Giving and receiving of gifts between pharmaceutical companies and medical specialists in Australia.

BACKGROUND: This study investigated the 'gift-relationship' between pharmaceutical companies and doctors. METHODS: The study was based on a survey questionnaire of 823 medical specialists from across Australia. The aim of this study was to investigate gifts offered to medical specialists in Australia by pharmaceutical companies, financial support actively sought by medical specialists for activities other than research and to consider what is ethically appropriate. RESULTS: A high percentage of specialists received offers of food (96%), items for the office (94%), personal gifts (51%) and journals or textbooks (50%). Most specialists were invited to product launches, symposia or educational events (75-84%) and 52% received offers of travel to conferences. A high proportion of offers were accepted (66-79%) except invitations to product launches (49%), sponsored symposia (53%) and offers of travel that included partners (27%). Fifteen per cent of specialists requested financial support from pharmaceutical companies for activities and items, including conferences, travel, educational activities, salaries and donations to specific funds. The study outlined guidelines on gifts from pharmaceutical companies and differing standards applying to gifts and grants for travel. We found that, although most gifts and requests for support complied with professional and pharmaceutical industry guidelines, some--including personal gifts, tickets to sporting events, entertainment and travel expenses for specialists' partners--did not. CONCLUSION: To ensure that physicians' judgements are free from real or perceived influence from industry and to maintain public trust, we support a shift towards more conservative standards on gifts and support for travel evident in recent guidelines.

Cooperative partnerships or conflict-of-interest? A national survey of interaction between the pharmaceutical industry and medical organizations.

BACKGROUND: There is extensive and varied interaction between the pharmaceutical industry and the medical profession. Most empirical research concerns contact between individual physicians and industry, and reflects North American experience. We sought to clarify the extent and nature of relationships between the pharmaceutical industry and Australian medical organizations. METHODS: We administered questionnaires to 63 medical organizations concerned with clinical practice, continuing medical education or professional accreditation, or the political representation of medical professionals. RESULTS: Survey instruments were received from 29 organizations, giving a response rate of 46%. Seventeen of these organizations (59%) had received support from one or more pharmaceutical company in the past financial year. Support was predominantly for annual conferences, with some support for continuing medical education, research, travel and library purchases. The majority of organizations had an academic journal or newsletter, and 10 (34%) accepted revenue from pharmaceutical advertising. Twenty organizations (72%) had policies or guidelines covering their relationship with industry. Few organizations indicated that they would be unable to continue their activities without pharmaceutical industry support. CONCLUSION: These data indicate a high level of inter-action between the pharmaceutical industry and medical organizations in Australia. While most organizations have policies for guiding their relationship with industry, it is unclear whether these are effective in preventing conflicts of interest and maintaining public trust.

An ethics core curriculum for Australasian medical Schools.

Teaching ethics incorporates teaching of knowledge as well as skills and attitudes. Each of these requires different teaching and assessment methods. A core curriculum of ethics knowledge must address both the foundations of ethics and specific ethical topics. Ethical skills teaching focuses on the development of ethical awareness, moral reasoning, communication and collaborative action skills. Attitudes that are important for medical students to develop include honesty, integrity and trustworthiness, empathy and compassion, respect, and responsibility, as well as critical self-appraisal and commitment to lifelong education.

A critical analysis of Australian clinical ethics committees and the functions they serve.

The predominant function of Australian clinical ethics committees (CECs) is policy formation. Some committees have an educational role. Few committees play any direct role in advising on ethics in the management of individual patients and this occurs only in exceptional circumstances. There is a tendency to exaggerate both the number and function of committees. It is suggested that studies of ethics committees, based on questionnaire surveys, should be interpreted cautiously. An examination of ethical issues indicates that there is a role for a critical analysis of power relations in Australian hospitals that is not fulfilled by CECs.

The effect of unilateral posteroventral pallidotomy on the kinematics of the reach to grasp movement.

OBJECTIVE: To assess postoperative effects of unilateral posteroventral pallidotomy on the organisation of upper limb movement. METHODS: A three dimensional kinematic system (ELITE, B/T/S/ Italy) was used to record reach to grasp movements to objects of either small (0.7 cm) or large (8 cm) diameter placed at a reaching distance of either 20 or 30 cm. Four patients with Parkinson's disease were assessed in "off" (12 hours without medication) and "on" (1 hour after administration of medication) preoperatively and postoperatively. RESULTS: Duration of the movement and the time spent in arm deceleration were significantly reduced after surgery. However, movement patterning according to object size was adversely affected. Postoperatively, all four patients showed an abnormal pattern of a longer movement duration, and three showed a longer time of reaching arm deceleration, for reach to grasp movements to the large object than for those to the small object. CONCLUSION: Posteroventral pallidotomy seems to be beneficial in reducing bradykinesia of upper limb movements but may have "costs" to movement patterning, particularly for reach to grasp movements to objects of differing sizes. This study raises interesting questions about the role of the globus pallidus interna in coordinating stimulus bound visual information with appropriate motor patterning.

