Bioethical Inquiry DOI 10.1007/s11673-015-9648-2

ORIGINAL RESEARCH

Teaching Conflict: Professionalism and Medical Education K. J. Holloway

Received: 31 July 2014 / Accepted: 31 January 2015 # Journal of Bioethical Inquiry Pty Ltd. 2015

Abstract Resistance by physicians, medical researchers, medical educators, and medical students to pharmaceutical industry influence in medicine is often based on the notion that physicians (guided by the ethics of their profession) and the industry (guided by profit) are in conflict. This criticism has taken the form of a professional movement opposing conflict of interest (COI) in medicine and medical education and has resulted in policies and guidelines that frame COI as the problem and outline measures to address this problem. In this paper, I offer a critique of this focus on COI that is grounded in a broader critique of neoliberalism, arguing it individualizes the relationship between physicians and industry, too neatly delineates between the two entities, and reduces the network of social, economic, and political relations to this one dilemma. Keywords Conflict of interest . Pharmaceutical industry . Medical education . Professionalism . Neo-liberalism

Resistance by physicians, medical researchers, medical educators, and medical students to pharmaceutical industry influence in medicine is often based on the notion that physicians (guided by the ethics of their profession) and the industry (guided by profit) are in conflict. This criticism has taken the form of a professional movement opposing conflict of interest (COI) in medicine and K. J. Holloway (*) Dalhousie University, Halifax, Nova Scotia, Canada e-mail: [email protected]

medical education and has resulted in policies and guidelines that frame COI as the problem and that outline measures to address this problem. I offer a critique of this focus on COI that is grounded in a broader critique of neo-liberalism, arguing that COI individualizes the relationship between physicians and industry, too neatly delineates between the two entities, and reduces the network of social, economic, and political relations to this one dilemma. I will first discuss the relevance of neo-liberalism for an analysis of the organization of medicine, then explain how physicians have objected to the pharmaceutical industry by appealing to medical professionalism and focusing on COI. I will then look at two influential guidelines that specifically address COI in medical education. Finally, I explore COI guidelines and data from both Canada and the United States, demonstrating that despite important differences in the organization of healthcare in each country, they can be subjected to similar critique. Ultimately, I argue that acceptance of industry influence is written into the very policies meant to address COI and that those policies actually help to facilitate industry influence. Furthermore, the movement for professionalism in medicine does little to disrupt important structural issues and thus has not addressed the source of the conflict. While COI is in many ways a valuable way to begin the discussion about pharmaceutical industry influence (herein referred to as Bindustry influence^) in medicine, it does not address the wider social and political contexts that contribute to industry’s presence in medical education. This context is in part characterized by a neoliberal framework, which emphasizes state-supported

Bioethical Inquiry

markets as the best and most efficient allocators of resources, promotes the notion that societies are composed of producers and consumers motivated by material or economic considerations (Coburn 2000, 138), and helps to facilitate close relationships between medical research and industry interests (Slaughter and Rhoades 2009). While COI in medicine is not directly a product of neo-liberalism, that political framework creates conditions ripe for conflict; the partnership between medical schools and the pharmaceutical industry is a case in point.

Conflict of Interest in a Neo-Liberal Context Contemporary forms of commercialized medicine have been facilitated by neo-liberal policies and ideologies. A key feature of this commercialization is the growth of the pharmaceutical industry, which since the 1980s has developed into a healthcare marketplace. Neo-liberalism arose out of The Mont Pelerin Society with the purpose of shifting government focus Bfrom public welfare to market creation and protection^ (Lave, Mirowski, and Randalls 2010, 660). It is a set of political ideas and practices that gained prominence as a dominant political ideology in the 1980s; it holds individual liberty and freedom as paramount values to be protected and achieved through institutional structures like free markets and free trade. Neo-liberalism is not Blaissez-faire^; the state should participate in transforming all publicly funded services to generate private capital accumulation. In this context, discussions about health care are motivated by efforts to promote Bproductivity,^ Befficiency,^ and Bchoice^—healthcare is increasingly represented as a commodity (Leys 2010, 15). In short, neoliberalism is a form of capitalism, promoting individual competition in the market and advocating privatization and corporatization of everything. The term medical neo-liberalism has been used to refer specifically to policies that define health individually Baccording to who is willing to pay and for what kind of care,^ the commodification of health that transforms individuals from patients to customers, and—at a cultural level—through the commodification of the body itself through fragmentation of the body into parts to be fixed (Fisher 2007, 4). Fisher refers specifically to managed care and direct-to-consumer advertising as neo-liberal developments in the United States and to the clinical research trial, which is increasingly framed in neo-liberal terms as Bresponsible choice^ for

