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).

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).

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 [2008]). 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 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. 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).

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.

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.

TABLE 5-1

Third-Year Medical Students’ Interactions with Drug Companies.

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).

Site Access by Drug and Device Company Representatives

Responses

AAMC has recommended tight limits on site access by sales representatives from medical product companies, particularly uninvited and unscheduled visits and unsupervised access to individual students and residents (see Box 5-1) (see, e.g., AMSA [2008a] and AAMC [2008c]). The recommended rules for device representatives are somewhat less stringent than those for drug representatives and allow limited exceptions for training on the use of complex new devices and the other activities mentioned above. A number of medical schools and teaching hospitals have adopted policies consistent with the AAMC recommendations.

BOX 5-1

AAMC Recommendations on Site Access by Sales Representatives. Site Access by Pharmaceutical Representatives To protect patients, patient care areas, and work schedules, access by pharmaceutical representatives to individual physicians should be restricted (more...)

A quality assurance and risk management document prepared by the ECRI Institute (2007) recommends several additional safety and administrative provisions for device representatives who are allowed access to the operating room.⁷ The recommendations include training requirements for device representatives as well as procedures to ensure patient safety, privacy, and informed consent and to prevent kickbacks (ECRI Institute, 2007). In addition, the ECRI Institute document suggests that medical schools have not provided adequate training in the use of devices. It emphasizes that hospitals and physicians are responsible for seeing that personnel have the appropriate training on the use of the devices that they regularly use, so that reliance on device representatives is limited and appropriately supervised.

Drug Samples

Gifts from Medical Product Companies

Industry-Sponsored Scholarships and Training Positions

Changing the Environment or Creating Educational Interventions

To the extent that industry influence operates at an unconscious level, the most effective strategies for reducing the risk of undue influence may involve changing the environment in ways that eliminate or reduce the source, especially when the source offers little or no countervailing educational benefit. That is a major rationale for the policies cited above that eliminate gifts, meals, and other noneducational interactions from the learning environment. Some evidence suggests that the learning environment influences attitudes. Two studies have reported that residents who trained in environments that restricted interactions between industry representatives were less likely than residents who trained in environments without such restrictions to view promotional interactions as being beneficial (Brotzman and Mark, 1993; McCormick et al., 2001). One literature review found weak evidence that trainees who were exposed to educational interventions may be “less accepting of pharmaceutical industry marketing tactics” than those who are not (Carroll et al., 2007, p. e1533). The review noted that two studies that involved industry personnel in the design of the educational intervention found that the participants were more positive toward industry and industry representatives than they were before the intervention.

Some research—including research in academic medical centers as well as community settings (see, e.g., Solomon et al. [2001])—suggests the value of “academic detailing” or educational outreach programs provided by clinical pharmacists or other experts as an objective educational alternative to the activities of medical product companies. Because these programs are aimed at physicians outside academic institutions, this research is reviewed in Chapter 6.

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).⁹ Moreover, profit margins increased substantially, from 5.5 percent in 1998 to 31 percent in 2006 (Steinbrook, 2008b). For the many providers of accredited continuing medical education, this combination of increased reliance on industry funding and increased profitability provides strong incentives to resist efforts to curtail such funding.

The contribution of funding from industry (primarily from drug, medical device, and biotechnology companies) varies by the type of provider of accredited continuing medical education (Table 5-3). Funding from industry provides more than half of the total income for medical schools and almost three-quarters of the total income for MECCs. Professional societies (i.e., physician membership organizations) as well as MECCs show a significant margin of income over expenses.

TABLE 5-3

Income, Expenses, and Source of Support as Percentage of Income, by Type of Accredited Provider of Continuing Medical Education, 2007.

Although professional societies are not as dependent on industry funding for their accredited educational programs as MECCs or medical schools, they receive nearly equal amounts of funding from commercial sources (24 percent) and advertising and exhibit income (25 percent). ACCME’s survey does not count the latter as commercial support.

SACME surveys provide additional data on the significance of industry funding for medical school programs. In 2006, the typical (median) medical school received some commercial support for about 45 courses, which represented almost 70 percent of its educational activities (SACME, 2007). About 7 percent of schools reported that the majority of their courses were supported by a single commercial source, and the mean number of such courses across all respondents was two. Respondents also reported that “if commercial support were no longer provided, the typical school would no longer hold 11 courses, representing 23% of the school’s courses” (p. 3).

