Quantitative analysis of sponsorship bias in economic studies of antidepressants.
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BACKGROUND: Concern is widespread about potential sponsorship influence on research, especially in pharmacoeconomic studies. Quantitative analysis of possible bias in such studies is limited. AIMS: To determine whether there is an association between sponsorship and quantitative outcomes in pharmacoeconomic studies of antidepressants. METHOD: Using all identifiable articles with original comparative quantitative cost or cost-effectiveness outcomes for antidepressants, we performed contingency table analyses of study sponsorship and design v. study outcome. RESULTS: Studies sponsored by selective serotonin reuptake inhibitor (SSRI) manufacturers favoured SSRIs over tricyclic antidepressants more than non-industry-sponsored studies. Studies sponsored by manufacturers of newer antidepressants favoured these drugs more than did non-industry-sponsored studies. Among industry-sponsored studies, modelling studies favoured the sponsor's drug more than did administrative studies. Industry-sponsored modelling studies were more favourable to industry than were non-industry-sponsored ones. CONCLUSIONS: Pharmacoeconomic studies of antidepressants reveal clear associations of study sponsorship with quantitative outcome. (+info)
Absent virtues: the poacher becomes gamekeeper.
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Since its inception, bioethics' principled stance has been to argue against paternalism and elitism, and for an inclusive ethical perspective. But at least in North America, the growth of bioethics as a special area of applied ethics has created conflicts within the field itself. Those who, a generation earlier, argued against paternalism and for both professional and public accountability in medical decision making are now part of the decision making process. Too often, it is argued in this paper, their allegiance is to the employer, or to a view of medicine that is institutionally based. As a result, it is suggested by this review, medical ethicists have adopted the perspective that, in the early 1970s, they most criticised. The answer, it is argued here, is to revisit a lexicographical ordering of responsibility in bioethics, one that recognises professionals as individuals with responsibilities, as citizens with a public posture, and finally, as professionals involved in the process of medical decision making. (+info)
Stored human tissue: an ethical perspective on the fate of anonymous, archival material.
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The furore over the retention of organs at postmortem examination, without adequate consent, has led to a reassessment of the justification for, and circumstances surrounding, the retention of any human material after postmortem examinations and operations. This brings into focus the large amount of human material stored in various archives and museums, much of which is not identifiable and was accumulated many years ago, under unknown circumstances. Such anonymous archival material could be disposed of, used for teaching, used for research, or remain in storage. We argue that there are no ethical grounds for disposing of the material, or for storing it in the absence of a teaching or research rationale. Nevertheless, with stringent safeguards, it can be used even in the absence of consent in research and teaching. Regulations are required to control the storage of all such human material, along the lines of regulations governing anatomy body bequests. (+info)
Leveraging of open EMR architecture for clinical trial accrual.
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Accrual to clinical trials is a major bottleneck in scientific progress in clinical medicine. Many methods for identifying potential subjects and improving accrual have been pursued; few have succeeded, and none have proven generally reproducible or scalable. We leveraged the open architecture of the core clinical data repository of our electronic medical record system to prototype a solution for this problem in a manner consistent with contemporary regulations and research ethics. We piloted the solution with a local investigator-initiated trial for which candidate identification was expected to be difficult. Key results in the eleven months of experience to date include automated screening of 7,296,708 lab results from 69,288 patients, detection of 1,768 screening tests of interest, identification of 70 potential candidates who met all further automated criteria, and accrual of three candidates to the trial. Hypotheses for this disappointing impact on accrual, and directions for future research, are discussed. (+info)
Relationship between conflicts of interest and research results.
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CONTEXT: To date, research regarding the influence of conflicts of interest on the presentation of findings by researchers has been limited. OBJECTIVE: To evaluate the sources of funding for published manuscripts, and association between reported findings and conflicts of interest. METHODS: Data from both print and electronic issues of The New England Journal of Medicine (NEJM) and The Journal of the American Medical Association (JAMA) were analyzed for sources of funding, areas of investigation, conflict of interest (COI), and presentation of results. We reviewed all original manuscripts published during the year 2001 within NEJM (N = 193) and JAMA (N = 205). We use 3 definitions for COI in this paper: a broadly defined criterion, the criterion used by The International Council of Medical Journal Editors (ICMJE), and a criterion defined by the authors. RESULTS: Depending on the COI criteria used, 16.6% to 32.6% of manuscripts had 1 or more author with COI. Based on ICMJE criterion, 38.7% of studies investigating drug treatments had authors with COI. We observed a strong association between those studies whose authors had COI and reported positive findings (P <.001). When controlling for sample size, study design, and country of primary authors, we observed a strong association between positive results and COI (ICMJE definition) among all treatment studies (adjusted odds ratio [OR], 2.35; 95% confidence interval [CI], 1.08 to 5.09) and drug studies alone (OR, 2.64; 95% CI, 1.09 to 6.39). CONCLUSION: COI is widespread among the authors of published manuscripts and these authors are more likely to present positive findings. (+info)
A case report: ethics of a proposed qualitative study of hospital closure in an Australian rural community.
