Trust and Transparency: Patient Perceptions of Physicians' Financial Relationships with Pharmaceutical Companies

Lo B. Field M. J. , eds., Conflict of Interest in Medical Research, Education, and Practice (Washington, D.C.: The National Academies Press, 2009) (hereinafter COI);

Campbell E. G. , “A National Survey of Physician-Industry Relationships,” New England Journal of Medicine 356, no. 17(2007): 1742–1750, at 1746 (“Overall, 94% of respondents reported some kind of relationship with industry during the previous year.”).

Morgan M. A. , “Interactions of Doctors with the Pharmaceutical Industry,” Journal of Medical Ethics 32, no. 10(2006): 559–563, at 559.

See COI, supra note 1, at 166.

See Morgan , supra note 2, at 561. However, while physicians are adamant in their denial that financial relationships inappropriately influence their personal medical decision making, studies consistently show that physicians believe these relationships may cause other physicians to be biased in their prescribing behaviors. Id., at 562.

See Zipkin D. A. Steinman M. A. , “Interactions between Pharmaceutical Representatives and Doctors in Training: A Thematic Review,” Journal General Internal Medicine 20, no. 8(2005): 777–786.

Carthy P. , “A Study of Factors Associated with Cost and Variation in Prescribing among GPs,” Family Practice 17, no. 1(2000): 36–41.

McKinney W. P. , “Attitudes of Internal Medicine Faculty and Residents toward Professional Interaction with Pharmaceutical Sales Representatives,” JAMA 264, no. 3(1990): 1693–1697.

Id.

Patient Protection and Affordable Care Act, Pub. L. No. 111–148, § 6002, 124 Stat. 119 (codified as amended 42 U.S.C. § 1320a-7h) (2010).

Sclar D. Keilty G. , “Sunshine and Strategy: Managing and Monitoring Compliance With PPACA's Sunshine Provisions – Evolving Legal Requirements and Operational Considerations,” The Health Lawyer 24, no. 5(2012): 14–24, at 15. Sclar and Keilty note that the PPSA had been previously introduced by Senators Charles Grassley (R-Iowa) and Herb Kohl (D-Wisc.) in the 110th and 11th Congresses. Id., at 16–17 (citing Physician Payments Sunshine Act of 2007 (S. 2029, 110th Cong.) and the Physician Payments Sunshine Act of 2009 (S. 301, 111th Cong.)).

Federal Register 66 (February 8, 2013): 78,9457, 78,9477–78,9481: 42 CFR 402 (as specified by Pub. L. No. 111–148 § 6002, (2010) (codified at 42 U.S.C.A § 1128G(a)(1)(A)(vi) (West Supp. 2011)).

Federal Register 66 (February 8, 2013): 78,9457, 78,9458–78,9459 42: CFR 402 “Increased transparency regarding the extent and nature of relationships between physicians, teaching hospitals, and industry manufacturers will permit patients to make better informed decisions when choosing health care professionals and making treatment decisions, and deter inappropriate financial relationships which can sometimes lead to increased health care costs.”).

See COI, supra note 1, at 94.

Id.

Sismondo S. , “Key Opinion Leaders and the Corruption of Medical Knowledge: What the Sunshine Act Will and Won't Cast Light On,” Journal of Law, Medicine & Ethics 41, no. 3(2013): 635–643, at 635.

Gorlach I. Pham-Kanter G. , “Brightening Up: The Effect of the Physician Payment Sunshine Act on Existing Regulation of Pharmaceutical Marketing,” Journal of Law, Medicine & Ethics 41, no. 1(2013): 315–322, at 320.

Loftus P. , “Doctors Face New Scrutiny over Gifts,” Wall Street Journal, August 23, 2013. In fact, the Open Payments scheme provides for physicians and teaching hospitals to register to access their data prior to public posting, initiate data disputes, and work with applicable manufacturers and group purchasing organizations to resolve any disputes. See <http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/How-OPEN-PAYMENTS-Works.html>(last visited November 5, 2014).

See COI, supra note 1, at 46.

See Pellegrino E. D. Relman A. S. , “Professional Medical Associations: Ethical and Practical Guidelines,” JAMA 282, no. 10(1999): 984–986, at 986 (“Temptations to use medical power for personal, commercial, or organizational advantage have always existed…Given the pervasive spread of commercialism throughout the health care system, the obligation to use medical power with ethical constraint is more urgent than ever.”).

