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Conflict of Interest in Medical Research, Education, and Practice 5 Conflicts of Interest in Medical Education Medical education prepares physicians for a lifetime of professional work. Education that is objective and that teaches students how to critically evaluate the evidence prepares physicians to keep current with scientific advances throughout their professional lives. This chapter is organized around the concept of the learning environment, which shapes and reinforces the professional attitudes and behavior of physicians throughout the continuum of learning that begins in medical school and extends through residency training and to lifelong learning. Learning environments in medicine are diverse. They include conference rooms and lecture halls, patient care locales (such as inpatient service and outpatient practice locations), laboratories, and the Internet. Some continuing education programs take place at restaurants or resorts. If the learning environment provides the stage for education, the curriculum provides the script. Reviews of undergraduate and graduate medical education often emphasize the “formal curriculum” (i.e., required courses and explicit educational objectives).1 That formal curriculum aims to help students develop the core competencies that are defined by accreditation agencies. Each educational activity has learning objectives, and the totality of educational sessions must address all the core competencies. The learning environment also includes two other elements: the informal curriculum (i.e., ad hoc interactions among teachers and students) and 1 The committee follows the convention in medical education of referring to the years of medical school as “undergraduate medical education” and the post-M.D. years of residency and fellowship as “graduate medical education.” Unless otherwise described (e.g., research fellows), fellows are physicians in subspecialty training programs. This report refers to “residents” and “fellows” rather than “trainees” (a description commonly used by medical educators).
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Conflict of Interest in Medical Research, Education, and Practice the hidden curriculum (i.e., institutional practices and culture) (see, e.g., Hafferty , Ratanawongsa et al. , Cottingham et al. , and Haidet ). Ideally, these two elements convey messages that are consistent with the formal curriculum, but in practice they may not. For example, the formal curriculum might include course work on medical ethics, research methodology, and appropriate relationships with industry. Concurrently, the informal and hidden curricula might be characterized by disparaging faculty comments on their institution’s conflict of interest policies and the failure of institutions to adopt and implement sound policies. Unfortunately, some aspects of each curriculum may contribute to undesirable attitudes or practices. The Association of American Medical Colleges (AAMC) observed in a 2008 report that the conflicts created by a range of common interactions with industry can “[f]or medicine generally, and for academic medicine in particular … have a corrosive effect on three core principles of medical professionalism: autonomy, objectivity, and altruism” (AAMC, 2008c, p. 4). Members of the U.S. Congress have also expressed concern about commercial relationships in medical education, primarily continuing medical education (see, e.g., Finance Committee, U.S. Senate ). In contrast to the requirements for recipients of U.S. Public Health Service research awards, the federal government does not require the recipients of direct or indirect funds for medical education to establish and administer conflict of interest policies. This chapter next provides a brief background on the current context of medical education. It then examines the literature on conflict of interest issues and responses in the learning environments of undergraduate, graduate, and continuing medical education. The discussion covers access to educational environments by sales representatives of medical product companies (e.g., drug detailing, which is a visit to a doctor by a sales representative for a pharmaceutical company), the provision of drug samples and other gifts to faculty and students, and industry-sponsored scholarships and fellowships. A separate section considers a concern that cuts across all phases of education: intellectual independence in presentations and publications and the risks associated with speakers bureaus and ghostwritten publications. (Chapter 4 discussed concerns about how researcher conflicts of interest might affect their advice or supervision involving the research of medical students, residents, fellows, and junior faculty.) The committee concluded that, in general, industry financial relationships do not benefit the educational missions of medical institutions in ways that offset the risks created. The chapter thus ends with recommendations that are intended to protect the integrity and limit the potential for undue industry influence in medical education. As explained in Chapter 1, the committee focused on conflicts of interest involving physicians and biomedical researchers; but much of the core rationale for the recommendations
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Conflict of Interest in Medical Research, Education, and Practice may be relevant to nursing, pharmacy, dentistry, and other professions, even though some of the specifics might differ. Chapter 6 considers many of the same issues in the context of physicians in practice outside academic settings. BACKGROUND AND CONTEXT Scale and Oversight of Medical Education American medical education evolved during the 19th and early 20th centuries from pure apprenticeships to proprietary medical schools of variable quality to a reformed and formal educational system that stresses both science and professionalism. During the middle decades of the 20th century, an increasingly elaborate structure of graduate (post-M.D.) medical education emerged, characterized by multiyear residencies in medical specialties beyond the traditional internship year. The latter half of the century saw the growth of requirements by state licensing boards and specialty certification boards for demonstrated participation in accredited continuing education activities (Caplan, 1996). Today, the scale of American medical education is impressive. The United States has 130 accredited medical schools (AAMC, 2008d),2 approximately 400 major teaching hospitals (Salsberg, 2008), more than 100,000 faculty members (Salsberg, 2008), and approximately 75,000 medical students (AAMC, 2008e); 8,355 accredited residency programs for 126 specialties and subspecialties (2006–2007) and more than 107,000 active full-time and part-time residents (2005–2006) (ACGME, 2007b); and 740 national providers of accredited continuing medical education (and 1,600 accredited state providers)3 that reported more than 7 million physician participants in their programs (ACCME, 2008a, 2009), a number that includes multiple registrations among the nation’s more than 800,000 active physicians (a count that includes medical residents) (Salsberg, 2008). 2 The count includes four schools granted preliminary accreditation in 2008. It does not include accredited Canadian schools or the 20 accredited U.S. schools of osteopathic medicine. 3 These providers are accredited by state medical societies under the rules of the Accreditation Council on Continuing Medical Education.
