Примечания

Глава 1. Пропавшие данные

1. Bourgeois FT, Murthy S, Mandl KD. Outcome Reporting Among Drug Trials Registered in ClinicalTrials.gov. Annals of Internal Medicine. 2010;153(3):158-66.

2. Bero L, Oostvogel F, Bacchetti P, Lee K. Factors Associated with Findings of Published Trials of Drug-Drug Comparisons: Why Some Statins Appear More Efﬁcacious than Others. PLoS Med. 2007 Jun 5;4(6):e184.

3. Kelly RE Jr, Cohen LJ, Semple RJ, Bialer P, Lau A, Bodenheimer A, et al. Relationship between drug company funding and outcomes of clinical psychiatric research. Psychol Med. 2006 Nov;36(11):1647-56.

4. Bekelman JE, Li Y, Gross CP. Scope and impact of ﬁnancial conﬂicts of interest in biomedical research: a systematic review. JAMA 2003;289:454-65. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003;326:1167-70.

5. Sismondo S. Pharmaceutical company funding and its consequences: A qualitative systematic review. Contemporary Clinical Trials. 2008 Mar;29(2):109-13.

6. Eyding D, Lelgemann M, Grouven U, Harter M, Kromp M, Kaiser T, et al. Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials.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. 2010 Oct 12;341:c4737-c4737.

7. Suntharalingam G, Perry MR, Ward S, Brett SJ, Castello-Cortes A, Brunner MD, et al. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N. Engl. J. Med. 2006 Sep 7;355(10):1018—28.

8. Expert Group on Phase One Clinical Trials: Final report [Internet]. 2006 [cited 2012 Apr 5]. Available from: http://www.dh. gov.uk/en/Publicationsandstatistics/Publications /PublicationsPolicyAndGuidance/DH_063117

9. Decullier E, Chan A-W, Chapuis F. Inadequate Dissemination of Phase I Trials: A Retrospective Cohort Study. PLoS Med. 2009 Feb 17;6(2):e1000034.

10. Cowley AJ, Skene A, Stainer K, Hampton JR. The effect of lorcainide on arrhythmias and survival in patients with acute myocardial infarction: an example of publication bias. International journal of cardiology. 1993;40(2):161-6. Iain Chalmers was the ﬁrst to raise TGN1412 and anti-arrhythmics as examples of the harm done when individual early trials are left unpublished. They are the best illustrations of this problem, but you should not imagine that they are unusual: the quantitative data shows that they are just two among many, many similar cases.

11. Antman EM, Lau J, Kupelnick B, Mosteller F, Chalmers TC. A comparison of results of meta-analyses of randomized control trials and recommendations of clinical experts. Treatments for myocardial infarction. JAMA. 1992 Jul 8;268(2):240-8.

12. Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R. Selective Publication of Antidepressant Trials and its Inﬂuence on Apparent Efﬁcacy. N Engl J Med. 2008 Jan 17;358(3):252-60.

13. Here is the classic early paper arguing this point: Chalmers Iain. Underreporting Research Is Scientiﬁc Misconduct. JAMA. 1990 Mar 9;263(10):1405–1408.

14. Sterling T. Publication decisions and their possible effects on inferences drawn from tests of signiﬁcance or vice versa. Am Stat Assoc J 1959;54:30-4.

15. Sterling TD, Rosenbaum WL, Weinkam JJ. Publication decisions revisited the effect of the outcome of statistical tests on the decision to publish and vice-versa. Am Stat 1995;49: 108-12.

16. Bacon F (1645). Franc Baconis de Verulamio/Summi Angliae Cancellarii/Novum organum scientiarum. [Francis Bacon of St. Albans Lord Chancellor of England. A ‘New Instrument’ for the sciences] Lugd. Bat: apud Adrianum Wiingaerde, et Franciscum Moiardum. Aphorism XLVI (p.45–46).

17. Fowler T (1786). Medical reports of the effects of arsenic in the cure of agues, remitting feveres and periodic headachs. London: J Johnson, pp 105–107.

18. Hemminki E. Study of information submitted by drug companies to licensing authorities. Br Med J. 1980 Mar 22;280(6217): 833-6.

19. Lee K, Bacchetti P, Sim I. Publication of clinical trials supporting successful new drug applications: a literature analysis. PLoS Med 2008;5(9):e191.

20. Melander H, Ahlqvist-Rastad J, Meijer G, Beermann B. Evidence b(i)ased medicine selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ 2003;326:1171-3.

21. Rising K, Bacchetti P, Bero L. Reporting Bias in Drug Trials Submitted to the Food and Drug Administration: Review of Publication and Presentation. PLoS Med. 2008 Nov 25;5(11):e217.

22. Scherer RW, Langenberg P, von Elm E. Full publication of results initially presented in abstracts. Cochrane Database Syst Rev 2007; 2: MR000005.

23. Song F, Parekh S, Hooper L, Loke YK, Ryder J, Sutton AJ, et al. Dissemination and publication of research ﬁndings: an updated review of related biases. Health Technol Assess. 2010 Feb;14(8):iii, ix-xi, 1-193.

24. Dickersin K. How important is publication bias? A synthesis of available data. Aids Educ Prev 1997;9(1 SA):15–21.

25. Ioannidis J. Effect of the statistical signiﬁcance of results on the time to completion and publication of randomized efﬁcacy trials. JAMA 1998;279:281-6.

26. Bardy AH. Bias in reporting clinical trials. Brit J Clin Pharmaco 1998;46:147-50.

27. Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS ONE 2008;3(8):e3081.

28. Decullier E, Lheritier V, Chapuis F. Fate of biomedical research protocols and publication bias in France: retrospective cohort study. BMJ 2005;331:19. Decullier E, Chapuis F. Impact of funding on biomedical research: a retrospective cohort study. BMC Public Health 2006;6:165.

29. Cronin E, Sheldon T. Factors inﬂuencing the publication of health research. Int J Technol Assess 2004;20:351-5.

30. Song F, Parekh S, Hooper L, Loke YK, Ryder J, Sutton AJ, et al. Dissemination and publication of research ﬁndings: an updated review of related biases. Health Technol Assess. 2010 Feb;14(8):iii, ix-xi, 1-193.

31. This was ﬁrst pointed out to me by Jamie Heywood from PatientsLikeMe, who spent huge resources trying and failing to replicate research ﬁndings in another area of medicine. The last time I saw him we talked about writing up his idea that the likelihood of a claim being true is proportional to the cost of making it, and inversely proportional to the cost of refuting it. We’ve not done so, and until then, a description of our conversation is the only reference for this neat idea.

32. Begley CG, Ellis LM. Drug development: Raise standards for preclinical cancer research. Nature. 2012 Mar 28;483(7391): 531-3.

