rpcardioRational Pharmacotherapy in CardiologyРациональная Фармакотерапия в Кардиологии1819-64462225-3653«SILICEA-POLIGRAF» LLC10.20996/1819-6446-2015-11-4-420-425rpcardio-172Research ArticlePOINT OF VIEWТОЧКА ЗРЕНИЯDRUGS EFFICIENCY AND SAFETY: THE ROLE OF PHARMACEUTICAL INDUSTRYЭФФЕКТИВНОСТЬ И БЕЗОПАСНОСТЬ ЛЕКАРСТВ: РОЛЬ ФАРМАЦЕВТИЧЕСКОЙ ИНДУСТРИИБеляловФ. И.BelyalovF. I.

664049, Иркутск, микрорайон Юбилейный, 100

Microrion Yubileiniy 100, Irkutsk, 664079 Russia

fbelyalov@mail.ruИркутская государственная медицинская академия последипломного образованияРоссияIrkutsk State Medical Academy of Postgraduate EducationRussian Federation201523092015114420425Copyright © Belyalov F.I., 20152015Белялов Ф.И.Belyalov F.I.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.rpcardio.online/jour/article/view/172

Relationships of pharmaceutical industry with medical science and practice are analyzed. The influence of pharmaceutical industry on clinical trials, journal publications, governmental organizations, physicians and researchers is discussed.

Проанализированы связи фармацевтической индустрии с медицинской наукой и практикой. Рассмотрены вопросы влияния фармацевтических компаний на иссле-дования лекарственных препаратов, на публикации результатов исследований, на государственные контролирующие органы, врачей и научных работников.