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Conflict of Interest in Medical Research, Education, and Practice The Liaison Commission on Medical Education (LCME) is the oversight agency that is responsible for the accreditation of the nation’s medical schools. Its members are appointed by AAMC and the American Medical Association (AMA). The Accreditation Council for Graduate Medical Education (ACGME) accredits residency training programs in the United States. The sponsoring institution for a residency program may be a hospital, medical school, university, or group of hospitals (ACGME, 2008). Accreditation bodies define the core competencies for students, residents, and fellows and ensure that the formal curriculum covers all essential aspects of medical education. ACGME board members are appointed by AAMC, AMA, the American Board of Medical Specialties, the American Hospital Association (AHA), and the Council of Medical Specialty Societies (CMSS). Accredited continuing medical education providers are accredited by the Accreditation Council for Continuing Medical Education (ACCME). Its member organizations are AHA, AMA, AAMC, CMSS, the Association for Hospital Medical Education, and the Federation of State Medical Boards. State medical societies may also accredit providers within a state.4 In addition, AMA, the American Academy of Family Physicians, and certain other groups set standards and certify credits for specific courses that physicians can take (from accredited providers) to meet state licensure board and other requirements for accredited continuing medical education (see, e.g., AMA [2006, 2008b]).5 Accredited providers usually issue certificates to document that a physician has completed a certified course. Consistent with common usage, this report uses the phrase accredited continuing medical education to refer to education that is (1) presented by accredited providers and (2) certified for course credits. Changing Environment and Fiscal Challenges Academic medical centers dominate the provision of undergraduate and graduate medical education. The institutions consist of two related enterprises: a medical school that trains physicians and conducts research and a system that provides health care services. The latter system may include teaching hospitals, satellite clinics, and physician office practices. Academic health centers include other health professions schools, such as a school of dentistry, nursing, or pharmacy (Wartman, 2007). 4 As described by ACCME, “ACCME has two major functions: the accreditation of providers whose CME [continuing medical education] activities attract a national audience and the recognition of state or territorial medical societies to accredit providers whose audiences for its CME activities are primarily from that state/territory and contiguous states/territories” (ACCME, 2005). 5 AMA also authorizes credits for other activities, such as publishing an article in a peer-reviewed journal or achieving and maintaining specialty board certification.
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Conflict of Interest in Medical Research, Education, and Practice In recent years, academic medical centers have struggled financially because of low levels of payment for poor and uninsured patients, reductions in the Medicare indirect medical education adjustment for hospital payment rates, and lower profit margins for the provision of hospital services to Medicare patients. (In the late 1990s, medical schools also faced declining admissions, but admissions increased from 2003 to 2007 [AAMC, 2008a].) At the same time, teaching hospitals have faced rising costs because of the incorporation of new medical informatics systems and expensive medical technologies and restrictions on the numbers of hours that residents may work. The Medicare Policy Advisory Commission has characterized 53 percent of major teaching hospitals as being under high financial pressure—compared to 28 percent of hospitals overall (MedPAC, 2009). Given these circumstances, financial support from industry may seem attractive. Physicians in training also face financial challenges. In 2006, the median levels of debt of medical students graduating from public and private medical schools were $120,000 and $160,000, respectively (Jolly, 2007). Medical school graduates can expect to pay approximately 9 to 12 percent of their after-tax income after graduation for educational debt service (Jolly, 2007). This level of indebtedness and the delayed gratification of a profession that requires years of training before independent practice is permitted can contribute to a sense of entitlement, which, in turn, may position medical students, residents, and fellows to be strongly influenced by gifts and attention from representatives of pharmaceutical and medical device companies (see, e.g., Levine ). Sierles and colleagues (2005) found that 80 percent of the medical students that they surveyed believed that they were entitled to gifts. In addition, as discussed in Chapter 6, once they are in practice, limits on reimbursements for physician services make debt repayment more of a burden than in the past and may make gifts and other financial relationships with industry more appealing. Industry Funding of Medical Education During most of the 20th century, medical product companies were not major participants in medical education. The exception was sales representatives, who provided information to residents and faculty as well as to nonacademic physicians. In the latter decades of the century, however, medical product companies became increasingly involved in sponsoring continuing medical education, including grand rounds and other academic-based programs. In a 2008 report on industry funding of medical education, a task force of AAMC observed generally that Over recent decades, medical schools and teaching hospitals have become increasingly dependent on industry support of their core educational mis-
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Conflict of Interest in Medical Research, Education, and Practice sions. This reliance raises concerns because such support, including gifts, can influence the objectivity and integrity of academic teaching, learning, and practice, thereby calling into question the commitment of academia and industry together to promote the public’s interest by fostering the most cost-effective, evidence-based medical care possible. (AAMC, 2008c, p. iii) The committee found no data on the amount or proportion of undergraduate or graduate medical education supported by industry. It also found little systematic information on specific categories of financial support, for example, grants for residencies or fellowships, direct or indirect financial support for grand rounds, or donations for buildings or other capital items. The most extensive information on academic institutions’ ties with industry comes from a 2006 survey of department chairs at medical schools and the 15 largest independent teaching hospitals (67 percent response rate). The responses indicated that 65 percent of clinical departments received industry support for continuing medical education, 37 percent received industry support for residency or fellowship training, 17 percent received industry support for research equipment, and 19 percent received unrestricted funds from industry for department operations (Campbell et al., 2007b). The committee did not