Coleman, David L. MD; Kazdin, Alan E. PhD; Miller, Lee Ann MS, RPh; Morrow, Jon S. MD, PhD; Udelsman, Robert MD, MBA
Dr. Coleman is professor and interim chair, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.
Dr. Kazdin is professor and chair, Child Study Center, Yale University School of Medicine, New Haven, Connecticut.
Ms. Miller is clinical coordinator, Drug Use Policy, Yale-New Haven Hospital, New Haven, Connecticut.
Dr. Morrow is professor and chair, Department of Pathology, Yale University School of Medicine, New Haven, Connecticut.
Dr. Udelsman is professor and chair, Department of Surgery, Yale University School of Medicine, New Haven, Connecticut.
Correspondence should be addressed to Dr. Coleman at Department of Internal Medicine, LMP 1072, Yale University School of Medicine, 333 Cedar St., New Haven, CT 06510; e-mail: 〈firstname.lastname@example.org〉.
Synergies between the pharmaceutical industry and physicians have promoted drug discovery and public health. However, potentially serious conflicts of interest complicate the relationships between physicians and the marketing components of industry. Although the pharmaceutical industry has played a very important role in distributing information about new and existing agents, biased or misleading information may be disseminated in the education of physicians and trainees.1 In addition, some physicians may seek relationships with industry that are inconsistent with professional standards. These interactions have affected practice patterns, the cost of medications, and the integrity of educational and clinical programs.2 With this problem in mind, we describe herein an approach by one medical school to set more stringent standards for the interactions of physicians with the marketing components of the pharmaceutical industry in order to facilitate the mutual efforts of physicians and industry to enhance the public health.
According to the Pharmaceutical Research and Manufacturers Association of America (PhRMA), member companies spent approximately $33 billion on research and development in 2003.3 In addition to the vital research and development activities of the pharmaceutical industry, substantial resources are devoted to marketing new or existing medications. According to industry estimates in 2003, $25.3 billion was spent on promotional activities, the great majority of which was directed at practicing physicians.3 Common marketing activities include direct-to-physician marketing by sales representatives; distribution of free drug samples to physicians; funding of medical meetings, journals, and educational events including continuing medical education (CME); direct-to-consumer advertising; some forms of research sponsorship; and advertising in print and electronic media.
The industry supports over 80,000 sales representatives; 80% to 95% of physicians meet regularly with sales representatives.4 On average, physicians meet with a pharmaceutical representative four times per month5 and, in one survey, 83% of internists meet with pharmaceutical representatives.6 A survey of physicians by the Kaiser Family Foundation in 2001 found that over 90% of physicians accepted free drug samples, over 60% received meals, tickets to entertainment, or free travel, and more than 10% received financial incentives, or financial or other in-kind benefits.7 Industry-sponsored promotional activities are also prevalent in residency programs.8
Continuing medical education in the United States is substantially supported by commercial sources.9 Although an important element of physician education, a review of industry-sponsored educational events revealed that they do not consistently present a balanced view of therapeutic alternatives,5 and are associated with subsequent requests to add the sponsor’s drugs to hospital formularies and increased prescription rates of the sponsor’s drug.5 In some instances these changes in physician behavior are warranted by true therapeutic advances, but in others reflect increased use of what may be therapeutically equivalent yet more costly medications.
