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Professionalism and Physician Interactions With Industry
Professionalism and Physician Interactions With Industry Jannette Collins, MD, MEd
Many gifts from industry to physicians and medical organizations serve important and beneficial functions. However, the spiraling cost of health care is resulting in increasing governmental and medical scrutiny of legal and ethical issues concerning relationships between commercial companies and physicians. Professional oversight bodies are updating standards concerning the ethical responsibilities of physicians. This article presents a broad framework for understanding the professional and legal responsibilities of physicians when interacting with industry. Physicians have unique responsibilities based on the “fiduciary” nature of the patient-physician relationship and specified laws regarding health care. Physicians must protect the best interests of patients, with clinical decisions free of undue influence. Physicians have special obligations related to receiving gifts from industry or receiving payments that may be construed as “kickbacks” or fraud. To ensure that gifts do not compromise (or seem to compromise) professional judgment, physicians should generally not accept personal gifts from industry and consider accepting only those that primarily entail a benefit to patients, are not of substantial value, and have no “strings” attached. After reading this article, the reader should be able to describe the impact gifts have on physicians’ behavior, the privileges and obligations of physicians, and conflicts between professional obligations and personal gifts. Key Words: Professionalism, physician ethics, physician interactions with industry, gifts to physicians J Am Coll Radiol 2006;3:325-332. Copyright © 2006 American College of Radiology
DEFINITION OF PROFESSIONALISM The 28th edition of Dorland’s Illustrated Medical Dictionary [1] defines a professional as “one who is a specialist in a particular field or occupation” but does not define professionalism. The Random House Webster’s Dictionary [2] defines professionalism as “professional character, spirit, or methods.” Neither of these definitions gets at the spirit of medical professionalism. The Accreditation Council for Graduate Medical Education [3] requires radiology residency programs to define the specific knowledge, skills, behaviors, and attitudes required, and provide educational experiences as needed for their residents to demonstrate professionalism, as manifested through a commitment to carrying out professional responsibilities, adherence to ethical principles, and sensitivity to patients of diverse backgrounds.
The American Board of Radiology [4] and the American Board of Medical Specialties have defined professionalism as “demonstrating self-awareness and knowledge of limits, high standards of ethical and moral behavior, reDepartment of Radiology, University of Wisconsin Hospital and Clinics, Madison, Wis. Corresponding author and reprints: Jannette Collins, MD, MEd, University of Wisconsin Hospital and Clinics, Department of Radiology, E3/311 CSC, 600 Highland Avenue, Madison, WI 53792-3252; e-mail: [email protected]. © 2006 American College of Radiology 0091-2182/06/$32.00 ● DOI 10.1016/j.jacr.2006.01.022
liability and responsibility, respect for patient dignity, and autonomy.” The American Board of Radiology will evaluate competence in professionalism as part of the maintenance-of-certification process. Kuczewski [5] defined professionalism as “an expression of the norms that guide the relationships in which physicians are engaged.” In her review of the literature, Arnold [6] identified traits commonly associated with professionalism as altruism, respect for others as embodied in humanistic qualities, honor, integrity, ethical behavior, accountability, excellence, a sense of duty, and advocacy. Responding to a call for a renewed sense of professionalism, the European Federation of Internal Medicine, the American College of Physicians–American Society of Internal Medicine Foundation, and the American Board of Internal Medicine Foundation combined efforts to launch the Medical Professionalism Project in late 1999. These organizations developed a charter on medical professionalism that encompasses a set of principles to which “all medical professionals can and should aspire” [7]. The 3 fundamental principles are (1) the primacy of patient welfare, (2) patient autonomy, and (3) social justice. Also outlined in the charter are a set of professional responsibilities, described as commitments to (1) professional competence, (2) honesty with patients, (3) patient confidentiality, (4) maintaining appropriate relations with 325
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patients, (5) improving the quality of care, (6) improving access to care, (7) a just distribution of finite resources, (8) scientific knowledge, (9) maintaining trust by managing conflicts of interest, and (10) professional responsibilities. The issue of conflicts of interest is related to the opportunities that medical professionals and their organizations have that can compromise their professional responsibilities. Such compromises are especially threatening in the pursuit of personal or organizational interactions with for-profit industries, including medical equipment manufacturers, insurance companies, and pharmaceutical firms. In the document “Principles to Guide the Relationship Between Graduate Medical Education and Industry,” the Accreditation Council for Graduate Medical Education [8] outlined the principles that promote professionalism in programs and sponsoring institutions with regard to relationships with industry: (1) ethics curricula must include instruction in and discussion of published guidelines regarding gift giving to physicians; (2) the full and appropriate disclosure of sponsorship and financial interests is required at all program-sponsored and institution-sponsored events, above and beyond those already governed by the Standards for Commercial Support promulgated by the Accreditation Council for Continuing Medical Education; and (3) programs and sponsoring institutions must determine through policy which contacts, if any, between residents and industry representatives may be suitable and exclude occasions when involvement by industry representatives or promotion of industry products is inappropriate. PHYSICIANS’ RELATIONSHIPS WITH INDUSTRY Over the past 2 decades, increasing attention has been paid to the relationships between physicians and the biomedical industry, including the industry funding of biomedical research, the sponsorship of continuing medical education programs, and the marketing of drugs and devices to physicians. More than half of the income of the organizers of continuing medical education is generated from the pharmaceutical industry [9]. In 2001, the US pharmaceutical industry spent an estimated $21 billion promoting the sale of prescription drugs [10]. In a competitive trillion dollar industry, sales personnel are finding creative strategies to “detail” physicians, spending between $8,000 and $13,000 a year per physician. Social scientists describe and the pharmaceutical industry follows the “norm of reciprocity,” that is, the obligation to help those who have helped you, as one of the guiding principles of human interactions [11]. A study examining the success of marketing efforts by pharmaceutical companies with 161 residents [12] re-
ported that 97% of residents surveyed were carrying items with pharmaceutical company logos or product brands on them, and 91% acknowledged that industry gifts and meals influenced their prescribing patterns. A 1995 study [13] found that compared with physicians, patients were less likely to find gifts acceptable. Another study found that compared with physicians, patients were more likely to believe that gifts from industry biased physicians’ decisions about prescriptions [14]. Pharmaceutical companies continue promotional practices because they see a positive return on their investment. For every marketing dollar spent, the pharmaceutical companies have very precise figures on the return of investment of that marketing strategy [15]. A study has shown that physicians who accepted money from industry to attend conferences, speak at meetings, or participate in research projects were more likely to request that drugs be added to formularies [12]. Physicians typically report that they are not biased by financial arrangements with pharmaceutical companies, although a large body of research suggests that they are [16]. Although most physicians do not perceive themselves as biased, they do admit that conflicts of interest might compromise other physicians’ decisions. This finding is similar to that from the social science research showing that bias is recognizable, but only in others [16]. If, contrary to much evidence, gifts from drug companies do not influence physicians’ selection of therapy, then many billions of marketing dollars are being wasted. A review of 29 empirical articles showed that physician interactions with pharmaceutical companies led to increased prescription costs and nonrational prescribing [17]. Even small gifts from industry, often referred to as “reminder items” (ballpoint pens, notepads, and similar items bearing a company’s logo) affect physicians’ judgment toward products. Social science research has shown that even when individuals try to be objective, their judgments are subject to an unconscious and unintentional self-serving bias [16]. Furthermore, individuals are generally unaware of the bias, so they do not make efforts to correct for it or to avoid conflicts of interest in the first place. Limiting gift sizes, educational initiatives, and mandatory disclosure are unlikely to eliminate bias because they rest on a faulty model of human behavior. The finding that individuals are not aware of their biases, even when taught about them, suggests that the problem cannot be dealt with effectively through training. Because even small gifts can subtly bias how arguments are evaluated, they can be surprisingly influential. The problem with disclosure, at least to a patient, is that most patients would have little idea about, for example, how much to discount their physicians’ recommendations to participate in clinical trials if they were informed that their physicians would benefit financially from their participation. Arguments have been made in favor of and against
