Another resident perspective: Resident education and the pharmaceutical industry:
Another resident perspective: Resident education and the pharmaceutical industry
Article Outline
Advertising bombards us. From the time we're old enough to comprehend words and their meaning, we're exposed to aggressive attempts to market everything from food and clothes to cars and vacations, and since 1997, even prescription drugs. Although scientific evidence suggests otherwise, most consumers tend to think of themselves as savvy and not particularly susceptible to advertising ploys. We continue to tolerate, and in some cases even welcome, the intrusion into our lives of advertising (for example, Super Bowl halftime). Our lives are almost never completely free from exposure to advertisement, and the workplace is no exception. Why then do some residency programs attempt to shield their residents from exposure to pharmaceutical company representatives?1, 2 In this article, we review the history of the interaction between physicians and the pharmaceutical industry, assess the ethical and practical considerations behind restricting resident exposure to industry, and argue for allowing some relations, based on a practical approach that accepts the current realities of our profession. We highlight resident training for such interactions and explore certain benefits the pharmaceutical industry has to offer residents.
The history of pharmaceutical company representatives dates back to 1850, when Sir William Osler called attention to this “dangerous enemy to the mental virility of the general practitioner—the ‘drummer’ of the drug house.”3 The controversy over physician contact with pharmaceutical company representatives has continued since then and has recently enjoyed a renewed emphasis.3 Gifts to physicians have been called “bribes” with the expense passed on to the patient.4 The American College of Physicians, in 1990, published a position statement entitled “Physicians and the Pharmaceutical Industry” that was prompted in large part by evidence of the drug industry's influence on physician behavior.5 These guidelines ask the physician to consider what their patients, the public, and their colleagues, among others, would think of the gift when judging its appropriateness. However, since the release of that statement, physician-industry relationships have continued to multiply. In fact, promotion to physicians accounted for more than 80% of all promotional spending by pharmaceutical companies in 2001.6 Reasons cited for this spending are the increased number of patients with conditions that can be effectively treated with pharmaceuticals and the development of innovative drugs for previously untreatable conditions.6
Pharmaceutical company representative contact with physicians is not the only means the pharmaceutical industry has available to affect physician behavior. In medical journals, including some of the most respected, we see evidence of potential pharmaceutical industry influence on the performance and conclusions of large clinical trials. Given that as many as 75% of randomized trials in major journals are funded at least partially by the pharmaceutical industry,7 the need for physicians to develop critical appraisal skills is greater than ever. One need not look hard for examples of selection bias, use of placebo controls, use of subtherapeutic controls, equivalence or “noninferiority” trials, the use of relative rather than absolute values, use of surrogate end points, and other tactics used to enhance the appearance of efficacy or safety of pharmaceuticals. Yet another source of influence, or bias, lies in the direct financial ties of individual physicians to industry. For example, physicians may hold stock in or work for industry as researchers, perform research in academia while funded by industry, or serve as industry consultants for clinical trials. Recently, it was discovered that some National Institutes of Health researchers have been paid substantial sums of money by drug companies while conducting government-sponsored research involving drugs manufactured by the same companies.7 Clearly, pharmaceutical company representative interactions are only one component of pharmaceutical industry influence, and elimination of these meetings would do little to change overall industry-physician interaction.
The argument for the restriction or prohibition of pharmaceutical company representatives in the residency setting is based on ethical standards, given that data have shown that interaction with pharmaceutical company representatives influences physician decisionmaking. The paternalistic view holds that residents are less mature than practicing physicians and therefore lack the ability to interpret and scrutinize what a pharmaceutical company representative tells them or to properly dismiss inaccurate or misleading information. For this reason, this view holds, residents should be prohibited from interacting with pharmaceutical company representatives. Although residents do lack the broad knowledge base to bear on pharmaceutical company representative information, research shows little difference in the degree of industry influence on residents versus faculty. A meta-analysis of 29 studies, including both resident and staff physicians, concluded that physician-industry interactions appear to affect prescribing and professional behavior.8 Residents are also affected, even though most believe themselves immune; a survey of emergency medicine chief residents showed that only 20% believed that accepting gifts from pharmaceutical companies could affect their own prescribing habits.9 Staff physicians whose decisions have been affected by commercial influences10 also often deny being influenced by industry.11 If both resident and staff physicians are affected by their interactions with industry, then to follow through on the principle would be to prohibit both from interacting with industry. Although this may be optimal, it is not a realistic goal. Staff physicians, who are not subject to the responsibilities of a residency program, are free to interact with industry as they see fit and will continue to do so in the future, so that neglecting to train resident physicians for this challenge is neglecting the future reality. In addition, does it make sense to temporarily shield residents from this influence at a time when they may be most open to develop the skills needed to impede aggressive pharmaceutical industry tactics that will undoubtedly confront them as a staff physician? A more practical solution is to allow some specific interactions that are concurrent with resident training for these situations. Certainly, reckless interaction with the pharmaceutical industry can have a negative influence on patient care and medical research; however, if these interactions are approached in a systematic and critical manner, in conjunction with training, the overall benefits to research, the physician, and the patient may outweigh the inherent conflict of interest that accompanies these interactions.
