Hostname: page-component-586b7cd67f-l7hp2 Total loading time: 0 Render date: 2024-11-24T17:01:52.729Z Has data issue: false hasContentIssue false
  • English
  • Français

Oversight of Marketing Relationships between Physicians and the Drug and Device Industry: A Comparative Study

Published online by Cambridge University Press:  06 January 2021

Timothy Stoltzfus Jost
Get access Rights & Permissions [Opens in a new window]

Abstract

Throughout the world, complex mutually-dependent relationships exist between physicians and pharmaceutical and medical device companies. This article focuses on one particular aspect of these relationships—payments made by drug and device companies to physicians and their organizations and institutions to market drugs and devices. It is widely believed that drug and device company marketing to physicians creates conflicts of interest that corrupt physician judgment and increase the cost of medical care. This article examines first the economic basis of physician/industry relationships that causes conflicts to arise. It next considers the measures that a number of developed countries have taken to respond to these relationships. Finally, it proposes an approach that would comprehensively address the problems caused by drug and device company marketing to physicians.

Type
Article
Information
American Journal of Law & Medicine , Volume 36 , Issue 2-3 , June 2010 , pp. 326 - 342
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2010

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

1 See Conflict of Interest in Medical Research, Education, and Practice 170-75 (Bernard Lo & Marilyn Field eds., 2008) (documenting these relationships); Eric Campbell et al., A National Survey of Physician-Industry Relationships, 356 NEW ENG. J. MED. 1742, 1746-47 (2007) (94% of physicians in a recent survey in the United States had some type of relationship with the pharmaceutical industry).

2 See Ezekiel J. Emanuel & Dennis F. Thompson, The Concept of Conflicts of Interest, in The Oxford Textbook of Clinical Research Ethics 758, 760-61 (Ezekiel J. Emanuel et al. eds., 2008).

3 See Lo & Field, supra note 1, at 102-09; Justin E. Bekelman, Yan Li & Cary P. Gross, Scope and Impact of Financial Conflicts of Interest in Biomedical Research: A Systematic Review, 289(4) JAMA 454, 456-59 (2004); Trudo, Lemmens, Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene, 32 J. L. Med. & Ethics 641, 644-45 (2004)Google Scholar; Brian, C. Martinson, Melissa, S. Anderson & Raymond, de Vries, Scientists Behaving Badly, 435 Nature 737, 737 (2005)Google Scholar; Robert, Steinbrook, Gag Clauses in Clinical- Trial Agreements, 352 New Eng. J. Med. 2160, 2160 (2005)Google Scholar.

4 Ashley Wazana, Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?, 283(3) JAMA 373, 378 (2000).

5 See Lo & Field, supra note 1, at 189-210; Niteesh K. Choudhry, Henry Thomas Stelfox & Allan S. Detsky, Relationships Between Authors of Clinical Practice Guidelines and the Pharmaceutical Industry, 287(5) JAMA 612, 615 (2002); Peter, Q. Eichacker, Charles, Natanson & Robert, L. Danner, Surviving Sepsis-Practice Guidelines, Marketing Campaigns, and Eli Lilly, 355 NEW ENG. J. MED. 1640, 1640 (2006)Google Scholar.

6 See Thomas, P. Stossel, Regulation of Financial Conflicts of Interest in Medical Practice and Medical Research: A Damaging Solution in Search of a Problem, 50 BIO. & MED. 54, 55-56 (2007)Google Scholar.

7 Jason, Dana & George, Lowenstein, A Social Science Perspective on Gifts to Physicians from Industry, 290(2) JAMA 252, 252 (2003)Google Scholar; Dana, Katz, Arthur, L. Caplan & Jon, F. Merz, All Gifts Large and Small: Toward an Understanding of the Ethics of Pharmaceutical Industry Gift-Giving, 3 AM. J. BIOETHICS 39, 42-43 (2003)Google Scholar.

8 Dana & Loewenstein, supra note 7, at 254.

9 Wazana, supra note 4, at 373.

10 See, e.g., AAMC-AAU Advisory Comm., Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research 1-4 (2008); FASEB, Call to Action: Managing Financial Relationships Between Academia and Industry in Biomedical Research 1-4 (2007); Lo & Field, supra note 1, at 110-21.

