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The Informed Hospitalist and the Pharmaceutical Industry
The ideal patient-physician relationship is one of choice, competence, communication, compassion, and continuity, and is free of any conflict of interest. There is heated controversy about whether the relationship between the pharmaceutical industry and medical professionals betrays this ideal. The heart of this debate lies in the fundamental difference in priorities and goals of the pharmaceutical industry and hospitalists. Hospitalists are trusted with the lives and well-being of patients. A physician is expected to make an unbiased analysis of the treatment options for a given patient and to apply that treatment to the best of his or her abilities. In contrast, the ultimate interest of the pharmaceutical industry lies with the shareholders, and the primary goal is to maximize profit. Many feel that these two goals are mutually exclusive (1,2). Medical educators believe that it is the responsibility of the medical profession, not pharmaceutical companies, to educate physicians. The entanglement of the pharmaceutical industry with physicians calls into question the credibility of information obtained from any pharmaceutical-sponsored event and casts doubt over the medical profession as a whole. Governmental regulation and legislative initiatives such as the Bayh-Dole Act (3) have furthered the commercialization of academic research and realigned academic centers’ approach to clinical research.
The pharmaceutical industry argues that its goals and the goals of the medical profession are complementary (4) and that their involvement optimizes the benefit to the patient. The pharmaceutical industry is quick to point out that pharmaceutical companies are an important source of funding for clinical trials and are the leading sponsors of continuing medical education, and that it is the most research-intensive industry in the United States supported by private funds (5). Corporate contributions to research and development in academia have increased by 900% between 1980 and 2000. The pharmaceutical industry devoted 18% of profits in 2002 to research, development, and testing activities (6). The pharmaceutical industry claims that these are designed to serve the mutual interests of the pharmaceutical industry and the medical community by providing accurate and up-to-date information to maximize patient care. The advances made as a result of commercial development have dramatically altered the landscape of research. Pharmaceutical courtship of hospitalists, who find themselves on the front line in clinical settings as prescribers or researchers, is part of an aggressive marketing campaign that some believe contributes little to the common good.
Hospitalists have increased their financial incentives with stock options, fees for consultation, speaking arrangements, and memberships on advisory boards for pharmaceutical companies. Disclosure of financial conflicts is becoming an empty ritual providing a false sense of security. Pharmaceutical research is increasingly organized by Contract Research Organizations, written up with the help of ghostwriters, and published under the name of established investigators (7,8). Not all industry-funded studies are necessarily fl awed and without scientific merit, but the fact that negative consequences can be devastating to the financial health of a corporation has to be considered.
A leading catalyst for continued pharmaceutical industry/hospitalist interaction is continuing medical education (CME). In 2003, the pharmaceutical industry provided 900 million of the one billion dollars spent on CME in the United States. Currently, the pharmaceutical industry funds approximately 60% of all CME activities in the United States (9). Information provided to physicians by a pharmaceutical representative has an inaccuracy rating of 13% (10). Not surprisingly, many of these inaccuracies favor the product being presented and casts an unfavorable light on competing drugs (10,11). This has led some to believe that this pharmaceutical representative/physician interaction is having a negative impact on patients (12) through the dissemination of inaccurate information. In addition, misleading advertisements have been found to overstate the effectiveness and minimize the risks of a given drug (11). Another form of bias is the selective publication of research studies by the pharmaceutical industry (13).
Bedside and Conference Detailing
Interactions with pharmaceutical representatives (drug detailers) often begin in medical school and proceed throughout a physician’s career (12,14). In 2003, the pharmaceutical industry spent more than 13 billion dollars on promotional activities for doctors, an average of about $10,500 per physician. There is one drug detailer for every 4.7 office-based physicians. Interactions include conferences with free lunch, personal visits by drug detailers, sponsored CME workshops/seminars, sponsored dinners, sponsored scientific conferences, sponsored research, direct gifts (e.g., cash payments for prescribing a given medication), and indirect gifts (e.g., subsidizing a trip to a medical conference). These interactions evolve from merely lunches and pens early in a physician’s career to positions as a consultant and advisory board honoree as the relationship matures. Some physicians view such exchanges as helpful and informative while others view it as unethical (2) and harmful.
Hospitalists, residents, and medical students alike believe their interactions with drug detailers, and the small gifts that they receive, do not influence their behavior (14,15). Wazana found that as physicians continue to receive gifts from drug detailers, they become even less likely to believe that the gifts can influence their behavior (16). Many physicians believe that their interactions with drug companies are beneficial not only to them but also to their patients. However, studies have found that this is in fact not the case. Physicians who interact with pharmaceutical representatives prescribe newer and more expensive drugs, rather than cheaper and equally effective generic drugs (16,17). There are a significantly higher number of prescriptions written for the drugs manufactured by pharmaceutical companies who sponsor a given CME activity than pharmaceutical companies who do not. A rise in prescription expenditures (17), as well as an increase in irrational prescribing, often follows in-house exposure to drug detailers (16).
The enormous amount spent on marketing can also be used as further proof of the pharmaceutical industry’s avarice. However, we often fail to acknowledge the role that medical educators and professionals play in this problem. Pharmaceutical companies are profitable because of our prescribing habits. For example, many medical professionals prescribe expensive “me too” drugs that often offer little if any benefit over cheaper established or prototypical drugs. Our actions encourage what we claim to be bad behavior by the pharmaceutical industry.
