Conflict of Interest in Medical Research, Education, and Practice (2009) / Chapter Skim
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5 Conflicts of Interest in Medical Education
5 Conflicts of Interest in Medical Education
Pages 122-165
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From page 122... ...
Reviews of undergraduate and graduate medical education often emphasize the "formal curriculum" (i.e., required courses and explicit educational objectives) . That formal curriculum aims to help students develop the core competencies that are defined by accreditation agencies.
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From page 123... ...
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)
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From page 124... ...
(ACGME, 2007b) ; and • 740 national providers of accredited continuing medical education (and 1,600 accredited state providers)
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From page 125... ...
State medical societies may also accredit providers within a state. 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]
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From page 126... ...
In the latter decades of the century, however, medical product companies became increasingly involved in sponsoring continuing medical education, including grand rounds and other academicbased 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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From page 127... ...
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)
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From page 128... ...
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)
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From page 129... ...
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.
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Medical students' exposure to and attitudes about drug company interactions: a national survey. Journal of the American Medical Association 294(9)
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From page 131... ...
and which has received considerable attention from the media. 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.
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From page 132... ...
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.
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From page 133... ...
A number of medical schools and teaching hospitals have adopted policies consistent with the AAMC recommendations. A quality assurance and risk management document prepared by the ECRI Institute (2007)
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From page 134... ...
For low-income patients, many of whom are treated at academic medical centers and teaching hospitals, samples can provide access to needed medications (Daugherty, 2005)
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From page 135... ...
Other research points to risks associated with physician acceptance of drug samples. In academic medical centers, drug samples may be associated with the prescription of new brand name drugs in situations in which the sample drugs are different from the physician's preferred drug or are not recommended by evidence-based practice guidelines or in situations in which less expensive drugs or generic equivalents are available for the same indication.
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From page 136... ...
Gifts from Medical Product Companies Issues As noted earlier in this chapter, surveys indicate that almost every medical student has received a meal and a small noneducational gift from a drug company and that other interactions are common as well (see, e.g., Sigworth et al.
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From page 137... ...
Both students and faculty perceived visiting attending faculty as more susceptible to such influence than regular faculty, and both perceived off-site teaching as more subject to influence than on-site activities. For example, residents were more likely than faculty to believe that gifts or income from industry influences how attending physicians teach on rounds (47 versus 34 percent)
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From page 138... ...
As discussed further in Chapter 6, the revised code more strongly discourages "noninformational" physician-company relationships, such as the provision of tickets to sporting events, token consulting arrangements, speaker training programs at resorts, and meals by sales representatives outside a physician's office or other medical setting. Industry-Sponsored Scholarships and Training Positions Issues Little information on the extent of industry funding for undergraduate and graduate medical education is available, although AAMC has stated that medical schools have become increasingly dependent on such funding for such major activities.
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From page 139... ...
Responses AAMC (2008c) recommends that academic medical centers establish and implement policies requiring that industry funds for scholarships and similar purposes be given centrally to the administration of the medical center.
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From page 140... ...
accounted for by several types of accredited continuing medical education providers. Medical schools accounted for a considerably larger share of total hours of instruction than might be expected from their share of the total income received by education providers.
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From page 141... ...
They have also recently adopted a "maintenance of certification" model for ensuring continuing physician competence, and this model has implications for the future content of accredited continuing medical education. Approximately 85 percent of U.S. TheAmerican Board of Medical Specialties and its 24 member boards have been moving from a process of recertification based on an examination taken once every several years to
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From page 142... ...
Because of limited budget and staff, a small society may not pursue the provision of continuing medical education credits even when it provides safeguards against commercial bias consistent with accreditation standards. When medical product companies organize nonaccredited continuing medical education, the offerings may range from dinner seminars to training on the use of a medical device and satellite symposia at professional society meetings (some satellite symposia offer credit)
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From page 143... ...
to the major role of industry funding for continuing medical education may exist. Industry Funding in Accredited Continuing Medical Education Survey data from ACCME show that industry funding of accredited continuing medical education increased by more than 300 percent between 1998 and 2007 (ACCME, 2008a, Table 7)
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From page 144... ...
