Hostname: page-component-848d4c4894-wg55d Total loading time: 0 Render date: 2024-05-14T22:05:07.778Z Has data issue: false hasContentIssue false
  • English
  • Français

Conflicts of Interest, Institutional Corruption, and Pharma: An Agenda for Reform

Published online by Cambridge University Press:  01 January 2021

Marc A. Rodwin
Get access Rights & Permissions [Opens in a new window]

Extract

Why do physicians have financial conflicts of interest? They arise because society expects physicians to act in their patients’ interest, while simultaneously, financial incentives encourage physicians to practice medicine in ways that promote their own interests or those of third parties. Because physicians’ clinical choices, referrals, and prescriptions affect the fortune of third parties (providers, medical facilities, insurers, drug firms and suppliers of ancillary services), these third parties may offer physicians financial incentives to make income-driven clinical choices. In the past, physicians and scholars typically conceived of conflicts of interest as an ethical issue to be resolved according to individual judgment or professional and organizational norms. However, society can mitigate or eliminate conflicts of interest by changing financial and organizational arrangements in medicine. Conflicts of interest, therefore, are as much matters of public policy and management as individual choices or social norms.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 40 , Issue 3 , Fall 2012 , pp. 511 - 522
Copyright
Copyright © American Society of Law, Medicine and Ethics 2012

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

My own research suggests that we need to broaden the way in which we conceptualize Conflicts of interest and respond to them. See Rodwin, M. A., “Physicians' Conflicts of Interest: The Limitations of Disclosure,” New England Journal of Medicine 321, no. 20 (1989): 1405–1408. Rodwin, M. A., “Conflicts in Managed Care,” New England Journal of Medicine 332, no. 9 (1995): 604–607. Rodwin, M. A., Medicine, Money and Morals: Physicians' Conflicts of Interest (New York: Oxford University Press, 1993). Rodwin, M. A., Conflicts of Interest and the Future of Medicine: The United States, France and Japan (New York: Oxford University Press, 2011).CrossRefGoogle Scholar
Rodwin, M. A., “Strains in the Fiduciary Metaphor: Divided Physician Loyalties and Obligations in a Changing Health Care System,” American Journal of Law and Medicine 2, no. 2 (1995): 241–257.CrossRefGoogle Scholar
Sage, W. M., “Some Principles Require Principals: Why Banning ‘Conflicts of Interest’ Won't Solve Incentive Problems In Biomedical Research,” Texas Law Review 85, no. 6 (2007): 1413–1463.Google Scholar
Rodwin, M. A., Medicine, Money and Morals: Physicians' Conflicts of Interest (New York: Oxford University Press, 1993): 179–211.Google Scholar
Several scholars are now exploring institutional corruption in relation to the pharmaceutical industry and policy industry as part of the research lab project on Institutional Corruption at the Edmund J. Safra Center at Harvard University. They include Lisa Cosgrove, Carl Eliot, Marc-Andre Gagnon, Garry Gray, Aaron Kesselheim, Genevieve Pham-Kanter, Susannah Rose, Sergio Sismondo, and Robert Whitaker available at <http://www.ethics.harvard.edu/lab>(last visited August 1, 2012).(last+visited+August+1,+2012).>Google Scholar
Lessig, L., “Two Conceptions of ‘Corruption,’” in Republic, Lost: How Money Corrupts Congress – and a Plan to Stop It (New York: Twelve-Hackette Book Group, 2011): 226–247. Thompson, D. F., Ethics in Congress: From Individual to Institutional Corruption (Washington D.C.: Brookings Institution Press, 1995).Google Scholar