конфликт интересовфармацевтическая индустрияconflict of interestpharmaceutical industryReferencesLo B., Field M.J., eds. Institute of Medicine. Conflict of interest in medical research, education, and practice. Washington. D.C.: The national academies press: 2009.Lo B., Field M.J., eds. Institute of Medicine. Conflict of interest in medical research, education, and practice. Washington. D.C.: The national academies press: 2009.Als-Nielsen B., Chen W., Gluud C., et al. Association of Funding and Conclusions in Randomized Drug Trials: A Reflection of Treatment Effect or Adverse Events? JAMA. 2003;290:921-8.Als-Nielsen B., Chen W., Gluud C., et al. Association of Funding and Conclusions in Randomized Drug Trials: A Reflection of Treatment Effect or Adverse Events? JAMA. 2003;290:921-8.Ridker P.M., Torres J. Reported Outcomes in Major Cardiovascular Clinical Trials Funded by For-Profit and Not-for-Profit Organizations: 2000-2005. JAMA 2006;295:2270-4.Ridker P.M., Torres J. Reported Outcomes in Major Cardiovascular Clinical Trials Funded by For-Profit and Not-for-Profit Organizations: 2000-2005. JAMA 2006;295:2270-4.Lundh A., Sismondo S., Lexchin J., et al. Industry sponsorship and re-search outcome. Cochrane Database of Systematic Reviews 2012; 12: MR000033.Lundh A., Sismondo S., Lexchin J., et al. Industry sponsorship and re-search outcome. Cochrane Database of Systematic Reviews 2012; 12: MR000033.Lexchin J., Bero L.A., Djulbegovic B., Clark. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003;326;1167-70.Lexchin J., Bero L.A., Djulbegovic B., Clark. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003;326;1167-70.Perlis R.H., Perlis C.S., Wu Y., et al. Industry Sponsorship and Financial Conflict of Interest in the Reporting of Clinical Trials in Psychiatry. Am J Psychiatry 2005;162:1957-60.Perlis R.H., Perlis C.S., Wu Y., et al. Industry Sponsorship and Financial Conflict of Interest in the Reporting of Clinical Trials in Psychiatry. Am J Psychiatry 2005;162:1957-60.Turner E.H., Matthews A.M.,Linardatos E., et al. Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy. N Engl J Med 2008;358:252-60.Turner E.H., Matthews A.M.,Linardatos E., et al. Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy. N Engl J Med 2008;358:252-60.Rochon P.A., Gurwitz J.H., Simms R.W., et al. A study of manufacturer-supported trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis. Arch Intern Med 1994;154(2):157-63.Rochon P.A., Gurwitz J.H., Simms R.W., et al. A study of manufacturer-supported trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis. Arch Intern Med 1994;154(2):157-63.Krumholz H.M., Ross J.S., Presler A.H., et al. What have we learnt from Vioxx? BMJ 2007;334: 120-3.Krumholz H.M., Ross J.S., Presler A.H., et al. What have we learnt from Vioxx? BMJ 2007;334: 120-3.FitzGerald G.A. Coxibs and Cardiovascular Disease. N Engl J Med 2004;351;1709-11.FitzGerald G.A. Coxibs and Cardiovascular Disease. N Engl J Med 2004;351;1709-11.Trelle S., Reichenbach S., Wandel S., et al. Cardiovascular safety of non-steroidal anti-inflammatory drugs: network meta-analysis. BMJ 2011; 342:c7250.Trelle S., Reichenbach S., Wandel S., et al. Cardiovascular safety of non-steroidal anti-inflammatory drugs: network meta-analysis. BMJ 2011; 342:c7250.Nelson H.S., Weiss S.T., Bleecker E.R. et al. The Salmeterol Multicen-ter Asthma Research Trial: A Comparison of Usual Pharmacotherapy for Asthma or Usual Pharmacotherapy Plus Salmeterol. Chest 2006;129:15-26.Nelson H.S., Weiss S.T., Bleecker E.R. et al. The Salmeterol Multicen-ter Asthma Research Trial: A Comparison of Usual Pharmacotherapy for Asthma or Usual Pharmacotherapy Plus Salmeterol. Chest 2006;129:15-26.Shelley R.S., Andrew J.W., Buckley N.S. Long-acting Beta-Agonists with and without Inhaled Corticosteroids and Catastrophic Asthma Events. The American Journal of Medicine 2010;123(4): 322-8.Shelley R.S., Andrew J.W., Buckley N.S. Long-acting Beta-Agonists with and without Inhaled Corticosteroids and Catastrophic Asthma Events. The American Journal of Medicine 2010;123(4): 322-8.Sun X., Briel M., Busse J.W., et al. The influence of study characteristics on reporting of subgroup analyses in randomised controlled trials: systematic review. BMJ 2011;342:d1569.Sun X., Briel M., Busse J.W., et al. The influence of study characteristics on reporting of subgroup analyses in randomised controlled trials: systematic review. BMJ 2011;342:d1569.Kasenda B., Schandelmaier S., Sun X., et al. Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications. BMJ 2014;349.Kasenda B., Schandelmaier S., Sun X., et al. Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications. BMJ 2014;349.Sun X, Ioannidis J.A., Agoritsas T., et al. How to Use a Subgroup Analysis: Users’ Guide to the Medical Literature. JAMA 2014;311(4):405-11.Sun X, Ioannidis J.A., Agoritsas T., et al. How to Use a Subgroup Analysis: Users’ Guide to the Medical Literature. JAMA 2014;311(4):405-11.Yank V., Rennie D., Bero L.A. Financial ties and concordance between re-sults and conclusions in metaanalyses: retrospective cohort study. BMJ 2007;335:1202-5.Yank V., Rennie D., Bero L.A. Financial ties and concordance between re-sults and conclusions in metaanalyses: retrospective cohort study. BMJ 2007;335:1202-5.Ebell M.H., Call M., Shinholser J. Effectiveness of oseltamivir in adults: a meta-analysis of published and unpublished clinical trials. Fam Pract 2013;30(2):125-33.Ebell M.H., Call M., Shinholser J. Effectiveness of oseltamivir in adults: a meta-analysis of published and unpublished clinical trials. Fam Pract 2013;30(2):125-33.Dunn A.G., Arachi D., Hudgins J., et al. Financial Conflicts of Interest and Conclusions About Neuraminidase Inhibitors for Influenza: An Analysis of Systematic Reviews. Ann Intern Med 2014;161: 513-8.Dunn A.G., Arachi D., Hudgins J., et al. Financial Conflicts of Interest and Conclusions About Neuraminidase Inhibitors for Influenza: An Analysis of Systematic Reviews. Ann Intern Med 2014;161: 513-8.Cates C.J., Cates M.J. Regular treatment with salmeterol for chronic asthma: serious adverse events. Cochrane Database Syst Rev 2013;3:CD006922.Cates C.J., Cates M.J. Regular treatment with salmeterol for chronic asthma: serious adverse events. Cochrane Database Syst Rev 2013;3:CD006922.Bateman E., Nelson H., Bousquet J. et al. Meta-analysis: Effects of Adding Salmeterol to Inhaled Corticosteroids on Serious Asthma-Related Events. Ann Intern Med 2008;149:33-42.Bateman E., Nelson H., Bousquet J. et al. Meta-analysis: Effects of Adding Salmeterol to Inhaled Corticosteroids on Serious Asthma-Related Events. Ann Intern Med 2008;149:33-42.Sears M.R., Radner F. Safety of formoterol in asthma clinical trials: an update. European Respiratory Journal 2014;43(1):103-14.Sears M.R., Radner F. Safety of formoterol in asthma clinical trials: an update. European Respiratory Journal 2014;43(1):103-14.Cates C.J., Wieland L.S., Oleszczuk M., Kew K.M. Safety of regular formoterol or salmeterol in adults with asthma: an overview of Cochrane reviews. Cochrane Database of Systematic Reviews 2014; 2: CD010314.Cates C.J., Wieland L.S., Oleszczuk M., Kew K.M. Safety of regular formoterol or salmeterol in adults with asthma: an overview of Cochrane reviews. Cochrane Database of Systematic Reviews 2014; 2: CD010314.Jorgensen A.W., Hilden J., Gotzsche P.C. Cochrane reviews compared with industry supported metaanalyses and other meta-analyses of the same drugs: systematic review. BMJ 2006;333:782.Jorgensen A.W., Hilden J., Gotzsche P.C. Cochrane reviews compared with industry supported metaanalyses and other meta-analyses of the same drugs: systematic review. BMJ 2006;333:782.Roseman M., Milette K., Bero L.A., et al. Reporting of Conflicts of Interest in Meta-analyses of Trials of Pharmacological Treatments. JAMA 2011;305(10):1008-17.Roseman M., Milette K., Bero L.A., et al. Reporting of Conflicts of Interest in Meta-analyses of Trials of Pharmacological Treatments. JAMA 2011;305(10):1008-17.Michelle R., Erick H.T., Joel L., et al. Reporting of conflicts of interest from drug trials in Cochrane reviews: cross sectional study. BMJ 2012;345: e5155.Michelle R., Erick H.T., Joel L., et al. Reporting of conflicts of interest from drug trials in Cochrane reviews: cross sectional study. BMJ 2012;345: e5155.Smith R. Medical journals and pharmaceutical companies: uneasy bed-fellows. BMJ 2003;326(7400):1202-5.Smith R. Medical journals and pharmaceutical companies: uneasy bed-fellows. BMJ 2003;326(7400):1202-5.Wilkes M.S., Doblin B.H., Shapiro M.F. Pharmaceutical advertisements in leading medical journals: experts’ assessments. Ann Intern Med 1992;116:912-9.Wilkes M.S., Doblin B.H., Shapiro M.F. Pharmaceutical advertisements in leading medical journals: experts’ assessments. Ann Intern Med 1992;116:912-9.Villanueva P., Peiro S., Librero J., Pereiro I. Accuracy of pharmaceuti-cal advertisements in medical journals. Lancet 2003;361(9351):27-32.Villanueva P., Peiro S., Librero J., Pereiro I. Accuracy of pharmaceuti-cal advertisements in medical journals. Lancet 2003;361(9351):27-32.Davidoff F., DeAngelis C.D., Drazen J.M. et al. Sponsorship, author-ship, and accountability. Ann Intern Med 2001;135(6):463-6.Davidoff F., DeAngelis C.D., Drazen J.M. et al. Sponsorship, author-ship, and accountability. Ann Intern Med 2001;135(6):463-6.Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. Updated December 2013. Available at: http://www.icmje.org/icmje-recommendations.pdf. Accessed by 10.06.2015.Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. Updated December 2013. Available at: http://www.icmje.org/icmje-recommendations.pdf. Accessed by 10.06.2015.Wilson D. Drug app comes free, ads included. New York Times. July 28, 2011. Available at: http://www.nytimes.com/2011/07/29/business/the-epocrates-app-provides-drug-informationand-drug-ads.html. Accessed by 10.06.2015.Wilson D. Drug app comes free, ads included. New York Times. July 28, 2011. Available at: http://www.nytimes.com/2011/07/29/business/the-epocrates-app-provides-drug-informationand-drug-ads.html. Accessed by 10.06.2015.Neuman J., Korenstein D., Ross J.S., et al. Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study. BMJ 2011;343:d5621.Neuman J., Korenstein D., Ross J.S., et al. Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study. BMJ 2011;343:d5621.European Society of Cardiology. 2013 ESC guidelines on the management of stable coronary artery disease. Eur Heart J 2013;34:2949-3003.European Society of Cardiology. 2013 ESC guidelines on the management of stable coronary artery disease. Eur Heart J 2013;34:2949-3003.Fox K., Ford I., Steg P.G., Tardif J.-C., et al. Ivabradine in Stable Coronary Artery Disease without Clinical Heart Failure. N Engl J Med 2014;371:1091-9.Fox K., Ford I., Steg P.G., Tardif J.-C., et al. Ivabradine in Stable Coronary Artery Disease without Clinical Heart Failure. N Engl J Med 2014;371:1091-9.Camm A.J., Kirchhof P., Lip G.Y.H., et al. Guidelines for the management of atrial fibrillation. Eur Heart J 2010;31:2369-429.Camm A.J., Kirchhof P., Lip G.Y.H., et al. Guidelines for the management of atrial fibrillation. Eur Heart J 2010;31:2369-429.Connolly S.J., Camm A.J., Halperin J.L., et al. Dronedarone in High-Risk Permanent Atrial Fibrillation. N Engl J Med 2011;365(24):2268-76.Connolly S.J., Camm A.J., Halperin J.L., et al. Dronedarone in High-Risk Permanent Atrial Fibrillation. N Engl J Med 2011;365(24):2268-76.2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation. J Am Coll Cardiol 2014;64(21):e1-e76.2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation. J Am Coll Cardiol 2014;64(21):e1-e76.Campbell E.G., Gruen R.L., Mountford J., et al. A National Survey of Physician-Industry Relationships. N Engl J Med 2007;356:1742-50.Campbell E.G., Gruen R.L., Mountford J., et al. A National Survey of Physician-Industry Relationships. N Engl J Med 2007;356:1742-50.Henry D., Doran E., Kerridge I., et al. Ties That Bind: Multiple Rela-tionships Between Clinical Researchers and the Pharmaceutical Indus-try. Arch Intern Med 2005;165:2493-6.Henry D., Doran E., Kerridge I., et al. Ties That Bind: Multiple Rela-tionships Between Clinical Researchers and the Pharmaceutical Indus-try. Arch Intern Med 2005;165:2493-6.Sierles F.S., Brodkey A.C., Cleary L.M. et al. Medical Students' Expo-sure to and Attitudes About Drug Company Interactions: A National Survey. JAMA 2005;294:1034-42.Sierles F.S., Brodkey A.C., Cleary L.M. et al. Medical Students' Expo-sure to and Attitudes About Drug Company Interactions: A National Survey. JAMA 2005;294:1034-42.Kesselheim A.S., Robertson C.T., Siri K., et al. Distributions of Industry Payments to Massachusetts Physicians. N Engl J Med 2013;368(22):2049-52.Kesselheim A.S., Robertson C.T., Siri K., et al. Distributions of Industry Payments to Massachusetts Physicians. N Engl J Med 2013;368(22):2049-52.Access Monitor 2013: executive summary. ZS, July 2013. Available at: http://www.zsassociates.com/publications/videos/accessmonitor-2013-executive-summary.aspx. Accessed by 10.06.2015.Access Monitor 2013: executive summary. ZS, July 2013. Available at: http://www.zsassociates.com/publications/videos/accessmonitor-2013-executive-summary.aspx. Accessed by 10.06.2015.Steinbrook R. Conflicts of Interest at the NIH - Resolving the Problem. N Engl J Med 2004;351; 955-7.Steinbrook R. Conflicts of Interest at the NIH - Resolving the Problem. N Engl J Med 2004;351; 955-7.Steinbrook R. Financial Conflicts of Interest and the Food and Drug Administration's Advisory Committees. N Engl J Med 2005; 353(2):116-8.Steinbrook R. Financial Conflicts of Interest and the Food and Drug Administration's Advisory Committees. N Engl J Med 2005; 353(2):116-8.Lurie P., Almeida C.M., Stine N. et al. Financial Conflict of Interest Disclosure and Voting Patterns at Food and Drug Administration Drug Advisory Committee Meetings. JAMA 2006;295:1921-8.Lurie P., Almeida C.M., Stine N. et al. Financial Conflict of Interest Disclosure and Voting Patterns at Food and Drug Administration Drug Advisory Committee Meetings. JAMA 2006;295:1921-8.Bauchner H, Fontanarosa PB. Restoring Confidence in the Pharmaceutical Industry. JAMA 2013;309(6):607-9Bauchner H, Fontanarosa PB. Restoring Confidence in the Pharmaceutical Industry. JAMA 2013;309(6):607-9

The authors declare that there are no conflicts of interest present.