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REVIEW ARTICLE |
a Children's Health Services Research
c Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana
b Regenstrief Institute, Inc, Indianapolis, Indiana
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ABSTRACT |
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 TOP ABSTRACT METHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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OBJECTIVE. Our goal was to summarize the recent literature regarding the impact of educational interventions and regulatory policies on trainee perceptions of pharmaceutical industry interactions and/or pharmaceutical industry–related trainee behavior.
METHODS. We searched Medline and the bibliographies of review articles for relevant studies. Articles published before the Accreditation Council for Continuing Medical Education standards for commercial support of continuing medical education were issued in 1991 were excluded. Two reviewers selected empiric studies that (1) reported empiric data about educational interventions that were meant to shape trainee knowledge, attitudes, or practices concerning the pharmaceutical industry or (2) evaluated the impact of regulatory policies on trainee attitudes or behaviors.
RESULTS. From 247 identified articles, 12 met the inclusion criteria. In 2 of these studies, the impact of regulatory policies on trainee attitudes and/or behaviors was assessed. In the remaining 10 studies, the impact of various educational interventions developed by training programs or schools to shape trainee knowledge, attitudes, or practices concerning the pharmaceutical industry were evaluated.
CONCLUSIONS. Although modest in size, a body of empirical research exists that might inform medical educators. Beyond institutional policy that excludes the pharmaceutical industry, the evidence reviewed suggests that well-designed seminars, role playing, and focused curricula can affect trainee attitudes and behavior, although it is not entirely clear whether these changes are sustainable over the long-term.
Key Words: medical education • pharmaceutical industry • gifts • residents • students
Abbreviations: AMC—academic medical center • CME—continuing medical education • PR—pharmaceutical representative
The primary goal of pharmaceutical companies, like all large businesses, is maximization of product sales and profits. Because physicians act as the gatekeepers to prescription drugs, it is no surprise that the majority of pharmaceutical companies' marketing strategies target physicians.1 Despite a dramatic increase in direct-to-consumer advertising, 
90% of the pharmaceutical industry's $21 billion marketing budget is still aimed at physicians (including residents and medical students).2 Interactions between pharmaceutical companies and physicians are pervasive and range from seemingly inconsequential exchanges (eg, dispensing inexpensive gifts such as logo-inscribed pens and notepads) to much more significant and potentially problematic interactions (eg, payment of large honoraria to prominent physicians who speak about the merits of a company's products or payment of trip expenses for physicians who commonly prescribe a company's products).3
Although the existence of physician–pharmaceutical company interactions is unquestioned, debate continues over whether these interactions actually influence physician behavior, either positively or negatively. Many physicians believe that their interactions with pharmaceutical companies have a positive educational value, and they are confident that their own behavior is in no way influenced by these interactions.2–5 However, social science literature has suggested that it would be very unusual if physician behavior was not influenced by both small- and large-scale interactions with pharmaceutical companies.2,3 In the past 25 years, 2 reviews of the literature have examined the extent of the physician–pharmaceutical industry interaction and its impact on physician behavior.6,7 Both reviews showed strong evidence that physician–pharmaceutical company interactions have a negative impact on physician knowledge, attitude, and behavior.
These findings have led some to call for a tougher stance on physician–pharmaceutical company interactions. In fact, a workgroup sponsored by the American Board of Internal Medicine Foundation and the Institute of Medicine as a Profession recently challenged academic medical centers (AMCs) to take the lead in voluntarily instituting more stringent regulations.2 Recommendations from this group included completely banning faculty and trainees from accepting gifts of any size from pharmaceutical companies, prohibiting the provision of drug samples, and eliminating manufacturer support of continuing medical education (CME) programs.2 Several AMCs clearly heard this challenge and responded with more restrictive policies regarding physician–pharmaceutical company interactions, including Stanford University School of Medicine in California and Yale School of Medicine.8,9 It is important to note, however, that these programs' policies refer only to physicians, not medical students or other trainees. In fact, a 2005 survey found that only 10% of medical schools had a policy that pertained specifically to pharmaceutical company–medical student interactions.10
AMCs have been called on to take the lead in controlling physician–pharmaceutical company interactions precisely because of the major role they play in training medical students and housestaff. A review by Zipkin and Steinman11 of the literature on the pharmaceutical industry's influence on medical trainees found that the pharmaceutical industry has a significant presence during residency training and that the majority of residents believe that these industry interactions are appropriate. In addition, a majority of residents felt that their own prescribing behavior could not be influenced by such interactions, but they did believe that others' behavior could be influenced. Other studies have demonstrated that trainees believe that their personal economic hardships entitle them to gifts from pharmaceutical companies.10,12 It may be especially important to understand the vulnerability of trainees to pharmaceutical company marketing tactics and influences, because the habits learned or acquired during training persist into their later careers.
