Acad Psychiatry 30:36-39, February 2006
doi: 10.1176/appi.ap.30.1.36
© 2006 Academic Psychiatry
Medical Education and the Pharmaceutical Industry: Managing an Uneasy Alliance
Michael D. Jibson, M.D., Ph.D.
Received October 11, 2005; accepted October 11, 2005. Dr. Jibson is Associate Professor and Director of Residency Education, University of Michigan, Department of Psychiatry, Ann Arbor, Michigan. Dr. Jibson is on the speakers bureau for Bristol-Myers Squibb and Janssen Pharmaceutica. Address correspondence to Dr. Jibson, University of Michigan, Department of Psychiatry, 1500 E. Medical Center Drive, Ann Arbor, MI 48109-0118; mdjibson{at}umich.edu (E-mail). Copyright © 2006 Academic Psychiatry.
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INTRODUCTION
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The most useful ethical discussions are those that force us to examine our values, motives, and behaviors, that highlight the conflicting values and goals inherent in most real-life situations, and that lead us to make changes based on what we discover. Although there are some cases in which black-and-white thinking is appropriate ("Should I seduce this patient?" "Should I send some fraudulent billings to Medicare today?"), most cases are less useful when reduced to that paradigm.
In discussions of the interactions between clinical or academic medicine and the pharmaceutical industry, black-and-white thinking leads to two tempting but indefensible endpoints. The first is that physicians are immune to marketing and are at liberty to engage in whatever activity they wish without regard for possible conflicts of interest. This position is at odds with a substantial body of evidence showing that marketing clearly affects physician practice (1), even when they do not believe it is occurring (2). The counterposition is that industry is inherently corrupt and corrupting to any who have contact with it. Thus, the ethical stance is to maintain total separation of physicians from industry. This position is both implausible and unwise, failing to acknowledge the importance of industry contributions to our knowledge base and not distinguishing among the various types of interactions that occur between physicians and industry. The realities are more complex.
In the modern world, neither clinical medicine and industry nor academic medicine and industry can survive independent of one another. Through a process of social evolution and policy design, each has a unique and crucial role to play in the advancement and delivery of health care. Recognition of this interdependency is essential to any discussion of the respective roles of these endeavors and to any resolution of the conflicts that arise between them.
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Background
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Most basic science is publicly funded. Congressional appropriations to the National Institutes of Health in the U.S. totaled $27.9 billion in fiscal year 2004, 80% of which went to research grants in academia, the remainder to intramural research and administrative costs (3). The results of this research remain in the public domain, mostly in the form of peer-reviewed publications.
Translation of these basic findings into marketable treatments is largely a private enterprise. U.S. pharmaceutical companies invested an estimated $38.8 billion in research and development in 2004 (4). Many of the results of this effort remain proprietary, but much reaches the public through the Food and Drug Administration (FDA) approval process, marketing efforts, and peer-reviewed publications. This investment in research is stimulated by marketing incentives. Total sales of prescription drugs by U.S. companies in 2004 reached $243.8 billion (4). This combination of public and private investment has been remarkably successful, resulting in the introduction of 17 new drugs in 2001, seven of which were demonstrably superior to existing medications (5).
The delivery of the resulting treatments is handled through a patchwork of public and private payers and institutions that connect patients with physicians. The cumulative cost of these encounters was $366.8 billion in direct payments to physicians in 2000 (6).
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Convergence and Conflicts of Interests
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Despite the enormity of the numbers involved in these efforts, medical care inevitably culminates in a unique interaction between a physician and a patient. Every sale of a prescription drug is the result of a patient presenting a complaint and a physician attempting to intervene. It is the quality of that relationship and that process that medical education seeks to enhance.
Academic medicine, clinical medicine, patients, and industry enjoy a convergence of interests on this point. The development and appropriate distribution of effective medications benefit all. Both of those processes require open communication, mutual trust, respect for autonomy, and free access to information by all participants.
These qualities are difficult to maintain when each party brings unique and sometimes conflicting goals and ethical standards. Although physicians are the largest financial stakeholders in this enterprise, they are bound by ethical and legal expectations to act in the best interest of their patients. The unavoidable conflict of interest that exists when the same professional is paid both to recommend and to provide treatment is addressed by separation of clinical training from financial incentives, continuing education efforts, and maintenance of standards of care through peer review and other professional oversight.