33. Harrabin R et al (2003). Health In The News, The King’s Fund, London, UK.

34. Forsyth, Alasdair J. M. 2001. Distorted? a quantitative exploration of drug fatality reports in the popular press. International Journal of Drug Policy 12, no. 5–6 (November 1): 435–453.

35. Dickersin K, Min YI, Meinert CL: Factors inﬂuencing publication of research results: follow-up of applications submitted to two institutional review boards. JAMA 1992, 267:374–378.

36. Olson CM, Rennie D, Cook D, Dickersin K, Flanagin A, Hogan JW, Zhu Q, Reiling J, Pace B: Publication bias in editorial decision making. JAMA 2002, 287:2825–2828.

37. Lee KP, Boyd EA, Holroyd-Leduc JM, Bacchetti P, Bero LA. Predictors of publication: characteristics of submitted manuscripts associated with acceptance at major biomedical journals. Med J Aust 2006;184:621-6. Lynch JR, Cunningham MRA, Warme WJ, Schaad DC, Wolf FM, Leopold SS. Commercially funded and United States-based research is more likely to be published; good-quality studies with negative outcomes are not. J Bone Joint Surg Am 2007;89:1010-8. Okike K, Kocher MS, Mehlman CT, Heckman JD, Bhandari M. Publication bias in orthopaedic research: an analysis of scientiﬁc factors associated with publication in the Journal of Bone and Joint Surgery. J Bone Joint Surg Am 2008;90:595–601.

38. Epstein WM. Conﬁrmation response bias among social work journals. Sci Techol Hum Values 1990;15:9-38.

39. Mahoney MJ. Publication prejudices: an experimental study of conﬁrmatory bias in the peer review system. Cognitive Ther Res 1977;1:161-75.

40. Ernst E, Resch KL. Reviewer bias a blinded experimental study. J Lab Clin Med 1994;124:178-82.

41. Abbot NE, Ernst E. Publication bias: direction of outcome less important than scientiﬁc quality. Perfusion 1998;11:182-4.

42. Emerson GB, Warme WJ, Wolf FM, Heckman JD, Brand RA, Leopold SS. Testing for the Presence of Positive-Outcome Bias in Peer Review: A Randomized Controlled Trial. Arch Intern Med. 2010 Nov 22;170(21):1934-9.

43. Smith R. The Trouble With Medical Journals. RSM Books, UK; 2006.

44. Weber EJ, Callaham ML, Wears RL, Barton C, Young G. Unpublished research from a medical specialty meeting: why investigators fail to publish. JAMA 1998;280:257-9.

45. Kupfersmid J, Fiala M. A survey of attitudes and behaviors of authors who publish in psychology and education journals. Am Psychol 1991;46:249-50.

46. Song F, Parekh S, Hooper L, Loke YK, Ryder J, Sutton AJ, et al. Dissemination and publication of research ﬁndings: an updated review of related biases. Health Technol Assess. 2010 Feb;14(8):iii, ix-xi, 1-193.

47. Gotzsche PC, Hrobjartsson a, Johansen HK, Haahr MT, Altmar DG, Chan A-W: Constraints on publication rights in industryinitiated clinical trials. JAMA 2006, 295:1645–1646.

48. Gornall, J. ‘Industry attack on academics.’ BMJ 338, no. mar09 1 (March 9, 2009): b736-b736.

49. Ibid.

50. Steinbrook R. Gag clauses in clinical-trial agreements. N. Engl. IJ. Med. 2005 May 26;352(21):2160-2.

51. Mello MM, Clarridge BR, Studdert DM. Academic medical centers’ standards for clinical-trial agreements with industry. N. Engl. J. Med. 2005;352(21):2202.

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

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: http://www.badscience.net/ 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.

87. This is a vast story, told well elsewhere. Start with Curfman GD, Morrissey S, Drazen JM. Expression of concern reafﬁrmed. N. Engl. J. Med. 2006 Mar 16;354(11):1193.

88. Opinion: Misleading Drug Trials. The Scientist [Internet]. [cited 2012 May 15]. Available from: http://thescientist. com/2012/05/14/opinion-misleading-drug-trials/

89. The Yale Open Data Archive project, or YODA, is one good example of how this might look in the future.

Глава 2. Откуда берутся лекарства?

1. I recommend the classic medical student textbook ‘Rang and Dale’: Rang & Dale’s Pharmacology. 6th ed. Churchill Livingstone; 2007. But also this, on the regulatory process around early drug development: Friedhoff LT. New Drugs: An Insider’s Guide to the FDA’s New Drug Approval Process for Scientists, Investors and Patients. 1st ed. PSPG Publishing, 2009.

2. Elliott C, Abadie R. Exploiting a research underclass in phase 1 clinical trials. New England Tournal of Medicine. 2008;358(22):2316.

3. Cohen LP. To screen new drugs for safety, Lilly pays homeless alcoholics: it’s ‘quick cash’ to habitues of Indianapolis shelters; it vanishes quickly, too. Wall St J (East Ed). 1996 Nov 14;A1, A10.

4. Abadie R. The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects. 1st ed. Duke University Press, 2010.

5. Helms R, editor. Guinea Pig Zero: An Anthology of the Journal for Human Research Subjects. 1st ed. Garrett County Press; 2006.

6. Tucker T. Great Starvation Experiment: Ancel Keys and the Men Who Starved for Science. 1st University of Minnesota Press Ed. University of Minnesota Press; 2008.

7. Gorkin L, Schron EB, Handshaw K, Shea S, Kinney MR, Branyon M, et al. Clinical trial enrollers vs. nonenrollers: The Cardiac Arrhythmia Suppression Trial (CAST) Recruitment and Enrollment Assessment in Clinical Trials (REACT) project. Controlled Clinical Trials. 1996 Feb;17(1):46–59.

8. Sheppard VB, Cox LS, Kanamori MJ, Canar J, Rodriguez Y, Goodman M, et al. BRIEF REPORT: If You Build It, They Will Come. J Gen Intern Med. 2005 May;20(5):444-7.

9. ACRO CRO Market [Internet]. [cited 2012 Feb 11].Available from: http://www.acrohealth.org/cro-market1.html.

10. MacDonald T, Hawkey C, Ford I. Time to treat as independent. BMJ. 2010 Nov 30;341(nov30 2):c6837-c6837.

11. Kassirer T. On the Take: How Medicine’s Complicity with Big Business Can Endanger Your Health. Ch 8. 1st ed. Oxford University Press, USA; 2004.

12. Pharmaceutical CSO – Pharmaceutical Commercialization – Quintiles [Internet.] Available from: http://www.quintiles.com/ commercial-services/

13. DRUG TESTING GOES OFFSHORE August 8, 2005 [Internet]. [cited 2012 Feb 11]. Available from: http://money.cnn.com/ magazines/fortune/fortune_archive/200 5/08/08/8267653/index. htm

14. Thiers FA, Sinskey AJ, Berndt ER. Trends in the globalization of clinical trials. Nature Reviews Drug Discovery. 2008 Jan;7(1):13-4.

