School of Historical and Philosophical Studies - Research Publications

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    Chinese health biotech and the billion-patient market
    Frew, SE ; Sammut, SM ; Shore, AF ; Ramjist, JK ; Al-Bader, S ; Rezaie, R ; Daar, AS ; Singer, PA (NATURE PUBLISHING GROUP, 2008-01)
    UNLABELLED: Chinese government support and 'sea turtles' are spurring the sector, but investors lack exits. SUPPLEMENTARY INFORMATION: The online version of this article (doi:10.1038/nbt0108-37) contains supplementary material, which is available to authorized users.
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    Science and society -: Genomic medicine and developing countries:: creating a room of their own
    Seguin, B ; Hardy, B-J ; Singer, PA ; Daar, AS (NATURE PUBLISHING GROUP, 2008-06)
    The notion that developing countries must wait for the developed world to make advances in science and technology that they later import at great cost is being challenged. We have previously argued that developing countries can harness human genetic variation to benefit their populations and economies. Based on our empirical studies of large-scale population genotyping projects in Mexico, India and Thailand, we describe how these resources are being adopted to improve public health and create knowledge-based economies. A significant additional benefit is building the capacity for scientific research and internalizing advances in technology, whatever their source.
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    Evaluating priority setting success in healthcare: a pilot study
    Sibbald, SL ; Gibson, JL ; Singer, PA ; Upshur, R ; Martin, DK (BMC, 2010-05-19)
    BACKGROUND: In healthcare today, decisions are made in the face of serious resource constraints. Healthcare managers are struggling to provide high quality care, manage resources effectively, and meet changing patient needs. Healthcare managers who are constantly making difficult resource decisions desire a way to improve their priority setting processes. Despite the wealth of existing priority setting literature (for example, program budgeting and marginal analysis, accountability for reasonableness, the 'describe-evaluate-improve' strategy) there are still no tools to evaluate how healthcare resources are prioritised. This paper describes the development and piloting of a process to evaluate priority setting in health institutions. The evaluation process was designed to examine the procedural and substantive dimensions of priority setting using a multi-methods approach, including a staff survey, decision-maker interviews, and document analysis. METHODS: The evaluation process was piloted in a mid-size community hospital in Ontario, Canada while its leaders worked through their annual budgeting process. Both qualitative and quantitative methods were used to analyze the data. RESULTS: The evaluation process was both applicable to the context and it captured the budgeting process. In general, the pilot test provided support for our evaluation process and our definition of success, (i.e., our conceptual framework). CONCLUSIONS: The purpose of the evaluation process is to provide a simple, practical way for an organization to better understand what it means to achieve success in its priority setting activities and identify areas for improvement. In order for the process to be used by healthcare managers today, modification and contextualization of the process are anticipated. As the evaluation process is applied in more health care organizations or applied repeatedly in an organization, it may become more streamlined.
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    The three main monotheistic religions and gm food technology: an overview of perspectives
    Omobowale, EB ; Singer, PA ; Daar, AS (BIOMED CENTRAL LTD, 2009)
    BACKGROUND: Public acceptance of genetically modified crops is partly rooted in religious views. However, the views of different religions and their potential influence on consumers' decisions have not been systematically examined and summarized in a brief overview. We review the positions of the Judaism, Islam and Christianity - the three major monotheistic religions to which more than 55% of humanity adheres to - on the controversies aroused by GM technology. DISCUSSION: The article establishes that there is no overarching consensus within the three religions. Overall, however, it appears that mainstream theology in all three religions increasingly tends towards acceptance of GM technology per se, on performing GM research, and on consumption of GM foods. These more liberal approaches, however, are predicated on there being rigorous scientific, ethical and regulatory scrutiny of research and development of such products, and that these products are properly labeled. SUMMARY: We conclude that there are several other interests competing with the influence exerted on consumers by religion. These include the media, environmental activists, scientists and the food industry, all of which function as sources of information and shapers of perception for consumers.
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    Priority setting: what constitutes success? A conceptual framework for successful priority setting
    Sibbald, SL ; Singer, PA ; Upshur, R ; Martin, DK (BMC, 2009-03-05)
    BACKGROUND: The sustainability of healthcare systems worldwide is threatened by a growing demand for services and expensive innovative technologies. Decision makers struggle in this environment to set priorities appropriately, particularly because they lack consensus about which values should guide their decisions. One way to approach this problem is to determine what all relevant stakeholders understand successful priority setting to mean. The goal of this research was to develop a conceptual framework for successful priority setting. METHODS: Three separate empirical studies were completed using qualitative data collection methods (one-on-one interviews with healthcare decision makers from across Canada; focus groups with representation of patients, caregivers and policy makers; and Delphi study including scholars and decision makers from five countries). RESULTS: This paper synthesizes the findings from three studies into a framework of ten separate but interconnected elements germane to successful priority setting: stakeholder understanding, shifted priorities/reallocation of resources, decision making quality, stakeholder acceptance and satisfaction, positive externalities, stakeholder engagement, use of explicit process, information management, consideration of values and context, and revision or appeals mechanism. CONCLUSION: The ten elements specify both quantitative and qualitative dimensions of priority setting and relate to both process and outcome components. To our knowledge, this is the first framework that describes successful priority setting. The ten elements identified in this research provide guidance for decision makers and a common language to discuss priority setting success and work toward improving priority setting efforts.