Are more stringent regulations the only answer to the problems associated with trainee–pharmaceutical industry interactions? Some believe that regulations and policies that advocate for a complete lack of contact with pharmaceutical representatives (PRs) during training would leave physicians unprepared to deal with them after the completion of residency or fellowship.13 Still others claim that the costs of medical education are so high that medical trainees would suffer without external support from industry.14 This has led to questions about whether educational interventions can play a role in changing trainee attitudes about the pharmaceutical industry and thereby counteract the negative outcomes of trainee-industry interactions.
The purpose of this study was to review the recent literature regarding the impact of educational interventions and regulatory policies on trainee perceptions of pharmaceutical company interactions and/or trainee physician behavior.
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METHODS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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We included studies that reported empiric data about educational interventions meant to shape trainee knowledge, attitudes, or practices concerning the pharmaceutical industry. Studies that evaluated the impact of regulatory policies on trainee attitude or behaviors were also included. Articles were excluded if they (1) did not include data on medial trainees (medical students, residents, and fellows), (2) were letters or editorials with no new data, or (3) were not published in the English language. We also excluded studies published before 1991, when the Accreditation Council for Continuing Medical Education standards for commercial support of CME were first issued, because we felt that studies from social and political climates before the institution of these standards would not have as much relevance in today's climate. Studies that were descriptive in nature and/or presented no formal outcome data about the educational intervention or regulatory policy's impact on trainee knowledge, attitudes, or behaviors were also excluded.
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RESULTS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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Of these 247 articles, 12 met our inclusion criteria (see Table 1). In 2 of these studies, the impact of regulatory policies on trainee attitudes and/or behaviors was assessed.13,18 In the remaining 10 studies, the impact of various educational interventions developed by training programs or schools to shape trainee knowledge, attitudes, or practices concerning the pharmaceutical industry was evaluated.19–28 Two of the 12 studies were published before 1994, and 5 were published between 2004 and 2006. All of these studies used written surveys in the collection of data. Although all 12 of the studies surveyed attitudes, only 2 studies attempted to examine trainee behavior change.13,25 The sample sizes in these studies also varied greatly from 12 to 265, with a median of 56. Response rates ranged from 51% to 100% (median: 81%).
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Studies of Educational Interventions to Counter the Pharmaceutical Industry's Impact on Trainees
The 10 studies that examined the impact of educational interventions for trainees varied in the strength of study design. Seven of these studies were designed as pre-post studies, measuring outcomes before and after the educational intervention,20–24,26,27 and 3 were controlled trials.19,25,28
The first pre-post study examined 12 family practice residents who were exposed to a program designed to help them evaluate presentations by PRs.20 This intervention involved an initial lecture/discussion at the beginning of each residency year regarding the goals and techniques of pharmaceutical advertising. Residents then participated in a half-hour discussion session after luncheon PR presentations that occurred twice a month. The residents filled out a form to help them evaluate the completeness of the presented information, what persuasive techniques were used, and the use of rational and nonrational appeals. The 12 residents did not significantly change their beliefs that PRs could provide useful information or that they served an important teaching function. However, 12 months after the intervention, the residents were significantly more likely to believe that they could be influenced by pharmaceutical interventions ("Discussion with PRs has no impact on my prescribing behavior": 5-point Likert-scale score change from 3.3 to 3.1; P < .05) and gifts ("Acceptance of promotional items from PRs has no impact on my prescribing behavior": 5-point Likert-scale score change from 2.3 to 1.8; P < .05). They were also more likely to endorse beliefs that PRs should not support conferences or provide speakers ("PRs help to support important conferences and speakers at this institution": 5-point Likert-scale score change from 2.2 to 1.7; P < .05).
