Trust and Transparency: Patient Perceptions of Physicians’ Financial Relationships with Pharmaceutical Companies Joshua E. Perry, Dena Cox, and Anthony D. Cox
Introduction Financial relationships and business transactions between physicians and the health care industry are common.1 These relationships take a variety of forms, including payments to physicians in exchange for consulting services, reimbursement of physician travel expenses when attending medical device and pharmaceutical educational conferences, physician ownership in life science company stocks, and the provision of free drug samples.2 Such practices are not intrinsic to medical practice, but as the Institute of Medicine described in its 2009 report, these relationships have the potential to produce positive collaborations that improve patient care and public health,3 and most physicians view it as “ethically proper to accept items ranging from drug samples to a lucrative consultantship.”4 However, financial relationships between physicians and pharmaceutical, medical device and biotechnology companies can also create negative influences on physician judgment that compromise patient care and jeopardize the public’s trust.5 In response to these concerns, when Congress passed the Patient Protection and Affordable Care Act (ACA) in March 2010, it seized the opportunity to mandate greater transparency regarding these financial relationships by including a provision known as the Physician Payment Sunshine Act (Sunshine Act).6 The Sunshine Act has been labeled “a novel approach and potential game-changer” because unlike existing state and federal laws that rely on whistleblowers and government investigators, the Sunshine Act shifts the burden to those organizations in the pharmaceutical, medical device and life science industries to self-report and thereby expose their financial relationships with physicians.7 Under the purview of the Center for Medicare and Medicaid Services (CMS) — to which the Secretary of the Department of Health and Human Services has delegated authority — the Sunshine Act has been re-labeled the “National Physician Payment Transparency Program,” or “Open Payments.” Pursuant to the CMS Final Rule’s regulatory dictates, pharmaceutical companies, medical device and supplies companies, and others in the biotechnology industry began in 2013 to collect specific data on the payments or transfers of value they made to physiJoshua E. Perry, J.D., M.T.S., is an Assistant Professor of Business Law and Ethics and a Research Coordinator in the Center for the Business of Life Sciences at Indiana University’s Kelley School of Business. Dena Cox, Ph.D., is Professor of Marketing and Roger Schmenner Faculty Fellow at Indiana University’s Kelley School of Business. Anthony D. Cox, Ph.D., is Professor of Marketing and Kelley Venture Fellow at Indiana University’s Kelley School of Business.
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cians pursuant to the following categories: consulting fees; compensation for services other than consulting, including serving as faculty or as a speaker at a venue other than a continuing education program; honoraria; gifts; entertainment; food and beverage; travel and lodging; education; charitable contributions; royalties or licenses; current or prospective ownership or investment interests; direct compensation for serving as faculty or as a speaker for a medical education program; and grants.8 The initial data gathering period
informed patients to understand them” and make health care decisions accordingly.12 However, “it is not clear how this information will be used, interpreted or understood by the public” and “the public may have difficulty distinguishing between ‘good’ research payments…and ‘bad’ research payments.”13 Moreover, physicians reportedly worry that the public will misinterpret the disclosed information, fail to distinguish compensation for research-related services from payments of a more promotional nature, and generally
The purpose of our study was to determine how American health care consumers think and feel about specific types of payments made by drug and device companies to health care providers that routinely occur in the U.S. health care market place. We also asked a number of questions designed to shed light on how patients understand the relational dynamics between trust and transparency when they interact with health care professionals. In other words, we wanted to know if the stated rationale for the Sunshine Act’s Open Payments scheme is justified: do health care consumers care about these financial relationships, and will they avail themselves of this data in an effort to be better informed and more confident that their physician can be trusted, particularly in a post-ACA climate where millions of previously uninsured individuals will be seeking to create new health care relationships with a physician? was August 1, 2013 through December 31, 2013, with the first reports due to CMS by March 31, 2014. CMS posted the first batch of data on the Open Payments website on September 30, 2014. The stated policy rationale for this online database is to increase public awareness of financial relationships between drug and device manufacturers and certain health care providers so that patients can make better-informed decisions when choosing health care providers and also to deter inappropriate financial relationships.9 It is also anticipated that a searchable public website will facilitate a watchdog-effect, such that physician colleagues and other interested stakeholders will be able to better monitor adherence to disclosure policies and industry norms.10 The Open Payments program is premised on the assumption that making these financial relationships transparent and thereby enhancing patients’ decision making or otherwise safeguarding patient trust and subtly policing physician conduct will produce positive results throughout the health care system.11 Indeed, as observers have noted, “exposing conflicts of interest…might lessen their impact or at least allow 476
view these financial relationships as “tainting their medical decisions.”14 In an effort to better understand how patients view these physician-industry financial relationships, potential conflicts of interest, and this unprecedented access to more transparent information on such matters, we designed an empirical study of health care consumer perceptions of financial relationships between physicians and pharmaceutical companies and medical device manufacturers. The purpose of our study was to determine how American health care consumers think and feel about specific types of payments made by drug and device companies to health care providers that routinely occur in the U.S. health care market place. We also asked a number of questions designed to shed light on how patients understand the relational dynamics between trust and transparency when they interact with health care professionals. In other words, we wanted to know if the stated rationale for the Sunshine Act’s Open Payments scheme is justified: do health care consumers care about these financial relationships, and will they avail themselves of this data in an effort to be better informed and more
journal of law, medicine & ethics
Perry, D. Cox, and A. Cox
confident that their physician can be trusted, particularly in a post-ACA climate where millions of previously uninsured individuals will be seeking to create new health care relationships with a physician? In Part I we discuss further the relevant literature and rationales that resulted in passage of the Sunshine Act and creation of the Open Payments database, which we describe. Our study methodology is presented in Part II. We report our results in Part III and discuss relevant findings in their broader context in Part IV.