This influence on physician decisionmaking, as well as the conflict of interest entailed in meeting with or accepting a gift from a pharmaceutical company representative, is at the root of the ethical argument against pharmaceutical representatives. The physician has a self-interest, both financially and socially, that has been shown to influence physician decisionmaking.8 This self-interest may be in opposition to the physician's professional interest, to that decision that is best for the patient. Conflict of interest refers to any situation in which an individual with responsibility to others might be influenced, consciously or unconsciously, by financial or personal factors that involve self-interest.12 By itself, this does not indicate wrongdoing, but rather refers to a setting in which factors exist that might influence one's conduct, and actually denotes a nearly universal circumstance.12 Recognizing such conflict entails recognizing a risk. Recognizing that there is a choice is the important first step. Making the right choice, or balancing the possibilities, is the subsequent step and is a situation one has to deal with throughout life.
The decision to restrict pharmaceutical company representative access to residency programs is also based on practical considerations. Residency directors are faced with the task of training emergency physicians in a limited time frame. Careful consideration is taken to allocate formal teaching time to most efficiently provide accurate, pertinent, and necessary information. Nonindustry resources of information are arguably more appropriate and have less potential for biased influence. These practical considerations, in concert with the ethical concerns, make residency programs wary of pharmaceutical company representatives.
Given the prevalence and influence of pharmaceutical advertising, many strategies have already been instituted to limit and guide the interactions of pharmaceutical company representatives with physicians. As with any potentially negative aspect of society, there are two general approaches to controlling damaging influence. First, guidelines or regulations are imposed to contain the problem, and second, susceptible individuals are educated about possible negative effects.
In the case of pharmaceutical advertising and the funding of physician conferences, the American Medical Association, the American College of Emergency Physicians (ACEP), and the Accreditation Council for Continuing Medical Education (ACCME) have all developed guidelines in an attempt to limit the influence of pharmaceutical companies.13, 14, 15 According to these guidelines, physicians may accept gifts that are of minimal value and that either entail a benefit to patients or serve a genuine educational function. Conferences should be without commercial bias, and any support should be disclosed. The American Medical Association does not characterize all industry interactions with physicians as detrimental: “Over time, many gifts to physicians from pharmaceutical, device and medical equipment industry sales-representatives have served an important and beneficial function. For example, industry has provided funds for educational seminars and conferences for many years.” Indirect funding for medical students, residents, and fellows by industry is acceptable if the selection of individuals who will receive the funds is made by the academic or training institution, and educational conferences are carefully selected, such as major educational, scientific, or policymaking meetings of national, regional, or specialty medical associations.15 Both ACEP13 and the Society for Academic Emergency Medicine16 allow training programs to accept subsidies from industry to enable physicians in training to attend appropriately accredited continuing medical education programs. Resident interactions with pharmaceutical company representatives should be approached in a similar manner, allowing for contact under certain, prespecified circumstances.
Ultimately, residencies aim to train physicians with independent decisionmaking skills, physicians who are able to wade through many external influences to make the best treatment decisions for their individual patients. To support restrictions on resident interaction with pharmaceutical company representatives, one would expect that limitations on these interactions would produce tangible results or evidence of decreased future influence by changing physician attitudes and decreasing meetings with representatives. Studies have shown only slight changes in attitude2 but no changes in meeting frequency17 after such restrictions, calling into question the practical efficacy of current pharmaceutical company representative restriction policies.