Because they depend on industry for almost three-quarters of their income, MECCs could be severely challenged by an end to direct commercial funding, which some have proposed (Fletcher, 2008), or by a decision by medical product companies to shift their support to academic institutions, as one company recently did (Loftus, 2008). They could still have a role if academic medical centers continued to contract with them to manage or administer some of their continuing medical education programs.

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. Other organizations sell sponsorship opportunities for everything from meeting coffee breaks to hand sanitizers and flash drives.

BOX 5-2

Example of a Solicitation of Industry Support (Educational Grants) for a Large Accredited Continuing Medical Education Program. Several support levels are listed below. Please note that educational support is appreciated at any dollar level. Please contact (more...)

In addition to support for organizational programs, industry also provides support to individual physicians. On the basis of the findings from a 2004 survey, Campbell and colleagues (2007a) found that 26 percent of physicians reported that industry paid for their admission to continuing medical education meetings and 16 percent reported payments for serving as a speaker or on a speakers bureau.

Conceptually, industry support may be direct or indirect. Direct funding is from the company to the program provider. Indirect funding may occur in several ways. The company may set up a foundation that it substantially controls to provide the funding, or the provider may set up a foundation to receive the funds. Such arrangements may not provide any protection against the company influencing the content of the accredited continuing medical education. Alternatively, the company may provide funds to an intermediary, such as a central continuing medical education office in an academic health center. These arrangements are intended to separate the funding from decisions about the course content. The committee has heard criticisms that despite ACCME requirements that course directors review the course content for bias, the recipient of industry funds may have an implicit understanding that additional industry funds will not be offered in the future if the course does not present topics of interest to the company and use speakers who are favorable to the company’s products.

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 for many accredited continuing medical education programs than they otherwise would. As the preceding section indicates, industry support also contributes to the financial well-being of many educational providers that depend on it for the major part of their income for the provision of accredited continuing medical education.

The committee found little systematic research on other consequences of industry-supported continuing medical education, for example, whether it promotes bias in individual programs or in overall educational offerings. One study published before the adoption of the first ACCME standards for commercial support compared programs funded by rival pharmaceutical companies and found that the programs favored the products of their funders (Bowman, 1986). A study by Orlowski and Wateska (1992) focused on a kind of industry-sponsored activity that provoked considerable criticism and that now is not permitted for accredited education, that is, a program held at a resort with all expenses paid for attendees and with limited time actually devoted to the educational content. The authors found, using actual prescribing data obtained before and after the activity, that this “elaborate promotional technique … was associated with a significant increase in the prescribing of the promoted drugs at one institution” (p. 273). The investigators also found that the physicians involved did not believe that the activity would affect their practices.

Another study found that courses on primary care directed by academic faculty covered a broader range of topics than symposia sponsored directly by industry (Katz et al., 2002). Moreover, 91 percent of the industry-sponsored symposia were sponsored by a company that had recently obtained FDA approval for a drug related to the symposium topic. The industry-sponsored symposia did not cover prevention screening, dermatological diagnoses, child abuse, alcoholism, or the technology resources available for clinicians, which were considered important in the academic program. In that study, the university-based accredited continuing medical education courses received funding from multiple companies through a MECC to the university. University faculty determined the content of their courses, and the MECC handled marketing and meeting logistics. During meal breaks at these courses, symposia funded by industry were also offered.

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). A commer cial provider selected a program concept to “provide a platform for one of the sponsors,” which was working on a drug covered by the program. The provider also organized informal workshops with experts who were hired on the basis of their support for the sponsor’s message.

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). Work is needed to validate this and other instruments that are intended to be used to assess bias in presentations retrospectively or identify presentations at risk of bias during the planning stage (see, e.g., Barnes et al. [2007]).

The Senate Finance Committee staff report on the use of educational grants by pharmaceutical manufacturers noted that ACCME’s reports documented numerous cases of undue influence by companies over “supposedly independent educational programs” (Finance Committee, U.S. Senate, 2007, p. 2). For example, during 2005 and 2006, 18 of 76 program providers were found to be out of compliance with at least one of the ACCME standards related to independence, and some were cited for being under the improper influence of industry.