The second pre-post study involved a 3-hour curriculum on PR discussions, promotional materials, and ethical issues given to 29 family practice residents.21 This curriculum included a 1-hour seminar with videotape examples of PR interactions and 2 practice sessions with PRs. During a final session, the resident was observed and evaluated by other residents and faculty. Residents who attended the program felt that they could more effectively set the agenda while talking to PRs. In addition, they felt that they could identify and deal with marketing techniques used by PRs (numeric Likert-score changes were not given, but changes were reported to be significant: P < .05).
Another pre-post study examined how a 40-minute lecture and discussion on PR behavior and marketing techniques affected 31 internal medicine/pediatrics residents.22 The intervention included 6 brief vignettes of physician-PR interactions to demonstrate the types of marketing techniques used. After the intervention, residents were more likely to believe that interactions with PRs influenced their prescribing behavior ("Interactions with PRs are likely to influence my prescribing behavior in negative ways": 5-point Likert-scale item with mean difference scores of 0.13 vs –0.40; P = .046). They were also more likely to believe that PRs engaged in unethical marketing practices ("PRs may use unethical marketing practices": 5-point Likert-scale item with mean difference scores of 0.63 vs –0.20; P = .007) and less likely to believe that accepting gifts without patient benefit was ethically acceptable ("It is ethically appropriate to receive marketing gifts without patient benefit": 5-point Likert-scale item with mean difference scores of –0.37 vs 0.24; P = .05).
In an another pre-post study, 120 third-year medical students participated in a 3-hour group exercise.23 A hospital pharmacist who played the role of a PR provided a 20-minute presentation to a small group of medical students, followed by a question-and-answer session with discussion. After the session, more students felt that gifts from pharmaceutical companies affected physician behavior ("When drug companies give physicians pens, calendars, or other noneducational materials, this biases the subsequent behavior of those physicians": 20% vs 13% agree; P < .05), and fewer of them agreed that advertisements provided educational information about drugs ("Product information presented in a drug advertisement provides you with educational material about the drug": 43% vs 49% agree; P < .01). Although the medical students recognized the effects of many techniques used by pharmaceutical companies, they were not more likely to view any of them as unethical.
The pre-post study by Agrawal et al24 examined how a 2 1/2-hour workshop on PR interactions affected 37 family practice residents. This seminar was given over 2 days and included a faculty-led debate on whether pharmaceutical marketing affects physicians, a review of the literature on the pharmaceutical industry's impact on physician behavior, and problem-based discussions. After the intervention, residents reported thinking that many of the interactions between physicians and PRs were less ethically appropriate, including the acceptance of drug samples (5-point Likert-scale score change from 3.9 to 3.4; P < .01), free meals (5-point Likert-scale score change from 2.6 to 2.3; P < .01), and gifts of small monetary value (5-point Likert-scale score change from 2.8 to 2.1; P < .01). Their intention to engage in CME activities sponsored by drug companies (5-point Likert-scale score change from 3.2 to 2.7; P < .01) and to interact with their PRs (5-point Likert-scale score change from 2.5 to 2.2; P < .01) also decreased significantly.
A pre-post study of medical students in England examined how a course designed in conjunction with a pharmaceutical company could convey key features of drug development.26 Twenty-nine students participated in the course, and 23 of them completed both the preopinion and postopinion surveys. The medical school and local pharmaceutical company teamed up to develop the curriculum, which included both didactic and self-study components. Some of the lectures were even given at the drug company's campus. Students who attended the course demonstrated increased knowledge that correlated with the presented information on drug costs, phase I studies, and the yellow-card scheme for adverse-event reporting (P < .05). They also were significantly less likely to believe that pharmaceutical companies were overcharging the national health system or were "fat cats" (P < .05).
