Âñÿ ïðàâäà î ëåêàðñòâàõ. Ìèðîâîé çàãîâîð ôàðìêîìïàíèé Ãîëäàêð Áåí
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 Scientic 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 Scientic 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: Pzer ‘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-pzer-nigeria
23. US embassy cable Monday 20 April 2009, 16:00, Abuja 000671 ‘Pzer 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: Pzer ‘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-pzer-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.
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/proles/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 conicts 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/les/documents/lonngrendoc.pdf
6. http://www.alter-eu.org/sites/default/les/documents/lonngrendoc.pdf
7. http://www.alter-eu.org/fr/press-releases/2011/02/25/conictof-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 conict 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.nyimes.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 Efcacy 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 reection on placebo does not reect 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, ecainide, 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 Ofce. 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 specically 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 Pzer for not reporting side effects Reuters [Internet]. [cited 2012 May 8]. Available from: http://www.reuters.com/ article/2010/06/10/us-pzer-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 rst 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 Ofce, 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. Reputatin 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 Benets 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.
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 efcacy 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 efcacy 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 modications 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 Benet. 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 Benet 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 Benet: 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 modications 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. Manseld. 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: nal 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 sulnpyrazone 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, Prole 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. Inuence of method of reporting study results on decision of physicians to prescibe drugs to lower cholesterol concentration. BMJ. 1994 Sep 24;309(6957):761-4.
38. Fahey T, Grifths 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 Nonsignicant 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.
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.
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 gure, 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. Benets 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. Inuence 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 rst 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 Prot 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 Scientic 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.
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66. Ibid.
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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, condential subject to protection order ZY200187608. http://zyprexalitigationdocuments.com/per cent5Cdocuments per cent5CCondentiality-Challenge per cent5CDocschallenged-in-10-3list per cent5C145-ZY200187608-7614.pdf
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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-les/letters/publichealth/ ph-iis-20101129.html
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