Бен Голдакр - Вся правда о лекарствах. Мировой заговор фармкомпаний

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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

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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 Statistical 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.

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

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

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

125. http://www.propublica.org/article/dollars-to-doctorsphysiciandisciplinary-records/single

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128. Carlowe J. Drug companies to declare all payments made to doctors from 2012. BMJ. 2010 Nov 5;341(nov051):c6290-c6290.

129. Tuffs A. Two doctors in Germany are convicted of taking bribes from drug company. BMJ. 2010 Nov 9;341(nov092):c6359-c6359.

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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-civ842.html

2. Glaxo executives cited in case now lead Sanofi, Actelion. Bloomberg News, 3/7/12. http://www.businessweek.com/news/ 201207-03/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/gskrulinganother-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-fraudsettlement.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-despitesetback/

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-oncarepathways-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.

1. The citation here is, for obvious reasons, ‘personal communication’. The email from the academic continued: ‘From my perspective, I don’t think we should be anything but indignant!’

2. Davis C, Abraham J. Is there a cure for corporate crime in the drug industry? BMJ. 2013;346:f755.

3. Gale EAM. Post-marketing studies of new insulins: sales or science? BMJ. 2012;344:e3974.

4. Light DW, Lexchin JR. Pharmaceutical research and development: what do we get for all that money? BMJ. 2012;345:e4348.

5. Svensson S, Menkes DB, Lexchin J. Surrogate Outcomes in Clinical Trials: A Cautionary Tale. JAMA Intern Med. 2013;173(8):611612.

6. „JAMA, Integrity, Accessibility, and Social vs. Scientific Peer Review“. Emergency Medicine Literature of Note, Feb 26, 2013.

7. Abbasi, K. Blood on our hands: seeing the evil in inappropriate comparators. J R Soc Med. 2013 January;106(1): 1.

8. Inside Health, BBC Radio 4, January 2013.

9. Duijnhoven RG, Straus SMJM, Raine JM, de Boer A, Hoes AW, et al. (2013) Number of Patients Studied Prior to Approval of New Medicines: A Database Analysis. PLoS Med 10(3): e1001407. doi:10.1371/journal.pmed.1001407

10. Ioannidis JPA. How Many Contemporary Medical Practices Are Worse Than Doing Nothing or Doing Less? Mayo Clinic Proceedings. 2013 Aug;88(8):779-81.

11. Zarin DA, Tse T. Trust but Verify: Trial Registration and Determining Fidelity to the Protocol. Ann Intern Med. 2013;159(1): 65–67.

12. Rosenthal R, Dwan K. Comparison of randomized controlled trial registry entries and content of reports in surgery journals. Ann Surg. 2013 Jun;257(6):1007-15.

13. Zetterqvist AV, Mulinari S (2013) Misleading Advertising for Antidepressants in Sweden: A Failure of Pharmaceutical Industry Self-Regulation. PLoS ONE 8(5): e62609. doi:10.1371/journal. pone.0062609

14. Mintzes B, Lexchin J, Sutherland JM, Beaulieu M-D, Wilkes MS, Durrieu G, et al. Pharmaceutical Sales Representatives and Patient Safety: A Comparative Prospective Study of Information Quality in Canada, France and the United States. J Gen Intern Med. 2013 Apr 5.

15. http://dailycaller.com/2013/04/27/critics-see-conflict-ofinterestas-obama-admin-advises-doctors-on-prescriptions/

16. http://www.propublica.org/article/pay-to-prescribe-twodozendoctors-named-in-novartis-kickback-case

17. Bosch X, Hernandez C; Pericas JM, Doti P. Ghostwriting Policies in High-Impact Biomedical Journals: A Cross-Sectional Study. JAMA Intern Med. 2013;173(10):920–921.

18. Nancarrow, CM. Editorial Policies to Ensure Honesty and Transparency: Comment on „Ghostwriting Policies in HighImpact Biomedical Journals: A Cross-Sectional Study“. JAMA Intern Med. 2013;173(10):921–922.

19. Persaud N. Questionable content of an industry-supported medical school lecture series: a case study. J Med Ethics. doi:10.1136/ medethics-2013-101343

20. India’s poor duped into clinical drug trials. Economic Times, 7th July 2013.

21. Vedula SS, Li T, Dickersin K. Differences in Reporting of Analyses in Internal Company Documents Versus Published Trial Reports: Comparisons in Industry-Sponsored Trials in Off-Label Uses of Gabapentin. PLoS Med. 2013 Jan 29;10(1):e1001378.