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    'Relief of oppression': An organizing principle for researchers' obligations to participants in observational studies in the developing world
    Lavery, JV ; Bandewar, SVS ; Kimani, J ; Upshur, REG ; Plummer, FA ; Singer, PA (BIOMED CENTRAL LTD, 2010-06-30)
    BACKGROUND: A central question in the debate about exploitation in international research is whether investigators and sponsors from high-income countries (HIC) have obligations to address background conditions of injustice in the communities in which they conduct their research, beyond the healthcare and other research-related needs of participants, to aspects of their basic life circumstances. DISCUSSION: In this paper, we describe the Majengo sexually transmitted disease (STD) Cohort study, a long-term prospective, observational cohort of sex workers in Nairobi, Kenya. Despite important scientific contributions and a wide range of benefits to the women of the cohort, most of the women have remained in the sex trade during their long-standing participation in the cohort, prompting allegations of exploitation. The Majengo STD cohort case extends the debate about justice in international research ethics beyond clinical trials into long-term observational research. We sketch the basic features of a new approach to understanding and operationalizing obligations of observational researchers, which we call 'relief of oppression'. 'Relief of oppression' is an organizing principle, analogous to the principle of harm reduction that is now widely applied in public health practice. Relief of oppression aims to help observational researchers working in conditions of injustice and deprivation to clarify their ethical obligations to participants. It aims to bridge the gap between a narrow, transaction-oriented account of avoiding exploitation and a broad account emphasizing obligations of reparation for historic injustices. We propose that relief of oppression might focus researchers' consideration of benefits on those that have some relevance to background conditions of injustice, and so elevate the priority of these benefits, in relation to others that might be considered and negotiated with participants, according to the degree to which the participating communities are constrained in their realization of fundamental freedoms. SUMMARY: The over-arching aim of relief of oppression is that, within the range of benefits negotiated over time with the local communities and organizations, an increasing proportion reflects a shared interest in improving participants' fundamental freedoms. We describe how harm reduction serves as a useful analogy for how we envision relief of oppression functioning in international research.
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    The road to commercialization in Africa: lessons from developing the sickle-cell drug Niprisan
    Perampaladas, K ; Masum, H ; Kapoor, A ; Shah, R ; Daar, AS ; Singer, PA (BIOMED CENTRAL LTD, 2010-12)
    BACKGROUND: Developing novel drugs from traditional medicinal knowledge can serve as a means to improve public health. Yet countries in sub-Saharan Africa face barriers in translating traditional medicinal knowledge into commercially viable health products. Barriers in moving along the road towards making a new drug available include insufficient manufacturing capacity; knowledge sharing between scientists and medical healers; regulatory hurdles; quality control issues; pricing and distribution; and lack of financing. The case study method was used to illustrate efforts to overcome these barriers during the development in Nigeria of Niprisan - a novel drug for the treatment of sickle cell anemia, a chronic blood disorder with few effective therapies. DISCUSSION: Building on the knowledge of a traditional medicine practitioner, Nigeria's National Institute for Pharmaceutical Research and Development (NIPRD) developed the traditional herbal medicine Niprisan. The commercialization of Niprisan reached a number of commercial milestones, including regulatory approval in Nigeria; securing US-based commercial partner XeChem; demonstrating clinical efficacy and safety; being awarded orphan drug status by the US Food and Drug Administration; and striking important relationships with domestic and international groups. Despite these successes, however, XeChem did not achieve mainstream success for Niprisan in Nigeria or in the United States. A number of reasons, including inconsistent funding and manufacturing and management challenges, have been put forth to explain Niprisan's commercial demise. As of this writing, NIPRD is considering options for another commercial partner to take the drug forward. SUMMARY: Evidence from the Niprisan experience suggests that establishing benefit-sharing agreements, fostering partnerships with established research institutions, improving standardization and quality control, ensuring financial and managerial due diligence, and recruiting entrepreneurial leaders capable of holding dual scientific and business responsibilities should be incorporated into future drug development initiatives based on traditional medicines. Country-level supporting policies and conditions are also important. With more experience and support, and an improved environment for innovation, developing new drugs from traditional medicines may be an attractive approach to addressing diseases in sub-Saharan Africa and other regions.