11 The cost of developing a new drug has been estimated at over $800 million, though this estimate is quite controversial. See Christopher, P. Adams & Van, V. Brantner, Estimating the Cost of New Drug Development: Is it Really $802 Million?, 25 Health Aff. 420, 427 (2006)Google Scholar. Only about a quarter of drug company revenues are spent on production costs. Uwe, E. Reinhardt, Perspectives on the Pharmaceutical Industry, 20 Health Aff. 136, 141 (2001)Google Scholar.

12 See Lenny H. Pattikawa, Longitudinal Study on the Performance of U.S. Pharmaceutical Firms: The Increasing Role of Marketing, in Research in Management 2007, at 1, 1-3 (Erasmus Research Inst. of Mgmt. Series Ref. No. 20, 2007).

13 See Nina Pavcnik, Do Pharmaceutical Prices Respond to Insurance? 16-19 (Nat’l Bureau of Econ. Research, Working Paper No. 20, 2000).

14 See Antonio Cabrales & Sergi Jiménez-Martín, The Determinants of Pricing in Pharmaceuticals: Are U.S. Prices Really Higher Than Those of Canada? 12-13 (Dept. of Econ. and Business, Universitat Pompeu Fabra, Econ. Research, Working Paper No. 1032, 2007); Patricia M. Danzon & Michael F. Furukawa, International Prices and Availability of Pharmaceuticals, in 2005, 27 Health Aff. 221, 222-23 (2008).

15 See Jeanne S. Ringel et al., Nat’l Defense Research Inst., The Elasticity of Demand for Health Care, 35-36 (2002).

16 Pavcnik, supra note 13, at 20.

17 This is usually done on a national basis, although in Europe it is also done at the European level by the European Medicines Agency. For a brief description and history of the drug approval process, see History and Future of ICH, http://www.ich.org/cache/compo/276-254-1.html (last visited Apr. 11, 2010).

18 See Sharon, Conroy et al., Survey of Unlicensed and Off Label Drug Use in Paediatric Wards in European Countries, 320 BMJ 79, 79 (2000)Google Scholar; David, C. Radley et al., Off-label Prescribing Among Office-Based Physicians, 166 Archives Internal Med. 1021, 1021 (2006)Google Scholar.

19 See Michael, A. Steinman et al., Characteristics and Impact of Drug Detailing for Gabapentin, 4 PLoS Med. 743, 747 (2007)Google Scholar.

20 See Alan M. Garber et al., Insurance and Incentives for Medical Innovation 16 (Nat’l Bureau of Econ. Research, Working Paper No. 12080, 2006).

21 Charles King III, Marketing, Product Differentiation, and Competition in the Market for Antiulcer Drugs 2 (Harvard Bus. Sch., Working Paper No. 01-014, 2002), available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=891128. This marketing is often aimed at getting physicians to switch from one drug to another rather than to expand a market. Id. at 23-24.

22 Barbara Mintzes et al., Influence of Direct to Consumer Pharmaceutical Advertising and Patients’ Requests on Prescribing Decisions: Two Site Cross Sectional Survey, 324 BMJ 278, 278-79 (2002).

23 See Sridhar Narayanan et al., The Informative Versus Persuasive Role of Marketing Communication in New Product Categories: An Application to the Prescription Antihistamines Market 4 (Univ. Chicago Graduate Sch. of Bus., Working Paper, 2003) available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=472881.

24 Marc-André, Gagnon & Joel, Lexchin, The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States, 5 PLoS Med. 29, 32 (2008)Google Scholar.

25 See Richard, Smith, Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies, 2 PLoS Med. 364, 364 (2005Google Scholar).

26 Troyen A. Brennan et al., Health Industry Practices That Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers, 295 JAMA 429, 430 (2006).

27 Arnold S. Relman, Defending Professional Independence: ACCME's Proposed New Guidelines for Commercial Support of CME, 289 JAMA 2418, 2418 (2003).

28 STAFF OF S. FIN. COMM., 110th Cong., Use of Educational Grants by Pharmaceutical Manufacturers 9 (Comm. Print 2007); Lo & Field, supra note 1, at 143- 49.

29 Ray, Moynihan, Doctor's Education: The Invisible Influence, 336 BMJ 416, 416 (2008)Google Scholar.

30 See, e.g., Gardiner Harris, Drug Makers Scrutinized Over Grants, N.Y. Times, Jan. 11, 2006, at C1; Christopher Rowland, Doctors Fight Over Drug Firm Influence, Boston Globe, June 16, 2005, at E1.

