TY - JOUR
AU - Banks,, David
AB - Conflicts of interest (COIs) represent an expanding challenge for pharmacists as their therapeutic influence grows. Many potential COI relationships involve pharmaceutical manufacturers, who have characterized pharmacists as “a growing force to be reckoned with.”1 The expanded influence of pharmacists may increase their likelihood of being targeted for offers to become involved in ethically questionable relationships, particularly COI arrangements that may pose a threat to their relationships with patients. COIs. The theoretical construct underlying COIs is based first on the concept of discretionary action involving professional judgment.2 This discretionary action of a professional is widely expected to reflect fidelity. Professional fidelity involves adherence to principles of “respect for autonomy, justice, and utility, [reflected by] the obligation to act in good faith to keep vows and promises, fulfill agreements, maintain relationships, and discharge fiduciary responsibilities.”3 A COI is defined as “a situation in which a person, such as a public official, an employee, or a professional, has a private or personal interest sufficient to appear to influence the objective exercise of his or her official duties.”4 Such situations involve a private interest (i.e., an interest based on a relationship with another person or organization) or a personal interest (self-interest) that is in conflict with an official duty and that interferes with professional responsibilities by diminishing professional judgment. According to Latham,5 A person has a conflict of interest when, in the presence of some duty to pursue the interests of another, she is motivated by self-interest to do something inconsistent with that duty. Thus a physician has a conflict of interest when, in the presence of some duty to promote the interests of another (usually, though not always, a patient), she is motivated by self-interest to do something inconsistent with that duty. Divided loyalties. Divided loyalties are fundamental to a COI and are the means through which COIs undermine trust. Divided loyalties occur when an individual’s relationships become irreconcilable in ways that force that person to choose between them.6 People with a COI may overestimate their own ability to assess the potential for divided loyalties.2 The concept of self-serving bias is based on individuals’ judgments of what is fair being biased in favor of their self-interests. For example, physicians describe themselves as not being vulnerable to COI-related bias but their physician peers as being vulnerable.7 Because of the risk of individuals’ underestimating the potential adverse consequences of COI relationships, many organizations ban relationships involving even the appearance of a COI. Uncertainty, vulnerability, and trust. Medical care involves considerable uncertainty, with a broad range of outcomes potentially resulting from a given medical intervention. Medical treatment also involves profound vulnerability on the part of the patient.8 Given the uncertainty of medical outcomes, patient vulnerability, and the risk of divided loyalties, demand for professional commitment is greatest when patients are sickest and under greatest emotional duress, their choices are most complex and important, their capacity to acquire and weigh medical information is most diminished, and information asymmetry is sharpest. Health care professionals’ violation of this trust can lead to patients feeling a profound sense of betrayal, which can seriously undermine or destroy health care relationships. Avoiding COIs. The best means for pharmacists to deal with potential COIs is to avoid situations that may produce them. An avoidance strategy requires that pharmacists know enough about the practices of pharmaceutical manufacturers and others to be able to recognize potential COIs in advance. Such a strategy also requires that pharmacists establish and adhere to personal standards of behavior. Dealing with COIs. In some cases, it is possible to manage a COI when it is potential rather than actual or when all parties involved acknowledge the COI but agree to tolerate it. Escape, in the form of recusement or divestment, can be costly or impractical because of the important role of the person involved. Disclosure has been pointed to as a means for patients to learn about COIs and to establish more reasonable expectations, but disclosure may diminish the openness that is essential to competent diagnosis and treatment.9 Disclosure of COIs is an incomplete remedy—it does not resolve the conflict, requiring only that it be transparent, informing others of the need to judge the professional’s conduct. Patients may be ill-equipped to make such judgments. Pharmaceutical industry COI practices. Pharmaceutical manufacturers and others employ a wide range of practices to develop COI relationships with pharmacists, including gifts. Gifts from manufacturers take many forms, from pens and notepads to all-expense-paid trips to meetings or luxury resorts. Acceptance of gifts can trigger the instinct to reciprocate, eliciting a divided-loyalty dilemma. Jewesson10 notes that “reciprocation is so highly valued a social norm that those who do not reciprocate are often regarded