individuals who require medical intervention (2007, 6). While the healthcare system is organized differently in Canada, it has been subject to similar neo-liberal transformations. Canada’s public healthcare system has been undermined through federal and provincial funding cuts and privatization, shifting healthcare costs to individuals and healthcare delivery to the for-profit sector, shifting managerial practices to for-profit approaches, and shifting care responsibility to households and unpaid caregivers (Armstrong and Armstrong 2003). Higher education has also undergone a transformation in neo-liberal terms, increasingly prioritizing the promotion and protection of intellectual property in hopes of gaining commercial value from knowledge (Lave, Mirowski, and Randalls 2010). The privatization and commercialization of federally funded research has moved forward under the auspices of the Bknowledge economy,^ in which market relations are expanded into traditionally public arenas like universities, and national science policies are created to encourage private investment in science and university–industry partnerships by strengthening intellectual property rights and decreasing public funding (Lave, Mirowski, and Randalls 2010). In this neo-liberal framework, regulations become an impediment to the individual or individual company’s ability to operate freely in the market. To the extent that actors who represent the state create and facilitate policies and guidelines meant to regulate the pharmaceutical industry’s influence in medicine, they emphasize self-regulation. In the context of medicine, COI becomes a professional matter. Abraham and Ballinger argue that neoliberalism has Bredefined the regulatory state to have much greater convergence of interest and goals with the drug industry than previously, particularly regarding acceleration and cost reduction of drug development and regulatory review^ (Abraham and Ballinger 2012, 445). Before neo-liberalism, they add, governments still worked with industry in a capitalist system, but there was an expectation that the basic goal of pharmaceutical regulation was to protect public health over and above the commercial interests of firms (Abraham and Ballinger 2012). The Bneoliberal shift^ they describe involves Bchanging that expectation into enrolment of the state in the service of industry’s ever-expanding appetite for increased market access and profits^ (Abraham and Ballinger 2012, 447, referencing Lave, Mirowski, and Randalls 2010). This analysis is important in the examination of policies and guidelines addressing COI in medical education, which seem to facilitate industry’s role in medicine.

Bioethical Inquiry

The conflict that physicians face between professional obligation and personal gain takes specific forms as the pharmaceutical industry becomes more present in medicine. Personal gains take the form of gifts, meals, vendor access, samples, positions on pharmacy and therapeutic committees, funding for continuing medical education, consulting positions, honoraria, scholarships, fellowships, travel reimbursement, ghostwriting, and speakers bureaux (Chimonas et al. 2011). Many of those who point to the problems with the pharmaceutical industry’s influence in medicine limit their analysis to these sites of conflict, reducing the complex interrelationships between medicine and business to an interpersonal relationship between a physician and various forces seeking to profit from medicine. This characterization of the conflict suggests that there are simply two competing interests. It negates the power relations between physicians (not to mention patients and the general public) and the representatives of industry, sometimes in collusion with the state, who support and promote the increasingly profit-oriented character of the contemporary health industry. It also suggests that the problem can be easily parsed out and solved with policy—that it is not a feature of a consistent and quite pervasive drive for profit within medicine. Framing the issue of industry influence only, or even primarily, as COI runs the risk of reproducing physician–industry relations as merely a professional matter. In fact, the influence of industry exists beyond the direct interaction between physicians and representatives of industry. In both the United States and Canada, industry gives money to research institutions, universities, professional associations, regulatory agencies, and patient organizations. It hires lobbyists to influence government decision-making. More than this, the relationship that industry has to medicine has been intensified by neoliberal reforms to universities where medical students are trained (Slaughter and Rhoades 2009; Newson and Polster 2010). Social scientists have only recently started developing an understanding of the pharmaceutical industry in relation to global political, economic, and medical processes (Bell and Figert 2012). The fact that those within medicine who object to pharmaceutical industry influence focus so intently on COI is an important point of departure for a sociological critique that seeks to uncover the various facets of pharmaceutical industry influence. The limited focus on COI ignores the structural issues that help to perpetuate the conflict and ultimately

runs the risk of entrenching those structures by making them more palatable, rather than challenging them. The shifts in medicine associated with neo-liberalism described above have made profit an integral component of the way that medicine is organized. This shift is not always readily accepted by physicians, but it could be argued that neo-liberalism has contributed to the way that the response has been conceived of as an individual physician’s professional responsibility, rather than a societal or structural problem.

The Professionalism Project Physicians have wrestled with COI as a classic tension of their profession since the turn of the century, a tension between a commitment to healing others and their own economic self-interest (Rodwin 1995). Fee-for-service payment is the most obvious representation of that conflict, wherein a physician has a financial incentive for dispensing medical services whether or not those services are needed (Rodwin 1995). COI is a particularly salient concept in the current era of commercialized medicine. Various exposés about the U.S. Food and Drug Administration (FDA), physician ties to industry, and journal editors with financial stakes in industry have led to a growing public awareness about the issue of COI (Rodwin 2011). Commentary expressing concern over the pharmaceutical industry’s presence in medicine has proliferated in editorials and letters in medical journals since the mid-1980s and more fully in the 1990s, when a substantial body of research demonstrated the effects of industry gifts on physician behaviours. This torrent of articles denounced the arrival of Bcorporate medicine^ and identified commercialism as the enemy—the antithesis to professionalism (Hafferty and Castellani 2011). Concerns about corporate medicine are substantiated by high-profile books that criticize the industry’s objectives and practices (Abramson 2004; Avorn 2008; Angell 2004; Kassirer 2005; Goozner 2004). A few scholars have attempted to understand the conflict in more complex terms—not as simply the individual physician’s moral conflict between competing ideas but as a broader structural issue. For instance, Angell (2008) has acknowledged the extent to which industry funding has pervaded all aspects of medicine, affecting not only research but also professional, governmental, and regulatory bodies. Others have pointed