For some classic discussion of the pharmaceutical industry see, Dowling, H. F., Medicines for Man: The Development, Regulation and Use of Prescription Drugs (New York: Alfred A. Knopf, 1970). Temin, P., Taking Your Medicine: Drug Regulation in the United States (Cambridge: Harvard University Press, 1980). For some more recent critiques see, Angel, M., The Truth About Drug Companies: How They Deceive Us and What To Do About It (New York: Random House, 2004). Kassirer, J. P., On the Take: How Medicine's Complicity with Big Business Can Endanger Your Health (New York: Oxford University Press, 2005).Google Scholar
Center for Drug Evaluation & Research, Manual of Policies and Procedures 6020.3 (2007).Google Scholar
Ashburn, T. T. Thor, K. B., “Drug Repositioning: Identifying and Developing New Uses for Existing Drugs,” Nature Reviews Drug Discovery 3, no. 8 (2004): 673–683.CrossRefGoogle Scholar
Ashburn, T. T. Thor, K. B., “Drug Repositioning: Identifying and Developing New Uses for Existing Drugs,” Nature Reviews Drug Discovery 3, no. 8 (2004): 673–683.CrossRefGoogle Scholar
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 351 (2012). U.S. Food and Drug Administration, Hearing Regulations and Regulations Describing Scientific Content of Adequate and Well Controlled Clinical Investigations, Federal Register 35, no. 90 (1970): 7250.Google Scholar
See, Hilts, P. J., Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation (New York: Alfred A. Knopf, 2003). Carpenter, D., Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA (Princeton: Princeton University Press, 2010).Google Scholar
See, e.g., Interagency Coordination in Drug Research and Regulation: Hearing Before the Subcomm on Reorganization and Int'l Org. of the Comm. on Gov't Operations, 88th Cong. (1963) Examination of the Pharmaceutical Industry.: Hearing on Section 3441 and Section 966 Before the Subcomm. on Health and the Comm. on Labor and Pub. Welfare, 93rd Cong. (1974) Preclinical and Clinical Testing by the Pharmaceutical Industry.: Hearing on Preclinical and Clinical Testing by the Pharmaceutical Industry. Before the Subcomm. on Health of the Senate and the Subcomm. on Admin. Practice and Procedure and the Comm. on Labor & Pub. Welfare, 94th Cong. (1976) Preclinical and Clinical Testing by the Pharmaceutical Industry.: Hearing on Preclinical and Clinical Testing by the Pharm. Indus. Before the Subcomm. on Health of the Senate and the Subcomm. on Admin. Practice and Procedure and the Comm. on Labor & Pub. Welfare, 94th Cong. (1975) Drug Regulation Reform Act of 1978: Hearing on S. 2755 Before the Subcomm. on Health and Scientific Research and the Comm. on Human Resources, 95th Cong. (1978).Google Scholar
FDA, Merck, and Vioxx: Putting Patient Safety First?: Hearing Before the Comm. on Fin., 186th Cong. (2004), available at <http://www.finance.senate.gov/hearings/hearing/?id=48b33994–9de9-df09-dfb8-bb3599a92fbb>(last visited August 1,2012).(last+visited+August+1,2012).>Google Scholar
See, e.g., Chan, A. W. Hróbjartsson, A. Haahr, M. T. Gøtzsche, P. C. Altman, D. G., “Empirical Evidence for Selective Reporting of Outcomes in Randomized Trials: Comparison of Protocols to Published Articles,” JAMA 291, no. 20 (2004): 2457–5465. Kesselheim, A. S. Mello, M. M., “Confidentiality Laws and Secrecy in Medical Research: Improving Public Access to Data on Drug Safety,” Health Affairs 26, no. 2 (2007): 483–91.CrossRefGoogle Scholar
Rodwin, M. A., “The Need for Independent Drug Testing for the FDA to Evaluate Whether to Grant Marketing Approval,” Saint Louis University Law Review 6, no. 1 (2012).Google Scholar
21 C.F.R. §§ 310.3–5.21; 21 C.F.R. § 314.80.Google Scholar
Sasich, L. D. Lurie, P. Wolfe, S. M., The Drug Industry's Performance in Finishing Post-marketing Research (Phase IV) Studies: A Public Citizen's Health Research Group Report, available at <http://www.citizen.org/hrg1520>(last visited August 1, 2012).(last visited August 1, 2012).' href=https://scholar.google.com/scholar?q=Sasich,+L.+D.+Lurie,+P.+Wolfe,+S.+M.,+The+Drug+Industry's+Performance+in+Finishing+Post-marketing+Research+(Phase+IV)+Studies:+A+Public+Citizen's+Health+Research+Group+Report,+available+at+(last+visited+August+1,+2012).>Google Scholar
