Acad Psychiatry 30:40-44, February 2006
doi: 10.1176/appi.ap.30.1.40
© 2006 Academic Psychiatry
The Role of the Pharmaceutical Industry in Medical Education in Psychiatry
Arthur Lazarus, M.D., M.B.A.
Received July 14, 2005; revised September 26, 2005; accepted September 28, 2005. Dr. Lazarus is affiliated with AstraZeneca Pharmaceuticals LP, Wilmington, Delaware. Address correspondence to Dr. Lazarus, AstraZeneca Pharmaceuticals LP, Clinical Research, 1800 Concord Pike, PO Box 15437 Wilmington, DE 19850-5437; arthur.lazarus{at}astrazeneca.com (E-mail). Copyright © 2006 Academic Psychiatry.
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INTRODUCTION
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The pharmaceutical industry has come under attack for many reasons: the high cost of drugs, a strong stand against drug re-importation, biased clinical trials, and direct advertising to consumers, to name a few. Once considered a respected partner to medical schools and medical education, pharmaceutical companies are now being shunned by academic medical centers. Some medical schools have restricted or prohibited interactions between pharmaceutical representatives and residents and students (1).
The role of the pharmaceutical industry in medical education is one of the most widely contested issues in medical practice today. In psychiatry, the debate has reached a fevered pitch, in part because psychiatric disorders have become ripe for "condition branding" (2), while efforts to counteract the pervasive influence of the pharmaceutical industry have not always been successful. Economist Kevin Hassett perceives the war against the pharmaceutical industry second only to the war on terror (3).
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Components of the Debate
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On one hand, staunch industry opponents are calling for a "cease and desist" of all pharmaceutical educational activities—lunch ‘n learn, grand rounds, continuing medical education (CME) symposia, and other events—and for professional organizations and academic institutions to refuse drug funding for such activities. The rationale is that all educational activities sponsored by pharmaceutical companies are inherently biased because the aim of these activities is to sell a product, whether a drug or device, rather than provide genuine education.
Numerous studies have shown that pharmaceutical company "details" and gifts influence drug prescribing in the direction of the company’s product, even when students and practitioners believe they are not susceptible to influence (4). A major concern is that, as a result of industry influence, inaccurate, incomplete, or otherwise biased information based on the results of pharmaceutical-sponsored clinical trials may be incorporated into practice guidelines that ultimately become treatment recommendations, which could lead to established medical policies.
Individuals who propose a role for the pharmaceutical industry in medical education point to the potential benefits of collaborating with physicians in industry, for example, improved clinical trials and access to role models (5). In fact, most physicians working in industry began their careers in academia, which is ideal for trainees wishing to learn about the conduct of clinical trials and pharmaceutical medicine as a career pathway. Residents require detailed information on how pharmaceutical companies function, but they rarely receive it during training (6).
Furthermore, isolating residents from industry marketing activities during training will not prepare them for future careers in which contact with industry is certain. Upon concluding their training, residents have remarked, "we needed help learning to interpret information from pharmaceutical companies" (7). Even some academicians admit that shielding students and residents from the influence of pharmaceutical companies will not necessarily improve the quality of their education. The authors of one study (8) wrote: "We believe there are many circumstances where effective and efficient strategies involving pharmaceutical products are underutilized (e.g., treatment of hypertension in the 1970s, thrombolysis for acute myocardial infarction in the 1980s, secondary prevention of coronary artery disease by reducing cholesterol, and anticoagulation for atrial fibrillation in the 1990s) where marketing by pharmaceutical companies plays an important role in improving outcomes for patients."
Insofar as the pharmaceutical industry has played a role in medical education in the past, and will likely continue to have a role in the future, even if diminished, it seems prudent to explore the areas that have been the focus of criticism and discuss what is being done, and what more can be done, to define reasonable boundaries between industry and academia. The essential areas to focus on are the funding of education by pharmaceutical companies, the content of the education, and the expertise and qualifications of the teacher, including potential conflicts of interest. Indeed, these are key areas addressed by several organizations’ guidance documents including the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support (9); Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers (10); Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions With Health care Professionals (11); and the U.S. Food and Drug Administration (FDA) Guidance for Industry (12). Medical school faculty and trainees should become familiar with these organizations and documents. Collectively, this material forms the basis of many principles and recommendations discussed in this article.