22. Sample, Ian. Big pharma mobilising patients in battle over drugs trials data. Guardian, 21st July 2013.

23. http://www.alltrials.net/2013/responses-to-leaked-memo/

24. Huser V, Cimino JJ (2013) Linking ClinicalTrials.gov and PubMed to Track Results of Interventional Human Clinical Trials. PLoS ONE 8(7): e68409. doi:10.1371/journal.pone.0068409

25. Schroll JB, Bero L, G0tzsche PC. Searching for unpublished data for Cochrane reviews: cross sectional study. BMJ 2013;346:f2231.

26. Wieseler B, McGauran N, Kerekes MF, Kaiser T. Access to regulatory data from the European Medicines Agency: the times they are a-changing. Syst Rev. 2012 Oct 30;1:50.

27. Little RJ, D’Agostino R, Cohen ML, Dickersin K, Emerson SS, Farrar JT, et al. The Prevention and Treatment of Missing Data in Clinical Trials. N Engl J Med. 2012; 367:1355–1360.

28. Mathieu S, Chan A-W, Ravaud P (2013) Use of Trial Register Information during the Peer Review Process. PLoS ONE 8(4): e59910. doi:10.1371/journal.pone.0059910

29. Prayle AP, Hurley MN, Smyth AR (2012) Data from: Compliance with mandatory reporting of clinical trial results on Clinical-Trials.gov: cross sectional study. Dryad Digital Repository. doi:10.5061/dryad.j512f21p

30. Simmonds MC, Brown JVE, Heirs MK, Higgins JPT, Mannion RJ, Rodgers MA, et al. Safety and Effectiveness of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Fusion: A Meta-analysis of Individual-Participant Data. Ann Intern Med. 2013;158(12):877–889.

Примечания

1

Вместо разработки новых методов исследований для поиска ответа на вопрос, могут ли люди осознанно предсказывать будущее, Бем просто провел несколько классических экспериментов по психологии, только изменил порядок действий. Так, например, он осуществил хорошо известный опыт по изучению влияния подсознания на осознанный выбор: людям показывают два зеркальных изображения одной и той же картинки и просят выбрать ту, которая им больше нравится, но перед тем как они скажут свое конечное слово, им в течение долей секунды демонстрируют какое-нибудь неприятное изображение, спрятанное под одной из картинок. При обычном ходе такого опыта демонстрация скрытого изображения заставляла людей реже выбирать ту картинку, под которой оно было спрятано. В исследовании Бема неприятные изображения показывались уже после того, как испытуемый выбирал понравившуюся ему картинку. Как бы это ни звучало неправдоподобно, но Бем обнаружил, что и тогда демонстрация скрытых образов все равно оказывала влияние на выбор подопытных.

2

Иэну Чалмерсу был пожалован рыцарский титул за создание организации Cochrane Collaboration. Будучи очень практичными людьми, исследователи из компании захотели узнать, была ли какая-нибудь реальная польза от полученного звания, поэтому было решено провести исследования по методу случайной выборки. Будет ли наблюдаться разница в количестве откликов на письма в зависимости от подписи. «Иэн Чалмерс» или «сэр Иэн Чалмерс» — как лучше? Была создана простая система: перед отправкой часть наугад выбранных писем была подписана «сэр Иэн Чалмерс», а другая — просто «Иэн Чалмерс». Затем исследователи сравнили количество полученных ответов на каждое из посланий, подписанных двумя разными способами. Оказалось, что приставка «сэр» вообще не оказала на людей никакого воздействия. Это исследование было опубликовано полностью, несмотря на получение негативных результатов, в журнале Королевского общества медицины, и это вовсе не несерьезный предмет исследования. В медицине встречается много людей, обладающих титулом рыцаря. Многие готовы на ряд сомнительных и даже опасных вещей, чтобы увеличить шансы получения заветной регалии. Большинство думает: «Если бы у меня был рыцарский титул, люди воспринимали бы все мои идеи более серьезно». Работа была озаглавлена «Да, сэр. Нет, сэр. Без разницы, сэр».56 После ее прочтения вы можете снизить уровень ваших амбиций.