Industry support of continuing medical education: evidence and arguments.
Physicians are required by law and by professional codes of ethics to participate in continuing medical education. (3) Given CME's high cost, and given declining support for CME from public and academic institutions, it is not surprising that medical educators and physicians have sought financial support from private industry. (4) This effort has been successful; the amount and proportion of funds provided by industry have increased despite reservations about the influence that industry can exert over content and mission. (5) According to a national survey of physicians conducted in 2003 and 2004, more than one-third of physicians (35 percent) are reimbursed for costs associated with professional meetings or continuing medical education. (6) Over half of financial support for CME comes from industry, and CME increasingly is provided by primarily for-profit medical education and communication companies (MECCs), which receive nearly all of their income from commercial sources. (7)
No one knows exactly how much industry support physicians receive, however, because it comes in many forms and types. Pharmaceutical firms and other health-related businesses sponsor speakers at conferences, organize and sponsor dinners with faculty presenters whom they select and pay, provide food at grand rounds or conferences, and sponsor educational events at a variety of other venues, with a variety of providers, and with varying input and control over content. Indeed, one could characterize three categories of CME: (1) CME that is accredited by the Accrediting Council on CME, (2) unaccredited CME that nonetheless includes learning objectives and methods, and (3) promotional activities purporting to be CME (also unaccredited). No clear agreement exists about what industrial activities go in the last two categories. Unaccredited CME can include industry sponsored dinners, satellite conferences, and speakers' bureaus. Although some of these activities doubtless mix education and marketing, accurately distinguishing between the two is very difficult. Nonetheless, most reasonable observers would include the distribution of trinkets--pens, notepads, and coffee mugs--sporting industrial logos, drug samples, food and beverages, and tickets to cultural or sporting events as pure promotion, not in any way educational. Since the latter two categories may not be readily distinguished on their face, accreditation has the potential to serve as the only way to reliably distinguish CME from promotions masquerading as CME. Accredited CME must comply with guidelines developed by the Accrediting Council for CME (ACCME), which include prohibitions about the sponsor's control over content. (8)
Perhaps the most compelling ethical argument for permitting industry funding of education rests on physicians' liberty interests. These liberty interests, however, are outweighed by the ethical obligations of physicians to place patient interests ahead of their own, and by the duty and privilege of a profession to control the education of its members. Claims that industry funding benefits patients by improving physician knowledge and competence have little empirical evidence to support them. In contrast, some evidence exists that physicians are inappropriately influenced by industry-funded CME, and that patients and the public view such activities negatively.
A number of positive effects of industry funding on CME have been proposed. By keeping the cost of attendance down or making participation more attractive (such as by providing meals), industry support may result in greater participation in CME. Certainly, physicians are more likely to attend continuing education events when refreshments are provided, and they regularly voice concerns about the cost of CME. (9) Surveys of physicians indicate that some favor industry funding if it keeps the cost of attendance down, although some also prefer that CME not receive funding from pharmaceutical companies. Physicians say they are aware that industry funding leads to bias, even though they are less likely to report that industry funding of CME influences their own practice. (10)
Little evidence exists either to support or refute claims that the availability, affordability, or attendance levels of continuing medical education would change if industry funding were tightly restricted or prohibited. Some medical professional societies convene well-attended meetings with little or no industry funding; the Society of General Internal Medicine is one example. Also, the experience with continuing education in other professions, such as law, suggests that industry involvement is not necessary. Case studies at institutions that have removed commercial support for internal conferences suggest physician participation does not decline, although most of these institutions are academic medical centers and their success may not be replicable elsewhere, particularly in rural areas where access to in-person CME is more difficult. Physicians in these and other underserved areas may find accessing and paying for CME more difficult without industry subsidies.
Some have also proposed that industry representatives serve an important function in bringing new treatment modalities to the attention of busy physicians. Similarly, some have claimed that industry-supported CME events can be particularly effective in providing up-to-the-minute information. In a survey of physicians about the pharmaceutical industry, busy physicians were more likely to report meeting with representatives--as were older and male physicians--and to report more frequent interactions. It is not clear whether industry support for CME encourages physicians to be more closely involved in continuing education, or just to have more frequent interactions. (11) Given that the cost of attending CME includes lost practice revenue in addition to tuition and possibly travel expenses, alternatives to face-to-face, off-site conferences and meetings could prove more economical. Online education and office-based learning would also accord better with educational leaders' suggestions that continuing education occur in closer proximity to daily practice. (12) Although these activities are also sometimes sponsored by the pharmaceutical industry, they're cheaper and so have less need for support.
