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Corruption of Pharmaceutical Markets: Addressing the Misalignment of Financial Incentives and Public Health

Published online by Cambridge University Press:  01 January 2021

Extract

This article argues that the misalignment of private profit-maximizing objectives with public health needs causes institutional corruption in the pharmaceutical sector and systematically leads firms to act contrary to public heath. The article analyzes how financial incentives generate a business model promoting harmful practices and explores several means of realigning financial incentives in order to foster therapeutic innovation and promote the rational use of medicines.

Type
Symposium
Copyright
Copyright © American Society of Law, Medicine and Ethics 2013

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References

Gagnon, M.-A. Lexchin, J., “The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States,” PLoS Medicine 5, no. 1 (2008): 00290033.CrossRefGoogle Scholar
Montalban, M. Sakinç, M. E., “How Financialization Shapes Productive Models in the Pharmaceutical Industry: The Domination and Contradictions of the Blockbuster Productive Model,” GREThA Working Paper, Université of Bordeaux (2011); Gagnon, M.-A., The Nature of Capital in the Knowledge-Based Economy; The Case of the Global Pharmaceutical Industry, Ph.D. Dissertation, York University (2009).Google Scholar
Alpert, B., “Roche's Revolution,” Barron's 85, no. 14 (April 4, 2005): 2022.Google Scholar
A blockbuster drug is normally defined as a drug with sales of more than $1 billion per year.Google Scholar
Steinman, M. A. et al., “Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents,” Annals of Internal Medicine 145, no. 4 (2006): 284293; Evans, D., “Big Pharma's Crime Spree,” Bloomberg Special Report, December 2009; Spielmans, G. I., “The Promotion of Olanzapine in Primary Care: An Examination of Internal Industry Documents,” Social Science and Medicine 69, no. 1 (2009): 1420.CrossRefGoogle Scholar
Rodwin, M. A., Conflicts of Interest and the Future of Medicine (Oxford: Oxford University Press, 2011); Institute of Medicine, Conflicts of Interest in Medical Research, Education, and Practice (Washington, D.C.: National Academies Press, 2009).CrossRefGoogle Scholar
Goldacre, B., Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients (Toronto: McClelland & Stewart, 2012); Mintzes, B. et al., “Pharmaceutical Sales Representatives and Patient Safety: A Comparative Prospective Study of Information Quality in Canada, France and the United States,” Journal of General Internal Medicine 28, no. 4 (April 2013): 18.Google Scholar
See Gagnon, Lexchin, , supra note 1.Google Scholar
Sismondo, S., “Ghost Management: How Much of the Medical Literature Is Shaped behind the Scenes by the Pharmaceutical Industry?” PLoS Med 4, no. 9 (2007): 14291433; Matheson, A., “Corporate Science and the Husbandry of Scientific and Medical Knowledge by the Pharmaceutical Industry,” BioSocieties 3, no. 4 (2008): 355–385; Spielmans, G. I. Parry, P., “From Evidence-Based Medicine to Marketing-Based Medicine: Evidence from Internal Industry Documents,” Bioethical Inquiry 7, no. 1 (2010): 13–29; Sismondo, S., “Linking Research and Marketing: A Pharmaceutical Innovation,” in Quirke, V. Slinn, J., eds., Perspectives on 20th Century Pharmaceuticals (New York: Peter Lang, 2010): at 241–256.Google Scholar
Sismondo, S., “Ghosts in the Machine: Publication Planning in the Medical Sciences,” Social Studies of Science 39, no. 2 (2009): 171–198; Lacasse, J. R. Leo, J., “Ghostwriting at Elite Academic Medical Centers in the United States,” PLoS Med 7, no. 2 (2010): 1–4; U.S. Senate Committee on Finance, Ghostwriting in Medical Literature,111th Cong., June 24, 2010; Sismondo, S. Doucet, M., “Publication Ethics and the Ghost Management of Medical Research,” Bioethics 24, no. 6 (2010): 273283.Google Scholar
Cosgrove, L. et al., “Financial Ties between DSM-IV Panel Member and the Pharmaceutical Industry,” Psychotherapy and Psychosomatics 75, no. 3 (2006): 154160; Angell, M., “Drug Companies & Doctors: A Story of Corruption,” NY Review of Books 56, no. 1 (2009); see Institute of Medicine, supra note 6.CrossRefGoogle Scholar
