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Abstract Background Biopiracy – the use of a people’s long-established medical knowledge without acknowledgement or compensation – has been a disturbing historical reality and exacerbates the global rich-poor divide. Bioprospecting, however, describes the commercialization of indigenous medicines in a manner acceptable to the local populace. Challenges facing bioprospectors seeking to develop traditional medicines in a quality-controlled manner include a lack of skilled labor and high-tech infrastructure, adapting Northern R&D protocols to Southern settings, keeping products affordable for the local population, and managing the threat of biopiracy. The Malagasy Institute of Applied Research (IMRA) has employed bioprospecting to develop new health treatments for conditions such as diabetes and burns. Because of its integration of Western science and Malagasy cultural traditions, IMRA may provide a useful example for African and other organizations interested in bioprospecting. Discussion IMRA’s approach to drug development and commercialization was adapted from the outset to Malagasy culture and Southern economic landscapes. It achieved a balance between employing Northern R&D practices and following local cultural norms through four guiding principles. First, IMRA’s researchers understood and respected local practices, and sought to use rather than resist them. Second, IMRA engaged the local community early in the drug development process, and ensured that local people had a stake in its success. Third, IMRA actively collaborated with local and international partners to increase its credibility and research capacity. Fourth, IMRA obtained foreign research funds targeting the “diseases of civilization” to cross-fund the development of drugs for conditions that affect the Malagasy population. These principles are illustrated in the development of IMRA products like Madeglucyl, a treatment for diabetes management that was developed from a traditional remedy. Summary By combining local and international research interests, IMRA has been able to keep its treatments affordable for the Malagasy population. Our analysis of IMRA’s history, strategy, and challenges suggests that other developing world institutions seeking to use bioprospecting to address issues of local access to medicines would be well-advised to treat traditional medical knowledge with respect and humility, share its benefits with the local community, and pursue strategic partnerships.

Abstract Background Little is known about the fertility desires of HIV infected individuals on highly active antiretroviral therapy (HAART). In order to contribute more knowledge to this topic we conducted a study to determine if HIV-infected persons on HAART have different fertility desires compared to persons not on HAART, and if the knowledge about HIV transmission from mother-to-child is different in the two groups. Methods The study was a cross-sectional survey comparing two groups of HIV-positive participants: those who were on HAART and those who were not. Semi-structured interviews were conducted with 199 HIV patients living in a rural area of western Uganda. The desire for future children was measured by the question in the questionnaire "Do you want more children in future." The respondents' HAART status was derived from the interviews and verified using health records. Descriptive, bivariate and multivariate methods were used to analyze the relationship between HAART treatment status and the desire for future children. Results Results from the multivariate logistic regression model indicated an adjusted odds ratio (OR) of 1.08 (95% CI 0.40-2.90) for those on HAART wanting more children (crude OR 1.86, 95% CI 0.82-4.21). Statistically significant predictors for desiring more children were younger age, having a higher number of living children and male sex. Knowledge of the risks for mother-to-child-transmission of HIV was similar in both groups. Conclusions The conclusions from this study are that the HAART treatment status of HIV patients did not influence the desire for children. The non-significant association between the desire for more children and the HAART treatment status could be caused by a lack of knowledge in HIV-infected persons/couples about the positive impact of HAART in reducing HIV transmission from mother-to-child. We recommend that the health care system ensures proper training of staff and appropriate communication to those living with HIV as well as to the general community.

Abstract 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.

