Bad Science

by Ben Goldacre

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-database-licensing/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 Gøtzsche PC, Hróbjartsson 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-Grassley-Report.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 cent5CDocs-challenged-in-10-3-list 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: 1800–1812.

  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/public-health/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, Dörter 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. Möbius: 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 Stat
istical 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. JAMA. 2011;305(10):1008–1017. doi: 10.1001/jama.2011.257

  118 Loewenstein G, Sah S, Cain DM. The Unintended Consequences of Conflict of Interest Disclosure. JAMA. 2012 Feb 15;307(7):669–70.

  119 Cain, D. M., Loewenstein, G., & Moore, D. A. (2005). The dirt on coming clean: perverse effects of disclosing conflicts of interest. Journal of Legal Issues, 34, 1e25.

  120 Campbell EG, Weissman JS, Ehringhaus S et al. Institutional academic industry relationships. JAMA 2007;298:1779–86.

  121 http://www.propublica.org/series/dollars-for-docs

  122 http://www.propublica.org/article/doctors-dine-on-drug-companies-dime

  123 http://www.propublica.org/article/dollars-for-docs-sparks-policy-rewrite-at-colorado-teaching-hospitals

  124 http://www.propublica.org/article/medical-schools-plug-holes-in-conflict-of-interest-policies

  125 http://www.propublica.org/article/dollars-to-doctors-physician-disciplinary-records/single

  126 http://www.propublica.org/article/drug-companies-reduce-payments-to-doctors-as-scrutiny-mounts

  127 http://www.propublica.org/article/piercing-the-veil-more-drug-companies-reveal-payments-to-doctors

  128 Carlowe J. Drug companies to declare all payments made to doctors from 2012. BMJ. 2010 Nov 5;341(nov05 1):c6290–c6290.

  129 Tuffs A. Two doctors in Germany are convicted of taking bribes from drug company. BMJ. 2010 Nov 9;341(nov09 2):c6359–c6359.

  130 http://www.fcaalert.com/2011/02/articles/dojhhs-releases-new-statistics-about-sealed-qui-tam-cases/

  131 Sweet M. Experts criticise industry sponsorship of articles on health policy in Australian newspaper. BMJ. 2011 Oct 25;343(oct25 2):d6903–d6903.

  132 http://www.pmcpa.org.uk/?q=node/499

  133 http://www.propublica.org/documents/item/87376-heart-rhythm-society

  134 http://www.propublica.org/article/medical-groups-shy-about-detailing-industry-financial-support

  135 JP Kassirer. On the Take: How Medicine’s Complicity with Big Business Can Endanger Your Health. 1st ed. Oxford University Press, USA; 2004.

  136 http://www.eatright.org/corporatesponsors/.

  137 JP Kassirer. On the Take: How Medicine’s Complicity with Big Business Can Endanger Your Health. 1st ed. Oxford University Press, USA; 2004, p105.

  138 Choudhry NK, Stelfox HT, Detsky AS. Relationships between authors of clinical practice guidelines and the pharmaceutical industry. JAMA. 2002 Feb 6;287 (5):612–7.

  Afterword: Better Data

  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-civ-842.html

  2 Glaxo executives cited in case now lead Sanofi, Actelion. Bloomberg News, 3/7/12. http://www.businessweek.com/news/ 2012-07-03/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/gsk-ruling-another-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-fraud-settlement.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-despite-setback/

  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-on-care-pathways-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.

  Illustrations

  Fig. 1: http://www.cochrane.org/about-us/history/our-logo%23files

  Fig. 2: Mulrow CD. Rationale for systematic reviews. BMJ. 1994 Sep 3;309(6954):597–9. Available at: http://www.ncbi.nlm. nih.gov/pmc/articles/PMC2541393/?page=1;

  Fig. 3: Ranibizumab and pegaptanib for the treatment of age-related macular degeneration: a systematic review and economic evaluation. NICE 2006. Available at: http://www.nice.org.uk/ nicemedia/live/11700/34991/34991.pdf

  Fig. 4: http://www.prescrire.org/editoriaux/EDI33693.pdf

  Fig. 6: Carpenter D. Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA. Princeton University Press, 2010.

  Fig. 7: Schwartz LM, Woloshin 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. Available at: http://dartmed.dartmouth.edu/spring08/pdf/ disc_drugs_we/lunesta_box.pdf

  Fig. 8: http://www.lunesta.com/PostedApprovedLabelingText.pdf

  Fig. 9: Lurie P, Wolfe SM. Misleading data analyses in salmeterol (SMART) study. The Lancet. 2005 Oct;366(9493): 1261–2.

  Fig. 11: Rothwell PM. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation. The Lancet. 2005;365(9454):176–86. Available at: http://apps.who.int/ rhl/Lancet_365-9454.pdf

  Fig. 12: Moynihan R. The making of a disease: female sexual dysfunction. BMJ. 2003;326(7379):45–47. Available at: http:// www.ncbi.nlm.nih.gov/pmc/articles/PMC1124933/table/TN0x95f 06b0.0x98eca30/

  Fig. 13, fig. 14 (p.294 bottom), fig. 15 (p.295 top), fig. 16 (p.295 bottom): http://zyprexalitigationdocuments.com/%5 Cdocuments%5CConfidentiality-Challenge%5CDocs-challenged-in-10-3-list%5C145-ZY200187608-7614.pdf

  Fig. 17: Drug Industry Document Archive [Internet]. Available at: http://dida.library.ucsf.edu/pdf/vou38h10

  Fig. 18: http://pogoblog.typepad.com/pogo/gw-attachment-e.html

  Fig. 19: 15 August 2012, http://uk.finance.yahoo.com/ echarts?s=GSK.L#symbol=GSK.L;range=1y

  ABOUT THE AUTHOR

  BEN GOLDACRE is a doctor and writer. His first book Bad Science reached Number One in the nonfiction charts, sold over 400,000 copies in the UK alone, and has been translated into 25 languages. He is 38 and lives in London.

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  * Instead of designing elaborate new studies to see whether people could consciously see forward in time, Bem simply ran some classic psychology experiments backwards. So, for example, he conducted a well-known experiment on subliminal influence, where you show people two mirror images of the same picture, and then ask them which they prefer; but you flash up an unpleasant subliminal image underneath one or other image for just a few milliseconds before they make their choice. In the normal run of this study, the subliminal image makes people less likely to choose that option. In the Bem study, the unpleasant subliminal images were flashed up just after the participants made their choice of favourite image. However unlikely it sounds, Bem found that these subliminal images still had an effect on people’s choices.