Kesselheim A. S. Orentlicher D. , “Insights from a National Conference: ‘Conflicts of Interest in the Practice of Medicine,’” Journal of Law, Medicine & Ethics 40, no. 3(2012): 436–440, at 436.

Rodwin M. A. , “Conflicts of Interest, Institutional Corruption, and Pharma: An Agenda for Reform,” Journal of Law, Medicine & Ethics 40, no. 3(2012): 511–522, at 511.

Dana J. , “How Psychological Research Can Inform Policies for Dealing with Conflicts of Interest in Medicine,” in COI, supra note 1, at 358, 364. The credibility of physician denials that they are personally influenced, however, is compromised by those studies revealing that physicians do believe other physicians are susceptible to being influenced.

See generally, Zipkin Steinman , supra note 4, at 781.

Steinman M. A. Shlipak M. G. McPhee S. J. , “Of Principles and Pens: Attitudes and Practices of Medicine Housestaff toward Pharmaceutical Industry Promotions,” American Journal of Medicine 110, no. 7(2001): 551–557, at 554.

Campbell E. G. , “Doctors and Drug Companies: Scrutinizing Influential Relationships,” New England Journal of Medicine 357, no. 18(2007): 1796–1797 (“Although most physicians deny that receiving free lunches, subsidized trips, or other gifts from pharmaceutical companies has any effect on their practices, research has shown that physician-industry relationships do influence prescribing behavior.”).

See generally Brennan T. A. , “Health Industry Practices That Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers,” JAMA 295, no. 4(2006): 429–433, at 431.

Adair R. Holmgren L. , “Do Drug Samples Influence Resident Prescribing Behavior? A Randomized Trial,” American Journal of Medicine 118, no. 8(2005): 881–884, at 883.

Mizik N. Jacobson R. , “Are Physicians ‘Easy Marks’? Quantifying the Effects of Detailing and Sampling on New Prescriptions,” Management Science 50, no. 12(2004): 1704–1715.

Keim S. M. Mays M. Z. Grant D. , “Interactions between Emergency Medicine Programs and the Pharmaceutical Industry,” Academic Emergency Medicine 11, no. 1(2004): 19–26, at 23.

Finucane T. E. Boult C. E. , “Association of Funding and Findings of Pharmaceutical Research at a Meeting of a Medical Professional Society,” American Journal of Medicine 117, no. 11(2004): 842–845, at 843.

Blumenthal D. , “Doctors and Drug Companies,” New England Journal of Medicine 351, no. 18(2004): 1885–1890.

Brett A. S. Burr W. Moloo J. , “Are Gifts From Pharmaceutical Companies Ethically Problematic? A Survey of Physicians,” Archives of Internal Medicine 163, no. 18(2003): 2213–2218, at 2217.

Wazana A. , “Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?” JAMA 283, no. 3(2000): 373–380, at 378.

Caudill T. S. , “Physicians, Pharmaceutical Sales Representatives, and the Cost of Prescribing,” Archives of Family Medicine 5, no. 4(1996): 201–206, at 205.

Chren M. M. Landefeld C. S. , “Physicians' Behavior and Their Interactions with Drug Companies: A Controlled Study of Physicians Who Requested Additions to a Hospital Drug Formulary,” JAMA 271, no. 9(1994): 684–689.

Orlowski J. P. Wateska L. , “The Effects of Pharmaceutical Firm Enticements on Physician Prescribing Patterns: There's No Such Thing as a Free Lunch,” Chest 102, no. 1(1992): 270–273, at 273.

Lurie N. , “Pharmaceutical Representatives in Academic Medical Centers: Interaction with Faculty and Housestaff,” Journal of General Internal Medicine 5, no. 3(1990): 240–243, at 242.

Avorn J. Chen M. Hartley R. , “Scientific Versus Commercial Sources of Influence on the Prescribing Behavior of Physicians,” American Journal of Medicine 73, no. 1(1982): 4–8, at 7.

See COI, supra note 1, at 167.

Id., at 169 (

“Physicians' ownership interests in facilities to which they refer patients constitute a conflict of interest. Their secondary interest (i.e., increased income from increased services) has the potential to bias physicians' primary interest in their patients' welfare.”).

See also Perry J. E. , “Physician-Owned Specialty Hospitals and the Patient Protection and Affordable Care Act: Health Care Reform at the Intersection of Law and Ethics,” American Business Law Journal 49, no. 2(2012): 369–417.