Bioethical Inquiry

to the limitations of COI and COI-disclosure policies (Elliott 2008; de Melo-Martín and Intemann 2009) and offer alternative strategies such as encouraging more independently funded research (Elliott 2008). However, the dominant discourse within the medical profession seems to be to appeal to medical professionalism. Physician and former editor in chief of The New England Journal of Medicine, Jerome Kassirer, has been an outspoken critic of so-called commercialized medicine, arguing professionalism has been eroded by financial ties between physicians and the pharmaceutical, medical device, and biotechnology industries. According to Kassirer, there is a new era of awareness about COI, particularly brought on by pharmaceutical industry influence in medicine. His solution lies in an appeal to professionalism, which he recognizes has been woefully compromised given that Bthe onslaught of industry money has deflected many physicians’ internal moral compasses^ (Kassirer 2005, 192). Kassirer says that physicians should aspire to eliminate financial Bentanglements,^ but if they cannot (he doesn’t think divestment is realistic), they must have methods to protect patients and engage in complete disclosure about conflicts. This approach—an appeal to the profession to retrieve moral ground and self-regulate—is the essence of the professionalism movement. Kassirer acknowledges that if the profession cannot be more accountable, government must intervene, but he hopes this can be avoided because regulations can Black the nuance to preserve the benefits of physician–industry collaboration^ (Kassirer 2005, 202). Influential critics like Kassirer have inspired students of medicine who are concerned about industry; for example, the American Medical Student Association (AMSA) has established a Medical Professionalism Action Committee in which they advocate for professionalism over commercialism. The appeal to professionalism is a noteworthy turn given sociology’s preoccupation with this subject in the 1970s. The insights generated by that substantial and sometimes heated theoretical debate have been cu riously a bsent in the new moveme nt for professionalism in medicine. Medical sociologists Hafferty and Castellani (2011) refer to Robert Straus’s 1950s distinction between sociology of and sociology in medicine, where sociologists of medicine study medicine as anthropologically strange, and sociologists in medicine (who often would not identify primarily as sociologists) work in the service of medicine. They argue that both worlds have evolved but have done so

as separate domains, Btwo ships passing in the night^ (Hafferty and Castellani 2011, 202). The literature on professionalism within medical sociology dates back to Talcott Parsons, crystallizing with Eliot Freidson’s Professional Dominance (1970) and Profession of Medicine (1970) and unfolding as a body of theory in sociology with authors like Marie Haug, Donald Light, and John McKinlay. This literature attempts to understand medicine as a profession, wrestling with concepts such as commercialism, professional dominance, de-professionalization, proletarianization, corporatization, and countervailing powers. When sociological interests in professionalism started to dwindle in the 1990s, organized medicine’s concerted campaign for professionalism was in full swing, with accompanying movements for evidence-based medicine and patient safety (Hafferty and Castellani 2011). The professionalism project from within medicine has argued that commercialism is antithetical to professionalism, and thus there is a need to Brediscover^ and Brecommit^ to an ethic of professionalism (Hafferty and Castellani 2011). Courses on professionalism were deployed at medical schools across the United States by the mid-1990s, stressing the motives and behaviours of individual practitioners and students (Hafferty and Castellani 2011). While this movement for professionalism is conceived in opposition to Bcommercialism,^ there is little discussion of the processes that have contributed to that seemingly encroaching commercial ethos. It is not tied into a broader capitalist framework, and the changes that have come with neo-liberalism are not particularly well understood. This is part of what makes professionalism a viable solution; it is simply a different framework by which to approach medicine—one that is not commercial. The material transformations that continue to give the Bcomm ercial^ approach permanence are underexplored. I argue that this focus on the professional conduct of individuals ignores the industry’s embeddedness in medicine and inappropriately places the responsibility for ethical oversight with the very people who have accepted industry influence.

Regulating the Conflict Key regulatory documents meant to outline professional conduct in the face of COI frame the collaboration between industry and medicine as positive and thus help to perpetuate that relationship as a normal part of

Bioethical Inquiry

medicine. Furthermore, these regulations are not particularly effective in mitigating or addressing COI. Concerns about COI resulting from closer ties between universities and industry have been recognized and addressed in public statements by professional associations since the 1960s (Institute of Medicine [IOM] 2009). Despite concerns, the Association of American Universities declined to propose COI policies for its members in 1984, instead undertaking a survey. This was possibly spurred by U.S. congressional hearings in the 1980s posing questions about whether conflicts of interest were reducing openness in universities and biasing the advice given to policy-makers (IOM 2009). In 1985, The New England Journal of Medicine published the first policy on COI in an editorial (Relman 1985). It asked authors to disclose their relationships with companies that could affect their published findings. Since that time, a growing body of literature about industry influence on physician prescribing, media exposés of physician–industry ties and undue influence on patient care, and high-profile legal cases about drug companies’ illegal marketing of drugs to physicians led several prominent organizations to devise and evaluate guidelines for managing clinical conflicts of interest (Chimonas et al. 2011). In 1990, the Association of American Medical Colleges (AAMC) published Guidelines for Dealing With Faculty Conflicts of Commitment and Conflicts of Interest in Research and the American Medical Association (AMA) adopted a statement on inappropriate gifts to physicians from industry. In this same year, the American College of Physicians issued a position paper on physicians and the pharmaceutical industry. In the following 20 years, particularly after 2000, countless other organizations followed suit, issuing reports on COI in aspects of medical research education or practice. The International Committee of Medical Journal Editors, the National Science Foundation, the FDA, the Pharmaceutical Research and Manufacturers of America, and The Advanced Medical Technology Association each called for more accountability, openness, and more effective implementation (IOM 2009). It was not until 2006 that the AAMC charged a special Task Force on Industry Funding of Medical Education to develop policy to manage industry gifting practices and financial support of their programs of medical education for students, trainees, faculty, and community physicians. The report of this task force, Industry Funding of Medical Education, was published

