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

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).

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.

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.

Rodwin M. A. , Medicine, Money and Morals: Physicians' Conflicts of Interest (New York: Oxford University Press, 1993): 179–211.

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).

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).

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).

Center for Drug Evaluation & Research, Manual of Policies and Procedures 6020.3 (2007).

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.

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.

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.

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).

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).

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).

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.

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21 C.F.R. §§ 310.3–5.21; 21 C.F.R. § 314.80.

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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).

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Angell M. , The Truth About the Drug Companies: How They Deceive Us and What To Do About It (New York: Random House, 2004):.

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):.

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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.

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Food and Drug Administration Amendments Act, U.S. Public Law 110–85 (2007).

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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.

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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).

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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.].

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Dowling H. F. , Medicines for Man (New York: Alfred A. Knopf, 1970): At 183.

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.