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CLINICAL ETHICS

CLINICAL ETHICS

Ethical issues concerning the relationships between medical practitioners and the pharmaceutical industry Paul A Komesaroff and Ian H Kerridge
RELATIONSHIPS INVOLVING medical practitioners and the pharmaceutical industry raise serious concerns and The Medical Journal of the medical profession and the controversy within bothAustralia ISSN: 0025-729X 4 February 2002 176 2 118-121 broader community.1,2 Within the profession itself views differ sharply, from the conviction 2001 www.mja.com.au ©The Medical Journal of Australia that the risks associated with such relationships are minimal to a concern that all Clinical Ethics contact between doctors and industry involves compromise and should therefore be avoided as far as possible.3 The relationship between the pharmaceutical industry and the medical profession includes clearly desirable aspects (eg, the cooperative efforts of industry, government and prescribers in trying to achieve quality use of medicines) and less clearly ethically justifiable ones (eg, acceptance of lavish gifts and money for entertainment expenses by doctors). Sources of concern

ABSTRACT
• Medical practitioners and the pharmaceutical industry serve interests that sometimes overlap and sometimes conflict. • There is strong evidence that associations between industry and doctors influence the behaviour of the latter in relation to both clinical decision making and the conduct of research. • In view of the risk of compromising relationships with patients and the integrity of the research process, doctors must exercise care in their dealings with industry. • The basic principles underlying the conduct of doctors with respect to pharmaceutical companies should be openness and transparency. • Clearly articulated procedures should be developed to deal with specific issues such as travel subsidies, receipt of gifts, sponsorship of conferences and continuing education activities, and dualities of interest arising in clinical and research settings.

Doctors and the pharmaceutical industry share a number of common interests. For example, both are concerned with encouraging effective and responsible use of existing drugs in treatment and care, monitoring of their use, and innovative research. However, the parties have different emphases and focus on different stakeholders. Doctors are interested primarily in patient care and scientific advance, while industry is interested primarily in commercial outcomes. The primary stakeholder in patient care is the patient, whereas the principal stakeholder in industry is the shareholder. The similarities and differences between participants and their interests create both a need for discourse and the potential for conflict. The contribution made by industry to medical knowledge and practice has been considerable. The cost of development of a new drug is between US$300 and $600 million, most of which is provided by industry.4 Clinical research is also expensive: last year, in the United States, about US$6 billion was spent on clinical research, of which 70% came directly

MJA 2002; 176: 118-121
from industry.5 The total amount spent on research and development is much larger still.6 In spite of these clear common interests and benefits of cooperation, concerns of an ethical nature have been expressed by both the medical profession and the community. There are three main concerns: s The possibility that associations between doctors and drug companies may serve commercial objectives of industry and acquisitive interests of clinicians rather than legitimate care, educational or research goals, thereby compromising the primary ethical obligation of doctors to patients, dividing the loyalties of doctors and undermining the basic trust on which clinical relationships depend; s The risk that drug promotion will inappropriately influence doctors’ decisions; and s The danger that industry involvement in research will lead to distortions in...
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