Arguments in favor of restricting industry support for CME, like arguments about restricting other physician-industry interactions, often claim that industry-funded CME could bias and inappropriately influence physicians' clinical practice, that such influence on clinical recommendations could affect health care costs, and that even the appearance of influence can undermine public and patient trust in doctors. As far back as 1991, pharmaceutical marketing experts noted that direct mail, journal advertising, and detailing were declining in importance while conventions, meetings, and conferences were growing. (13) Although recent research has been sparse, several studies suggest that industry-sponsored CME contains content biased in ways that favor the sponsors, and physicians attending CME sessions sponsored by a single company were more likely to prescribe that company's product. (14)
Not all changes in physician practice stimulated by industry should be criticized, however, since some may result in improved patient care, and some may represent equivalent care and costs. To date, no evidence exists about the impact on patient outcomes or on health care costs of industry-supported CME compared to CME without such support. Nor has any research examined the quality of CME (other than investigating bias) or differences in educational outcomes, although this may reflect a dearth of research on the outcomes of CME generally. (15) Convincing evidence indicates that physician prescribing behavior changes as a result of interaction with pharmaceutical representatives outside of educational events, and a growing body of biological and behavioral research--some of it in medicine--indicates that the acceptance of "gifts" engenders feelings of reciprocity. (16)
Although no research addresses the impact of industry sponsorship of CME on patients' trust in physicians specifically, some studies have examined patient's views of physician-industry relationships. In one study, patients viewed pharmaceutical gifts as more influential and less appropriate than did their physicians. (17) In a survey of patients in waiting rooms, 32.5 percent did not approve of their physicians accepting reimbursement from a pharmaceutical company for medical conference expenses, and from 28 percent to 43.4 percent disapproved of their physicians attending social events sponsored by pharmaceutical companies at a medical conference. Seventy percent of the subjects in that study believed that gifts sometimes or frequently influence a physician's prescribing of medication. (18)
Of course, arguments for and against tighter restrictions on industry support for CME do not rely solely on empirical claims. Ethical arguments supporting limits and restrictions appeal to both patient-centered obligations and professional standards. Doctors should avoid circumstances that could inappropriately influence (or appear to influence) patient care decisions, for instance, as the influence may compromise their obligations of advocacy and beneficence. The American Medical Association's principles of medical ethics state that "A physician shall, while caring for a patient, regard responsibility to the patient as paramount." (19) In addition, medicine's status as a self-regulating profession includes the obligation and privilege to oversee and control the education of its current and future members.
Ethical arguments opposing such restrictions often include appeals to individual liberties; these arguments hold, for example, that physicians should have the right to accept compensation for services from any entity, or that restrictions on their freedom to accept compensation, gifts, or subsidies for CME would require more compelling ethical justification--including evidence of negative consequences--than currently exists. Furthermore, some argue that industry-supported CME represents a benefit to patients and the public by contributing to physician knowledge. Nearly all agree that, when physicians have relationships with industry that could appear to present conflicts with their duties to patients, such relationships must be disclosed to preserve transparency and trust.
Organizations focused on regulating medical education have established guidelines related to industry support for conferences and other educational events. (20) The guidelines of the Accreditation Council on Continuing Medical Education (ACCME) have been widely adopted by medical school and other CME providers, and an American Association of Medical Colleges task force recently examined industry support for CME and issued recommendations. (21) The Department of Health and Human Services Office of the Inspector General compliance guidelines specify that industry should have no control over speakers or content of CME programs, consistent with ACCME standards. What is not known is the impact of these guidelines on the activities of CME providers. Much CME still occurs without formal accreditation, and some is an opaque mix of education and marketing, promoted by CME providers to pharmaceutical companies as expenses with a good rate of return. (22) Even when ACCME guidelines are followed, adherence is probably not sufficient to remove the inappropriate influence of industry funding on CME speakers or content (both in individual events and, perhaps more importantly, by influencing the topics offered). Some speculate that the existence of accreditation standards might, perversely, lessen the skepticism of CME audiences that the material presented is independent, unbiased, and free from the influence of industry sponsors. Additional research should address these issues.