Another study examined 75 medical students who attended a mandatory workshop on interactions with PRs.27 This 90-minute session was developed by 2 faculty members and a PR and included lecture, discussion, and role playing. After the workshop, students were significantly more likely to believe that information from PRs would be of educational value to them ("In your opinion, what is the educational value to medical students offered by detailing from pharmaceutical representatives": 5-point Likert-scale score change noting educational value 22% to 41%; P = .0007). They were also less likely, although not significantly so, to believe that information from PRs was biased ("What is your perception of the degree of bias in the information provided by pharmaceutical representatives detailing to practicing physicians": 5-point Likert-scale score change noting bias from 84% to 73%; P = .065).
The first controlled trial of an educational intervention examined the effect of a 50-minute lecture and discussion on the attitudes of 72 second-year medical students regarding the appropriateness of the pharmaceutical industry's marketing practices.19 Fifty-nine first-year medical students served as the control group. The investigators administered surveys to the experimental and control groups 6 weeks before and 7 weeks after the educational intervention. After the intervention, second-year students approved less of books, pens, CME dinners, paid travel, and expensive gifts (P < .05), whereas the attitudes of those in the control group did not change significantly.
Another controlled trial examined how a 1 1/2-hour session regarding physician–pharmaceutical industry interactions and ethical guidelines would affect psychiatry residents.25 This intervention consisted of reading and discussing editorials about pharmaceutical industry marketing strategies and discussion of 4 humorous vignettes of typical PR interactions. The 18 psychiatry residents who rotated at the Veterans Affairs Medical Center participated in the educational intervention, and 25 psychiatry residents who rotated at community mental health centers or private facilities served as the control group. This 1-time interaction had no effect on the residents' attitudes toward PRs 2 months later, but the self-reported acceptance of office supplies (P = .0001) and gifts of no educational value decreased significantly (P = .032).
The final nonrandomized, controlled trial involved 118 internal medicine residents.28 This study's purposes were to (1) examine residents' attitudes toward the pharmaceutical industry at different stages of their training and (2) determine the effect of an educational intervention meant to increase resident awareness of potential conflicts of interest when interacting with the pharmaceutical industry. These researchers found that trainee perceptions of appropriateness of interactions such as pharmaceutical industry–sponsored noon conference lunches (postgraduate year [PGY] 1 mean: 3.2 on a 5-point Likert scale; PGY 3 mean: 3.5 on a 5-point Likert scale; P = .007) and PR talks at noon conferences (PGY 1 mean: 2.5 on a 5-point Likert scale; PGY 3 mean: 3.0 on a 5-point Likert scale; P = .014) demonstrated small changes over time. To examine the effect of the educational intervention, the researchers examined 6 types of interactions and gifts that had demonstrated inducing a statistically significant change for all residents. Compared with the control group, those in the intervention group were more likely to rate only 1 of the appropriate interactions as less appropriate (lunch at noon conference: P = .042), and several of the inappropriate gifts were perceived as more inappropriate over time, but these findings were not statistically significant.
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DISCUSSION |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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Although the body of work examining the impact of educational interventions on trainee attitudes and behaviors toward the pharmaceutical industry is larger (n = 10), the majority of studies (n = 7) were pre-post in design and, therefore, not as methodologically strong as we might desire. Sample sizes for these studies ranged from 12 to 161, with 6 of the 10 studies having fewer than 40 participants.
Virtually all of the educational intervention studies were brief in nature. In fact, 4 of the 10 interventions were 1 hour or less in duration. The curriculum often took on a lecture/discussion format, and several interventions included a role-playing component. Receiving the educational intervention was associated with increased beliefs by trainees that PR interactions are problematic and that PRs can influence prescribing practices of physicians. In addition, trainees who participated in the interventions were less accepting of pharmaceutical industry marketing tactics and gift giving. An interesting exception to these findings concerns the 2 studies in which the pharmaceutical industry was directly involved in the development of the educational intervention. In these studies, trainee attitudes were found to be more positive toward PRs and the pharmaceutical industry.
