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3.
PLoS One ; 15(10): e0233948, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33104731

RESUMEN

The US budget for global health funding, which was by far the largest of similar funding in the world, increased from US $1.3 billion in 2001 to more than US $10 billion in recent years. More than 54% of this funding was allocated to the Global Fund to Fight HIV/AIDS through the US President's Emergency Plan for AIDS Relief (PEPFAR) in Africa. However, recent studies indicate contradictory results regarding the effectiveness of PEPFAR. One by Bendavid, Holmes, Bhattacharya, and Miller shows positive effects of PEPFAR in reducing adult mortality in Africa, while another by Duber, Coates, Szekeras, Kaji, and Lewis finds that there are no significant differences in reducing adult mortality in countries that received PEPFAR funding vs countries that did not. Due to their potential impact on policy decisions regarding critical global health funding, we wanted to assess why the results are discrepant. To do this, we replicated the Bendavid study. The replication provides verification that the study replicable and that the analytic choices of the authors are robust to different assumptions or restrictions. This allows us to assess the different choices and data available to the two research groups and draw some conclusions about why the results may be different. Then, focusing on two of the prominently discrepant studies, i.e., the Bendavid study (1998-2008) and the Duber study (2000-2006), we establish why the two studies are in disagreement. We apply appropriate individual-level and country-level analytical methodology as used by Bendavid over the analytical time period used for the Duber study (2000-2006), which originally focused on nationally aggregated data and differed in some key focus countries. For our first objective, we replicated the original Bendavid study findings and our findings support their conclusion that between 1998-2008 all-cause mortality decreased significantly more (OR = 0.84, CI, 0.72-0.99) in countries that implemented PEPFAR. For our second objective (Bendavid's data and methodology applied to Duber's study period), we found reduction in all cause adult mortality to be borderline insignificant (OR = 0.87 CI, 0.75-1.01, p = 0.06), most possibly reflecting the abbreviated fewer number of events and sample size over a shorter period. Therefore, our overall analyses are consistent with the conclusion of positive impact of the PEPFAR program in reducing adult mortality. We believe that the discrepancy observed in the original studies mainly a reflection of shortcomings in the analytical approach necessitated by the Duber study's nationally aggregated dataset or "may reflect a lack of data quality" in the Duber study (Duber, et al. 2010).


Asunto(s)
Salud Global/legislación & jurisprudencia , Infecciones por VIH/mortalidad , Evaluación de Programas y Proyectos de Salud/métodos , Adulto , África del Sur del Sahara/epidemiología , Países en Desarrollo , Femenino , Salud Global/economía , Infecciones por VIH/economía , Promoción de la Salud/economía , Promoción de la Salud/legislación & jurisprudencia , Humanos , Cooperación Internacional/legislación & jurisprudencia , Evaluación del Resultado de la Atención al Paciente , Estados Unidos
4.
BMJ ; 371: m4040, 2020 10 23.
Artículo en Inglés | MEDLINE | ID: mdl-33097492