categorize industry payments for meals, gifts, and visits by sales representatives as support for medical education because these activities do not fit the learning objectives in the formal curriculum. Information on industry funding for accredited continuing medical education comes from yearly surveys by ACCME. Figure 5-1 shows that commercial sources (excluding advertising and exhibits at programs organized by accredited providers) provide a substantially larger share of income for education providers today than they did in 1998. By 2003, about half of all funding for accredited continuing medical education programs came from commercial sources. The fees paid by program attendees once provided the majority of provider income, but today industry-supported programs are often provided free or at reduced cost to physicians (Steinbrook, 2008a). LEARNING ENVIRONMENTS IN MEDICAL SCHOOLS AND RESIDENCY PROGRAMS The ultimate mission of medical education is to prepare physicians to provide effective, safe, high-quality, efficient, timely, affordable, and patient-centered care to patients. In revising the standards that provide the framework for essential aspects of medical education, both LCME and ACGME have recently emphasized how the learning environment can affect the development of core professional values and core competencies, includ-
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Conflict of Interest in Medical Research, Education, and Practice FIGURE 5-1 Sources of income reported by respondents (accredited providers of continuing medical education) to ACCME annual survey, 1998 to 2007. SOURCE: Compiled from ACCME, 2008a. ing how to critically review the evidence and to commit to lifelong learning about scientific advances. Both LCME and ACGME recognize the power of the local learning environment to shape the knowledge, skills, behaviors, and attitudes of the next generation of physicians. To achieve accreditation, institutions providing undergraduate or graduate medical education must have curricula and resources that, among other requirements, (1) promote the development of appropriate professional attributes; (2) help learners at all levels think critically and appraise the evidence base for research reports, practice guidelines, and marketing materials; and (3) provide appropriate role models and mentoring. In addition, a standard on the creation of the appropriate learning environment must be implemented (LCME Standard MS-31-A). Recently, ACGME has required institutions to have a statement or institutional policy that addresses interactions between vendor representatives or corporations and residents and their programs (Requirement III. B.13 [ACGME, 2007a]).
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Conflict of Interest in Medical Research, Education, and Practice The Learning Environment in Undergraduate and Graduate Medical Education as a Target of Industry Influence Scope of Relationships Between Industry and Students, Medical Schools, and Teaching Hospitals Interactions between medical students and industry are common. Table 5-1 summarizes the results from a survey of third-year medical students at eight major medical schools. Almost all students had received an industry-provided lunch or other gift. More than one-third had attended a social event hosted by a drug company. Information from two surveys of residency directors similarly documents frequent interactions with pharmaceutical companies. For example, a 2002 survey of emergency medicine residency program directors found that approximately 40 percent allowed industry to fund social activities, and a similar percentage allowed pharmaceutical representatives to teach residents (Keim et al., 2004). Twenty-nine percent said that industry travel support could be made contingent on residents attending an industry event. Only 50 percent said that they always or very frequently followed ACGME recommendations for industry funding of core lectures, and 10 percent said that they always or very frequently allowed pharmaceutical representatives unrestricted access to residents. In a 2002 survey of psychiatric residency program directors, 88 percent reported that they allowed industry to provide lunches for their residents, and among this group, the mean was about five lunches per week (Varley et al., 2005). Approximately a third of the programs solicited travel funds from industry (31 percent) or allowed residents to seek such funding from industry on their own (34 percent). Value of Relationships Some interactions with industry can have educational value, for example, when an industry scientist participates in a seminar on drug development strategies or when a device company representative provides supervised training on a complex and innovative medical device that has recently been approved for marketing. Other examples may include unrestricted grants to academic medical centers that support student or resident research stipends or participation in scientific conferences. On a much larger scale, universities have benefited from company gifts for buildings, research programs, and auditoriums. Pharmaceutical companies argue that their representatives provide information on new drugs. Yet, medical students, residents, and fellows have ready access to the latest scientific information through faculty members, information technologies that allow them to search the medical literature,
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Conflict of Interest in Medical Research, Education, and Practice TABLE 5-1 Third-Year Medical Students’ Interactions with Drug Companies Type of Event No. of Students. (N = 826) No. (%) of Students Who Received a Gift or Participated in at Least One Event Exposure Frequency per Montha Mean (SD) Range A lunch provided by a drug company 793 768 (96.8) 1.08 (0.76) 0–4.2 A small, noneducational gift (e.g., pen or coffee mug) 801 754 (94.1) 0.87 (0.69) 0–3.5 A journal reprint or a glossy brochure from a pharmaceutical representative 800 716 (89.5) 0.53 (0.52) 0–3.5 A snack (e.g., donut, candy, coffee) provided by a pharmaceutical representative 800 713 (89.1) 0.75 (0.72) 0–8.5 A grand rounds sponsored by a drug company 798 690 (86.5) 0.54 (0.57) 0–2.4 A dinner provided by a drug company 801 405 (50.6) 0.13 (0.21) 0–2.4 A drug sample from a pharmaceutical representative 799 435 (54.4) 0.10 (0.20) 0–2.1 Another social event (e.g., party) sponsored by a drug company 799 272 (34.0) 0.06 (0.11) 0–0.8 A book donated by a drug companyb 826 421 (51.0) Attendance at a workshop sponsored by a drug companyb 826 214 (25.9) Registration fee for a conference paid for by a drug companyb 826 37 (4.5) Participation in a market survey sponsored by a drug companyb 826 29 (3.5) Participation in a research project sponsored by a drug companyb 826 22 (2.7) Travel expenses for a conference paid for by a drug companyb 826 15 (1.8) Nominated for an award sponsored by a drug companyb 826 5 (0.6) Obtained a fellowship sponsored by a drug companyb 826 4 (0.5) aFor each student, an exposure index was calculated as the sum of the monthly frequencies for the first eight items. bMonthly frequency data were not requested. SOURCE: Sierles et al. Medical students’ exposure to and attitudes about drug company interactions: a national survey. Journal of the American Medical Association 294(9):1034–1042 (September 7, 2005). Copyright © 2005 American Medical Association. All rights reserved.