in 2008, outlining a number of recommendations to academic medical centres regarding gifts, pharmaceutical samples, site access by pharmaceutical representatives, and so on. This influential document has been taken up at institutions across the United States. Canadian professional organizations and governmental representatives have not addressed COI with the vigour of their U.S. counterparts. The Canadian Medical Association published its Guidelines for Physicians in Interaction With Industry in 2007 but decided that they could not adopt a formal set of specific regulations for physicians. The association’s journal published an editorial in 2010 lamenting Canada’s lack of regulations on this topic (Hébert et al. 2010) and acknowledging that in medical schools across North America students are taught by faculty who receive funds from the pharmaceutical industry—while claiming that the situation is, to a degree, unavoidable. Hébert and colleagues do not blame the industry; rather B[t]he fault lies with medical schools that encourage and depend on physicians to teach their curriculum but neglect to protect the quality of undergraduate medical education by mandating disclosure of competing interests^ (Hébert et al. 2010, 1279). They call on faculties of medicine and the Association of Faculties of Medicine of Canada to immediately adopt AAMC guidelines and recommend that medical school curricula incorporate formal teaching on the effects of competing interests on evaluation of medical information (Hébert et al. 2010). In response, Nick Busing, then-president and CEO of the Association of Faculties of Medicine of Canada (AFMC), argued that the AFMC (consisting of seventeen deans of medicine and four public members) had already voted to endorse the principles contained in the AAMC report on industry funding of medical education, noting B[a]ll of our faculties have reviewed their codes and guidelines relating to COI and many have made, or are making, substantial advances^ (Busing 2011, 463). The AFMC’s November 2010 newsletter is devoted to COI. In it, Busing says that COI is important now, in part because of developments in the United States where lawmakers have taken members of the medical establishment to task for issues like nondisclosure and COI. In both the United States and Canada, the 2008 AAMC task force document Industry Funding of Medical Education and the IOM’s 2009 Conflict of Interest in Medical Research, Education and Practice are heralded as key position papers addressing industry influence in medical education. Several critics of

Bioethical Inquiry

industry influence describe the significance of these documents in the same way. Kassirer says these two documents set new standards for academic institutions and physicians and that Bone by one, universities and medical schools developed or revised their conflict of interest policies^ (Kassirer’s introduction in Rodwin 2011, x).1 The introduction to the American Medical Student Association’s (AMSA) 2014 PharmFree Scorecard notes: Medical schools and academic medical centers have played a powerful leadership role in setting new standards for the profession, supported by strong guidelines set by the Association of American Medical Colleges (AAMC) in the summer of 2008 and the Institute of Medicine in spring 2009 (AMSA 2014, ¶1 under BBackground^). These documents are used as models to shape the objectives of an organized challenge to industry influence in medical education and thus deserve close attention. Both documents advocate a close relationship between medicine and industry and suggest that this partnership is essential for scientific progress. The AAMC’s document urges all academic medical centres to accelerate their adoption of policies that better manage, and when necessary prohibit, academic–industry interactions that can inherently create conflicts of interest and undermine standards of professionalism. It begins with this statement: An effective and principled partnership between academic medical centers and various health industries is critical in order to realize fully the benefits of biomedical research and ensure continued advances in the prevention, diagnosis, and treatment of disease. Appropriate management of this partnership by both academic medical centers and industry is crucial to ensure that it remains principled, thereby sustaining public trust in the proposition that both partners are fundamentally dedicated to the welfare of patients and the improvement of public health (AAMC 2008, iii). The above passage contains important value-laden assumptions about medicine and health industries and their relationship to one another. First, it supports the 1

Kassierer acknowledges that a lot of those policies were not particularly restrictive and failed to eliminate the most egregious practices like paid participation in speakers bureaux.

Bpartnership^ between medical centres and health industries. BPartnership^ is a neo-liberal watchword, suggesting that the relationship between the public and the private sector is equal and mutually beneficial. Second, it suggests that this partnership is necessary for modern medicine to achieve its goals of prevention, diagnosis, and treatment of disease—that the private sector is essential for scientific progress. Third, it argues that any problems resulting from that partnership, which the document frames as COI, can be managed, so that the partnership Bremains principled.^ This management is directly related to manufacturing consent for the public—to ensuring Bpublic trust.^ Suggesting that the objectives of medicine and the objectives of industry are both Binterests^ depoliticizes the two entities and mitigates the power relationships endemic to the complex dynamic of the Bpartnership.^ The very word Bpartner^ suggests a complicity that neutralizes the conflict. Thus, this document does not just accept the context of commercialized medicine under neo-liberalism; it operates to shape that context and legitimate it. The report came out of a task force involving thirty-one stakeholders, including two representatives from the pharmaceutical industry—Jeff Kindler, CEO of Pfizer Incorporated, and Sidney Taurel, chairman and CEO of Eli Lilly and Company. It was chaired by the former chairman and CEO of Merck, Roy Vagelos. The IOM’s document also celebrates the partnership between industry and medicine. The opening sentences of Conflict of Interest in Medical Research, Education and Practice are: Patients and the public benefit from constructive collaboration between academic medicine and pharmaceutical, medical device, and biotechnology companies. At the same time, medical leaders, public officials, public interest groups, and others have raised concerns about the risks associated with the extensive financial ties that link industry with the individuals and institutions that carry out medical research, medical education, patient care, and practice guideline development (IOM 2009, 23). According to this document, the primary problem with the relationship is that conflicts of interest can threaten the integrity of scientific investigations, the objectivity of medical education, the quality of patient care, and the public’s trust in medicine (IOM 2009). The themes of the report essentially suggest that COI