I. Background At the most fundamental level, a conflict of interest arises in those situations where there is “a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest.”15 In the context of physician conflicts of interest, the primary interest would include the best interests of the patient, while secondary interests would include the physician’s personal financial interest, as well as professional recognition, scientific awards, or career advancement.16 Such conflicts of interest are “inevitable and pervasive in our health care system,”17 and, as illustrated by passage of the Sunshine Act, these conflicts are “as much matters of public policy and management as individual choices or social norms.”18 When confronted with the pervasiveness of financial conflicts of interest, most physicians — reflecting the psychological research showing that each of us is prone to have an optimistic, often unconscious and unintentional, bias about ourselves — will deny that they are influenced by financial transactions with industry.19 An overwhelmingly convincing body of research, however, suggests otherwise.20 In fact, 30 years of data demonstrate that, to varying degrees, physicianindustry relationships including the provision of gifts, such as meals or drug samples, do create conflicts of interest that influence physician decision making and inevitably cloud judgment. Payments made to physicians when they speak and write on behalf of a company,21 as well as ownership or investment interests, such as stock, in companies that produce products used, recommended or prescribed by physicians can also compromise a physician’s objectivity.22 By the mid/late-2000s, the persistence of these conflicts of interest, compounded by the mountain of literature demonstrating their influence over the professional judgment of physicians, began to coalesce around calls — from federal regulators,23 influential sectors of the academic medical community,24 and the halls of Congress25 — for detailed disclosure and increased transparency of these physician-industry financial relationships. Two stated goals animated the buying and selling of health care • winter 2014
the calls for reform: (1) distinguish legitimate financial relationships from improper ones and (2) inform patients about these relationships so that, as health care consumers, they might make better-educated decisions about where to seek care and who to trust.26 Relative to the number of studies examining physician behaviors and beliefs regarding the influence of industry, the literature exploring these concerns from the patient perspective is thin.27 As Michael Green and colleagues noted in a study of patients and their views on physician-industry financial relationships published in 2012, “[s]urprisingly, little is known about patients’ attitudes about industry gift-giving to physicians.”28 The centrality and importance of trust in the context of a therapeutic relationship between a patient and a physician, however, has been well documented.29 In a 2011 study published by David Grande and colleagues, researchers demonstrated for the first time that patients’ perceptions of relationships between physicians and the pharmaceutical industry are associated with decreased trust in doctors and the health care system more generally.30 As noted above, the Sunshine Act’s Open Payments program proposes to address these concerns by establishing “a national disclosure program that promotes transparency by publishing the financial relationships between the medical industry and healthcare providers (physicians and hospitals) on a publicly accessible website…organized and designed to increase access to and knowledge about these relationships and to provide information to enable consumers to make informed decisions.”31 Thus, the promise of increased transparency includes an additional potential benefit beyond improved levels of trust between the patient and physician.32 Open Payments aims to improve levels of sophistication and awareness among patients, in an effort to further educate and empower health care consumers consistent with so-called market-driven approaches to health care.33 Our goal in this study was to bolster the empirical literature on how patients perceive the variety of financial dealings that are common between physicians and the life sciences industry. Specifically, in the context of Open Payments, we wanted to know how knowledge of these financial relationships might impact a patient’s level of trust in their physician, as well as a patient’s perception of that physician’s expertise. We wanted to better understand whether patients (in an effort to be better-informed health care consumers), would even consult with the Open Payments database, i.e., would they use this opportunity afforded them by the ACA to better inform themselves about their physician’s potential financial conflicts of interest and then “shop around” accordingly for less-conflicted physicians? 477
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Finally, for those patients who do plan to access and use the information generated by Open Payments, we wondered what, where, and how to best deliver this database content to the end user, i.e., the health care consumer/patient? Our findings in response to these questions are set forth in Part III, and their implications for federal regulators charged with oversight and administration of the Open Payments program are discussed in greater detail in Part IV.
1. A physician received money for consulting with a pharmaceutical company for helping to develop a new drug; 2. A physician owned stock in a pharmaceutical company; 3. A physician received travel, meals, and/or entertainment from a pharmaceutical company; and 4. A physician received free drug samples from a pharmaceutical company.
II. Study Methodology
The first three payment types were selected for inclusion in our study because they each must be reported in a pharmaceutical company’s Open Payments disclosure, and yet they each seem qualitatively different in terms of how patients might understand the dynamics of that financial relationship. The free drug samples scenario was included because it is an exception that is carved out of the Open Payments disclosure mandate, despite the considerable controversy surrounding the acceptance and distribution of free samples by health care providers.34 The second factor we varied was the payment amount, in which the magnitude of a given payment type was either small ($153) or large ($4153).35 The third factor we varied across scenarios was the type of doctor, either a family physician or a specialist. We also created “control” scenarios for both the family physician and the specialist, in which the physician received zero payments of any kind. In all (including the two control scenarios) there were 18 possible financial scenarios, which were randomly assigned to respondents (i.e., each respondent only viewed one of the 18 scenarios). For an illustration of one of the 18 scenarios, see Survey Scenario 1.