31 See Thomas Ginsberg, Donations Tie Drug Firms and Nonprofits: Many Patient Groups Reveal Few, if Any, Details on Relationships with Pharmaceutical Donors, Phila. Inquirer, May 28, 2006, at A1.

32 Richard, Smith, Curbing the Influence of the Drug Industry: A British View, 2 PLoS Med. 821, 822 (2005)Google Scholar.

33 See Daniel Carlat, Dr. Drug Rep, N. Y. TIMES, Nov. 25, 2007, at 64.

34 See OIG Compliance Program Guidance for Pharmaceutical Manufacturers, 68 Fed. Reg. 23731 (May 5, 2003).

35 Smith, supra note 32, at 821; Emily Clayton, ‘Tis Always the Season for Giving 3 (2004), available at http://www.calpirg.org/uploads/Le/LW/LeLWJ1Gv4Nwd9MVJapxdkQ/TistheSeasonForGiving04.pdf.

36 See Ray Moynihan, Who Pays for the Pizza? Redefining the Relationships Between Doctors and Drug Companies. 1: Entanglement, 326 BMJ 1189 (2002).

37 Christopher, Sikora, Whose Pen is In Your Pocket?, 52 Canadian. Fam. Physician. 394, 394 (2006)Google Scholar.

38 See Charles, Mather, The Pipeline and the Porcupine: Alternate Metaphors of the Physician-Industry Relationship, 60 Soc. Sci. Med. 1323 (2005)Google Scholar.

39 See Jeanne Lenzer, Secret US Report Surfaces on Antidepressants in Children, 329 BMJ 307, 307 (2004); Eric, J. Topol, Failing the Public Health–Rofecoxib, Merck, and the FDA, 351 New Eng. J.Med. 1707, 1707 (2004)Google Scholar.

40 See Ray, Moynihan, Iona, Health & David, Henry, Selling Sickness: The Pharmaceutical Industry and Disease Mongering, 324 BMJ 886 (2002)Google Scholar.

41 Frederick, Sierles et al., Medical Students’ Exposure to and Attitudes About Drug Company Interactions: A National Survey, 294 JAMA 1034, 1035 (2005)Google Scholar.

42 Eur. Fed’n of Pharm. Indus. & Ass’n, Code on the Promotion of Prescription- Only Medicines to, and Interactions With, Healthcare Professionals, §§ 9.01, 9.07.

43 Id. at §§ 10.01, 10.02.

44 Farm Serv. Agency, Code of Conduct on the Collaboration with Healthcare Professionals, § 13(1) (2004).

45 Marc. Rodwin, Physicians’ Conflicts of Interest in Japan and the United States: Lessons for the United States, 25 J. Health Pol., Pol’y & L. 343, 354 (2000).

46 Eur. Fed’n of Pharm. Indus. & Ass’n, supra note 42, at art.18.

47 Prescription Med. Code of Practice Auth., Annual Report 2 (2007).

48 See World Medical Association, WMA Statement concerning the Relationship between Physicians and Commercial Enterprises, http://www.wma.net/en/30publications/10policies/r2/index.html (last visited Apr. 2, 2010).

49 See American Medical Association, Ethical Opinion E-8.061, Gifts to Physicians from Industry, available at http://www.ama-assn.org/ama/pub/physician-resources/medicalethics/code-medical-ethics/opinion8061.shtml (last visited Apr. 2, 2010).

50 Canadian Medical Association Policy, Guidelines for Physicians in Interactions with Industry § 44 (2007).

51 Id. § 49.

52 Hans-Dieter Lippert & R. Ratzel, Kommentar zur Musterberufsordnung der deutschen Ärzte, § 33(2)-(3) (2006) [hereinafter MBO].

53 MBO §§ 33-34. See also Hans-Dieter Lippert & Rudolph Ratzel, Arzt und Industrie nach den Besculüssen des 106. Deutschen Ärztetags 46 NJW 3301 (2003).

54 MBO § 33(4).

55 Elizabeth, Wager, How to Dance with Porcupines: Rules and Guidelines on Doctor's Relations With Drug Companies, 326 BMJ 1196, 1197 (2003)Google Scholar.