with disgust and assigned negative labels, such as ‘moocher’ . . . and ‘welcher.’” While a legally binding obligation may not arise from accepting gifts from pharmaceutical manufacturers, the expression “no strings attached” seldom applies in principle. Rather than being simple courtesies, gifts to health care professionals represent targeted marketing investments intended to elicit sales. Pharmaceutical manufacturers invest heavily in market research to carefully assess the value derived from various forms of marketing activities.11 Because of this extensive market research, manufacturers are in a much stronger position than pharmacists to assess whether gifts or other promotional expenditures are serving their business interests. Industry expenditures on gifts are deducted as marketing expenses, not charity, and are considered a business expense for tax purposes. Hence, it is argued that referring to these items as gifts is disingenuous and that they should be referred to as marketing wares.12 Many believe that the monetary value of a gift from a pharmaceutical manufacturer to a physician or pharmacist is of little significance. Internal drug company memorandums indicate that gifts of modest value are effective as a means of accessing physicians and potentially influencing them to change prescribing practices.13 COIs can also result from relationships between pharmacists and pharmaceutical manufacturers involving consultation work and research funding,10,14 and particular concerns have arisen regarding so-called sham research and sham consulting relationships. Such activities can represent a means for manufacturers to provide cash, lodging, and other goods or services of considerable cash value to health care professionals in return for “services” of little or no value to those manufacturers. One drug company, for example, is accused of issuing checks of up to $10,000 to physicians for participation in fake trials and phoney consulting services,15 in some cases creating a financial interest in prescribing one product in place of another.16 Gifts, sham consulting, and sham research are increasingly directed at pharmacists as their therapeutic influence expands. While pharmaceutical researchers and consultants deserve to be compensated for legitimate services, such relationships can result in COIs. Sham research and sham consulting represent a particular challenge to health care practitioners who may be ill-equipped to distinguish between legitimate services and sham relationships intended primarily to create a COI. Pharmacists, professionalism, and COIs. In polls of American consumers, pharmacists consistently rank high in perceived honesty and ethics. The pharmacy community recognizes the importance of pharmacists’ trustworthiness, noting that characteristics of a profession include that (1) The profession must serve the needs of society rather than a special interest group, usually for the benefit of society, with an altruistic goal as opposed to a materialistic one, (2) the profession should have a group identity and group consciousness that can be recognized by others, and (3) the profession should develop and enforce its own code of ethics, standards of practice, and peer review.17 The pharmacy education community also recognizes the ethical dimension of pharmacy, asserting that “entry-level graduates must have value systems and incipient ethical standards . . . the graduate must have a sense of the obligation which pharmacists owe their patients and their duty to ensure that obligation is carried out.”18 Concerns have been raised about the behind-the-scenes involvement of manufacturers in preparing manuscripts for publication in pharmacy journals, as well as about pharmacists being paid to serve as authors of record for such publications, despite their minimal involvement in the preparation of those manuscripts.19 Pharmacists have responded to ethical dilemmas involving pharmaceutical manufacturers with calls for limiting acceptance of gifts,20,21 for greater specificity in manufacturer guidelines on relationships with practitioners, and for improving COI disclosures.22 Actions have also been taken by organizations outside of pharmacy and medicine to address COI-related concerns. Pharmaceutical manufacturer guidelines on gifts. The manufacturers’ predominant trade association, the Pharmaceutical Research and Manufacturers of America, announced in April 2002 that, starting in July of that year, new voluntary ethical guidelines would limit drug company gifts to physicians and other health care professionals while continuing to allow drug companies to hire physicians as consultants.23 This code has been characterized as inferior to marketing codes in Australia, Canada, and the United Kingdom, with no provisions for monitoring, no complaints procedure, and no sanctions for violators.24 There is some evidence that member firms are reducing their offering of gifts to physicians.25 These guidelines do not meaningfully address artificial “value-added” relationships, such as sham research and sham consulting. Federal actions on drug company relationships. In 1991 the Office of Inspector General issued a report on the promotion of prescription drugs through payments and gifts from pharmaceutical companies and the