Reforming Pharmaceutical Industry-Physician Financial Relationships: Lessons from the United States, France, and Japan

Journal of Law, Medicine and Ethics

Volumn 39, Issue 4, 2011, Pages 662-670

  Rodwin, Marc A ^a  

^a HARVARD UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL PRACTICE; CONFLICT OF INTEREST; DRUG INDUSTRY; ECONOMICS; EDUCATION; ETHICS; FRANCE; FRAUD; GIFT GIVING; HUMAN; JAPAN; LEGAL ASPECT; MEDICAL EDUCATION; MEDICAL ETHICS; PHYSICIAN; PUBLIC RELATIONS; UNITED STATES;

CODES OF ETHICS; CONFLICT OF INTEREST; DRUG INDUSTRY; EDUCATION, MEDICAL, CONTINUING; FRANCE; FRAUD; GIFT GIVING; HUMANS; INTERPROFESSIONAL RELATIONS; JAPAN; PHYSICIAN'S PRACTICE PATTERNS; PHYSICIANS; TRAINING SUPPORT; UNITED STATES;

EID: 81255125368     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2011.00633.x     Document Type: Article

References (55)

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22. Telephone interview by author with David Orentlicher, former counsel, AMA Council on Ethical and Judicial Affairs, December 12, 2006.
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28. PhRMA's comments on the draft, submitted by Sidley Austin Brown and Wood LLP, Comment No. 119, obtained under the Freedom of Information Act.
29. Comments from 19 pharmaceutical companies on the draft, submitted by Arnold & Porter and PriceWaterhouseCoopers LLP, obtained under the Freedom of Information Act.
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33. A table of state legislation is available at <> (last visited September 6, 2011).
34. Physician Payment Sunshine Act S.2029, introduced by Senator Charles Grassley (R-IA).
35. Patient Protection and Affordable Care Act, Section 1128 G (a) Physician Payment Sunshine Act Transparency Reports.
36. Office of Inspector General, "Draft OIG Compliance Program Guidance, supra note 29, at 62057-62067; see Chimonas and Rothman, supra note 32. AMA comments on the draft, submitted by Michael Maves, executive vice president, obtained via the Freedom of Information Act.
37. American Association of Electro-diagnostic Medicine, Comment No. 55; American College of Rheumatology; American College of Chest Physicians, Comment No. 87; the Endocrine Society, comment No. 106; American College of Chest Physicians, Comment No. 87; and the Endocrine Society, comment No. 106. All comments were obtained by the author from the Office of Inspector General through the Freedom of Information Act.
38. U.S. Department of Health and Human Services, Office of Inspector General, "Compliance Program Guidance, " Federal Register 68, no. 86 (May 5, 2003): 23731-23743, at 23738.
39. ACCME, Updated Standards for Commercial Support: With Back-Ground Rationale and Answers to Questions about Compliance (Chicago: ACCME, 2004), available at <> (last visited September 3, 2011); R. Steinbrook, "Commercial Support and Continuing Medical Education, " New England Journal of Medicine 352, no. 6 (2005): 534-535.
40. ACCME Standard for Commercial Support, 3.2, available at <> (last visited September 3, 2011) (emphasis added).
41. Letter from Max Baucus, Chair, Senate Finance Committee, to Murray Kopelow, ACCME, April 27, 2007, Committee on Finance, United States Senate, 2007, Use of Educational Grants by Pharmaceutical Manufacturer, Prt. 110-21, 110th Cong., 1st Session (April), available at <> (last visited September 6, 2011).
42. Letter from Murray Kopelow, Chief Executive of ACCME to Max Bucus and Charles Grassley, Senate Committee on Finance, August 3, 2007, available at <> (last visited September 6, 2011) (emphasis added); see also, ACCME, "Policy Updates, " August 24, 2007, available at <> (last visited September 6, 2011).
43. ACCME, "Standards for Commercial Support, "available at <> (last visited September 6, 2011).