More specific information on industry practices comes from litigation. Prompted in many instances by whistleblower complaints, the U.S. Department of Justice as well as state attorneys general have filed charges against a number of pharmaceutical and medical device companies for illegal practices related to purported educational activities as well as speaking and writing arrangements. In some cases, one focus of litigation has been the giving of educational grants as an inducement to use the company’s products, which can be illegal under the Medicare law. In other cases, the focus has been on industry efforts to bias the content of educational programs and presentations, particularly as part of efforts to promote the off-label use of drugs (i.e., for purposes not approved by the FDA), which is also illegal.¹⁰

Box 5-3 lists some of the cases in which settlements have been reached. Internal company documents that were made public as a result of the first case described in the box provided insights into the use of speakers bureaus (which included chairs of neurology departments), “educational” teleconferences, and grants to medical education companies (with multiple ties to the company) to further marketing objectives for the drug Neurontin (gabapentin) (Steinman et al., 2006; see also Landefeld and Steinman [2009]). The conditions associated with the settlement in the case specified requirements for the company’s reporting of its support for continuing medical education and its financial relationships with speakers and participants (OIG, 2004).¹¹

BOX 5-3

Settlements Involving Educational Activities and Speaking and Writing Arrangements. In 2004, Warner-Lambert paid $430 million to settle U.S. Department of Justice charges that the company promoted off-label uses of the drug Neurontin in violation of the (more...)

Responses to Concerns About Bias in Industry-Funded Accredited Continuing Medical Education

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. Certain practices by medical school faculty create a hidden curriculum that subverts the professional values endorsed by the formal curriculum. One example is taking credit as the author of a manuscript prepared by an unacknowledged or inadequately acknowledged industry-paid writer. (An adequate acknowledgment would specify the roles of these writers, for example, as the preparers of the first draft, as well as the roles of the listed authors.) Another example is participating in an industry speakers bureau or other long-term speaking arrangement with a company, regardless of how the relationship is labeled. One concern is that ongoing company payments for presentations (and travel to attractive locations) create a risk of undue influence. A second concern that is frequently tied to the speakers bureau label is that the company exerts substantial control over the content of a presentation. Industry influence in these arrangements may be direct (e.g., when a talk and slides are largely or entirely prepared by someone else or when speakers are instructed to provide the company-prepared responses to questions and avoid the favorable mention of competing products). Influence may also be less direct (e.g., when a company-trained and company-paid physician modifies talks to fit the objectives of the company) (see, e.g., Elliott [2006] and Carlat [2007]). The committee recognizes that companies have an interest in some oversight of presentations for a variety of reasons, including the need to comply with FDA prohibitions on promoting the use of drugs for the treatment of conditions not approved by the agency.

Serving on speakers bureaus appears to be common in clinical medicine. A 2006 survey of academic-industry relationships found that 21 percent of clinical department chairs reported being on a speakers bureau (whereas 2 percent of nonclinical department chairs reported being on a speakers bureau) (Campbell et al., 2007b). As reported earlier, another survey, which was not limited to academics and which asked less specific questions, found that 16 percent of physicians reported serving on a speakers bureau or as a speaker, which could have involved a single presentation (Campbell et al., 2007a). 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. 3).

Unacknowledged industry influence over publications is also common. In one study, 13 percent of research articles in major biomedical journals had “ghost” authors, that is, people who filled the criteria for authorship but who were not listed as authors (Flanagin et al., 1998). None of these ghost authors was even acknowledged in the paper. A review of documents obtained during litigation against a major pharmaceutical company concluded that review manuscripts were often prepared by writers for medical publishing companies but authorship was “subsequently attributed … to academically affiliated investigators who often did not disclose industry financial support” (Ross et al., 2008, p. 1800). One incident illustrates that such ghostwriting may be discovered only by accident. An academic physician reported that a MECC sent her a draft manuscript of a review article commissioned by a drug company and invited her to be its “author.” She declined, but she was subsequently asked by a journal to review an article that was similar to that article and that now had another author (Fugh-Berman, 2005; see also Eaton [2005]). The analysis by Steinman and colleagues (2006) of documents obtained through litigation cited earlier found that those documents describe plans for recruiting academic authors of a series of ghostwritten articles to be prepared by a medical education company. Box 5-3 included examples of company settlements with the Department of Justice related to speaking and writing arrangements.

Another concern about industry relationships is that academic authors of research articles may not have full access to the data from an industry-sponsored study. This issue was discussed in Chapter 4.

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. [1997], Davidoff et al. [2001], ICMJE [2008], and WAME [2008]). 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. [2008]). 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 [2002] and Woolley et al. [2006]).

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. 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.

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 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).

Medical Schools and Residency Programs

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 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 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 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 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).