Drug reps off campus! promoting professional purity by suppressing commercial speech

Journal of Law, Medicine and Ethics

Volumn 37, Issue 3, 2009, Pages 431-443

  Stell, Lance K ^a  

^a DAVIDSON COLLEGE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CONFERENCE PAPER; CONFLICT OF INTEREST; DRUG CONTROL; DRUG INDUSTRY; ETHICS; HUMAN; LEGAL ASPECT; MARKETING; MEDICAL SCHOOL; PUBLIC RELATIONS; UNITED STATES;

CONFLICT OF INTEREST; DRUG AND NARCOTIC CONTROL; DRUG INDUSTRY; HUMANS; INTERINSTITUTIONAL RELATIONS; MARKETING; SCHOOLS, MEDICAL; UNITED STATES;

EID: 69649107055     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2009.00404.x     Document Type: Conference Paper

References (61)

1. L. Edelstein The Hippocratic Oath: Text, Translation and Interpretation Bulletin of the History of Medicine, Supplement 1 (Baltimore : Johns Hopkins Press, 1943 at 3.
2. J. Todd Professionalism at Its Worst JAMA 266, no. 2 (1991 3338.
3. IMS, a firm that specializes in gathering and analyzing data on the pharmaceutical market and disseminating it for a fee, is commonly regarded as "the authority" on the industry's promotional expenditures. Relying on IMS data, the U.S. GAO concluded that, in aggregate, pharmaceutical companies spend more on research and development than on marketing - US$29.6 billion on R&D versus US$27.7 billion for promotion. However, a reanalysis by Gagnon and Lexchin that included data from CAM (Cegedim, a global company that audits promotional activity worldwide as well as in the U.S.) estimated that promotional spending by the industry in the U.S. was more than twice as high as the IMS estimate for 2004, the latest year for which data was available. PLoS Medicine 5, no. 1 (2008).
4. C. Elliott The Drug Pushers The Atlantic Monthly (April 2006 82 93. A physicians group known to the author (LKS) and composed of 6 practitioners of general internal medicine, decided to inventory and then purge from their office drug company-logo-bearing stuff. Among the items inventoried for discard were: 5 clocks, 11 tissue boxes, 31 refrigerator magnets, 39 mugs/cups, 44 pieces of office equipment such as calculators and staplers, 119 paper pads, 257 pens, and 1609 patient handouts/brochures/drug discount coupons.
5. S. L. Coyle Physician-Industry Relations, Part 1: Individual Physicians Annals of Internal Medicine 136, no. 5 (2002 396 402.
6. S. L. Coyle, "Physician-Industry Relations, Part 2: Organizational Issues," Annals of Internal Medicine 136, no. 5 (2002): 396-402.
7. D. M. Studert, M. M. Mello, and T. A. Brennan Financial Conflicts of Interest in Physicians' Relationships with the Pharmaceutical Industry - Self-Regulation in the Shadow of Federal Prosecution New England Journal of Medicine 351 (2004 1891 1900.
8. For example, PhRMA's 2002 Code on Interactions with Healthcare Professionals affirmed the basic principle "... that a health care professionals care of patients should be based, and should be perceived as being based, solely on each patient's needs and the health care professional's medical knowledge and experience." The Code interpreted this principle as ruling out free tickets to entertainment and recreational events. Free golf balls and sports bags were prohibited because they were not primarily of benefit to patients. Free gas fill-ups were excluded on similar grounds. De minimis items ($100 or less) intended primarily for patient benefit were OK. Stethoscopes and medical textbooks were OK. Logo-bearing notepads, pens, and "reminder" items are OK. Continuing the practice of providing occasional meals is OK, provided that they are "modest by local standards," occur in a venue conducive to communication of scientific or educational value, and no spouses allowed. (No more "dine and dash," no more dropping off food for the office). Gift certificates given as premiums for attending drug talks is prohibited. Reimbursement for meeting travel expenses? No longer allowed. Payments to compensate physicians for bona fide services, such as speaker fees, was still OK. PhrMA's Revised Code (effective January 1, 2009) prohibits all reminder items, as well as stethoscopes and medical textbooks).