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accepting gifts from industry [10]. Those in favor cite physician autonomy, benefits to patients (samples provide access to drug therapy for indigent patients, industry representatives provide information on products to busy physicians, educational gifts increase physicians’ knowledge and improve patient care), benefits to physicians, and freedom from bias (physicians can accept gifts and still make unbiased clinical judgments). Those against argue that gifts compromise physicians’ objectivity, are financially harmful to patients (companies may pass on the cost of gifts to patients by charging higher prices, and the influence of gifts on physicians’ prescribing behavior promotes practices that are not evidence based, cost efficient, or clinically efficacious), the erosion of the physician-patient relationship, and self-protection (refraining from accepting gifts may protect physicians from prosecution under federal antikickback regulations). There is no free lunch. It is fact that the costs of industry-sponsored trips, meals, gifts, conferences, symposiums and honorariums, consulting fees, and research grants are added to the prices of drugs and devices [18]. One author stated, “The freebies offered by the pharmaceutical industry to physicians are not an act of disinterested generosity and ultimately costs the patient” [11]. Some physicians feel that gifts from drug companies represent the spending of patients’ money, which is “spent” without patients’ knowledge or consent [19]. Rogers et al [20] pointed out potential harms to the social and moral character of medical students from industry relationships. They felt that medical educators have a duty of care to protect students from influence by pharmaceutical companies. Because medical students do not have the power to prescribe, they may regard themselves as being free from reciprocal obligations to giftgiving pharmaceutical companies. During their training, doctors come to take for granted many of the privileges necessary for patient care. There is a danger that accepting free gifts might be seen as just another medical privilege, inducing an unwarranted sense of entitlement among future doctors [21]. Students may see accepting gifts as “normal” when they see their teachers and other doctors accepting industry gifts. An illusion of unique invulnerability leads doctors to believe that promotions may influence the prescribing of other doctors, but not their own [16]. The fact that companies give gifts to medical students alone suggests the companies have evidence that gifts to students provide a return on investment. Even if there is no direct effect on the future prescribing of specific products, the goodwill engendered by receiving gifts may be invaluable to the industry in terms of paving the way for future access and influence once students are qualified and able to prescribe [22]. Kassirer [23], who has published extensively on conflict of interest in medicine, argued that medical schools
Table 1. Obligations and privileges of physicians Obligations Privileges Competence Control over knowledge Responsible actions Considerable autonomy ● Integrity and morality ● Altruism ● Accountability ● Service to others ● Regulation in profession ● Professional associations Prestige Financial rewards
should teach that there is no free lunch (or dinner, or textbook, or ballpoint pen). The American Medical Student Association [24] developed its PharmFree policy and pledge for medical students. By taking the pledge, students promise to accept no money, gifts, or hospitality from the pharmaceutical industry. The American Medical Student Association’s PharmFree campaign was developed in association with No Free Lunch, an organization of physicians who have pledged not to accept any drug company gifts [25]. SOCIAL CONTRACT BETWEEN SOCIETY AND THE MEDICAL PROFESSION A discussion of professionalism can be framed around the privileges given to physicians and their obligations under a tacit and sometimes unrecognized “social contract” between medicine and society (Table 1). Being part of a profession entails a societal contract. The profession is granted a monopoly over the use of a body of knowledge and the privilege of self-regulation, and, in turn, guarantees society professional competence, integrity, and the provision of altruistic service [26].
Professions with special privileges and obligations in our society include medicine, law, and the ministry. Physicians have the obligation to be competent in their knowledge, its application, and its integrity. In return, physicians are given certain privileges or rights, including control over knowledge, considerable autonomy, prestige, and financial rewards. Physicians can view and touch individuals in ways that could be criminal violations if done by others. The practice of medicine without a license is illegal. Health insurance companies require that health care be performed by or under the supervision of physicians. Physicians are generally allowed to exercise considerable individual judgment when
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determining their professional actions and in directing the activities of others and remain largely unquestioned in their medical judgments (although this is changing). In a 2002 Harris Poll survey [27], a variety of occupations were ranked according to their levels of prestige. Physicians and scientists topped the list of professions considered to have “very great” prestige. The American Medical Association (AMA) Working Group for the Communication of Ethical Guidelines on Gifts to Physicians From Industry [28] outlined the obligations of physicians as (1) integrity and morality (be honest and uphold moral standards), (2) altruism (place the needs of patients ahead of personal interests), (3) accountability (be able and willing to explain the reasons for professional behavior to patients and peer-review committees), (4) service to others (work for the general health of all people, placing the welfare of society above your own profession), (5) self-regulation within the profession (establish mechanisms for professional accountability, education, and discipline), and (6) the operation of professional associations (establish and support professional organizations to govern standards of practice). COMMERCIAL VS PROFESSIONAL ACTIVITIES The general societal obligations of industry differ from those of physicians. Physicians have an obligation to develop, teach, and practice evidence-based medicine. Industry is obligated to meet legal standards regarding the misrepresentation of company products. Physicians must be honest and uphold moral standards. Industry is obligated to follow legal regulations regarding conduct. Physicians must place patients’ interests ahead of personal interests, whereas industry places personal and company interests ahead of those of buyers. Industry is accountable to stockholders. Physicians must be ready to explain actions to patients and others. Industry has no such obligation, except when legally required to do so. Physicians have an obligation to advance the general health of society, whereas industry has no such general societal obligation. Physicians are obligated to establish effective mechanisms for the functioning and accountability of the profession, and industry has no such obligation. To understand the variance between industry and physician obligations, consider this example. Commercial entities are required by the US Food and Drug Administration to provide information regarding the benefits and limitations of a drug but are not required to provide other information about a drug (such as pricing strategy), and are required to inform physicians only about their products. Physicians, on the other hand, must act on behalf of all patients; seek information about all products and services; and compare the benefits, limitations, and costs of all treatments relevant to a patient’s condition.