Background and methodology This study determined the unmet need for family planning among HIV-positive and HIV-negative individuals living in western Uganda. Semistructured interviews were conducted with individuals who were randomly selected from HIV testing lists. Of those individuals, further analysis was conducted on a subset of 206 participants who did not desire more children and were not using a highly effective method of contraception. Descriptive, bivariate and multivariate methods were performed to assess the relationship between HIV status and unmet need for effective family planning. Results The unmet need for effective family planning was much greater in HIV-infected individuals compared to HIV-negative individuals [75.0% vs 33.8%, adjusted odds ratio (OR) 3.97, 95% confidence interval (CI) 1.97-8.03, p<0.001]. Females were more likely to report an unmet need compared to males (69.0% vs 49.5%; adjusted OR 1.94, 95% CI 0.94-4.00, p=0.071). Other predictors of unmet need for effective family planning were older age (adjusted OR 1.08 for each year of age, 95% CI 1.00-1.16, p=0.018) and single/cohabiting vs being married (OR 2.36, 95% CI 1.16-4.80, p=0.036). Being on antiretroviral therapy was not a predictor of having a lower unmet need for effective family planning methods. Discussion and conclusions There is high unmet need for effective family planning in HIV-positive study participants in a region of western Uganda, which should be of concern. This suggests that HIV-infected individuals do not want to use family planning or encounter barriers to accessing and utilising family planning services. Family planning programmes and HIV care and prevention services have to work together more effectively to create services conducive to clients from both programmes. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Biopiracy - the use of a people's long-established medical knowledge without acknowledgement or compensation - has been a disturbing historical reality and exacerbates the global rich-poor divide. Bioprospecting, however, describes the commercialization of indigenous medicines in a manner acceptable to the local populace. Challenges facing bioprospectors seeking to develop traditional medicines in a quality-controlled manner include a lack of skilled labor and high-tech infrastructure, adapting Northern R&D protocols to Southern settings, keeping products affordable for the local population, and managing the threat of biopiracy. The Malagasy Institute of Applied Research (IMRA) has employed bioprospecting to develop new health treatments for conditions such as diabetes and burns. Because of its integration of Western science and Malagasy cultural traditions, IMRA may provide a useful example for African and other organizations interested in bioprospecting. Discussion: IMRA's approach to drug development and commercialization was adapted from the outset to Malagasy culture and Southern economic landscapes. It achieved a balance between employing Northern R&D practices and following local cultural norms through four guiding principles. First, IMRA's researchers understood and respected local practices, and sought to use rather than resist them. Second, IMRA engaged the local community early in the drug development process, and ensured that local people had a stake in its success. Third, IMRA actively collaborated with local and international partners to increase its credibility and research capacity. Fourth, IMRA obtained foreign research funds targeting the "diseases of civilization" to cross-fund the development of drugs for conditions that affect the Malagasy population. These principles are illustrated in the development of IMRA products like Madeglucyl, a treatment for diabetes management that was developed from a traditional remedy. Summary: By combining local and international research interests, IMRA has been able to keep its treatments affordable for the Malagasy population. Our analysis of IMRA's history, strategy, and challenges suggests that other developing world institutions seeking to use bioprospecting to address issues of local access to medicines would be well-advised to treat traditional medical knowledge with respect and humility, share its benefits with the local community, and pursue strategic partnerships. [ABSTRACT FROM AUTHOR]

A mutant, T7, highly sensitive to oxidative stress as caused by diamide was isolated from a Mycobacterium smegmatis mc2155 transposon mutant library. While wild-type M. smegmatis is able to grow well on solid media supplemented with 10 mM diamide, T7 is only able to grow on solid media containing up to 1 mM diamide. This mutant is also sensitive to other thiol modifying agents such as iodoacetamide and chlorodinitrobenzene. By sequencing the genomic DNA flanking the transposon, T7 was found to be mutated in the region upstream of the homolog of M. tuberculosis Rv0274 open reading frame. Sequence analysis revealed that Rv0274 is a member of a superfamily of metalloenzymes comprising enzymes such as extradiol dioxygenases, glyoxalases, and fosfomycin resistant glutathione transferases. Cloning and epichromosomal expression of M. tuberculosis Rv0274 in the mutant resulted in complementation of the sensitivity to diamide. [Copyright &y& Elsevier]

The article describes the case of the development of an inexpensive Indian hepatitis B vaccine by Indian biotechnology firm Shantha Biotechnics. The owner of the firm, K. I. Varaprasad, recognized the urgent need for the vaccine after he attended a conference in 1992. He realized that most Indian families with multiple children are living on one U.S. dollar a day which means that they cannot afford to avail the vaccine. The company became the first Indian firm to successfully prequalify a hepatitis B vaccine by the World Health Organization (WHO).

The rationale of this qualitative study was to determine how a positive HIV diagnosis influenced fertility desires and reproductive decisions for women and men living in western Uganda and what the reasons were behind these fertility desires. The qualitative study was undertaken as part of a larger study on the same topic in order to better understand the quantitative findings. Five focus groups with a total of 35 participants, 20 women and 15 men were conducted. Eighteen participants were HIV positive. Almost all HIV-positive participants reported that they did not wish to have more children. The most important reasons given were the devastating impact of HIV on the health of the mother and the high risk of HIV transmission to the child. Most participants were not aware of the benefits of highly active antiretroviral therapy on reducing the risk of mother-to-child transmission of HIV. Some HIV-negative participants viewed ongoing childbearing by HIV-positive individuals as the result of a lack of education regarding the risks of childbearing while HIV-positive and also as contrary to the current expectations of lifestyle practice. They also emphasized that the community's perceptions of having children when mothers are HIV-infected was unfavorable and that fertility norms for all persons in the study area have now changed due to economic concerns and desire to educate all children in the family. The study findings have to be incorporated in the counselling curriculum for programs directed at HIV prevention and care and family planning. Specific recommendations are provided to improve the districts' primary healthcare programs for HIV care/prevention and family planning.