15. All of the issues around trials in developing countries are well covered in two books, Shah S. BODY HUNTERS, THE: Testing New Drugs on the World’s Poorest Patients. SCIE. THE NEW PRESS; 2007. And Petryna A. When Experiments Travel: Clinical Trials and the Global Search for Human Subjects. 1st ed. Princeton University Press; 2009.

16. Ethical and Scientiﬁc Implications of the Globalization of Clinical Research Seth W. Glickman, M.D., M.B.A., John G. McHutchison, M.D., Eric D. Peterson, M.D., M.P.H., Charles B. Cairns, M.D., Robert A. Harrington, M.D., Robert M. Califf, M.D., and Kevin A. Schulman, M.D. N Engl J Med 2009; 360:816–823. February 19, 2009.

17. Bansal N. The opportunities and challenges in conducting clinical trials globally. Clinical Research and Regulatory Affairs. 2012 Feb 9;1–6.

18. Ethical and Scientiﬁc Implications of the Globalization of Clinical Research Seth W. Glickman, M.D., M.B.A., John G. McHutchison, M.D., Eric D. Peterson, M.D., M.P.H., Charles B. Cairns, M.D., Robert A. Harrington, M.D., Robert M. Califf, M.D., and Kevin A. Schulman, M.D. N Engl J Med 2009; 360:816–823. February 19, 2009

19. Hyder AA, Wali SA, Khan AN, Teoh NB, Kass NE, Dawson L. Ethical review of health research: a perspective from developing country researchers. J Med Eth’cs. 2004 Feb;30(1):68–72.

20. Zhang D, Yin P, Freemantle N, Jordan R, Zhong N, Cheng KK. An assessment of the quality of randomised controlled trials conducted in China. Trials. 2008;9:22.

21. FDA Requires Foreign Clinical Studies be in Accordance with Good Clinical Practice to Better Protect Human Subjects by W. Thomas Smith American Bar Association Health eSource October 2008 Volume 5 Number 2 [Internet]. [cited 2012 Feb 11]. Available from: http://www.americanbar.org/ newsletter/ publications/aba_health_esource_home/Volume5_0 2_smith. html

22. WikiLeaks cables: Pﬁzer ‘used dirty tricks to avoid clinical trial payout’ Business The Guardian [Internet]. [cited 2012 Feb 11]. Available from: http://www.guardian.co.uk/business/2010/ dec/09/wikileaks-cables-pﬁzer-nigeria

23. US embassy cable Monday 20 April 2009, 16:00, Abuja 000671 ‘Pﬁzer reaches preliminary agreement for $75m settlement’ [cited 2012 Feb 11]. Available from: http://www.guardian.co.uk/ world/us-embassy-cablesdocuments/203205

24. WikiLeaks cables: Pﬁzer ‘used dirty tricks to avoid clinical trial payout’ Business The Guardian [Internet]. [cited 2012 Feb 11]. Available from: http://www.guardian.co.uk/business/ 2010/ dec/09/wikileaks-cables-pﬁzer-nigeria

25. Jonathan Kimmelman, Charles Weijer, and Eric M Meslin, ‘Helsinki discords: FDA, ethics, and international drug trials,’ The Lancet 373, no. 9657 (January 3, 2009): 13–14.

26. Goodyear MDE, Lemmens T, Sprumont D, Tangwa G. Does the FDA have the authority to trump the Declaration of Helsinki? BMJ. 2009 Apr 21;338(apr21 1):b1559-b1559.

Глава 3. Плохой контроль

1. Royal College of Physicians, London UK. INNOVATING FOR HEALTH. Patients, physicians, the pharmaceutical industry and the NHS. February 2009. Report of a Working Party.

2. If you’re very confused about the European Medicines Agency, and the UK MHRA, and how they relate to each other, it’s fairly simple. The MHRA used to approve drugs, now the EMA do, but they farm out some of the local work to the old national regulators, especially monitoring and communication, as well as some of the approval stuff.

3. I recommend the work of John Abraham, collected here: (http://www.sussex.ac.uk/proﬁles/6

4. Owen BM, Braeutigam R. The Regulation Game: Strategic Use of the Administrative Process. Ballinger Pub Co; 1978. Via Abraham J. On the prohibition of conﬂicts of interest in pharmaceutical regulation: Precautionary limits and permissive challenges. A commentary on Sismondo (66:9, 2008, 1909-14) and O’Donovan and Lexchin. Social Science & Medicine. 2010 Mar;70(5):648-51.

5. http://www.alter-eu.org/sites/default/ﬁles/documents/lonngrendoc.pdf

6. http://www.alter-eu.org/sites/default/ﬁles/documents/lonngrendoc.pdf

7. http://www.alter-eu.org/fr/press-releases/2011/02/25/conﬂictof-interest-case-involving-ex-ema-director

8. http://www.corporateeurope.org/publications/block-revolvingdoor

9. Lurie, P., Almeida, C., Stine, N., Stine, A. R., & Wolfe, S. M. (2006). Financial conﬂict of interest disclosure and voting patterns at food and drug administration drug advisory committee meetings. JAMA, 295, 1921e1928.

10. If you’re interested in starting on this, the following are a good place to start: http://www.nytimes.com/2009/09/25/health/ policy/25knee.html?_r=1; http://www.nytimes.com/ 2005/02/25/ politics/25fda.html. And the work of the Project On Government Oversight is excellent, led by the researcher who worked on Senator Grassley’s reports into the pharmaceutical industry: http://www.pogo.org/ investigations/public-health/fda.html; http://pogoblog.typepad.com/pogo/2011/08/fdas-janetwoodcock-thesubstance-behind-her-nonsubstantivesubstantive – ties-to-industry.html

11. Light D, editor. The Risks of Prescription Drugs (A Columbia/ SSRC Book. Columbia University Press; 2010).

12. Survey of FDA Scientists Shows They Feel Pressure to Exclude…: Oncology Times [Internet]. [cited 2012 May 6]. Available from: http://journals.lww.com/oncology-times/Fulltext/2006/08250/Survey_of_FDA_Scientists_Shows_T hey_ Feel_Pressure.8.aspx

13. USATODAY.com Survey: FDA scientists question safety [Internet]. [cited 2012 May 6]. Available from: http://www.usatoday.com/news/health/2004-12-16-fda-surveyusat_x.htm

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

15. Goldberg NH, Schneeweiss S, Kowal MK, Gagne JJ. Availability of Comparative Efﬁcacy Data at the Time of Drug Approval in the United States. JAMA: The Journal of the American Medical Association. 2011 May 4;305(17):1786-9.