Medicare Payment Advisory Commission, Report to Congress: Medicare Payment Policy 21 (March 17, 2009) “The Commission recommends that the Congress require manufacturers to report their financial relationships with physicians and other health care entities and that the Secretary post this information on a public, searchable website.”).

See generally supra note 1 and Alpert J. S. , “Doctors and the Drug Industry: How Can We Handle Potential Conflicts of Interest?” American Journal of Medicine 118, no. 2(2005): 99–100, at 99 (“Thus, I would propose a national Internet-based registry of transactions between doctors and pharmaceutical companies with the market values of these transactions…. The public registry would allow everyone to evaluate the level of financial gain and potential conflict of interest that a particular doctor, partner, or medical lecturer has with respect to a specific product or company.”).

See 153 Cong. Rec. 11,217–18 (2007) (Senator Grassley speaking on the Senate floor describing the need for greater transparency regarding industry payments and the importance of this issue for all Americans who take prescription drugs or use medical devices); 154 Cong. Rec. 2,320 (2008) (Senator Grassley discussing the influence of industry payments over physician decision making); 155 Cong. Rec. 787–88 (2009) (Senators Grassley and Kohl discussing their hope that the Sunshine Act serve as a catalyst for patients to discuss with their physician any concerns about improper financial relationships and noting their attempt to balance “legitimate” industry payments to physicians for research, as well as industry's right to spend an unlimited amount of money on marketing their products).

Stamatoglou A. , “The Physician Payment Sunshine Act: An Important First Step in Mitigating Financial Conflicts of Interest in Medical and Clinical Practice,” John Marshall Law Review 45, no. 3(2012): 963–1008, at 977.

Green M. J. , “Do Gifts from the Pharmaceutical Industry Affect Trust in Physicians?” Family Medicine 44, no. 5(2012): 325–31, at 325.

Id., at 326. We do have the benefit of a few previously published findings. For example, most patients interviewed in a cancer-research trial neither worried about nor seemed to care greatly about financial ties between researchers or institutions and life science companies.

Hampson L. A. , “Patients' Views on Financial Conflicts of Interest in Cancer Research Trials,” New England Journal of Medicine 355, no. 22(2006): 2330–2337, at 2335.

See generally Pearson S. D. , “A Trial of Disclosing Physicians' Financial Incentives to Patients,” Archives of Internal Medicine 166, no. 6(2006): 623–680 (“Patients who received a disclosure felt more competent to judge the impact of their physician's compensation on their health care, and…. patients who remembered receiving a disclosure reported that it had increased their trust in their primary care physician”).

Gibbons R. V. et al., “A Comparison of Physicians' and Patients' Attitudes toward Pharmaceutical Industry Gifts,” Journal of General Internal Medicine 13, no. 3(1998): 151–154 (finding that patients generally consider pharmaceutical gifts more influential and less appropriate than do their physicians).

Mainous A. G. Hueston W. J. Rich E. C. , “Patient Perceptions of Physician Acceptance of Gifts from the Pharmaceutical Industry,” Archives of Family Medicine 4, no. 4(1995): 335–339 (finding that patients are more likely to see personal gifts to physicians as having negative effects on both the cost and quality of health care than gifts – such as drug samples – that might have patient benefit).

Hall M. A. Schneider C. E. , “Patients as Consumers: Courts, Contracts, and the New Medical Marketplace,” Michigan Law Review 106, no. 4(2008): 643.

Hall M. A. , “Trust in Physicians and Medical Institutions: What Is It, Can It Be Measured, and Does It Matter?” Millbank Quarterly 79, no. 4(2001): 613–639.

Pearson S. D. Raeke L. H. , “Patients' Trust in Physicians: Many Theories, Few Measures, and Little Data,” Journal of General Internal Medicine 15, no. 7(2000): 509–513.

Mechanic D. , “The Functions and Limitations of Trust in the Provision of Medical Care,” Journal of Health Politics, Policy, and Law 23, no. 4(1998): 661–687.

Grande D. Shea J. A. Armstrong K. , “Pharmaceutical Industry Gifts to Physicians: Patient Beliefs and Trust in Physicians and the Health Care System,” Journal of General Internal Medicine 27, no. 3(2011): 274–279, at 274.

Centers for Medicare and Medicaid Services, “Open Payments User Guide for Industry” (July 2013), at 1.1b.