Policy options related to industry funding of CME span a spectrum from a total ban on all such sponsorship to continued reliance on accreditation, guidelines, and voluntary compliance on the part of physicians and the industries involved in such support. (23) Most in the medical community prefer to limit physician-industry interactions, (24) rather than ban them altogether, despite evidence that industry-sponsored CME reflects the sponsor's bias, that physicians change their practices in line with those biases, and that patients and the public think physicians should not accept gifts or compensation from industry, including for CME expenses. Although some research suggests that physicians are concerned about the cost of CME and prefer CME supported by industry if it costs less, no evidence exists for the view that CME would be less frequently offered or attended in the absence of industry funding, and physicians themselves raise concerns about potential bias in the content of industry-funded education.
The two main arguments opposing restrictions on CME--that the negative consequences are too minor to restrict physicians' liberty and that industry funding benefits patients by improving physician knowledge--are outweighed by evidence of negative consequences, a lack of evidence of the proposed benefit to patients of industry funding of CME, the ethical obligations of physicians to place patients' interests ahead of financial gain, and the duty of a profession to control and oversee its own education, training, and competence. If industry support for professional self-education is prohibited, however, then alternative sources and financial support of CME should be sought for physicians, particularly those in rural areas who would have difficulty attending or accessing CME.
The authors began this work while supported by a grant from the Greenwall Foundation Bioethics Program. They thank Nancy Adams for excellent manuscript preparation.
(1.) P. Loftus, "Pfizer to End Financial Support For Commercial Doctor Classes," Wall Street Journal, July 2, 2008.
(2.) M. Gould, "End of the Free Lunch?" British Medical Journal 337 (2008): 487-88.
(3.) American Medical Association, "Code of Medical Ethics: Current Opinions with Annotations, 2006-7," section E8.061.
(4.) Council on Graduate Medical Education, Fifteenth Report: Financing Graduate Medical Education in a Changing Health Environment (Rockville, Md.: Department of Health and Human Services, 2000).
(5.) R.V. Harrison, "The Uncertain Future of Continuing Medical Education: Commercialism and Shifts in Funding," Journal of Continuing Education in the Health Professions 23 (2003): 198-209; P. Rutledge et al., "Do Doctors Rely on Pharmaceutical Industry Funding to Attend Conferences and Do They Perceive That This Creates a Bias in Their Drug Selection? Results From a Questionnaire Survey," Pharmacoepidemiology & Drug Safety 12, no. 8 (2003): 663-67; M.M. Chren and C.S. Landefeld, "Physicians' Behavior and Their Interaction with Drug Companies," Journal of the American Medical Association 271 (1994): 684-89; R. Steinbrook, "Commercial Support and Continuing Medical Education," New England Journal of Medicine 352, no. 6 (2005): 534-35.
(6.) E.G. Campbell et al., "A National Survey of Physician-Industry Relationships," New England Journal of Medicine 356 (2007): 1742-50.
(7.) Ibid.; Steinbrook, "Commercial Support and Continuing Medical Education"; Accreditation Council on Continuing Medical Education, Annual Report, 2002, (Chicago, Ill.: Accreditation Council for Continuing Medical Education, 2003), 6.
(8.) Accreditation Council on Continuing Medical Education, Annual Report, 2002, 6.
(9.) Rutledge et al., "Do Doctors Rely on Pharmaceutical Industry Funding?"; C.M. Segovis et al., "If You Feed Them, They Will Come: A Prospective Study of the Effects of Complimentary Food on Attendance and Physician Attitudes at Medical Grand Rounds at an Academic Medical Center," BMC Medical Education 7 (2007): 22.