reactions of government and private groups to such practices.26 The Department of Health and Human Services (DHHS) has asserted its authority with respect to prescription drug-marketing practices, citing its responsibility to prevent “fraud, waste, and mismanagement, and promote economy, efficiency, and effectiveness in DHHS programs and operations.”27 The antikickback statute was pointed to as “penalizing anyone who knowingly and willfully solicits, receives, offers, or pays remuneration” to induce, or in return for referring an individual to a person for, “the furnishing, or arranging for the furnishing, of any item or service payable under the Medicare or Medicaid program, or purchasing, leasing, or ordering, or arranging for or recommending purchasing, leasing or ordering, any good, facility, service, or item payable under the Medicare or Medicaid program.”28 DHHS initiated a regulatory action against TAP Pharmaceuticals after a six-year investigation, accusing it of numerous violations of federal law, including the provision of improper incentives to physicians; an $875 million settlement was ordered in 2001.29 Many physicians have also been prosecuted. In 2002 the Office of Inspector General issued draft guidelines warning pharmaceutical manufacturers not to offer financial incentives to health care professionals to prescribe, recommend, or switch medications.30 Some responded that these guidelines were “not grounded in an understanding of industry practices,” unduly restricted patient education programs and industry support of continuing medical education, and undermined “the free market for pharmaceutical products.”31 Pharmacy benefit management companies (PBMs) and manufacturers. PBMs administer prescription drug benefits for health care insurance plans and are of particular concern with respect to COIs. In many cases, mail-order and other pharmacy activities are integrated with PBM services. PBMs have been accused of accepting kickbacks and rebates from pharmaceutical manufacturers that were not passed on to patients.32 The U.S. Department of Justice has accused PBMs of taking kickbacks and asserted that PBMs must not interfere in pharmacists’ relationships with patients.33,34 In 2004, Medco Health Solutions agreed to pay $29.3 million to states to settle charges by 20 state attorneys general. Pharmacists’ relationships with manufacturers. Pharmacists’ relationships with pharmaceutical manufacturers may be influenced to a significant extent by their attitudes about manufacturers. In a regional survey published in 1994, pharmacists expressed negative views about pharmaceutical marketing and detailing and about the objectivity of manufacturers’ drug information.35 Pharmacists disagreed that COIs could affect clinical decisions regarding drug use or recommendations or could adversely affect patient care. They agreed that COIs could increase the cost of drug therapy for patients and influence formulary decisions if efficacy, toxicity, and cost are the same. Basis of cooperative and adversarial relationships. There is a strong basis for cooperative relationships between pharmacists and manufacturers, since drug products are primarily what enable pharmacists to serve and benefit patients. Medical innovations funded by pharmaceutical manufacturers are the primary source of treatment advances for patients with serious and life-threatening diseases. Manufacturers make important contributions in many other research areas and support continuing education for pharmacists. Many firms have patient assistance programs that make some of their products available to patients unable to pay for them, and many firms make promising investigational drugs available to thousands of patients at no charge. There is also a strong basis for conflicts between the interests of pharmacists’ patients and those of pharmaceutical manufacturers.36 It is in patients’ interest to be treated with the safest and most effective drug, whereas each manufacturer seeks to promote the use of its marketed drug in each pharmacologic category. It is in the interest of patients to buy prescription drugs at the best price, whereas manufacturers have a fiduciary responsibility to maximize return on investment by selling their products at the highest possible price. Generic drugs represent an important means of lowering drug expenditures and expanding access to prescription drugs, but research-based manufacturers have sought to limit the availability of generic drugs.37,38 Pharmaceutical manufacturers have disseminated false or misleading information about their products and were cited 569 times by FDA during 1997–2001 for false or misleading claims.39,40 Manufacturers have been accused of promoting marketed products for unapproved uses.41 The pharmaceutical industry has created and used numerous “citizen” organizations, such as Citizens for Better Medicare, the Maryland Partnership for Quality Healthcare, the Consumer Alliance, and the United Seniors Association, to oppose policy initiatives intended to enable large prescription drug programs to use their market buying power to buy prescription drugs at discounted prices.42,43 Manufacturers sell prescription drugs in the United States at prices considerably higher than in other nations, and they charge the