56 Ann, McGuaran, Royal College Issues New Guidelines on Gifts from Drug Companies, 325 BMJ 511, 511 (2003)Google Scholar.

57 See Cathy Peck et al., Continuing Medical Education GMC, Guidance on Continuing Professional Development, International Comparisons, 320 BMJ 432, 432-33 (2000); See also General Medical Council, Guidance on Continuing Professional Development, http://www.gmc-uk.org/education/continuing_professional_development/cpd_guidance.asp (last visited Apr. 1, 2010).

58 Peck et al., supra note 57, at 433.

59 Moynihan, supra note 29, at 416.

60 See Accreditation Council for Continuing Medical Education, ACCME Standards for Commercial Support-Standards to Ensure the Independence of CME Activities, 1-3 (2007).

61 See Memorandum of Understanding between the Ass’n of the British Pharm. Indus., the Prescription Medicines Code of Practice Auth., and the Medicines and Healthcare Prod. Regulatory Agency, (Nov. 3, 2005) available at http://www.abpi.org.uk/links/assoc/PMCPA/Memo_understanding_nov3.pdf (last visited Apr. 15, 2010).

62 Medicine and Healthcare Products Regulatory Agency, The Blue Guide: Advertising and Promotion of Medicines in the UK 30 (TSO 2005).

63 21 U.S.C. §§ 352(f),(n),(q) & (r), 353 (2006).

64 See Fed. Drug Administration, Guidance for Industry: Industry-Supported Scientific and Educational Activities 1, 3 (1997), http://www.gwumc.edu/cehp/pdf/CMEPolicies/FDAguidance.pdf.

77 Pub. L. No. 111-148, § 6002

65 See Ass’n Am. Med. C., Industry Funding of Medical Education vi-xi (2008), http://services.aamc.org/publications/showfile.cfm?file=version114.pdf&prd_id=232.

66 See, e.g., Beamtenstatusgesetz [BeamtStG] [Civil Service Law] Feb. 5, 2009, § 42 (F.R.G.).

67 Strafgesetzbuch [StGB] [Penal Code] §§ 331, 332 (F.R.G.). See Erwin Deutsch & Andreas Spickhoff, Medizinrecht, ¶¶ 491, 492 ((6th ed. 2008); Lippert & Ratzel, supra note 53, at 3304-05.

68 See Bundsgerichtshof [BGH] [Federal Court of Justice] Feb. 25, 2003, 5 StR [Strafsenat] 363/02 (F.R.G.).

69 Akira Akabayashi, Brian Taylor Slingsby & Yoshiyuki Takimoto, Conflict of Interest: A Japanese Perspective, 14 Camb. Q. Healthcare Eth. 277, 278 (2005).

70 42 U.S.C. § 1320a-7b(b) (2010).

71 42 U.S.C. § 1395nn(a)(1)(A) (2010).

72 United States v. Greber, 760 F.2d 68, 69 (3rd Cir. 1985). Actually, there isn't at this time. There are older cases that conflict with Greber but they are based on the statute before it was amended.

73 See OIG, supra note 34, at 23733.

74 U.S. Dep't of Justice, Five Companies in Hip and Knee Replacement Industry Avoid Prosecution by Agreeing to Compliance Rules and Monitoring 1, 2 (Sept. 27, 2007), http://www.usdoj.gov/usao/nj/press/files/pdffiles/hips0927.rel.pdf.

75 See Deutsch & Spickhoff, supra note 67, at ¶ 493.

76 See Bryan, Christie, Scottish Doctors Will Have to Register Financial Links to Drug Companies, 328 BMJ 69, 69 (2004)Google Scholar.

78 Lo & Field, supra note 1.

79 See RJR-MacDonald Inc. v. Canada [1995] 3 S.C.R. 199 (Can.) (commercial speech protected in Canada); Aaron, Kesselheim & Jerry, Avorn, Pharmaceutical Promotion to Physicians and First Amendment Rights, 358 New Eng. J. Med. 1727, 1728 (2008)Google Scholar.

80 See Statement of Jerry Avorn, http://aging.senate.gov/events/hr190ja.pdf.

81 See Brennan, supra note 26, at 431-432 (calling for funding of CME through voluntary pooling of funding by drug companies).