As categorized by ACCME, other income represents income other than commercial support and advertising and exhibit income. Data for providers accredited by state medical societies are not included, but ACCME survey data show that commercial sources accounted for about 25 percent of their income.
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From page 145... ...
Providers of accredited continuing medical education may solicit industry support for their programs. For example, a medical education company described opportunities to provide educational grants for a large meeting sponsored jointly with an academic medical center, as shown in Box 5-2.
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SOURCE: Excerpted from Oncology Congress, 2008, 2009. Concerns About Industry Support for Accredited Continuing Medical Education The substantial support that industry provides for accredited continuing medical education indirectly subsidizes physicians who pay less
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From page 147... ...
Unfortunately, much information about accredited continuing medical education, particularly that offered by for-profit providers, is not based on good data but, rather, is based on personal experiences with covert relationships with providers or inferences made on the basis of the nearly total dependence of these providers on pharmaceutical, medical device, and biotechnology companies. One 2008 article, based on personal experience, describes how accredited continuing medical education providers can tailor programs to secure company grants (Gilbert, 2008, unpaged)
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From page 148... ...
Using a checklist that they developed to assess bias in education programs, Takhar and colleagues (2007) concluded that 9 of the 17 continuing medical education programs that they assessed were biased (e.g., by limiting the discussion to the sponsor's product and ignoring alternatives)
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From page 149... ...
. The associated corporate integrity agreement required, among other provisions, that the company create procedures to ensure that sponsored continuing medical education and educational activities be inde pendent and nonpromotional (OIG, 2007)
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Slightly less than half of the respondents thought that the standards had reduced bias a little or somewhat. In 2008, the ACCME board of directors adopted a statement that indicated that accredited continuing medical education providers "cannot receive guidance, either nuanced or direct, on the content of the activity or on who should deliver that content" (ACCME, 2008b, p.
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The report observed that given "the heavy dependence by academic medical centers on industry funding" for continuing medical education, it was essential that they comply with "evolving" ACCME standards and take other steps to ensure the independence of their program offerings (AAMC, 2008c, p.
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From page 152... ...
At least one other institution has also announced that it will no longer accept direct industry funding for specific accredited continuing medical education courses either on or off campus, nor will it accept payments from third parties that have received commercial support (Stanford University School of Medicine, 2008)
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From page 153... ...
The 2007 Senate Finance Committee staff report cited above concluded that most large pharmaceutical companies had established written policies and procedures on educational grants, limited sales representatives from soliciting requests or promising funding, and established a centralized mechanism for administering grants. GHOSTWRITING, SPEAKERS BUREAUS, AND INDEPENDENCE OF PUBLICATIONS AND PRESENTATIONS Concerns about Ghostwritten Publications, Participation in Speakers Bureaus, and Other Industry-Controlled Work Two hallmarks of academic integrity are intellectual independence and accountability for one's work.
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From page 154... ...
. ACGME has expressed concern about "a new variation of a promotional activity in which residents and even medical students receive slides, lecture materials and honoraria and subsequently act as ‘experts,' delivering the packaged information at continuing medical education events" (ACGME, 2002, p.
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. 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)
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From page 156... ...
continuing medical education and company-sponsored speaker programs (PhRMA, 2008)
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From page 157... ...
The risks are substantial and are not offset by meaningful benefits. RECOMMENDATION 5.1 For all faculty, students, residents, and fel lows 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 pharmaceuti cal, medical device, and biotechnology companies, except in specified situations; • educational presentations or scientific publications that are con trolled 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 cer tain specified situations for training, patient safety, or the evaluation of medical devices; and • the use of drug samples, except in specified situations for pa tients who lack financial access to medications.
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From page 158... ...
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.
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From page 159... ...
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)
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From page 160... ...
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. Accredit ing organizations should develop standards that require formal educa tion on these topics.
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From page 161... ...
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.
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From page 162... ...
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)
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From page 163... ...
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.
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From page 164... ...
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.
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From page 165... ...
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.
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