Kessler, D. A. et al., “Therapeutic-class Wars: Drug Promotion in a Competitive Marketplace,” New England Journal of Medicine 331, no. 20 (1994): 1350–1353; La Puma, J. Seltzer, J., “Phase IV Market Steams Ahead,” CenterWatch 9, no. 10 (2002): 1–13; Andersen, M. Kragstrup, J. Sondergaard, J., “How Conducting a Clinical Trial Affects Physicians' Guidelines Adherence and Drug Preferences,” JAMA 295, no. 23 (2006): 27592764.Google Scholar
Healy, D., Let Them Eat Prozac (New York: New York University Press, 2004); Turner, E. H. et al., “Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy,” New England Journal of Medicine 358, no. 3 (2008): 252260; Hart, B. Lundh, A. Bero, L., “Effect of Reporting Bias on Meta-Analyses of Drug Trials: Reanalysis of Meta-Analyses,” BMJ 344, no. 7838 (2012).Google Scholar
U.S. Senate Committee on Finance, Staff Report on GlaxoSmithKline and the Diabetes drug Avandia, 111th Cong., 2nd Session, January, 2010; Egilman, D. Ardolino, E., “The Pharmaceutical Industry, Disease Industry,” in Wiist, W. H., ed., The Bottom Line or Public Health (New York: Oxford University Press, 2010): at 193–224; Favereau, E. Philippin, Y., “Servier: La technique de l'intimidation,” Libération, December 23, 2010; Prescrire, “Des firmes s'attaquent à des chercheurs,” Prescrire 31, no. 328 (2011).Google Scholar
Miller, S., “Corruption,” in Zalta, E. N., ed., The Stanford Encyclopedia of Philosophy (spring 2011 ed.), available at <http://plato.stanford.edu/archives/spr2011/entries/corruption/> (last visited June 17, 2013); Lessig, L., Republic, Lost: How Money Corrupts Congress – and a Plan to Stop It (New York: Twelve, 2011): at 226–248.Google Scholar
See Egilman, Ardolino, , supra note 14; Gagnon, M.-A., “Corporate Influence over Clinical Research: Considering the Alternatives,” Prescrire International 21, no. 129 (2012): 191194.Google Scholar
See Gagnon, , supra note 2.Google Scholar
OECD, Pharmaceutical Pricing Policies in a Global Market (Paris: OECD, 2008); Morgan, S. J. et al., The Public Provision of Pharmaceuticals: A Synthesis of Policies in Ten Developed Countries, Pharmaceutical Policy Research Collaboration, December 2012.Google Scholar
Gorry, P. Montalban, M. Smith, A., “When Medical Science Meets Economics & Politics: The Institutionalization of Health Technology Assessment within the European Government of Pharmaceuticals,” GEDI working paper, 2011.Google Scholar
Schoonveld, E., The Price of Global Health (Farnham: Gower Publishing Limited, 2011).Google Scholar
Drahos, P. Braithwaite, J., Information Feudalism: Who Owns the Knowledge Economy (London: Earthscan, 2002).Google Scholar
EFPIA, The Pharmaceutical Industry in Figures (EFPIA-Various years), available at <http://www.efpia.eu/documents/80/61/The-Pharmaceutical-Industry-in-figures-Edition-2013> (last visited June 26, 2013); David, E. Tramontin, T. Zemmel, R., “Pharmaceutical R&D: The Road to Positive Returns,” Nature Reviews Drug Discovery 8, no. 8 (2009): 609610. For a discussion of the misalignment of incentives for research and development, see Rodwin, M. A., “Five UnEasy Pieces to Pharmaceutical Policy Reform,” Journal of Law, Medicine & Ethics 41, no. 3 (2013): 581589.Google Scholar
Patented Medicines Price Review Board, Annual Report 2011 (Ottawa: PMPRB, 2012); Prescrire, “L'année 2012 du medicament; ProgrÖs en berne, mesures timides pour la protection des patients,” Prescrire 33, no. 352 (February 2013): 134–137; Light, D. Lexchin, J., “Pharmaceutical Research and Development: What Do We Get for All That Money,” BMJ 345, no. e4348 (August 2012): 22–28. Note that Light and Lexchin contend that there is no innovation crisis in terms of the number of new drugs arriving on the market, but that there is a real innovation crisis in terms of the therapeutic innovation that these new drugs represent. See also, Light, D. W. Lexchin, J. Darrow, J., “Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs,” Journal of Law, Medicine & Ethics 41, no. 3 (2013): 590600.Google Scholar
Harris, G., “Federal Research Center to Help Develop Medicines,” New York Times, January 22, 2011.Google Scholar
For more information on methods, see Gagnon, , supra note 2.Google Scholar
