Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients (54 page)

25
Chan A-W, Hróbjartsson A, Haahr MT, Gøtzsche 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) 73–81 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_365-9454.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):c4875–c4875.

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

Chapter 5: Bigger, Simpler Trials

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.

Chapter 6: Marketing

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-to-consumer 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
Castrén 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-has-only-one-sponsored-answer-youre-at-risk/?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-we-ve-got-a-pill-forthat.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//files/06/72/68/f067268/public/peer/prc_program2001.htm#ABSTRACTS.