Study Overview and Design In the fall of 2013, the authors conducted an online experiment to determine how a national panel of adults ages 30-65 would perceive a variety of financial relationships that occur between physicians and pharmaceutical companies. Each respondent read a scenario about a hypothetical physician and his financial ties to the pharmaceutical industry. The study employed a 4 x 2 x 2 between-subjects experimental design, in which each respondent was randomly assigned to a different scenario version, which varied along three factors: payment type, payment amount, and physician type (each of these factors is described in greater detail below). In addition, some respondents were assigned to a control scenario (in which the physician received no payments) to provide a baseline assessment of consumers’ attitudes toward the physician. The Institutional Review Board at our university approved this study. The first factor we varied across scenarios was payment type, involving four different types of financial ties that occur between physicians and pharmaceutical companies:
Survey Scenario 1 Family physician; Consulting on New Drug Development; $4153 Imagine that you just moved to a new town and are trying to select a family physician to become your regular doctor. One family physician you are considering is Dr. Matt Wilson, whose office is near your home. As part of your search process, you have looked up Dr.Wilson in a new online database that reports on relationships between doctors and pharmaceutical companies. Here is what you found: PAYMENTS RECEIVED FROM DRUG COMPANIES IN 2012
Physician Name Matt Wilson
478
Consulting on new drug development. $4153
Ownership of drug company stock. 0
Travel meals & entertainment. 0
Free drug samples to be given to patients. 0
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Procedure and Measures The scenarios and questions were programmed in a web survey software package called Qualtrics. This web survey package is used extensively in academic research and is especially well-suited for conducting experiments, given the randomization capabilities of the software. After the survey had been programmed and thoroughly pretested, the unique URL link to the study was sent to respondents from a national on-line survey panel purchased from a commercial sample vendor, Survey Sampling International (SSI). SSI maintains a national panel of over 6 million potential respondents. For each study, SSI sends email invitations to a random subset of panel members meeting the study’s demographic criteria. SSI places volunteers into a lottery to win a monetary prize, to increase response rates. After initial recruitment by SSI, potential respondents were directed to a web survey, where they were first asked a screening question confirming their age (between 30 and 65). We used a wide age range to allow us to examine whether attitudes toward physician payments varied by age category. Immediately after the respondents viewed the scenario, each subject was also asked an open-ended question about the scenario they had just viewed: “What are your thoughts about Dr. Wilson?” Designed to further aid in the interpretation of the experimental findings, subjects’ verbatim comments were then examined by the investigators’ graduate research assistants and organized according to recurring themes.36 Next, respondents were asked a series of 5-point Likert (agree-disagree) questions concerning their perceptions of Dr. Wilson (e.g., his expertise, trustworthiness, knowledge of the latest treatments, moral character, focus on patients’ interests) and were asked to state the likelihood they would choose Dr. Wilson as their doctor and the likelihood they would take a drug if Dr. Wilson prescribed it. Following this question, all respondents were shown a series of seven different types of financial relationships between physicians and drug companies, and asked to evaluate these on several dimensions. The seven relationship types were: 1. A doctor owns stock in a pharmaceutical company. 2. A doctor helped develop a drug and received royalty payments on the sales of the drug. 3. A doctor received money from speaking fees from a pharmaceutical company. 4. A drug company donated drug samples to a doctor. 5. A pharmaceutical company sales rep provided lunch for a doctor’s office staff. the buying and selling of health care • winter 2014
6. A doctor was paid to help a pharmaceutical company develop a new drug. 7. A pharmaceutical company paid for a doctor’s plane travel and hotel room for a medical conference in a resort. Respondents rated each of the seven financial relationships on: perceived ethicality (on a 5-point scale anchored by “Not at all ethical” to “Very Ethical”); how knowledge of such a relationship would affect their likelihood of choosing a doctor (5-point scale from “Much LESS likely to go to this doctor” to “Much MORE likely to go to this doctor”), and whether and how they thought each type of relationship should be disclosed to patients. The disclosure options (from which respondents could choose more than one) were: 1. There is no need to disclose this information. 2. This information should be placed on the doctor’s website. 3. A sign should be posted in the doctor’s office. 4. The doctor should tell me face-to-face about this relationship. 5. An online database where you can look up this information for any doctor. 6. Other [respondents were allowed to write in other disclosures method] Finally, respondents reported basic demographic and health-behavior information, including their prior use of online ratings of doctors, whether they had a “regular” doctor, frequency of visits to clinic or doctor in last six months, whether they had ever received drug samples, the number of times they had received drug samples in the last six months and the likelihood that they would use an online database that included full disclosure of financial payments to doctors by pharmaceutical companies. We asked respondents to assess the percentage of pharmaceutical companies’ promotional expenditures that are targeted toward physicians vs. consumers, using two sliding scales that ranged from 1 to 100 percent. The total of those two scales was required to add up to 100 percent. Sample An initial sample of 881 adult respondents was recruited from a national on-line survey panel purchased from a commercial sample vendor, Survey Sampling International (SSI). After initial recruitment by SSI, potential respondents were directed to a web survey, where they were first asked a screening question confirming their age (between ages of 30 and 65). Eleven individuals were not in the age range and 479
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16 elected not to participate at some time during the survey, leaving us with a usable sample of 854. The sample was closely divided among females and males (50.6% vs. 49.1%), about 46 percent of the sample had a high school diploma or less, about 82% had a total household income less than $80,000 and the sample was about 65% Caucasian, 14% African American and 13% Hispanic, which approximates the national ethnic proportions.
