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Drug Reps Off Campus! Promoting Professional Purity by Suppressing Commercial Speech

Published online by Cambridge University Press:  01 January 2021

Lance K. Stell
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Extract

In purity and holiness I will guard my life and my art.

Every physician-patient encounter is a conflict of interest. Every physician-payer encounter is also a conflict of interest.

Wide-spread criticism of the pharmaceutical industry’s extravagant marketing practices and some doctors’ undignified, even appalling eagerness to stuff themselves, their pockets and their offices with the industry’s “stuff,” prompted physician groups, the drug and device industry itself (albeit synergized by the federal government’s ominous shadow) to institute reforms designed better to limit industry influence on physicians.

But according to Troyen Brennan and his coauthors, the reforms, while reducing some of the most egregious instances of industry influence peddling and physicians’ self-debasement, were doomed fundamentally, for three reasons. First, they were based on common sense but incorrect assumptions about the mechanism of industry influence and on myths about the efficacy of disclosure as an ethical disinfectant. Second, they relied on voluntary adherence and so failed to pinpoint responsibility for monitoring compliance and enforcement.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 37 , Issue 3 , Fall 2009 , pp. 431 - 443
Copyright
Copyright © American Society of Law, Medicine and Ethics 2009

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References

Edelstein, L., “The Hippocratic Oath: Text, Translation and Interpretation,” Bulletin of the History of Medicine, Supplement 1 (Baltimore: Johns Hopkins Press, 1943): at 3.Google Scholar
Todd, J., “Professionalism at Its Worst,” JAMA 266, no. 2 (1991): 3338.CrossRefGoogle Scholar
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).Google Scholar
Elliott, C., “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.Google Scholar
Coyle, S. L., “Physician-Industry Relations, Part 1: Individual Physicians,” Annals of Internal Medicine 136, no. 5 (2002): 396–402; Coyle, S. L., “Physician-Industry Relations, Part 2: Organizational Issues,” Annals of Internal Medicine 136, no. 5 (2002): 396-402.CrossRefGoogle Scholar
Studert, D. M., Mello, M. M. and Brennan, T. A., “‘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.CrossRefGoogle Scholar
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).Google Scholar
Brennan, T. A., Rothman, D. J. and Blank, L. et al., “Health Industry Practices that Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers,” JAMA 295, no. 4 (2006): 429–433.CrossRefGoogle Scholar
Campbell, E. G. 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.CrossRefGoogle Scholar
DeMaria, A. N., “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.CrossRefGoogle Scholar
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.Google Scholar
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.Google Scholar
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.Google Scholar
“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.Google Scholar
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.” McMurray, R. J. et al., “Gifts to Physicians from Industry,” JAMA 261, no. 4 (1991): 501.CrossRefGoogle Scholar
Harris, G., “Group Urges Ban on Medical Giveaways,” New York Times, April 28, 2008.Google Scholar
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.Google Scholar
Gagnon, M. A. and Lexchin, J., “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.CrossRefGoogle Scholar
Brennan, T. A. 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.CrossRefGoogle Scholar
Woolf, S. H., “The Meaning of Translational Research and Why It Matters,” JAMA 294 (2008): 211–213.Google Scholar
Phillips, L. S., Branch, W. T. and Cook, C. B. et al., “Clinical Inertia,” Annals of Internal Medicine 135, no. 2 (2001): 825–834, at 825.CrossRefGoogle Scholar
Safford, M. M., Shewchuk, R. and Qu, H. 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.CrossRefGoogle Scholar
Psaty, B. M. and Burke, S. P., “Institute of Medicine on Drug Safety,” New England Journal of Medicine 355, no. 17 (2006): 1753–1755.CrossRefGoogle Scholar
Buchanan, A. E., “Is There a Doctor in the House,” in Spece, R. G., Shimm, D. S. and Buchanan, A. E., Conflict of Interest in Clinical Practice and Research (New York: Oxford University Press, 1996): 105–136, at 125.Google Scholar
Keitz, S. A. et al., “Behind Closed Doors,” Archives of Internal Medicine 167, no. 5 (2007): 445–452.CrossRefGoogle Scholar
Wazana, A., “Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?” JAMA 283, no. 3 (2000): 373–380, at 378.CrossRefGoogle Scholar