It is often argued by the pharmaceutical industry that these “me too” drugs have a different side effect profile, may improve compliance in long-term treatment, or will reduce cost when compared to the prototype drug. This is true in some instances, as exemplified by the wide array of anti-hypertensives and the even wider array of side effect profiles. However, there are many instances when this is far from the case. If a financial incentive did not exist for pharmaceutical companies to introduce “me too” drugs, the pharmaceutical industry would not do so unless the drug being introduced provided a substantial clinical advantage over the prototype drug. As a result, the pharmaceutical industry would be spending their time, effort, and finances on research aimed at finding new and innovative cures.
Proposed Solution to the Problem
In an effort to remedy this situation, many professional societies (as well as the pharmaceutical industry itself) have established guidelines on the interactions between the pharmaceutical industry and physicians. The AMA has established guidelines responsible for the regulation of gifts bestowed on physicians by industry (18). The Pharmaceutical Research Manufacturers of America has established similar guidelines known as the PhRMA Code (19). Increasingly, many professional organizations have taken it upon themselves to establish their own code of conduct. However, there remains a low level of awareness of the guidelines (15) that are currently in place, and some of the pharmaceutical companies have chosen not to abide by the PhRMA Code. In response to the increasing influence pharmaceutical companies are having on the medical decision-making process, many training programs are adopting policies to limit the contact between pharmaceutical representatives and physicians in training. This is being carried out at both the undergraduate and graduate medical education levels (20). The effects of such restrictions are currently unknown. McCormick found that physicians who trained in institutions with such policies were less likely to find information from pharmaceutical company representatives useful (20). However, Ferguson found that being trained in a program with a policy that limited access to pharmaceutical sales representatives did not affect the subsequent likelihood of future physician-pharmaceutical representative interactions (21).
The Informed Hospitalist in the 21st Century
The literature clearly documents that the pharmaceutical industry influences physician prescribing habits. Hospitalists can take a four-prong approach to help counteract these effects:
1. Academic Detailing
Medical educators can shield residents and medical students from the influence of pharmaceutical representatives by limiting or prohibiting contact, or they can teach trainees how to effectively manage such interactions through academic detailing. As stated above, Ferguson found that policies limiting access to drug detailers did not affect the subsequent likelihood of future physician and pharmaceutical representative interactions (21). It might be wiser to teach trainees how to manage their interactions with the drug representatives and thereby take control of the situation. In order for doctors to effectively manage such interactions, we must learn how to evaluate the literature and interpret the information given to us by representatives. Watkins found that both attendings and residents feel that they should learn how to critically evaluate promotional materials, recognize potential conflicts of interest, and consider how patients perceive physician-pharmaceutical relationships (22). Previous studies have found that educational interventions can have a significant effect on the attitudes of medical students and residents towards pharmaceutical marketing and drug detailers (23,24).
One way to evaluate pharmaceutical literature is to have academic detailing of the clinical studies and statements made by pharmaceutical detailers at sponsored events. During these academic detailing conferences the drug in question can be compared to other drugs in the class, and indications and differences should be mentioned if they exist. This should be done in the presence of both an attending who is very familiar with the drug and drug class in question and a hospital pharmacist. If this is done in a small setting, the medical students and residents can take turns critically evaluating the presentations. This approach is comparable to teaching medicine at the bedside; learners develop a deeper appreciation and understanding by experiencing various situations first-hand.
An additional benefit of critically evaluating pharmaceutical representative presentations is that when they know that the information they provide will be closely scrutinized, pharmaceutical representatives will have an incentive to provide more accurate information.
2. Cost Sensitivity
One of the many topics that can be discussed by the hospital pharmacist or attending is the price of the given drug. In discussing price, two critical points must be evaluated. The first is the price-benefit ratio of the given drug and the second is the financial situation of the patient. Physicians should always have the patient’s best interest in mind. However, this does not mean that cost should not be considered when making therapeutic decisions. Rather, a more practical therapeutic decision can be made with cost in mind. Cost is the major factor to some patients when determining whether they will fill their prescriptions. In such an instance, if cost is taken into consideration when writing the prescription, a physician is more apt to write a prescription for a less expensive medication (if one exists).
3. Three-Way Transparency
In order for hospitalists to effectively interact with the pharmaceutical industry, it must be realized that medical professionals are not victims of the marketing strategies of the pharmaceutical industry; rather, we are accomplices. We often fail to acknowledge the role medical educators and professionals play in this problem. Many years ago, Troyan Brennan called for transparency, stating “Conflict will remain with us. Physicians’ relationship with the pharmaceutical industry must be better managed” (25). However, Brennan did not offer any proposals on a better management system. Our current management system of disclosure of conflict has become obsolete. It has become a ritual practice in academia to acknowledge that one may have a conflict of interest, but this does nothing to address the real issue: the conflict of interest itself. Hospitalists can adopt a three-way transparency between the patient, colleagues, and the pharmaceutical industry where all conflicts are fully disclosed, rather than simply stating that a conflict might exist.
4. High Threshold for Rationalization
Most medical professionals, to some degree, rationalize interactions with the pharmaceutical industry. Almost all physicians insist that these interactions do not influence their judgment. The simple fact that the industry spends thousands of dollars per doctor per year indicates that we are wrong. If physicians were not being influenced, the pharmaceutical companies would not be spending such a considerable amount of money marketing to us. Patients trust physicians to make the best decision for them, they depend on researchers to publish impartial studies, and they count on educators to present unbiased truths. The cost of betrayal is paid in human lives. We should learn from the past, as well as the recent coxib debacle.