Main Effects of Payment Type Respondents’ perceptions of a physician were significantly influenced by the types of payments he had received from pharmaceutical companies. Table 1 shows the significant ANOVAs for the overall effects of payment type on each of the perceptual dimensions, as well as the mean (and standard deviation) of each perceptual dimension within each payment type. Table 2 highlights the significant pairwise differences in respondents’ perceptions of a physician receiving specific types of payments (e.g., consulting vs. travel) as well as the differences in perceptions of a physician receiving no payment vs. one receiving any type of payment (averaged across specific payment types). For each pairwise comparison, Table 2 shows the difference between the two means, the adjusted p value (p values for differences between specific payment types reflect a Bonferroni correction37) and Cohen’s d effect-size statistic.38 Cohen’s d is the difference between two group means divided by their pooled standard deviation. According to Cohen’s approximate guidelines for behavioral-science research, effects with d ≤ .20 are considered “small,” effects with d ≥ .80 are considered “large,” and effect sizes between those two values (i.e., with d
III. Results Effects of Payment-Scenario Elements on Perceptions of Physician First, we analyzed the effects of the three paymentscenario elements (payment type, payment amount and physician type) on respondents’ perceptions of Dr. Wilson. This involved conducting a series of Analyses of Variance (ANOVAs), in which the three scenario elements were entered as independent variables (factors), and the perceptual dimensions (e.g., perceived physician trustworthiness, expertise, etc.) were entered as dependent variables. As summarized below, these analyses revealed a number of significant effects of payment type, payment amount, and doctor type on perceptions of Dr. Wilson.
Table 1 ANOVA Results: Effects of Payment Type on Perception of Doctor Group Means (and Standard Deviations) F(4,~842) Expert Trustworthy
4.77 7.92
a
b
c
d
e
No Payment
Consult.
Stock
Travel
Samples
.001
3.26 (.94)
3.36d
3.15 (.77)
3.04be (.88)
3.30d (.75)
.000
3.57cd
Sig.
(.73)
(1.00)
3.36 (.79)
3.13ae (.89)
3.15ae (.92)
3.49cd (.85)
Informed
5.63
.000
3.21 (1.02)
3.43d (.84)
3.16 (.91)
3.03be (1.00)
3.35d (.86)
Moral character
15.22
.000
3.55cd (.98)
3.28e (.86)
3.02ae (.94)
3.02ae (1.03)
3.58bcd (.87)
Patient Interests
13.04
.000
3.60bcd (1.01)
3.24a (.87)
3.00ae (1.02)
2.99ae (1.06)
3.50cd (.88)
Choose Dr.
13.45
.000
3.48cd (1.08)
3.25cd (.92)
2.89abe (1.07)
2.88abe (1.13)
3.46cd (.99)
Take Rx.
8.56
.000
3.43cd (.98)
3.28d (.88)
2.99ae (.99)
2.98abe (1.05)
3.41cd (.96)
Note: superscripts indicate significant differences between groups; e.g., on the “expert” line, 3.04be indicates that Dr. Wilson’s perceived expertise when receiving payments for travel (mean=3.04) is significantly lower than when receiving either payments for consulting (mean=3.36) or drug samples (mean=3.30)
480
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≅ .50) are considered “medium-sized.” As can be seen in Table 2, most differences in perceptions between specific payment types fall into this latter, intermediate effect-size range. Tables 1 and 2 reveal several interesting findings. First, they show that payment type had a significant effect on doctor’s perceived expertise (F (4, 842) = 4.77, p=.001). Specifically, those who accepted consulting payments and drug samples were perceived to be significantly higher on expertise than those who accepted
money for travel. However, neither of these was significantly different from the no payment control. Tables 1 and 2 reveal a similar pattern for perceptions of how informed the doctor was (F (4, 842) = 5.63, p Travel
0.32 0.26
.001 .012
.40 .32
Trustworthy
No payment > Stock No payment > Travel Samples > Stock Samples > Travel No payment > ANY payment
0.44 0.42 0.36 0.34 0.27
.001 .002 Travel Samples > Travel
0.40 0.32
Stock No payment > Travel Samples > Consulting Samples > Stock Samples > Travel No payment > ANY payment
0.53 0.53 0.30 0.56 0.56 0.31
Stock Samples > Travel No payment > ANY payment
0.36 0.60 0.61 0.50 0.51 0.40
.43 Stock Samples > Travel No payment > ANY payment
0.59 0.60 0.36 0.37 0.57 0.58 0.35
Stock Samples > Travel No payment > ANY payment
0.44 0.45 0.30 0.42 0.43 0.25
.007 .003 .031
Introduction Financial relationships and business transactions between physicians and the health care industry are common.1 These relationships take a variety of forms, including payments to physicians in exchange for consulting services, reimbursement of physician travel expenses when attending medical device and pharmaceutical educational conferences, physician ownership in life science company stocks, and the provision of free drug samples.2 Such practices are not intrinsic to medical practice, but as the Institute of Medicine described in its 2009 report, these relationships have the potential to produce positive collaborations that improve patient care and public health,3 and most physicians view it as “ethically proper to accept items ranging from drug samples to a lucrative consultantship.”4 However, financial relationships between physicians and pharmaceutical, medical device and biotechnology companies can also create negative influences on physician judgment that compromise patient care and jeopardize the public’s trust.5 In response to these concerns, when Congress passed the Patient Protection and Affordable Care Act (ACA) in March 2010, it seized the opportunity to mandate greater transparency regarding these financial relationships by including a provision known as the Physician Payment Sunshine Act (Sunshine Act).6 The Sunshine Act has been labeled “a novel approach and potential game-changer” because unlike existing state and federal laws that rely on whistleblowers and government investigators, the Sunshine Act shifts the burden to those organizations in the pharmaceutical, medical device and life science industries to self-report