The Ethics of Pharmaceutical Industry Gift Giving: The Role of a Professional Association

With their insightful analysis of the complexity of gift-giving in the context of interactions between physicians and industry representatives, Dana Katz, Arthur L. Caplan, and Jon F. Merz (2003) are inviting the bioethics community to explore an issue it has long neglected. This undertaking is welcomed by organized medicine, which for more than ten years has recognized that the potential conflicts of interest that can arise from these gifts deserve careful attention. In 1990 the American Medical Association (AMA) developed guidelines regarding gifts from industry (AMA 1991). The guidelines were endorsed by the Pharmaceutical Manufacturers Association, now the Pharmaceutical Research and Manufacturers of America (PhRMA). Many other professional associations have since done likewise (Brody et al. 2001). The initial impact of these guidelines was a marked abatement of the excesses, such as trips to luxurious resorts, that had raised governmental concerns (Randall 1991). However, with a new generation of physicians and a dramatic expansion in the industry's sales force, awareness of and adherence to these guidelines have waned over time, both among physicians and pharmaceutical sales representatives.

Contemporaneously, pharmaceutical representatives' access to physicians has been curtailed due in part to time constraints imposed by managed care, and the industry perceives an increasingly competitive environment that requires rapid dissemination of information about new products to gain therapeutic implementation and market advantage. These conditions have led to new promotional tactics, including off-site events, such as "dine-n-dash" or more lavish dinners that bring together physicians with a "thought leader." Concerns that physicians are being unduly influenced by such gifts have led to calls like the one by Katz, Caplan, and Merz that all gifts to physicians from industry should be prohibited. In our opinion such a conclusion is unwarranted.

Despite many changes in the healthcare system, physicians continue to hold the welfare of their individual patients as their primary ethical responsibility (AMA 2001). Second to patient welfare is the acknowledgment that the public's trust in the medical profession must be safeguarded and, therefore, that physicians' medical judgment cannot succumb to undue influences. It is from these two perspectives that the AMA's ethical guidelines on gifts from industry and their impact on physicians' decisions ought to be examined.

To begin, it is indisputable that a substantial proportion of research is conducted by industry and that industry representatives often are aware of new clinically-relevant knowledge. Industry can disseminate this information rapidly to physicians, when doing so is to its advantage; arguably, this often is also of benefit to patients. But time spent with a pharmaceutical representative is time that is not spent treating a patient; it thereby constitutes both a professional and a financial "opportunity cost." In this regard, courtesy alone might justify some form of gift- giving, so long as the gift meets reasonable guidelines and does not result in undue influence.

According to the AMA's guidelines, gifts are permissible only if they might procure a benefit to patients or are related to the physician's work (a penlight or a pocket algorithm but not golf balls), are of modest value (a modest lunch but not a lavish dinner), and come with no "strings" attached (e.g., gifts cannot be based on the volume of prescriptions written). The gifts guidelines also separate educational interactions from professional services. Specifi- cally, physicians should not derive direct financial or personal gains from their participation in educational activities, although they may be reimbursed for services rendered under contractual agreements (such as research performed under an industry-financed grant). Because they are receiving information, not providing a professional service, physicians must not accept any payment for time spent with a pharmaceutical representative.

Next, it is necessary to acknowledge that the industry's profit motive differs from the tenets of professionalism in medicine. But...