Bioethical Inquiry

policies can solve these problems by protecting the integrity of professional judgement and preserving public trust. While the IOM uses the word Bcollaboration^ instead of Bpartnership,^ both words imply that the working relationship between academic medicine and industry is positive. This collaboration or partnership between the public and private sectors is a central feature of neo-liberal reforms that roll back government funding for public services and institute matched funding schemes with the private sector. Both documents promote professionalism as a correction to COI in medical education. The AAMC’s chapter on professionalism notes: BProfessionalism lies at the heart of medicine, and inculcating the values associated with it in future generations of physicians is a primary responsibility of academic medicine^ (AAMC 2008,13). The IOM document’s introduction says: In medical education, it is particularly troublesome when a faculty member is a promotional speaker for a pharmaceutical, medical device, or biotechnology company or agrees to be listed as an author for a ghostwritten publication. This is because faculty members are expected to present unbiased information and objective assessments of the scientific literature and to help medical students, residents, and fellows develop life-long habits of exercising independent judgment and critically evaluating scientific evidence. They are also expected to serve as role models of professionalism (IOM 2009, 24). The report encourages policies that address interactions between medical personnel and industry. According to the AAMC’s document, policies such as prohibiting gifts to individuals, centrally managing samples, restricting site access by pharmaceutical representatives, and auditing continuing medical education (CME) courses will Boptimize the benefits inherent in the relationship between academic medicine and industry and minimize the risks^ (AAMC 2008, vii). BEducation for professionalism^ means raising awareness among students, trainees, and faculties of challenges to professionalism presented by interactions with industry and providing opportunities to build critical evaluation skills that Breinforce high individual standards, norms, and behaviors^ (AAMC 2008, 11). This approach emphasizes managing the one-on-one

interaction amongst physicians and industry and endorses the structures that facilitate the broader conflict. The AAMC’s document attempts to use the notion of the Bhidden curriculum^ to suggest that educational interventions must not only address the explicit curriculum but also the learning environment, suggesting academic medicine could more effectively Bteach students and trainees how to think about receiving things of value from industry^ (AAMC 2008, 11). But this very sentence assumes that Breceiving things of value from industry^ is an appropriate and inevitable practice in medicine. They pose a set of restrictions that are supposed to manage industry–physician and industry–student interactions but do not address the fact that the purpose of the industry’s presence in medical education is to influence future physicians in a way that allows the industry to profit from drugs.

Failing to Regulate the Conflict In addition to being rooted in a problematic framework, the guidelines addressing COI mentioned above are not taken up very consistently at a local level, in medical schools and in research centres. Medical schools in the United States and Canada are currently subjected to COI standards that are linked to accreditation. The Liaison Committee for Medical Education (LCME) in the United States has standards for medical schools and COI and accredits complete and independent medical education programs in the United States and Canada. Initially, medical schools are asked to undertake an evaluation of their own institution following the LCME guidelines. The components that address COI are in the LCME guidelines under BInstitutional Setting,^ number 5: The governing board responsible for oversight of an institution that offers a medical education program must have and follow formal policies and procedures to avoid the impact of conflicts of interest of members in the operation of the institution and its associated clinical facilities and any related enterprises^ (LCME 2015, see 2014–2015 DCI documents, IS5). And under BFaculty,^ number 8: A medical education program should have policies in place that deal with circumstances in which

Bioethical Inquiry

the private interests of a faculty or staff member may be in conflict with his or her official institutional or programmatic responsibilities (LCME 2015, see 2014–2015 DCI documents, FA8). Following the self-evaluation, a survey team evaluates the school and makes recommendations in a report, which is one of the documents available to the nineteenmember LCME committee. The committee issues an accreditation decision. Accreditation of Canadian medical education programs is undertaken in cooperation with the Committee on the Accreditation of Canadian Medical Schools (CACMS). Both CACMS and LCME make independent decisions about Canadian schools, and then the two decisions are compared—the more severe action is used. If a school does not meet accreditation guidelines, it can be put on warning or probation. It is possible for a school to have its accreditation withdrawn, but this is rare. The ruling that is published is an overall ruling—scores for specific categories are not publicly available—so if a school doesn’t meet standards for a particular category, for instance COI, this information would not be publicly available. Questions IS5 and FA8 of the LCME evaluation guidelines are vague. They require institutions to have and follow policies on COI but do not specify what these policies should contain. Furthermore, the LCME does not report publicly on whether the institutions meet these requirements. Part of AMSA’s PharmFree campaign was the PharmFree Scorecard, created in 2007 not only to assess COI policies of academic medical centres and medical schools in regard to the interaction between students or faculty and the pharmaceutical industry but also to make the policies publicly available so that the students, faculty, and public could hold that school to a particular standard. In the document’s fifth iteration in 2012, it evaluated the conflict-of-interest policies at 152 allopathic and osteopathic medical colleges in the United States and Puerto Rico. As of March 7, 2012, 149 of 152 medical institutions considered eligible for grading have participated in the Scorecard, a 98 per cent participation rate, improved from 92 per cent in 2009. Of these 152 U.S. medical schools, twenty-eight received As (18 per cent), seventy-four Bs (49 per cent), fifteen Cs (10 per cent), and thirteen Ds (9 per cent). Nine schools (6 per cent) received a grade of F. The 2013–2014 Scorecard has been put together in collaboration with the Pew Prescription Project, aiming for a more rigorous and transparent methodology.