Table 2. How gifts can potentially compromise the professional obligations of physicians Physician Obligation Potential Compromise Competence ● Physician focuses on information provided ● Physician alters orders for purchases Integrity and morality ● Gifts can potentially influence a physician’s objectivity when evaluating alternatives Altruism ● Physicians put personal welfare ahead of that of patients Self-regulation ● Physician bias in oversight and regulation in favor of commercial interests Operate professional ● Associations promote association endorsement of product
In typical commercial transactions, the recipient of a commercial gift is also the potential buyer. Gifts are intended to positively influence the feelings and views of a recipient regarding a company and its products. In customary commercial interactions, a buyer both receives the benefit of gifts and bears the consequences of purchasing decisions, payment with personal funds, and personally receiving the product or service. In contrast, physicians make “buying decisions” on behalf of patients; do not personally bear the consequences of the cost, inconvenience, or quality of any influence from outside sources; and are open to special scrutiny. What do radiologists purchase from industry on behalf of patients? Examples include contrast agents, catheters, biopsy needles, anesthetic drugs, equipment (computed tomographic scanners, ultrasound machines, mammography machines, etc), and picture archiving and communications systems. Consider this scenario: a computed tomographic scanner manufacturer gives a radiologist 4 tickets to a sold-out football game. What might be the intentions for giving this gift? Possibilities are provoking feelings of goodwill, provoking feelings of indebtedness, elevating the importance of the giver, enhancing the industry representative–physician relationship, extending the duration of the relationship, and implying compensation for services rendered. These intentions can potentially compromise the professional obligations of the radiologist (Table 2). Consider this scenario: a manufacturer of mammog-
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raphy equipment provides an expensive dinner for a group of radiologists. The catering manager sees the radiologists at the dinner. Later, when the catering manager has her mammogram, she sees one of the radiologists from the dinner. What might the patient think? What if the patient had just heard about a “new” digital mammography machine that is better than the “old” machines for young women with dense breasts? This is information that was recently published in the New England Journal of Medicine and received a great deal of media coverage [29]. The patient asks the technologist if the mammogram can be performed on one of these new machines. The technologist informs the patient that the facility has not purchased digital mammography machines (in fact, the majority of mammography centers do not perform digital mammography). There are many reasons why the facility may not have digital mammography equipment, such as cost and, until recently, unproven benefit over film-screen mammography. But the patient may be left to think of her own reasons. For example, the patient may wonder if the facility was biased in purchasing equipment from the manufacturer that hosted the dinner, a manufacturer that may not market digital mammography equipment. The patient could think the facility chose the equipment it did because the manufacturer provided incentives, such as nice dinners. Of course, this reasoning may be completely inaccurate, but it doesn’t prevent the patient from leaping to such conclusions. Gifts have the potential to bias a physician’s actions. By accepting gifts, physicians can create the impression that they are biased. GUIDELINES ON GIFTS TO PHYSICIANS In 1990, the AMA, through the work of its Council of Ethical and Judicial Affairs (CEJA), addressed the general issue of physicians accepting gifts from commercial companies [30]. The CEJA developed operational guidelines to help physicians make decisions that ensure that professional obligations are not compromised (Appendix). The CEJA specified that the following 4 conditions should be met before a physician considers accepting a personal gift from a commercial source: (1) the gift primarily benefits patients; (2) the gift should not be of substantial value (defined by the AMA as more than $100); (3) if the gift is an educational activity, it must be unbiased and legitimate (free of bias in content or selection of speaker); and (4) no “strings” must be attached (gifts should not be contingent on physicians performing an activity specified by the company). The AMA also developed 4 online educational modules related to physicians’ relationships with industry, complete with PowerPoint (Microsoft Corporation, Redmond, Wash) slide shows, comprehensive presenter’s guides, handouts that
can be copied and distributed to learners, and online self-study continuing medical education [31]. To understand how the AMA’s guidelines can be applied to radiologists, consider the following scenario: a radiologist receives an invitation from a computed tomographic scanner manufacturer to attend an educational symposium on current techniques for imaging aortic disease. The symposium will be held at a ski resort. There is no cost for the conference registration, and the physician will receive $1,500 for travel and lodging. Should the physician accept? Each physician obligation and AMA guideline can be considered individually. Competence is potentially compromised, depending on how the content and control over it is determined. Integrity is potentially compromised because the offer includes substantial personal inducement (a trip to a ski resort). Altruism is potentially compromised because personal benefit could affect the radiologist’s decisions, putting personal interests ahead of patient interests. It is questionable as to whether the activity would be of primary benefit to patients because of its substantial personal benefit. The activity would be considered to be of very substantial value. The educational activity may be biased. There are no obvious strings attached. According to the AMA’s guidelines, at least 1 condition is not met, and the invitation should be declined. To illustrate this further, consider the following scenario: all radiologists in a state receive an e-mail invitation to participate in an online educational program on fetal ultrasound sponsored by an ultrasound manufacturer. The author has published widely on the topic. Each person who registers receives a $100 gift certificate to Amazon.com toward the purchase of a medical book. Should a radiologist participate and accept the gift? This will be analyzed in 2 parts: first, whether the radiologist should participate and second, whether the radiologist should accept the gift. Regarding participating, competence is potentially supported, because the information would be useful if unbiased. Integrity and morality are supported, because all radiologists in the state were invited, and no special favors were offered to individual radiologists. Altruism is supported, because participating will benefit patients. The activity is of primary benefit to patients, not of substantial value, potentially unbiased, and no strings are attached. According to the AMA’s guidelines, all conditions seem to be met to participate in the program. Regarding gift acceptance, competence is uncertain, because the gift may determine participation in company activity. Integrity and morality are compromised, because the gift may influence the radiologist’s decisions. Altruism is supported, because the book is for patient care. The gift would be of primary benefit to patients and approaching substantial value. The educational activity is unbiased because the self-selected text
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would likely be unbiased and legitimate. There are strings attached, because participation is a requirement for receiving the gift. Therefore, according to the AMA’s guidelines, the gift certificate has a condition controlled by the company and therefore should be declined. If the certificate had been offered as a gift with no condition, it could be accepted. If a company invites physicians to visit its facilities for a tour or to become educated about one of its products, may the company pay travel expenses and honoraria? After the CEJA published its “Guidelines on Gifts to Physicians From Industry,” it followed up with detailed answers to this and a number of other questions [32]. To this question, the CEJA provided the following answer: In general, travel expenses should not be reimbursed, nor should honoraria be paid for the visiting physicians’ time since the presentations are analogous to a pharmaceutical company’s educational or promotional meetings. The CEJA recognized that medical devices, equipment and other technologies may require, in some circumstances, special evaluation or training in proper usage which can not practicably be provided except on site. In such cases, physicians and their specialties should make the judgment. Any travel expenses should be only those strictly necessary.
This is in keeping with the Advanced Medical Technology Association Code of Ethics [33], which states, Members have a responsibility to make product education and training available to Health Care Professionals. In fact, the U.S. Food and Drug Administration mandates training and education to facilitate the safe and effective use of certain medical technology. Such programs often occur at centralized locations (necessitating out-of-town travel for some participants).
In addition to the AMA’s guidelines, numerous other organizations have developed policy documents regarding physician interactions with industry. These include the Accreditation Council for Graduate Medical Education, the Accreditation Council for Continuing Medical Education, Pharmaceutical Research and Manufacturers of America, the American College of Physicians, the US Department of Veterans Affairs, and the American Association of Medical Colleges. In 2003, the Office of Inspector General at the US Department of Health and Human Services issued a notice regarding voluntary compliance programs for pharmaceutical manufacturers. The National Electrical Manufacturers Association (NEMA) [34] developed guidelines for interactions between diagnostic imaging manufacturers and health care providers, effective January 1, 2005. Per these guidelines, NEMA members should not pay for hospitality in the form of sporting event tickets, theater tickets, or golf outings. Any meals, receptions, and hospitality provided by NEMA members should be modest in value (“neither the most nor the least expensive as measured against local community standards”). Other than the gift of medical textbooks or anatomic models used for educational pur-
poses, any gift from a NEMA member should have a fair market value of less than $100. Philips Medical Systems (Andover, Mass) sent a letter and a copy of NEMA’s Code of Ethics to health care providers in November 2005. In this letter, the company stated that it could provide only modest meals and hospitality at receptions, is no longer able to pay for spouses and guests, and cannot pay for customer travel and lodging expenses. Several health care institutions are developing their own guidelines regarding physician interactions with industry. The University of Wisconsin Hospital and Clinics guidelines concerning gifts disallows any hospital employee from accepting a gift valued at more than $50 from a patient, patient’s family, or anyone doing business with the hospital [35]. Gifts are defined as money, property, favors, services, entertainment, and travel (including tickets for sporting or theatrical events and golfing fees) but do not include items offered equally to the general public (not offered because of hospital employment). Items with product or manufacturer names or logos (pens, pads, coffee mugs, caps, etc) may not be accepted, used, or displayed regardless of value. No meals or food may be accepted from any sales representative within any hospital facility regardless of value except at continuing medical education events sponsored by the University of Wisconsin School of Medicine Office of Continuing Medical Education. The Advanced Medical Technology Association developed the revised industry “Code of Ethics for Interactions With Health Care Professionals,” which went into effect on January 1, 2004. The association represents nearly 90% of the US medical device and diagnostics industry. A link to the entire code can be found online on the ACR’s [33] Web site. The code allows members to provide a grant either directly to a conference sponsor to reduce conference costs or to a training institution or the conference sponsor to allow attendance by medical students, residents, fellows, and others who are health care professionals in training. According to the Advanced Medical Technology Association’s code, pens and notepads that could be used in a health care professional’s work environment are examples of minimal-value, branded promotional items appropriate as gifts. Golf balls and tee-shirts would not be allowed, because they are neither related to the health care professional’s work nor for the benefit of patients. During the holiday season or at any other time, a member may provide a gift that benefits patients, serves a genuine educational function, or is a branded promotional item of minimal value related to the health care professional’s work or for the benefit of the patients. Gifts of food or wine are not permitted by the code, regardless of the season. Medical technology firms are starting to focus on ethics. Medical Alley, the trade organization for Minnesota’s
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medical device industry, recently held a seminar—at the request of members— on how to avoid a federal investigation and what to do if one is the target [36]. Jim McCartney [36] wrote, “After targeting fraud at hospitals, home care facilities and pharmaceutical companies, the feds are now setting their sights on the medical device industry.” The issues are fraud and ethics. For instance, is a doctor prescribing a device and filing a Medicare claim because the device is the best available or most cost effective? Or is it because of inducements or misinformation from the medical device company? This question illustrates how a gourmet dinner or a weekend at a nice resort can turn into a bribe to defraud the federal government. Device makers that have pleaded guilty to felony charges and agreed to pay large fines include Guidant Corporation (Indianapolis, Ind; $92 million), and Abbott Laboratories (Abbott Park, Ill; $614 million) [36]. Of physicians who responded to a Medical Economics 2002 ethics survey [37], 71% didn’t think that accepting gifts, trips, and hospitality diminished their objectivity. Many of the responding physicians found the suggestion insulting, stating, “I prescribe based on science and my experience.” One physician said that she would quit the AMA over the issue, stating, It’s an insult to think that I would prescribe a drug just because I went on a trip or dinner to learn about it. If a drug is good, helps my patients and is economical, I will use it. Otherwise, I won’t.