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Educational Funding
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Broadly speaking, pharmaceutical companies fund two types of educational activities. One is purely educational, funded through an independent or "unrestricted" grant, and the other is promotional, to advance the use of the company’s marketed drug(s). The educational value of the latter is less certain than the value of the former.
Promotional programs funded and conducted by pharmaceutical companies are highly regulated by the FDA. Essentially, promotional educational presentations must be "on-label," presenting only information about FDA-approved uses contained in the product’s package insert. Promotional talks must also contain "fair balance," i.e., a discussion of the risks and benefits of the drug, including adverse effects, precautions, and warnings. (Fair balance is frequently misconstrued as a discussion of competing products.) Above all, promotional programs must be truthful and not misleading. All presentation slides, whether provided by the pharmaceutical company or developed by the speaker, should be designed to meet these requirements.
A narrow exception to the "on-label" rule exists. Speakers may answer questions about unapproved drug uses so long as the questions posed by the audience are unsolicited. Speakers should clearly advise the audience that the answer is outside the scope of approved labeling and that they are speaking from independent medical judgment. Questions should be answered briefly, to avoid unnecessary off-label discussion, and then the discussion should be guided back to the originally planned on-label presentation.
Educational programs are sponsored by pharmaceutical companies and funded through third parties, so-called CME providers. The content of these programs is intended to be independent of drug companies, even though the companies pay for the programs themselves. According to ACCME standards (9) and FDA guidance (12), independent educational grants cannot be tied to the purchase, sale, prescription or recommendation of the company’s products. There cannot be price concessions to help offset a customer’s purchase or reimbursement of drugs, and there cannot be any payment to ensure that the grant recipient markets the company’s drugs during the educational program. Grants provided to customers of a pharmaceutical company (retail chain pharmacies, pharmacy benefit managers, managed care organizations and others) must be especially focused on educating health care professionals in order to avoid any appearance of price concession or quid pro quo arrangement. Responsibility for and control over the selection of content, faculty, educational methods, materials, and venue belong solely to the CME provider in accordance with their guidelines.
Pharmaceutical companies should not offer financial support for the costs of travel, lodging, attendance, or other personal expenses of nonfaculty health care professionals attending promotional and CME conferences. However, medical students and trainees are permitted to receive financial assistance for scholarships or other educational funds to attend carefully selected educational conferences so long as the academic institution makes the selection. "Carefully selected educational conferences" are generally defined as the major educational, scientific, or policy-making meetings of national, regional, or specialty medical associations.
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Blurred Boundaries
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The FDA has established clear boundaries between promotional and nonpromotional (independent) educational programs. Despite this, speakers and meeting attendees may be unaware of the differences between promotional and CME events, resulting in misconceptions and rules violations. In general, independent educational grants should not be provided for:
1. Charitable contributions or sponsorships not involving general health care education;
2. Promotional programs and educational activities that are controlled or influenced by the company;
3. Research or studies;
4. Payments for data purchases or the purchases of bona fide services; and
5. Exhibit fees
Pharmaceutical companies should not offer, and physicians should not accept, honoraria to attend promotional and interactive events masquerading as scientific consulting and advisory meetings. Physicians participating in these "token" consulting arrangements may be subject to disciplinary actions by state medical licensing boards for unethical behavior (13). Pharmaceutical companies do need consultants and advisers, and it is appropriate to compensate consultants who provide legitimate services to the company. The following factors support the existence of a bona fide consulting arrangement (not all factors may be relevant to any particular arrangement):
1. A written contract specifying the nature of the services to be rendered and the basis for payment of those services;
2. The need for expert services has been clearly identified in advance of entering into the contractual arrangement;
3. The criteria for selecting consultants conform to the purpose of the meeting, and the person(s) responsible for selecting the consultants are capable of determining whether they qualify as experts;
4. The number of consultants retained does not exceed the number considered reasonably necessary to achieve the purpose of the meeting; and
5. Minutes of the meeting are recorded and appropriate feedback is developed into an action plan
The Office of Inspector General (OIG) has counseled pharmaceutical companies to lower their legal risks by separating grant-making functions from sales and marketing functions so that the approval and processing of educational grants occur independently. This appears to have had an impact on CME funding, as the overall percentage of pharmaceutical spending in two categories, commercial support and advertising and exhibit support, decreased in 2004 for the first time in 7 years, according to ACCME (14). Still, approximately $2 billion a year is spent on the commercial funding of CME activities, and it is not known whether the decreased funding in 2004 is transitory or permanent.