If these changes were to occur, one would have to consider the long-term impact: how would the pharmaceutical industry respond and would the net effect be beneficial? Pharmaceutical promotion would undoubtedly continue through direct-to-consumer advertising. Spending on direct-to-consumer advertising of prescription drugs has already increased, tripling in recent years.6 In 2001, pharmaceutical spending on direct-to-consumer advertising was US$2.7 billion, which represents less than 20% of total advertising dollars and leaves a good portion of the budget that could be re-allocated.6 Although direct-to-consumer marketing does not violate ethical and fiduciary principles, from a practical standpoint the resultant outcome of this marketing strategy may be as detrimental as advertising to physicians, for different reasons. Clearly, patients are far less prepared than resident or staff physicians to handle pharmaceutical industry persuasion. These advertisements rarely detail potential adverse effects, often do not specify what disease the medication treats, and with recent changes directed by the US Department of Health and Human Services limiting the US Food and Drug Administration's ability to enforce regulatory compliance, appear to be increasingly misleading.6 Physicians who ultimately have control of their prescription pads should theoretically limit the effect of these misleading ads; however, inciting patient demand for particular medications indirectly affects physician prescribing patterns and increases spending on brand name medications. One survey found that more than 70% of family practitioners believe that direct-to-consumer advertising leads them to prescribe medications that they would not otherwise prescribe.18 Although one could simply label these physicians as weak and not upholding their duty to the public, this attitude does not offer any practical solution to the problem. In the end, direct-to-consumer advertising results in unwary consumers receiving incomplete information and may be a worse alternative to pharmaceutical company representatives marketing to physicians.
Residency is the ideal educational environment in which to learn how to manage the influence of pharmaceutical companies. Along with the Accreditation Council for Graduate Medical Education, the Council of Emergency Medicine Residency Directors has recently mandated training residents on interaction with the pharmaceutical industry.19 As mentioned, most resident physicians do not believe that gifts from pharmaceutical company representatives could affect their prescribing habits. To quell the influence of pharmaceutical company representatives, residents first need to understand that they are vulnerable to it. Then, if residents can appreciate and understand the techniques used by pharmaceutical representatives, they will be better equipped to resist this potential influence.20 Using an interactive classroom format, experts in the field could teach seminars on how to critically evaluate biased sales material and how to glean any potentially beneficial information from pharmaceutical resources. These seminars should be required for at least one faculty member of all accredited residency programs. These faculty members would then be responsible for incorporating appropriate education in their respective residency programs. This education should take place in resident lunch rounds, journal clubs, or large conferences. This arrangement would provide financial benefits (eg, lunches, textbooks) to the residency program and training for critical appraisal skills of residents.
As an example, one residency program has designed a curriculum and a formal Pharmaceutical Representative Evaluation Form to help residents assess the validity of pharmaceutical company representative presentations; they found that residents rapidly acquire the ability to identify potential fallacies of logic and other misleading sales techniques in representatives' presentations.21 Medical students have also been shown to derive benefit from an educational program on pharmaceutical promotion.22 Once they have acquired enhanced critical appraisal skills, they must practice them in order to retain them, as in any learning environment. This mandates some interaction with pharmaceutical company representatives. Residencies are in a position to take an active and supervising role in preparing future physicians for inevitable contact with pharmaceutical company representatives and other industry influence.
Some physicians may argue that residents meeting with pharmaceutical company representatives and discussing their presentations will only serve to encourage the growth of this enterprise. This is possible; however, this argument is similar to that against offering sex education to youths. Although there are obvious differences in the underlying construction of principles, one could argue that the overall social atmosphere will have far more influence on resident interaction with industry, as it did to the US teenage pregnancy rate.23 In addition, pharmaceutical company representatives are just one of many external pressures faced by residents, including eager lawyers, billing regulations, and administrative personnel. Almost every aspect of a patient encounter, including treatment plans, dispositions, and documentation, involve some degree of influence, some of which affect financial self-interest. The reality is that residents will become practicing physicians who may recommend tests and follow-up visits that increase their personal income. They will refer patients to specialists and primary physicians who are their friends and colleagues. An end goal of stopping all of these practices is impractical and naive. All these outside influences, including pharmaceutical advertising, are part of the reality of emergency medicine and should be addressed during residency training.
The mere existence of pharmaceutical company representatives in medicine is not a good reason for residents to meet with them. However, the pharmaceutical industry, including pharmaceutical company representatives, offers many benefits to medicine and to resident training. Industry support of graduate medical education is difficult to quantify but is potentially of great importance.24 As universities and community hospitals cut funding to residency programs, grants from pharmaceutical companies are increasingly helpful funding options for resident education. The ACCME, in their Standards for Commercial Support of Continuing Medical Education, states that, with minimal limitations, scholarship or other special funding to permit medical students, residents, or fellows to attend selected educational conferences may be provided.14 ACEP has stated that, without financial support from industry, physician specialty societies would most likely be forced to curtail important scientific and policy meetings.25 On a smaller scale, lunch at weekly conferences and dinner at journal club is a benefit to residents and has been shown to improve attendance.26, 27 These meals are usually accompanied by a pharmaceutical company representative who is available for discussion but does not make any part of the presentation.