Fretheim, A., “Back to Thiazide-Diuretics for Hypertension: Reflections after a Decade of Irrational Prescribing,” BMC Family Practice 4, no. 19 (2003): 14; Pollack, A., “The Minimal Impact of a Big Hypertension Study,” New York Times, November 27, 2008.CrossRefGoogle Scholar
Jones, P. B. et al., “Randomized Controlled Trial Effect on Quality of Life of Second- vs. First-Generation Antipsychotic Drugs in Schizophrenia: Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study (CUtLASS 1),” Archives of General Psychiatry 63, no. 10 (2006): 10791087; Girgis, R. R. et al., “Clozapine v. Chlorpromazine in Treatment-Naïve, First-Episode Schizophrenia: 9-Year Outcomes of Randomised Clinical Trial,” British Journal of Psychiatry 199, no. 4 (2011): 281–288.Google Scholar
Fournier, J. et al., “Antidepressant Drug Effects and Depression Severity: A Patient-Level Meta-analysis,” JAMA 303, no. 1 (2010): 4753; Kirsch, I., The Emperor's New Drugs: Exploding the Antidepressant Myth (New York: Basic Books, 2010).Google Scholar
Fugh-Berman, A., “The Haunting of Medical Journals: How Ghostwriting Sold ‘HRT,’” PLoS Medicine 7, no. 9 (2010): 111.CrossRefGoogle Scholar
See Sismondo, , supra note 9.Google Scholar
See Spielmans, Parry, , supra note 9.Google Scholar
Norris, S. et al., “Characteristics of Physicians Receiving Large Payments from Pharmaceutical Companies and the Accuracy of Their Disclosures in Publications: An Observational Study,” BMC Medical Ethics 13, no. 24 (September 2012): 17; Pear, R., “U.S. to Force Drug Firms to Report Money Paid to Doctors,” New York Times, January 16, 2012. For discussions of the limitations of transparency, and its potential benefits, see in this issue of JLME 41, no. 3 (2013): Sismondo, S., “Key Opinion Leaders and the Corruption of Medical Knowledge: What the Sunshine Act Will and Won't Cast Light On,” 635643; Feldman, Y. Gauthier, R. Schuller, T., “Curbing Misconduct in the Pharmaceutical Industry: Insights from Behavioral Ethics and the Behavioral Approach to Law,” at 620–628; Brown, A., “Understanding Pharmaceutical Research Manipulation in the Context of Accounting Manipulation,” at 611–619; Cosgrove, L. Wheerler, E. E., “Drug Firms, Codification of Diagnostic Categories & Bias in Clinical Guidelines,” at 644–653.Google Scholar
Almashat, S. Wolfe, S., Pharmaceutical Industry Criminal and Civil Penalties: An Update, Report for Public Citizen, September 27, 2012.Google Scholar
See Almashat, Wolfe, , supra note 33.Google Scholar
See Goldacre, supra note 7, at 346.Google Scholar
The Economist, “An Unhealthy Burden,” June 30, 2007.Google Scholar
For example, in his testimony for the US Senate Finance Committee, Graham, David J., Associate Director for Science and Medicine in FDA's Office of Drug Safety, estimated that the drug Vioxx caused between 88,000 and 137,000 excess cases of heart attacks in the United States. Of these between 30% and 40% died. The drug was marketed by Merck between May 1999 and June 2004 in the United States. To promote the drug Merck organized a ghostwriting campaign involving around 96 scientific articles. Key ones omit mentioning the death of some patients during clinical trials. During a class action lawsuit against Vioxx in Australia in 2009, it was discovered that the company had created a fake medical journal for Merck – the Australasian Journal of Joint and Bone Medicine, published by Elsevier. Merck's internal e-mails, revealed during the class lawsuit, exposed that the company drew up a hit list of “rogue” researchers who needed to be “discredited” or “neutralized.” Eight researchers at Stanford complained that they received threats from Merck after publishing unfavorable results. In the United States, the only charges against the company have been charges of unlawful promotion, for which the company agreed to pay $950 M in an out-of-court settlement. Between 1999 and 2004, sales amounted to $11 billion in the United States. See Gagnon, M.-A. Sismondo, S., “The Ghosts of Medical Research,” Genetic Engineering and Biotechnology News 30, no. 10 (May 15, 2010); Loftus, P. Kendall, B., “Merck to Pay $950 Million in Vioxx Settlement,” Wall Street Journal, November 23, 2011.Google Scholar