highest prices to seniors and the working poor.44 They have been accused of overcharging public hospitals and clinics serving low-income patients.45 These characteristics of the industry may serve as the basis of adversarial relationships with pharmacists if pharmacists are to be effective advocates for patients. One health professional has said that “the pharmaceutical industry is no more evil than any other industry. They are for-profit. Their goal is not to help us provide the best care for our patients, nor should it be. That is our job; their job is to make money for the stockholders.”46 Pharmacists’ control over relationships. Pharmacists have the option of exerting control over their relationships with pharmaceutical manufacturers and others with whom they may potentially enter into COI relationships. A manufacturer may offer gifts or other perquisites to pharmacists, and pharmacists are free to decline them. Pharmacists earning more than $80,000 per year need not depend on free or low-cost continuing education from sources they suspect are controlled or influenced by manufacturers. Pharmacists can work to neutralize information asymmetry, retrieving drug information from authoritative sources and challenging manufacturers to document their promotional claims. Pharmacists can exert a beneficial influence over drug therapy, steering physicians and patients toward the best therapy, regardless of the manufacturers’ aspirations. Pharmacists are also well positioned to advocate for patients by speaking out on public policy issues related to the delivery of drug therapy and health care. However, to the extent that pharmacists are involved in extensive relationships with manufacturers, they may be less likely to vigorously advocate approaches that best serve patients’ needs but are not the interests of the industry. Pharmacy’s professional obligations. Elmer Hess,47 former president of the American Medical Association, said, “If a man is good in his heart, then he is an ethical member of any group in society. If he is bad in his heart, he is an unethical member. To me, the ethics of medical practice is as simple as that.” This philosophy does not fully explain pharmacist receptivity to COI relationships, which may result from ignorance of COIs and their significance. COIs are often reported or mentioned by the mass and professional media, but the concept is seldom explained. Education on ethics varies widely in pharmacy schools, and the pharmacy literature presents few discussions on this topic. Pharmacy codes of ethics do not make clear distinctions about potential COIs. Pharmacists practice in environments where gifts from pharmaceutical manufacturers are often referred to as honoraria for those with exceptional knowledge and influence, rather than as potential threats to relationships with patients. Pharmacists, as a group, are broadly receptive to potential COI relationships with pharmaceutical manufacturers.48 This receptivity is a problem for the profession, patients, and the health care system. Pharmacy has worked diligently to expand the technical expertise and influence the profession can offer patients, but use of this expertise and influence to attract COI relationships can undermine patient care and pharmacists’ standing as professionals committed to serving patients. Pharmacy need not allow itself to become captive to the pharmaceutical industry or others who might seek to step between pharmacists and patients. Pharmacists cannot serve effectively as advocates for patients if pharmacists are unwilling to bear the cost of continuing education and involvement in professional organizations. Pharmacists, pharmacy schools, and pharmacy professional organizations can do more to expand knowledge and to forge a new consensus regarding COIs in pharmacy. Pharmacists can choose to pursue an ethic that reciprocates trust with trustworthy behavior. Pharmacists stand to benefit individually and professionally by having a widely accepted, intrinsic set of ethical standards reflecting fidelity to patients, rather than having ethical behavior that is imposed by regulatory authorities in the wake of scandals attracting negative media attention. If the profession better appreciates how ethical dilemmas may arise in relationships with pharmaceutical manufacturers, PBMs, and others, and if it chooses to commit to serving patients first, then pharmacists, patients, and the health care system will benefit. Conclusion. A more thorough understanding of COIs and how to avoid them will help pharmacists meet their obligation to provide the best patient care. Footnotes The views presented here are those of the author and do not necessarily represent the policy of the Food and Drug Administration or the U.S. Public Health Service. References 1 Cassell D. 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Copyright © 2005. American Society of Health-System Pharmacists, Inc. All rights reserved.
TI - Pharmacists, pharmaceutical manufacturers, and conflicts of interest
JO - American Journal of Health-System Pharmacy
DO - 10.2146/ajhp040504
DA - 2005-09-01
UR - https://www.deepdyve.com/lp/oxford-university-press/pharmacists-pharmaceutical-manufacturers-and-conflicts-of-interest-TCljNO00Ou
SP - 1827
VL - 62
IS - 17
DP - DeepDyve
ER -