9. 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.
10. E. G. Campbell et al. A National Survey of Physician-Industry Relationships New England Journal of Medicine 356, no. 17 (2007 1742 1750. The study asked 3167 physicians in six specialties whether, in the past year, they had received: food or beverages in the workplace; free drug samples; honoraria for consulting; payment for service on scientific advisory boards or on boards of directors; payment in excess of costs for enrolling patients in industry-sponsored trials; costs of travel, time, meals, lodging, or other personal expenses for attending meetings; gifts received as a result of prescribing practices; free tickets to cultural or sporting events; free or subsidized admission to meetings or conferences for continuing medical education (CME) credits. 94% of physician-respondents reported some type of industry relationship within the last year. 83% reported getting food in the workplace. 78% reported getting drug samples. 35% got reimbursement for attending professional meetings or continuing medical education. 18% got paid for consulting, 16% for giving lectures, 9% for serving on advisory boards, 3% for enrolling patients as research subjects in clinical trials. 7% reported getting free tickets to cultural or sporting events. Family medicine doctors met more frequently with industry reps than physicians in other specialties and were more likely to get drug samples, or reimbursements than pediatricians and anesthesiologists. Hospital- or clinic-based physicians met with reps less frequently than doctors in solo or group practice. Cardiologists were more than twice as likely to get paid for consulting or giving lectures than pediatricians, anesthesiologists, or surgeons. Industry has an incentive to target its marketing resources on physicians perceived as influencing the prescribing behavior of other physicians. The survey's results were consistent with that prediction. Overall, all specialties except anesthesiology seem to be meeting more frequently with industry reps than they did only seven years ago.
11. A. N. DeMaria Your Soul for a Pen Journal of the American College of Cardiology 49, no. 11 (2007 1220 1222. While acknowledging the pervasiveness of industry influence, Dr. Pointing expresses concern about over-deterrence and points out that the very venue in which the Brennan group proposed its ban, the Journal of the American Medical Association, contains substantial industry advertising.
12. If the sheer number of physicians' interactions with industry is the right outcome measure for judging the reforms' effectiveness, a recent study found that physicians are meeting more frequently with industry representatives than ever. A 2007 survey of 3167 physicians in six specialties found that all specialties except anesthesiology were meeting more frequently with industry than they did only seven years ago. It should be noted however, that only 7% reported receiving personal items as "gifts" from industry. See Campbell, supra note 9.
13. Stanford, Yale, the University of Michigan, and the University of Pennsylvania have announced their commitment to comply with the Brennan group's recommendations. The University of California at Davis joined their ranks in the summer of 2008.
14. The commercial speech doctrine traces to Valentine v. Chrestensen, 316 U.S. 52 (1942) which sustained a ban on the distribution of handbill advertisements soliciting customers to pay admission to tour a submarine. The Court viewed the ban as a regulation of business activity rather than an infringement of First Amendment protected speech. Later cases made it clear, however, that speech does not lose 1A protection simply because of a commercial context. The doctrine is vexed, complicated and somewhat arbitrary in application. I cannot give it a fair analysis here, so I leave the idea of "commercial speech" intuitive but vague.
15. "Zero Tolerance," a form of ethical absolutism, has become an unfortunately popular surrogate for "ethical seriousness." It manifests in pronouncements of state medical boards. Thus the North Carolina Medical Board's position statement on "The Physician-Patient Relationship provides Patient trust... requires that: there be no conflict of interest between the patient and the physician or third parties.' NCMB Forum 4, no. 1 (2007 12.