Peter Lavine, an orthopedic surgeon in Washington, DC, in testimony at a committee meeting that considers changes to the AMA’s bylaws and ethics, proposed a resolution that would establish a parallel policy on gifts from pharmaceutical companies. One policy would be the ethical guidelines as established by the CEJA, and the other would be a policy “that allows physicians to accept ‘gifts’ from industry under more realistic guidelines that reflect the value of a physician’s time, education and opportunity costs.” Dr Lavine stated, These [CEJA] guidelines are cumbersome, onerous, and inconsistent, in that they undervalue physicians’ time as professionals and impede and restrict physician education on medical and pharmaceutical products. The CEJA guideline infuriates physicians and could adversely affect AMA membership. This CEJA guideline is often ignored by physicians and therefore undermines other truly valuable ethical principles.
Dr Lavine’s arguments against the AMA’s guidelines were not met with much support at the committee hearing. There was considerable opposition to the resolution. When the matter was put to the house for its consideration, the decision to not recommend the resolution was accepted without dissent. Although there are people, as described above, who object to newly developed ethical guidelines, the movement to change the way physicians interact with industry
is under way and will continue to gain momentum. The full implementation of and compliance with ethical guidelines will require the wide-scale training and oversight of industry sponsors and health care professionals. This includes medical students and residents and the faculty members responsible for their training. SUMMARY ● ● ● ●
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Physicians have special obligations and receive special privileges in our society. Accepting personal gifts from commercial companies can result in conflicts with professional obligations. Physicians’ first obligation is the interest of patients. In commercial interactions related to health care, expectations for physicians are higher than those for commercial companies and their representatives. Physicians should generally not accept gifts from industry and consider accepting only those that primarily entail a benefit to patients, are not of substantial value, if they involve an educational activity are unbiased and legitimate, and have no strings attached.
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14. Gibbons RV, Landry FJ, Blouch DL, et al. A comparison of physicians’ and patients’ attitudes toward pharmaceutical industry gifts. J Gen Intern Med 1988;13:151-4.
37. Murray D.Gifts: what’s all the fuss about? Med Econ. Available at: http:// www.memag.com/memag/content/printContentPopup.jsp?id⫽116468. Accessed December 12, 2005.
15. RxPromoROI. RAPP study. Available at: http://www.rxpromoroi.org/ rapp/exec_sum.html. Accessed December 19, 2005. 16. Dana J, Loewenstein G. A social science perspective on gifts to physicians from industry. JAMA 2003;290:252-5. 17. Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA 2000;283:373-80. 18. Angell M. Is academic medicine for sale? N Eng J Med 2000;342:1516-8. 19. Chren MM, Landefeld CS, Murray TH. Doctors, drug companies, and gifts. JAMA 1989;262:3448-51. 20. Rogers WA, Mansfield PR, Braunack-Mayer AJ, Jureidini J. The ethics of pharmaceutical industry relationships with medical students. JAMA 2004;180:411-4. 21. Rothman D. Medical professionalism—focusing on the real issues. N Engl J Med 2000;342:1284-6. 22. Sandberg WS, Carlos R, Sandberg EH, Roizen MF. The effect of educational gifts from pharmaceutical firms on medical students’ recall of company names or products. Acad Med 1997;72:916-8. 23. Kassirer JP. A piece of my mind: financial indigestion. JAMA 2000;284: 2156-7. 24. American Medical Student Association. PharmFree medical student pledge. Available at: http://www.amsa.org/prof/pledge.cfm. Accessed December 19, 2005. 25. No Free Lunch. Home page. Available at: http://www.nofreelunch.org. Accessed December 19, 2005. 26. Cruess SR, Johnston S, Cruess RL. Professionalism for medicine: opportunities and obligations. Med J Aust 2002;177:208-11. 27. Harris Poll Online. Home page. Available at: http://vr.harrispollon line.com/register/main.asp. Accessed December 19, 2005. 28. American Medical Association Working Group for the Communication of Ethical Guidelines on Gifts to Physicians From Industry. Online educational resources. Available at: http://www.ama-assn.org/ama/pub/category/8405.html. Accessed December 19, 2005. 29. Pisano ED, Gatsonis C, Hendrick E, et al. Diagnostic performance of digital versus film mammography for breast-cancer screening. N Engl J Med 2005;353:1773-83. 30. American Medical Association, Council on Ethical and Judicial Affairs. Guidelines on gifts to physicians from industry: an update. Food Drug Law J 1992;47:445-58. 31. American Medical Association. What you should know about gifts to physicians from industry. Available at: http://www.ama-assn.org/go/ethicalgifts. Accessed December 20, 2005. 32. American Medical Association. Opinion E-8.061: clarifying addendum. Available at: http://www.ama-assn.org/ama/pub/category/print/4263. html. Accessed December 12, 2005. 33. American College of Radiology. AdvaMed code of ethics. Available at: http://www.acr.org/s_acr/doc.asp?CID⫽1539&DID⫽16900. Accessed December 19, 2005. 34. National Electrical Manufacturers Association. NEMA code of ethics on interactions with healthcare providers. Available at: http://www. nema.org/media/pr/20050104a.cfm. Accessed December 19, 2005. 35. University of Wisconsin Hospital and Clinics. Guidelines concerning gifts. Available at: http://www.hosp.wisc.edu/codeofethics/gift_guidelines.htm. Accessed December 19, 2005.