Industry is a significant source of innovative development in medicine and is responsible for informing physicians about the benefits and risks of promising diagnostic and therapeutic discoveries.24 Adoption of new therapies is highly dependent on the use of interventions to promote clinical change.28 Because physicians are often slow to change, industry serves a need in providing a stimulus to change outdated practices and existing habits. Although it has been argued that only more expensive treatments are advertised,29 there are many examples in clinical practice where effective and efficient strategies involving pharmaceutical products have been underutilized and where marketing by pharmaceutical companies played an important role in improving outcomes for patients.2 Some of these examples are the 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,2 and perhaps influenza vaccination in the 2000s.
Physicians have an obligation to themselves, their profession, and society to evaluate, correct for, and eliminate potential bias in medical information from all sources.5 The prohibition of resident contact with pharmaceutical company representatives will not facilitate this goal, nor is it a necessary starting point. Unless the influence of the pharmaceutical industry is removed completely from medical practice and unless the industry is prohibited from the funding of research, direct-to-consumer advertising, and contact with practicing physicians, industry influence will continue, and it makes little sense to restrict resident exposure to pharmaceutical company representatives for their brief period of residency. Such a restriction would not mitigate the pervasiveness of the pharmaceutical industry in medicine. Instead, residents should be taught skills to handle all types of industry influence and given the opportunity to practice those skills in certain settings. As long as the pharmaceutical industry continues to have access to physicians in practice and consumers, a physician's time in residency should be used to foster critical appraisal and deductive reasoning skills so as to better prepare him or her for the assault that may take place on a daily basis. Recent federal prosecution of pharmaceutical company representatives and physicians,30 as well as Web sites geared toward educating physicians about the perils of dealings with pharmaceutical company representatives,31, 32 suggest that attention to the promotional tactics of the pharmaceutical industry is increasing. For now, active discussion of any presentation, information, or articles given by pharmaceutical company representatives should take place between trained faculty and residents, with particular emphasis placed on discovering sources of bias, misleading sales techniques, and omission of facts, as well as on uncovering useful information.
This column was edited by Clare Atzema, MD, Resident Fellow 2003-2004.
References
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- Government Accounting Office. General Accounting Office report to congressional requesters: prescription drugs—FDA oversight of direct-to-consumer advertising has limitations. 2002. Available at: http://www.gao.gov/new.items/d03177.pdf. Accessed April 5, 2004.
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- Accreditation Council for Continuing Medical Education Web site. Standards for commercial support of continuing medical education. 1992. Available at: http://www.accme.org/pdfs/disclosure_pol.pdf. Accessed April 5, 2004.
- American Medical Association Web site. Gifts to physicians from industry. 1998. Available at: http://www.ama-assn.org/ama/pub/article/4001-7922.html. Accessed April 5, 2004.
- Society for Academic Emergency Medicine. Policy on commercial support of SAEM activities. Available at: http://www.saem.org/inform/commerci.htm. Accessed September 20, 2004.
- Encounters with pharmaceutical sales representatives among practicing internists. Am J Med. 1999;107:149–152
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- Molzen GW. ACEP comment letter to OIG [American College of Emergency Physicians Web site]. 2002. Available at: http://www.acep.org/library/pdf/pharmmfrs.pdf. Accessed April 5, 2004.
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- . Direct to consumer advertising of prescription drugs. An idea whose time should not come. BMJ. 1999;318:1301–1302
- Lavoie D. Eleven drug-company executives face trial in kickback case. The Seattle Times. April 13, 2004. Available at: http://seattletimes.nwsource.com/cgi-bin/PrintStory.pl?document_id=2001901813&zsection_id-268448455&slug=drugtrial13&date=20040413. Accessed October 28, 2004.
- Goodman R. No free lunch: just say no to drug reps. Available at: http://www.nofreelunch.org. Accessed April 13, 2004.
- Department of Essential Drugs and Medicines Policy Drug Promotion Database. Available at: http://www.drugpromo.info/. Accessed April 13, 2004.
The authors report this study did not receive any outside funding or support.Reprints not available from the authors.
PII: S0196-0644(04)01581-1
doi:10.1016/j.annemergmed.2004.10.028
© 2005 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.
