1 Anything new in EU pharmacovigilance? Silvio Garattini1 and Vittorio Bertele’1

53. Uncommon knowledge. Drug and Tuerapautics Bulletin. 2009 Nov 1; 47(11):121

54. Schwartz LM, Vvoloshin S, Welch HG. Using a Drug Facts Box to Communicate Drug Benefits and Harms Two Randomized Trials. Ann Intern Med. 2009 Apr 21;150(8):516-27.

55. Germany’s tough reimbursement rules cause drug companies to consider alternative drug trial solutions FT.com [Internet]. [cited 2012 Feb 15]. Available from: http://www.ft.com/cms/s/2/ d458d470-4696-11e1-89a800144feabdc0.html#axzz1mTzZ2jdb.

Глава 4. Обман в исследованиях

1. Anesthesiology News Fraud Case Rocks Anesthesiology Community [Internet]. [cited 2012 Feb 12]. Available from: http://www.anesthesiologynews.com/ViewArticle.aspx?d=Policy per cent2B per cent26amp per cent3B per cent2BManagement&d_id=3&i=March per cent2B2009&i_id=494&a_id=12634&ses=ogst

2. This story is well covered in Wells F. Fraud and Misconduct in Biomedical Research. Chapter 5, Fourth ed. RSM Books; 2008. I highly recommend this book if you want to get started reading about fraud detection and management. Beware that it’s an academic book, and therefore appallingly expensive.

3. Rothwell PM. External validity of randomised controlled trials: ‘To whom do the results of this trial apply?’ The Lancet. 2005 Jan 1; 365(9453):82–93.

4. Pratt, C.M. & Moye, L.A., 1995. The Cardiac Arrhythmia Suppression Trial: Casting Suppression in a Different Light. Circulation, 91(1), pp.245–247.

5. Travers, J. et al., 2007. External validity of randomised controlled trials in asthma: to whom do the results of the trials apply? Thorax, 62(3), pp.219–223.

6. Zimmerman, M., Chelminski, I. & Posternak, M.A., 2004. Exclusion criteria used in antidepressant efficacy trials: consistency across studies and representativeness of samples included. The Journal of Nervous and Mental Disease, 192(2), pp.87–94.

7. Keitner, G.I., Posternak, M.A. & Ryan, C.E., 2003. How many subjects with major depressive disorder meet eligibility requirements of an antidepressant efficacy trial? The Journal of Clinical Psychiatry, 64(9), pp.1091-3.

8. Jarvinen TLN, Sievanen H, Kannus P, Jokihaara J, Khan KM. The true cost of pharmacological disease prevention. BMJ. 2011 Apr 19;342(apr19 1):d2175-d2175.

9. Van Staa T-P, Leufkens HG, Zhang B, Smeeth L. A Comparison of Cost Effectiveness Using Data from Randomized Trials or Actual Clinical Practice: Selective Cox-2 Inhibitors as an Example. PLoS Med. 2009 Dec 8;6(12):e1000194.

10. Safer DJ. Design and reporting modifications in industrysponsored comparative psychopharmacology trials. J. Nerv. Ment. Dis. 2002 Sep;190(9):583-92.