44. S. Sugita, "A Historical Study of Iyaku-Bungyo (The Separation of the Dispensary from Medical Practice) in Japan, " in Y. Kawakita, S. Sakai, and Y. Otsuka, eds., History of the Doctor-Patient Relationship: Proceedings of the 14th International Symposium on The Comparative History of Medicine - East and West (Tokyo: Ishiyaku EuroAmerica, 1989): 147-164
45. K. Rupp, Gift-Giving in Japan: Cash, Connections, Cosmologies (Stanford, CA: Stanford University Press, 2003).
46. Japan Medical Association (JMA), Physician's Ethics Code (Tokyo: JMA, 1951); JMA, Principles of Medical Ethics (Tokyo: JMA 2002). English summary of 25-page text is available at <> (last visited September 6, 2011); "The JMA Guidelines for Physician's Professional Ethics 2008, " Japan Medical Association Journal 52, no. 2 (2009): 75-91.
47. Act Against Unjustifiable Premiums and Misleading Representations, Act no. 134 of May 15, 1962, as amended October 1, 2007. Fair Trade Commission, Pub. Notice no. 31 of 1991; Fair Trade Commission, Pub. Notice no. 54 of August 11, 1997.
48. Fair Trade Commission, Fair Competition Code Concerning Restriction on Premium Offers in Ethical Pharmaceutical Drugs Marketing Industry, issued March 10, 1984, revised, October 1, 2007.
49. Fair Trade Council of the Ethical Pharmaceutical Drugs Marketing Industry, Fair Competition Code Concerning Restrictions on Premium Offers in Ethical Pharmaceutical Drugs Marketing Industry, 1984, as revised in 1997 and 2007; Fair Trade Council of the Ethical Pharmaceutical Drugs Marketing Industry, Enforcement Rules of the Fair Competition Code Concerning Restrictions on Premiums Officers in The Ethical Pharmaceutical Drugs Marketing Industry, 1984 as revised in 1997 and 2005.
50. In 1993, the JPMA developed three sets of guidelines: (1) Promotional Code of Pharmaceuticals (March 1993, a revision of the 1976 Federation of Pharmaceutical Manufacturer Associations of Japan's Code of Practices for the Promotion of Ethical Drugs; (2) Guidelines on Gift-Giving to Health Care Providers Permissible Under JFTC Rules; and (3) Guidelines on Remuneration for Case Reporting Allowable under JFTC Rules (1993), revised as Promotion Code for Prescription Drugs (May 23, 2008), available at <> (last visited September 6, 2011). The JMPA modified its code of conduct again in 2008.
51. PMAT, Organization Correspondence Contribution Scheme for Academic Society Which Used the Associations as a Focal Point (typescript). Osamu Nagayama, interview by Marc Rodwin, November 12, 2002. Correspondence with Takashi Sakabe, executive secretary to Osamu Nagayama, November 18, 2002. The 2007 data is from correspondence with Shigeo Morioka, June 25, 2008.
52. Act against Unjustifiable Premiums and Misleading Representations, Act no. 134 of 15 May 1962, as amended by Act No. 44 of 30 May 1977.
53. This distinction is inspired by Charles Bosk's and Eliot Freidson's distinction between normal and abnormal errors: normal errors are technical errors that any physician can make; abnormal errors have a moral component that call the physician's character and judgment into question. C. Bosk, Forgive and Remember: Managing Medical Failure (Chicago: University of Chicago Press, 1979)
54. E. Freidson, Doctoring Together: A Study of Professional Social Control (Chicago: University of Chicago Press, 1984).
55. Senate investigations found that pharmaceutical industry net profits after taxes from 1958-1959 were 21 percent. U.S. Senate Subcommittee on Antitrust and Monopoly, 1965, 278. Peter Temin analyzed the data from the FTC, SEC, and other studies and concluded that profits after taxes were between 17 percent and 19 percent from 1948 through 1973, see P. Temin, Taking Your Medicine: Dug Regulation in the United States (Cambridge: Harvard University Press, 1980): at 80-82. For other analysis of pharmaceutical industry profits, see M. Angel, The Truth about Drug Companies: How They Deceive Us and What To Do about It (New York: Random House, 2004).