and thereby expose their financial relationships with physicians.7 Under the purview of the Center for Medicare and Medicaid Services (CMS) — to which the Secretary of the Department of Health and Human Services has delegated authority — the Sunshine Act has been re-labeled the “National Physician Payment Transparency Program,” or “Open Payments.” Pursuant to the CMS Final Rule’s regulatory dictates, pharmaceutical companies, medical device and supplies companies, and others in the biotechnology industry began in 2013 to collect specific data on the payments or transfers of value they made to physiJoshua E. Perry, J.D., M.T.S., is an Assistant Professor of Business Law and Ethics and a Research Coordinator in the Center for the Business of Life Sciences at Indiana University’s Kelley School of Business. Dena Cox, Ph.D., is Professor of Marketing and Roger Schmenner Faculty Fellow at Indiana University’s Kelley School of Business. Anthony D. Cox, Ph.D., is Professor of Marketing and Kelley Venture Fellow at Indiana University’s Kelley School of Business.
the buying and selling of health care • winter 2014
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cians pursuant to the following categories: consulting fees; compensation for services other than consulting, including serving as faculty or as a speaker at a venue other than a continuing education program; honoraria; gifts; entertainment; food and beverage; travel and lodging; education; charitable contributions; royalties or licenses; current or prospective ownership or investment interests; direct compensation for serving as faculty or as a speaker for a medical education program; and grants.8 The initial data gathering period
informed patients to understand them” and make health care decisions accordingly.12 However, “it is not clear how this information will be used, interpreted or understood by the public” and “the public may have difficulty distinguishing between ‘good’ research payments…and ‘bad’ research payments.”13 Moreover, physicians reportedly worry that the public will misinterpret the disclosed information, fail to distinguish compensation for research-related services from payments of a more promotional nature, and generally
The purpose of our study was to determine how American health care consumers think and feel about specific types of payments made by drug and device companies to health care providers that routinely occur in the U.S. health care market place. We also asked a number of questions designed to shed light on how patients understand the relational dynamics between trust and transparency when they interact with health care professionals. In other words, we wanted to know if the stated rationale for the Sunshine Act’s Open Payments scheme is justified: do health care consumers care about these financial relationships, and will they avail themselves of this data in an effort to be better informed and more confident that their physician can be trusted, particularly in a post-ACA climate where millions of previously uninsured individuals will be seeking to create new health care relationships with a physician? was August 1, 2013 through December 31, 2013, with the first reports due to CMS by March 31, 2014. CMS posted the first batch of data on the Open Payments website on September 30, 2014. The stated policy rationale for this online database is to increase public awareness of financial relationships between drug and device manufacturers and certain health care providers so that patients can make better-informed decisions when choosing health care providers and also to deter inappropriate financial relationships.9 It is also anticipated that a searchable public website will facilitate a watchdog-effect, such that physician colleagues and other interested stakeholders will be able to better monitor adherence to disclosure policies and industry norms.10 The Open Payments program is premised on the assumption that making these financial relationships transparent and thereby enhancing patients’ decision making or otherwise safeguarding patient trust and subtly policing physician conduct will produce positive results throughout the health care system.11 Indeed, as observers have noted, “exposing conflicts of interest…might lessen their impact or at least allow 476
view these financial relationships as “tainting their medical decisions.”14 In an effort to better understand how patients view these physician-industry financial relationships, potential conflicts of interest, and this unprecedented access to more transparent information on such matters, we designed an empirical study of health care consumer perceptions of financial relationships between physicians and pharmaceutical companies and medical device manufacturers. The purpose of our study was to determine how American health care consumers think and feel about specific types of payments made by drug and device companies to health care providers that routinely occur in the U.S. health care market place. We also asked a number of questions designed to shed light on how patients understand the relational dynamics between trust and transparency when they interact with health care professionals. In other words, we wanted to know if the stated rationale for the Sunshine Act’s Open Payments scheme is justified: do health care consumers care about these financial relationships, and will they avail themselves of this data in an effort to be better informed and more
journal of law, medicine & ethics
Perry, D. Cox, and A. Cox
confident that their physician can be trusted, particularly in a post-ACA climate where millions of previously uninsured individuals will be seeking to create new health care relationships with a physician? In Part I we discuss further the relevant literature and rationales that resulted in passage of the Sunshine Act and creation of the Open Payments database, which we describe. Our study methodology is presented in Part II. We report our results in Part III and discuss relevant findings in their broader context in Part IV.
