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 MA, 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. 76. G0tzsche PC, Hrobjartsson A, Johansen HK, Haahr MT, Altman DG, Chan A-W. Ghost Authorship in Industry-Initiated Randomised Trials. PLoS Med. 2007 Jan 16;4(1):e19. 77. ‘Ghost writing in the medical literature’ 111th Congress, United States Senate Committee on Finance Sen. Charles E. Grassley, 2010. [cited 2012 Mar 24]. Available from: http://www.grassley. senate.gov/about/upload/Senator-GrassleyReport.pdf 78. Richard Horton PI 108, House of Commons Health Minutes of Evidence [Internet]. [cited 2012 Mar 24]. Available from: http://www.publications.parliament.uk/pa/cm200405/ cmselect/ cmhealth/42/4121604.htm 79. Galanter M, Galanter M, Felstiner WLF, Friedman LM, Girth M, Goldstein P, et al. Why the haves come out ahead: Speculations on the limits of legal change. Law Society Review. 1974;9:95-169. 80. Lilly ‘Ghostwrote’ Articles to Market Drug, Files Say (Update2) Bloomberg [Internet]. [cited 2012 Mar 24]. Available from: http:// www.bloomberg.com/apps/news?pid=newsarchive&sid=a6yFu_ t9NyTY 81. http://www.psychiatrynorthwest.co.uk/general_adult_ psychiatry/spr_posts/salford-haddad/index.html 82. Medical Press Pre-Launch Feature Outline, Zyprexa MDL 1596, confidential subject to protection order ZY200187608. http://zyprexalitigationdocuments.com/per cent5Cdocuments per cent5CConfidentiality-Challenge per cent5CDocschallenged-in-10-3list per cent5C145-ZY200187608-7614.pdf 83. Drug Industry Document Archive [Internet]. [cited 2012 Mar 24]. Available from: http://dida.library.ucsf.edu/ 84. Drug Industry Document Archive Search Results [Internet]. [cited 2012 Mar 24]. Available from: http://dida.library.ucsf. edu/ tid/anu38h10 85. Ibid. 86. Ross, J.S., K.P. Hill, D.S. Egilman, and H.M. Krumholz. 2008. Guest authorship and ghostwriting in publications related to rofecoxib: A case study of industry documents from rofecoxib litigation. Journal of the American Medical Association 299: 18001812. 87. POGO Letter to NIH on Ghostwriting Academics [Internet]. Project On Government Oversight. [cited 2012 Mar 24]. Available from: http://www.pogo.org/pogo-files/letters/publichealth/ ph-iis-20101129.html 88. http://www.nytimes.com/2010/11/30/business/30drug.html 89. http://pogoblog.typepad.com/pogo/gw-attachment-e.html 90. Lacasse JR, Leo J. Ghostwriting at Elite Academic Medical Centers in the United States. PLoS Med. 2010 Feb 2;7(2):e1000230. 91. Matheson A. How Industry Uses the ICMJE Guidelines to Manipulate Authorship And How They Should Be Revised. PLoS Med. 2011;8(8):e1001072. 92. Dyer O. Journal rejects article after objections from marketing department. BMJ. 2004 Jan 31;328(7434):244-b-244. 93. Fugh-Berman A, Alladin K, Chow J. Advertising in Medical Journals: Should Current Practices Change? PLoS Med. 2006 May 2;3(6):e130. 94. Becker A, Dorter F, Eckhardt K, Viniol A, Baum E, Kochen MM, et al. The association between a journal’s source of revenue and the drug recommendations made in the articles it publishes. CMAJ. 2011 Feb 28 Available from: http://www.cmaj.ca/content/early/2011/02/28/cmaj.100951 95. Smith R. Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies. PLoS Med. 2005 May 17;2(5):e138. 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. 97. Handel AE, Patel SV, Pakpoor J, Ebers GC, Goldacre B, Ramagopalan SV. High reprint orders in medical journals and pharmaceutical industry funding: case-control study. BMJ. 2012 Jun 28;344(jun28 1):e4212-e4212. 98. Jefferson T, Di Pietrantonj C, Debalini MG, Rivetti A, Demicheli V. Relation of study quality, concordance, take home message, funding, and impact in studies of influenza vaccines: systematic review. BMJ. 2009 Feb 12;338(feb12_2):b354. 99. http://classic.the-scientist.com/blog/display/55679/ 100. http://elsevier.com/wps/find/authored _newsitem.cws_home/ companynews05_01203 101. Bowman MA. The impact of drug company funding on the content of continuing medical education. Mobius: A Journal for Continuing Education Professionals in Health Sciences. 1986 Jan 1;6(1):66-9. 102. Bowman MA, Pearle DL. Changes in drug prescribing patterns related to commercial company funding of continuing medical education. Journal of Continuing Education in the Health Professions. 1988 Jan 1;8(1):13–20. 103. The Carlat Psychiatry Blog: PRMS [Internet]. [cited 2012 Mar 31]. Available from: http://carlatpsychiatry.blogspot.co.uk/ search/label/PRMS 104. Stephan Sahm, ‘Of mugs, meals and more: the intricate relations between physicians and the medical industry.,’ Medicine, health care, and philosophy (2011). 105. Avorn J, Choudhry NK. Funding for Medical Education: Maintaining a Healthy Separation From Industry. Circulation. 2010 May 25;121(20):2228-34. 106. L. Garattini et al., ‘Continuing Medical Education in six European countries: A comparative analysis,’ Health policy 94, no. 3 (2010): 246–254. 107. Eckardt VF. Complimentary journeys to the World Congress of Gastroenterology an inquiry of potential sponsors and beneficiaries. Z Gastroenterol. 2000 Jan;38(1):7-11. 108. http://www.pmlive.com/find_an_article/allarticles/categories/ General/2011/november_2011/features/cme_continuing_medic al_education_change 109. US Senate Committee on Finance. Committee Staff Report to the Chairman and Ranking Member: Use of Educational Grants by Pharmaceutical Manufacturers. Washington, DC: Government Printing Office; 2007. 110. Hensley S, Martinez B. To sell their drugs, companies increasingly rely on doctors. Wall St J (East Ed). 2005 Jul 15;A1,A2. 111. Tabas JA, Boscardin C, Jacobsen DM, Steinman MA, Volberding PA, Baron RB. Clinician Attitudes About Commercial Support of Continuing Medical Education: Results of a Detailed Survey. Arch Intern Med. 2011 May 9;171(9):840-6. 112. Amy T Wang et al., ‘Association between industry affiliation and position on cardiovascular risk with rosiglitazone: cross sectional systematic review,’ BMJ 340, no. 18 (March 18, 2010): c1344. 113. Rothman KJ, Evans S (2005) Extra scrutiny for industry funded trials. BMJ 331: 1350-1351 114. Wager E, Mhaskar R, Warburton S, Djulbegovic B (2010) JAMA Published Fewer Industry-Funded Studies after Introducing a Requirement for Independent Statistical Analysis. PLoS ONE 5(10): e13591. doi:10.1371/journal.pone.0013591 115. Chalmers TC, Frank CS, Reitman D. Minimizing the Three Stages of Publication Bias. JAMA. 1990 Mar 9;263(10):1392-5. 116. Samena Chaudhry et al., ‘Does declaration of competing interests affect readers’ perceptions? A randomised trial,’ BMJ 325, no. 7377 (December 14, 2002): 1391–1392. (below). 117. Reporting of Conflicts of Interest in Meta-analyses of Trials of Pharmacological Treatments. 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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.
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