Even with OIG guidance to the pharmaceutical industry and the changes the industry is implementing in response, it is possible for academic thought leaders to construct presentations around clinical themes consistent with individual companies’ marketing strategies. Similarly, professional organizations may attempt to steer CME symposia to certain drug companies based on diseases for which a company has product lines. CME providers need to pay close attention to the proposed title and content of symposia to prevent this type of bias from entering into educational programs.
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Educational Content
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The role that industry plays in advancing medical education and improving patient care is being scrutinized very closely. Very few people would question the contribution of industry in terms of real dollars. To varying degrees, medical schools, hospitals, and professional organizations depend on the support of pharmaceutical companies to help educate students, trainees, and practicing physicians. What is being questioned, however, is the value of the education, specifically whether industry is sponsoring bona fide educational activities.
Feedback from APA members who have attended industry-sponsored symposia indicates that these sessions are highly valuable. Pharmaceutical symposia have received consistently high marks from attendees of APA’s annual meetings. Aggregate evaluation scores for the 45 symposia offered at the 2005 meeting (Atlanta, Georgia) demonstrated a positive assessment of the sessions in all categories: overall quality, usefulness of handouts, quality of audiovisual aids, utility of information to practice, degree of audience interaction, and representation of multiple viewpoints. Scores were in the ninetieth percentile for agreement (15). Respondents overwhelmingly agreed (98%) that the symposia met their educational objectives.
Certainly, the legitimacy of educational activities will be enhanced if objectives are associated with them and their relevance to health care can be unequivocally demonstrated. The content or format of a CME activity or its related materials should promote improvements or quality in health care and not a specific proprietary business interest or a commercial interest. Presentations should give a balanced view of therapeutic options. Use of generic names will contribute to this impartiality. If the CME educational material or content includes trade names, available trade names from several companies should be used, not just trade names from a single company.
For both promotional and independent educational programs, the title of the activity must fairly and accurately represent the scope of the presentation. The educational activity should not be an extravagant event or an event in which the educational activity is clearly subordinate in terms of time, cost, or emphasis to other activities such as meals, entertainment, and recreation. The main incentive for bringing attendees together must be to educate them on the topics being presented.
Pharmaceutical companies typically sponsor educational events related to clinical pharmacology, epidemiology, disease management, drug discovery and safety, good clinical practices (GCP) in research, pharmacokinetics, pharmacogenomics, pharmacoeconomics, and many other topics. Guidelines do not specify health care topics to teach. In fact, pharmaceutical companies are given wide latitude in sponsoring topics, including areas of therapeutic controversy, new techniques, and emerging science.
In contrast to promotional programs, independent educational programs should avoid a central theme based on a single product marketed by one company or a competing product, except when existing treatment options are so limited as to preclude any meaningful discussion of alternative therapies. This is not to suggest that each treatment option must be discussed with precisely equal emphasis. However, emphasis on a newer or, in the view of the presenter, more beneficial treatment modality should be provided in the context of a discussion of all reasonable and relevant options.
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Examples of Industry-Academia Collaboration
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Approximately 1 out of 10 medical school graduates plans a career that is exclusively or significantly devoted to research (16). Physicians and scientists in industry are in a unique position to mentor and advise such students. The Department of Health Policy at Jefferson Medical College (Philadelphia) is noteworthy in this respect. In collaboration with several pharmaceutical companies, the department has developed model educational and learning programs for medical students, trainees, and early career physicians. The department offers a 2-year fellowship program in health economics and outcomes research, and it recently implemented a Senior Scholars Program. Created as an alternative to traditional faculty affiliations (i.e., adjunct or secondary status), the Senior Scholars Program provides an opportunity for professionals from the pharmaceutical and other health care industries to benefit from an association with the department while contributing meaningfully to current department research, mentoring, teaching, and publication activities.