Academic investigations of COI policies in medical schools have demonstrated that policies are sparse and inconsistent. A 2005 survey of 126 deans of student affairs at medical schools (with a response rate of 87.3 per cent) examined the prevalence of school-wide policies on interactions between drug companies and medical students. It revealed that 99 per cent knew their policy status but only 10.1 per cent actually had a school-wide policy about these interactions (Sierles et al. 2005). Chimonas et al. (2011) asked deans and compliance officers at all 125 MD-granting U.S. medical schools to participate in a study of COI policies at U.S. medical schools, receiving responses from seventy-seven schools (62 per cent) and finding that adoption of COI policies was incomplete. The authors of the study write: BThe absence of policy was the most prevalent finding in 7 of 11 COI areas. Even the most frequently regulated areas— gifts and consulting—had ‘no policy’ rates of 25 and 23 %, respectively^ (Chimonas et al. 2011, 297). A recent study of COI policies at medical schools in Canada found that most medical faculties (70 per cent) have permissive policies or no policy concerning faculty involvement in company speakers bureaux, 70 per cent of medical faculties had permissive policies or no policies concerning interactions with sales representatives, and most universities (70 per cent) also failed to cover conflicts of interest or drug promotion in the curriculum (Shnier et al. 2013). The authors also note that COI policies were most stringent in the area of disclosure, ghostwriting, gifts (considered to be the easiest to prohibit), and scholarships, corroborating AMSA’s findings in its annual reviews of policies in U.S. medical schools and osteopathic schools. Medical professionals and students have focused on COI as a way to address the problems with pharmaceutical industry influence in medical education. This is a useful step but also one riddled with problems. First, the guidelines that are meant to address the problems with industry influence actually endorse a close partnership between industry and medicine—which is perhaps the source of the conflict. Second, medical schools in the United States and Canada do not tend to follow those guidelines, thus they are not particularly effective without adequate oversight or follow-up. Third, physicians see it as their responsibility to address COI as professionals, while at the same time their profession has been quite effectively courted by the pharmaceutical industry. A 2007 survey of 459 department chairs in 125 accredited U.S. allopathic medical schools and the fifteen largest independent teaching hospitals found that

Bioethical Inquiry

60 per cent of department chairs had some sort of personal relationship with industry, including serving as a consultant (27 per cent), a member of a scientific advisory board (27 per cent), a paid speaker (14 per cent), an officer (7 per cent), a founder (9 per cent), or a member of the board of directors (11 per cent) (Campbell et al. 2007). Sixty-seven per cent of departments as administrative units had a relationship with industry (Campbell et al. 2007). Seventy-two per cent of chairs perceived that having a relationship with industry had no effect on their professional activities (Campbell et al. 2007). A 2010 study of internal medicine program directors received 236 responses and revealed that most did not find pharmaceutical support desirable but that more than half received industry support (Loertscher et al. 2010). These profitable relationships are an indication of why few institutions have COI policies, why professional associations wish to manage COI on their own, why those professional organizations create guidelines that help to facilitate a close relationship between industry and medicine, and why those guidelines do not always stick. However, the tension inherent in the above finding, where institutional actors do not endorse private funding but accept it nevertheless, speaks to more fundamental problems tied to the way in which research funding now operates. As public funding declines under neo-liberalism, private funding becomes a necessity. The conflicts that can arise from this relationship cannot entirely be mitigated or erased with COI policies. This paper emerges from a broader investigation of pharmaceutical industry influence in medical education in the United States and Canada, in which I interviewed students from both countries who were critical of industry influence in medical education about their responses to this phenomenon (Holloway 2014). These students had taken up the call for attention to COI in their efforts to resist industry influence. This critique of the reliance on professionalism and COI can offer insight to students and trainees who are uncomfortable with the influence of the pharmaceutical industry and want to shape a future for medicine that does not accommodate to industry’s needs.

