Key Opinion Leaders and the Corruption of Medical Knowledge: What the Sunshine Act Will and Won't Cast Light on

The Physician Payment Sunshine Act S. 301 (111th) was enacted as section 6002 of the Patient Protection and Affordable Care Act, 111 Congress HR 3590 2010.

66 Federal Register 78,9457 (February 8, 2013): 42 CFR 402.

Id., at 8, 18.

Quoted in Fiegl C. , “Public Can See Pharma Payments to Doctors Starting in 2014,” American Medical News, February 11, 2013, available at <http://www.ama-assn.org/amed-news/2013/02/11/gvl10211.htm> (last visited July 3, 2013).

Editorial, “Finding Out Who Pays Your Doctor,” New York Times, February 18, 2013.

For a discussion of the psychology principles underlying marketing efforts to influence physicians see, Sah S. Fugh-Berman A. , “Physicians under the Influence: Social Psychology and Industry Marketing Strategies,” Journal of Law, Medicine & Ethics 41, no. 3 (2013): 665–672.

Nguyen D. Ornstein C. Weber T. , “Dollars for Docs: How Industry Dollars Reach your Doctors,” Propublica, available at <http://projects.propublica.org/docdollars/> (last visited July 3, 2013).

For discussions of the limitations of disclosures, see in this issue of the Journal of Law, Medicine & Ethics 41, no. 3 (2013): Brown A. , “Understanding Pharmaceutical Research Manipulation in the Context of Accounting Manipulation,” at 611–619; Cosgrove L. Wheeler E. E. , “Drug Firms, the Codification of Diagnostic Categories, and Bias in Clinical Guidelines,” at 644–653; Feldman Y. Gauthier R. Schuller T. , “Curbing Misconduct in the Pharmaceutical Industry: Insights from Behavioral Ethics and Behavioral Law and Economics,” at 620–628.

Lessig L. , Republic, Lost: How Money Corrupts Congress – and a Plan to Stop It (New York: Twelve, 2011).

Lazarsfeld P. F. Berelson B. Gaudet H. , The People's Choice: How the Voter Makes Up His Mind in a Presidential Election (New York: Duell, Sloan and Pearce, 1944). Katz E. Lazarsfeld P. F. , Personal Influence: The Part Played by People in the Flow of Mass Communication (Glencoe, IL: The Free Press, 1955).

Rasmussen N. , “The Drug Industry and Clinical Research in Interwar America: Three Types of Physician Collaborator,” Bulletin of the History of Medicine 79, no. 1 (2005): 50–80.

Coleman J. S. Katz E. Menzel H. , Medical Innovation: A Diffusion Study (Indianapolis: Bobbs-Merrill, 1966).

Oldani M. , “Thick Prescriptions: Toward an Interpretation of Pharmaceutical Sales Practices,” Medical Anthropology Quarterly 18, no. 3 (2004): 325–356, at 334.

Thought Leader Select, available at <http://www.thoughtleaderselect.com> (last visited July 3, 2013).

LNX Pharma, “KOL Identification,” available at <http://lnx-pharma.com/KOL-identification/> (last visited July 10, 2013). InsiteResearch, “Can KOL Management Generate a Return on Investment?” Next Generation Pharmaceutical 14 (2008), available at <http://www.ngpharma.com/article/Can-KOL-Management-Generate-a-Return-on-Investment/> (last visited July 10, 2013).

Moynihan R. , “Key Opinion Leaders: Independent Experts or Drug Representatives in Disguise,” BMJ 336, no. 7658 (2008): 1402–1403.

Wave Healthcare, “KOL Training,” available at <http://www.wavehealthcare.co.uk/en/1/koltraining.html> (last visited March 25, 2011).

KnowledgePoint360, promotional brochure, 2010.

Zuffoletti J. Freire O. , “Marketing to Professionals: Key Opinion Control,” Pharmaceutical Executive, October 1, 2006, available at <http://www.pharmexec.com/pharmexec/Professional+Marketing/Marketing-to-Professionals-Key-Opinion-Control/ArticleStandard/Article/detail/378072> (last visited July 10, 2013).

Author notes, “Inaugural West Coast Forum on Defining Compliant & Effective Interactions with Thought Leaders and KOLs,” San Diego, CA, 2011.

