Drug advertising, continuing medical education, and physician prescribing: A historical review and reform proposal

Journal of Law, Medicine and Ethics

Volumn 38, Issue 4, 2010, Pages 807-815

  Rodwin, Marc A ^a  

^a SUFFOLK UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADVERTIZING; CLINICAL PRACTICE; CONFLICT OF INTEREST; DRUG CONTROL; DRUG INDUSTRY; EDUCATION; HISTORY; HUMAN; LEGAL ASPECT; MEDICAL EDUCATION; PRACTICE GUIDELINE; REVIEW; UNITED STATES;

ADVERTISING AS TOPIC; CONFLICT OF INTEREST; DRUG AND NARCOTIC CONTROL; DRUG INDUSTRY; EDUCATION, MEDICAL, CONTINUING; GUIDELINES AS TOPIC; HISTORY, 20TH CENTURY; HUMANS; PHYSICIAN'S PRACTICE PATTERNS; TRAINING SUPPORT; UNITED STATES;

EID: 78649572612     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2010.00534.x     Document Type: Review

References (79)

1. I develop the themes in this article, along with analysis of other financial conflicts of interest, in M. A. Rodwin, Conflicts of Interest and the Future of Medicine: The United States, France and Japan ( New York Oxford University Press, forthcoming February, 2011).
2. G. H. Simmons, "The Abbott Alkaloidal Company - High Finance and Methods of Working the Medical Profession, " JAMA 50, no. 11 (1908): 897.
3. U.S. Federal Trade Commission, Economic Report on Antibiotics Manufacturers ( Washington, D.C. Government Printing Office, 1958): at 128. R. Ferber and H. G. Wales, "The Effectiveness of Pharmaceutical Promotion, " in University of Illinois Bureau of Economic and Business Research Bulletin (Urbana: University of Illinois Press, 1958).
4. C. D. Leake, "The Pharmacologic Evaluation of New Drugs, " JAMA 93, no. 21 (1909): 1632-1634. See also E. E. Irons, "The Clinical Evaluation of Drugs, "JAMA 93, no. 20 (1929): 1523-1524; W. A. Puckner and P. N. Leech, "The Introduction of New Drugs, "JAMA 93, no. 21 (1929): 1627-1630.
5. Study of Administered Prices in the Drug Industry, Report No. 448, Subcommittee on Antitrust and Monopoly, Committee on the Judiciary, 87th Congress (1961) (statement of Warner); see id., at 210. Study of Administered Prices in the Drug Industry, Subcommittee on Antitrust and Monopoly, Committee on the Judiciary, 87th Congress, at 210 (1961) (statement of Smith).
6. C. D. May, "Selling Drugs by Educating Physicians, " Journal of Medical Education 36, no. 1 (1961): 1-23.
7. Study of Administered Prices in the Drug Industry, Report No. 448, Subcommittee on Antitrust and Monopoly, Committee on the Judiciary, 87th Congress (1961) (testimony of Dr. Charles D. May at hearings, citing T. Wagner in Ethical Pharmaceutical Promotion: The Workings and Philosophies of the Pharmaceuticals Industry (New York: National Pharmaceutical Council, Inc., 1959).
8. Subcommittee on Antitrust and Monopoly, Committee on the Judiciary, 87th Congress (1961).
9. Subcommittee on Antitrust and Monopoly, Committee on the Judiciary, Administered Prices Drugs, U.S. Senate Hearings, vol. 18, 10, 338 (1960) (testimony of William B. Bean, Chair of the Department of Internal Medicine, University of Iowa Medical School).
10. S. H. Podolsky and J. A. Greene, "A Historical Perspectives of Pharmaceutical Promotion and Physician Education, " JAMA 300, no. 9 (2008): 1071-1073; J. A. Greene and S. H. Podolsky, "Keeping Modern in Medicine: Pharmaceutical Promotion and Physician Education in Postwar America, "Bulletin of the History of Medicine 83, no. 2 (2009): 331-377.
11. Gaffin Report, reprinted in U.S. Senate Hearings, at 505 (19611962).
12. Committee on Ways and Means (1969) (statement from Bernard D. Hirsh before U.S. Senate, cited in M. Silverman and P. Lee, Pills, Profits & Politics [Berkeley: University of California Press, 1974]: at 53-54); M. Mintz, "JAMA Pleads Case for Tax Exemption, "Washington Post, March 20, 1969, at 24.
13. M. Mintz, "Not-Guilty Plea Entered in False Drug Ad Case, " Washington Post, December 7, 1965, at 12.
14. P. Villanueva, 'Accuracy of Pharmaceutical Advertisements in Medical Journals, " The Lancet 361, no. 4 (2003): 26-32.
15. E. Sevringhaus, "Interdependence of the Medical Profession and the Pharmaceutical Industry, " JAMA 152, no. 16 (1953): 1525.
16. Task Force on Prescription Drugs, Office of the Secretary, U.S. Department of Health, Education, and Welfare, The Drug Makers and the Drug Distributors (1968), at 6.