I. Background At the most fundamental level, a conflict of interest arises in those situations where there is “a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest.”15 In the context of physician conflicts of interest, the primary interest would include the best interests of the patient, while secondary interests would include the physician’s personal financial interest, as well as professional recognition, scientific awards, or career advancement.16 Such conflicts of interest are “inevitable and pervasive in our health care system,”17 and, as illustrated by passage of the Sunshine Act, these conflicts are “as much matters of public policy and management as individual choices or social norms.”18 When confronted with the pervasiveness of financial conflicts of interest, most physicians — reflecting the psychological research showing that each of us is prone to have an optimistic, often unconscious and unintentional, bias about ourselves — will deny that they are influenced by financial transactions with industry.19 An overwhelmingly convincing body of research, however, suggests otherwise.20 In fact, 30 years of data demonstrate that, to varying degrees, physicianindustry relationships including the provision of gifts, such as meals or drug samples, do create conflicts of interest that influence physician decision making and inevitably cloud judgment. Payments made to physicians when they speak and write on behalf of a company,21 as well as ownership or investment interests, such as stock, in companies that produce products used, recommended or prescribed by physicians can also compromise a physician’s objectivity.22 By the mid/late-2000s, the persistence of these conflicts of interest, compounded by the mountain of literature demonstrating their influence over the professional judgment of physicians, began to coalesce around calls — from federal regulators,23 influential sectors of the academic medical community,24 and the halls of Congress25 — for detailed disclosure and increased transparency of these physician-industry financial relationships. Two stated goals animated the buying and selling of health care • winter 2014
the calls for reform: (1) distinguish legitimate financial relationships from improper ones and (2) inform patients about these relationships so that, as health care consumers, they might make better-educated decisions about where to seek care and who to trust.26 Relative to the number of studies examining physician behaviors and beliefs regarding the influence of industry, the literature exploring these concerns from the patient perspective is thin.27 As Michael Green and colleagues noted in a study of patients and their views on physician-industry financial relationships published in 2012, “[s]urprisingly, little is known about patients’ attitudes about industry gift-giving to physicians.”28 The centrality and importance of trust in the context of a therapeutic relationship between a patient and a physician, however, has been well documented.29 In a 2011 study published by David Grande and colleagues, researchers demonstrated for the first time that patients’ perceptions of relationships between physicians and the pharmaceutical industry are associated with decreased trust in doctors and the health care system more generally.30 As noted above, the Sunshine Act’s Open Payments program proposes to address these concerns by establishing “a national disclosure program that promotes transparency by publishing the financial relationships between the medical industry and healthcare providers (physicians and hospitals) on a publicly accessible website…organized and designed to increase access to and knowledge about these relationships and to provide information to enable consumers to make informed decisions.”31 Thus, the promise of increased transparency includes an additional potential benefit beyond improved levels of trust between the patient and physician.32 Open Payments aims to improve levels of sophistication and awareness among patients, in an effort to further educate and empower health care consumers consistent with so-called market-driven approaches to health care.33 Our goal in this study was to bolster the empirical literature on how patients perceive the variety of financial dealings that are common between physicians and the life sciences industry. Specifically, in the context of Open Payments, we wanted to know how knowledge of these financial relationships might impact a patient’s level of trust in their physician, as well as a patient’s perception of that physician’s expertise. We wanted to better understand whether patients (in an effort to be better-informed health care consumers), would even consult with the Open Payments database, i.e., would they use this opportunity afforded them by the ACA to better inform themselves about their physician’s potential financial conflicts of interest and then “shop around” accordingly for less-conflicted physicians? 477
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Finally, for those patients who do plan to access and use the information generated by Open Payments, we wondered what, where, and how to best deliver this database content to the end user, i.e., the health care consumer/patient? Our findings in response to these questions are set forth in Part III, and their implications for federal regulators charged with oversight and administration of the Open Payments program are discussed in greater detail in Part IV.
1. A physician received money for consulting with a pharmaceutical company for helping to develop a new drug; 2. A physician owned stock in a pharmaceutical company; 3. A physician received travel, meals, and/or entertainment from a pharmaceutical company; and 4. A physician received free drug samples from a pharmaceutical company.
II. Study Methodology
The first three payment types were selected for inclusion in our study because they each must be reported in a pharmaceutical company’s Open Payments disclosure, and yet they each seem qualitatively different in terms of how patients might understand the dynamics of that financial relationship. The free drug samples scenario was included because it is an exception that is carved out of the Open Payments disclosure mandate, despite the considerable controversy surrounding the acceptance and distribution of free samples by health care providers.34 The second factor we varied was the payment amount, in which the magnitude of a given payment type was either small ($153) or large ($4153).35 The third factor we varied across scenarios was the type of doctor, either a family physician or a specialist. We also created “control” scenarios for both the family physician and the specialist, in which the physician received zero payments of any kind. In all (including the two control scenarios) there were 18 possible financial scenarios, which were randomly assigned to respondents (i.e., each respondent only viewed one of the 18 scenarios). For an illustration of one of the 18 scenarios, see Survey Scenario 1.