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Conflict of Interest in Medical Research, Education, and Practice and open-access sources of evidence-based literature reviews and summaries. The committee recognizes that some medical students and residents who have become accustomed to interactions with representatives may value the meals that they receive as a respite and may view the gifts that they bring as either inconsequential or as an appropriate reward for their demanding schedules and economic sacrifices. The discussion below focuses on several different types of academic-industry relationships and the literature about their consequences. Each section includes a discussion of private- and public-sector responses to concerns about the extent and consequences of these relationships. In addition to consulting reports by AAMC and other groups, the committee examined the policies of a number of medical schools. It found many of these policies at or available through links from the websites of the American Medical Student Association (AMSA) and the Institute on Medicine as a Profession (IMAP). The AMSA website also includes the organization’s scorecard, which presents school-by-school ratings of various policy elements (e.g., the policy on the acceptance of gifts) and which has received considerable attention from the media.6 The committee notes that the recommendations in the 2008 AAMC report on medical education apply off campus as well as on campus. The report calls for academic medical centers to “communicate to off-site training facilities their expectation that the off-site venues will adhere to the standards of the academic center regarding interactions with industry” (AAMC, 2008c, p. 10). Site Access by Drug and Device Company Representatives Issues and Evidence Drug detailing, that is, a visit to a doctor by a sales representative for a pharmaceutical company, is a common way that companies promote their products and establish relationships with physicians in academic and community settings. In 2004, an estimated 36 percent of the $57.5 billion that pharmaceutical companies spent on product promotion went for detailing (Gagnon and Lexchin, 2008). Medical device companies also employ sales representatives to promote their products to physicians and hospitals, although the responsibilities of 6 The AMSA ratings, the methodology, and other information can be found at http://amsascorecard.org/. The IMAP information can be found at http://www.imapny.org/coi_database/. Both groups use information and policies received in response to a survey conducted under the auspices of the Prescription Project with funding from the Pew Charitable Trust. Some schools did not respond initially, and others refused to supply their policies.
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Conflict of Interest in Medical Research, Education, and Practice some of these representatives may be more complex. They may provide training, equipment calibration, and additional services or advice related to implants and other sophisticated technologies used in the operating room and elsewhere (see, e.g., ECRI Institute ). In one instance, the Food and Drug Administration (FDA) has required physicians to be trained by company representatives as a condition for the approval of a device (see, e.g., FDA [2004b] and Dawson ). The committee did not locate any information about how drug or device detailing activity differs between academic and nonacademic settings or how specific tactics of detailing and their effects may vary by setting or type of physician (e.g., resident versus faculty member versus community physician). Interactions with drug company representatives are common in academic settings. Medical students average about one interaction with drug company representatives a week, and 80 to 100 percent of students report interactions (see, e.g., Bellin et al. , Sierles et al. , and Fitz et al. ). As described by one faculty member, [d]rug company representatives are a major presence. They sponsor Journal Club (where trainees learn to review new data and research), they pay for many of our weekly speakers and regularly offer free dinners for the residents and faculty. They enjoy free access to our mailboxes and regularly detail our trainees in their offices, hallways and in our little kitchen. (Shapiro, 2004, p. F5) Medical students and residents reported that they received insufficient training in interacting with drug representatives. Studies also indicate that students and residents believe that their own prescribing behavior is not affected by drug company gifts, although they believe that the prescribing behavior of their colleagues is (Sierles et al., 2005; Zipkin and Steinman, 2005). Limited evidence suggests that educational interventions “show some promise” in affecting the attitudes and behaviors related to relationships with industry (Carroll et al., 2007). Overall, research suggests that drug company representatives may influence prescribing patterns and requests for additions to hospital formularies. The effects appear to be modest but consistent across various kinds of research and disciplines. One review concluded that the “pharmaceutical industry has a significant presence during residency training, has gained the overall acceptance of trainees, and appears to influence prescribing behavior” (Zipkin and Steinman, 2005, p. 777). Another review (which was not limited to educational settings) concluded that detailing “affects physician prescription behavior in a positive [i.e., the more detailing that there is, the more of an effect that it has] and significant manner” (Manchanda and Honka, 2005, p. 787).