17. Subcommittee on Monopoly, Select Committee on Small Business, Present Status of Competition in the Pharmaceutical Industry, 91st Congress 4056 (1969), at 10 (testimony of James M. Faulkner); Select Committee on Small Business, Present Status of Competition in the Pharmaceutical Industry, Subcommittee on Monopoly, 91st Congress, 5727 (1969), at 14, (testimony of Edward Pinkney); Subcommittee on Monopoly, Select Committee on Small Business, Effect of Promotion and Advertising of Over-the-Counter Drugs on Competition, Small Business, and the Health and Welfare of the Public, 92nd Congress 541 (1971), at 2.
18. K. M. Ludmerer, Time to Heal: American Medical Education from the Turn of the Century to the Era of Managed Care ( New York Oxford University Press, 1999): Chap. 4, the "Rise of Graduate Medical Education, " at 79-101.
19. D. W. Petit, "The Physician Recognition Award, " JAMA 213, no. 10 (1970): 1668-1670; N. S. Stearns, M. E. Getchell, and R. A. Gold, Continuing Medical Education in Community Hospitals: A Manual for Program Development (Boston: Massachusetts Medical Society, 1971).
20. Institute of Medicine, Committee on Planning a Continuing Health Professional Education Institute, Redesigning Continuing Education in the Health Professions ( Washington, D.C. National Academies Press, 2010), available at <> (last visited September 30, 2010).
21. Subcommittee on Monopoly of Select Committee on Small Business, Competitive Problems in the Drug Industry, Part 30, 94th Congress, 2nd Session (1976).
22. Id., at 13919.
23. Id., at 13920.
24. Id., at 13913.
25. Id., at 13914.
26. Id., at 14015.
27. The organizations that founded and govern Accreditation Council for Continuing Medical Education (ACCME) are the following: American Board of Medical Specialties; American Hospital Association; American Medical Association; Association of American Medical Colleges; Association for Hospital Medical Education; Council for Medical Specialty Societies; and Federation of State Medical Boards of the U.S.
28. American Medical Association, U.S. Medical Licensure Statistics 1985 and Licensure Requirements 1986 ( Chicago American Medical Association, 1987): at Table 14, 30; American Medical Association, Continuing Medical Education for Licensure Reregistration, State Medical Licensure Requirements and Statistics, 2009 (Chicago: American Medical Association, 2008).
29. Data supplied by ACCME for 2000 and 2006, Data for 1990 from personal communication from Murray Kopelow, President, ACCME to author (November, 2007); see also, E. D. Peterson, K. M. Overstreet, J. N. Parochka, and M. R. Lemon, "Medical Education and Communication Companies in CME: An Updated Profile, "Journal of Continuing Education in the Health Professions 24, no. 8 (2008): 205-219.
30. Statement from the Accreditation Council for Continuing Medical education (ACCME) to the Institute of Medicine Committee on Conflict of Interest in Medical Research, Education, and Practice, June 2008, at 5, available at <> (last visited September 30, 2010).
31. Senate Committee of Labor and Human Resources, Advertising, Marketing and Promotion, 101st Congress (1990), at 174-175.
32. A. Witt, "Drug Company Supported Activities in Scientific or Education Contexts: Draft Concept Paper, " Federal Register 57, no. 229 (1991): 56412 (obtained under the Freedom of Information Act).
33. "Final Guidance on Industry-Supported Scientific and Educational Activities, " Federal Register 62, no. 232 (December 3, 1997): 64074-64100.
34. J. N. Joseph, D. Deaton, H. Ehsan, and M. A. Bonanno, "Enforcement Related to Off-Label Marketing and Use of Drugs and Devices: Where Have We Been and Where are We Going?" Journal of Health & Life Sciences Law 2, no. 2 (2009): 73-108.
35. Civil Settlement Agreement between the United States and Serono, Inc., available at <> (last visited September 30, 2010); G. Craft, Jr., "Promoting Off-Label In Pursuit Of Profit: An Examination of a Fraudulent Business Model, "Houston Journal of Health Law & Policy 8, no. 1 (2007): 103-131.
36. D. Armstrong, "Drug Firm's Cash Sways Debate Over Test for Pregnant Women, " Wall Street Journal, December 13, 2006, at A1.
37. Personal communication from Anonymous to author (September 2007).
38. Personal communication from Mark Schaffer to author (October 2007).
39. Physicians World, available at <> (last visited December 3, 2001).
40. Institute of Medicine, Redesigning Continuing Education in the Health Professions, supra note 21.
41. R. Steinbrook, "Financial Support of Continuing Education in the Health Professions, " in Continuing Education in the Health Professions: Improving Healthcare Through Lifelong Lessons, at 104-126, available at <> (last visited September 30, 2010).