(10.) Rutledge et al., "Do Doctors Rely on Pharmaceutical Industry Funding?"; J.K. Cornish and J.C. Leist, "What Constitutes Commercial Bias Compared with the Personal Opinion of Experts?" Journal of Continuing Education in the Health Professions 26, no. 2 (2006): 161-67; P.S. Mueller, C.C. Hook, and S.C. Litin, "Physician Preferences and Attitudes Regarding Industry Support of CME Programs," American Journal of Medicine 120, no. 3 (2007): 281-85.
(11.) R.P. Ferguson et al., "Encounters with Pharmaceutical Sales Representatives among Practicing Internists," American Journal of Medicine 107, no. 2 (1999): 149-52.
(12.) Accreditation Council on Continuing Medical Education, Annual Report, 2002, 6; N.L. Bennett et al., "Physicians' Internet Information-Seeking Behaviors," Journal of Continuing Education in the Health Professions 24, no. 1 (2004): 31-38.
(13.) J.R. Williams, and P.J. Hensel, "Changes in Physicians' Sources of Pharmaceutical Information: A Review and Analysis," Journal of Health Care Marketing 11, no. 3 (1991): 46-61.
(14.) J.P. Orlowski and L. Wateska, "The Effects of Pharmaceutical Firm Enticements on Physician Prescribing Patterns," Chest 102 (1992): 270-73; M.A. Bowman and D.L. Pearle, "Changes in Drug Prescribing Patterns Related to Commercial Company Funding of Continuing Medical Education," Journal of Continuing Education in the Health Professions 8, no. 1 (1988): 13-20.
(15.) S.S. Marinopoulos et al., "Effectiveness of Continuing Medical Education," Evidence Report/Technology Assessment 149 (2007): 1-69.
(16.) Chren and Landefeld, "Physicians' Behavior and Their Interaction with Drug Companies"; Orlowski and Wateska, "The Effects of Pharmaceutical Firm Enticements on Physician Prescribing Patterns"; M.Y. Peay and E.R. Peay, "The Role of Commercial Sources in the Adoption of a New Drug," Social Science & Medicine 26 (1988): 118389; A. Wazana, "Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?" Journal of the American Medical Association 283 (2000): 373-80; J. Dana and G. Loewenstein, "A Psychological Perspective on the Influence of Gifts to Physicians from Industry," Journal of the American Medical Association 290, no. 2 (2003): 252-55.
(17.) R.V. Gibbons et al., "A Comparison of Physicians' and Patients' Attitudes toward Pharmaceutical Industry Gifts," Journal of General Internal Medicine 13, no. 3 (1998): 151-54.
(18.) R.L. Blake, Jr., and E.K. Early, "Patients' Attitudes about Gifts to Physicians from Pharmaceutical Companies," Journal of the American Board of Family Practice 8, no. 6 (1995): 457-64.
(19.) American Medical Association, "Code of Medical Ethics: Current Opinions with Annotations, 2006-7," Section E8.061, p. xv.
(20.) Steinbrook, "Commercial Support and Continuing Medical Education"; ACGME White Paper on the Relationship of GME and Industry, "Principles to Guide the Relationship between Graduate Medical Education and Industry," September 10, 2002, at http://www.acgme.org/acWebsite/positionPapers/pp_GMEGuide.pdf.
(21.) Report of the AAMC Task Force on Industry Funding of Medical Education to the AAMC Executive Council, June 2008, http://www.aamc.org/research/coi/industryfunding.pdf (accessed on June 6, 2008).
(22.) J. Mack, "A Strategic Approach to CME Offers High Return on Education Investment," Pharma Marketing News 4, no. 6 (2005): 1-3.
(23.) Harrison, "The Uncertain Future of Continuing Medical Education:"; A.S. Relman, "Defending Professional Independence," Journal of the American Medical Association 289, no. 18 (2003): 2418-20; A. Opar, "Medical Students Protest Perks from Drug Companies," Nature Medicine 12, no. 10 (2006): 1104; T.A. Brennan et al., "Health Industry Practices that Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers," Journal of the American Medical Association 295, no. 4 (2006): 429-33.
(24.) Campbell et al., "A National Survey of Physician-Industry Relationships."
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|Author:||Goold, Susan Dorr; Campbell, Eric G.|
|Publication:||The Hastings Center Report|
|Date:||Nov 1, 2008|
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