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Conflict of Interest in Medical Research, Education, and Practice In the setting of medical education, the question is not whether assistance by professional writers and others may improve publications and help busy researchers get important, objectively presented findings into print; it may do both. The questions are whether the assistance is hidden, whether it is intended to promote a company’s interests rather than present unbiased information, and whether the author takes credit for work that he or she did not do and thus misrepresents the provenance of the article. Such arrangements (which are essentially gifts) send the wrong message about the values of intellectual independence, professional ethics, accountability, and evidence-based medicine. In the context of research, they raise questions about the objectivity of research reports that other researchers as well as practitioners and developers of practice guidelines rely on. Responses to Concerns About Independence and Accountability in Writing and Speaking Medical journal editors (including the International Committee of Medical Journal Editors and the World Association of Medical Editors) have taken steps to eliminate ghostwriting (see, e.g., Rennie et al. , Davidoff et al. , ICMJE , and WAME ). As stated by the International Committee of Medical Journal Editors, “[a]ll persons designated as authors should qualify for authorship, and all those who qualify should be listed” (ICMJE, 2008, p. 3; see also Ross et al. ). The objective of authorship policies is to eliminate unethical practices and generally not to preclude legitimate and properly acknowledged writing assistance (see, e.g., Lagnado  and Woolley et al. ). As described in Chapter 3, one journal has revised its conflict of interest disclosure form to include questions intended to detect commercial sponsorship and unacknowledged authors after concluding that such questions were necessary to detect ghostwritten or promotional submissions (AFMI, 2008). In its disclosure form for continuing medical education programs, the same professional society asks several questions about relationships with speakers bureaus (e.g., whether an individual is acting independently or as an agent) as well as questions about the receipt of assistance with manuscript preparation from commercial entities (AAFP, 2006b). In its 2008 report on medical education, AAMC recommended, “[a]cademic medical centers should prohibit physicians, trainees, and students from allowing their professional presentations of any kind, oral or written, to be ghostwritten by any party, industry or otherwise” (AAMC, 2008c, p. 22). It noted that properly acknowledged collaborations with industry personnel or medical writers is not ghostwriting. The report also recommends that participation in industry-sponsored speakers bureaus be discouraged.
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Conflict of Interest in Medical Research, Education, and Practice A few medical school policies reviewed by the committee mention speakers bureaus by name. For example, the University of Massachusetts views speakers bureaus as an “extension of the marketing process” and forbids faculty participation in them. The Mayo Clinic has long prohibited faculty from speaking on behalf of industry, and its current policy prohibits participation in the speakers bureaus of commercial firms because the linkage would imply endorsement by the Mayo Clinic (personal communication, Marianne Hockema, Administrator, Office of Conflict of Interest Review, Mayo Clinic, September 19, 2008). Faculty at the University of Louisville (2008) are “strongly discouraged” from serving as speakers hired by vendors (p. 4). A policy recently adopted by the Johns Hopkins University School of Medicine (2009) states that faculty may not participate on-site or off-site in “activities with any of the following characteristics … a company has the contractual right to dictate what the faculty member says; a company (not the faculty member) creates the slide set (or other presentation materials) and has the final approval of all content and edits; the faculty member receives compensation from the company and acts as the company’s employee or spokesperson for the purposes of dissemination of company-generated presentation materials or promotion of company products; and/or a company controls the publicity related to the event” (p. 7). The policy notes that some of these activities occur in the context of speakers bureaus but it is the conditions of an activity that determine whether it is permissible. In addition, a few medical schools (e.g., the University of California at San Francisco, the University of Louisville, and the University of Colorado) forbid ghostwriting (using that term). A few other medical schools (e.g., Stanford University, the University of Missouri, Emory University, and the University of Rochester) cover the practice of ghostwriting by forbidding medical school personnel from publishing, under their own name, articles that are written entirely or in significant part by an industry employee. The ACCME standards for commercial support require that presenters disclose relevant financial relationships. They provide no explicit guidance or reference to the appropriateness of commercial assistance in the preparation of talks. The 2008 PhRMA Code on Interactions with Healthcare Professionals notes that companies and speakers should understand the difference between (accredited) continuing medical education and company-sponsored speaker programs (PhRMA, 2008). For the latter, “[s]peaker training is an essential activity because the FDA holds companies accountable for the presentations of their speakers” (p. 9). This is a reference to FDA’s ban on company promotion of the use of a medication for the treatment of conditions that have not been approved by the agency (FDA, 1997). The
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Conflict of Interest in Medical Research, Education, and Practice PhRMA code specifies that company policies should provide a cap on the total annual amount that it will pay a speaker and address the “appropriate number of engagements for any particular speaker over time” (p. 10). RECOMMENDATIONS Medical Schools and Residency Programs Policies on Relationships with Industry This chapter has documented the extensive relationships that exist between industry and medical institutions, faculty, students, and residents and the concerns that have been raised about the risks that these relationships pose to the basic educational missions of academic medical centers and the lack of benefits from such relationships, such as those that support academic-industry collaborations in medical research. It has cited research indicating that even small gifts can be influential and has reviewed the recommendations of organizations such as AAMC and PhRMA. The committee concluded that it is time for medical schools to end a number of long-accepted relationships and practices that create conflicts of interest, threaten the integrity of their missions and their reputations, and put public trust in jeopardy. The risks are substantial and are not offset by meaningful benefits. RECOMMENDATION 5.1 For all faculty, students, residents, and fellows and for all associated training sites, academic medical centers and teaching hospitals should adopt and implement policies that prohibit the acceptance of items of material value from pharmaceutical, medical device, and biotechnology companies, except in specified situations; educational presentations or scientific publications that are controlled by industry or that contain substantial portions written by someone who is not identified as an author or who is not properly acknowledged; consulting arrangements that are not based on written contracts for expert services to be paid for at fair market value; access by drug and medical device sales representatives, except by faculty invitation, in accordance with institutional policies, in certain specified situations for training, patient safety, or the evaluation of medical devices; and the use of drug samples, except in specified situations for patients who lack financial access to medications.