Conclusion
The interaction between hospitalists and the pharmaceutical industry continues to evolve. With increasing scrutiny from the medical profession and the government, many of the marketing practices that were considered acceptable in the past are now viewed as unacceptable and even criminal. As the relationship evolves, new conflicts are sure to arise as long as the fundamental difference between the medical profession and pharmaceutical industry continues to exist. As medical professionals, we must keep in mind that the pharmaceutical industry is a for-profit industry whose interest lies with its shareholders. It is to be expected that the pharmaceutical industry will try to maximize profits through marketing efforts directed at physicians and patients.
Medical educators must take on the responsibility of preparing medical students, residents, and fellow attendings on how to manage their interactions with the pharmaceutical industry and not just shield them from the issue. In applying the four-point approach of academic detailing, cost sensitivity, three-way transparency, and a high threshold for justification, we can better manage such interactions.
We would like to thank Dr. Anna Headly and Emily Hartsough for their constructive comments in the preparation of the manuscript.
Disclaimer: The content of the article is solely the responsibility of the authors and does not necessarily represent the official view of the Society of Hospital Medicine.
Dr. Rajput can be contacted at rajputvk@umdnj.edu.
References
- Abbasi K, Smith R. No more free lunch: patients will benefit from doctors and drug companies disentangling. BMJ. 2003;326:1155-6.
- Relman AS. Separating continuing medical education from pharmaceutical marketing. JAMA. 2001;285:2009-12.
- Thursby JG, Thursby MC. Intellectual property. University licensing and the Bayh-Dole Act. Science. 2003;301:1052.
- Holmer AF. Industry strongly supports continuing medical education. JAMA. 2001;285:2012-4.
- Scherer FM. The pharmaceutical industry: price and progress. N Engl J Med. 2004;351:927-32.
- Pharmaceutical industry profiles 2003. Washinton, DC; 2003.
- Moynihan R. Who pays for the pizza? Redefining the relationships between doctors and drug companies. 2: Disentanglement. BMJ. 2003;326:1193-6.
- Smith R. Medical journals and pharmaceutical companies: uneasy bedfellows. BMJ. 2003;326:1202-5.
- Relman AS. Defending professional independence: ACCME’s proposed new guidelines for commercial support of CME. JAMA. 2003;289:2418-20.
- Ziegler MG, Lew P, Singer BC. The accuracy of drug information from pharmaceutical sales representatives. JAMA. 1995;273:1296-8.
- Gottlieb S. Congress criticises drug industry for misleading advertising. BMJ. 2002;325:1379.
- Rogers WA, Mansfield PR, Braunack-Mayer AJ, Jureidini JN. The ethics of pharmaceutical industry relationships with medical students. Med J Aust. 2004;180:411-4.
- Melander H, Ahlqvist-Rastad J, Me&er G, Beermann B. Evidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ. 2003;326:1171-3.
- Lexchin J. Interactions between physician and the pharmaceutical industry: what does the literatue say? Can Med Assoc J. 1993;149:1401-7.
- Steinman MA, Shlipak MG, McPhee SJ. Of principles and pens: attitudes and practices of medicine housestaff toward pharmaceutical industry promotions. Am J Med. 2001;110:551-7.
- Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA. 2000;283:373-80.
- Watkins C, Moore L, Harvey I, Carthy P, Robinson E, Brawn R. Characteristics of general practitioners who frequently see drug industry representatives: national cross sectional study. BMJ. 2003;326:1178-9.
- Guidelines on gifts to physicians from industry: an update. Food Drug Law J. 2001;56:27-40.
- PhRMA CODE On Interactions with Health Care Professionals. Infectious Diseases in Clinical Practice. 2002;(11):153-4.
- McCormick BB, Tomlinson G, Brill-Edwards P, Detsky AS. Effect of restricting contact between pharmaceutical company representatives and internal medicine residents on posttraining attitudes and behavior. JAMA. 2001;286:1994-9.
- Ferguson RP, Rhim E, Belizaire W, Egede L, Carter K, Lansdale T. Encounters with pharmaceutical sales representatives among practicing internists. Am J Med. 1999;107:149-52.
- Watkins RS, Kimberly JJ. What residents don’t know about physician-pharmaceutical industry interactions. Acad Med. 2004;79:432-7.
- Wilkes MS, Hoffman JR. An innovative approach to educating medical students about pharmaceutical promotion. Acad Med. 2001;76:1271-7.
- Vinson DC, McCandless B, Hosokawa MC. Medical students’ attitudes toward pharmaceutical marketing: possibilities for change. Fam Med. 1993;25:31-3.
- Brennan TA. Buying editorials. N Engl J Med. 1994;331: 673-5; discussion 76.
The ideal patient-physician relationship is one of choice, competence, communication, compassion, and continuity, and is free of any conflict of interest. There is heated controversy about whether the relationship between the pharmaceutical industry and medical professionals betrays this ideal. The heart of this debate lies in the fundamental difference in priorities and goals of the pharmaceutical industry and hospitalists. Hospitalists are trusted with the lives and well-being of patients. A physician is expected to make an unbiased analysis of the treatment options for a given patient and to apply that treatment to the best of his or her abilities. In contrast, the ultimate interest of the pharmaceutical industry lies with the shareholders, and the primary goal is to maximize profit. Many feel that these two goals are mutually exclusive (1,2). Medical educators believe that it is the responsibility of the medical profession, not pharmaceutical companies, to educate physicians. The entanglement of the pharmaceutical industry with physicians calls into question the credibility of information obtained from any pharmaceutical-sponsored event and casts doubt over the medical profession as a whole. Governmental regulation and legislative initiatives such as the Bayh-Dole Act (3) have furthered the commercialization of academic research and realigned academic centers’ approach to clinical research.
