Academic Psychiatry 29:215-221, June 2005
© 2005 Academic Psychiatry
Psychiatric Training Program Engagement With the Pharmaceutical Industry: An Educational Issue, Not Strictly an Ethical One
Paul C. Mohl, M.D.
Dr. Mohl is Professor and Vice Chair for Education at the University of Texas Southwestern Medical Center at Dallas, Dallas, Texas. Address correspondence to Dr. Mohl, Dept. of Psychiatry, University of Texas Southwestern Medical Center at Dallas, 5323 Harry Hines Blvd., Dallas, Texas 79390-9070; paul.mohl{at}utsouthwestern.edu (E-mail). Copyright © 2005 Academic Psychiatry.
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ABSTRACT
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OBJECTIVE: To analyze the educational and ethical issues involved in interactions between departments of psychiatry and the pharmaceutical industry. METHODS: The author analyzes the history of attitudes toward pharmaceutical companies, various conflicting ethical principles that apply, and areas of confluence and conflict of interest between psychiatric education and the drug industry. These attitudes are applied to a variety of specific types of interactions with representatives of the pharmaceutical industry. RESULTS: A number of forms of interaction are found to be on balance, ethical, and productive, while others are found to be problematic. CONCLUSIONS: Careful analysis of both ethical and educational dimensions can produce meaningful and constructive involvement with the pharmaceutical industry, without inevitably corrupting psychiatric educators.
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INTRODUCTION
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It is always easier to argue an absolutist moral position than a balanced one. The very nature of moral judgements, fraught with goods and evils, places moderate positions in sticky, ambiguous areas. The issue of training program involvement with the pharmaceutical industry offers an alternative, better choice. That choice is to regard the issue as a training concern, not purely as an either/or moral choice.
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History
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It is important to note that this issue is not new. It dates at least to the late 1960s and quite possibly long before. I was a member of the medical school class of 1971, from which many graduates refused, for the first time, the "Lilly bags," traditional physician’s black bags given to all graduating students by a drug company. The attitude, the times, and the ethical motivation were different, but the issue was on the table. Accepting the Lilly bag was seen as being coopted by the medical pharmaceutical industrial complex, the moral equivalent of participating in the military industrial complex and supporting the Viet Nam War.
The issue lost its steam in the late 1970s, but has risen again in recent years, fueled by huge increases in spending and marketing activity by pharmaceutical companies, affecting psychiatry and all of medicine. It is tempting to claim that the issue of relationships with pharmaceutical companies is merely one of increased intensity, but increased quantity of exposure can translate into qualitatively different kinds of relationships. My PGY-I and PGY-II trainees calculated that they each receive, on average, $100 per week in benefits from drug company expenditures, including gifts, meals, speakers’ honoraria, etc. When presented with the above calculation, our education committee responded with disbelief.
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Problematic Responses to the Issue
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There are two worrisome reactions to this situation. One is the disbelief noted above, or shrugging away the problem—"What’s the big deal"—often seen from faculty who receive substantial drug company support for research. Despite the large amount of evidence that drug company interventions influence physician practices at all levels (1–7), many of those most intimately involved seem remarkably oblivious to the dangers and are strikingly confident that they are different (i.e., unaffected by marketing efforts while certain that their peers are). Anecdotally, this confirms what many empirical studies have found (8).
The other worrisome reaction is the opposite extreme: an absolutist avoidance of the complexities of physicians’ relationships with pharmaceutical companies. A slippery slope argument is often advanced because drug company efforts influence physicians in demonstrable ways, the only way to stay "clean" is to avoid all contact. In my opinion, this "morally pure" stance oversimplifies the complex nature of medicine’s relationship with the pharmaceutical industry and abdicates our obligation to address a significant training need.
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The Ethical Case for Engaging With Pharmaceutical Companies in the Education of Psychiatric Trainees
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I fully accept the data and some of the arguments of those who oppose any educational engagement with pharmaceutical companies. There is a major ethical and educational problem. But I also maintain that there are two countervailing ethical imperatives that impel us to seek a way to effectively use drug company resources to advance our educational mission.