Despite evidence to the contrary, many physicians believe that marketing does not substantially affect their practice patterns.10–14 Surveys of physicians have suggested that physicians in and outside of academic medicine believe that a wide variety of behaviors in their relationships with the pharmaceutical industry are ethically acceptable.10 In addition, individual physicians believe that they are less susceptible to influence by marketing of pharmaceutical agents than their colleagues.12,14
The potential impact of marketing practices and the pervasiveness of financial conflict of interest among physicians have raised concern among the public and among academic institutions.1,2,14–18 Patients have raised specific concerns about the effect of pharmaceutical advertising and conflicts of interest on practice patterns and the cost of medications.1,2,16 Indeed, one patient opinion survey suggested that overwhelming majorities would like physicians to stop seeing drug representatives (79%) and to stop receiving gifts (84%). In the same survey, patients believe that physicians should receive their education from independent sources (84%) and the ties between physicians and the pharmaceutical industry should be transparent (96%).16
In addition to the concerns of the public, two important developments have increased the federal government’s scrutiny of the relationship between the pharmaceutical industry and physicians. The Prescription Drug Plan adopted by Medicare has raised the federal government’s stake in the cost and use of medications. Moreover, federal anti-kickback and false claims laws have been used to prosecute several pharmaceutical companies for their marketing practices in addition to their arbitrage relationships with physicians.1 The possibility that individual physicians will be liable in future criminal or civil litigation cannot be excluded.1
In response to the growing concern among physicians, patients, and industry, national organizations representing physicians,19–21 the federal government,22 or industry23 have developed guidelines designed to eliminate extravagant gifts and excessive compensation for consulting, reduce financial conflicts of interest, increase disclosure, and to encourage objective educational programs. In addition, the Accreditation Council for Continuing Medical Education has developed more stringent standards for industry support of CME activities.24 These guidelines attempt to manage the relationship between the pharmaceutical industry and physicians to reduce the excesses that have led to legal liability while preserving the beneficial aspects of the relationship. To varying degrees, the guidelines of these organizations have potential to reduce the prevalence and impact of biased information or conflicts of interest. Nonetheless, many of the existing guidelines still permit behaviors and practices among physicians that may not adequately minimize conflicts of interest or ensure the objectivity of educational programs, and may have the unintended effect of increasing costs to consumers.1,2,5,6
Because of their importance in education, training, and research, academic medical centers have a critical role in establishing standards for the interactions among physicians and trainees with the marketing components of the pharmaceutical industry. Erosion of the public’s trust in the integrity of physicians and academic medicine will threaten clinical care, research, and education. Accordingly, we believe that academic medical centers must develop and refine their local standards governing these interactions. In order to learn how other academic medical centers have responded to this challenge, we queried other centers on the University HealthSystem Consortium listserv in December 2004. We received responses from 19 institutions: one banned industry sponsorship of food, three restricted distribution of promotional materials, and one limited food and gifts to a low dollar amount.
The Yale Guidelines
Since we sought a more comprehensive approach for our medical school than that used in the available guidelines of national organizations or other medical schools, the faculty of Yale School of Medicine (YSM) developed new guidelines (see the Appendix) to more rigorously address the potential areas of conflict between our physicians and the marketing components of industry. The overriding goal of these guidelines was to ensure as much as possible that the integrity of clinical decision making is not compromised by financial or other personal relationships with industry. The guidelines were developed and refined with extensive faculty input over a 12-month period. In addition, we sought the input of representatives from several pharmaceutical companies in formulating the guidelines. The Board of Governors of the Yale Medical Group (YMG), which is a group practice composed of Yale full-time faculty, approved the guidelines in May 2005.
The guidelines are not technically binding on YMG physicians, except in certain areas cited in the guidelines that are legally prohibited. The provisions in the guidelines that either reflect legal prohibition or have been identified as having a high potential for abuse have been both boldfaced and italicized in the text of the guidelines in the Appendix.
The Yale guidelines contain important differences from those in existing recommendations (see Table 1). In contrast to the recommendations of the American Medical Association, American College of Physicians, Office of Inspector General, and PhRMA, the Yale guidelines do not allow any form of gifts to Yale physicians. The rationale for excluding all gifts regardless of monetary value is as follows. First, gifts have been shown to influence behavior independent of the size of the gift.4,5,13,25 Second, the acceptance of gifts may diminish the stature of the medical profession from the viewpoint of patients. No gift is worth threatening the public’s trust. Third, defining “substantial value” or the exact monetary value of many gifts is too imprecise and arbitrary. Therefore, it is practically impossible to determine which gifts are permissible based on estimates of monetary value. Fourth, gifts may contribute to the cost of advertising and medications. Physicians cannot fulfill their obligation to promote access to health care if their behaviors increase the cost of health care. Finally, physicians may be liable for receiving gifts under anti-kickback laws.1
In addition to the ban on gifts, the Yale guidelines also eliminate industry-sponsored meals. In contrast, meals are permissible in the other guidelines (Table 1). Since industry-sponsored meals are a form of gift, a ban on meals was included in order to be consistent with the principles described above that led to the ban on any gifts.