It is important to note that all but 2 of these studies measured short-term changes in attitude. Therefore, it is unclear what impact these interventions will have over the long run, although both studies that examined attitude change over a more extended period of time did demonstrate lasting changes in attitudes. In addition, it is important to point out that although many of these studies demonstrated statistical significance, this is not necessarily synonymous with educational and clinical importance; therefore, these brief interventions might lack sufficiency.
Only 1 of the studies that examined educational interventions tried to assess changes in behavior, and that study found that trainees who had participated in the educational intervention 2 months before reported significantly reduced acceptance of miscellaneous office supplies and gifts with no educational value. With only 1 study assessing behavior change, it is difficult to ascertain whether these educational interventions have any impact on trainee behavior in the short-term or long-term.
Certain limitations of this study merit discussion. We only searched Medline after 1991, because we wished to include studies that were implemented only after publication of the first Accreditation Council for Continuing Medical Education standards for commercial support of CME. We also only included studies in the English language. Although the potential exists, therefore, that we may have overlooked some relevant studies, we did not locate any non–English-language studies during our searches that required exclusion.
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CONCLUSIONS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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Evidence also exists that can inform the choices of those responsible for educating medical trainees. Policy decisions to restrict contact between trainees and the pharmaceutical industry are associated with greater skepticism toward information given by PRs and altered behavior in future contact with such PRs.13,18 Those who believe that an all-or-nothing approach is too severe can find other alternatives, and it seems that many are doing just that. In a recent survey of American medical and pharmacy schools, 64% of the respondents reported that education about drug promotion is part of the required curriculum at their institution, and 25% reported that it was a required component within specialty/residency training.36 Our review suggests that educational interventions, both complex and simple, can affect trainee attitudes and even behavior to some extent.20,21,23–25 Every intervention included in this review, even those as brief as 1 hour, had some impact on trainees.19,22 However, it is not entirely clear from these studies that the changes in attitudes and/or behavior are sustainable over the long run. It also is not clear what format these educational interventions should take. More research is needed to determine the long-term impact of these educational interventions, and those who undertake any future research should make an effort to assess changes in trainee behavior.
The recommendations put forward by the American Board of Internal Medicine Foundation and the Institute of Medicine as a Profession2 have led AMCs to focus on severely restricting faculty and trainee interactions with the pharmaceutical industry. However, with health care costs continuing to rise in the United States, in no small part because of increased spending on drugs,37 we must teach our trainees how to choose and use medications properly. As part of this training, we should also prepare them to deal with PRs and with patients who have been exposed to pharmaceutical marketing. The American Association of Medical Colleges recently formed a task force to "1) examine, especially, the current interactions that drug and device makers have with the educational mission of medical schools and teaching hospitals, and 2) bring forth recommendations expeditiously for implementing safeguards to ensure that industry marketing efforts do not undermine the objectivity of educational programs or otherwise bias the evidence-based decision making of physicians."38 The information summarized in this review could inform this task force's decision. We suggest that any recommendations made by this group be studied on a large scale to evaluate both short-term and long-term outcomes and then refine these recommendations as needed.
It is not enough to take a stand on one side or another of this issue on the basis of political or monetary principles. In settings where banning physician–pharmaceutical company interaction is simply impractical or not possible, there are other alternatives that can be pursued such as educational interventions. Although this body of research is still small, these interventions do show some promise of affecting the attitudes and behaviors of physician trainees.
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FOOTNOTES |
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Address correspondence to Aaron E. Carroll, MD, MS, HITS Building, Suite 1020, 410 W 10th St, Indianapolis, IN 46202. E-mail: aaecarro{at}iupui.edu
Financial Disclosure: The authors have indicated that they have no financial relationships relevant to this article to disclose.
The views expressed in this article are those of the authors and do not necessarily represent the views of the Indiana University School of Medicine.
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