1. We have an ethical obligation to provide the most we possibly can to our trainees for the benefit of their education. This means maximizing the resources available to us without compromising the content.
a. This obligation implies that each interaction must be measured as an educational risk/benefit judgment. Every time we nominate a resident for an industry sponsored national fellowship, request a meal of a pharmaceutical representative, accept a gift, request sponsorship of a grand rounds speaker, we must make a complex educational and ethical judgment about the potential benefits and potential undue influence that may accrue.
2. We have an ethical obligation to prepare our trainees for future inevitable interactions with the pharmaceutical industry and its representatives.
a. This principle suggests that we must provide direct education and professional modeling of how to handle these relationships. It is not realistic to expect our graduates to avoid interactions with drug companies. Some will enter independent practice. Others may become clinical trials researchers. Many will serve institutional formulary committees. All will encounter drug company representatives. All will decide medications they prescribe, keep in their offices, and request for formularies. And all will read studies funded by pharmaceutical companies. This creates a major educational need.
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Principles for Making Risk/Benefit Decisions in Obtaining Educational Resources From Pharmaceutical Companies
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There are two principles that, consistently kept in mind, help maintain ethical engagements with pharmaceutical companies: 1) recognition of areas of commonality and areas of conflict of interest and 2) locus of control.
There is not an inherent, total conflict of interest between drug companies and physicians. Areas of overlapping interest include development of effective treatments, basic and applied research related to such development, and education of professionals and patients about effective treatments. Areas of conflicting interest include pursuit of profits related to particular products, competitive advantage of one medication versus another, and use of monetary and personal relationships to influence treatment decisions. These lists are neither total nor comprehensive. Nor are areas of overlap necessarily easily separable from areas of conflict. For example, pharmaceutical companies’ efforts to promote particular psychotropic medications via television advertising educate the public, destigmatize mental illness, seek to maximize profits, and gain competitive advantage over other companies.
Therefore, one can ask of each transaction: What are the dominant agendas? Are they in areas of common interest? What agendas are present that represent conflicts of interest? What is the relative balance between them? Is there some way the educator can influence this balance?
Control is crucial. There is a vast difference between a drug company offering a preselected list of speakers versus a grand rounds coordinator identifying a speaker and then asking if the company is willing to support the person’s visit. Control of content and disbursement of funds (gifts, fellowships, honoraria, etc.) provide two important areas. Control allows the exercise of a veto when one judges that the balance between confluence and conflict of interest is tipped in the wrong direction. Decisions about content, disbursement of funds, assessment of educational need, and clarity to beneficiaries of what is provided and who is in charge all need to be in place for this crucial dimension to be effective in managing the relationship and ensuring that it truly supports education.
It may seem that power in relation to the pharmaceutical industry lies primarily with the industry. They have money; we want some of it. But it is important to recognize that power is truly balanced, even skewed toward educators. The industry cannot function without access to physicians and trainees. In fact, local representatives are partially evaluated on the demonstration of access to a large number of potential and future prescribers. Educators must understand the power they hold, use it to protect themselves and their trainees from undue influence and to control the nature of interactions.
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The Dimension of Need
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I have made no mention of the importance of a program’s needs in considering relationships with pharmaceutical companies. Every program "needs" more resources to maximize its ability to train. Some programs have less from other sources and may have important educational areas with no resources at all. Other programs cannot afford grand rounds, even monthly, without pharmaceutical company support for every presentation.
Another dimension of need is that of our trainees. I exited medical school with $5,000 debt, earning $10,000 as a PGY-I. Considering inflation, my residents make 25% less and owe 400% more. The approximately $5,200 per year in benefits from pharmaceutical company activities represents a 14% increase in resources available to my PGY-II trainees. The felt need of the average resident, even for an extra lunch, is far greater than mine when I self-righteously refused my Lilly bag.
Nonetheless, I submit that "need," beyond the general need all programs have to maximize their educational resources, should not be a significant variable in structuring the complex relationship with the pharmaceutical industry.