APPENDIX American Medical Association Ethical Opinion E-8.061: Gifts to Physicians From Industry This is an abridged summary of the opinion; the full text of the opinion is available online at http://www. ama-assn.org/ama/pub/category/print/4001.html. Many gifts given to physicians by companies in the pharmaceutical, device, and medical equipment industries serve an important and socially beneficial function. For example, companies have long provided funds for educational seminars and conferences. However, there has been growing concern about certain gifts from industry to physicians. Some gifts that reflect customary practices of industry may not be consistent with the Principles of Medical Ethics. To avoid the acceptance of inappropriate gifts, physicians should observe the following guidelines: 1. Any gifts accepted by physicians individually should primarily entail a benefit to patients and should not be of substantial value. Textbooks, modest meals, and other gifts are appropriate if they serve a genuine educational function. Cash payments should not be accepted. 2. Individual gifts of minimal value are permissible as long as the gifts are related to the physicians’ work (eg, pens and notepads). 3. The Council on Ethical and Judicial Affairs defines a legitimate “conference” or “meeting” as any activity, held at an appropriate location, where (a) the gathering is primarily dedicated, in both time and effort, to promoting objective scientific and educational activities and discourse, and (b) the main incentive for bringing attendees together is to further their knowledge on the topic(s) being presented. 4. Subsidies to underwrite the costs of continuing medical education conferences or professional meetings can contribute to the improvement of patient care and therefore are permissible. Since the giving of a subsidy directly to a physician by a company’s representative may create a relationship that could influence the use of the company’s products, any subsidy should be accepted by the conference’s sponsor who in turn can use the money to reduce the conference registration fee. Payments to defray the costs of a conference should not be accepted directly from the company by the physicians attending the conference. 5. Subsidies from industry should not be accepted directly or indirectly to pay for the costs of travel, lodging, or the personal expenses of nonfaculty physicians attending conferences or meetings, nor should subsidies be accepted to compensate for the physicians’ time. 6. Scholarship or other special funds to permit medical students, residents, and fellows to attend carefully selected educational conferences may be permissible as long as the selection of students, residents, or fellows who will receive the funds is made by the academic or training institution. 7. No gifts should be accepted if there are strings attached. When companies underwrite medical conferences or lectures other than their own, responsibility for and control over the selection of content, faculty, educational methods, and materials should belong to the organizers of the conferences or lectures.
Many gifts from industry to physicians and medical organizations serve important and beneficial functions. However, the spiraling cost of health care is resulting in increasing governmental and medical scrutiny of legal and ethical issues concerning relationships between commercial companies and physicians. Professional oversight bodies are updating standards concerning the ethical responsibilities of physicians. This article presents a broad framework for understanding the professional and legal responsibilities of physicians when interacting with industry. Physicians have unique responsibilities based on the “fiduciary” nature of the patient-physician relationship and specified laws regarding health care. Physicians must protect the best interests of patients, with clinical decisions free of undue influence. Physicians have special obligations related to receiving gifts from industry or receiving payments that may be construed as “kickbacks” or fraud. To ensure that gifts do not compromise (or seem to compromise) professional judgment, physicians should generally not accept personal gifts from industry and consider accepting only those that primarily entail a benefit to patients, are not of substantial value, and have no “strings” attached. After reading this article, the reader should be able to describe the impact gifts have on physicians’ behavior, the privileges and obligations of physicians, and conflicts between professional obligations and personal gifts. Key Words: Professionalism, physician ethics, physician interactions with industry, gifts to physicians J Am Coll Radiol 2006;3:325-332. Copyright © 2006 American College of Radiology
DEFINITION OF PROFESSIONALISM The 28th edition of Dorland’s Illustrated Medical Dictionary [1] defines a professional as “one who is a specialist in a particular field or occupation” but does not define professionalism. The Random House Webster’s Dictionary [2] defines professionalism as “professional character, spirit, or methods.” Neither of these definitions gets at the spirit of medical professionalism. The Accreditation Council for Graduate Medical Education [3] requires radiology residency programs to define the specific knowledge, skills, behaviors, and attitudes required, and provide educational experiences as needed for their residents to demonstrate professionalism, as manifested through a commitment to carrying out professional responsibilities, adherence to ethical principles, and sensitivity to patients of diverse backgrounds.
The American Board of Radiology [4] and the American Board of Medical Specialties have defined professionalism as “demonstrating self-awareness and knowledge of limits, high standards of ethical and moral behavior, reDepartment of Radiology, University of Wisconsin Hospital and Clinics, Madison, Wis. Corresponding author and reprints: Jannette Collins, MD, MEd, University of Wisconsin Hospital and Clinics, Department of Radiology, E3/311 CSC, 600 Highland Avenue, Madison, WI 53792-3252; e-mail: [email protected]. © 2006 American College of Radiology 0091-2182/06/$32.00 ● DOI 10.1016/j.jacr.2006.01.022
liability and responsibility, respect for patient dignity, and autonomy.” The American Board of Radiology will evaluate competence in professionalism as part of the maintenance-of-certification process. Kuczewski [5] defined professionalism as “an expression of the norms that guide the relationships in which physicians are engaged.” In her review of the literature, Arnold [6] identified traits commonly associated with professionalism as altruism, respect for others as embodied in humanistic qualities, honor, integrity, ethical behavior, accountability, excellence, a sense of duty, and advocacy. Responding to a call for a renewed sense of professionalism, the European Federation of Internal Medicine, the American College of Physicians–American Society of Internal Medicine Foundation, and the American Board of Internal Medicine Foundation combined efforts to launch the Medical Professionalism Project in late 1999. These organizations developed a charter on medical professionalism that encompasses a set of principles to which “all medical professionals can and should aspire” [7]. The 3 fundamental principles are (1) the primacy of patient welfare, (2) patient autonomy, and (3) social justice. Also outlined in the charter are a set of professional responsibilities, described as commitments to (1) professional competence, (2) honesty with patients, (3) patient confidentiality, (4) maintaining appropriate relations with 325
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patients, (5) improving the quality of care, (6) improving access to care, (7) a just distribution of finite resources, (8) scientific knowledge, (9) maintaining trust by managing conflicts of interest, and (10) professional responsibilities. The issue of conflicts of interest is related to the opportunities that medical professionals and their organizations have that can compromise their professional responsibilities. Such compromises are especially threatening in the pursuit of personal or organizational interactions with for-profit industries, including medical equipment manufacturers, insurance companies, and pharmaceutical firms. In the document “Principles to Guide the Relationship Between Graduate Medical Education and Industry,” the Accreditation Council for Graduate Medical Education [8] outlined the principles that promote professionalism in programs and sponsoring institutions with regard to relationships with industry: (1) ethics curricula must include instruction in and discussion of published guidelines regarding gift giving to physicians; (2) the full and appropriate disclosure of sponsorship and financial interests is required at all program-sponsored and institution-sponsored events, above and beyond those already governed by the Standards for Commercial Support promulgated by the Accreditation Council for Continuing Medical Education; and (3) programs and sponsoring institutions must determine through policy which contacts, if any, between residents and industry representatives may be suitable and exclude occasions when involvement by industry representatives or promotion of industry products is inappropriate. PHYSICIANS’ RELATIONSHIPS WITH INDUSTRY Over the past 2 decades, increasing attention has been paid to the relationships between physicians and the biomedical industry, including the industry funding of biomedical research, the sponsorship of continuing medical education programs, and the marketing of drugs and devices to physicians. More than half of the income of the organizers of continuing medical education is generated from the pharmaceutical industry [9]. In 2001, the US pharmaceutical industry spent an estimated $21 billion promoting the sale of prescription drugs [10]. In a competitive trillion dollar industry, sales personnel are finding creative strategies to “detail” physicians, spending between $8,000 and $13,000 a year per physician. Social scientists describe and the pharmaceutical industry follows the “norm of reciprocity,” that is, the obligation to help those who have helped you, as one of the guiding principles of human interactions [11]. A study examining the success of marketing efforts by pharmaceutical companies with 161 residents [12] re-