Braithwaite, J., Corporate Crime in the Pharmaceutical Industry (London: Routledge, 1984): at 308.Google Scholar
Pigou, A., The Economics of Welfare (New York: Macmillan, 1920). The clearest example of a negative externality is environmental pollution: A manufacturer can sell his product according to his private cost of production, but if the production process generates pollution (for example by spilling mercury in drinking water), this social cost is not included in the private cost that the manufacturer has to pay. This external social cost, which is not included in the cost of production of the manufacturer, is a negative externality.Google Scholar
Baumol, W. J., “On Taxation and the Control of Externalities,” American Economic Review 62, no. 3 (1972): 307322.Google Scholar
AIFA Research and Development Working Group, “Feasibility and Challenges of Independent Research on Drugs: The Italian Medicines Agency (AIFA) Experience,” European Journal of Clinical Investigations 40, no. 1 (2010): 6986.CrossRefGoogle Scholar
Moja, L. et al., “Using Clinical Evidence in a National Continuing Medical Education Program in Italy,” PLoS Medicine 4, no. 5 (2007): 799802.CrossRefGoogle Scholar
See AIFA Research and Development Working Group, supra note 42.Google Scholar
Lexchin, J., “Models for Financing the Regulation of Drug Promotion,” Globalization and Health 8, no. 24 (July 2012): 17.CrossRefGoogle Scholar
Spurling, G. K. et al., “Information from Pharmaceutical Companies and the Quality, Quantity, and Cost of Physicians' Prescribing: A Systematic Review,” PLoS Medicine 7, no. 10 (2010).CrossRefGoogle Scholar
Current pricing incentives also encourage promotion of off-label prescribing. For a discussion of how to change reimbursement for drugs prescribed off label, see Rodwin, M. A., “Rooting Out Institutional Corruption to Manage Inappropriate Off-Label Drug Use,” Journal of Law, Medicine & Ethics 41, no. 3 (2013): 654664.CrossRefGoogle Scholar
Drummond, M. Jonsson, B. Rutten, F. Stargardt, T., “Reimbursement of Pharmaceuticals: Reference Pricing Versus Health Technology Assessment,” European Journal of Health Economics 12, no. 3 (2011): 263271.CrossRefGoogle Scholar
Lee, J. L.-Y. et al., “A Systematic Review of Reference Pricing: Implications for US Prescription Drug Spending,” American Journal of Managed Care 18, no. 11 (November 2012): E429-e437.Google Scholar
Mabasa, V. H., “Effect of a Therapeutic Maximum Allowable Cost (MAC) Program on the Cost and Utilization of Proton Pump Inhibitors in an Employer-Sponsored Drug Plan in Canada,” Journal of Managed Care Pharmacy 12, no. 5 (2006): 371376.CrossRefGoogle Scholar
See Lee, et al., supra note 49.Google Scholar
Morgan, S. Hanley, G. Greyson, D., “Comparison of Tiered Formularies and Reference Pricing Policies: A Systematic Review,” Open Medicine 3, no. 3 (2009): 131139.Google Scholar
Husereau, D. Cameron, C. G., Value-Based Pricing of Pharmaceuticals in Canada: Opportunities to Expand the Role of Health Technology Assessment?, CHSRF Series of Reports on Cost Drivers and Health System Efficiency: Paper 5 (December 2011); Claxton, K. et al., “Value Based Pricing for NHS Drugs: An Opportunity Not to Be Missed?” BMJ 336, no. 7638 (February 2008): 251254.Google Scholar
See Gorry, Montalban, Smith, , supra note 19.Google Scholar
Wieseler, B. McGauran, N. Kerekes, M. F. Kaiser, T., “Access to Regulatory Data from the European Medicines Agency: The Times They Are A-Changing,” Systematic Reviews 1, no. 50 (October 2012): 14.CrossRefGoogle Scholar
Smith, M. D. Drummond, M. Brixner, D., “Moving the QALY Forward: Rationale for Change,” Value in Health 12, Supp. 1 (March 2009): S1–S4; Neumann, P. J., “What's Next for QALYs?” JAMA 305, no. 17 (May 4, 2011): 18061807.Google Scholar
Sorenson, C., “Use of Comparative Effectiveness Research in Drug Coverage and Pricing Decisions: A Six Country Comparison,” Commonwealth Fund Publications 1420, vol. 91 (July 2010); see Husereau, Cameron, , supra note 53.Google Scholar
Claxton, K. Sculpher, M. Carroll, S., Value-Based Pricing for Pharmaceuticals: Its Role, Specification and Prospects in a Newly Devolved NHS, Centre for Health Economics, University of York (2011).Google Scholar