42. The ACCME distinguishes between commercial support (grants to CME providers) and income from advertising and exhibits at CME meetings. I included both under commercial support. Most funding comes from the grants. See ACCME, Annual Report Data 2004, available at <> (last visited September 30, 2010); ACCME, Annual Report Data 1998, available at <> (last visited September 30, 2010); ACCME, Annual Report Data 2008, available at <> (last visited September 30, 2010).
43. See M. A. Steinman, L. A. Bero, and M. Chren et al., "Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents, " Annals of Internal Medicine 145, no. 4 (2006): 284-293. See, also United States of America ex. Rel David Franklin vs. Pfizer, Inc, and Parke-Davis, available through <> (last visited August 16, 2010).
44. E. Campbell, R. Gruen, and J. Mountford et al., "A National Survey of Physician-Industry Relationships, " New England Journal of Medicine 356, no. 17 (2007): 1742-1750.
45. M. A. Bowman, "The Impact of Drug Company Funding on the Content of Continuing Medical Education, " Mobius 6, no. 1 (1986): 66-69; M. A. Bowman and D. L. Pearle, "Changes in Drug Prescribing Patterns Related to Commercial Company Funding of Continuing Medical Education, "Journal of Continuing Education in the Health Professions 8, no. 1 (1988): 13-20; R. W. Spingarn, J. A. Berlin, and B. L. Strom, "When Pharmaceutical Manufacturers' Employees Present Grand Rounds, What do Residents Remember?"Academic Medicine 71, no. 1 (1996): 86-88. However, in 2008, the ACCME commissioned a report to review published studies on the effect of commercial support on CME in terms of bias. The authors reviewed ten empirical studies and concluded the evidence was inconclusive. See R. M. Cervero and J. He, The Relationship between Commercial Support and Bias in Continuing Medical Education Activities: A Review of the Literature, 2008, available at <> (last visited September 30, 2010).
46. A. Witt, 'AMA Guidelines: 'We'll Stay the Course. Here's Why, '" Medical Marketing & Media 26 (1991): 82-88.
47. The FDA said CME programs are unlikely to be independent if: it focuses on a single product; a commercial firm owns the CME provider or employs it for marketing or sales, or recommends individuals who promote its products as faculty, or arranges program invitations or disseminates program materials through its marketing department; a provider is not financially viable without a single commercial firm's support, has significant contacts with FDA-regulated firms, or previously organized programs that did not meet standards for independence.
48. ACCME, Standards for Commercial Support, 1992, available through <> (last visited September 30, 2010); A. S. Relman, "Separating Continuing Medical Education from Pharmaceutical Marketing, "JAMA 28, no. 15 (2001): 2009-2012; A. S. Relman, "Defending Professional Independence: ACCME's Proposed New Guidelines for Commercial Support of CME, "JAMA 289, no. 18 (2003): 2418-2420.
49. See Id. (Relman, 2001).
50. "Final Guidance on Industry-Supported Scientific and Educational Activities, " Federal Register 62, no. 232 (1997) (the FDA issued new guidelines on dissemination of articles in 2009); "Guidance for Industry Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices, "Federal Register 74, no. 8 (2009): 1694-1695.
51. U.S. Department of Health and Human Services, Office of Inspector General, Draft OIG Compliance Program (2002), at 62057-62067; S. Chimonas and D. J. Rothman, "New Federal Guidelines for Physician-Pharmaceutical Industry Relations: The Politics of Policy Formation, "Health Affairs 24, no. 4 (2005): 949-960 (AMA comments on the draft, submitted by Michael Maves, Executive Vice President, obtained via FOIA).
52. See, for example, 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.
53. U.S. Department of Health and Human Services, Office of Inspector General, Compliance Program Guidance for Pharmaceutical Manufacturers, " Federal Register 68, no. 86 (2003).
54. U.S. Department of Health and Human Services, Office of Inspector General, "Compliance Program Guidance, " Federal Register 68, no. 86 (2003).
55. Standard 3.2.
56. Accreditation Council for Continuing Medical Education, Updated Standards for Commercial Support: With Background Rationale and Answers to Questions about Compliance, Chicago, 2004); R. Steinbrook, "Commercial Support and Continuing Medical Education, "New England Journal of Medicine 352, no. 6 (2005): 534-535.
57. Letter from Max Baucus, Chair, Senate Finance Committee, to Murray Kopelow, ACCME, April 27, 2007, available at <> (last visted October 8, 20010; Senate Committee on Finance, 110th Cong., 1st Sess, Use of Educational Grants by Pharmaceutical Manufacturers, Washington, D.C., April 2007, at Prt. 110-21, available at <> (last visited October 8, 2010).