Study Overview and Design In the fall of 2013, the authors conducted an online experiment to determine how a national panel of adults ages 30-65 would perceive a variety of financial relationships that occur between physicians and pharmaceutical companies. Each respondent read a scenario about a hypothetical physician and his financial ties to the pharmaceutical industry. The study employed a 4 x 2 x 2 between-subjects experimental design, in which each respondent was randomly assigned to a different scenario version, which varied along three factors: payment type, payment amount, and physician type (each of these factors is described in greater detail below). In addition, some respondents were assigned to a control scenario (in which the physician received no payments) to provide a baseline assessment of consumers’ attitudes toward the physician. The Institutional Review Board at our university approved this study. The first factor we varied across scenarios was payment type, involving four different types of financial ties that occur between physicians and pharmaceutical companies:
Survey Scenario 1 Family physician; Consulting on New Drug Development; $4153 Imagine that you just moved to a new town and are trying to select a family physician to become your regular doctor. One family physician you are considering is Dr. Matt Wilson, whose office is near your home. As part of your search process, you have looked up Dr.Wilson in a new online database that reports on relationships between doctors and pharmaceutical companies. Here is what you found: PAYMENTS RECEIVED FROM DRUG COMPANIES IN 2012
Physician Name Matt Wilson
478
Consulting on new drug development. $4153
Ownership of drug company stock. 0
Travel meals & entertainment. 0
Free drug samples to be given to patients. 0
journal of law, medicine & ethics
Perry, D. Cox, and A. Cox
Procedure and Measures The scenarios and questions were programmed in a web survey software package called Qualtrics. This web survey package is used extensively in academic research and is especially well-suited for conducting experiments, given the randomization capabilities of the software. After the survey had been programmed and thoroughly pretested, the unique URL link to the study was sent to respondents from a national on-line survey panel purchased from a commercial sample vendor, Survey Sampling International (SSI). SSI maintains a national panel of over 6 million potential respondents. For each study, SSI sends email invitations to a random subset of panel members meeting the study’s demographic criteria. SSI places volunteers into a lottery to win a monetary prize, to increase response rates. After initial recruitment by SSI, potential respondents were directed to a web survey, where they were first asked a screening question confirming their age (between 30 and 65). We used a wide age range to allow us to examine whether attitudes toward physician payments varied by age category. Immediately after the respondents viewed the scenario, each subject was also asked an open-ended question about the scenario they had just viewed: “What are your thoughts about Dr. Wilson?” Designed to further aid in the interpretation of the experimental findings, subjects’ verbatim comments were then examined by the investigators’ graduate research assistants and organized according to recurring themes.36 Next, respondents were asked a series of 5-point Likert (agree-disagree) questions concerning their perceptions of Dr. Wilson (e.g., his expertise, trustworthiness, knowledge of the latest treatments, moral character, focus on patients’ interests) and were asked to state the likelihood they would choose Dr. Wilson as their doctor and the likelihood they would take a drug if Dr. Wilson prescribed it. Following this question, all respondents were shown a series of seven different types of financial relationships between physicians and drug companies, and asked to evaluate these on several dimensions. The seven relationship types were: 1. A doctor owns stock in a pharmaceutical company. 2. A doctor helped develop a drug and received royalty payments on the sales of the drug. 3. A doctor received money from speaking fees from a pharmaceutical company. 4. A drug company donated drug samples to a doctor. 5. A pharmaceutical company sales rep provided lunch for a doctor’s office staff. the buying and selling of health care • winter 2014
6. A doctor was paid to help a pharmaceutical company develop a new drug. 7. A pharmaceutical company paid for a doctor’s plane travel and hotel room for a medical conference in a resort. Respondents rated each of the seven financial relationships on: perceived ethicality (on a 5-point scale anchored by “Not at all ethical” to “Very Ethical”); how knowledge of such a relationship would affect their likelihood of choosing a doctor (5-point scale from “Much LESS likely to go to this doctor” to “Much MORE likely to go to this doctor”), and whether and how they thought each type of relationship should be disclosed to patients. The disclosure options (from which respondents could choose more than one) were: 1. There is no need to disclose this information. 2. This information should be placed on the doctor’s website. 3. A sign should be posted in the doctor’s office. 4. The doctor should tell me face-to-face about this relationship. 5. An online database where you can look up this information for any doctor. 6. Other [respondents were allowed to write in other disclosures method] Finally, respondents reported basic demographic and health-behavior information, including their prior use of online ratings of doctors, whether they had a “regular” doctor, frequency of visits to clinic or doctor in last six months, whether they had ever received drug samples, the number of times they had received drug samples in the last six months and the likelihood that they would use an online database that included full disclosure of financial payments to doctors by pharmaceutical companies. We asked respondents to assess the percentage of pharmaceutical companies’ promotional expenditures that are targeted toward physicians vs. consumers, using two sliding scales that ranged from 1 to 100 percent. The total of those two scales was required to add up to 100 percent. Sample An initial sample of 881 adult respondents was recruited from a national on-line survey panel purchased from a commercial sample vendor, Survey Sampling International (SSI). After initial recruitment by SSI, potential respondents were directed to a web survey, where they were first asked a screening question confirming their age (between ages of 30 and 65). Eleven individuals were not in the age range and 479
S Y MPO SIUM
16 elected not to participate at some time during the survey, leaving us with a usable sample of 854. The sample was closely divided among females and males (50.6% vs. 49.1%), about 46 percent of the sample had a high school diploma or less, about 82% had a total household income less than $80,000 and the sample was about 65% Caucasian, 14% African American and 13% Hispanic, which approximates the national ethnic proportions.