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Rules, Guidelines, and Principles
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The pervasive nature of the pharmaceutical industry’s efforts to influence physicians has led to a plethora of rules and guidelines (9–15). Several programs and teaching hospitals have promulgated their own regulations, adding to those written by national organizations. Rules and guidelines are efforts to articulate and concretize ethical principles. Their limitation is the limitation of all bureaucratic efforts: they have a way of missing the mark, replacing principled reflection with legalistic adherence, often resulting in bizarre contradictions. One university’s rules specify that all gifts be kept in the recipient’s clinical office (principle: no gift should be for personal use). Another rule from that same university’s teaching hospital specifies that no gift should be kept in clinical areas (principle: there should be no suggestion to patients that physicians are influenced by anything other than the patient’s medical need) (16, 17). Rules also have a way of achieving the opposite of what might be optimal. A number of company representatives have interpreted the Phrma rules’ failure to mention unrestricted educational grants as eliminating them entirely (principle: nonrestriction increases the risk of noneducational use). But unrestricted grants had the advantage of providing educators with control, one of the principles in maintaining an ethical relationship.
On the other hand, rules and guidelines call attention to an issue and the reaction previously noted by some of my own faculty suggest that this is important. They also have the advantage of limiting the behavior of large groups of individuals who might otherwise vary in their interpretation of principles. This is important when individuals are at risk for compromising what they do based on institutional exigencies (e.g., representatives under pressure to increase sales or educators under pressure to provide quality programming with limited resources).
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Examples of the Principles Applied
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Instead of endorsing one or another set of rules, I would like to provide examples of how my stated ethical/educational guidelines might be applied.
Grand Rounds
The potential educational value to students, residents, faculty, and community attendees of increased ability to fund excellent outside speakers is very high. The pharmaceutical companies’ agenda is twofold: general goodwill garnered from attendees and providing speakers who will emphasize their particular product. Thus, if the latter agenda can be controlled effectively, the risk–benefit of this interaction will fall strongly on the side of educational benefit. It is incumbent on educators to exercise strong control over the selection of speakers. Selecting speakers from a drug company’s list may occasionally be an effective control if the list is extensive enough and the selection is by experts in the speaker’s area. Pharmaceutical companies have been known to supply their own speakers with slides, outlines, and other resources that influence content. The best control is a completely independent selection of the speaker based on a totally internal needs assessment, followed by solicitation of funds specifically for that speaker. It is also important that it be clear to the speaker who is in charge. Tempting though it may be to rely on the drug company representative to make all of the arrangements, the wrong message is given to the speaker as for whom he or she is speaking. I have seen nationally known researchers, who deliver sterling presentations when hosted by an academic institution, give very pedestrian talks when totally industry sponsored.
Drug Company Supported Clinical Research
Often, teachers of psychopharmacology receive pharmaceutical company support. Educators must gauge the extent to which these relationships influence educational content.
Two forms of industry sponsorship for clinical trials, company versus investigator initiated, create differing relationships. An independent-practice colleague who conducts industry initiated clinical trials clarified the issues when he said, "I’m not a researcher; I’m a contract physician." He identified several variables that lead him to accept some contracts from some companies, but not for others. Resident education benefits much from teaching by faculty conducting industry sponsored clinical trials. Familiarity with new agents, new indications, and side-effect profiles puts trainees at the forefront of new knowledge. This is an area where drug company agendas are aligned with the academic agendas of extending our knowledge and availability of effective treatments. At the same time, there is evidence that industry sponsored research may be somewhat less reliable than that funded by more independent agencies (18–23).
Lucrative industry sponsored clinical trials are critical to researchers’ ability to collect pilot data, enabling them to conduct independent studies that accrue other sources of support. Such individuals constitute a very valuable educational resource. At the same time, there can be no illusions about the risks of psychopharmacologists’ complex, financially dependent relationship with drug companies, influencing the content and judgment of their teaching.
The issue becomes how dependent is the individual on which kind of research dollars, a variation on the control variable. Educators, in deciding which teachers should teach what material, must make a judgment about the degree of influence that may be exerted by the teacher’s relationship with the industry. This implies that it behooves educators to know the nature of various faculty members’ sources of funding. On our faculty there are some excellent teachers I utilize widely, but not in certain areas where their dependence on support from pharmaceutical companies is, in my opinion, skewed. Michael Jibson has proposed "full disclosure," a creative approach to this issue (24). Teachers would include a slide opening the presentation, identifying the percentage of their annual income from industry sources (including honoraria for outside speaking). Additionally, the teacher would detail the percentage of the entire costs of their research enterprise derived from industry sources. While this would be a major departure from current practices, any researcher reluctant to identify what percentage from university sources, private foundations, governmental grants, and industry contracts should inquire of themselves about their discomfort. Trainees would become informed and sensitized consumers.
