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"Who Owns Truth?" - Biomedical Research in a Health Policy Context

By Samuel A. Richmond

The Bioethics Center, Cleveland State University, Cleveland, OH

Published on

Abstract

This presentation examines a claim made by PhRMA on behalf of pharmaceutical manufacturing companies of America, and the response of the International Committee of Medical Journal Editors (ICMJE) questioning drug company publication policies and practices. Also considered are changes in law (2007) governing Food and Drug Administration regulation and public access to results of clinical trials. I propose that the contractual relation between the investigator and subjects (patients) is the source of a competing claim requiring public access to the evidence of clinical trials. The ownership claim is not settled. Do not individuals acting on their own best judgment and publishing data for the public good contrary to corporate authority deserve the support of their institutions and professional associations?

Bio

Samuel Richmond Sam Richmond is Professor Emeritus, Department of Philosophy, Cleveland State University. He served as Director or Co-director of the Bioethics Program at CSU from 1998-2008. His research interests include simplicity and science, simplicity and rational change of mind, and administrative discretion in relation to mandate of lawful corporate authority.

Credits

Research for this presentation was supported in part by a Presidential Initiative Grant, Cleveland State University.

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References

Abramson, J. D. Overdosed America: The Broken Promise of American Medicine. New York: Harper Collins, (2004). Alexander, Jennifer and Samuel A. Richmond, “Administrative Discretion: Can We Move Beyond Cider House Rules?”, The American Review of Public Administration, Mar 2007; vol. 37: pp. 51 – 64. Angell, Marcia The Truth About the Drug Companies: How They Deceive Us, and What to Do About It. New York, NY, Random House, (2004). Angell, Marcia, "Industry-Sponsored Clinical Research A Broken System" JAMA, September 3, 2008, Vol 300, No. 9 1069 Applbaum, A. I. (1999). Ethics for adversaries: The morality of roles in public and professional life. Princeton, NJ: Princeton University Press. Frank Davidoff, Catherine D DeAngelis, Jeffrey M Drazen, John Hoey, Lisselotte Højgaard, Richard Horton, Sheldon Kotzin, M Gary Nicholls, Magne Nylenna, A John, PM Overbeke, Harold C Sox, Martin B Van Der Weyden and Michael S Wilkes, “Editorial”, The Lancet, Volume 358, Issue 9285, 15 September 2001, Pages 854-856. DeAngelis CD, Fontanarosa PB. Impugning the integrity of medical science: the adverse effects of industry influence. JAMA. 2008;299(15):1833-1835. Hobbes, Leviathan, Ch. 16, “Authors and Agents”. Kant, I. (1982). Perpetual peace and other essays (T. Humphrey, Trans.). Indianapolis, IN: Hackett. (Original work published 1785.) Psaty BM, Kronmal RA. Reporting mortality findings in trials of rofecoxib for Alzheimer disease or cognitive impairment: a case study based on documents from rofecoxib litigation. JAMA. 2008;299(15):1813-1817. Ross JS, Hill KP, Egilman DS, Krumholz HM. Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. JAMA. 2008;299(15):1800-1812. Spitz, Bruce, Spitz Consulting Group, and John Abramson, Harvard Medical School, “When Health Policy Is the Problem: A Report from the Field”, Journal of Health Politics, Policy and Law, Vol. 30, No. 3, June 2005 327 - 365, Duke University Press. Steinbrook R. Gag clauses in clinical-trial agreements. N Engl J Med. 2005; 352(21):2160-2162.

Publications

Alexander, Jennifer and Samuel A. Richmond, “Administrative Discretion: Can We Move Beyond Cider House Rules?” The American Review of Public Administration, Mar 2007; vol. 37: pp. 51 – 64.

Cite this work

Researchers should cite this work as follows:

  • Samuel A. Richmond (2009), ""Who Owns Truth?" - Biomedical Research in a Health Policy Context," Purdue Bioethics Seminar Series, http://nanohub.org/resources/6483.

Time

Location

BMED Conference Room 1001, Purdue University, West Lafayette, IN

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