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Электронная библиотека книг » Бен Колдакр » Торговец смертью: Торговец смертью. Большие гонки. Плейбой и его убийца » Текст книги (страница 31)
Торговец смертью: Торговец смертью. Большие гонки. Плейбой и его убийца
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Текст книги " Торговец смертью: Торговец смертью. Большие гонки. Плейбой и его убийца"


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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/publichealth/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).

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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 metaanalyses 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.

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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. Underreporting 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. 2011Nov 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 industrysponsored 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 metaanalyses: 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 metaanalyses 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/thenation-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.amaassn.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.


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