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CURRENT CONTROVERSIES IN CRITICAL CARE |
Much has been written about the influence of pharmaceutical and medical device industry marketing on the decisions of healthcare providers. It is well established and, at this point, old news that industry marketing has an influence on physicians’ prescribing practices even when those who are affected are unaware of this influence.1–3 Industry marketing comes in many forms. Advertisements in professional journals, advertisements on television and radio, product detailing by industry representatives, and industry-sponsored continuing education are just some of the ways pharmaceutical and medical device companies market their products.
Some of these tactics come with gifts attached: the now infamous "free lunch" offered for those who attend an education session, the pens and pads of scratch paper inscribed with the product name and corporate logo handed out at professional conferences, the all-expense-paid trip to an exotic location where a corporation-sponsored educational conference is being held.
Corporate gifts raise questions about the relationship between healthcare providers and the industries that support healthcare. To what extent and in what ways do gifts from the pharmaceutical and medical device product industry influence the practices of healthcare providers? The actual influences of industry gifts are many and varied, and probably result in benefits as well as harm. In this brief column I wish to call into question the appropriateness of healthcare providers accepting gifts from corporate representatives by exploring the nature of gift giving, conflict of interest, and some of the less obvious harms to healthcare practice and patient-provider relationships introduced by industry gifts.
Gift Exchange and Conflicts of Interest
Conflicts of interest can take many forms—some more obvious than others. In general, a conflict of interest exists whenever an interest, duty, or obligation conflicts with some other interest. In healthcare practice, this most often comes up when a personal interest, usually the possibility of financial or other personal gain, conflicts with one’s responsibilities as a professional.
One classic example of a conflict of interest is that of prescriber "kickbacks" in which those who write prescriptions make deals with the companies who produce the drugs so that the prescriber is paid directly for prescribing the drugs. In this case the potential financial reward of prescribing a certain drug conflicts with the professional’s responsibility to prescribe only what the patient needs. The temptation of financial gain may cloud the healthcare provider’s judgment and cause her or him to prescribe the drug inappropriately. Kickbacks are well established as unethical; in fact, there are federal laws against offering and taking them. Prescribers who take kickbacks will be sanctioned by professional organizations and charged with a crime.4
In addition to financial kickback arrangements, corporate gifts, even those purported to come with "no strings attached," also can set up a conflict of interest for healthcare providers who accept them. Gift exchange is a well-established feature of most, if not all, world cultures.5 Anthropologists who have studied gift exchange, such as Mauss, Lévi-Strauss, and Godelier, agree that gift giving is always understood as an exchange. One gives a gift to receive a gift in return. Perhaps one of the unacknowledged results of accepting a gift is the obligation and impulse to return the gift. This way of understanding gift giving comes from the study of cultures in which gift exchange forms a strong organizing basis for social relations and hierarchies. It is not clear that this understanding applies in every respect to gift giving in a 21st century market economy such as that found in the United States. Still, one cannot help but wonder what the pharmaceutical or medical device corporations are expecting in return for the free lunches and other perks they provide.
Corporations are for-profit entities that have as their primary interest the highest financial return for shareholders.6,7 This may not be the primary interest of any given individual working for the corporation, but it is the basis of decisions made by the corporation as a whole.4 Although the goals are not necessarily mutually exclusive, often there is an actual or at least a potential conflict between the primary interest of the corporation (the highest financial return for investors) and the interests of healthcare providers (what is best for the patient’s and the general public’s health). If a corporation gives a gift to a healthcare provider to open an exchange that will leave the healthcare provider in debt to that corporation, such gift giving introduces a potential conflict of interest.8
How the recipients of industry gifts might repay the debt introduced by accepting the corporate gift depends on what position they hold in the decision-making hierarchy. If gifts are given to introduce indebtedness, it makes sense that gifts would be aimed at those in positions from which they can offer the most valuable reciprocal gift. For example, those with the power to make drug formulary and equipment-buying decisions for a hospital and to prescribe specific drugs and devices for patients are in the most vulnerable positions as targets of industry gifts.
