Ethical issues in the pharmaceutical industry.
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In many developed countries, the physician/pharmaceutical sales representative relationship has increasingly become the focus of ethical questions. Given this context, the purpose of the present study was to determine the ethical dilemmas faced by pharmaceutical sales representatives in Turkey in their relations with physicians, and to identify possible solutions. Through an investigator-designed questionnaire, the ethical problems perceived by 215 pharmaceutical sales representatives were quantitatively analyzed. Nearly all of the participants (96.7%) reported that they had faced ethical dilemmas in marketing drugs to physicians. The most commonly reported problems included paramedical requests (for free lab test kits, etc.) and the necessity of bargaining with physicians over the use of their firm's drugs by offering gifts and sponsorships. The participants in the study felt that physicians were the primary source of ethical problems in the marketing of drugs, and the participants' most highly ranked potential solution to these ethical problems was a better understanding, on the part of physicians, of the role of pharmaceutical sales representatives. At the end of this study, suggestions are given with a view to helping health policy makers understand and address the current controversies involving drug company representatives and physicians.
1. There seems no reason why clinical pharmacology studies conducted within the pharmaceutical industry should be exempt from the requirement of ethical review, and independent review in this situation reduces the vulnerability of the company and its employees, in addition to serving its primary function of protecting the volunteer subjects. 2. Experience within one company has shown that independent ethical review need not seriously influence the pace of research. 3. It is important that such committees should be seen to be independent and competent.
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Pharmaceutical manufacturers commonly contract with clinical investigators for pre-market testing of new products. The per-patient reimbursement offered to the investigator generally exceeds the per-patient costs incurred by the investigator. This excess represents a windfall that can be used to pay for travel, equipment, or supplies, or to fund research for which the investigator cannot obtain funding through peer-reviewed granting channels. This excess raises a potential conflict of interest, because it may lead the investigator to propose experimental treatment for a patient when the patient might be better served by conventional treatment or by no treatment at all. Not only does this situation pose a conflict of interest, it also is a conflict of which few patients are aware and fewer are informed. We propose that all experimental subjects be informed of the source, amount, and mechanism of funding for the experimental treatments they undergo. Further, we propose that payments from pharmaceutical manufacturers for pre-market testing of drugs go to the medical school dean rather than to the individual investigator. With this money, the dean can defray the direct as well as the indirect costs of the clinical study; the remainder, which would otherwise go directly to the investigator, should be placed in a funding pool for which the entire medical school could compete. This solution largely eliminates conflict of interest, addresses informed consent, and reasonably balances the interests of the experimental subject, the clinical investigator, the pharmaceutical manufacturer, and the academic institution.
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Since their appearance in 1850, Pharmaceutical Sales Representatives (PSR) interactions with physicians have engendered intense emotional responses. The controversy has continued unabated since that time. Arguments in favor of the moral impermissibility of the PSR-physician relationship can be divided into four general categories; (1) influence, (2) patients pay but they do not choose, (3) violation of principlism, and (4) the erosion of the patient-physician relationship. None of the arguments that have thus far been proposed against the moral permissibility of these interactions gives sufficient warrant to avoid them (or pursue them). It may be the case that PSR-physician interactions place the patient-physician relationship in jeopardy. This would constitute enough warrant, from a pragmatic perspective, to shun such relationships. However, no research supports this contention. A careful evaluation of the literature leaves one ambivalent at best.
The ethical (prescription) pharmaceutical industry depends on a stream of innovative, patent-protected products to maintain growth and profitability. With Sterling Drug's entry into a new therapeutic area (oncology, the study and treatment of cancer), licensing and research collaborations have become an important part of the process of developing a pipeline of potential new drugs. The application of the analytic hierarchy process has led to improved articulation of the relevant criteria and better definition of organizational procedures, thereby benefiting Sterling's decision-making process.
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