But see Loewenstein G. Sah S. Cain D. M. , “The Unintended Consequences of Conflict of Interest Disclosure,” Journal of the American Medical Association 307, no. 7(2012): 669–670 (“[D]isclosure can have adverse effects, exacerbating bias and hurting those it is ostensibly intended to help.”).

Pearson S. D. , “A Trial of Disclosing Physicians' Financial Incentives to Patients,” Archives of Internal Medicine 166, no. 6(2006): 623–628 (“Disclosure's limitations must be acknowledged: It will most likely always be imperfect and inadequate to endow all patients with an understanding of compensation and the risks for conflict of interest.”).

Herzlinger R. E. , Market-Driven Health Care (Reading, MA: Perseus Books, 1997): At 290–291.

Porter M. E. Teisberg E. O. , Redefining Health Care (Boston: Harvard Business School Press, 2006): At 83–84.

Cutrona S. L. , “Characteristics of Recipients of Free Prescription Drug Samples: A Nationally Representative Analysis,” American Journal of Public Health 98, no. 2(2008): 284–289.

These payment amounts were selected after review of the payments voluntarily disclosed by Pfizer on their website. See <http://www.pfizer.com/responsibility/working_with_hcp/payments_report>(last visited November 5, 2014).

Ritchie J. Spencer L. , “Qualitative Data Analysis for Applied Policy Research,” in Bryman A. Burgess R. , eds., Analysing Qualitative Data (London: Routledge, 1994): At 172–194.

Leydon G. , “Cancer Patients' Information Needs and Information Seeking Behavior: In Depth Interview Study,” British Medical Journal, 320, no. 7239 (2000): 909–924.

The use of open-ended questions to interpret experimental findings dates back at least to Merton and Kendall's classic article on the “focused interview.” Merton R. K. Kendall P. , “The Focused Interview,” American Journal of Sociology, 51, no. 6 (1946): 541–557 (“The primary purpose of the focused interview was to provide some basis for interpreting statistically significant effects of mass communication [in experimental studies].”).

Keppel G. Wickens T. D. , Design and Analysis: A Researcher's Handbook (Upper Saddle, NJ: Pearson, 2004).

Cohen J. , Statistical Power Analysis in the Behavioral Sciences (Hillsdale, NJ: Erlbaum, 1988).

See Ritchie Spencer , supra note 36

Leydon , supra note 36.

A cautionary tale in this regard: The 2013 problem-plagued launch of the Healthcare.gov website. Stolbert S. G. Shear M. D. , “Inside the Race to Rescue a Health Care Site, and Obama,” New York Times, November 30, 2013.

Donohue J. M. , “A Decade of Direct-to-Consumer Advertising of Prescription Drugs,” New England Journal of Medicine 357, no. 7(2007): 673–681, at 675.

Pinckney R. G. , “The Effect of Medication Samples on Self-Reported Prescribing Practices: A Statewide, Cross-Sectional Survey,” Journal of General Internal Medicine 26, no. 1(2010): 40–44 (“Research suggests that samples result in increased prescribing of brand name medications when more evidence-based, less costly generic or over-the-counter alternative exist.”);

Cutrona et al., supra note 34, at 284:

“Studies [of free samples] have described potential safety problems, health professionals who divert samples for self-administration or resale, the influence of pharmaceutical representatives who distribute samples, and the contribution of samples to rising drug and health insurance costs.”

See Cutrona , supra note 34, at 287.

Centers for Medicare and Medicaid Services, “Open Payments User Guide for Industry” (July 2013), at 1.1b.

See text accompanying note 8.

See generally Lamkin M. Elliott C. , “Curing the Disobedient Patient: Medication Adherence Programs as Pharmaceutical Marketing Tools,” Journal of Law, Medicine & Ethics 42, no. 4(2014): 492–500 (“Medical professionals have built a vast reservoir of public trust by acting as fiduciaries with duties to protect patient health. Building that kind of trust is a long and arduous process. Squandering it is quick and easy.”).

See supra note 32;

Loewenstein G. Cain D. M. Sah S. , “The Limits of Transparency: Pitfalls and Potential of Disclosing Conflicts of Interest,” American Economic Review: Papers and Proceedings 101, no. 3(2011): 423–428, at 427 (“Care must be taken, however, to ensure that disclosure does not replace more effective measures, such as working harder to eliminate conflicts of interest in the first place.”).