58. 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 30, 2010); see also, ACCME "Announcements, " August 24, 2007, available at (last visited September 30, 2010).
59. The ACCME made this clear in its response to frequently asked questions on line, see, ACCME response to frequently asked questions regarding commercial support and independence, available at <> (last visited September 30, 2010). However, the ACCME did not change its standards for commercial support, Standard 3.3., which states only that providers "cannot be required by a commercial interest to accept advice.".
60. Institute of Medicine, Conflict of Interest in Medical Research, Education, and Practice ( Washington, D.C. National Academies Press, 2009).
61. AMA, Council on Ethical and Judicial Affairs, CEJA Report-A-09 "Financial Relationships with Industry in Continuing Medical Education" 2009, available at <> (last visited September 30, 2010).
62. A. S. Relman, "Industry Support of Medical Education, " JAMA 300, no. 9 (2008): 1071-1073.
63. L. Morris and J. K. Taitsman, "The Agenda for Continuing Medical Education - Limiting Industry's Influence, " New England Journal of Medicine 361, no. 25 (2009): 2478-2482; R. Steinbrook, "Financial Support of Continuing Medical Education, "JAMA 299, no. 9 (2008): 1060-1062; Institute of Medicine, Redesigning Continuing Education in the Health Professions, 2010, at Chap. 3, "Regulation and Financing, " at 55-78; Association of American Medical Colleges, Industry Funding of Medical Education: Report of an AAMC Task Force, Washington, D.C., 2008, available at <> (last visited September 30, 2010); E. G. Campbell and M. Rosenthal, "Reform of Continuing Medical Education: Investments in Physician Human Capital, "JAMA 302, no. 16 (2009): 1807-1808.
64. M. A. Rodwin, "Physicians' Conflicts of Interest: the Limitations of Disclosure, " New England Journal of Medicine 321, no. 20 (1989): 1405-1408; Association of American Medical Colleges, The Scientific Basis of Influence and Reciprocity: A Symposium, Washington, D.C., 2007, at 22-23.
65. Association of American Medical Colleges, Industry Funding of Medical Education, 2008, at viii.
66. See Relman (2001), supra note 49.
67. J. P. Kassirer, "Professional Societies and Industry Support: What Is the Quid Pro Quo?" Perspectives in Biology and Medicine 50, no. 1 (2007): 7-17; J. P. Kassirer, On the Take: How Medicine's Complicity with Big Business Can Endanger Your Health (New York: Oxford University Press, 2005).
68. See Morris and Taitsman, supra note 64, at 280.
69. T. A. Brennan, D. J. Rothman, and L. Blank et al., "Health Industry Practices That Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers, " JAMA 295, no. 4 (2006): 429-433.
70. Accreditation Council for Continuing Medical Education, Accredited CME Is Education That Matters to Patient Care, June 2008, available at <> (last visited September 30, 2010).
71. L. Morris and J. K. Taitsman, "The Agenda for Continuing Medical Education - Limiting Industry's Influence, " New England Journal of Medicine 361, no. 25 (2009) 2478-2482; H. Brody, Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry (Lanham, Maryland: Rowman & Littlefiled Publishers, Inc., 2007): at 328-330; M. Angel, The Truth About the Drug Companies: How They Deceive Us and What to Do About It (New York: Random House, 2004): at 250-252; Institute of Medicine, Redesigning Continuing Education in the Health Professions, supra note 21, at 207.
72. M. Saxton, "A View from Industry: The Foundations of Future Commercial Support and a Call for Action, " Journal of Continuing Education in the Health Professions 29, no. 1 (2009):71-75.
73. Institute of Medicine, Redesigning Continuing Education in the Health Professions, supra note 21, at 73.
74. R. H. Brook, "Continuing Medical Education: Let the Guessing Begin, " JAMA 303, no. 4 (2010): 359-360; P. E. Mazmanian and D. A. Davis "Continuing Medical Education and the Physician as Learners Guide to the Evidence, "JAMA 288, no. 9 (2002): 1057-1060.
75. See Rodwin, supra note 1.
76. 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, 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).
77. National health spending for 2008 was estimated at $2.4 billion, or about $7, 900 per person, based on a July 2008 U.S. population estimate of 303, 824, 640. See S. Keehan, A. Sisko, and C. Truffer et al., "Health Spending Projections through 2017: The Baby-Boom Generation Is Coming to Medicare, "Health Affairs 27 (2008): W145-W155, available at <> (last visited September 30, 2010).