Left posteroventral pallidotomy results in a deficit in verbal memory.

Whilst pallidotomy is emerging as a popular approach to the treatment to Parkinson's disease, little is yet known about the cognitive effects of this procedure. This study presents 19 patients (6 right, 13 left) who were assessed both before and after the procedure on a battery of cognitive tests. The results indicate that subjects with left-sided lesions display significant decline in verbal memory between one and three months following the procedure. The results are consistent with the notion of either a classic amnesic syndrome or a deficit in striato-frontal working memory.

The formation of professional and consumer solutions: ethics in the general practice setting.

A general practice research project on ethics is underway at the University of New South Wales, funded by GPEP (General Practice Evaluation Program, Commonwealth Department of Human Services and Health, GPEP 386). Ethical issues, as defined and explored by general practitioners and consumers, are being examined across four areas of Sydney. So far, telephone interviews have been conducted (64% response rate) with a random sample of general practitioners (GPs). Face-to-face interviews have been conducted with 107 consumers, randomly sampled using ABS collection district information. Focus groups have been formed to discuss acceptable solutions to GP and consumer identified ethical issues. This report will report on some preliminary findings to date and will explore professional and consumer roles in the formation of ethical solutions.

Ethics decision-making in Australian hospitals.

OBJECTIVE: To describe the methods used to resolve ethical issues in hospitals throughout Australia. DESIGN: A descriptive study from data collected by a questionnaire survey of Australian public and private hospitals. PARTICIPANTS: Hospital administrators and employees nominated by hospital administrators. RESULTS: Completed questionnaires were received from 739 (74%) hospitals. Methods used to resolve ethical issues included personal reflection, discussion between health professionals and discussion between health professionals and patients. A variety of committees were identified as having some role in the discussion of ethical issues, but only a small number of hospitals had established ethics committees. CONCLUSION: Doctor-patient interaction and discussion between practitioners are the most common methods used to resolve ethical issues. Various committees are also used and, of these, ethics committees are not the most commonly consulted.

Ethical issues in Australian hospitals.

OBJECTIVE: To identify the most common ethical issues of concern in Australian hospitals. DESIGN: A descriptive study using data collected by means of a questionnaire. PARTICIPANTS: Seven hundred and thirty-nine (74%) hospital administrators and employees nominated by hospital administrators in Australian public and private hospitals. RESULTS: Over half the respondents reported that ethical concerns had been raised in relation to: making "not for resuscitation orders"; the treatment of patients with HIV and AIDS; interprofessional conflict; and the allocation of resources. CONCLUSION: "End of life" concerns, patient autonomy issues, questions of resource distribution, and communication difficulties commonly raise ethical concerns in Australian hospitals.

Do Australian researchers accept committee review and conduct ethical research?

We sought researchers' views on the ethics of research practice and the Australian system of review of research proposals by research ethics committees (RECs). Researchers were found to be supportive of review of research proposals, even though they thought that the process of review was time consuming and demanding. However, our findings suggest that not all researchers present their research proposals for review by committees, and that some researchers deviate from their approved proposals without seeking approval for those deviations from an REC. Researchers supported monitoring of research by RECs.

Heparin inhibition of von Willebrand factor-dependent platelet function in vitro and in vivo.

The intravenous administration of heparin to patients before open heart surgery reduced ristocetin cofactor activity by 58% (P less than 0.01, t test), and this impairment of von Willebrand factor-dependent platelet function was closely related to plasma heparin levels (r2 = 0.9), but not to plasma von Willebrand factor (vWF) levels. We hypothesized that heparin may inhibit vWF-dependent platelet hemostatic functions by directly binding vWF in solution and interfering with vWF-GpIb binding. Using the in vitro techniques of ristocetin-induced platelet agglutination, fluorescent flow cytometric measurement of vWF-platelet binding, and conventional radioligand binding assays we observed that heparin inhibited both vWF-dependent platelet function and vWF-platelet binding in a parallel and dose-dependent manner. Heparin also inhibited platelet agglutination induced by bovine vWF and inhibited the binding of human asialo-vWF to platelets in ristocetin-free systems. The inhibitory potency of heparin was not dependent upon its affinity for antithrombin III, but was molecular weight dependent: homogeneous preparations of lower molecular weight were less inhibitory. Heparin impairment of vWF function may explain why some hemorrhagic complications of heparin therapy are not predictable based on techniques for monitoring the conventional anticoagulant effects of heparin.