But this does not mean that the risk introduced by taking gifts depends only on one’s power to make decisions directly. The opinions of staff members who have no direct decision-making power often influence more powerful higher-ups. Often, too, direct decision makers consult with the staff who will be using the products before finalizing a purchase order or other contract. Therefore, staff members who think they have no decision-making power and are immune from conflicts of interest also can come to the attention of industry representatives as indirect decision makers.
The power of industry marketing, including gift giving, is well known. Studies have demonstrated how pharmaceutical industry detailing (ie, sending out a corporate representative to provide information on a new product or drug while at the same time building relationships with hospital or clinical staff by handing out gifts of various types) affects physicians’ prescribing practices.2,3 The more contact between corporate representatives and physicians, the more likely the physician is to prescribe the drug discussed, resulting in more of the company’s product being sold.
Most studies on the influence of industry marketing on prescribing practices have focused on physicians. Although similar studies have not yet captured the extent of this influence on other healthcare providers, it is not difficult to imagine how contact with product representatives might influence the buying and prescribing practices of nurse practitioners,9 hospital administrators, pharmacists, and others who participate indirectly in these decisions. Those new to healthcare practice or new to positions that carry responsibilities of direct or indirect decision making may be particularly vulnerable because they may interpret attention from industry representatives as confirmation of their importance.
Regulating Conflicts of Interest
Obvious conflicts of interest exist in certain industry-provider relationships, whereas less obvious forms are introduced by industry marketing techniques such as gift giving. Despite the risk, healthcare providers often must interact with industry representatives to have access to necessary pharmaceuticals and devices. In an effort to limit the risks of conflict introduced by these interactions, the federal government and some professional organizations have passed laws and issued recommendations related to industry-provider relationships; the anti-kickback laws referred to earlier are one such example.
However, a financial relationship between a pharmaceutical or medical device corporation and a healthcare provider in which increased sales of company product result in indirect financial gain for the provider may not be covered by anti-kickback laws. Such relationships become problematic when the provider is also prescribing medications or making decisions about what will be included on a hospital formulary or supply order. How much will the thought of a consulting bonus or some other financial dividend influence these decisions? The industry gift introduces another, more subtle conflict of interest that often goes unacknowledged depending on the nature of the gift.
Some professional organizations have published guidelines on how the more obvious forms of conflict of interest that fall short of violating anti-kickback laws ought to be handled.10,11 For Coyle,10 who represents the American College of Physicians–American Society of Internal Medicine, full disclosure of all relationships that may result in conflict is sufficient. For others, however, disclosure is not enough. As Brennan et al11 point out, stopping with full disclosure is a way of making the relationship seem innocent without truly analyzing the potential for conflict and harm. If a healthcare provider is involved in a relationship that introduces a potential conflict of interest in her practice, in addition to making this information public she should enlist the help of colleagues to analyze and come to an understanding about how the relationship might influence her decisions related to patient care.
In addition to the effect on her decisions, the provider also should evaluate how the appearance of a conflict of interest might influence the way decisions are perceived by others who are affected. If there is some possibility that the healthcare provider might personally benefit from decisions that favor a particular product or if that provider has a history of accepting gifts or services from a company whose product is under consideration, then perhaps these factors should preclude her participation in the decision.
Limits on corporate gifts are recommended by some professional groups.9,10 Some of these groups recommend refusing gifts worth a great deal, such as expenses-paid travel, but stipulate that accepting less financially significant gifts such as pens and mugs creates no conflict. If we understand the gift as a way to open an exchange that obligates the recipient, accepting any gift seems to create an unwanted debt for the healthcare professional. In this sense there is no such thing as a "no strings attached" gift, since the very nature of the gift carries the obligation to reciprocate.5 Healthcare professionals should be encouraged to refuse all gifts from industry no matter how seemingly inconsequential. The practice of refusing corporate gifts eliminates this as a source of conflict of interest and reduces the ubiquitous presence of corporate and product logos in hospitals and other healthcare institutions. After all, the presence of such logos gives the impression of product endorsement even when endorsement is not intended.
