School of Historical and Philosophical Studies - Research Publications
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ItemThe case for conducting first-in-human (phase 0 and phase 1) clinical trials in low and middle income countries(BMC, 2011-10-18)BACKGROUND: Despite the increase in the number of clinical trials in low and middle income countries (LMICs), there has been little serious discussion of whether First in Human (FIH; phase 0 and phase 1) clinical trials should be conducted in LMICs, and if so, under what conditions. Based on our own experience, studies and consultations, this paper aims to stimulate debate on our contention that for products meant primarily for conditions most prevalent in LMICs, FIH trials should preferably be done first in those countries. DISCUSSION: There are scientific and pragmatic arguments that support conducting FIH trials in LMIC. Furthermore, the changing product-development and regulatory landscape, and the likelihood of secondary benefits such as capacity building for innovation and for research ethics support our argument. These arguments take into account the critical importance of protecting human subjects of research while developing capacity to undertake FIH trials. SUMMARY: While FIH trials have historically not been conducted in LMICs, the situation in some of these countries has changed. Hence, we have argued that FIH should be conducted in LMICs for products meant primarily for conditions that are most prevalent in those contexts; provided the necessary protections for human subjects are sufficient.
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ItemIndian vaccine innovation: the case of Shantha Biotechnics(BMC, 2011-04-20)BACKGROUND: Although the World Health Organization had recommended that every child be vaccinated for Hepatitis B by the early 1980s, large multinational pharmaceutical companies held monopolies on the recombinant Hepatitis B vaccine. At a price as high as USD$23 a dose, most Indians families could not afford vaccination. Shantha Biotechnics, a pioneering Indian biotechnology company founded in 1993, saw an unmet need domestically, and developed novel processes for manufacturing Hepatitis B vaccine to reduce prices to less than $1/dose. Further expansion enabled low-cost mass vaccination globally through organizations such as UNICEF. In 2009, Shantha sold over 120 million doses of vaccines. The company was recently acquired by Sanofi-Aventis at a valuation of USD$784 million. METHODS: The case study and grounded research method was used to illustrate how the globalization of healthcare R&D is enabling private sector companies such as Shantha to address access to essential medicines. Sources including interviews, literature analysis, and on-site observations were combined to conduct a robust examination of Shantha's evolution as a major provider of vaccines for global health indications. RESULTS: Shantha's ability to become a significant global vaccine manufacturer and achieve international valuation and market success appears to have been made possible by focusing first on the local health needs of India. How Shantha achieved this balance can be understood in terms of a framework of four guiding principles. First, Shantha identified a therapeutic area (Hepatitis B) in which cost efficiencies could be achieved for reaching the poor. Second, Shantha persistently sought investments and partnerships from non-traditional and international sources including the Foreign Ministry of Oman and Pfizer. Third, Shantha focused on innovation and quality - investing in innovation from the outset yielded the crucial process innovation that allowed Shantha to make an affordable vaccine. Fourth, Shantha constructed its own cGMP facility, which established credibility for vaccine prequalification by the World Health Organization and generated interest from large pharmaceutical companies in its contract research services. These two sources of revenue allowed Shantha to continue to invest in health innovation relevant to the developing world. CONCLUSIONS: The Shantha case study underscores the important role the private sector can play in global health and access to medicines. Home-grown companies in the developing world are becoming a source of low-cost, locally relevant healthcare R&D for therapeutics such as vaccines. Such companies may be compelled by market forces to focus on products relevant to diseases endemic in their country. Sanofi-Aventis' acquisition of Shantha reveals that even large pharmaceutical companies based in the developed world have recognized the importance of meeting the health needs of the developing world. Collectively, these processes suggest an ability to tap into private sector investments for global health innovation, and illustrate the globalization of healthcare R&D to the developing world.
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ItemAccess and use of human tissues from the developing world: ethical challenges and a way forward using a tissue trust(BIOMED CENTRAL LTD, 2011-01-25)BACKGROUND: Scientists engaged in global health research are increasingly faced with barriers to access and use of human tissues from the developing world communities where much of their research is targeted. In part, the problem can be traced to distrust of researchers from affluent countries, given the history of 'scientific-imperialism' and 'biocolonialism' reflected in past well publicized cases of exploitation of research participants from low to middle income countries. DISCUSSION: To a considerable extent, the failure to adequately engage host communities, the opacity of informed consent, and the lack of fair benefit-sharing have played a significant role in eroding trust. These ethical considerations are central to biomedical research in low to middle income countries and failure to attend to them can inadvertently contribute to exploitation and erode trust. A 'tissue trust' may be a plausible means for enabling access to human tissues for research in a manner that is responsive to the ethical challenges considered. SUMMARY: Preventing exploitation and restoring trust while simultaneously promoting global health research calls for innovative approaches to human tissues research. A tissue trust can reduce the risk of exploitation and promote host capacity as a key benefit.
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ItemFranchising Rabies Vaccine Delivery: The Case of Indian Immunologicals(PUBLIC LIBRARY SCIENCE, 2011-04)
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ItemWhat could infant and young child nutrition learn from sweatshops?(BMC, 2011-05-05)BACKGROUND: Adequate infant and young child nutrition demands high rates of breastfeeding and good access to nutrient rich complementary foods, requiring public sector action to promote breastfeeding and home based complementary feeding, and private sector action to refrain from undermining breastfeeding and to provide affordable, nutrient rich complementary foods. Unfortunately, due to a lack of trust, the public and private sectors, from both the North and the South, do not work well together in achieving optimal infant and young child nutrition. DISCUSSION: As the current debate in infant and young child nutrition is reminiscent of the "sweatshop" debate fifteen years ago, we argue that lessons from the sweatshops debate regarding cooperation between public and private sectors - and specific organizational experiences such as the Ethical Trading Initiative in which companies, trade unions, and civil society organizations work together to enhance implementation of labour standards and address alleged allegations - could serve as a model for improving cooperation and trust between public, civil society and private groups, and ultimately health, in infant and young child nutrition. SUMMARY: Lessons from the sweatshops debate could serve as a model to promote cooperation and trust between public and private groups, such that they learn to work together towards their common goal of improving infant and young child nutrition.
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ItemAccess to Life-Saving Medicines and Intellectual Property Rights: An Ethical Assessment(CAMBRIDGE UNIV PRESS, 2011-04)Dying before one’s time has been a prominent theme in classic literature and poetry. Catherine Linton’s youthful death inWuthering Heightsleaves behind a bereft Heathcliff and generations of mourning readers. The author herself, Emily Brontë, died young from tuberculosis. John Keats’Ode on Melancholycaptures the transitory beauty of 19th century human lives too often ravished by early death. Keats also died of tuberculosis, aged 25. “The bloom, whose petals nipped before they blew, died on the promise of the fruit” is how Percy Bysshe Shelley expressed his grief over Keats’ death. Emily Dickinson wroteSo Has a Daisy Vanished, being driven into depression by the early loss of loved ones from typhoid and tuberculosis.