Hostname: page-component-78c5997874-m6dg7 Total loading time: 0 Render date: 2024-11-10T09:41:30.120Z Has data issue: false hasContentIssue false
  • English
  • Français

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

Published online by Cambridge University Press:  01 January 2021

Sergio Sismondo
Get access Rights & Permissions [Opens in a new window]

Extract

In 2010, in connection with the Patient Protection and Affordable Care Act (Obamacare), the United States Congress passed the Physician Payment Sunshine Act. This legislation requires pharmaceutical companies, medical device companies, and other manufacturers of medical supplies to collect information on their payments to physicians, beginning on August 1, 2013, and to annually report this information to the Centers for Medicare and Medicaid Services (CMS), beginning on March 31, 2014. All payments of over $10 are to be reported and aggregate payments of more than $100 to a single physician in a single year must also be reported.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 41 , Issue 3 , Fall 2013 , pp. 635 - 643
Copyright
Copyright © American Society of Law, Medicine and Ethics 2013

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

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.Google Scholar
66 Federal Register 78,9457 (February 8, 2013): 42 CFR 402.Google Scholar
Id., at 8, 18.Google Scholar
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).+(last+visited+July+3,+2013).>Google Scholar
Editorial, “Finding Out Who Pays Your Doctor,” New York Times, February 18, 2013.Google Scholar
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.CrossRefGoogle Scholar
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).+(last+visited+July+3,+2013).>Google Scholar
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.Google Scholar
Lessig, L., Republic, Lost: How Money Corrupts Congress – and a Plan to Stop It (New York: Twelve, 2011).Google Scholar
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).Google Scholar
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.CrossRefGoogle Scholar
Coleman, J. S. Katz, E. Menzel, H., Medical Innovation: A Diffusion Study (Indianapolis: Bobbs-Merrill, 1966).Google Scholar
Oldani, M., “Thick Prescriptions: Toward an Interpretation of Pharmaceutical Sales Practices,” Medical Anthropology Quarterly 18, no. 3 (2004): 325–356, at 334.CrossRefGoogle Scholar
Thought Leader Select, available at <http://www.thoughtleaderselect.com> (last visited July 3, 2013).+(last+visited+July+3,+2013).>Google Scholar
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).+(last+visited+July+10,+2013).+InsiteResearch,+“Can+KOL+Management+Generate+a+Return+on+Investment?”+Next+Generation+Pharmaceutical+14+(2008),+available+at++(last+visited+July+10,+2013).>Google Scholar
Moynihan, R., “Key Opinion Leaders: Independent Experts or Drug Representatives in Disguise,” BMJ 336, no. 7658 (2008): 1402–1403.CrossRefGoogle Scholar
Wave Healthcare, “KOL Training,” available at <http://www.wavehealthcare.co.uk/en/1/koltraining.html> (last visited March 25, 2011).+(last+visited+March+25,+2011).>Google Scholar
KnowledgePoint360, promotional brochure, 2010.Google Scholar
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).+(last+visited+July+10,+2013).>Google Scholar
Author notes, “Inaugural West Coast Forum on Defining Compliant & Effective Interactions with Thought Leaders and KOLs,” San Diego, CA, 2011.Google Scholar
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).+(last+visited+March+29,+2011).>Google Scholar
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.Google Scholar
See supra note 20.Google Scholar
Author notes, “KOL Relationship Summit,” Philadelphia, PA, 2010.Google Scholar
Id.Google Scholar
See supra note 20.Google Scholar
See supra note 24.Google Scholar
See supra note 16.Google Scholar
See supra note 10.Google Scholar
Fishman, J., “Manufacturing Desire: The Commodification of Female Sexual Dysfunction,” Social Studies of Science 34, no. 2 (2004): 187–218.CrossRefGoogle Scholar
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.CrossRefGoogle Scholar
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.CrossRefGoogle Scholar
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.Google Scholar
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.”CrossRefGoogle Scholar
Author notes, “KOL and Stakeholder Engagement Europe,” Berlin, 2012.Google Scholar
Dana, J. Loewenstein, G., “A Social Science Perspective on Gifts to Physicians from Industry,” JAMA 290, no. 2 (2003): 252–255.CrossRefGoogle Scholar
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.CrossRefGoogle 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
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).Google Scholar
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).Google Scholar
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.CrossRefGoogle Scholar
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.Google Scholar
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.CrossRefGoogle Scholar
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).Google Scholar