RESUMEN

OBJECTIVE: To assess the relation between autocratisation-substantial decreases in democratic traits (free and fair elections, freedom of civil and political association, and freedom of expression)-and countries' population health outcomes and progress toward universal health coverage (UHC). DESIGN: Synthetic control analysis. SETTING AND COUNTRY SELECTION: Global sample of countries for all years from 1989 to 2019, split into two categories: 17 treatment countries that started autocratising during 2000 to 2010, and 119 control countries that never autocratised from 1989 to 2019. The treatment countries comprised low and middle income nations and represent all world regions except North America and western Europe. A weighted combination of control countries was used to construct synthetic controls for each treatment country. This statistical method is especially well suited to population level studies when random assignment is infeasible and sufficiently similar comparators are not available. The method was originally developed in economics and political science to assess the impact of policies and events, and it is now increasingly used in epidemiology. MAIN OUTCOME MEASURES: HIV-free life expectancy at age 5 years, UHC effective coverage index (0-100 point scale), and out-of-pocket spending on health per capita. All outcome variables are for the period 1989 to 2019. RESULTS: Autocratising countries underperformed for all three outcome variables in the 10 years after the onset of autocratisation, despite some improvements in life expectancy, UHC effective coverage index, and out-of-pocket spending on health. On average, HIV-free life expectancy at age 5 years increased by 2.2% (from 64.7 to 66.1 years) during the 10 years after the onset of autocratisation. This study estimated that it would have increased by 3.5% (95% confidence interval 3.3% to 3.6%, P<0.001) (from 64.7 to 66.9 years) in the absence of autocratisation. On average, the UHC effective coverage index increased by 11.9% (from 42.5 to 47.6 points) during the 10 years after the onset of autocratisation. This study estimated that it would have increased by 20.2% (95% confidence interval 19.6% to 21.2%, P<0.001) (from 42.5 to 51.1 points) in the absence of autocratisation. Finally, on average, out-of-pocket spending on health per capita increased by 10.0% (from $4.00 (£3.1; €3.4) to $4.4, log transformed) during the 10 years after the onset of autocratisation. This study estimated that it would have increased by only 4.4% (95% confidence interval 3.9% to 4.6%, P<0.001) (from $4.0 to $4.2, log transformed) in the absence of autocratisation. CONCLUSIONS: Autocratising countries had worse than estimated life expectancy, effective health service coverage, and levels of out-of-pocket spending on health. These results suggest that the noticeable increase in the number of countries that are experiencing democratic erosion in recent years is hindering population health gains and progress toward UHC. Global health institutions will need to adjust their policy recommendations and activities to obtain the best possible results in those countries with a diminishing democratic incentive to provide quality healthcare to populations.


Asunto(s)
Democracia , Atención de Salud Universal , Anciano , Salud Global/legislación & jurisprudencia , Gastos en Salud , Humanos , Esperanza de Vida , Persona de Mediana Edad , Política
7.
PLoS One ; 15(10): e0238782, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33021973

RESUMEN

In 2015, UN member states committed to eliminate female genital mutilation (FGM) by 2030 as part of the Sustainable Development Agenda. To reach this goal, interventions need to be targeted and guided by the best available evidence. To date, however, estimates of the number of girls and women affected by FGM and their trends over time and geographic space have been limited by the availability, specificity and quality of population-level data. We present new estimates based on all publicly available nationally representative surveys collected since the 1990s that contain both information on FGM status and on the age at which FGM occurred. Using survival analysis, we generate estimates of FGM risk by single year of age for all countries with available data, and for rural and urban areas separately. The likelihood of experiencing FGM has decreased at the global level, but progress has been starkly uneven between countries. The available data indicate no progress in reducing FGM risk in Gambia, Guinea-Bissau, Mali and Guinea. In addition, rural and urban areas have diverged over the last two decades, with FGM declining more rapidly in urban areas. We describe limitations in the availability and quality of data on FGM occurrence and age-at-FGM. Based on current trends, the SDG goal of eliminating FGM by 2030 is out of reach, and the pace at which the practice is being abandoned would need to accelerate to eliminate FGM by 2030. The heterogeneity in trends between countries and rural vs urban areas offers an opportunity to contrast countries where FGM is in rapid decline and explore potential policy lessons and programmatic implications for countries where the practice of FGM appears to remain entrenched.