Watermeadow, “Rethinking the ‘KOL Culture,’” Next Generation Pharmaceutical Europe 4 (2006), available at <http://www.ngpharma.eu.com/article/Rethinking-the-KOL-culture/> (last visited March 29, 2011).

Carlat D. , “Dr. Drug Rep,” New York Times, November 25, 2007. However, drug firms still have a powerful economic incentive to encourage off-label prescribing. See, Rodwin M. , “Rooting Out Institutional Corruption to Manage Inappropriate Off-label Drug Use,” Journal of Law, Medicine & Ethics 41, no. 3 (2013): 654–664.

See supra note 20.

Author notes, “KOL Relationship Summit,” Philadelphia, PA, 2010.

Id.

See supra note 20.

See supra note 24.

See supra note 16.

See supra note 10.

Fishman J. , “Manufacturing Desire: The Commodification of Female Sexual Dysfunction,” Social Studies of Science 34, no. 2 (2004): 187–218.

Mirowski P. Van Horne R. , “The Contract Research Organization and the Commercialization of Scientific Research,” Social Studies of Science 35, no. 4 (2005): 503–534.

Melander H. Ahlqvist-Rastad J. Meijer G. Beermann B. ,. “Evidence B(i)ased Medicine – Selective Reporting from Studies Sponsored by Pharmaceutical Industry: Review of Studies in New Drug Applications,” BMJ 326, no. 7400 (3236): 1171–1173.

Sismondo S. , “Ghost Management: How Much of the Medical Literature Is Shaped behind the Scenes by the Pharmaceutical Industry?” PLoS Medicine 4, no. 9 (2007): e286; Sismondo S. , “Ghosts in the Machine: Publication Planning in the Medical Sciences,” Social Studies of Science 39, no. 2 (2009): 171–198.

Gøtzsche P. C. Hróbjartsson A. Krogh Johansson H. Haahr M. T. Altman D. G. Chan A.-W. , “Ghost Authorship in Industry-Initiated Randomised Trials,” PLoS Medicine 4, no. 1 (2007): 47–52. See Sismondo , supra note 33, especially, “Ghosts in the Machine.”

Author notes, “KOL and Stakeholder Engagement Europe,” Berlin, 2012.

Dana J. Loewenstein G. , “A Social Science Perspective on Gifts to Physicians from Industry,” JAMA 290, no. 2 (2003): 252–255.

Chimonas S. Brennan T. A. Rothman D. J. , “Physicians and Drug Representatives: Exploring the Dynamics of the Relationship,” Journal of General Internal Medicine 22, no. 2 (2007): 184–190, at 187.

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.

Almashat S. Preston C. Waterman T. Wolfe S. , “Rapidly Increasing Criminal and Civil Monetary Penalties against the Pharmaceutical Industry: 1991 to 2010,” Report of the Public Citizen's Health Research Group (2010).

Lundh A. Sismondo S. Lexchin J. Busuioc O. Bero L. , “Industry Sponsorship and Research Outcome,” Cochrane Database of Systematic Reviews 12 (December 2012), available at <http://onlinelibrary.wiley.com/doi/10.1002/14651858.MR000033.pub2/full> (last visited July 10, 2013).

Healy D. Cattell D. , “Interface between Authorship, Industry and Science in the Domain of Therapeutics,” British Journal of Psychiatry 183, no. 1 (2003): 22–27.

Schafer A. , “Biomedical Conflicts of Interest: A Defence of the Sequestration Thesis – Learning from the Cases of Nancy Olivieri and David Healy,” Journal of Medical Ethics 30, no. 1 (2004): 8–24. Angell M. , The Truth about the Drug Companies: How they Deceive Us and What To Do about It (New York: Random House, 2005): At 244–247. Discussion of sequestration, and of governments taking responsibility for the testing of drugs, has a long history; for a review of arguments, and the limitations of those arguments, see Rodwin M. , “Independent Clinical Trials to Test Drugs: The Neglected Reform,” Saint Louis University Journal of Health Law & Policy 6, no. 1 (2013): 113–165.

Id. (Angell) at 245. Schafer's proposal is essentially the same. See, also, See, 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): 590–600.

Finkelstein S. Temin P. , Reasonable Rx: Solving the Drug Price Crisis (Upper Saddle River, New Jersey: Pearson Education, 2008). See also the Medical Innovation Prize Act. H.R. 417 (109th).