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Conflict of Interest in Medical Research, Education, and Practice Until their institutions adopt these recommendations, faculty and trainees at academic medical centers and teaching hospitals should voluntarily adopt them as standards for their own conduct. This recommendation has several targets, most of which focus on promotional relationships. One target is the acceptance by faculty or trainees of items of material value (including small gifts and meals) from industry except in certain situations. These situations, which should be defined in institutional policies, include (1) appropriate payment for legitimate services (such as contracts, grants, and consulting arrangements); (2) charitable donations, which should be given to the institution; and (3) sharing of research materials or data. Under appropriate transfer agreements, the sharing of research materials or data is encouraged, as it promotes medical research. This recommendation covers not only physical gifts, such as pens, notepads, and meals, but also preferences, such as paid speaking engagements that are intended as rewards or inducements. Consulting arrangements and drug samples are discussed further below. The second target of this recommendation is the involvement of faculty or trainees in presentations or publications for which they cannot ethically claim credit or intellectual independence. Although no physician or researcher should accept authorship of a ghostwritten academic publication (see the discussion earlier in this chapter), failure to meet this standard is particularly troublesome when it involves faculty who have a special obligation to demonstrate intellectual independence and to act as role models. For similar reasons, faculty should not participate in speakers bureaus and similar promotional activities in which they either present content directly controlled by industry or formulate their remarks to win favor and continued speaking fees. If institutions fail to adopt these recommendations, then acceptance of authorship for ghostwritten publications or industry-controlled presentations would constitute a gift to be disclosed to the institution even if the institution’s policies do not explicitly mention these arrangements as gifts. The recommendation’s third target is consulting arrangements. Faculty should engage only in bona fide consulting arrangements that require their expertise, that are based on written contracts with specific tasks and deliverables, and that are paid for at fair market value. As part of their administration of conflict of interest policies, university review of faculty consulting and other contracts is prudent and desirable. The fourth target of this recommendation concerns access to educational environments by sales representatives of pharmaceutical, medical device, or biotechnology companies. Clinical teaching should be done by faculty, not by marketing agents. The recommended restrictions on site access should not discourage appropriate and productive research collabora-
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Conflict of Interest in Medical Research, Education, and Practice tions between industry and academic researchers. In addition to promoting scientific progress and the development of useful products, collaborations can provide educational benefits to medical students, graduate students, and postdoctoral fellows who might participate in legitimate collaborative research projects with industry under proper supervision. As described earlier, the AAMC recommendations and some medical school policies set stringent restrictions on access by pharmaceutical sales representatives but establish slightly less restrictive conditions for access by representatives of medical device companies. The recommendations and policies reflect assessments that access by device representatives—if they are properly managed and appropriately limited—can contribute to patient safety. Nonetheless, the expectation is that faculty will quickly learn how to use complex new devices, including relevant surgical techniques, and will then instruct and supervise residents and fellows rather than rely on company representatives to do so. Access under these circumstances would occur after the institutional purchase of a complex device. For the purposes of device evaluation, access by the device representatives would occur before purchase of the device. The fifth target of this recommendation, which covers drug samples, presents difficult issues. Caring for patients who cannot afford needed drugs is frustrating for physicians who are trying to meet their professional obligations to act in their patients’ best interests. Despite the aid provided through Medicaid and Medicare, other public programs, and the patient access initiatives of pharmaceutical companies, many patients are not eligible for such aid and cannot afford to continue to take medications after they have used a sample. Moreover, although physicians and others may believe that drug samples allow low-income patients access to drugs that they could not readily obtain otherwise, this chapter has cited research that suggests that most samples are not, in fact, given to indigent patients and that access to samples may change trainee behavior such that they move away from practicing evidence-based and lower-cost care. Drug samples are not a satisfactory answer to the serious problem of the lack of affordability of medications for many patients, but the committee was reluctant to call on physicians to abandon them completely in the short term. For academic medical centers, the use of drug samples may often be managed without a direct interaction between a physician and a company representative. Thus, AAMC recommends and this committee agrees that samples (if the institution permits them) should, whenever possible, be centrally managed in ways that allow timely and appropriate patient access. In the absence of such centralized arrangements, institutions should limit the provision of free drug samples and provide them only to patients who lack financial access to medications in situations in which generic alternatives are not available and the sample medication can be continued at