Industry, in contrast, has clear obligations to achieve financial gains for stockholders as well as to provide the public with safe and effective medications. Marketing is an essential part of that process and allows companies to inform physicians and patients of the availability of newly developed (or newly approved) treatments, train physicians in their appropriate use, and warn physicians and patients of their potential hazards. Marketing may also include a motivational component to encourage potential customers to consider options different from those currently in use or to preferentially select one agent over another when there is no substantive difference between the two. No conflict of interest need arise if a drug is marketed exclusively to those who would legitimately benefit from it. Conflict often occurs, however, when there is the potential for increased profits by inappropriate promotion of the drug. These conflicts are handled primarily by government regulation and oversight and by education of prescribing physicians.
Conflict may also arise when there are direct interactions between physicians and industry. When the interaction is limited to the candid sharing of information, problems are few. When confounding factors are introduced, such as financial incentives, gifts, or emotional marketing appeals, clinical decision making may be compromised. This interface has been the focus of extensive, often rancorous, debate within the profession and in the media. Much of this debate has suffered from its narrow focus, without consideration of the larger context and issues involved.
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The Role of Medical Education
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Medical education has a critical role in the resolution of conflicts of interest within the practice of medicine and during the marketing of drugs. It is the task of the clinical educator to convey information, skills, and attitudes to medical students, to bring residents up to professional standards of care, and to keep practicing physicians’ knowledge base and skill sets current. Much of this education involves the use of medications, making interaction between educators and industry inevitable.
Educators face conflicts of their own, including financial constraints, limited access to information, and the need to prepare trainees for future contacts with industry (7). Faced with constrained resources and seemingly bottomless wells of industry largesse, educators have often allowed industry access to trainees and training programs both at the medical school (8) and residency levels (9). Much of this access is used for marketing, with demonstrable bias (10) and predictable consequences for prescribing behavior (11). In response, total separation of education from industry sponsorship and sources of information has been advocated (12).
Complete separation, however, is both impractical and unwise. Industry has a large financial stake in medical practice and has a legitimate interest in promoting its products. Furthermore, physicians benefit from contacts with industry. Input into drug development, access to proprietary information, updates on FDA actions, and findings from industry-sponsored research are beneficial and desirable. Industry is among the largest contributors to education, providing $1.1 billion for CME programs in 2004 (13). Academic psychiatrists, including medical educators, are appropriately called upon to serve as arbiters of information, evaluating the quality of data and teaching trainees to assess information from all sources, including industry.
Educators have a variety of resources to assist in managing these tasks and the conflicts they entail. The Accreditation Council for Continuing Medical Education (ACCME) and the FDA have mandatory guidelines for presentations made under their jurisdictions (14, 15). The Accreditation Council for Graduate Medical Education (ACGME) offers a comprehensive review of the implications of this issue within their six core competencies, including specific guidelines for avoiding conflicts (16). Professional organizations offer a variety of voluntary guidelines, some of which address educational issues directly (17).
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Recommendations
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Several recommendations follow from these considerations. First, there must be clear distinctions between educational and promotional programs. Both serve legitimate functions, but they must not be confused with one another. Speakers and attendees must be clear on this point, and trainees must be taught the difference.
Second, institutions and organizations should be active in establishing, promulgating, and enforcing clear and consistent policies regulating educational activities. This should include attention to contact between industry and trainees at all levels. For medical educators, as for other physicians, policies reflect the values and standards of the institution or profession and serve as an objective standard by which ethical practitioners may judge their actions. They ensure the integrity of the education program and provide an objective basis for accreditation and credentialing.
Third, training programs must maintain control over all educational activities. Sponsorship should not be a consideration in selection of the content or teaching faculty of educational programs. Educators have a special obligation to preserve the integrity and independence of their teaching activities.
Fourth, disclosure of financial arrangements should be clear, candid, and complete. Trainees are entitled to know the financial ties of their teachers, not only with regard to the single topic at hand, but more broadly in all their academic endeavors. Faculty unwilling to provide such disclosure might reflect on their reticence and consider the implications of their clandestine obligations.
Fifth, training programs should include formal didactic and supervisory instruction on physician interactions with industry. Despite evidence for the impact of such interventions (18) and the widespread desire for such teaching, few programs provide structured education in this area (9).
Finally, there is no substitute for constant attention to personal integrity and professional rigor. For physicians and for educators, this alone should be compelling.