Outside Speaker Dinners
Pharmaceutical companies frequently sponsor expensive dinner meetings followed by a speaker, our own faculty, a recognized outside expert, or a nonfaculty individual who conducts industry initiated data collection contracts. Many leading psychiatric researchers and educators use these opportunities to substantially bolster their incomes. As with the industry sponsored symposia at the American Psychiatric Association’s (APA’s) Annual Meeting, the quality can be very high, with little bias apparent, or it can be mediocre, with substantial bias in the content. One leading psychiatrist advocates that faculty should provide these lectures as part of their continuing educational responsibilities to practitioners in the field.
These activities are problematic for training programs. First, the balance between confluent and conflicting agendas is dicey. The companies’ agenda is largely promotional and the speakers, no matter how honorable, are clearly and exclusively the company’s agent. Virtually all of these dinners exceed the American Medical Association Guidelines ("modest") for appropriate cost of meals provided by drug companies and programs have control over neither content nor speaker selection. Thus, this activity fails to achieve an adequate ethical/educational balance on the two key dimensions I have identified. Nor can it be argued that the need of trainees is great, assuming they are in a reasonable academic, intellectual setting.
However, these events are off campus, beyond legitimate exercise of control by training programs. But programs can take a stand by refusing to allow publicity for these dinners in departmental facilities and by discussing these programs during didactics. My residents were stunned when they learned the size of the typical honorarium for speakers at these events.
Small Gifts
Many disparage concern about the omnipresent trinkets, mugs, erasers, pens, etc. Their value is limited, so accepting them seems meaningless. Applying the principles I have outlined, this is another area where confluence is little and the conflict large. Gifts are purely promotional, subliminal advertising that contains no useful information directed to physicians and patients. Control is theoretically possible, as the education office could screen all gifts given to trainees. However, it is hard to imagine that any of these small gifts would be seen as truly promoting education, research, or patient care. Small gifts should be eliminated, as are larger ones by the American Medical Association (AMA), Food and Drug Administration (FDA), and Phrma guidelines. Books, CD-ROMs and other clearly educational gifts might well be legitimate, but it is important to sensitize residents to the complicated relationship that results from accepting a gift (25).
Free Samples
This is a complicated issue. The agenda of industry representatives is promotional, minimally enhancing patient care. Making free samples available makes it easier to prescribe one product over another. I recently consulted a physician who handed me a sample of an expensive antibiotic. Other antibiotics are just as effective for the purpose intended. I can easily afford the time, hassle, and expense of filling a prescription for an equally effective generic. The drug company’s agenda was fully achieved, with no advantage to patient care.
On the other hand, situations exist where availability of free samples can dramatically enhance patient care. Our residents rotate at student health services at two colleges. At one, student insurance includes generous prescription benefits. At the other, benefits are limited, and students often cannot afford the cost of medications. Residents rotating at the less well-insured location identify medications their patients need, seek out the appropriate company representatives, and maintain a large stock of samples for their patients. Patient care is dramatically improved by this effort. Control exercised by the residents affects the agenda of the pharmaceutical companies toward greater confluence with educational and patient care concerns.
Clearly, there needs to be some education and external control over the acceptance, distribution, and use of free samples. Either a program or clinic ombudsman should be the primary contact individual for drug company representatives, identifying what is accepted based on the clinical and financial needs of the particular patient population. Access to the site medication cabinet needs to be strictly limited to professional staff, as the sales people may be more interested in what other agents are being stocked than in simply helping with delivery of samples.
On Site Food
I find this interaction one of the most difficult to deal with. What makes it difficult is the felt need of the residents. Despite being a relatively well-funded program, we are unable to provide regular lunches for our residents’ weekly meetings. In addition, breakfast and pizza are ubiquitous in our clinic and psychiatric emergency service. When raising my discomfort with residents, they speak with passion about the importance to morale of breaking bread together. The pharmaceutical company agenda in providing food is pure promotion, reflecting their philosophy of "relationship marketing." Their goal is to establish a lifelong positive relationship with physicians, beginning in residency, which will be a tool in promoting their products. Control is relatively neutral in this interaction as the residents initiate contact with the pharmaceutical representatives. A case could be made that there is indirect educational benefit by virtue of morale maintenance.