Fruitful relationships between industry and academia based on shared learning objectives have been developed elsewhere, although most training programs arising from industry-academic alliances are geared toward pharmacy students (17). The reality is that for academic medical centers to survive, they must renew ties to practicing physicians and broad research communities, including the pharmaceutical industry (18).
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Qualifications and Conflicts
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Physicians who fulfill the tripartite mission of academic medical centers—teaching, research, and patient care—often have ties to the pharmaceutical industry. Medical school faculty are responsible for much of the research that has been identified as fraudulent and criticized as biased and commercially oriented. Furthermore, income or gifts from industry influence the teaching of attending physicians in various educational settings (19). To the extent that academic medical centers have attempted to rectify these problems through the development of policies and curricula addressing industry relationships within undergraduate and graduate medical education, less attention has been given to conflicts among teaching faculty compared to the role of industry as an educational sponsor.
It would not be unreasonable to require teaching faculty to disclose conflicts of interest to students and residents, as faculty are required to do for CME events. Meaningful disclosure includes research grants and honoraria received from industry, and any other significant relationship between the faculty member and the pharmaceutical company, including stock ownership and work-for-hire as a company speaker, adviser, or consultant. Any other legal or business relationship between the company and the faculty member that could place the company in a position whereby it may exert influence over the faculty member’s teaching activities should be disclosed, as well as the specific relevancy of the conflict to the subject matter.
Simply disclosing conflicts of interest does not resolve them. Much of the medical community appears to have become desensitized to the notion of disclosing conflicts. It has become perfunctory for key opinion leaders to list relationships with pharmaceutical companies when presenting clinical trial results at medical conferences and publishing articles in peer-reviewed journals. The process of disclosing conflicts reveals nothing about how conflicts are actually managed, which is the crucial point here. When a person has disclosed a relationship, or even divested themselves of a relationship, any associated conflict of interest may be resolved, but it is naive to believe that clinician-researchers will permanently sever ties to industry, and even if they do, prior interactions with industry may influence future behavior.
According to ACCME guidelines, "providers must develop solutions that best fit the facts and circumstances of their program of CME" (20). Essentially this means that managing or resolving any conflict of interest must involve the content of the CME.
Mechanisms proposed to resolve conflicts of interest include limiting the lecturer’s presentation to areas that are not relevant to the conflict; asking someone else to discuss content areas in which the lecturer has a conflict; and changing the focus of the activity so that the content is not about products or services of the commercial interest that are the basis of the conflict of interest.
When an individual has been principal investigator of a clinical trial funded by a pharmaceutical company, his or her presentation can be limited to the data and results. Someone else could address the broader clinical implications and recommendations for treatment. In cases where presenters refuse to alter the content of their talk or designate another individual for a portion of the activity, it is recommended that the entire presentation undergo peer review (prior to the presentation) to ensure it conforms to best practices in accordance with evidence-based medicine.
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Conclusion
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Pharmaceutical companies should provide valuable scientific and educational benefits to students, trainees, and health care professionals, ultimately benefiting patients. Interactions between industry and academia should be focused on informing practitioners about health care products and services, providing balanced scientific and educational information, and supporting medical research and education.
Medical schools should strive to minimize conflicts of interest in medical practice, teaching and research. Policies regarding drug company-student interactions should enlighten students about sources of influence with the goal of ensuring clinical integrity in practice. Maintaining the association between industry and academia will require the development of corporate and individual citizenship beyond the conventional values we have lived with until now.
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ACKNOWLEDGMENTS
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The opinions expressed in this commentary do not necessarily reflect those of AstraZeneca, its management, agents, or employees.
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REFERENCES
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This article has been cited by other articles:
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C. H. Chan
The Pharmaceutical Role
Acad Psychiatry,
February 1, 2006;
30(1):
45 - 47.
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INTRODUCTION
Components of the Debate