16. Bertele’ V, Banzi R, Gluud C, Garattini S. EMA’s reﬂection on placebo does not reﬂect patients’ interests. European Journal of Clinical Pharmacology [Internet]. 2011 Dec 2 [cited 2012 Feb 13]; Epub ahead of print. Available from: http://www.springerlink.com/content/4j733734v35381jk/

17. Garattini S, Chalmers I. Patients and the public deserve big changes in evaluation of drugs. BMJ. 2009 Mar 31;338(mar313):b1025b1025.

18. Van Luijn JCF, Gribnau FWJ, Leufkens HGM. Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization. Br J Clin Pharmacol. 2007;63(2):159–162.

19. Stafford RS, Wagner TH, Lavori PW. New, but Not Improved? Incorporating Comparative-Effectiveness Information into FDA Labeling. N Engl J Med. 2009 Aug 12;NEJMp0906490.

20. Echt DS, Liebson PR, Mitchell LB, Peters RW, Obias-Manno D, Barker AH, et al. Mortality and morbidity in patients receiving encainide, ﬂecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med. 1991 Mar;324(12):781–788.

21. ALLHAT Collaborative Research Group. Major cardiovascular events in hypertensive patients randomized to doxazosin vs chlorthalidone: the antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT). JAMA. 2000 Apr;283(15):1967–1975.

22. Lenzer J. Spin doctors soft pedal data on antihypertensives. BMJ. 2003 Jan 18;326(7381):170.

23. Vilsboll T, Christensen M, Junker AE, Knop FK, Gluud LL. Effects of glucagon-like peptide-1 receptor agonists on weight loss: systematic review and meta-analyses of randomised controlled trials. BMJ. 2012 Jan 11;344(jan10 2):d7771-d7771.

24. Grimes DA, Schulz KF. Surrogate end points in clinical research: hazardous to your health. Obstet Gynecol 2005;105:1114-8.

25. This graph is from Chapter 7 of an excellent (though long and serious) history of the FDA: Carpenter D. Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA. Princeton University Press; 2010.

26. Mitka M. FDA Takes Slow Road Toward Withdrawal of Drug Approved With Fast-Track Process. JAMA. 2011 Mar 9;305(10):982-4.

27. Press Announcements > FDA Proposes Withdrawal of Low Blood Pressure Drug [Internet]. [cited 2012 May 7]. Available from: http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm222580.htm

28. United States Government Accountability Ofﬁce. September 2009. NEW DRUG APPROVAL. FDA Needs to Enhance Its Oversight of Drugs Approved on the Basis of Surrogate Endpoints. http://www.gao.gov/new.items/d09866.pdf

29. Davis C, Abraham J. Desperately seeking cancer drugs: explaining the emergence and outcomes of accelerated pharmaceutical regulation. Sociology of Health & Illness. 2011 Jul 1;33(5):731—47.

30. Barbui C, Cipriani A, Lintas C, Bertel V, Garattini S. CNS drugs approved by the centralised European procedure: true innovation or dangerous stagnation? Psychopharmacology. 2006 Nov 22;190(2):265-8.

31. There is a good, free summary of the issues around this area in this PDF from the WHO: Aidan Hollis. Me Too Drugs: is there a problem? http://www.who.int/intellectualproperty/ topics/ip/ Me-tooDrugs_Hollis1.pdf

32. NICE, ‘CG17 Dyspepsia: full guideline,’ Guidance/Clinical Guidelines, http://guidance.nice.org.uk/CG17/Guidance/pdf/ English. But also, if the NICE guideline and its references aren’t enough for you (it’s from 2004) please do waste an hour of your time browsing other more recent trials. There’s nothing magical happening here for esomeprazole.

33. http://www.nytimes.com/2004/10/12/business/media/12drug.html

34. http://www.mediapost.com/publications/?fa=Articles.show Article&art_aid=92473

35. http://www.forbes.com/forbes/2010/0412/opinions-healthcarenexium-hmo-prescriptions-heads-up.html

36. Here I should declare an interest: I sit on the funding panel to address this exact question, every quarter, for the NHS ‘Health Technology Assessment’ programme. This funding stream exists speciﬁcally to identify trials that need to be done, but which no company would fund, comparing one drug against another, and if you are aware of any important areas where we don’t know which of two important treatments is best, you should submit a request (or if you’re lazy, email it to me).

37. http://www.isdbweb.org/publications/view/pharmacovigilancedata (‘Broadening access to signal is a positive step, but access to VigiBase is also needed’, ISDB, February 15th 2012).

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.

11. Califf RM, DeMets DL. Principles From Clinical Trials Relevant to Clinical Practice: Part I. Circulation. 2002 Aug 20;106(8):1015-21.

12. Mueller PS, Montori VM, Bassler D, Koenig BA, Guyatt GH. Ethical Issues in Stopping Randomized Trials Early Because of Apparent Beneﬁt. Annals of Internal Medicine. 2007 Jun 19;146(12):878–881.

13. Bassler D, Briel M, Montori VM, Lane M, Glasziou P, Zhou Q, et al. Stopping Randomized Trials Early for Beneﬁt and Estimation of Treatment Effects: Systematic Review and Meta¬regression Analysis. JAMA. 2010 Mar 24;303(12):1180-7.

14. Montori VM, Devereaux PJ, Adhikari NKJ, Burns KEA, Eggert CH, Briel M, et al. Randomized Trials Stopped Early for Beneﬁt: A Systematic Review. JAMA. 2005 Nov 2;294(17):2203-9.

15. Trotta F, Apolone G, Garattini S, Tafuri G. Stopping a trial early in oncology: for patients or for industry? Annals of Oncology [Internet]. 2008 Jan 1 [cited 2012 Feb 14]; Available from: http:// annonc.oxfordjournals.org/content/early/2008/04/09/ann onc. mdn042.full

16. Lurie P, Wolfe SM. Misleading data analyses in salmeterol (SMART) study. The Lancet. 2005 Oct;366(9493):1261-2.

17. Rickard KA. Misleading data analyses in salmeterol (SMART) study GlaxoSmithKline’s reply. The Lancet. 2005 Oct;366(9493): 1262.

18. Garcialopez F, Dealvaro F. INSIGHT and NORDIL. The Lancet. 2000 Dec 2;356(9245):1926–1926.

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

20. Gilbody S, Wahlbeck K, Adams C. Randomized controlled trials in schizophrenia: a critical perspective on the literature. Acta Psychiatr Scand. 2002;105:243–251.

21. Montori VM, Jaeschke R, Schunemann HJ, Bhandari M, Brozek JL, Devereaux PJ, et al. Users’ guide to detecting misleading claims in clinical research reports. BMJ. 2004 Nov 6;329(7474):1093-6.