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Conflict of Interest in Medical Research, Education, and Practice little or no cost to the patient for as long as it is needed. They should also help physicians and patients use alternative public and private resources to obtain the needed medications. The proposal by the Medicare Payment Advisory Commission for company reporting and U.S. Department of Health and Human Services analysis of data about the distribution of drug samples cited earlier in this chapter could, if it is adopted, produce helpful information to guide future policies. The elements of this recommendation apply both to campus settings and to off-site settings, for example, off-site locations for professional meetings and educational programs. They also apply to volunteer faculty who provide clinical education in their offices or in community hospitals. Chapter 6 presents a parallel recommendation (Recommendation 6.1) for physicians who are not affiliated with academic institutions. That chapter also presents a comprehensive recommendation (Recommendation 6.2) that calls for medical product companies to change their policies to be consistent with these recommendations. The committee recognizes that it takes time for academic medical centers to develop policies. It recognizes the value of policy development processes that involve the assessment of local conditions, the inclusion of those who will be affected, and investigation of the experiences of similar institutions. Until institutions act, faculty, students, and trainees should still change their own behavior so that it is in line with the recommendations presented above. In addition, consistent with Recommendation 9.1, the committee encourages AAMC, AMSA, and similar membership organizations to continue or initiate survey, monitoring, and other activities to promote the reform of conflict of interest policies in medical education. Education on Relationships with Industry RECOMMENDATION 5.2 Academic medical centers and teaching hospitals should educate faculty, medical students, and residents on how to avoid or manage conflicts of interest and relationships with pharmaceutical and medical device industry representatives. Accrediting organizations should develop standards that require formal education on these topics. Changing the environment within educational institutions is important, but medical schools also need to prepare trainees for practice in environments that may be characterized by more permissive standards of conduct regarding drug and device marketing. Faculty will continue to experience a range of situations in which they will interact with industry representatives and will also need to be prepared to act as educators and role models on industry relationships.
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Conflict of Interest in Medical Research, Education, and Practice The committee recognizes that the evidence on the effectiveness of educational programs of this sort on physician attitudes and behaviors is not strong, but it believes that a basic level of education supports the development of core competencies and prepares students and trainees for future practice. The establishment of educational standards will help ensure that such education is of high quality and receives appropriate attention. Accredited Continuing Medical Education The members of the committee had extensive internal discussions about industry support for accredited continuing medical education. Overall, there was general agreement that continuing medical education has become far too reliant on industry funding and that such funding tends to promote a narrow focus on products and to neglect the provision of a broader education on alternative strategies for managing health conditions and other important issues, such as communication and prevention. Given the lack of validated and efficient tools for preventing or detecting bias, industry funding creates a substantial risk of bias, to the extent that industry-reliant providers want to attract industry support for future programs. Although the committee did not reach agreement on a specific path to reform, it concluded that the current system of funding is unacceptable and should not continue. RECOMMENDATION 5.3 A new system of funding accredited continuing medical education should be developed that is free of industry influence, enhances public trust in the integrity of the system, and provides high-quality education. A consensus development process that includes representatives of the member organizations that created the accrediting body for continuing medical education, members of the public, and representatives of organizations such as certification boards that rely on continuing medical education should be convened to propose within 24 months of the publication of this report a funding system that will meet these goals. One option is for this broad-based consensus development process to be convened by the member organizations of ACCME. As described earlier in this chapter, they represent medical specialty boards (American Board of Medical Specialties), hospitals (AHA and the Association for Hospital Medical Education), organized medicine (AMA), medical schools (AAMC), medical specialty societies (CMSS), and state licensure boards (Federation of State Medical Boards). Although these organizations have interests in continuing medical education and in ensuring that continuing education is
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Conflict of Interest in Medical Research, Education, and Practice free of bias and supports core competencies, they do not all have a vested interest in the current system of funding that education. The consensus development process convened by this or another group should be broad based and should also include representatives of other medical education accrediting bodies (LCME and ACGME), other interested state and federal agencies, public interest and patient advocacy groups, and organizations such as specialty certification boards that rely on continuing medical education. It should also include providers of accredited continuing medical education and industry funders. The deliberations should take into account the findings of other groups that have analyzed funding for continuing medical education or that have made recommendations about improving continuing medical educational methods. Most committee members believed that a near-term end to industry funding would be unacceptably disruptive for the major providers of accredited continuing medical education, including medical schools and professional societies, which together provide 68 percent of the total number of hours of this type of education (see Table 5-2). A SACME survey found that 77 percent of respondents said that immediate elimination of commercial support would substantially reduce the number of courses at their academic centers and the scope of their programs and could potentially lead to the elimination of programs (SACME, 2008b). Eliminating all industry funding without having in place an alternative model could have other adverse consequences. For example, a surgical society may hold a premeeting accredited workshop involving hands-on teaching of surgical techniques, typically supported by indirect funds from industry. In the committee’s experience, the costs of setup and materials for multiple simultaneous workshops can be several million dollars and would be hard to cover by payments from attendees. Furthermore, other innovative educational formats—for example, Internet-based training, simulation-based training, and performance improvement learning activities—also require funding for start-up and updating costs that could be prohibitive for providers to self-fund or fund entirely through nonindustry sources. A majority of the committee supported the use of a consensus development process to develop a new funding system for accredited continuing medical education that would be free of industry influence but that would leave open the possibility of certain forms of indirect industry funding under conditions that minimized the risk of undue influence on program content. Some committee members supported the use of a consensus development process to develop an alternative funding model but believed that no form of direct or indirect industry funding was acceptable. Among the options that the consensus development activity could consider are proposals for some kind of pooled funding mechanism. For example, companies could grant funds to some independent central or regional