Food and Drug Administration Amendments Act, 21 U.S.C.A. § 301 (2007). The problems with the previous approach to pharmacovigilance are carefully described in, Institute of Medicine, The Future of Drug Safety: The Future of Drug Safety: Promoting and Protecting the Health of the Public (Washington, D.C.: National Academies Press, 2007). Behrman, R. E. Benner, J. S. Brown, J. S. et al. , “Developing the Sentinel System – A National Resource for Evidence Development,” New England Journal of Medicine 364, no. 6 (2011): 498–499.CrossRefGoogle Scholar
Bodenheimer, T., “Uneasy Alliance: Clinical Investigators and the Pharmaceutical Industry,” New England Journal of Medicine. 342, no. 20 (2000): 153942–153942. Angell, M., The Truth About the Drug Companies: How They Deceive Us and What To Do About It (New York: Random House, 2004):.CrossRefGoogle Scholar
For a thorough analysis of problems of drug safety see, Avorn, J., Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs (New York: Alfred A. Knopf, 2004):.Google Scholar
Davidson, R. A., “Source of Funding and Outcomes of Clinical Trials,” Journal of General Internal Medicine 1, no. 3 (1986): 155–58. Als-Nielsen, B. Chen, W. Glund, C. Kjaergard, L., “Association of Funding and Conclusions in Randomized Drug Trials: A Reflection of Treatment Effect or Adverse Events?” JAMA 290, no. 7 (2003): 921–928. Heres, S. Davis, J. Maino, K. Jetzinger, E. Kissling, W. Leucht, S., “Why Olanzapine Beats Risperidone, Risperidone Beats Quetiapine, and Quetiapine Beats Olanzapine: An Exploratory Analysis of Head-to-Head Comparison Studies of Second-Generation Antipsychotics,” American Journal of Psychiatry 163, no. 2 (2006): 185–194.CrossRefGoogle Scholar
Langreth, Robert, “Drug Marketing Drives Many Clinical Trials,” Wall Street Journal, November 16, 1998. Pieters, T., “Marketing Medicines through Randomized Controlled Trials: The Case of Interferon” BMJ 317, no 7167(1998): 1231–1233. Greenland, P. Lloyd-Jones, D., “Critical Lessons from the ENHANCE Trial” JAMA 299, no. 8 (2008): 953–955.Google Scholar
The FDA tried to prevent drug firms from disseminating articles on of-label uses of their products. Drug firms and the Washington Legal Foundation sued the FDA alleging that the FDA policy constituted an unconstitutional restriction of commercial speech. Federal appellate courts held that the FDA policy was unconstitutional. For a summary of the WLF challenge and related cases and current status of the law, see Washington Legal Foundation v. Henney, 202 F.3d 331 (2000) FDA, Decision in Washington Legal Foundation v. Henney, Federal Register 65, no. 52 (2000): 14286–88, FDA Docket No. 98N-0222.Google Scholar
Dwan, K. Altman, D. G. Arnaiz, J. A. Bloom, J. Chan, A. W. et al. , “Systematic review of the empirical evidence of study publication bias and outcome reporting bias,” PLoS ONE 3, no. 8 (2008): e3081. Chan, A. W. Hrobjartsson, A. Haahr, M. T. Gotzsche, P. C. Altman, D. G., “Empirical Evidence for Selective Reporting of Outcomes in Randomized Trials: Comparison of Protocols to Published Articles,” JAMA 291, no. 20 (2004): 2457–2465. Dickersin, K. Chan, S. Chalmers, T. C. et al. , “Publication Bias and Clinical Trials,” Controlled Clinical Trials 8, no. 4 (1987): 343–353. Easterbrook, P. J. Berlin, J. A. Gopalan, R., “Publication Bias in Clinical Research,” The Lancet 337 (1991): 867–872. Dickersin, K., “The Existence of Publication Bias and Risk Factors for Its Occurrence,” JAMA 263, no. 10 (1990): 1385–1389. Dickersin, K. Scherer, R. Lefebvre, C., “Identifying Relevant Studies for Systematic Reviews,” British Medical Journal 309 (1994): 1286–1291. Dickersin, K., “How Important Is Publication Bias? A Synthesis of Available Data,” AIDS Education and Prevention 9, no. 1 (1997): 15–21. Scherer, R. W. Langernberg, P. Von Elm, E., “Full Publication of Results Initially Presented in Abstracts,” Cochrane Database of Systematic Reviews 2, no. MR000005 (2007).CrossRefGoogle Scholar