ported that 97% of residents surveyed were carrying items with pharmaceutical company logos or product brands on them, and 91% acknowledged that industry gifts and meals influenced their prescribing patterns. A 1995 study [13] found that compared with physicians, patients were less likely to find gifts acceptable. Another study found that compared with physicians, patients were more likely to believe that gifts from industry biased physicians’ decisions about prescriptions [14]. Pharmaceutical companies continue promotional practices because they see a positive return on their investment. For every marketing dollar spent, the pharmaceutical companies have very precise figures on the return of investment of that marketing strategy [15]. A study has shown that physicians who accepted money from industry to attend conferences, speak at meetings, or participate in research projects were more likely to request that drugs be added to formularies [12]. Physicians typically report that they are not biased by financial arrangements with pharmaceutical companies, although a large body of research suggests that they are [16]. Although most physicians do not perceive themselves as biased, they do admit that conflicts of interest might compromise other physicians’ decisions. This finding is similar to that from the social science research showing that bias is recognizable, but only in others [16]. If, contrary to much evidence, gifts from drug companies do not influence physicians’ selection of therapy, then many billions of marketing dollars are being wasted. A review of 29 empirical articles showed that physician interactions with pharmaceutical companies led to increased prescription costs and nonrational prescribing [17]. Even small gifts from industry, often referred to as “reminder items” (ballpoint pens, notepads, and similar items bearing a company’s logo) affect physicians’ judgment toward products. Social science research has shown that even when individuals try to be objective, their judgments are subject to an unconscious and unintentional self-serving bias [16]. Furthermore, individuals are generally unaware of the bias, so they do not make efforts to correct for it or to avoid conflicts of interest in the first place. Limiting gift sizes, educational initiatives, and mandatory disclosure are unlikely to eliminate bias because they rest on a faulty model of human behavior. The finding that individuals are not aware of their biases, even when taught about them, suggests that the problem cannot be dealt with effectively through training. Because even small gifts can subtly bias how arguments are evaluated, they can be surprisingly influential. The problem with disclosure, at least to a patient, is that most patients would have little idea about, for example, how much to discount their physicians’ recommendations to participate in clinical trials if they were informed that their physicians would benefit financially from their participation. Arguments have been made in favor of and against
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accepting gifts from industry [10]. Those in favor cite physician autonomy, benefits to patients (samples provide access to drug therapy for indigent patients, industry representatives provide information on products to busy physicians, educational gifts increase physicians’ knowledge and improve patient care), benefits to physicians, and freedom from bias (physicians can accept gifts and still make unbiased clinical judgments). Those against argue that gifts compromise physicians’ objectivity, are financially harmful to patients (companies may pass on the cost of gifts to patients by charging higher prices, and the influence of gifts on physicians’ prescribing behavior promotes practices that are not evidence based, cost efficient, or clinically efficacious), the erosion of the physician-patient relationship, and self-protection (refraining from accepting gifts may protect physicians from prosecution under federal antikickback regulations). There is no free lunch. It is fact that the costs of industry-sponsored trips, meals, gifts, conferences, symposiums and honorariums, consulting fees, and research grants are added to the prices of drugs and devices [18]. One author stated, “The freebies offered by the pharmaceutical industry to physicians are not an act of disinterested generosity and ultimately costs the patient” [11]. Some physicians feel that gifts from drug companies represent the spending of patients’ money, which is “spent” without patients’ knowledge or consent [19]. Rogers et al [20] pointed out potential harms to the social and moral character of medical students from industry relationships. They felt that medical educators have a duty of care to protect students from influence by pharmaceutical companies. Because medical students do not have the power to prescribe, they may regard themselves as being free from reciprocal obligations to giftgiving pharmaceutical companies. During their training, doctors come to take for granted many of the privileges necessary for patient care. There is a danger that accepting free gifts might be seen as just another medical privilege, inducing an unwarranted sense of entitlement among future doctors [21]. Students may see accepting gifts as “normal” when they see their teachers and other doctors accepting industry gifts. An illusion of unique invulnerability leads doctors to believe that promotions may influence the prescribing of other doctors, but not their own [16]. The fact that companies give gifts to medical students alone suggests the companies have evidence that gifts to students provide a return on investment. Even if there is no direct effect on the future prescribing of specific products, the goodwill engendered by receiving gifts may be invaluable to the industry in terms of paving the way for future access and influence once students are qualified and able to prescribe [22]. Kassirer [23], who has published extensively on conflict of interest in medicine, argued that medical schools
Table 1. Obligations and privileges of physicians Obligations Privileges Competence Control over knowledge Responsible actions Considerable autonomy ● Integrity and morality ● Altruism ● Accountability ● Service to others ● Regulation in profession ● Professional associations Prestige Financial rewards
should teach that there is no free lunch (or dinner, or textbook, or ballpoint pen). The American Medical Student Association [24] developed its PharmFree policy and pledge for medical students. By taking the pledge, students promise to accept no money, gifts, or hospitality from the pharmaceutical industry. The American Medical Student Association’s PharmFree campaign was developed in association with No Free Lunch, an organization of physicians who have pledged not to accept any drug company gifts [25]. SOCIAL CONTRACT BETWEEN SOCIETY AND THE MEDICAL PROFESSION A discussion of professionalism can be framed around the privileges given to physicians and their obligations under a tacit and sometimes unrecognized “social contract” between medicine and society (Table 1). Being part of a profession entails a societal contract. The profession is granted a monopoly over the use of a body of knowledge and the privilege of self-regulation, and, in turn, guarantees society professional competence, integrity, and the provision of altruistic service [26].
Professions with special privileges and obligations in our society include medicine, law, and the ministry. Physicians have the obligation to be competent in their knowledge, its application, and its integrity. In return, physicians are given certain privileges or rights, including control over knowledge, considerable autonomy, prestige, and financial rewards. Physicians can view and touch individuals in ways that could be criminal violations if done by others. The practice of medicine without a license is illegal. Health insurance companies require that health care be performed by or under the supervision of physicians. Physicians are generally allowed to exercise considerable individual judgment when
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determining their professional actions and in directing the activities of others and remain largely unquestioned in their medical judgments (although this is changing). In a 2002 Harris Poll survey [27], a variety of occupations were ranked according to their levels of prestige. Physicians and scientists topped the list of professions considered to have “very great” prestige. The American Medical Association (AMA) Working Group for the Communication of Ethical Guidelines on Gifts to Physicians From Industry [28] outlined the obligations of physicians as (1) integrity and morality (be honest and uphold moral standards), (2) altruism (place the needs of patients ahead of personal interests), (3) accountability (be able and willing to explain the reasons for professional behavior to patients and peer-review committees), (4) service to others (work for the general health of all people, placing the welfare of society above your own profession), (5) self-regulation within the profession (establish mechanisms for professional accountability, education, and discipline), and (6) the operation of professional associations (establish and support professional organizations to govern standards of practice). COMMERCIAL VS PROFESSIONAL ACTIVITIES The general societal obligations of industry differ from those of physicians. Physicians have an obligation to develop, teach, and practice evidence-based medicine. Industry is obligated to meet legal standards regarding the misrepresentation of company products. Physicians must be honest and uphold moral standards. Industry is obligated to follow legal regulations regarding conduct. Physicians must place patients’ interests ahead of personal interests, whereas industry places personal and company interests ahead of those of buyers. Industry is accountable to stockholders. Physicians must be ready to explain actions to patients and others. Industry has no such obligation, except when legally required to do so. Physicians have an obligation to advance the general health of society, whereas industry has no such general societal obligation. Physicians are obligated to establish effective mechanisms for the functioning and accountability of the profession, and industry has no such obligation. To understand the variance between industry and physician obligations, consider this example. Commercial entities are required by the US Food and Drug Administration to provide information regarding the benefits and limitations of a drug but are not required to provide other information about a drug (such as pricing strategy), and are required to inform physicians only about their products. Physicians, on the other hand, must act on behalf of all patients; seek information about all products and services; and compare the benefits, limitations, and costs of all treatments relevant to a patient’s condition.