The pharmaceutical industry argues that its goals and the goals of the medical profession are complementary (4) and that their involvement optimizes the benefit to the patient. The pharmaceutical industry is quick to point out that pharmaceutical companies are an important source of funding for clinical trials and are the leading sponsors of continuing medical education, and that it is the most research-intensive industry in the United States supported by private funds (5). Corporate contributions to research and development in academia have increased by 900% between 1980 and 2000. The pharmaceutical industry devoted 18% of profits in 2002 to research, development, and testing activities (6). The pharmaceutical industry claims that these are designed to serve the mutual interests of the pharmaceutical industry and the medical community by providing accurate and up-to-date information to maximize patient care. The advances made as a result of commercial development have dramatically altered the landscape of research. Pharmaceutical courtship of hospitalists, who find themselves on the front line in clinical settings as prescribers or researchers, is part of an aggressive marketing campaign that some believe contributes little to the common good.
Hospitalists have increased their financial incentives with stock options, fees for consultation, speaking arrangements, and memberships on advisory boards for pharmaceutical companies. Disclosure of financial conflicts is becoming an empty ritual providing a false sense of security. Pharmaceutical research is increasingly organized by Contract Research Organizations, written up with the help of ghostwriters, and published under the name of established investigators (7,8). Not all industry-funded studies are necessarily fl awed and without scientific merit, but the fact that negative consequences can be devastating to the financial health of a corporation has to be considered.
A leading catalyst for continued pharmaceutical industry/hospitalist interaction is continuing medical education (CME). In 2003, the pharmaceutical industry provided 900 million of the one billion dollars spent on CME in the United States. Currently, the pharmaceutical industry funds approximately 60% of all CME activities in the United States (9). Information provided to physicians by a pharmaceutical representative has an inaccuracy rating of 13% (10). Not surprisingly, many of these inaccuracies favor the product being presented and casts an unfavorable light on competing drugs (10,11). This has led some to believe that this pharmaceutical representative/physician interaction is having a negative impact on patients (12) through the dissemination of inaccurate information. In addition, misleading advertisements have been found to overstate the effectiveness and minimize the risks of a given drug (11). Another form of bias is the selective publication of research studies by the pharmaceutical industry (13).
Bedside and Conference Detailing
Interactions with pharmaceutical representatives (drug detailers) often begin in medical school and proceed throughout a physician’s career (12,14). In 2003, the pharmaceutical industry spent more than 13 billion dollars on promotional activities for doctors, an average of about $10,500 per physician. There is one drug detailer for every 4.7 office-based physicians. Interactions include conferences with free lunch, personal visits by drug detailers, sponsored CME workshops/seminars, sponsored dinners, sponsored scientific conferences, sponsored research, direct gifts (e.g., cash payments for prescribing a given medication), and indirect gifts (e.g., subsidizing a trip to a medical conference). These interactions evolve from merely lunches and pens early in a physician’s career to positions as a consultant and advisory board honoree as the relationship matures. Some physicians view such exchanges as helpful and informative while others view it as unethical (2) and harmful.
Hospitalists, residents, and medical students alike believe their interactions with drug detailers, and the small gifts that they receive, do not influence their behavior (14,15). Wazana found that as physicians continue to receive gifts from drug detailers, they become even less likely to believe that the gifts can influence their behavior (16). Many physicians believe that their interactions with drug companies are beneficial not only to them but also to their patients. However, studies have found that this is in fact not the case. Physicians who interact with pharmaceutical representatives prescribe newer and more expensive drugs, rather than cheaper and equally effective generic drugs (16,17). There are a significantly higher number of prescriptions written for the drugs manufactured by pharmaceutical companies who sponsor a given CME activity than pharmaceutical companies who do not. A rise in prescription expenditures (17), as well as an increase in irrational prescribing, often follows in-house exposure to drug detailers (16).
The enormous amount spent on marketing can also be used as further proof of the pharmaceutical industry’s avarice. However, we often fail to acknowledge the role that medical educators and professionals play in this problem. Pharmaceutical companies are profitable because of our prescribing habits. For example, many medical professionals prescribe expensive “me too” drugs that often offer little if any benefit over cheaper established or prototypical drugs. Our actions encourage what we claim to be bad behavior by the pharmaceutical industry.
It is often argued by the pharmaceutical industry that these “me too” drugs have a different side effect profile, may improve compliance in long-term treatment, or will reduce cost when compared to the prototype drug. This is true in some instances, as exemplified by the wide array of anti-hypertensives and the even wider array of side effect profiles. However, there are many instances when this is far from the case. If a financial incentive did not exist for pharmaceutical companies to introduce “me too” drugs, the pharmaceutical industry would not do so unless the drug being introduced provided a substantial clinical advantage over the prototype drug. As a result, the pharmaceutical industry would be spending their time, effort, and finances on research aimed at finding new and innovative cures.