16. For example, at Carolinas Medical Center, where the author holds a part-time teaching position in the Department of Internal Medicine, the following restrictions have been in place since 2001: Brief Policy Summary: • Pharmaceutical sales representatives must display approved identification while on CHS campuses. • Pharmaceutical sales representatives must check in at the approved area in each facility to receive the approved identification and have appointments verified. • Pharmaceutical sales representatives will not have access to CHS campuses without prearranged appointments. • Pharmaceutical sales representatives must receive prior approval from the Pharmacy Department to access all professional lounges and the lab. • Detailing of pharmaceuticals is limited to designated areas. • Pharmaceutical detailing will be limited to formulary products and approved indications unless otherwise approved. • Pharmaceutical sales representatives will not access patient information, view procedures or make rounds in any patient care area. • Pharmaceutical industry sponsored educational offerings held on CHS campuses must have prior approval and be advertised only in designated areas. • Samples, when accepted, will be delivered only to the Pharmacy Department. Identification Violations: • No Identification badge. • Outdated identification badge. Location Violations: • Found on campus with no appointment. • Found in a restricted area. • Found after approved hours without prior approval Detailing Violations: • Detailing non-formulary agents or dosage forms. • Detailing non-formulary indications or usage. • Using inappropriate detail material. • Detailing in a restricted area. • Leaving samples in unapproved areas. Promotional Violations: • Providing unapproved educational offerings on campus. • Posting notices for unapproved educational offerings. • Posting or leaving any promotional material in unapproved areas. Violations Guidelines: • First Violation Received - Pharmacy Department will issue a written warning to the pharmaceutical sales representative and a copy will be sent to the company regional manager. • Second Violation Received - Pharmacy Department will issue a second written notice to the pharmaceutical sales representative indicating that he/she are banned for three months from all facilities named in the CHS Pharmaceutical Sales Representative policy. The pharmaceutical company's regional manager, will receive a copy of the written notice. • Third Violation Received - Pharmacy Department will issue the third and final written notice to the pharmaceutical sales representative indicating that he/she are banned permanently from all facilities named in the CHS Pharmaceutical Sales Representative policy. The pharmaceutical company's regional manager, will receive a copy of the written notice.
17. The American Medical Association's Council on Ethical and Judicial Affairs provides: "Any gifts accepted by physicians individually should primarilyentail a benefit to patients and should not be of substantial value." R. J. McMurray et al. Gifts to Physicians from Industry JAMA 261, no. 4 (1991 501.
18. G. Harris Group Urges Ban on Medical Giveaways New York Times, c 28, 2008.
19. The AMA's Council on Ethical and Judicial Affairs proposed amendments to its Constitution and Bylaws that include the following: "Individual physicians and institutions of medicine, such as medical schools, teaching hospitals, and professional organizations (including state and medical specialty societies) must not accept industry funding to support professional education activities." Report 1 of the Council on Ethical and Judicial Affairs (A-08): Industry Support of Professional Education in Medicine.
20. M. A. Gagnon and J. Lexchin The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States PLoS Medicine 5, no. 1 (2008). Gagnon and Lexchin express skepticism about the accuracy of the IMS data. IMS relies on surveys. This fails to rule out that companies may systematically underestimate their promotional spending for public image reasons. IMS does not count the cost of meetings and sponsored talks featuring speakers bureau members. IMS does not count spending on phase IV "seeding" trials. These are designed to promote prescribing of new drugs rather than to generate scientific data. And, since almost 75% of these trials are managed solely by the commercial, as opposed to the clinical, division of biopharmaceutical companies, Gagnon and Lexchin infer that the vast majority of these trials are promotional. Their revised estimate for promotional spending in the U.S. is twice as high as IMS.
21. T. A. Brennan et al. Health Industry Practices That Create Conflicts of Interest: A Policy for Academic Medical Centers JAMA 295, no. 4 (2006 429 433, at 429.