Table 2. How gifts can potentially compromise the professional obligations of physicians Physician Obligation Potential Compromise Competence ● Physician focuses on information provided ● Physician alters orders for purchases Integrity and morality ● Gifts can potentially influence a physician’s objectivity when evaluating alternatives Altruism ● Physicians put personal welfare ahead of that of patients Self-regulation ● Physician bias in oversight and regulation in favor of commercial interests Operate professional ● Associations promote association endorsement of product
In typical commercial transactions, the recipient of a commercial gift is also the potential buyer. Gifts are intended to positively influence the feelings and views of a recipient regarding a company and its products. In customary commercial interactions, a buyer both receives the benefit of gifts and bears the consequences of purchasing decisions, payment with personal funds, and personally receiving the product or service. In contrast, physicians make “buying decisions” on behalf of patients; do not personally bear the consequences of the cost, inconvenience, or quality of any influence from outside sources; and are open to special scrutiny. What do radiologists purchase from industry on behalf of patients? Examples include contrast agents, catheters, biopsy needles, anesthetic drugs, equipment (computed tomographic scanners, ultrasound machines, mammography machines, etc), and picture archiving and communications systems. Consider this scenario: a computed tomographic scanner manufacturer gives a radiologist 4 tickets to a sold-out football game. What might be the intentions for giving this gift? Possibilities are provoking feelings of goodwill, provoking feelings of indebtedness, elevating the importance of the giver, enhancing the industry representative–physician relationship, extending the duration of the relationship, and implying compensation for services rendered. These intentions can potentially compromise the professional obligations of the radiologist (Table 2). Consider this scenario: a manufacturer of mammog-
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raphy equipment provides an expensive dinner for a group of radiologists. The catering manager sees the radiologists at the dinner. Later, when the catering manager has her mammogram, she sees one of the radiologists from the dinner. What might the patient think? What if the patient had just heard about a “new” digital mammography machine that is better than the “old” machines for young women with dense breasts? This is information that was recently published in the New England Journal of Medicine and received a great deal of media coverage [29]. The patient asks the technologist if the mammogram can be performed on one of these new machines. The technologist informs the patient that the facility has not purchased digital mammography machines (in fact, the majority of mammography centers do not perform digital mammography). There are many reasons why the facility may not have digital mammography equipment, such as cost and, until recently, unproven benefit over film-screen mammography. But the patient may be left to think of her own reasons. For example, the patient may wonder if the facility was biased in purchasing equipment from the manufacturer that hosted the dinner, a manufacturer that may not market digital mammography equipment. The patient could think the facility chose the equipment it did because the manufacturer provided incentives, such as nice dinners. Of course, this reasoning may be completely inaccurate, but it doesn’t prevent the patient from leaping to such conclusions. Gifts have the potential to bias a physician’s actions. By accepting gifts, physicians can create the impression that they are biased. GUIDELINES ON GIFTS TO PHYSICIANS In 1990, the AMA, through the work of its Council of Ethical and Judicial Affairs (CEJA), addressed the general issue of physicians accepting gifts from commercial companies [30]. The CEJA developed operational guidelines to help physicians make decisions that ensure that professional obligations are not compromised (Appendix). The CEJA specified that the following 4 conditions should be met before a physician considers accepting a personal gift from a commercial source: (1) the gift primarily benefits patients; (2) the gift should not be of substantial value (defined by the AMA as more than $100); (3) if the gift is an educational activity, it must be unbiased and legitimate (free of bias in content or selection of speaker); and (4) no “strings” must be attached (gifts should not be contingent on physicians performing an activity specified by the company). The AMA also developed 4 online educational modules related to physicians’ relationships with industry, complete with PowerPoint (Microsoft Corporation, Redmond, Wash) slide shows, comprehensive presenter’s guides, handouts that
can be copied and distributed to learners, and online self-study continuing medical education [31]. To understand how the AMA’s guidelines can be applied to radiologists, consider the following scenario: a radiologist receives an invitation from a computed tomographic scanner manufacturer to attend an educational symposium on current techniques for imaging aortic disease. The symposium will be held at a ski resort. There is no cost for the conference registration, and the physician will receive $1,500 for travel and lodging. Should the physician accept? Each physician obligation and AMA guideline can be considered individually. Competence is potentially compromised, depending on how the content and control over it is determined. Integrity is potentially compromised because the offer includes substantial personal inducement (a trip to a ski resort). Altruism is potentially compromised because personal benefit could affect the radiologist’s decisions, putting personal interests ahead of patient interests. It is questionable as to whether the activity would be of primary benefit to patients because of its substantial personal benefit. The activity would be considered to be of very substantial value. The educational activity may be biased. There are no obvious strings attached. According to the AMA’s guidelines, at least 1 condition is not met, and the invitation should be declined. To illustrate this further, consider the following scenario: all radiologists in a state receive an e-mail invitation to participate in an online educational program on fetal ultrasound sponsored by an ultrasound manufacturer. The author has published widely on the topic. Each person who registers receives a $100 gift certificate to Amazon.com toward the purchase of a medical book. Should a radiologist participate and accept the gift? This will be analyzed in 2 parts: first, whether the radiologist should participate and second, whether the radiologist should accept the gift. Regarding participating, competence is potentially supported, because the information would be useful if unbiased. Integrity and morality are supported, because all radiologists in the state were invited, and no special favors were offered to individual radiologists. Altruism is supported, because participating will benefit patients. The activity is of primary benefit to patients, not of substantial value, potentially unbiased, and no strings are attached. According to the AMA’s guidelines, all conditions seem to be met to participate in the program. Regarding gift acceptance, competence is uncertain, because the gift may determine participation in company activity. Integrity and morality are compromised, because the gift may influence the radiologist’s decisions. Altruism is supported, because the book is for patient care. The gift would be of primary benefit to patients and approaching substantial value. The educational activity is unbiased because the self-selected text
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would likely be unbiased and legitimate. There are strings attached, because participation is a requirement for receiving the gift. Therefore, according to the AMA’s guidelines, the gift certificate has a condition controlled by the company and therefore should be declined. If the certificate had been offered as a gift with no condition, it could be accepted. If a company invites physicians to visit its facilities for a tour or to become educated about one of its products, may the company pay travel expenses and honoraria? After the CEJA published its “Guidelines on Gifts to Physicians From Industry,” it followed up with detailed answers to this and a number of other questions [32]. To this question, the CEJA provided the following answer: In general, travel expenses should not be reimbursed, nor should honoraria be paid for the visiting physicians’ time since the presentations are analogous to a pharmaceutical company’s educational or promotional meetings. The CEJA recognized that medical devices, equipment and other technologies may require, in some circumstances, special evaluation or training in proper usage which can not practicably be provided except on site. In such cases, physicians and their specialties should make the judgment. Any travel expenses should be only those strictly necessary.
This is in keeping with the Advanced Medical Technology Association Code of Ethics [33], which states, Members have a responsibility to make product education and training available to Health Care Professionals. In fact, the U.S. Food and Drug Administration mandates training and education to facilitate the safe and effective use of certain medical technology. Such programs often occur at centralized locations (necessitating out-of-town travel for some participants).