Shrank, W. 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.CrossRefGoogle Scholar
Kessler, D. P. and McClellan, C., “Do Doctors Practice Defensive Medicine?” Working Paper 5466, National Bureau of Economic Research, February 1996. Also see Harris Interactive, Cottreau, A., “Common Good: Fear of Litigation Study: The Impact on Medicine”, April, 11, 2002.CrossRefGoogle Scholar
Levinsky, N. G., “Non-Financial Conflicts of Interest in Research,” New England Journal of Medicine 347, no. 10 (2002): 759–761.CrossRefGoogle Scholar
Meinhard v. Salmon, 164 N.E. 545 (N.Y. 1928).Google Scholar
Hazard, G. C., “Conflict of Interest in the Classic Professions,” in Spece, R. G., Shimm, D. S. and Buchanan, A. E., Conflict of Interest in Clinical Practice and Research (New York: Oxford University Press, 1996): 85–104, at 85.Google Scholar
See, Erde, E. L., “Conflicts of Interest in Medicine: A Philosophical and Ethical Morphology,” in Spece, R. G., Shimm, D. S. and Buchanan, A. E., Conflicts of Interest in Clinical Practice and Research (New York: Oxford University Press, 1996): 12–41.Google Scholar
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.Google Scholar
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.Google Scholar
Carrasquillo, O. and Goodman, R. L., “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 <www.nofreelunch.org> for his adaptation of the CAGE questionnaire for diagnosing drug company dependency.Google Scholar
Brody, H., Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry (New York: Rowman and Littlefield, Inc., 2007).Google Scholar
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).+(last+visited+June+26,+2009).>Google Scholar
Stossel, T. P., “Regulating Academic-Industrial Research Relationships – Solving Problems of Stifling Progress,” New England Journal of Medicine 353, no. 10 (2005): 1060–1065, at 1063.CrossRefGoogle Scholar
Hampson, L., Agrawal, M., Joffe, S. and Cross, D. et al., “Patients Views on Financial Conflicts of Interest in Cancer Research Trials,” New England Journal of Medicine 355 (2006): 2330–2337.CrossRefGoogle Scholar
Schlesinger, M. A., “A Loss of Faith: The Sources of Reduced Political Legitimacy for the American Medical Profession,” The Milbank Quarterly 80, no. 2 (2002):Google Scholar
Cain, D. M., Lowenstein, G. and Moore, D. A., “The Dirt on Coming Clean: The Perverse Effects of Disclosing Conflicts of Interest,” Journal of Legal Studies 34, no. 1 (2005): 1–25.CrossRefGoogle Scholar
Kao, A. C., Zaslavsky, A. M., Green, D. C., Koplan, J. P. and Cleary, P. D., “Physician Incentives and Disclosure of Payment Methods to Patients,” Journal of General Internal Medicine 16, no. 3 (2001): 181–188.CrossRefGoogle Scholar
Pearson, S. D. and Hyams, T., “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.CrossRefGoogle Scholar
Bogert, G. G. and Bogert, G. T., The Law of Trusts and Trustees, 2nd ed. (St. Paul, Minn.: West Publishing Co., 1993): Sec 543, at 277.Google Scholar
The Ultimatum Game provides an empirical basis for doubting the assumption that human beings will maximize their personal advantage at every margin. The 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>..>Google Scholar
Buchanan, A. E., “Toward a Theory of the Ethics of Bureaucratic Organizations,” Business Ethics Quarterly 6, no. 4 (1996): 419–440, at 421.CrossRefGoogle Scholar
Stossel, T. P., “Regulating Academic-Industry Research Relationships – Solving Problems or Stifling Progress?” New England Journal of Medicine 353, no. 10 (2005): 1060–1065.CrossRefGoogle Scholar
Langbein, J. H., “Questioning the Trust Law Duty of Loyalty: Sole Interest or Best Interest?” Yale Law Journal 114 (2005): 929–990.Google Scholar
Id., at 938.Google Scholar
Plato, , The Dialogues of Plato in Five Volumes, Volume III, The Republic, Jowett, B. J., ed. (Oxford: Oxford University Press, 1875): at 281–285, at 215-216.Google Scholar
Code of Medical Ethics of the American Medical Association, May 1847, at Chapter 1, section 3.Google Scholar
McMurray, R. J., “Gifts to Physicians from Industry,” JAMA 265, no. 4 (1991): 501.CrossRefGoogle Scholar
Fugh-Berman, A. and Ahari, S., “Follwing the Script: How Drug Reps Make Friends and Influence Doctors,” PLoS 4, no. 4 (2007): 0621–0625.Google Scholar
Cialdini, R., Influence: Science and Practice, 4th ed. (Needham Heights, NJ: Allyn and Bacon, 2001): at 31, 34.Google Scholar
See Brody, , supra note 36, at 175–176.Google Scholar
See Cialdini, , supra note 55, at 27. The study Cialdini discussed is Stelfox, H. T., Chua, G., O'Rourke, K. and Detsky, A. S., “Conflict of Interest in the Debate over Calcium Channel Antagonists,” New England Journal of Medicine 338, no. 2 (1998): 101–106.Google Scholar
Fugh-Berman, A. and Ahari, S.,. “Following the Script: How Drug Reps Make Friends and Influence Doctors,” PLoS Medicine 4, no. 4 (2007): 621–625.CrossRefGoogle Scholar