Conclusion Acceptance of industry influence is written into the very policies meant to address COI. It appears that the policies actually help to facilitate industry influence in their intent

and, ironically, in their ineffectiveness in addressing COI. Industry and medicine are integrally connected in the United States and Canada: in the privatization of various aspects of healthcare delivery, in the considerable industry support for medical research, and in the close association between pharmaceutical Bdetailers^ and physicians. Those who advocate for COI policies might argue that this is exactly their point, that their project is to erect firewalls between medicine and industry. Ultimately, while those firewalls may serve to call attention to COI and in some cases serve to mitigate its negative effects, they are quite porous. Contemporary medical practice and education are constituted and shaped by neo-liberal ideas of the market, which promote individual competition and advocate privatization and corporatization. The movement for professionalism does little to disrupt that important structural dynamic located in the shifting norms of medical practice and training. Several campaigns are challenging industry influence in medicine. PharmedOut is a project of the Georgetown University Medical Center that educates healthcare professionals about pharmaceutical marketing practices (PharmedOut 2006–2011). No Free Lunch in the United States encourages healthcare providers to practise medicine on the basis of scientific evidence rather than on pharmaceutical promotion (No Free Lunch n.d.). AMSA’s Just Medicine (formerly PharmFree) advocates medicine based on evidence, Bnot marketing, personal gain, or any interest other than that of the patient^ (AMSA 2015, ¶2). In Canada, the Therapeutics Initiative provides evidencebased information on prescription drug therapy to physicians and pharmacists and promotes independent assessments of evidence on drug therapy to balance drug industry-supported sources (Therapeutics Initiative 1994– 2010). While some of these organizations, such as AMSA, have reproduced the professionalism argument, they are also critical of the extent of industry’s involvement in medicine and aware of the limitations of COI policies. Finding a solution to the pervasiveness of industry influence in medicine is complex, as it entails the daily management of conflicts of interest that have become commonplace in medicine but also the broader structural features of the commodification and privatization of both medicine and education. Elliott (2008) outlines the complicated question of how to conceive of an alternative to COI, given its limitations, offering solutions such as requiring independent studies by researchers without significant financial ties to interested parties and, related, encouraging universities to prevent or prohibit COIs more

Bioethical Inquiry

extensively. Given the neo-liberal context described above, where partnership with industry is now a fundamental organizing feature of research funding models, this is a significant shift from the current norm but perhaps a necessary one. As Elliott notes, Bthe approach of divestiture or recusal is likely to be quite unpopular with universities, because they are engaged in so many efforts to foster relationships with private industry^ (Elliott 2008, 25). Indeed, this is the point of my effort to draw on neoliberalism as a framework, because the processes outlined above as Bmedical neo-liberalism^ have promoted university reliance on private-sector funding for research, thus institutionalizing COI. It appears the only way to be free of COI is to sever the tie with industry. When it comes to research, scholars such as Schafer (2004) and Doucet and Sismondo (2008) have advocated the Bsequestration^ of drug research and the pharmaceutical industry. As Doucet and Sismondo argue with respect to medical research, B[n]othing short of a radical re-imagining of the relationship between research and industry can succeed in eliminating the distortions of the pharmaceutical industry on the scientific literature^ (2008, 629). To fully address COI, the sequestration proposal would have to extend beyond research to medical training and practice and can only move from a theory on the sidelines to a viable solution when the notion that industry is medicine’s Bpartner^ is called into question and health professionals begin to radically reimagine solutions to the conflict.

Conflict of Interest The author declares no potential conflict of interest with respect to the research, authorship, and/or publication of this article.

Funding The author discloses receipt of the following financial support for the research of this article: 2010 Ontario Graduate Scholarship: $15,000 2009 Ontario Graduate Scholarship: $15,000

References Abraham, J., and R. Ballinger. 2012. The neoliberal regulatory state, industry interests, and the ideological penetration of scientific knowledge: Deconstructing the redefinition of carcinogens in pharmaceuticals. Science, Technology & Human Values 37(5): 443–477. doi:10.1177/0162243911424914. Abramson, J. 2004. Overdosed America: The broken promise of American medicine. New York: HarperCollins.

American Medical Student Association (AMSA). 2014. AMSA Scorecard 2014: About the AMSA Scorecard. http://www. amsascorecard.org/about. Accessed June 15, 2015. American Medical Student Association (AMSA). 2015. Just medicine campaign. http://www.amsa.org/AMSA/Homepage/ TakeAction/JustMedicine.aspx. Accessed December 15, 2014. Angell, M. 2004. The truth about the drug companies: How they deceive us and what to do about it. New York: Random House. Angell, M. 2008. Industry-sponsored clinical research: A broken system. The Journal of the American Medical Association 300(9): 1069–1071. doi:10.1001/jama.300.9.1069. Armstrong, P., and H. Armstrong. 2003. Wasting away: The undermining of Canadian health care. Don Mills: Oxford University Press. Association of American Medical Colleges (AAMC). 2008. Industry funding of medical education: Report of an AAMC task force. Washington: Association of American Medical Colleges. Avorn, J. 2008. Powerful medicines: The benefits, risks, and costs of prescription drugs. New York: Random House. Bell, S.E., and A.E. Figert. 2012. Medicalization and pharmaceuticalization at the intersections: Looking backward, sideways and forward. Social Science and Medicine 75(5): 775–783. doi:10.1016/j.socscimed.2012.04.002. Busing, N. 2011. Canadian faculties of medicine not in denial. Canadian Medical Association Journal 183(4): 463. Campbell, E.G., J.S. Weissman, S. Ehringhaus, et al. 2007. Institutional academic industry relationships. The Journal of the American Medical Association 298(15): 1779–1786. Chimonas, S., L. Patterson, V.H. Raveis, and D.J. Rothman. 2011. Managing conflicts of interest in clinical care: A national survey of policies at U.S. medical schools. Academic Medicine 86(3): 293–299. doi:10.1097/ACM. 0b013e3182087156. Coburn, D. 2000. Income inequality, social cohesion and the health status of populations: The role of neo-liberalism. Social Science and Medicine 51(1): 135–146. doi:10.1016/ S0277-9536(99)00445-1. de Melo-Martín, I., and K. Intemann. 2009. How do disclosure policies fail? Let us count the ways. The Federation of American Societies for Experimental Biology (FASEB) Journal 23(6): 1638–1642. doi:10.1096/fj.08-125963. Doucet, M., and S. Sismondo. 2008. Evaluating solutions to sponsorship bias. Journal of Medical Ethics 34(8): 627–630. Elliott, K.C. 2008. Scientific judgment and the limits of conflictof-interest policies. Accountability in Research 15(1): 1–29. doi:10.1080/08989620701783725. Fisher, J.A. 2007. Coming soon to a physician near you: Medical neoliberalism and pharmaceutical clinical trials. Harvard Health Policy Review 8(1): 61–70. Freidson, E. 1970a. Professional dominance: The social structure of medical care. New Brunswick: Transaction Publishers. Freidson, E. 1970b. Profession of medicine: A study of the sociology of applied knowledge. Chicago and London: The University of Chicago Press. Goozner, M. 2004. The $800 million pill: The truth behind the cost of new drugs. Berkeley: University of California Press. Hafferty, F.W., and B. Castellani. 2011. Two cultures: Two ships: The rise of a professionalism movement within modern medicine and medical sociology’s disappearance from the professionalism debate. In Handbook of the sociology of health,