22. Shaughnessy AF, Slawson DC. What happened to the valid POEMs? A survey of review articles on the treatment of type 2 diabetes. BMJ. 2003 Aug 2;327(7409):266.

23. Melander H, Ahlqvist-Rastad J, Meijer G, Beermann B. Evidence b(i)ased medicine selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ 2003;326:1171-3.

24. Vedula, S Swaroop, Lisa Bero, Roberta W Scherer, and Kay Dickersin. ‘Outcome reporting in industry-sponsored trials of gabapentin for off-label use.’ The New England Journal of Medicine 361, no. 20 (November 12, 2009): 1963–1971.

25. Chan A-W, Hrobjartsson A, Haahr MT, G0tzsche PC, Altman DG: Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 2004, 291:2457–2465.

26. Jon N. Jureidini, Leemon B. McHenry, Peter R. Mansﬁeld. Clinical trials and drug promotion: Selective reporting of study 329. International Journal of Risk & Safety in Medicine 20 (2008) 7381 73 DOI 10.3233/JRS-2008-0426.

27. K L Lee et al., ‘Clinical judgment and statistics. Lessons from a simulated randomized trial in coronary artery disease,’ Circulation 61, no. 3 (March 1980): 508-15.

28. On subgroup analysis, I recommend this excellent 2005 review article by Peter Rothwell: Rothwell PM. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation. The Lancet. 2005;365(9454):176-86. Currently available free online at http://apps.who.int/rhl/Lancet_3659454.pdf

29. EuropeanCarotidSurgeryTrialists’CollaborativeGroup. Randomised trial of endarterectomy for recently symptomatic carotid stenosis: ﬁnal results of the MRC European Carotid Surgery Trial (ECST). Lancet 1998; 351: 1379-87.

30. The Canadian Cooperative Study Group. A randomised trial of aspirin and sulﬁnpyrazone in threatened stroke. N Engl J Med 1978; 299: 53–59.

31. Ioannidis JPA, Karassa FB. The need to consider the wider agenda in systematic reviews and meta-analyses: breadth, timing, and depth of the evidence. BMJ. 2010 Sep;341(sep13 1):c4875c4875.

32. Hill KP, Ross JS, Egilman DS, Krumholz HM. The ADVANTAGE Seeding Trial: A Review of Internal Documents. Annals of Internal Medicine. 2008;149(4):251-8.

33. Sox HC, Rennie D. Seeding Trials: Just Say „No» Annals of Internal Medicine. 2008;149(4):279-80.

34. Krumholz SD, Egilman DS, Ross JS. Study of Neurontin: Titrate to Effect, Proﬁle of Safety (STEPS) Trial: A Narrative Account of a Gabapentin Seeding Trial. Arch Intern Med. 2011 Jun 27;171(12):1100—7.

35. I recommend this book as an introduction to ‘shared decision making’ (I helped on one chapter): Gigerenzer G, Muir G. Better Doctors, Better Patients, Better Decisions: Envisioning Health Care 2020. 1st ed. MIT Press; 2011.

36. Malenka DJ, Baron JA, Johansen S, Wahrenberger JW, Ross JM. The framing effect of relative and absolute risk. J Gen Intern Med. 1993 Oct;8(10):543-8.

37. Bucher HC, Weinbacher M, Gyr K. Inﬂuence of method of reporting study results on decision of physicians to prescribe drugs to lower cholesterol concentration. BMJ. 1994 Sep 24;309(6957):761-4.

38. Fahey T, Grifﬁths S, Peters TJ. Evidence based purchasing: understanding results of clinical trials and systematic reviews. BMJ. 1995 Oct 21;311(7012):1056-9.

39. Express.co.uk New wonder heart pill that may save millions [Internet]. [cited 2012 Feb 12]. Available from: http://www.express. co.uk/posts/view/70343.

40. Drug could save thousands from heart attacks Science The Guardian [Internet]. [cited 2012 Feb 12]. Available from: http://www.guardian.co.uk/science/2008/nov/10/drugsmedical-research

41. Boutron I, Dutton S, Ravaud P, Altman DG. Reporting and Interpretation of Randomized Controlled Trials With Statistically Nonsigniﬁcant Results for Primary Outcomes. JAMA. 2010 May 26;303(20):2058-64.

42. Alasbali, T. et al., 2009. Discrepancy between results and abstract conclusions in industry vs nonindustry-funded studies comparing topical prostaglandins. American Journal of Ophthalmology, 147(1), pp.33–38.e2.

43. Jorgensen AW, Hilden J, Gotzsche PC. Cochrane reviews compared with industry supported meta-analyses and other metaanalyses of the same drugs: systematic review. BMJ. 2006 Oct 14;333(7572):782.

Глава 5. Клинические исследования: больше и проще

1. Staa T-P v., Goldacre B, Gulliford M, Cassell J, Pirmohamed M, Taweel A, et al. Pragmatic randomised trials using routine electronic health records: putting them to the test. BMJ. 2012 Feb 7;344(feb07 1):e55-e55.

2. Edwards P, Arango M, Balica L, Cottingham R, El-Sayed H, Farrell B, et al. Final results of MRC CRASH, a randomised placebo-controlled trial of intravenous corticosteroid in adults with head injury-outcomes at 6 months. Lancet. 2005 Jun 4;365(9475):1957-9.

3. Dresden GM, Levitt MA. Modifying a Standard Industry Clinical Trial Consent Form Improves Patient Information Retention as Part of the Informed Consent Process. Academic Emergency Medicine. 2001;8(3):246-52.

Глава 6. Маркетинг

1. Alper BS, Hand JA, Elliott SG, Kinkade S, Hauan MJ, Onion DK, et al. How much effort is needed to keep up with the literature relevant for primary care? J Med Libr Assoc 2004;92:429-37.

2. Moon JC, Flett AS, Godman BB, Grosso AM, Wierzbicki AS. Getting better value from the NHS drug budget. BMJ. 2010 Dec 17;341(dec17 1):c6449-c6449.

3. Marketing spend is a contested area, as the industry is keen to play it down. I recommend the following paper as it’s open access and offers a summary ﬁgure, methods from which it was derived, and a critical discussion of other estimates: Gagnon M¬A, Lexchin J. The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States. PLoS Med. 2008 Jan 3;5(1):e1.

4. Gilbody S, Wilson P, Watt I. Beneﬁts and harms of direct to consumer advertising: a systematic review. Quality and Safety in Health Care. 2005;14(4):246-50.

5. Kravitz RL, Epstein RM, Feldman MD, Franz CE, Azari R, Wilkes MS, et al. Inﬂuence of patients’ requests for direct-toconsumer advertised antidepressants: a randomized controlled trial. JAMA. 2005 Apr 27;293(16):1995–2002.

