Ties that bind: multiple relationships between clinical researchers and the pharmaceutical industry.

BACKGROUND: It is believed that pharmaceutical industry sponsorship of clinical research leads to the development of multiple ties between clinicians and the pharmaceutical industry. To quantify this relationship we conducted a survey of medical specialists listed in the Medical Directory of Australia in 2002 and 2003. METHODS: A questionnaire was mailed that elicited information about all aspects of research relationships between clinicians and pharmaceutical companies. The odds of reporting multiple additional ties (financial and professional) with pharmaceutical companies by clinicians who had an active research relationship were compared with those who did not. All clinicians who returned a completed questionnaire about their research activities were included in the study. RESULTS: A questionnaire was mailed to 2120 medical specialists; 823 (39%) responded. Of these, 338 (41%) reported involvement in industry-sponsored research in the previous year. They were more likely than others to have been offered industry-sponsored items or activities valued at more than 500 AU dollars (>382 US dollars; odds ratio [OR], 3.5; 95% confidence interval [CI], 2.6-4.7) and support for attending international conferences (OR, 5.4; 95% CI, 3.9-7.4). The strongest associations were seen for acting as a paid consultant to industry (OR, 9.0; 95% CI, 3.9-20.4) and for membership on advisory boards (OR, 6.9; 95% CI, 5.1-9.6). There was a strong relationship between research collaboration and accumulation of industry ties. For 1 additional tie the OR was 2.2 (95% CI, 1.2-3.8) and rose to 6.3 (95% CI, 3.5-11.1) with 3 ties and 41.8 (95% CI, 14.5-143.4) with 6 or more ties. CONCLUSIONS: Medical specialists who have research relationships with the pharmaceutical industry are much more likely to have multiple additional ties than those who do not have research relationships. Institutional review should discourage clinical researchers from developing multiple ties.

Medical specialists and pharmaceutical industry-sponsored research: a survey of the Australian experience.

OBJECTIVES: To characterise research relationships between medical specialists and the pharmaceutical industry in Australia. DESIGN AND SETTING: Questionnaire survey of medical specialists listed in the Medical Directory of Australia and believed to be in active practice, conducted in 2002 and 2003. MAIN OUTCOME MEASURES: Details of medical specialists' involvement in pharmaceutical industry-sponsored research, and reports of potentially undesirable research outcomes. RESULTS: Of 2120 specialists approached, 823 (39%) responded. Participation in pharmaceutical industry-sponsored research was more commonly reported by those in salaried practice (49%) than those in private practice (33%); P < 0.001. 216 reported that industry had made initial contact, compared with 117 who had initiated contact with industry. 14.0% of respondents reported premature termination of industry-sponsored trials, which they considered appropriate when in response to concerns about adverse drug effects. 12.3% of respondents reported that industry staff had written first drafts of reports, which they viewed as an acceptable practice for "internal" documents only. Of greatest concern to respondents were instances of delayed publication or non-publication of key negative findings (reported by 6.7% and 5.1% of respondents, respectively), and concealment of results (2.2%). Overall, 71 respondents (8.6%) had experienced at least one event that could represent breaches of research integrity. CONCLUSIONS: These data indicate a high level of engagement in research between the pharmaceutical industry and medical specialists, including those in private practice. Examples of possibly serious research misconduct were reported by 8.6% of respondents, equivalent to 21% of those with an active research relationship with industry.

Loved one's body in the anatomy laboratory.

An Australian medical student recognized parts of her father's body during classes in an anatomy laboratory and suffered considerable trauma as a consequence. While the risk of a further case may be small, the potential for trauma could be minimized by adopting appropriate policy and procedures. Institutions that receive donations of bodies may benefit from considering suggestions for minimizing that risk and for responding appropriately should it ever occur. The article draws on the investigation into this case to offer some suggestions for minimizing the chance of recognition of bodies or body parts by students and academic or professional staff and for managing those circumstances should they ever occur. The suggestions extend to minimizing the risk of recognition of deceased persons or their body parts through photographic records, video material, and case studies presented in a number of different formats.

Public health ethics: asylum seekers and the case for political action.

This paper is a case study in public health ethics. It considers whether there is a basis in ethics for political action by health professionals and their associations in response to inhumane treatment. The issue arises from Australia's treatment of asylum seekers and the charge that this treatment has been both immoral and inhumane. This judgement raises several questions of broader significance in bioethics and of significance to the emerging field of public health ethics. These questions relate to the role of health professionals in response to inhumane treatment of people in their charge; to the discipline of public health in light of a growing recognition of its ethical basis; and the role of public health and bioethical associations in response to ethical issues arising in a political context. It is argued that, in serious cases of humanitarian and human rights abuses affecting health and well-being, there is a case for political action by health professionals, academic and professional institutions, and associations of public health and ethics.

Medical harm and the consequences of error for doctors.

Mistakes in medicine, particularly when patients have suffered harm as a result, are of ethical concern as breaching a fundamental injunction in medicine: "first do not harm". To minimise the chances of a recurrence, an effective response to harm must take into account both the concerns of patients who have been harmed and the concerns of doctors who may fear extreme outcomes if a mistake is admitted. There is an apparent conflict between a need to respond to errors non-punitively, on the one hand, and ethical and legal requirements for accountability and compensation for anyone harmed, on the other. There is also confusion between arguments for a "blame-free" culture in the healthcare system and the need to attribute responsibility in some cases. Important elements in an ethical response to mistakes include disclosure to the patient and family; taking appropriate clinical steps to mitigate any harm that may result from a mistake; identifying the process leading to harm; and responding in an appropriate and humane manner to minimise the likelihood of any recurrence.

Declarations made by graduating medical students in Australia and New Zealand.

OBJECTIVE: To survey the use of declarations of ethical commitment made by graduating medical students in Australia and New Zealand. METHODS: Information, obtained by email and telephone, from faculty officers of all faculties of medicine (or medicine and health sciences) in Australia and New Zealand. RESULTS: Declarations are made by graduating medical students at seven of 12 Australasian faculties of medicine. To date, declarations have been based on the Declaration of Geneva or the Hippocratic Oath or have been formulated by academic staff or the students themselves. In six of the seven universities, declarations are made as part of a special declaration ceremony (usually combined with a prize-giving ceremony). One university includes a declaration as part of the official graduation ceremony. DISCUSSION: We discuss the relative merits of a declaration selected for students by staff members and a declaration written anew by each group of graduating students.

Research ethics review and the bureaucracy.

This paper suggests that the increasing bureaucracy of ethics review by committee is more about fulfilling institutional requirements than it is about ethics. It is suggested that ethics committees should not be instruments of bureaucratic regulation and control. They should be freed to play a critical role within the institution, to support and develop ethical research and researchers, and given time to discuss and explore the difficult ethical issues where they arise. To burden research ethics committees with trivial bureaucratic tasks is to miss an opportunity for healthy exchanges of views about ethics and to distort the nature and meaning of ethics.