22. S. H. Woolf The Meaning of Translational Research and Why It Matters JAMA 294 (2008 211 213.
23. L. S. Phillips, W. T. Branch, and C. B. Cook et al. Clinical Inertia Annals of Internal Medicine 135, no. 2 (2001 825 834, at 825.
24. M. M. Safford, R. Shewchuk, and H. Qu et al. Reasons for Not Intensifying Medications: Differentiating 'Clinical Inertia' from Appropriate Care Journal of General Internanl Medicine 22, no. 12 (2007 1648 1655, at 1648.
25. B. M. Psaty and S. P. Burke Institute of Medicine on Drug Safety New England Journal of Medicine 355, no. 17 (2006 1753 1755.
26. A. E. Buchanan Is There a Doctor in the House in R. G. Spece, D. S. Shimm, and A. E. Buchanan, Conflict of Interest in Clinical Practice and Research (New York : Oxford University Press, 1996 105 136, at 125.
27. S. A. Keitz et al. Behind Closed Doors Archives of Internal Medicine 167, no. 5 (2007 445 452.
28. A. Wazana Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift JAMA 283, no. 3 (2000 373 380, at 378. (Pubitemid 30051756)
29. W. Shrank et al. Cataract Surgery Rates and Costs Related to Physician Reimbursement Methods Archives of Ophthalmology 123 (2005 1733 1738. Comparing fee for service (FFS) and capitated care (CC), the study found that patients under CC were less than half as likely to get surgery as those under FFS.
30. D. P. Kessler and C. McClellan Do Doctors Practice Defensive Medicine? Working Paper 5466, National Bureau of Economic Research, February 1996.
31. Also see Harris Interactive, A. Cottreau, "Common Good: Fear of Litigation Study: The Impact on Medicine," April, 11, 2002.
32. N. G. Levinsky Non-Financial Conflicts of Interest in Research New England Journal of Medicine 347, no. 10 (2002 759 761.
33. Meinhard v. Salmon, 164 N.E. 545 (NY. 1928).
34. G. C. Hazard Conflict of Interest in the Classic Professions in R. G. Spece, D. S. Shimm, and A. E. Buchanan, Conflict of Interest in Clinical Practice and Research (New York : Oxford University Press, 1996 85 104, at 85.
35. See, E. L. Erde Conflicts of Interest in Medicine: A Philosophical and Ethical Morphology in R. G. Spece, D. S. Shimm, and A. E. Buchanan, Conflicts of Interest in Clinical Practice and Research (New York : Oxford University Press, 1996 12 41.
36. See Neade v. Portes, 193 Ill.2d 433 (2000). Despite that the Court agreed with Dr. Portes that his motive in denying decedent a referral for cardiac catheterization was irrelevant to the question whether his doing so constituted malpractice, the case narrative makes it very hard to resist the inference that the incentives Dr. Portes faced motivated the denial. We aren't told how many times Dr. Portes authorized referrals despite the incentive to deny them. Since the incentive to deny referral was always present, obviously it cannot explain the referrals he authorized.
37. See Neade v. Portes, 193 Ill.2d 433 (2000) for a case focused on fiduciary duty and incentives to disloyalty. The Court rejected inquiry into Dr. Portes incentive-prompted motives and insisted that the cause of action be framed in malpractice - namely, that the doctor's duty should be determined by reference to what a reasonable doctor would have done in the circumstances.
38. O. Carrasquillo and R. L. Goodman Pharma's Bad Karma: Resistance Is Not Futile Journal of General Internal Medicine 19, no. 4 (2004 315 316. Also see Dr. Goodman's website http://www.nofreelunch.org for his adaptation of the CAGE questionnaire for diagnosing drug company dependency.
39. H. Brody, Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry (New York : Rowman and Littlefield, Inc., 2007).
40. The Harris Poll Doctors and Teachers Most Trusted Among 22 Occupations and Professions: Fewer Adults Trust the President to Tell the Truth August 8, 2006, available at http://www.harrisinteractive.com/harris-poll/index.asp?PID= 688 last visited June 26, 2009).
