Ethical issues associated with gifts provided to physicians by the pharmaceutical industry

It is not known exactly how much money the pharmaceutical industry spends on promotional activities. It is, however, clear that it is a very large amount – some estimates put it at more than $US50 billion per year in the USA alone – and that it exceeds industry expenditure on research and development.1 Promotional activities take many forms, including provision of samples, face-to-face ‘detailing’ meetings between industry representatives and prescribers, advertising in print and the electronic media, and support for meetings and travel. One of the activities that has come under closest scrutiny in recent years is the provision of gifts to physicians, which themselves may vary from practice-related items of trivial value to expensive goods intended for the exclusive personal use of the recipients. There is nothing untoward about the concept of promotion of commercial goods as such. It is, after all, a familiar feature of all modern economies and can provide a useful means for disseminating information about available products and, by contributing to a healthy competitive market, help stimulate innovation and enterprise. However, promotion of pharmaceutical goods – and in particular, the use of gifts to do so – has been seen as a special case that raises serious ethical issues. The concern is not merely that the evidence shows that all promotional activities influence prescribing behaviour (contrary to the protestations of many physicians):2 the sheer volume of resources devoted to them shows that this must be the case. What is of concern is the possible impact of this influence on both the form and content of healthcare delivery. There are three major areas of ethical concern in relation to gift-giving.3 First, there is the kind of impact gifts may have on clinical deliberations. Prescribing decisions should be based on careful analyses of the circumstances of individual patients in light of available evidence and the doctors' professional knowledge and experience. Gifts, however, are not directed at rational prescribing principles, but instead seek to persuade doctors by appealing to them in a personal or emotional way. It is possible that through such a mechanism receipt of gifts may lead to outcomes that are not in the patient's best interests. Second, there is a possible negative impact on the public standing of doctors and medicine as a whole. Acceptance of gifts by doctors may create a public perception that the latter are not independent advocates for the welfare of their patients, but rather representatives or functionaries of business or other organizations, thereby undermining the basic, constitutive trust that is at the heart of all clinical relationships. Finally, there is the potential impact on the health system as a whole. While adding nothing to the value of a product, gifts – like other promotional activities – invariably add to the price, which ultimately has to be borne either by individual patients or by the community as a whole. In this manner, gift-giving may redirect scarce health resources away from areas of high need, thereby acting against the broader pubic interest. From an ethical point of view, these concerns raise two questions: should industry representatives offer gifts to physicians, and if they do, should the latter accept them? The question about industry poses the problem of the power of pharmaceutical companies to set the agenda for clinical practice and to limit the authority of government to make decisions about health resource allocation; that about physicians raises issues regarding the behaviour of individual doctors and the kinds of ethical decisions they make on a personal level and in the context of the clinical encounter. As with all other ethical questions, the answers depend on both an understanding and analysis of the problems, dialogues around value-related issues, and factual knowledge about current circumstances, common behaviours and implications for both individual patients and society. If the attitudes and behaviours of doctors fail to show a sensitive appreciation of the ethical issues, or if they are shown to be seriously at odds with the interests of the community, action on the part of either government or the professional associations may become necessary. The article by Macneill et al. in this issue makes a useful contribution to this debate.4 The authors conducted a survey of medical specialists and the general public in the Hunter River region of New South Wales. This survey inquired into attitudes about the ‘appropriateness’ of particular kinds of gifts that may be offered to doctors by industry representatives. The authors concede that response rates were suboptimal, raising the possibility of response bias, and they provide no breakdown of responses from practitioners in different specialities, despite different cultures and different approaches adopted by the various specialist colleges. In addition, the criteria for ‘appropriateness’ are left open, making the basis for the respondents' judgements uncertain. In spite of these limitations, the results are of considerable interest and raise useful questions. They suggest four main conclusions: (i) that there is considerable variability in opinion about the ‘appropriateness’ of certain gifts, among both specialists and the general public; (ii) that although both groups accept gift-giving in some circumstances, both also feel that there are limits to what is acceptable; (iii) that most specialists are aware of published guidelines with respect to relationships with industry and, in general, specialists' views about what is acceptable are consistent with current guidelines; and (iv) that the views of the public are somewhat more permissive than those of the practitioners. The last conclusion is contrary to what appears from the limited evidence to be the case overseas5–7 and in addition, the specialists appear to be more critical of pharmaceutical gifts than their overseas colleagues.8,9 These conclusions might give some encouragement to those working to develop guidelines that seek to promote critical attitudes among doctors to their relationships with industry. They also pose the question of what, if any, implications they have for the substantive content of such guidelines or for public policy. After all, while it may be true that there is a strong ethical case against receiving gifts from pharmaceutical companies, this does not in itself justify mandatory measures to prevent doctors from accepting gifts. Surveys of attitudes do not solve ethical problems. However, they may give some clues about the nature of the social context within which ethical decision-making is taking place and practices that may need to be subjected to critical questioning. As in many other areas in medical ethics, with respect to relations with industry there are frequent calls for mandatory systems to control doctors' behaviours.10,11 It is true that such systems may be the only way to curtail industry practices that are potentially contrary to the public interest – a judgement that is perhaps implicit in the recent decision of the peak industry association in Australia to introduce strict limitations on the use of gifts in pharmaceutical promotion.12 However, in relation to the behaviour of clinicians, mandatory regulation may actually be counter-productive. The primary responsibility of clinicians is to make decisions in the interests of their patients, taking into account the manifold complexity of the latter's personal and social circumstances. This requires a high level of ethical competence, including an ability to engage in open critical dialogue about one's own personal values and professional role. If one is simply following a rule or obeying a law, one is not making an ethical judgement: the risk of increasingly elaborated and directive codes of conduct is that they may erode such competence and undermine the fecundity of the dialogical process on which the clinical encounter is based.13 The article by Macneill et al. contributes to the ongoing ferment about dealings between physicians and industry and it may add to the broader debate about the nature of the relationship between clinical practice and the for-profit sector. Even if the arguments and the evidence suggest that doctors should refuse gifts from industry – as they evidently do – we need to convince doctors, not force them, to do so.