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Conflict of Interest in Medical Research, Education, and Practice entity that would establish educational priorities and make decisions—perhaps within broad categories—about the distribution of funds on the basis of an independent review of applications from education providers. Both direct company funding to institutions for specific continuing medical education programs and direct company provision of unrestricted grants to institutions offer clear opportunities for undue influence, particularly for continuing medical education providers that also receive the great majority of their funding overall from companies. A plan for a system free from industry influence would exclude such funding as well as funding from company-controlled foundations. The committee recognizes that industry willingness to provide funds under a restructured system of funding accredited continuing medical education might be quite limited. Thus, the consensus development process would also need to consider alternative means of financing, steps to reduce program costs, and other strategies that would support high-quality continuing medical education. Options include increased fees for attendees; subsidies from academic medical centers as part of their educational missions; elimination of expensive program locales and amenities; reduced payments to speakers; collaboration among education providers to share the costs of developing certain expensive programs; and rethinking the purpose and methods of continuing medical education, as is already being done in the development of programs for the maintenance of certification by specialty societies. Higher fees might be a particular burden for physicians with lower-than-average professional incomes, including rural physicians and physicians serving disadvantaged populations. The committee members who opposed any industry funding of continuing medical education through any mechanism believed that physicians (or their employers) should bear the entire cost of accredited continuing medical education that is required for renewal of licensure and specialty certification. Even giving industry funding and program decision-making responsibility to a central office within a medical school, MECC, or other institution would unnecessarily retain conflicts of interest over the choice of course topics, directors, content and speakers, and the leadership of the continuing medical education office. In the view of these committee members, all industry support for accredited continuing medical education should be rejected, just as it is for most undergraduate and graduate medical education. In the process of hearing testimony relevant to the issue of funding of continuing medical education, many committee members came to the conclusion that a number of other fundamental problems about the focus and the effectiveness of continuing medical education warranted attention. These issues were outside of the purview of the committee. Some will be considered by another committee of the Institute of Medicine, which is
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Conflict of Interest in Medical Research, Education, and Practice charged with making recommendations about the promotion of more effective methods of life-long education for health professionals (IOM, 2009). Analyses of the financing of continuing medical education are planned in conjunction with that project. Those analyses may provide a better understanding of the implications of different proposals about financing in the context of other changes in the system. The committee focused on accredited continuing medical education. As noted earlier, some nonaccredited activities with industry support are educational rather than promotional and apply safeguards to prevent bias in the selection of topics, speakers, and materials presented. One example is the scientific symposium that is organized and controlled by a professional society and supported by unrestricted grants from companies. Such meetings may be particularly important for fields with many Ph.D. researchers and relatively restricted budgets. Another example is training in the use of complex medical devices provided by medical device companies under the conditions outlined elsewhere in this report (e.g., no gifts or inducements to use the product). Other Recommendations in This Report In addition to the recommendations in this chapter, other recommendations in this report would affect institutions that provide undergraduate, graduate, or continuing medical education. The standardization of institutional disclosure policies and formats (Recommendation 3.3) would require work to change policies and information systems, but in the long term, it should make institutional policies less burdensome across all educational institutions—as well as for individuals who must disclose potential conflicts of interest. Academic medical centers, which have repeatedly been embarrassed by revelations of incomplete and inaccurate faculty disclosures of payments from industry, would benefit from a national program of company reporting of payments to physicians and researchers that would allow the verification of certain disclosures (Recommendation 3.4). Because that reporting program would also cover payments to academic medical centers and other providers of medical education, it could provide an incentive for the adoption of institution-level conflict of interest policies, as recommended in this report (Recommendation 8.1). Accrediting organizations, membership groups such as AAMC and CMSS, and government agencies should also develop incentives for institutions to adopt and implement conflict of interest policies (Recommendation 9.2). Adoption of the recommendation related to the conduct of research in which an investigator has a financial interest would encourage the development of management plans to protect trainees involved in such research if the institution concludes that the participation by the investigator with a
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Conflict of Interest in Medical Research, Education, and Practice conflict of interest in the research is essential (Recommendation 4.1). To the extent that physicians embrace Recommendation 6.1 to reject gifts and similar ties, it would reduce dissonance when students, trainees, and faculty interact with others in the medical community at professional society meetings and in other contexts. Further steps by companies to reform their policies and practices on gifts and payments to physicians (Recommendation 6.2) would allow medical centers to focus more attention on other issues, for example, consulting and other contractual arrangements. Finally, academic institutions can play an important role in implementing a program of research on conflict of interest (Recommendation 9.2).