Vedula, S. S. Bero, L. Scherer, R. W. Dickersin, K., “Outcome Reporting In Industry-Sponsored Trials of Gabapentin for Of-Label Use,” New England Journal of Medicine. 361, no. 20 (2009): 1963–1971.CrossRefGoogle Scholar
Dickersin, K. Rennie, D., “Registering Clinical Trials,” JAMA 290, no. 4 (2003): 516–523. Zarin, D. Ide, N. C. Tse, T. et al. , “Issues in Registration of Trials,” JAMA 297, no. 3 (2007): 2112.CrossRefGoogle Scholar
DeAngelis, C. D. Drazen, J. M. Frizelle, F. A. et al. , “Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors,” JAMA 292, no. 11 (2004): 1363–1364.CrossRefGoogle Scholar
Food and Drug Administration Amendments Act, U.S. Public Law 110–85 (2007).Google Scholar
Prayle, A. P. Hurley, M. N. Smyth, A. R., “Compliance With Mandatory Reporting of Clinical Trial Results On ClinicalTrials.gov: Cross Sectional Study,” BMJ 344 (2011): d7373.CrossRefGoogle Scholar
Law, M. R. Kawasumi, Y. Morgan, S. G., “Despite Law, Fewer Than One in Eight Completed Studies of Drugs and Biologics Are Reported on Time on ClinicalTrials.gov,” Health Affairs 30, no. 12 (2011): 2338–2345. Chan, A. W. Hrobjartsson, A. Haahr, M. T. Gotzsche, P. C. Altman, D. G., “Empirical Evidence for Selective Reporting of Outcomes in Randomized Trials: Comparison of Protocols to Published Articles,” JAMA 291, no. 20 (2004): 2457–2465. Mathieu, S. Boutron, I. Moher, D. Altman, D. G. Ravaud, P., “Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials,” JAMA 302, no. 9 (2009): 977–984.CrossRefGoogle Scholar
Zarin, D. Ide, N. C. Tse, T. et al. , “Issues in Registration of Trials,” JAMA 297, no. 3 (2007): 2112–2120.CrossRefGoogle Scholar
ICH Harmonised Tripartite Guideline Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use, available at <http://www.pmda.go.jp/ich/m/m4_ctd_betsu1_m4kosei_01_6_21e.pdf>(last visited August 1, 2012); ICH Harmonised Tripartite Guideline Structure and Content of Clinical Study Reports E3, available at <http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf>(last visited August 1, 2012 1). Doshi, P. Jefferson, T. Del Mar, C., “The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience,” PLoS Med 9, no. 4 (2012): E1001201.CrossRefGoogle Scholar
Rodwin, M. A. Abramson, J., “Clinical Trials as a Public Good,” JAMA 308, no. 9 (2012): 871–872.CrossRefGoogle Scholar
Turner, E. H., “A Taxpayer-Funded Clinical Trials Registry and Results Database,” Public Library of Medicine 1, no. 3 e60 (2004): 180–182.Google Scholar
Oldani, M. J., “Thick Prescriptions: Toward an Interpretation of Pharmaceutical Sales Practices,” Medical Anthropology Quarterly 18, no. 3 (2004): 325–356.CrossRefGoogle Scholar
Larkin, J. M., “Optimizing Resource Allocations with a Strategic Focus: An Accounting Perspective,” Journal of Business Case Studies, 5, no. 5 (2009) 55–60.Google Scholar
Ziegler, M. G. Lew, P. Singer, B. C., “The Accuracy of Drug Information from Pharmaceutical Sales Representatives,” JAMA 273 (1995): 1296–1298.CrossRefGoogle Scholar
Lexchin, J., “What Information Do Physicians Receive from Pharmaceutical Representatives?” Canadian Family Physician 43 (1997): 941–945.Google Scholar
“Cinq ans d'observation et un constat: Rien à attendre de la visite médicale pour mieux soigner,” [Five years of observation and the implications: Don't count on medical detailing to improve patient care]La Revue Prescrire 26, no. 272 (2006): 383–89. Bignall, J., “Monitoring Reps in France,” The Lancet 344 (1994): 536; European Directive 92/28 EEC, March 31, 1992. Loi N. 94–42 du 18 janvier 1994. R. 5122–11, Code de la santé publique [Law no. 94–42 of January 18, 1994, R.51222–11, Public Health Code]; Décret no. 96–531 du 14 juin 1996 relatif à la publicité pour les médicaments et certains produits à usage humain et modifiant le code de la santé publique; deuxième partie [Decree No. 96–531 of June 14, 1996 relative to publicity for medications and certain other products for human use, modifying the Public Health Code, second part.]; Décrets en Conseil d'Etat, Journal Officiel, 16 juin (1996): 8962–67. Decrees of the Counsel of State. Official Journal June 16 (1996): 8962–67.].CrossRefGoogle Scholar