Main Effects of Payment Type Respondents’ perceptions of a physician were significantly influenced by the types of payments he had received from pharmaceutical companies. Table 1 shows the significant ANOVAs for the overall effects of payment type on each of the perceptual dimensions, as well as the mean (and standard deviation) of each perceptual dimension within each payment type. Table 2 highlights the significant pairwise differences in respondents’ perceptions of a physician receiving specific types of payments (e.g., consulting vs. travel) as well as the differences in perceptions of a physician receiving no payment vs. one receiving any type of payment (averaged across specific payment types). For each pairwise comparison, Table 2 shows the difference between the two means, the adjusted p value (p values for differences between specific payment types reflect a Bonferroni correction37) and Cohen’s d effect-size statistic.38 Cohen’s d is the difference between two group means divided by their pooled standard deviation. According to Cohen’s approximate guidelines for behavioral-science research, effects with d ≤ .20 are considered “small,” effects with d ≥ .80 are considered “large,” and effect sizes between those two values (i.e., with d
III. Results Effects of Payment-Scenario Elements on Perceptions of Physician First, we analyzed the effects of the three paymentscenario elements (payment type, payment amount and physician type) on respondents’ perceptions of Dr. Wilson. This involved conducting a series of Analyses of Variance (ANOVAs), in which the three scenario elements were entered as independent variables (factors), and the perceptual dimensions (e.g., perceived physician trustworthiness, expertise, etc.) were entered as dependent variables. As summarized below, these analyses revealed a number of significant effects of payment type, payment amount, and doctor type on perceptions of Dr. Wilson.
Table 1 ANOVA Results: Effects of Payment Type on Perception of Doctor Group Means (and Standard Deviations) F(4,~842) Expert Trustworthy
4.77 7.92
a
b
c
d
e
No Payment
Consult.
Stock
Travel
Samples
.001
3.26 (.94)
3.36d
3.15 (.77)
3.04be (.88)
3.30d (.75)
.000
3.57cd
Sig.
(.73)
(1.00)
3.36 (.79)
3.13ae (.89)
3.15ae (.92)
3.49cd (.85)
Informed
5.63
.000
3.21 (1.02)
3.43d (.84)
3.16 (.91)
3.03be (1.00)
3.35d (.86)
Moral character
15.22
.000
3.55cd (.98)
3.28e (.86)
3.02ae (.94)
3.02ae (1.03)
3.58bcd (.87)
Patient Interests
13.04
.000
3.60bcd (1.01)
3.24a (.87)
3.00ae (1.02)
2.99ae (1.06)
3.50cd (.88)
Choose Dr.
13.45
.000
3.48cd (1.08)
3.25cd (.92)
2.89abe (1.07)
2.88abe (1.13)
3.46cd (.99)
Take Rx.
8.56
.000
3.43cd (.98)
3.28d (.88)
2.99ae (.99)
2.98abe (1.05)
3.41cd (.96)
Note: superscripts indicate significant differences between groups; e.g., on the “expert” line, 3.04be indicates that Dr. Wilson’s perceived expertise when receiving payments for travel (mean=3.04) is significantly lower than when receiving either payments for consulting (mean=3.36) or drug samples (mean=3.30)
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journal of law, medicine & ethics
Perry, D. Cox, and A. Cox
≅ .50) are considered “medium-sized.” As can be seen in Table 2, most differences in perceptions between specific payment types fall into this latter, intermediate effect-size range. Tables 1 and 2 reveal several interesting findings. First, they show that payment type had a significant effect on doctor’s perceived expertise (F (4, 842) = 4.77, p=.001). Specifically, those who accepted consulting payments and drug samples were perceived to be significantly higher on expertise than those who accepted
money for travel. However, neither of these was significantly different from the no payment control. Tables 1 and 2 reveal a similar pattern for perceptions of how informed the doctor was (F (4, 842) = 5.63, p Travel
0.32 0.26
.001 .012
.40 .32
Trustworthy
No payment > Stock No payment > Travel Samples > Stock Samples > Travel No payment > ANY payment
0.44 0.42 0.36 0.34 0.27
.001 .002 Travel Samples > Travel
0.40 0.32
Stock No payment > Travel Samples > Consulting Samples > Stock Samples > Travel No payment > ANY payment
0.53 0.53 0.30 0.56 0.56 0.31
Stock Samples > Travel No payment > ANY payment
0.36 0.60 0.61 0.50 0.51 0.40
.43 Stock Samples > Travel No payment > ANY payment
0.59 0.60 0.36 0.37 0.57 0.58 0.35
Stock Samples > Travel No payment > ANY payment
0.44 0.45 0.30 0.42 0.43 0.25
.007 .003 .031