A critical evaluation of transsphenoidal pituitary surgery in the treatment of Cushing's disease: prediction of outcome.

Twenty-eight patients underwent transsphenoidal pituitary surgery for Cushing's disease. Selective surgical procedures were performed in 26. In 19 patients pituitary adenoma was confirmed histologically and 5 had clumps or clusters of ACTH-staining cells. At follow-up after 22.3 (range 5-56) months 21 (75%) patients remained in clinical and biochemical remission. The 24-h urinary free cortisol performed between 1 and 4 weeks postoperatively while patients took replacement doses of dexamethasone (0.5 to 0.75 mg per day) was found to predict outcome. All patients with suppressed urinary free cortisol excretion have remained in remission, 3 with levels in the normal range have suffered late relapse after initial remission, and 4 with elevated urinary free cortisol excretion were regarded as having failed to remit. Furthermore, all patients with unsuccessful outcomes had no pituitary adenoma and 3 had features consistent with corticotrope nodular hyperplasia at histological examination compared to only 2 and 1, respectively, of patients still in remission. We conclude that 24-h urinary free cortisol performed at 1 to 4 weeks postoperatively whilst on low-dose dexamethasone and the histological findings may predict outcome following transsphenoidal pituitary surgery in Cushing's disease.

Reviewing the reviewers: a survey of institutional ethics committees in Australia.

Completed questionnaires were received from 89 (88%) of the 101 Australian institutions identified as having an ethics committee which reviewed research on human subjects. The majority (75%) of committees complied with national requirements to include a layman, a laywoman, a minister of religion, a lawyer and a medical graduate with research experience in their membership. On average, the committees considered 41 research protocols in the year from mid 1987 to mid 1988. The proposed projects were from the medical sciences, including health services and epidemiology research (80% of projects), and the behavioural and social sciences (20% of projects). Less than half the committees monitored research projects in progress as a general practice. Most of the monitoring that was conducted was based on a report from the researcher on the progress of the study. Although monitoring, frequency of meetings, selection of committee members, member involvement in the review of their own protocols and provisions for expedited review gave cause for concern, most committees were found to follow the national guide-lines.

Management of biliary obstruction in patients with unresectable carcinoma of the pancreas.

Clinical and pathologic data from 73 patients with unresectable carcinoma of the pancreas treated from 1980 to 1987 were reviewed to evaluate the efficacy of biliary enteric bypass and percutaneous transhepatic biliary drainage (PTBD) in the treatment of malignant biliary obstruction. Fifty-two patients underwent biliary enteric bypass with no operative deaths and with a 15% operative morbidity. These patients had a median postoperative hospitalization of 12 days. Four patients (8%) eventually developed recurrent jaundice, and three of these were successfully treated with PTBD. The median survival for these 52 patients was 7 months. Twenty-one patients underwent PTBD with an 81% technical-success rate. These patients had a 33% early complication rate and a 33% in-hospital mortality. The median hospitalization was 13 days postdrainage. Of the 14 patients surviving the initial hospitalization, 86% developed late complications requiring 16 hospital admissions and ten emergency room visits for a total of 155 days of hospitalization. The median survival for those patients undergoing PTBD was 4 months from the time of diagnosis and 2 months from the time of catheter drainage. Surgical bypass offers excellent palliation for malignant biliary obstruction with extremely low morbidity and mortality in properly selected patients; PTBD is useful in the treatment of those patients with extensive disease, who are poor surgical candidates, or who have failed previous surgical drainage. There is a role for both of these palliative procedures in the management of patients with biliary obstruction from pancreatic cancer.

The implications for Australia of the New Zealand report of the cervical cancer inquiry: no cause for complacency.

The New Zealand Cervical Cancer Inquiry established that patients with carcinoma-in-situ were left untreated in order to observe the natural history of their disease. Many patients developed invasive carcinoma unnecessarily and some died. The Inquiry found the research to have been unethical in that: the risk of progression to invasive carcinoma was known; the subjects had not consented to such study; and the study was designed and conducted poorly. The Inquiry was critical of the lack of proper review and the failure of responsible doctors and administrators to intervene in the interests of the patients. This article considers reasons for this failure and background issues of ethics and law. It is concluded that there is no cause for complacency in Australia in that provisions that are designed to protect patients may be ineffective. The NZ recommendations for changes in communication with patients, in the treatment of patients, in reviews of research, and in the training of doctors should be examined for their possible adoption in Australia.