In addition to the AMA’s guidelines, numerous other organizations have developed policy documents regarding physician interactions with industry. These include the Accreditation Council for Graduate Medical Education, the Accreditation Council for Continuing Medical Education, Pharmaceutical Research and Manufacturers of America, the American College of Physicians, the US Department of Veterans Affairs, and the American Association of Medical Colleges. In 2003, the Office of Inspector General at the US Department of Health and Human Services issued a notice regarding voluntary compliance programs for pharmaceutical manufacturers. The National Electrical Manufacturers Association (NEMA) [34] developed guidelines for interactions between diagnostic imaging manufacturers and health care providers, effective January 1, 2005. Per these guidelines, NEMA members should not pay for hospitality in the form of sporting event tickets, theater tickets, or golf outings. Any meals, receptions, and hospitality provided by NEMA members should be modest in value (“neither the most nor the least expensive as measured against local community standards”). Other than the gift of medical textbooks or anatomic models used for educational pur-
poses, any gift from a NEMA member should have a fair market value of less than $100. Philips Medical Systems (Andover, Mass) sent a letter and a copy of NEMA’s Code of Ethics to health care providers in November 2005. In this letter, the company stated that it could provide only modest meals and hospitality at receptions, is no longer able to pay for spouses and guests, and cannot pay for customer travel and lodging expenses. Several health care institutions are developing their own guidelines regarding physician interactions with industry. The University of Wisconsin Hospital and Clinics guidelines concerning gifts disallows any hospital employee from accepting a gift valued at more than $50 from a patient, patient’s family, or anyone doing business with the hospital [35]. Gifts are defined as money, property, favors, services, entertainment, and travel (including tickets for sporting or theatrical events and golfing fees) but do not include items offered equally to the general public (not offered because of hospital employment). Items with product or manufacturer names or logos (pens, pads, coffee mugs, caps, etc) may not be accepted, used, or displayed regardless of value. No meals or food may be accepted from any sales representative within any hospital facility regardless of value except at continuing medical education events sponsored by the University of Wisconsin School of Medicine Office of Continuing Medical Education. The Advanced Medical Technology Association developed the revised industry “Code of Ethics for Interactions With Health Care Professionals,” which went into effect on January 1, 2004. The association represents nearly 90% of the US medical device and diagnostics industry. A link to the entire code can be found online on the ACR’s [33] Web site. The code allows members to provide a grant either directly to a conference sponsor to reduce conference costs or to a training institution or the conference sponsor to allow attendance by medical students, residents, fellows, and others who are health care professionals in training. According to the Advanced Medical Technology Association’s code, pens and notepads that could be used in a health care professional’s work environment are examples of minimal-value, branded promotional items appropriate as gifts. Golf balls and tee-shirts would not be allowed, because they are neither related to the health care professional’s work nor for the benefit of patients. During the holiday season or at any other time, a member may provide a gift that benefits patients, serves a genuine educational function, or is a branded promotional item of minimal value related to the health care professional’s work or for the benefit of the patients. Gifts of food or wine are not permitted by the code, regardless of the season. Medical technology firms are starting to focus on ethics. Medical Alley, the trade organization for Minnesota’s
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medical device industry, recently held a seminar—at the request of members— on how to avoid a federal investigation and what to do if one is the target [36]. Jim McCartney [36] wrote, “After targeting fraud at hospitals, home care facilities and pharmaceutical companies, the feds are now setting their sights on the medical device industry.” The issues are fraud and ethics. For instance, is a doctor prescribing a device and filing a Medicare claim because the device is the best available or most cost effective? Or is it because of inducements or misinformation from the medical device company? This question illustrates how a gourmet dinner or a weekend at a nice resort can turn into a bribe to defraud the federal government. Device makers that have pleaded guilty to felony charges and agreed to pay large fines include Guidant Corporation (Indianapolis, Ind; $92 million), and Abbott Laboratories (Abbott Park, Ill; $614 million) [36]. Of physicians who responded to a Medical Economics 2002 ethics survey [37], 71% didn’t think that accepting gifts, trips, and hospitality diminished their objectivity. Many of the responding physicians found the suggestion insulting, stating, “I prescribe based on science and my experience.” One physician said that she would quit the AMA over the issue, stating, It’s an insult to think that I would prescribe a drug just because I went on a trip or dinner to learn about it. If a drug is good, helps my patients and is economical, I will use it. Otherwise, I won’t.
Peter Lavine, an orthopedic surgeon in Washington, DC, in testimony at a committee meeting that considers changes to the AMA’s bylaws and ethics, proposed a resolution that would establish a parallel policy on gifts from pharmaceutical companies. One policy would be the ethical guidelines as established by the CEJA, and the other would be a policy “that allows physicians to accept ‘gifts’ from industry under more realistic guidelines that reflect the value of a physician’s time, education and opportunity costs.” Dr Lavine stated, These [CEJA] guidelines are cumbersome, onerous, and inconsistent, in that they undervalue physicians’ time as professionals and impede and restrict physician education on medical and pharmaceutical products. The CEJA guideline infuriates physicians and could adversely affect AMA membership. This CEJA guideline is often ignored by physicians and therefore undermines other truly valuable ethical principles.
Dr Lavine’s arguments against the AMA’s guidelines were not met with much support at the committee hearing. There was considerable opposition to the resolution. When the matter was put to the house for its consideration, the decision to not recommend the resolution was accepted without dissent. Although there are people, as described above, who object to newly developed ethical guidelines, the movement to change the way physicians interact with industry
is under way and will continue to gain momentum. The full implementation of and compliance with ethical guidelines will require the wide-scale training and oversight of industry sponsors and health care professionals. This includes medical students and residents and the faculty members responsible for their training. SUMMARY ● ● ● ●
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Physicians have special obligations and receive special privileges in our society. Accepting personal gifts from commercial companies can result in conflicts with professional obligations. Physicians’ first obligation is the interest of patients. In commercial interactions related to health care, expectations for physicians are higher than those for commercial companies and their representatives. Physicians should generally not accept gifts from industry and consider accepting only those that primarily entail a benefit to patients, are not of substantial value, if they involve an educational activity are unbiased and legitimate, and have no strings attached.
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APPENDIX American Medical Association Ethical Opinion E-8.061: Gifts to Physicians From Industry This is an abridged summary of the opinion; the full text of the opinion is available online at http://www. ama-assn.org/ama/pub/category/print/4001.html. Many gifts given to physicians by companies in the pharmaceutical, device, and medical equipment industries serve an important and socially beneficial function. For example, companies have long provided funds for educational seminars and conferences. However, there has been growing concern about certain gifts from industry to physicians. Some gifts that reflect customary practices of industry may not be consistent with the Principles of Medical Ethics. To avoid the acceptance of inappropriate gifts, physicians should observe the following guidelines: 1. Any gifts accepted by physicians individually should primarily entail a benefit to patients and should not be of substantial value. Textbooks, modest meals, and other gifts are appropriate if they serve a genuine educational function. Cash payments should not be accepted. 2. Individual gifts of minimal value are permissible as long as the gifts are related to the physicians’ work (eg, pens and notepads). 3. The Council on Ethical and Judicial Affairs defines a legitimate “conference” or “meeting” as any activity, held at an appropriate location, where (a) the gathering is primarily dedicated, in both time and effort, to promoting objective scientific and educational activities and discourse, and (b) the main incentive for bringing attendees together is to further their knowledge on the topic(s) being presented. 4. Subsidies to underwrite the costs of continuing medical education conferences or professional meetings can contribute to the improvement of patient care and therefore are permissible. Since the giving of a subsidy directly to a physician by a company’s representative may create a relationship that could influence the use of the company’s products, any subsidy should be accepted by the conference’s sponsor who in turn can use the money to reduce the conference registration fee. Payments to defray the costs of a conference should not be accepted directly from the company by the physicians attending the conference. 5. Subsidies from industry should not be accepted directly or indirectly to pay for the costs of travel, lodging, or the personal expenses of nonfaculty physicians attending conferences or meetings, nor should subsidies be accepted to compensate for the physicians’ time. 6. Scholarship or other special funds to permit medical students, residents, and fellows to attend carefully selected educational conferences may be permissible as long as the selection of students, residents, or fellows who will receive the funds is made by the academic or training institution. 7. No gifts should be accepted if there are strings attached. When companies underwrite medical conferences or lectures other than their own, responsibility for and control over the selection of content, faculty, educational methods, and materials should belong to the organizers of the conferences or lectures.