Proposed Solution to the Problem
In an effort to remedy this situation, many professional societies (as well as the pharmaceutical industry itself) have established guidelines on the interactions between the pharmaceutical industry and physicians. The AMA has established guidelines responsible for the regulation of gifts bestowed on physicians by industry (18). The Pharmaceutical Research Manufacturers of America has established similar guidelines known as the PhRMA Code (19). Increasingly, many professional organizations have taken it upon themselves to establish their own code of conduct. However, there remains a low level of awareness of the guidelines (15) that are currently in place, and some of the pharmaceutical companies have chosen not to abide by the PhRMA Code. In response to the increasing influence pharmaceutical companies are having on the medical decision-making process, many training programs are adopting policies to limit the contact between pharmaceutical representatives and physicians in training. This is being carried out at both the undergraduate and graduate medical education levels (20). The effects of such restrictions are currently unknown. McCormick found that physicians who trained in institutions with such policies were less likely to find information from pharmaceutical company representatives useful (20). However, Ferguson found that being trained in a program with a policy that limited access to pharmaceutical sales representatives did not affect the subsequent likelihood of future physician-pharmaceutical representative interactions (21).
The Informed Hospitalist in the 21st Century
The literature clearly documents that the pharmaceutical industry influences physician prescribing habits. Hospitalists can take a four-prong approach to help counteract these effects:
1. Academic Detailing
Medical educators can shield residents and medical students from the influence of pharmaceutical representatives by limiting or prohibiting contact, or they can teach trainees how to effectively manage such interactions through academic detailing. As stated above, Ferguson found that policies limiting access to drug detailers did not affect the subsequent likelihood of future physician and pharmaceutical representative interactions (21). It might be wiser to teach trainees how to manage their interactions with the drug representatives and thereby take control of the situation. In order for doctors to effectively manage such interactions, we must learn how to evaluate the literature and interpret the information given to us by representatives. Watkins found that both attendings and residents feel that they should learn how to critically evaluate promotional materials, recognize potential conflicts of interest, and consider how patients perceive physician-pharmaceutical relationships (22). Previous studies have found that educational interventions can have a significant effect on the attitudes of medical students and residents towards pharmaceutical marketing and drug detailers (23,24).
One way to evaluate pharmaceutical literature is to have academic detailing of the clinical studies and statements made by pharmaceutical detailers at sponsored events. During these academic detailing conferences the drug in question can be compared to other drugs in the class, and indications and differences should be mentioned if they exist. This should be done in the presence of both an attending who is very familiar with the drug and drug class in question and a hospital pharmacist. If this is done in a small setting, the medical students and residents can take turns critically evaluating the presentations. This approach is comparable to teaching medicine at the bedside; learners develop a deeper appreciation and understanding by experiencing various situations first-hand.
An additional benefit of critically evaluating pharmaceutical representative presentations is that when they know that the information they provide will be closely scrutinized, pharmaceutical representatives will have an incentive to provide more accurate information.
2. Cost Sensitivity
One of the many topics that can be discussed by the hospital pharmacist or attending is the price of the given drug. In discussing price, two critical points must be evaluated. The first is the price-benefit ratio of the given drug and the second is the financial situation of the patient. Physicians should always have the patient’s best interest in mind. However, this does not mean that cost should not be considered when making therapeutic decisions. Rather, a more practical therapeutic decision can be made with cost in mind. Cost is the major factor to some patients when determining whether they will fill their prescriptions. In such an instance, if cost is taken into consideration when writing the prescription, a physician is more apt to write a prescription for a less expensive medication (if one exists).
3. Three-Way Transparency
In order for hospitalists to effectively interact with the pharmaceutical industry, it must be realized that medical professionals are not victims of the marketing strategies of the pharmaceutical industry; rather, we are accomplices. We often fail to acknowledge the role medical educators and professionals play in this problem. Many years ago, Troyan Brennan called for transparency, stating “Conflict will remain with us. Physicians’ relationship with the pharmaceutical industry must be better managed” (25). However, Brennan did not offer any proposals on a better management system. Our current management system of disclosure of conflict has become obsolete. It has become a ritual practice in academia to acknowledge that one may have a conflict of interest, but this does nothing to address the real issue: the conflict of interest itself. Hospitalists can adopt a three-way transparency between the patient, colleagues, and the pharmaceutical industry where all conflicts are fully disclosed, rather than simply stating that a conflict might exist.
4. High Threshold for Rationalization
Most medical professionals, to some degree, rationalize interactions with the pharmaceutical industry. Almost all physicians insist that these interactions do not influence their judgment. The simple fact that the industry spends thousands of dollars per doctor per year indicates that we are wrong. If physicians were not being influenced, the pharmaceutical companies would not be spending such a considerable amount of money marketing to us. Patients trust physicians to make the best decision for them, they depend on researchers to publish impartial studies, and they count on educators to present unbiased truths. The cost of betrayal is paid in human lives. We should learn from the past, as well as the recent coxib debacle.
Conclusion
The interaction between hospitalists and the pharmaceutical industry continues to evolve. With increasing scrutiny from the medical profession and the government, many of the marketing practices that were considered acceptable in the past are now viewed as unacceptable and even criminal. As the relationship evolves, new conflicts are sure to arise as long as the fundamental difference between the medical profession and pharmaceutical industry continues to exist. As medical professionals, we must keep in mind that the pharmaceutical industry is a for-profit industry whose interest lies with its shareholders. It is to be expected that the pharmaceutical industry will try to maximize profits through marketing efforts directed at physicians and patients.