“Charte de la visite médicale, 22 Decembre 2004 [Charter for medical detailers, December 22, 2004] Loi, N. 2004–810 du 13 août 2004 relative à l'Assurance Maladie,” Journal Officiel, 17 Aout (2004): 14598–626. [Law No. 204–810 of August 13 2004, relative to health Insurance. Official Journal August 17 (2004)].Google Scholar
Cinq ans d'observation et un constat, 386.Google Scholar
Armour v. City of Indianapolis, 132 S. Ct. 2073 (2012); San Antonio Independent School Dist. v. Rodriguez, 411 U.S. 1, 41 (1973).Google Scholar
Institute of Medicine, Committee on Planning a Continuing Health Professional Education Institute, Redesigning Continuing Education in the Health Professions Washington, D.C.: National Academies Press, 2010), available at <http://www.nap.edu/catalog/12704.html>(last visited August 1, 2012).(last+visited+August+1,+2012).>Google Scholar
Steinman, M. A. Bero, L. A. Chren, M. M. et al. , “Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents,” Annals of Internal Medicine 145, no. 4 (2006): 284–293. U.S. GovernmentAccountability Office, GAO-08-835, Prescription Drugs FDA's Oversight of the Promotion of Drugs for Off-Label Uses (2008). See also, Rodwin, M.A., 2011, supra note 1, at 135–137, 151–157.CrossRefGoogle Scholar
Compliance Program Guidance for Pharmaceutical Manufacturers, Office of Inspector General, 68 Fed. Reg. 86 (U.S. Department of Health and Human Services 2003). Letter from Max Baucus, Chair, Senate Finance Committee, to Murray Kopelow, ACCME, April 27, 2007. Senate Committee on Finance. Washington, D.C., 2007. Use of Educational Grants by Pharmaceutical Manufacturers. Prt. 110–21. 110th Cong., 1st Session, available at <http://www.finance.senate.gov/newsroom/chairman/release/?id=9b20d8ca-fca3–4cbe-8deb-94bd841eda7d>(last visited August 1, 2012).(last+visited+August+1,+2012).>Google Scholar
Rodwin, M. A., “Drug Advertising, Continuing Medical Education, and Physician Prescribing: A Historical Review and Reform Proposal,” Journal of Law, Medicine & Ethics 38, no. 4 (2010): 807–815.CrossRefGoogle Scholar
Rodwin, M. A., “Reforming Pharmaceutical Industry-Physician Financial Relationships: Lessons from the United States, France and Japan,” Journal of Law, Medicine & Ethics 39, no. 9, no. 4 (2011): 662–670.CrossRefGoogle Scholar
“Tap Pharmaceutical Products Inc. and Seven Others Charged with Health Care Crimes; Company Agrees to Pay $875 Million to Settle Charges,” U.S. Department of Justice, available at <http://www.justice.gov/opa/pr/2001/October/513civ.htm>(last visited August 1,2012). Rodriguez, T. A., “Physicians and the Pharmaceutical Industry: Knowing When to Look a Gift Horse in the Mouth,” in Gosfield, A., ed., Health Law Handbook (St. Paul: West Group, 2003).Google Scholar
Cosgrove, L. Krimsky, S. Vijayaraghavan, M. et al. , “Financial Ties Between DSM-IV Panel Members and the Pharmaceutical Industry,” Psychotherapy and Psychosomatics 75, no. 3 (2006): 154–160.CrossRefGoogle Scholar
Temin, P., Taking Your Medicine: Drug Regulation in the United States (Cambridge: Harvard University Press, 1980): 106–120. Moore, D. A. Cain, D. M. Loewenstein, G. et al. , Conflicts of Interest: Challenges and Solutions from Law, Medicine and Organization Settings (Cambridge: Cambridge University Press, 2004). Cain, D. M. Loewenstein, G. Moore, D. A., “The Dirt on Coming Clean: Perverse Effects of Disclosing Conflicts of Interest,” Journal of Legal Studies 34, no. 1 (2005): 1–23.Google Scholar
Adams, S. H., The Great American Fraud (New York: P. F. Collier and Son, 1905).Google Scholar
Dowling, H. F., Medicines for Man (New York: Alfred A. Knopf, 1970): At 183.Google Scholar
Regarding dialysis, see Dryer, O., “Journal Rejects Article after Objections from Marketing Department,” BMJ 328, no. 7434 (2004): 244. On drug advertising, see Kassirer, J., On the Take: How Medicine's Complicity with Big Business Can Endanger Your Health (New York: Oxford University Press, 2005): 90–91.CrossRefGoogle Scholar