6. Iizuka T. What Explains the Use of Direct-to-Consumer Advertising of Prescription Drugs? The Journal of Industrial Economics. 2004;52(3):349-79.

7. NICE. CG17 Dyspepsia: full guideline [Internet]. [cited 2011 Jan 4]. Available from: http://guidance.nice.org.uk/CG17/Guidance/pdf/English.

8. Law MR, Soumerai SB, Adams AS, Majumdar SR. Costs and Consequences of Direct-to-Consumer Advertising for Clopidogrel in Medicaid. Arch Intern Med. 2009 Nov 23;169(21): 1969-74.

9. I ﬁrst saw the Reynolds, Bacall, Lowe and Serial Mom examples in: Petersen M, p32: Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs. Picador; 2009.

10. Eisenberg D. It’s an Ad, Ad, Ad World. Time [Internet]. 2002 Aug 26 [cited 2012 Mar 25]; Available from: http://www.time. com/ time/magazine/article/0,9171,344045,00.html

11. Stars Proﬁt From Covert Drug Pitches CBS News [Internet]. [cited 2012 Mar 25]. Available from: http://www.cbsnews.com/ 2100-207_162-520196.html

12. Ibid.

13. Alzheimer’s Campaign Piques Public and Media Interest:: PR News May 21, 2001. Available from: http://www.prnewsonline. com/news/4782.html

14. Keidan J. Sucked into the Herceptin maelstrom. BMJ. 2007 Jan 6;334(7583):18.

15. Wilson PM, Booth AM, Eastwood A, Watt IS. Deconstructing Media Coverage of Trastuzumab (Herceptin): An Analysis of National Newspaper Coverage. J R Soc Med. 2008 Mar 1;101(3):125-32.

16. The selling of a wonder drug Science The Guardian [Internet]. [cited 2012 Mar 26]. Available from: http://www. guardian.co.uk/ science/2006/mar/29/medicineandhealth.health

17. Ibid.

18. To be absolutely clear, there is no evidence that a company was involved in promoting Barbara Moss to the media. This case simply illustrates the melodramatic ineptitude of coverage for new cancer drugs.

19. Castren E. Is mood chemistry? Nature Reviews Neuroscience. 2005 Mar 1;6(3):241-6.

20. The Pittsburgh Tribune Review (4/2/07).

21. Lacasse JR, Leo J. Serotonin and Depression: A Disconnect between the Advertisements and the Scientiﬁc Literature. PLoS Med. 2005 Nov 8;2(12):e392.

22. Petersen M, p102: Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs. Picador; 2009.

23. Ibid.

24. Leo J, Lacasse J. The Media and the Chemical Imbalance Theory of Depression. Society. 2008 Feb 19;45(1):35–45.

25. The test has now been altered; the original description is preserved online at: WebMD’s Depression Test Has Only One (Sponsored) Answer: You’re ‘At Risk’ – CBS News [Internet]. [cited 2012 Mar 26]. Available from: http://www.cbsnews. com/8301-505123_162-42844266/webmds-depression-test-hasonly-one-sponsored-answer-youre-atrisk/?tag=bnetdomain

26. Ebeling M. ‘Get with the Program!’: Pharmaceutical marketing, symptom checklists and self-diagnosis. Social Science & Medicine. 2011 Sep;73(6):825-32.

27. Laumann EO, Paik A, Rosen RC. Sexual Dysfunction in the United States Prevalence and Predictors. JAMA. 1999 Feb 10;281(6):537-44.

28. THE NATION: BETTER LOVING THROUGH CHEMISTRY; Sure, We’ve Got a Pill for That New York Times [Internet]. [cited 2012 Mar 27]. Available from: http://www.nytimes.com/1999/02/14/ weekinreview/the-nation-better-loving-through-chemistry-sure-weve-got-a-pill-for-that.html?pagewanted=all&src=pm.

29. Moynihan R. The making of a disease: female sexual dysfunction. BMJ. 2003;326(7379):45–47.

30. Moynihan R. Company launches campaign to ‘counter’ BMJ claims. BMJ. 2003 Jan 18;326(7381):120.

31. Tiefer L. Female Sexual Dysfunction: A Case Study of Disease Mongering and Activist Resistance. PLoS Med. 2006 Apr 11;3(4):e178.

32. Ibid.

33. Ibid.

34. Testosterone Patches for Female Sexual Dysfunction. DTB. 2009 Mar 1;47(3):30-4.

35. Durand M. Pharma’s Advocacy Dance [Internet]. Successful Product Manager’s Handbook. 2006 [cited 2012 Mar 26]. Available from: http://www.pharmexec.com/pharmexec/ Articles/Pharmas-Advocacy-Dance/ArticleStandard/Article/ detail/377999.

36. 11 August 2010 HAI Europe Research Article Patient & Consumer Organisations at the EMA: Financial Disclosure & Transparency. Written by Katrina Perehudoff and Teresa Leonardo Alves. 11 August 2010 HAI Europe Factsheet Patient & Consumer Organisations at the EMA: Financial Disclosure & Transparency.

37. HAI. The Patient & Consumer Voice and Pharmaceutical Industry Sponsorship [Internet]. [cited 2012 Mar 26]. Available from: http://apps.who.int/medicinedocs/en/m/abstract/Js17767en/

38. ‘Drug ﬁrms bankroll attacks on NHS’ Independent, 1 October 2008.

39. ‘Analysis: Are patient protests being manipulated?’ Independent, 1 October 2008.

40. Health chief attacks drug giants over huge proﬁts UK news The Observer [Internet]. [cited 2012 Mar 26]. Available from: http://www.guardian.co.uk/uk/2008/aug/17/pharmaceuticals. nhs.

41. Spurling GK, Mansﬁeld PR, Montgomery BD, Lexchin J, Doust J, Othman N, et al. Information from Pharmaceutical Companies and the Quality, Quantity, and Cost of Physicians’ Prescribing: A Systematic Review. PLoS Med. 2010 Oct 19;7(10):e1000352.

42. Azoulay P. Do pharmaceutical sales respond to scientiﬁc evidence? Journal of Economics & Management Strategy. 2002;11(4): 551-94.

43. Heimans L, van Hylckama Vlieg A, Dekker FW. Are claims of advertisements in medical journals supported by RCTs? Neth J Med. 2010 Jan;68(1):46-9.

44. Villanueva P, Peiro S, Librero J, Pereiro I. Accuracy of pharmaceutical advertisements in medical journals. The Lancet. 2003 Jan;361(9351):27–32.

45. Spielmans GI, Thielges SA, Dent AL, Greenberg RP. The accuracy of psychiatric medication advertisements in medical journals. J. Nerv. Ment. Dis. 2008 Apr;196(4):267-73.