The use of free samples of medications by Yale physicians or their family members was eliminated because faculty have the means to pay for medications. In addition, the dissemination of free samples is a substantial component of the industry’s promotional budget.3 Surveys have also suggested that distribution of free samples of prescription drugs may not be sufficiently regulated.26
The Yale guidelines strongly endorse the principle established by the American Association of Accreditation of Continuing Medical Education, the American Medical Association, and PhRMA that the content of CME activities should be controlled by the organizers of the educational activity rather than the sponsor. Indeed, all providers of CME must comply with the new requirements of the Accreditation Council for Continuing Medical Education (ACCME). The Yale guidelines, however, extend beyond formal CME activities. All industry-sponsored educational activities on the Yale School of Medicine campus must be compliant with the standards of the ACCME regardless of whether or not formal CME credit is awarded. Among the more notable requirements is that faculty must both disclose and resolve their financial conflicts of interest in order to participate in industry-sponsored educational events on the YSM campus. This provision recognizes that disclosure of financial conflicts alone is often not sufficient to eliminate bias, and the impact of the financial conflict may not be fully recognized by learners. Therefore, the Yale guidelines were expanded to include all industry-sponsored educational events. Resolution of the conflict of interest may be achieved by severing the financial relationship with the commercial entity or by submitting the educational materials to independent peer-review prior to the presentation to eliminate any potentially biased content. The ACCME has recently offered examples of how conflicts of interest can be resolved.27
The Yale guidelines also establish standards for the participation of faculty in two major types of educational activities that occur off campus (provision #5 in the Appendix). The first group includes educational activities run by professional societies and partially supported by industry. These activities frequently offer CME credits and are therefore also subject to the ACCME requirements. The second group includes educational activities fully sponsored and run by industry such as industry-sponsored speakers’ bureaus. These industry-run educational activities frequently seek to directly or indirectly promote new or existing drugs and are subject to the marketing regulations of the U.S. Food and Drug Administration. Since both of these groups of educational activities may include biased information, the Yale guidelines attempt to further ensure that the content of educational activities involving Yale faculty is controlled by the speaker, the presentation is as balanced as possible, advertising or gifts are not included in the session, attendees are not paid to attend, and that all potential conflicts of interest, including past or planned financial relationships, are disclosed.
In contrast to the policies identified at other academic medical centers, the Yale guidelines are intended to specifically ban all industry-sponsored meals and gifts on the Yale University School of Medicine campus, eliminate use of free drug samples by physicians or their family members, encourage disclosure and resolution of conflicts of interest in all industry-sponsored educational activities on campus even if formal CME credit is not awarded, and set standards for participation in industry-sponsored educational activities off campus.
The process of formulating the guidelines and building consensus for the provisions in the guidelines was particularly noteworthy. First, we discovered that the faculty from many different departments were generally enthusiastic about developing more stringent guidelines for the relationship between industry and the faculty. Although there was extensive discussion and revision of the text, the guidelines received strong support from the faculty and leadership of the school. Second, the ACCME and the pharmaceutical industry developed more restrictive policies during the period that the Yale guidelines were being formulated. These developments emphasize the broad interest in developing more effective guidelines for the relationship between industry and academic medicine. Finally, the guidelines do not specifically address relationships among Yale faculty and other commercial entities such as those in the device or biotechnology industry. We believe that the underlying principles inherent in the guidelines apply to relationships with all commercial entities, but chose to focus our initial efforts on the more prevalent relationships with the pharmaceutical industry.
Importance of Having Guidelines
The growing opportunities for drug discovery will require a strong partnership between academia and industry. The public must have the highest confidence in the integrity of this relationship. Educational programs with the highest standards of objectivity will be most effective in enhancing the public’s trust and in encouraging and sustaining proper use of advances in clinical therapeutics. Moreover, strategies to help physicians comply with new standards of therapy will be aided by the most credible, evidence-based approaches.
We believe that these guidelines will help to preserve the independence of our faculty and reduce the potential for real or perceived bias in our clinical decision making and educational programs. Since we would also like to enhance the ability of the pharmaceutical industry to perform research and development independently and in collaboration with medical schools, we hope that these guidelines will promote an effective and ethical partnership between medical schools and the pharmaceutical industry that will facilitate drug discovery and more widespread use of effective therapies.
Guidelines alone are not sufficient to eliminate conflicts of interest, substantially reduce health care costs, or ensure that educational programs are balanced and accurate. It will also be important to continue to educate faculty and trainees on how to develop and sustain productive and ethical relationships with commercial entities. In addition, we will need to monitor the effect of these and other guidelines to evaluate their effectiveness in reducing conflicts and bias in educational programs. Nonetheless, the process of developing local guidelines can help the faculty in our medical school—and, we believe, in any medical school—to develop a greater consensus on the underlying principles of professionalism, integrity, and public service that must be incorporated in all aspects of our programs, including the relationships of physicians with industry. The Yale guidelines are offered as an example of how one medical school has attempted to meet this challenge.
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Appendix 1, continue...Image Tools
Appendix 1, continue...Image Tools