Asunto(s)
Circuncisión Femenina , Adolescente , Adulto , Niño , Preescolar , Circuncisión Femenina/legislación & jurisprudencia , Circuncisión Femenina/estadística & datos numéricos , Circuncisión Femenina/tendencias , Estudios de Cohortes , Estudios Transversales , Femenino , Salud Global/legislación & jurisprudencia , Salud Global/estadística & datos numéricos , Salud Global/tendencias , Humanos , Lactante , Recién Nacido , Estimación de Kaplan-Meier , Persona de Mediana Edad , Estudios Retrospectivos , Salud Rural , Encuestas y Cuestionarios , Naciones Unidas , Salud Urbana , Salud de la Mujer/legislación & jurisprudencia , Salud de la Mujer/estadística & datos numéricos , Salud de la Mujer/tendencias , Adulto Joven
11.
Med Leg J ; 88(2): 86-89, 2020 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-32490756

RESUMEN

The Act and the regulations. How long they might last. The suspension of the renewals. Enforcement and the role of the police. Protection of whistleblowers. The trial scene. The ultimate impact.


Asunto(s)
Medicina Legal/tendencias , Salud Global/legislación & jurisprudencia , Control de Infecciones/legislación & jurisprudencia , Pandemias/legislación & jurisprudencia , Control de Enfermedades Transmisibles/legislación & jurisprudencia , Infecciones por Coronavirus , Humanos , Aplicación de la Ley , Patología Clínica/tendencias , Neumonía Viral
16.
Clin Pharmacol Ther ; 107(1): 136-139, 2020 01.
Artículo en Inglés | MEDLINE | ID: mdl-31376148

RESUMEN

"Regulatory science" (RS) has been defined in various ways, but, nevertheless, the definitions of RS in different parts of the world include many common elements. It seems to be a common view that RS is not basic or applied science but, rather, focuses on the estimation and prediction of safety and efficacy. Thus, we think RS overall should incorporate not only RS specifically for medical product assessment but also RS engineering to provide prediction and estimation tools for those purposes, including guideline/guidance development. It is important as well to consider the potential contribution of RS to rational medicine (i.e., to evidence-based medicine in a broader context), and especially to real-world evidence generation. We will look at how definitions of RS have evolved, and how we believe RS might develop in the future. Taking a patient-centric view, we re-emphasize RS is an ethical science contributing to society and human welfare.


Asunto(s)
Medicina Basada en la Evidencia/organización & administración , Salud Global/legislación & jurisprudencia , Evaluación de la Tecnología Biomédica/métodos , Medicina Basada en la Evidencia/legislación & jurisprudencia , Regulación Gubernamental , Humanos , Atención Dirigida al Paciente/legislación & jurisprudencia , Atención Dirigida al Paciente/organización & administración
17.
Clin Ter ; 170(1): e36-e43, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-31850482

RESUMEN

The author has delved into the most significant Italian and European court rulings related to heterologous fertilization and surrogate motherhood between 2012 and 2019, with a close focus on same-sex couples seeking to have their donor-conceived children born abroad legally registered in their country of origin. Undeniably, surrogacy has brought about a crisis in the traditional family model, made up of a mother and a father. The paper draws upon European Court of Human Rights established jurisprudence that upholds the children's best interests. Italian Court rulings are expounded upon as well, which have been instrumental in establishing the principles by which parental figures do not necessarily coincide with those who have generated the children (through biological bonds or delivery), but rather with those who wish to be recognized as parents. The cases herein examined involve homosexual couples who decided to travel abroad in order to gain access to surrogacy, from which children were born. In the case regarding two fathers, the child had no genetic tie with either one intended parent. The Italian Supreme Court's joint sessions have ruled that such children cannot be legally registered in Italy, since their foreign-issued birth certificates indicate no genetic connection between the children and their intended parents. The Author believes that the Supreme Court decision is valuable, but further legislative interventions will be necessary on account of scientific advancements; the issue of surrogacy is utterly complex and multi-faceted.