46. Van Winkelen P, van Denderen JS, Vossen CY, Huizinga TWJ, Dekker FW, for the SEDUCE study group. How evidence-based are advertisements in journals regarding the subspecialty of rheumatology? Rheumatology. 2006 Sep 1;45(9):1154-7.

47. Othman N, Vitry A, Roughead EE. Quality of Pharmaceutical Advertisements in Medical Journals: A Systematic Review. PLoS ONE. 2009 Jul 22;4(7):e6350.

48. Gibson L. UK government fails to tackle weaknesses in drug industry. BMJ. 2005 Sep 10;331(7516):534-40.

49. Wilkes MS, Kravitz RL. Policies, practices, and attitudes of North American medical journal editors. J Gen Intern Med. 1995 Aug;10(8):443-50.

50. Via: Cooper RJ, Schriger DL, Wallace RC, Mikulich VJ, Wilkes MS. The Quantity and Quality of Scientiﬁc Graphs in Pharmaceutical Advertisements. J Gen Intern Med. 2003 Apr;18(4):294-7. ‘Polling of the audience occurred as part of the discussion of the oral presentation of this abstract’. FOURTH INTERNATIONAL CONGRESS ON PEER REVIEW [Internet]. Available from: http://www.amaassn.org/public/peer/prc_program2001.htm#ABSTRACTS.

51. You might also enjoy some of the books written by retired drug reps, such as: Reidy J. Hard Sell: The Evolution of a Viagra Salesman. 1st ed. Andrews McMeel Publishing; 2005.

52. Rockoff JD. Drug Reps Soften Their Sales Pitches. Wall Street Journal [Internet]. 2012 Jan 10 [cited 2012 Mar 22]; Available from: http://online.wsj.com/article/ SB100014240529702043313 04577142763014776148.html

53. Fugh-Berman A, Ahari S. Following the Script: How Drug Reps Make Friends and Inﬂuence Doctors. PLoS Med. 2007 Apr;4(4).

54. Soyk, C., B. Pfefferkorn, P. McBride, and R. Rieselbach. 2010. Medical student exposure to and attitudes about pharmaceutical companies. World Medical Journal 109: 142–148.

55. Fischer MA, Keough ME, Baril JL, Saccoccio L, Mazor KM, Ladd E, et al. Prescribers and Pharmaceutical Representatives: Why Are We Still Meeting? J Gen Intern Med. 2009 Jul;24(7):795–801.

56. Morgan MA, Dana J, Loewenstein G, Zinberg S, Schulkin J. Interactions of doctors with the pharmaceutical industry. J Med Ethics. 2006 Oct;32(10):559-63.

57. B Hodges, ‘Interactions with the pharmaceutical industry: experiences and attitudes of psychiatry residents, interns and clerks,’ CMAJ: Canadian Medical Association Journal = Journal De l’Association Medicale Canadienne 153, no. 5 (September 1, 1995): 553–559.

58. Spurling GK, Mansﬁeld PR, Montgomery BD, Lexchin J, Doust J, Othman N, et al. Information from Pharmaceutical Companies and the Quality, Quantity, and Cost of Physicians’ Prescribing: A Systematic Review. PLoS Med. 2010 Oct 19;7(10):e1000352.

59. MM Chren and CS Landefeld, ‘Physicians’ behavior and their interactions with drug companies. A controlled study of physicians who requested additions to a hospital drug formulary,’ JAMA: The Journal of the American Medical Association 271, no. 9 (March 2, 1994): 684–689.

60. Ladd EC, Mahoney DF, Emani S. ‘Under the radar’: nurse practitioner prescribers and pharmaceutical industry promotions. Am J Manag Care. 2010;16(12):e358-362.

61. Zipkin DA, Steinman MA. Interactions Between Pharmaceutical Representatives and Doctors in Training. J Gen Intern Med. 2005 Aug;20(8):777-86.

62. Spingarn RW, Berlin JA, Strom BL. When pharmaceutical manufacturers’ employees present grand rounds, what do residents remember? Acad Med. 1996 Jan;71(1):86-8.

63. Wazana A. Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift? JAMA. 2000 Jan 19;283(3):373-80.

64. Lurie N, Rich EC, Simpson DE, Meyer J, Schiedermayer DL, Goodman JL, et al. Pharmaceutical representatives in academic medical centers: interaction with faculty and housestaff. J Gen Intern Med. 1990 Jun;5(3):240-3.

65. Fugh-Berman A, Ahari S. Following the Script: How Drug Reps Make Friends and Inﬂuence Doctors. PLoS Med. 2007 Apr;4(4).

66. Ibid.

67. Sismondo S. How pharmaceutical industry funding affects trial outcomes: Causal structures and responses. Social Science & Medicine. 2008;66(9):1909-14.

68. Completed Cases PMCPA Website [Internet]. [cited 2012 Mar 26]. Available from: http://www.pmcpa.org.uk/?q=node/868

69. Completed Cases PMCPA Website [Internet]. [cited 2012 Mar 26]. Available from: http://www.pmcpa.org.uk/?q=node/883

70. Orlowski JP, Wateska L. The effects of pharmaceutical ﬁrm enticements on physician prescribing patterns. There’s no such thing as a free lunch. Chest. 1992 Jul;102(1):270-3.

71. Steinbrook R. For sale: physicians’ prescribing data. N. Engl. J. Med. 2006 Jun 29;354(26):2745-7.

72. Physician Data Restriction Program (PDRP) [Internet]. [cited 2012 Mar 22]. Available from: http://www.ama-assn.org/ama/ pub/about-ama/physician-data-resources/ama-databaselicensing/amas-physician-data-restriction-program.page

73. Outterson K. Higher First Amendment Hurdles for Public Health Regulation. New England Journal of Medicine. 2011 Aug 18;365(7):e13.

74. Zipkin DA, Steinman MA. Interactions Between Pharmaceutical Representatives and Doctors in Training. J Gen Intern Med. 2005 Aug;20(8):777-86.

75. Wislar JS, Flanagin A, Fontanarosa PB, DeAngelis CD. Honorary and ghost authorship in high impact biomedical journals: a cross sectional survey. BMJ. 2011 Oct 25;343(oct25 1):d6128-d6128.

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89. http://pogoblog.typepad.com/pogo/gw-attachment-e.html

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96. AUTH/2424/8/11 and AUTH/2425/8/11 General Practitioner v Boehringer Ingelheim and Lilly. Available from: http://www. pmcpa.org.uk/?q=node/998.