Bioethical Inquiry illness, and healing, edited by B.A. Pescosolido, J.K. Martin, J.D. McLeod, and A. Rogers, 201–219. New York: Springer. Hébert, P.C., N. MacDonald, K. Flegel, and M.B. Stanbrook. 2010. Competing interests and undergraduate medical education: Time for transparency. Canadian Medical Association Journal 182(12): 1279. Holloway, K. 2014. Uneasy subjects: Medical students’ conflicts over the pharmaceutical industry. Social Science & Medicine 114: 113–120. Institute of Medicine. 2009. Conflict of interest in medical research, education, and practice. Washington, DC: The National Academies Press. Kassirer, J.P. 2005. On the take: How America’s complicity with big business can endanger your health. New York: Oxford University Press. Lave, R., P. Mirowski, and S. Randalls. 2010. Introduction: STS and neoliberal science. Social Studies of Science 40(5): 659– 675. doi:10.1177/0306312710378549. Leys, C. 2010. Health, health care and capitalism. Socialist Register 46: 1–28. http://socialistregister.com/index.php/srv/ article/view/6761#.VXt0Fvm6fIU. Liaison Committee for Medical Education (LCME). 2015. Data collection instrument (DCI). http://www.lcme.org/surveyconnect-dci-download.htm. Accessed June 15, 2015. Loertscher, L.L., A.J. Halvorsen, B.W. Beasley, E.S. Holmboe, J.C. Kolars, and F.S. McDonald. 2010. Pharmaceutical industry support and residency education: A survey of internal medicine program directors. Archives of Internal Medicine 170(4): 356–362. doi:10.1001/archinternmed.2009.524. Newson, J., and C. Polster. 2010. Academic callings: The university we have had, now have, and could have. Toronto: Canadian Scholars’ Press.

No Free Lunch. n.d. [Home page.] http://www.nofreelunch.org/ aboutus.htm. Accessed December 15, 2014. PharmedOut. 2006–2011. About us. http://pharmedout.org/ aboutus.htm. Accessed December 15, 2014. Relman, A.S. 1985. Dealing with conflicts of interest. The New England Journal of Medicine 313(12): 749–751. doi:10. 1056/NEJM198509193131209. Rodwin, M.A. 1995. Medicine, money, and morals physicians’ conflicts of interest. New York: Oxford University Press. Rodwin, M.A. 2011. Conflicts of interest and the future of medicine: The United States, France, and Japan. New York: Oxford University Press. Schafer, A. 2004. Biomedical conflicts of interest: A defence of the sequestration thesis—learning from the cases of Nancy Olivieri and David Healy. Journal of Medical Ethics 30(1): 8–24. doi:10.1136/jme.2003.005702. Shnier, A., J. Lexchin, B. Mintzes, A. Jutel, and K. Holloway. 2013. Too few, too weak: Conflict of interest policies at Canadian medical schools. PLoS ONE 8(7): e68633. doi: 10.1371/journal.pone.0068633. Sierles, F.S., A.C. Brodkey, L.M. Cleary, et al. 2005. Medical students’ exposure to and attitudes about drug company interactions: A national survey. The Journal of the American Medical Association 294(9): 1034– 1042. Slaughter, S., and G. Rhoades. 2009. Academic capitalism and the new economy: Markets, state, and higher education. Baltimore: The Johns Hopkins University Press. Therapeutics Initiative. 1994–2010. Therapeutics Initiative. http:// www.ti.ubc.ca/. Accessed December 15, 2014.

Teaching Conflict: Professionalism and Medical Education.

Resistance by physicians, medical researchers, medical educators, and medical students to pharmaceutical industry influence in medicine is often based...
379KB Sizes 1 Downloads 16 Views