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BACKGROUND: The GP and qualitative researcher use similar patient-centred approaches, but their roles are different. Guidelines for conducting GP research in small communities are limited. I planned a qualitative study about hospital closure in a small rural Australian town where I worked. Few studies have researched community reaction to hospital closure and this process of change. METHODS: I used historical analysis to improve external reliability, and purposeful sampling to develop and pre-test a qualitative semi-structured research instrument. Newspaper articles, minutes and tape recordings of public meetings, annual reports from 1991 to 1997, quality assurance data and interviews with two health professionals were analysed in this process. These sources were coded using content and thematic analysis. Ethical issues arose during early stages of planning. Ethical guidelines and bioethics principles were discussed with colleagues and a member of an ethics committee. I validated my findings with three other community members involved in the hospital closure. RESULTS: Themes of a transition, from resistance to change and divisions between key stake holders, to a need to appreciate the benefits of change emerged in coding material from 1991 to 1997. The principle of non-maleficence outweighed the principle of beneficence in this study. Existing health services could be harmed by examining the process of change after spending time and resources to reconcile community differences. Individuals could be harmed as confidentiality in a small community was difficult to maintain, and discussions about sensitive issues could produce adverse public criticism. The autonomy of participants to give informed consent was complicated by the author providing clinical services in the community, raising concerns about patients feeling an obligation to participate. CONCLUSIONS: A justified case for discontinuing this study was made by the researcher on ethical grounds. Use of bioethical principles and community representatives to validate findings was a useful technique to guide decisions in a small rural community. This discussion has application in planning other small community studies. (+info)
Biomedical conflicts of interest: a defence of the sequestration thesis-learning from the cases of Nancy Olivieri and David Healy.
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No discussion of academic freedom, research integrity, and patient safety could begin with a more disquieting pair of case studies than those of Nancy Olivieri and David Healy. The cumulative impact of the Olivieri and Healy affairs has caused serious self examination within the biomedical research community. The first part of the essay analyses these recent academic scandals. The two case studies are then placed in their historical context-that context being the transformation of the norms of science through increasingly close ties between research universities and the corporate world. After a literature survey of the ways in which corporate sponsorship has biased the results of clinical drug trials, two different strategies to mitigate this problem are identified and assessed: a regulatory approach, which focuses on managing risks associated with industry funding of university research, and a more radical approach, the sequestration thesis, which counsels the outright elimination of corporate sponsorship. The reformist approach is criticised and the radical approach defended. (+info)
Better governance in academic health sciences centres: moving beyond the Olivieri/Apotex Affair in Toronto.
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The Toronto experience suggests that there may be several general lessons for academic health sciences complexes to learn from the Olivieri/Apotex affair (OAA) regarding the ethics, independence, and integrity of clinical research sponsored by for profit enterprises. From a local perspective, the OAA occurred when there already was a focus on the complex and changing relationships among the University of Toronto, its medical school, the fully affiliated teaching hospitals, and off campus faculty because of intertwined interests and responsibilities. The OAA became a catalyst that accelerated various systemic reforms, particularly concerning academic/industry relations. In this article, the evolving governance framework for the Toronto academic health sciences complex is reviewed and these policy and process reforms discussed. These reforms have created collaborative activity among research ethics boards and contract research offices of the partner institutions, and allowed the joint university/hospital ethics centre to play a role in governance and policy, while respecting the missions and mandates of the involved institutions. Although few of the policies are dramatically innovative, what is arguably novel is the elaboration of an overarching governance framework that aims to move ethics to a central focus in the academic complex. Time alone will tell how sustainable and effective these changes are. (+info)