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Conclusion
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The medical profession and pharmaceutical industry constitute essential components of modern medical care. Although they have fundamental differences in goals and ethical standards, the interests of the two groups overlap in significant areas and their collaboration benefits all concerned. The ethical dangers inherent in this mixing of different systems can be managed only by careful attention to the independence of clinical and educational decision making. Medical educators hold a critical position in this process. Reasonable policies, clarity or roles, transparency of financial arrangements, and rigorous self-examination are essential elements for successful teaching and maintenance of the integrity of medical education.
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REFERENCES
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- Wazana A: Physicians and the pharmaceutical industry. Is a gift ever just a gift? JAMA 2000; 283:373–380[Abstract/Free Full Text]
- Orlowski JP, Wateska L: The effects of pharmaceutical firm enticements on physician prescribing patterns. Chest 1992; 102:270–273[Abstract/Free Full Text]
- National Institutes of Health. The NIH Almanac - Appropriations. Available at http://www.nih.gov/about/almanac/appropriations/index.htm; updated Jan 20, 2005. Accessed on Oct 5, 2005
- Pharmaceutical Research and Manufacturers of America: Pharmaceutical Industry Profile 2005. Washington, DC: PhRMA 2005
- Angell M: The Truth about Drug Companies: How They Deceive Us and What to Do About It. New York, Random House, 2004, pp 16-17
- Centers for Medicare and Medicaid Services: An overview of the U.S. healthcare system: two decades of change, 1980-2000. Available at http://www.cms.hhs.gov/charts/ healthcaresystem/chapter1.pdf. Accessed on Oct 5, 2005
- Mohl PC: Psychiatric training program engagement with the pharmaceutical industry: an educational issue, not strictly an ethical one. Acad Psychiatry 2005; 29:215–221[Abstract/Free Full Text]
- Sierles FS, Brodkey AC, Cleary LM, et al: Medical students’ exposure to and attitudes about drug company interactions: a national survey. JAMA 2005; 294:1034–1042[Abstract/Free Full Text]
- Varley CK, Jibson MD, McCarthy M, et al: A survey of the interactions between psychiatry residency programs and the pharmaceutical industry. Acad Psychiatry 2005; 29:40–46[Abstract/Free Full Text]
- Ziegler MG, Lew P, Singer BC: The accuracy of drug information from pharmaceutical sales representatives. JAMA 1995; 273:1296–1298[Abstract]
- Chren MM, Landefeld S: Physicians’ behavior and their interactions with drug companies: a controlled study of physicians who requested additions to a hospital drug formulary. JAMA 1994; 271:684–689[Abstract]
- Brodkey AC: The role of the pharmaceutical industry in teaching psychopharmacology: a growing problem. Acad Psychiatry 2005; 29:222–229[Abstract/Free Full Text]
- Accreditation Council for Continuing Medical Education: ACCME Annual Report Data 2004. Available at: http://www.accme.org/dir_docs/doc_upload/2130a818-1c9f-400b-9d54-56b3f8f9a2f6_uploaddocument.pdf. Accessed Oct 6, 2005
- Accreditation Council for Continuing Medical Education: ACCME accreditation policies including information for provider implementation. Available at: http://www.accme.org/dir_docs/doc_upload/8f4b847a-5917-4e4f-ae5f-ca0dc231dda7_uploaddocument.pdf. Accessed Oct 6, 2005
- Food and Drug Administration: Final Guidance on Industry-Supported Scientific and Educational Activities. Federal Register 1997; 62:64073–64100. Available at: http://www.fda.gov/cber/gdlns/sciedu.txt. Accessed Oct 6, 2005
- Accreditation Council for Graduate Medical Education: Principles to guide the relationship between graduate medical education and industry. Available at: http://www.acgme.org/acWebsite/positionPapers/pp_GMEGuide.pdf. Accessed Oct 6, 2005
- Coyle SL: Physician-industry relations. Part 1: individual physicians. Ann Intern Med 2002; 136:396–402[Abstract/Free Full Text]
- Randall ML, Rosenbaum JR, Rohrbaugh RM, et al: Attitudes and behaviors of psychiatry residents toward pharmaceutical representatives before and after an educational intervention. Acad Psychiatry 2005; 29:33–39[Abstract/Free Full Text]
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INTRODUCTION
Background