This is a battle I choose not to fight, though my principles imply that we should eliminate or limit the frequency and location of meals. Some programs have instituted a requirement that a faculty member must sit in on all drug company provided meals as a quality control and counterweight to what information is presented. Everyone seems to be searching for a compromise manner of regulating this activity much appreciated by trainees.
National Fellowships and Awards
Many organizations use pharmaceutical company support to fund participation of residents at their annual meetings and, in some cases, in the functioning of the organization. I have participated in this from the organizational side and from the nominating side. The problem for psychiatric educators is that they are dependent on the degree of control exercised by the national organizations on what the fellowship winners will experience. My experience with several organizations is that they are very mindful of the pitfalls of this relationship and very thoughtful about how the industry representatives are involved in the process. I have also been impressed with how the industry representatives (usually from national offices) are very respectful of boundaries. In fact, their target is not the fellowship winners but the goodwill of the members of the national organization. Thus, I am comfortable with nominating and exposing our residents to this interaction.
More complicated are the purely drug company sponsored meetings that parallel national meetings (usually APA’s annual meeting). Residents are funded to attend a drug company controlled series of events, usually a day or two before APA annual meeting. Thus, the control and content are that selected by the company. The questions become: How biased is the premeeting? Is the tradeoff of the opportunity to attend a major professional conference worthwhile? I have personally chosen to regularly nominate residents for these events, accepting the trade off after examining the premeeting agenda. However, I readily concede that this is an area that is very uncertain and difficult to parse out either way.
Didactics and Faculty Development
It seems superfluous to note that residents need didactics that address the complicated issues enumerated. Equally obvious, but less self-evident in the ongoing life of a department, is the need to sensitize faculty to the issues. Above all, both groups need sensitization to the topic. Interestingly, I have found that residents, at this point in time, are more attuned to some of the issues than are many members of faculty.
Faculty can be sensitized by proposing Michael Jibson’s approach of having all teachers and visiting speakers begin with a slide that fully acknowledges their dependence on pharmaceutical companies for income and professional functioning. This is likely to spark a lively debate, if not an insulted passionate reaction. The goal is not necessarily to implement Jibson’s proposal, but to initiate the conversation. Why such a strong reaction? Why the discomfort? Following up this by informing them of the data on the success of drug companies in influencing the prescribing behavior of physicians and the results of published studies should result in an interesting academic discussion. Most faculty are unaware of the data, especially the conviction among physicians that they themselves are immune but others are not.
Residents also need sensitization. Participating in a personal calculation of the financial benefits they receive and the percentage of their income it represents can be a powerful tool. Unlike faculty, residents also need more detailed education on how pharmaceutical companies actually function, how much they spend on physician promotions, how FDA approval is much more of a fiscal and political process than they imagine, the model of lifelong marketing they are being subjected to as residents, the difference between various kinds of sponsored research, their role in the discovery and availability of new medications, etc. Residents, like faculty, need information on the studies done on the effectiveness of marketing. I think of this education as a very immediate, case-based form of ethics training.
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Conclusion
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The high visibility of the pharmaceutical industry appears to be a permanent fixture of the world our residents will enter upon graduation. The effectiveness of their efforts to affect physician behavior is unarguable. This makes the issue of educational programs’ engagement with the industry a training issue. We must wrestle ourselves with the ethical complexities of the reality we face, and, in turn, teach our trainees to wrestle with these complements themselves. For better or for worse, medicine in the United States is practiced within a free market system and ethos. Our trainees must be prepared to cope with its opportunities, enticements, and seductions. The evidence suggests that education has an effect (26–28). Total prohibition infantilizes our trainees. With careful understanding of the complex nature of the physician/pharmaceutical industry relationship and detailed case-by-case analysis of the dimensions of agenda and control, one can—indeed, one must—seek drug company resources to maximize training opportunities. But we should have no illusions: psychiatric educators must be constantly watchful and mindful of the pitfalls along this road. Neither obliviousness to the dangers nor total avoidance serves our trainees.
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ACKNOWLEDGMENTS
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The author would like to express his appreciation to Daralynn Deardorff, D.O. for sharing her expertise in the preparation of this manuscript.
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TOP
ABSTRACT
INTRODUCTION