Acad Psychiatry 31:32-39, January-February 2007
doi: 10.1176/appi.ap.31.1.32
© 2007 Academic Psychiatry
Medical Education and the Pharmaceutical Industry: A Review of Ethical Guidelines and Their Implications for Psychiatric Training
Cynthia M.A. Geppert, M.D., Ph.D.
Received November 11, 2005; revised February 12, 2006; accepted March 23, 2006. Dr. Geppert is Assistant Professor, Department of Psychiatry, University of New Mexico, and Chief of Consultation Psychiatry and Ethics, New Mexico Veterans Affairs Health Care System, Albuquerque, New Mexico. Address correspondence to Dr. Geppert, 1501 San Pedro Drive Southeast, Albuquerque, NM 87108; ethicdoc{at}comcast.net (e-mail).
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ABSTRACT
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OBJECTIVE: This article reviews and summarizes eight ethical guidelines of major professional organizations regarding the pharmaceutical industry’s role in the psychiatric education of trainees. METHOD: The author conducted a literature review of research and guidelines pertaining to the pharmaceutical industry’s relationship to trainees, with special attention to ethical implications.RESULTS: A spectrum of ethical acceptability is represented in the various guidelines. The greatest disagreement exists regarding the appropriateness of gift-giving and hospitality. The greatest degree of consensus exists regarding the provision of and criteria for scholarships to trainees. Policies regarding the use of samples and the industry’s influence on graduate medical education were less well developed compared with other areas. CONCLUSIONS: A review of guidelines can serve as a basis for dialogue, curricula development, and further research on the ethics of pharmaceutical company interactions with trainees in academic psychiatry.
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INTRODUCTION
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The role of the pharmaceutical industry in medical training has become one of the most debated and divisive ethical issues in contemporary medical education (1). The spectrum of opinion and policy ranges from conservative positions that would ban almost all interactions to more liberal stances that argue for controlled collaboration, with many more nuanced positions in between (2, 3). Despite the divergence, all sides on the issue tend to agree that relationships with the pharmaceutical industry involve demonstrated and potentially negative effects on medical education (4–6). These effects include influencing prescribing patterns, biasing professional judgment, generating conflicts of interest, degrading professionalism, fostering a culture of entitlement among trainees, and denuding patient trust and respect for the medical profession (7–10). The central source of disagreement pertains to how to manage and govern interactions between the pharmaceutical industry and trainees and faculty (6, 11).
During the past decade, most of the major professional organizations and accrediting agencies in medical training have produced documents offering guidance and structure for both individual practice and institutional policies regarding the pharmaceutical industry’s involvement in medical education. It is logical and appropriate for physician-educators and academic leaders to consult these key statements when attempting to resolve ethical dilemmas relating to the pharmaceutical industry’s relationship to medical education. Yet, these highly vetted and well-researched expert judgments do not offer consistent counsel. Additionally, not every guideline equally addresses all aspects of the controversy, nor does every guideline consider trainees as well as physicians. As Wazana et al. (12) pointed out in an earlier review, most professional societies have developed guidelines but have neglected to address the specific needs of residents.
There are, however, some exceptions. Wazana et al. did note that the Association of American Medical Colleges (AAMC) has published guidelines for residency training, and the Accreditation Council for Graduate Medical Education (ACGME) has developed a draft policy, but these guidelines lack specificity about the kinds of relationships with the industry that are permitted or prohibited (12). The 2003 Toronto Department of Psychiatry Task Force Report (13) does provide the responses of three major guidelines as well as the Task Force’s comments regarding more than 30 scenarios that included educational, business, and personal interactions with industry. Some of those scenarios and responses discussed physician trainees. Faculty and students at McGill University in Canada developed guidelines for use by the university’s psychiatry program residents by reviewing the literature, analyzing guidelines from professional organizations, and discussing issues with experts (12). Chakrabarti et al. (14) surveyed psychiatry training program policies on pharmaceutical industry interactions.
Building on this previous fine work, this article endeavors to provide a review summarizing the positions of major professional organizations in an effort to identify areas of consensus and contradiction, as well as to underscore domains requiring additional research and consideration significant for psychiatry education.
These guidelines have particular importance for psychiatry education where the clinical and ethical influence of the pharmaceutical industry is especially intense, extensive, and subtle. The therapeutic category of central nervous system (CNS) agents was the second most commonly purchased drug class by retail pharmacies in the United States during the period from November 2004 to November 2005, with purchases totaling over $67 million of product in that period (15). Two antidepressant medications were among the top-selling prescriptions dispensed in the United States in September 2005 (16). There are, therefore, considerable financial incentives for the pharmaceutical industry to form good working relationships with medical students, residents, fellows, and the faculty who teach them.