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Заключение: усовершенствованные данные

1. Department of Justice, Ofﬁce of Public Affairs. GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data. Monday, July 2, 2012.http://www.justice.gov/opa/pr/2012/July/12-civ842.html

2. Glaxo executives cited in case now lead Sanoﬁ, Actelion. Bloomberg News, 3/7/12. http://www.businessweek.com/news/ 201207-03/glaxo-executives-cited-in-case-now-lead-sanoﬁactelion

3. Inpharm 4/7/12. GSK ruling: another failing, but will the industry learn? http://www.inpharm.com/news/173307/gskrulinganother-failing-will-industry-learn

4. Glaxo Agrees to Pay $3 Billion in Fraud Settlement. New York Times, July 2 2012. http://www.nytimes.com/2012/07/03/ business/glaxosmithkline-agrees-to-pay-3-billion-in-fraudsettlement.html

5. Level playing ﬁeld push to continue despite setback 8 December 2011. Medicines Australia. http://medicinesaustralia. com. au/2011/12/08/level-playing-field-push-to-continue-despitesetback/

6. Drug companies to work with CCGs on care pathways and case ﬁnding under DH-backed scheme. Pulse, 28 May 2012, http://www.pulsetoday.co.uk/ newsarticle-content/-/article_ display_ list/14029608/drug-companies-to-work-with-ccgs-oncarepathways-and-case-ﬁnding-under-dh-backed-scheme.

7. Bosch X, Esfandiari B, McHenry L. Challenging Medical Ghostwriting in US Courts. PLoS Med. 2012 Jan 24;9(1): e1001163.

Послесловие: что случилось потом?

1. The citation here is, for obvious reasons, ‘personal communication’. The email from the academic continued: ‘From my perspective, I don’t think we should be anything but indignant!’

2. Davis C, Abraham J. Is there a cure for corporate crime in the drug industry? BMJ. 2013;346:f755.

3. Gale EAM. Post-marketing studies of new insulins: sales or science? BMJ. 2012;344:e3974.

4. Light DW, Lexchin JR. Pharmaceutical research and development: what do we get for all that money? BMJ. 2012;345:e4348.

5. Svensson S, Menkes DB, Lexchin J. Surrogate Outcomes in Clinical Trials: A Cautionary Tale. JAMA Intern Med. 2013;173(8):611612.

6. „JAMA, Integrity, Accessibility, and Social vs. Scientiﬁc Peer Review“. Emergency Medicine Literature of Note, Feb 26, 2013.

7. Abbasi, K. Blood on our hands: seeing the evil in inappropriate comparators. J R Soc Med. 2013 January;106(1): 1.

8. Inside Health, BBC Radio 4, January 2013.

9. Duijnhoven RG, Straus SMJM, Raine JM, de Boer A, Hoes AW, et al. (2013) Number of Patients Studied Prior to Approval of New Medicines: A Database Analysis. PLoS Med 10(3): e1001407. doi:10.1371/journal.pmed.1001407

10. Ioannidis JPA. How Many Contemporary Medical Practices Are Worse Than Doing Nothing or Doing Less? Mayo Clinic Proceedings. 2013 Aug;88(8):779-81.

11. Zarin DA, Tse T. Trust but Verify: Trial Registration and Determining Fidelity to the Protocol. Ann Intern Med. 2013;159(1): 65–67.

12. Rosenthal R, Dwan K. Comparison of randomized controlled trial registry entries and content of reports in surgery journals. Ann Surg. 2013 Jun;257(6):1007-15.

13. Zetterqvist AV, Mulinari S (2013) Misleading Advertising for Antidepressants in Sweden: A Failure of Pharmaceutical Industry Self-Regulation. PLoS ONE 8(5): e62609. doi:10.1371/journal. pone.0062609

14. Mintzes B, Lexchin J, Sutherland JM, Beaulieu M-D, Wilkes MS, Durrieu G, et al. Pharmaceutical Sales Representatives and Patient Safety: A Comparative Prospective Study of Information Quality in Canada, France and the United States. J Gen Intern Med. 2013 Apr 5.

15. http://dailycaller.com/2013/04/27/critics-see-conﬂict-oﬁnterestas-obama-admin-advises-doctors-on-prescriptions/

16. http://www.propublica.org/article/pay-to-prescribe-twodozendoctors-named-in-novartis-kickback-case

17. Bosch X, Hernandez C; Pericas JM, Doti P. Ghostwriting Policies in High-Impact Biomedical Journals: A Cross-Sectional Study. JAMA Intern Med. 2013;173(10):920–921.

18. Nancarrow, CM. Editorial Policies to Ensure Honesty and Transparency: Comment on „Ghostwriting Policies in HighImpact Biomedical Journals: A Cross-Sectional Study“. JAMA Intern Med. 2013;173(10):921–922.

19. Persaud N. Questionable content of an industry-supported medical school lecture series: a case study. J Med Ethics. doi:10.1136/ medethics-2013-101343

20. India’s poor duped into clinical drug trials. Economic Times, 7th July 2013.

21. Vedula SS, Li T, Dickersin K. Differences in Reporting of Analyses in Internal Company Documents Versus Published Trial Reports: Comparisons in Industry-Sponsored Trials in Off-Label Uses of Gabapentin. PLoS Med. 2013 Jan 29;10(1):e1001378.

22. Sample, Ian. Big pharma mobilising patients in battle over drugs trials data. Guardian, 21st July 2013.

23. http://www.alltrials.net/2013/responses-to-leaked-memo/

24. Huser V, Cimino JJ (2013) Linking ClinicalTrials.gov and PubMed to Track Results of Interventional Human Clinical Trials. PLoS ONE 8(7): e68409. doi:10.1371/journal.pone.0068409

25. Schroll JB, Bero L, G0tzsche PC. Searching for unpublished data for Cochrane reviews: cross sectional study. BMJ 2013;346:f2231.

26. Wieseler B, McGauran N, Kerekes MF, Kaiser T. Access to regulatory data from the European Medicines Agency: the times they are a-changing. Syst Rev. 2012 Oct 30;1:50.

27. Little RJ, D’Agostino R, Cohen ML, Dickersin K, Emerson SS, Farrar JT, et al. The Prevention and Treatment of Missing Data in Clinical Trials. N Engl J Med. 2012; 367:1355–1360.

28. Mathieu S, Chan A-W, Ravaud P (2013) Use of Trial Register Information during the Peer Review Process. PLoS ONE 8(4): e59910. doi:10.1371/journal.pone.0059910

29. Prayle AP, Hurley MN, Smyth AR (2012) Data from: Compliance with mandatory reporting of clinical trial results on Clinical-Trials.gov: cross sectional study. Dryad Digital Repository. doi:10.5061/dryad.j512f21p

30. Simmonds MC, Brown JVE, Heirs MK, Higgins JPT, Mannion RJ, Rodgers MA, et al. Safety and Effectiveness of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Fusion: A Meta-analysis of Individual-Participant Data. Ann Intern Med. 2013;158(12):877–889.