Medical educators must take on the responsibility of preparing medical students, residents, and fellow attendings on how to manage their interactions with the pharmaceutical industry and not just shield them from the issue. In applying the four-point approach of academic detailing, cost sensitivity, three-way transparency, and a high threshold for justification, we can better manage such interactions.
We would like to thank Dr. Anna Headly and Emily Hartsough for their constructive comments in the preparation of the manuscript.
Disclaimer: The content of the article is solely the responsibility of the authors and does not necessarily represent the official view of the Society of Hospital Medicine.
Dr. Rajput can be contacted at rajputvk@umdnj.edu.
References
- Abbasi K, Smith R. No more free lunch: patients will benefit from doctors and drug companies disentangling. BMJ. 2003;326:1155-6.
- Relman AS. Separating continuing medical education from pharmaceutical marketing. JAMA. 2001;285:2009-12.
- Thursby JG, Thursby MC. Intellectual property. University licensing and the Bayh-Dole Act. Science. 2003;301:1052.
- Holmer AF. Industry strongly supports continuing medical education. JAMA. 2001;285:2012-4.
- Scherer FM. The pharmaceutical industry: price and progress. N Engl J Med. 2004;351:927-32.
- Pharmaceutical industry profiles 2003. Washinton, DC; 2003.
- Moynihan R. Who pays for the pizza? Redefining the relationships between doctors and drug companies. 2: Disentanglement. BMJ. 2003;326:1193-6.
- Smith R. Medical journals and pharmaceutical companies: uneasy bedfellows. BMJ. 2003;326:1202-5.
- Relman AS. Defending professional independence: ACCME’s proposed new guidelines for commercial support of CME. JAMA. 2003;289:2418-20.
- Ziegler MG, Lew P, Singer BC. The accuracy of drug information from pharmaceutical sales representatives. JAMA. 1995;273:1296-8.
- Gottlieb S. Congress criticises drug industry for misleading advertising. BMJ. 2002;325:1379.
- Rogers WA, Mansfield PR, Braunack-Mayer AJ, Jureidini JN. The ethics of pharmaceutical industry relationships with medical students. Med J Aust. 2004;180:411-4.
- Melander H, Ahlqvist-Rastad J, Me&er G, Beermann B. Evidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ. 2003;326:1171-3.
- Lexchin J. Interactions between physician and the pharmaceutical industry: what does the literatue say? Can Med Assoc J. 1993;149:1401-7.
- Steinman MA, Shlipak MG, McPhee SJ. Of principles and pens: attitudes and practices of medicine housestaff toward pharmaceutical industry promotions. Am J Med. 2001;110:551-7.
- Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA. 2000;283:373-80.
- Watkins C, Moore L, Harvey I, Carthy P, Robinson E, Brawn R. Characteristics of general practitioners who frequently see drug industry representatives: national cross sectional study. BMJ. 2003;326:1178-9.
- Guidelines on gifts to physicians from industry: an update. Food Drug Law J. 2001;56:27-40.
- PhRMA CODE On Interactions with Health Care Professionals. Infectious Diseases in Clinical Practice. 2002;(11):153-4.
- McCormick BB, Tomlinson G, Brill-Edwards P, Detsky AS. Effect of restricting contact between pharmaceutical company representatives and internal medicine residents on posttraining attitudes and behavior. JAMA. 2001;286:1994-9.
- Ferguson RP, Rhim E, Belizaire W, Egede L, Carter K, Lansdale T. Encounters with pharmaceutical sales representatives among practicing internists. Am J Med. 1999;107:149-52.
- Watkins RS, Kimberly JJ. What residents don’t know about physician-pharmaceutical industry interactions. Acad Med. 2004;79:432-7.
- Wilkes MS, Hoffman JR. An innovative approach to educating medical students about pharmaceutical promotion. Acad Med. 2001;76:1271-7.
- Vinson DC, McCandless B, Hosokawa MC. Medical students’ attitudes toward pharmaceutical marketing: possibilities for change. Fam Med. 1993;25:31-3.
- Brennan TA. Buying editorials. N Engl J Med. 1994;331: 673-5; discussion 76.
The ideal patient-physician relationship is one of choice, competence, communication, compassion, and continuity, and is free of any conflict of interest. There is heated controversy about whether the relationship between the pharmaceutical industry and medical professionals betrays this ideal. The heart of this debate lies in the fundamental difference in priorities and goals of the pharmaceutical industry and hospitalists. Hospitalists are trusted with the lives and well-being of patients. A physician is expected to make an unbiased analysis of the treatment options for a given patient and to apply that treatment to the best of his or her abilities. In contrast, the ultimate interest of the pharmaceutical industry lies with the shareholders, and the primary goal is to maximize profit. Many feel that these two goals are mutually exclusive (1,2). Medical educators believe that it is the responsibility of the medical profession, not pharmaceutical companies, to educate physicians. The entanglement of the pharmaceutical industry with physicians calls into question the credibility of information obtained from any pharmaceutical-sponsored event and casts doubt over the medical profession as a whole. Governmental regulation and legislative initiatives such as the Bayh-Dole Act (3) have furthered the commercialization of academic research and realigned academic centers’ approach to clinical research.