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    Public engagement on global health challenges
    Cohen, ERM ; Masum, H ; Berndtson, K ; Saunders, V ; Hadfield, T ; Panjwani, D ; Persad, DL ; Minhas, GS ; Daar, AS ; Singh, JA ; Singer, PA (BMC, 2008-05-20)
    BACKGROUND: Experience with public engagement activities regarding the risks and benefits of science and technology (S&T) is growing, especially in the industrialized world. However, public engagement in the developing world regarding S&T risks and benefits to explore health issues has not been widely explored. METHODS: This paper gives an overview about public engagement and related concepts, with a particular focus on challenges and benefits in the developing world. We then describe an Internet-based platform, which seeks to both inform and engage youth and the broader public on global water issues and their health impacts. Finally, we outline a possible course for future action to scale up this and similar online public engagement platforms. RESULTS: The benefits of public engagement include creating an informed citizenry, generating new ideas from the public, increasing the chances of research being adopted, increasing public trust, and answering ethical research questions. Public engagement also fosters global communication, enables shared experiences and methodology, standardizes strategy, and generates global viewpoints. This is especially pertinent to the developing world, as it encourages previously marginalized populations to participate on a global stage. One of the core issues at stake in public engagement is global governance of science and technology. Also, beyond benefiting society at large, public engagement in science offers benefits to the scientific enterprise itself. CONCLUSION: Successful public engagement with developing world stakeholders will be a critical part of implementing new services and technologies. Interactive engagement platforms, such as the Internet, have the potential to unite people globally around relevant health issues.
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    Shared Principles of Ethics for Infant and Young Child Nutrition in the Developing World
    Singh, JA ; Daar, AS ; Singer, PA (BMC, 2010-06-08)
    BACKGROUND: The defining event in the area of infant feeding is the aggressive marketing of infant formula in the developing world by transnational companies in the 1970s. This practice shattered the trust of the global health community in the private sector, culminated in a global boycott of Nestle products and has extended to distrust of all commercial efforts to improve infant and young child nutrition. The lack of trust is a key barrier along the critical path to optimal infant and young child nutrition in the developing world. DISCUSSION: To begin to bridge this gap in trust, we developed a set of shared principles based on the following ideals: Integrity; Solidarity; Justice; Equality; Partnership, cooperation, coordination, and communication; Responsible Activity; Sustainability; Transparency; Private enterprise and scale-up; and Fair trading and consumer choice. We hope these principles can serve as a platform on which various parties in the in the infant and young child nutrition arena, can begin a process of authentic trust-building that will ultimately result in coordinated efforts amongst parties. SUMMARY: A set of shared principles of ethics for infant and young child nutrition in the developing world could catalyze the scale-up of low cost, high quality, complementary foods for infants and young children, and eventually contribute to the eradication of infant and child malnutrition in the developing world.
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    Innovative health service delivery models in low and middle income countries - what can we learn from the private sector?
    Bhattacharyya, O ; Khor, S ; McGahan, A ; Dunne, D ; Daar, AS ; Singer, PA (BMC, 2010)
    BACKGROUND: The poor in low and middle income countries have limited access to health services due to limited purchasing power, residence in underserved areas, and inadequate health literacy. This produces significant gaps in health care delivery among a population that has a disproportionately large burden of disease. They frequently use the private health sector, due to perceived or actual gaps in public services. A subset of private health organizations, some called social enterprises, have developed novel approaches to increase the availability, affordability and quality of health care services to the poor through innovative health service delivery models. This study aims to characterize these models and identify areas of innovation that have led to effective provision of care for the poor. METHODS: An environmental scan of peer-reviewed and grey literature was conducted to select exemplars of innovation. A case series of organizations was then purposively sampled to maximize variation. These cases were examined using content analysis and constant comparison to characterize their strategies, focusing on business processes. RESULTS: After an initial sample of 46 studies, 10 case studies of exemplars were developed spanning different geography, disease areas and health service delivery models. These ten organizations had innovations in their marketing, financing, and operating strategies. These included approaches such a social marketing, cross-subsidy, high-volume, low cost models, and process reengineering. They tended to have a narrow clinical focus, which facilitates standardizing processes of care, and experimentation with novel delivery models. Despite being well-known, information on the social impact of these organizations was variable, with more data on availability and affordability and less on quality of care. CONCLUSIONS: These private sector organizations demonstrate a range of innovations in health service delivery that have the potential to better serve the poor's health needs and be replicated. There is a growing interest in investing in social enterprises, like the ones profiled here. However, more rigorous evaluations are needed to investigate the impact and quality of the health services provided and determine the effectiveness of particular strategies.