Ethical issues in the relationships with industry: An ongoing challenge. New Guidelines open for public comment

Abstract

Interactions between medical practitioners and industry have a profound impact on medical decision-making. It is important to establish clear guidelines to ensure that the values of clinical care, the welfare of society and science prevail over commercial imperatives and monetary values, The Royal Australasian Collage of Physicians has revised its Guidelines for the relationships involving medical practitioners and industry to provide practical assistance to health care professionals in the understanding and management of their interactions with industry. The Guidelines are advisory but provide argument and references to support their conclusions. They outline a practical approach to the management of dualities and conflicts of interests. Among other things, they recommend that gifts should be rejected, including those of small value and entertainment expenses. They argue that industry sponsorship to attend meetings should be restricted to cases where formal contributions are being made, that drug samples should not be accepted from pharmaceutical representatives and that endorsements of specific products and "advertorials" should be avoided. They propose that clinicians should not actively recruit their own patients into studies in which they are investigators and that it should be a condition of agreement to participate by researchers and approval by ethics committees that there is a commitment to make publicly available all results potentially relevant to clinical practice. The Guidelines are intended to reflect changing community attitudes and will continue to be revised from time to time.

Gifts, Drug Samples, and other Items Given to Medical Specialists by Pharmaceutical Companies

“…Pharmaceutical companies give gifts to doctors as a part of promoting and marketing their products [14]. There are concerns about the effect of these gifts however.…”

Physicians' attitudes towards interaction with the pharmaceutical industry

“…This relationship may be seen as beneficial to patients, as physicians and the pharmaceutical industry have common interests in conducting research and developing new, safe and effective medications (4). On the other hand, the relationship may be seen as harmful to patients, due to the conflict of interest between the physician, whose primary interest is patients' welfare, and the pharmaceutical industry, which has a primary interest in maximizing profits for shareholders (4,5).…”

“…This relationship may be seen as beneficial to patients, as physicians and the pharmaceutical industry have common interests in conducting research and developing new, safe and effective medications (4). On the other hand, the relationship may be seen as harmful to patients, due to the conflict of interest between the physician, whose primary interest is patients' welfare, and the pharmaceutical industry, which has a primary interest in maximizing profits for shareholders (4,5). This raises numerous ethical questions about the appropriateness of physicians' accepting gifts, the degree of transparency and disclosure of received benefits, the impact on health-care costs, influences on health-care decisions, the effect on the research agenda and its results, and the impact on the physician-patient relationship (6)(7)(8).…”

Guidelines for medical management of hyperglycaemia in type 2 diabetes and duality of interest

“…For instance, a broad review (based on 1,140 studies) evaluating the relationship between industry sponsorship and outcome in original research indicates a statistically significant association between industry sponsorship and pro-industry conclusions (pooled Mantel-Haenszel odds ratio 3.60) [4]. Moreover, there is evidence that acceptance of gifts by physicians increases the possibility that they will prescribe the drugs made by the pharmaceutical company donors, independently of the scientific data supporting these clinical decisions [5]. Finally, expert clinicians advising pharmaceutical companies gain access to privileged and non-peer reviewed information, and work with highly committed individuals whose professional lives revolve around a single product, generating another potential source of bias [6].…”