Compared with other fields of medicine, the therapeutic relationship in psychiatry is usually more intense and intimate and the patients more vulnerable and distressed. Consequently, a higher degree of professional integrity may be required to examine and prevent any real or apparent conflict of interest stemming from interaction with the pharmaceutical industry (17). Several studies have shown that interactions between psychiatry trainees and pharmaceutical representatives may indeed undermine ethical attitudes and professional behavior (14, 18, 19). Research also suggests that educational interventions can reduce pharmaceutical industry influence and that reviews of the literature can inform program policy development (12, 20). It is hoped that the present review will contribute to these initiatives.
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Method
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I first reviewed the background literature on pharmaceutical industry involvement in medical education, including both printed and electronic resources, to identify the organizational guidelines commonly cited. Second, I selected those guidelines that were most relevant for undergraduate and graduate medical education, as opposed to those directed primarily at practicing physicians and pertaining to such issues as continuing medical education. The statements of the Accreditation Council for Graduate Medical Education (ACGME) (21), the American College of Physicians (ACP) (22, 23), the Association of American Medical Colleges (AAMC) (24), the American Medical Association (AMA) (25), the American Medical Student Association (AMSA) (26), the Canadian Medical Association (CMA) (27), the Pharmaceutical Manufacturers of America (PhRMA) (28), and the U.S. Department of Veterans Affairs (29) were included. Though specific psychiatry department policies have been formulated and are available, these were thought to be less generalizable and so were excluded (12, 13). For similar reasons, guidelines of specialty societies were not covered (30). Since the ethical guidelines of APA and the Canadian Psychiatric Association on the subject of pharmaceutical industry relations are based on the statements of the parent organizations, the AMA and CMA, with only minor alterations, statements from the parent organizations were quoted.
The eight guidelines were then systematically examined against the background medical education literature to identify six significant interactions between trainees and the pharmaceutical industry and their ethical implications for psychiatry training (12, 13). The language used in formulating these interactions in the text and tables was adopted from the commonly employed terms in the actual guidelines and literature, such as "gifts" and "scholarships." The issues selected were 1) gifts; 2) hospitality that pharmaceutical representatives offer to trainees; 3) use of pharmaceutical representative-distributed drug samples; 4) pharmaceutical industry provision of scholarships to trainees to attend educational conferences; 5) pharmaceutical industry participation in graduate medical education; and 6) the need for programs to provide ethics education focused on trainee-pharmaceutical industry interactions.
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Results
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As expected, not every statement covered all aspects of the debate, but the majority at least commented upon the core topics. Nor should absence of mention in a single document imply that the cited organization has not expressed an opinion elsewhere. There was a wide divergence of opinions on some issues, such as the parameters for gift acceptability, and broad consensus on other issues, such as the rules governing scholarship awards. The two documents with trainee input—by the AMSA and AAMC—most directly address graduate medical education. Interestingly, they are also the most rigorous in their ethical requirements.
Gifts and Hospitality
Gifts from pharmaceutical representatives and "drug company lunches" have received more scholarly commentary than any of the other topics and incite strong emotions on both sides (31). The AMSA’s position is the most stringent, urging trainees to eschew all promotional items, such as the ubiquitous pens and notepads, and calling for an end to all pharmaceutical industry-sponsored meals and other forms of hospitality (26). The AMA deems gifts to physicians acceptable so long as they are of "nominal value," defined as $100 or less, and entail a benefit to the patients (25). PhRMA adopted this same limit in its marketing code (28). For comparison, the Department of Veterans Affairs restricts gifts to a value of no more than $20 per occurrence and no more than $50 in aggregate value over a year from one source (29), and the ACP points out that monetary value is a less ethically instructive criterion than context and intentionality (23). The AAMC’s statement similarly emphasizes that all interactions with even the appearance of conflict of interest should be avoided (24). All of the organizations, including PhRMA, agree that the gifts must relate to education or patient care, and meals and hospitality must be "modest" and be connected to an educational presentation. The ACGME particularly recommends that didactic instruction and policy formulation address gift-giving and hospitality funded by the pharmaceutical industry, and the AAMC indicates that each program should set a clear policy restricting the types and number of pharmaceutical representative interactions that can be extrapolated as hospitality (21, 24). The particular positions of each organization on gifts and hospitality are summarized in Appendix 1.
Samples and Scholarships
Compared with the voluminous literature on gifts, the place of drug samples in medical education has received far less scrutiny. This lack of attention is unfortunate as use of drug samples for indigent patients who cannot otherwise afford needed medication may be one of the most challenging ethical dilemmas residents face. For instance, the AAMC (24) does not mention them by name, the ACP (23) conceptualizes samples as gifts with similar ethical problems, and the ACGME adopts a pedagogical approach (21). The AMA and CMA posit conditions under which samples are acceptable (e.g., not involving material gain for the physician) (25, 27), and PhRMA refers to the acceptability of providing product samples for patient use in accordance with the Prescription Drug Marketing Act (27). The Veterans Health Administration (VHA), as behooves its public trust, tightly regulates individual provider reception of samples (29).