41. T. P. Stossel Regulating Academic-Industrial Research Relationships - Solving Problems of Stifling Progress New England Journal of Medicine 353, no. 10 (2005 1060 1065, at 1063.
42. L. Hampson, M. Agrawal, S. Joffe, and D. Cross et al. Patients Views on Financial Conflicts of Interest in Cancer Research Trials New England Journal of Medicine 355 (2006 2330 2337.
43. M. A. Schlesinger A Loss of Faith: The Sources of Reduced Political Legitimacy for the American Medical Profession The Milbank Quarterly 80, no. 2 (2002
44. D. M. Cain, G. Lowenstein, and D. A. Moore The Dirt on Coming Clean: The Perverse Effects of Disclosing Conflicts of Interest Journal of Legal Studies 34, no. 1 (2005 1 25.
45. A. C. Kao, A. M. Zaslavsky, D. C. Green, J. P. Koplan, and P. D. Cleary Physician Incentives and Disclosure of Payment Methods to Patients Journal of General Internal Medicine 16, no. 3 (2001 181 188.
46. S. D. Pearson and T. Hyams Talking About money: How Primary Care Physicians Respond to a Patient's Question about Financial Incentives Journal of General Internal Medicine 17, no. 1 (2002 75 78.
47. G. G. Bogert and G. T. Bogert, The Law of Trusts and Trustees, 2nd ed. (St. Paul, Minn. : West Publishing Co., 1993 sec 543, at 277.
48. The Ultimatum Game provides an empirical basis for doubting the assumption that human beings will maximize their personal advantage at every margThe game involves two players. The first proposes to the second how a sum of money will be divided between them. The second player has the option of accepting or rejecting the proposal. If the second player rejects, neither gets anything. Classic game theory says that the second player will accept any division giving him more than '0' and that the first player will propose the minimum to elicit acceptance. This prediction turns out false. Considerations of "fairness" effects what first players propose and what second players accept. For a concise introduction to the game, see http://en.wikipedia.org/ wiki/Ultimatum-game
49. A. E. Buchanan Toward a Theory of the Ethics of Bureaucratic Organizations Business Ethics Quarterly 6, no. 4 (1996 419 440, at 421.
50. T. P. Stossel Regulating Academic-Industry Research Relationships - Solving Problems or Stifling Progress New England Journal of Medicine 353, no. 10 (2005 1060 1065.
51. J. H. Langbein Questioning the Trust Law Duty of Loyalty: Sole Interest or Best Interest Yale Law Journal 114 (2005 929 990.
52. Id., at 938.
53. Plato, The Dialogues of Plato in Five Volumes, Volume III, The Republic, B. J. Jowett, ed. (Oxford : Oxford University Press, 1875 at 281 285, at 215-216.
54. Code of Medical Ethics of the American Medical Association, May 1847, at Chapter 1, section 3.
55. R. J. McMurray Gifts to Physicians from Industry JAMA 265, no. 4 (1991 501.
56. A. Fugh-Berman and S. Ahari Follwing the Script: How Drug Reps Make Friends and Influence Doctors PLoS 4, no. 4 (2007 0621 0625.
57. R. Cialdini, Influence: Science and Practice, 4th ed. (Needham Heights, NJ : Allyn and Bacon, 2001 at 31, 34.
58. See Brody, supra note 36, at 175-6.
59. See Cialdini, supra note 55, at 27.
60. The study Cialdini discussed is H. T. Stelfox, G. Chua, K. O'Rourke, and A. S. Detsky Conflict of Interest in the Debate over Calcium Channel Antagonists New England Journal of Medicine 338, no. 2 (1998 101 106.
61. A. Fugh-Berman and S. Ahari Following the Script: How Drug Reps Make Friends and Influence Doctors PLoS Medicine 4, no. 4 (2007 621 625.