The pharmaceutical industry argues that its goals and the goals of the medical profession are complementary (4) and that their involvement optimizes the benefit to the patient. The pharmaceutical industry is quick to point out that pharmaceutical companies are an important source of funding for clinical trials and are the leading sponsors of continuing medical education, and that it is the most research-intensive industry in the United States supported by private funds (5). Corporate contributions to research and development in academia have increased by 900% between 1980 and 2000. The pharmaceutical industry devoted 18% of profits in 2002 to research, development, and testing activities (6). The pharmaceutical industry claims that these are designed to serve the mutual interests of the pharmaceutical industry and the medical community by providing accurate and up-to-date information to maximize patient care. The advances made as a result of commercial development have dramatically altered the landscape of research. Pharmaceutical courtship of hospitalists, who find themselves on the front line in clinical settings as prescribers or researchers, is part of an aggressive marketing campaign that some believe contributes little to the common good.
Hospitalists have increased their financial incentives with stock options, fees for consultation, speaking arrangements, and memberships on advisory boards for pharmaceutical companies. Disclosure of financial conflicts is becoming an empty ritual providing a false sense of security. Pharmaceutical research is increasingly organized by Contract Research Organizations, written up with the help of ghostwriters, and published under the name of established investigators (7,8). Not all industry-funded studies are necessarily fl awed and without scientific merit, but the fact that negative consequences can be devastating to the financial health of a corporation has to be considered.
A leading catalyst for continued pharmaceutical industry/hospitalist interaction is continuing medical education (CME). In 2003, the pharmaceutical industry provided 900 million of the one billion dollars spent on CME in the United States. Currently, the pharmaceutical industry funds approximately 60% of all CME activities in the United States (9). Information provided to physicians by a pharmaceutical representative has an inaccuracy rating of 13% (10). Not surprisingly, many of these inaccuracies favor the product being presented and casts an unfavorable light on competing drugs (10,11). This has led some to believe that this pharmaceutical representative/physician interaction is having a negative impact on patients (12) through the dissemination of inaccurate information. In addition, misleading advertisements have been found to overstate the effectiveness and minimize the risks of a given drug (11). Another form of bias is the selective publication of research studies by the pharmaceutical industry (13).
Bedside and Conference Detailing
Interactions with pharmaceutical representatives (drug detailers) often begin in medical school and proceed throughout a physician’s career (12,14). In 2003, the pharmaceutical industry spent more than 13 billion dollars on promotional activities for doctors, an average of about $10,500 per physician. There is one drug detailer for every 4.7 office-based physicians. Interactions include conferences with free lunch, personal visits by drug detailers, sponsored CME workshops/seminars, sponsored dinners, sponsored scientific conferences, sponsored research, direct gifts (e.g., cash payments for prescribing a given medication), and indirect gifts (e.g., subsidizing a trip to a medical conference). These interactions evolve from merely lunches and pens early in a physician’s career to positions as a consultant and advisory board honoree as the relationship matures. Some physicians view such exchanges as helpful and informative while others view it as unethical (2) and harmful.
Hospitalists, residents, and medical students alike believe their interactions with drug detailers, and the small gifts that they receive, do not influence their behavior (14,15). Wazana found that as physicians continue to receive gifts from drug detailers, they become even less likely to believe that the gifts can influence their behavior (16). Many physicians believe that their interactions with drug companies are beneficial not only to them but also to their patients. However, studies have found that this is in fact not the case. Physicians who interact with pharmaceutical representatives prescribe newer and more expensive drugs, rather than cheaper and equally effective generic drugs (16,17). There are a significantly higher number of prescriptions written for the drugs manufactured by pharmaceutical companies who sponsor a given CME activity than pharmaceutical companies who do not. A rise in prescription expenditures (17), as well as an increase in irrational prescribing, often follows in-house exposure to drug detailers (16).
The enormous amount spent on marketing can also be used as further proof of the pharmaceutical industry’s avarice. However, we often fail to acknowledge the role that medical educators and professionals play in this problem. Pharmaceutical companies are profitable because of our prescribing habits. For example, many medical professionals prescribe expensive “me too” drugs that often offer little if any benefit over cheaper established or prototypical drugs. Our actions encourage what we claim to be bad behavior by the pharmaceutical industry.
It is often argued by the pharmaceutical industry that these “me too” drugs have a different side effect profile, may improve compliance in long-term treatment, or will reduce cost when compared to the prototype drug. This is true in some instances, as exemplified by the wide array of anti-hypertensives and the even wider array of side effect profiles. However, there are many instances when this is far from the case. If a financial incentive did not exist for pharmaceutical companies to introduce “me too” drugs, the pharmaceutical industry would not do so unless the drug being introduced provided a substantial clinical advantage over the prototype drug. As a result, the pharmaceutical industry would be spending their time, effort, and finances on research aimed at finding new and innovative cures.
Proposed Solution to the Problem
In an effort to remedy this situation, many professional societies (as well as the pharmaceutical industry itself) have established guidelines on the interactions between the pharmaceutical industry and physicians. The AMA has established guidelines responsible for the regulation of gifts bestowed on physicians by industry (18). The Pharmaceutical Research Manufacturers of America has established similar guidelines known as the PhRMA Code (19). Increasingly, many professional organizations have taken it upon themselves to establish their own code of conduct. However, there remains a low level of awareness of the guidelines (15) that are currently in place, and some of the pharmaceutical companies have chosen not to abide by the PhRMA Code. In response to the increasing influence pharmaceutical companies are having on the medical decision-making process, many training programs are adopting policies to limit the contact between pharmaceutical representatives and physicians in training. This is being carried out at both the undergraduate and graduate medical education levels (20). The effects of such restrictions are currently unknown. McCormick found that physicians who trained in institutions with such policies were less likely to find information from pharmaceutical company representatives useful (20). However, Ferguson found that being trained in a program with a policy that limited access to pharmaceutical sales representatives did not affect the subsequent likelihood of future physician-pharmaceutical representative interactions (21).
