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 исследованиях1. 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 проще1. 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. Маркетинг1. 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.