Those organizations that have a position on scholarships are remarkably consistent with the requirement that the department or program elect the recipient of the scholarship and receive the funds. The definition of a legitimate educational event is nearly identical in the PhRMA and professional statements. The AMSA is the outlier opposing program control of scholarship awards, and the AAMC has a general counsel that residents can look to professional organizations and teaching institutions for guidance (24, 26). The specific guidelines of each program regarding samples and scholarships are summarized in Appendix 2.
GME and Didactics
Many of the selected statements, and several not selected, contain thoughtful and detailed recommendations and requirements for continuing medical education (CME). Influential guidelines, such as those of the Accreditation Council for Continuing Medical Education (ACCME) (32), were not included unless the document specifically mentioned their application to graduate medical education (GME). Though the developmental appropriateness of applying CME guidelines to GME is one of the most important issues psychiatric educators must consider, a comprehensive discussion lies outside the scope of the present descriptive review. The influence of the pharmaceutical industry on graduate medical education is a more recent subject of concern as residency programs become more financially strapped and trainees’ morale lags. The ACGME reinforces, as does the VHA, that programs must have sufficient funds to accomplish educational goals independently and that disclosure, locus of control, and conflict of interest provisions similar to those for the ACCME must govern any pharmaceutical industry involvement (21). The AMSA urges dialogue between academia and the pharmaceutical industry on education, as does the AAMC (24), reflecting the emergent status of this issue (26). The entire AAMC report is dedicated to "a cooperative approach between resident physicians, their sponsoring institutions and educators, and the medical industry to acknowledge and preserve the educational mission of GME" (24).
Both the ACGME and AAMC directly mention the need for ethics curricula to cover major guidelines and interpret the bearing of the ACGME competencies and AAMC domains on pharmaceutical industry relationships (33). Guidelines from the CMA, ACP, and AMSA highlight that trainees are held to the same ethical standards as practicing physicians and emphasize the need to provide instruction in professionalism and pharmaceutical industry relationships, while those from the AAMC, ACGME, AMSA, VHA, and ACP outline curricular elements, such as evidence-based evaluation of pharmaceutical industry information and an understanding of drug research and development (21, 23, 24, 26, 29). The positions of each organization on GME and didactics are summarized in Appendix 3.
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Discussion
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This review of major organizations’ guidelines for the ethical conduct of pharmaceutical industry-trainee interaction presents six important implications for psychiatry education. An important caveat is that it is a primarily descriptive review of the content of source guidelines rather than an analysis of the ethical dilemmas outlined. The major limitation of the review is that although arguments are presented, they are not critically appraised. It is hoped that the comparison of the guidelines presented here and the initial observations sketched in this discussion can serve as a springboard for more in-depth analysis. First, as the controversy becomes increasingly polarized, such a comparison may show the diversity of professional opinion and so can serve to moderate more extreme positions. Second, the review underscores the recognition that more work must be done before we can achieve a reasonable consensus on the acceptability of gift-giving and hospitality, and it provides a foundation from which associations of medical students, residents, clerkships, and program directors can launch these efforts. Third, the review emphasizes topics, such as the function of samples, which merit more critical examination, thereby indicating directions for further research and policy formulation. Fourth, the relative underdevelopment of specific GME regulations raises questions as to whether ACCME guidelines applied to CME for practicing physicians should also be applied to trainees. Fifth, analysis of the guidelines delineates primary content areas to be covered in any program and can be utilized in designing and standardizing curricula on professional ethics. Finally, and most significantly, the review shows the increasing emphasis of all professional organizations on providing ethics instruction on pharmaceutical industry-trainee relationships, such as recognition of the effects of advertising and detailing on resident prescribing behavior and evidence-based analysis of product information. This laudable trend captures the heart of the educational matter, which is to encourage each student and resident to reflect seriously on his or her own attitudes and practices and arrive at mature and informed personal judgments.
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Conclusions
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A review of eight of the current guidelines from major professional organizations on pharmaceutical industry involvement in medical education regarding six core ethical issues discloses areas of both consensus and disagreement highly relevant for academic psychiatry. The comparison reveals topics that have received considerable study and others requiring further development on the part of psychiatry ethicists and educators. All statements agree that these challenging professional dilemmas merit curricular attention.
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ACKNOWLEDGMENTS
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The author thanks Ms. Arline Kaplan for her outstanding editing of this manuscript.
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ABSTRACT
INTRODUCTION