Asunto(s)
Derechos Civiles/legislación & jurisprudencia , Padre/legislación & jurisprudencia , Fertilización In Vitro/legislación & jurisprudencia , Salud Global/legislación & jurisprudencia , Derechos Humanos/legislación & jurisprudencia , Matrimonio/legislación & jurisprudencia , Madres Sustitutas/legislación & jurisprudencia , Adulto , Europa (Continente) , Femenino , Humanos , Recién Nacido , Italia , Estudios Longitudinales , Masculino
18.
Clin Ter ; 170(1): e66-e73, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-31850487

RESUMEN

BACKGROUND: Cross-contamination and mix-ups are among the problems which could have a negative impact on the quality of the finished product during the production of highly active or sensitizing drugs with campaign manufacturing. Standardised, validated procedures ensure quality standards are maintained during production. In spite of this, the operating conditions and applicability of methods adopted by the various regulatory agencies manifest significant differences which could consequently compromise the safety of the finished product. This work has analysed and compared the GMP of various Regulatory Agencies to examine issues connected to campaign manufacturing highly active or sensitizing drugs. METHODS: The GMP of the following Regulatory Agencies have been studied: EMA, CFDA, COFEPRIS, FDA, Health Canada, ANVISA, CDSCO, PIC/S and WHO. The study was carried out for the purpose of understanding which agencies consent to the use of campaign manufacturing for the following categories of medicinal products: hormones, immunosuppressants, cytotoxic agents, highly active pharmaceutical ingredients (APIs), biological preparations, steroids, sensitizing pharmaceutical materials, antibiotics, cephalosporins, penicillins, carbapenems and beta-lactam derivatives. RESULTS: The GMP of Health Canada, EMA, PIC/S and FDA show a number of similarities, starting with the fact that they allow campaign manufacturing for similar categories of pharmaceutical products after an appropriate risk evaluation has been performed. CFDA, WHO, ANVISA authorise campaign manufacturing in "exceptional circumstances", though they do not always define what they mean by this. COFEPRIS authorises campaign manufacturing for certain classes of drugs, while there is no mention of campaign manufacturing in the CDSCO regulations. CONCLUSIONS: Quite a few significant differences have been found in the various regulations concerning the use of campaign manufacturing and the classes of drugs that can be produced with this method. In the light of this, it is obvious that efforts to harmonise legislation internationally have not yet been successful: currently, states can adopt different quality standards. The pharmaceutical industry could use this situation to its advantage by delocalising production on the basis of existing standards. The need to harmonise GMPs is a priority which must be achieved as soon as possible.


Asunto(s)
Industria Farmacéutica/legislación & jurisprudencia , Industria Farmacéutica/normas , Salud Global/legislación & jurisprudencia , Salud Global/normas , Guías como Asunto , Medicamentos bajo Prescripción/normas , Control de Calidad , Humanos
20.
Lancet Oncol ; 20(11): e645-e652, 2019 11.
Artículo en Inglés | MEDLINE | ID: mdl-31674323

RESUMEN

When developed and implemented effectively, national cancer control plans (NCCPs) improve cancer outcomes at the population level. However, many countries do not have a high-quality, operational NCCP, contributing to disparate cancer outcomes globally. Until now, a standard reference of NCCP core elements has not been available to guide development and evaluation across diverse countries and contexts. In this Policy Review, we describe the methods, process, and outcome of an initiative to develop an itemised and evidence-based comprehensive checklist of core elements for NCCP formulation. The final list provides a ready-to-use guide to support NCCP development and to facilitate internal and external critical appraisal of existing NCCPs for countries of all income levels and settings. Governments, policy makers, and stakeholders can utilise this checklist, while considering their own unique contexts and priorities, from the drafting through to the implementation of NCCPs.


Asunto(s)
Prestación Integrada de Atención de Salud/organización & administración , Salud Global , Planificación en Salud/organización & administración , Política de Salud , Oncología Médica/organización & administración , Neoplasias/terapia , Lista de Verificación , Prestación Integrada de Atención de Salud/legislación & jurisprudencia , Salud Global/legislación & jurisprudencia , Planificación en Salud/legislación & jurisprudencia , Política de Salud/legislación & jurisprudencia , Humanos , Oncología Médica/legislación & jurisprudencia , Modelos Organizacionales , Neoplasias/diagnóstico , Neoplasias/mortalidad , Formulación de Políticas
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