All else being equal, however, just what is the harm? Not everyone agrees that accepting corporate gifts introduces a conflict of interest for healthcare providers. Even if there is an expectation that the gift will be returned, reciprocation does not have to take the form of consciously or unconsciously favoring the gift giver’s product when making patient care or institutional decisions. If the healthcare provider is aware of the risk, she or he can consciously avoid the consequences of any potential conflict.
One question that arises is this: What is the harm in taking gifts as long as the product the gift represents is a good—or at least harmless—product? After all, if one product is as good as any other, why not take the company perks and use their brand? If drug A is in all senses comparable to drug B, and if the product representative from the company that makes drug A treats the unit staff well by providing frequent free lunches with continuing education offerings, bringing pens and pads of scratch paper, textbooks, and other handouts to staff meetings, is there a problem in prescribing drug A to continue to receive these benefits?
First, even if we do not want to believe that we are the kind of people who can be influenced by the promise of personal gain (after all, we all want to believe we are incorruptible), there is strong evidence to the contrary.1–3 It is also well established that we are not getting the full truth about product comparison in education sponsored by the company that makes the brand in question.7 If I am basing my understanding of drug A as comparable to or better than drug B on information provided by a representative of the company that makes drug A, I am most likely rationalizing the irrational behavior reflected in my prescribing drug A. But even if I do my own research and find out for certain that drug A is as good as drug B, it is still difficult to justify prescribing drug A solely on the basis of the handouts offered by the company.
When acting as professionals, healthcare providers should be held to higher standards than they are in their personal lives, because they are engaged in a practice that is directed toward a larger social and civic good. As Sullivan12 has pointed out, professional integrity requires a disinterested stance toward personal gain. The healthcare professional—unlike, for example, the merchant—has a civic duty to make decisions based on what is best for the patient and the patient’s family, not based on maximizing his or her own profit. Once we begin to let marketing influence our decisions, we open the door to buying and selling as part of professional healthcare practice and introduce personal interest into decisions that should be based solely on the interests of our patients’ and/or the public’s health.
If there is no true conflict of interest in accepting corporate gifts and if healthcare providers are capable of protecting their professional decisions from the influence of industry marketing, then the fiduciary obligation that exists for healthcare professionals makes even the appearance of impropriety problematic. The appearance of impropriety can disrupt patient-provider trust and contribute to the breakdown of professional integrity in healthcare practice. For example, seeing a product logo displayed on the bag carried by a physician on a hospital unit or on the pen used by a nurse practitioner in a clinic can cause patients and family members to wonder why this particular product was chosen for them. Is it the best thing for them, or is it merely the most lucrative choice for the provider? That such questions arise in the first place undermines the trust between healthcare providers and the public. One reasonable step toward eliminating the question of conflict of interest in healthcare is for individual healthcare providers to begin to rethink our relationships with industry and say "no thank you" even to seemingly harmless corporate gifts. How many pens with different antibiotic names do we need, anyway?
For more information on pharmaceutical industry influence on healthcare providers and information on how to get amnesty for your drug company pens, visit the "No Free Lunch" Web site.8
To purchase electronic or print reprints, contact The InnoVision Group, 101 Columbia, Aliso Viejo, CA 92656. Phone, (800) 809-2273 or (949) 362-2050 (ext 532); fax, (949) 362-2049; e-mail, reprints{at}aacn.org.
This article has been cited by other articles:
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  R. F. Humphries Industry Gifting Should End Am. J. Crit. Care., July 1, 2007; 16(4): 332 - 332. [Full Text] [PDF]
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