The Informed Hospitalist in the 21st Century
The literature clearly documents that the pharmaceutical industry influences physician prescribing habits. Hospitalists can take a four-prong approach to help counteract these effects:
1. Academic Detailing
Medical educators can shield residents and medical students from the influence of pharmaceutical representatives by limiting or prohibiting contact, or they can teach trainees how to effectively manage such interactions through academic detailing. As stated above, Ferguson found that policies limiting access to drug detailers did not affect the subsequent likelihood of future physician and pharmaceutical representative interactions (21). It might be wiser to teach trainees how to manage their interactions with the drug representatives and thereby take control of the situation. In order for doctors to effectively manage such interactions, we must learn how to evaluate the literature and interpret the information given to us by representatives. Watkins found that both attendings and residents feel that they should learn how to critically evaluate promotional materials, recognize potential conflicts of interest, and consider how patients perceive physician-pharmaceutical relationships (22). Previous studies have found that educational interventions can have a significant effect on the attitudes of medical students and residents towards pharmaceutical marketing and drug detailers (23,24).
One way to evaluate pharmaceutical literature is to have academic detailing of the clinical studies and statements made by pharmaceutical detailers at sponsored events. During these academic detailing conferences the drug in question can be compared to other drugs in the class, and indications and differences should be mentioned if they exist. This should be done in the presence of both an attending who is very familiar with the drug and drug class in question and a hospital pharmacist. If this is done in a small setting, the medical students and residents can take turns critically evaluating the presentations. This approach is comparable to teaching medicine at the bedside; learners develop a deeper appreciation and understanding by experiencing various situations first-hand.
An additional benefit of critically evaluating pharmaceutical representative presentations is that when they know that the information they provide will be closely scrutinized, pharmaceutical representatives will have an incentive to provide more accurate information.
2. Cost Sensitivity
One of the many topics that can be discussed by the hospital pharmacist or attending is the price of the given drug. In discussing price, two critical points must be evaluated. The first is the price-benefit ratio of the given drug and the second is the financial situation of the patient. Physicians should always have the patient’s best interest in mind. However, this does not mean that cost should not be considered when making therapeutic decisions. Rather, a more practical therapeutic decision can be made with cost in mind. Cost is the major factor to some patients when determining whether they will fill their prescriptions. In such an instance, if cost is taken into consideration when writing the prescription, a physician is more apt to write a prescription for a less expensive medication (if one exists).
3. Three-Way Transparency
In order for hospitalists to effectively interact with the pharmaceutical industry, it must be realized that medical professionals are not victims of the marketing strategies of the pharmaceutical industry; rather, we are accomplices. We often fail to acknowledge the role medical educators and professionals play in this problem. Many years ago, Troyan Brennan called for transparency, stating “Conflict will remain with us. Physicians’ relationship with the pharmaceutical industry must be better managed” (25). However, Brennan did not offer any proposals on a better management system. Our current management system of disclosure of conflict has become obsolete. It has become a ritual practice in academia to acknowledge that one may have a conflict of interest, but this does nothing to address the real issue: the conflict of interest itself. Hospitalists can adopt a three-way transparency between the patient, colleagues, and the pharmaceutical industry where all conflicts are fully disclosed, rather than simply stating that a conflict might exist.
4. High Threshold for Rationalization
Most medical professionals, to some degree, rationalize interactions with the pharmaceutical industry. Almost all physicians insist that these interactions do not influence their judgment. The simple fact that the industry spends thousands of dollars per doctor per year indicates that we are wrong. If physicians were not being influenced, the pharmaceutical companies would not be spending such a considerable amount of money marketing to us. Patients trust physicians to make the best decision for them, they depend on researchers to publish impartial studies, and they count on educators to present unbiased truths. The cost of betrayal is paid in human lives. We should learn from the past, as well as the recent coxib debacle.
Conclusion
The interaction between hospitalists and the pharmaceutical industry continues to evolve. With increasing scrutiny from the medical profession and the government, many of the marketing practices that were considered acceptable in the past are now viewed as unacceptable and even criminal. As the relationship evolves, new conflicts are sure to arise as long as the fundamental difference between the medical profession and pharmaceutical industry continues to exist. As medical professionals, we must keep in mind that the pharmaceutical industry is a for-profit industry whose interest lies with its shareholders. It is to be expected that the pharmaceutical industry will try to maximize profits through marketing efforts directed at physicians and patients.
Medical educators must take on the responsibility of preparing medical students, residents, and fellow attendings on how to manage their interactions with the pharmaceutical industry and not just shield them from the issue. In applying the four-point approach of academic detailing, cost sensitivity, three-way transparency, and a high threshold for justification, we can better manage such interactions.
We would like to thank Dr. Anna Headly and Emily Hartsough for their constructive comments in the preparation of the manuscript.
Disclaimer: The content of the article is solely the responsibility of the authors and does not necessarily represent the official view of the Society of Hospital Medicine.
Dr. Rajput can be contacted at rajputvk@umdnj.edu.
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