60 research outputs found
Economics and the backlash against AIDS-specific funding
There is a growing backlash against AIDS-related funding on the grounds that too many resources have been allocated to the AIDS response, especially to antiretroviral treatment (ART). Proponents claim that health systems have been undermined, money wasted and misdirected, and that Africans themselves believe AIDS resources should be allocated elsewhere. We argue that such sweeping generalisations are not supported by the evidence and that the backlash fails to recognise the cross-cutting nature of the AIDS response, the powerful role that civil society organisations can play in holding governments to account and the potential for building better health systems on the back of AIDS-specific interventions. The paper also discusses the contributions of economists William Easterly (2006) and Mead Over (2008) to the backlash, arguing that economists can contribute most constructively when they inform rather than pre-empt social choice, cast their analytical nets broadly rather than narrowly, and adopt a more political-economic perspective
Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study
Background:
The U.S. Food and Drug Administration (FDA) often approves new drugs based on trials that use surrogate markers for endpoints, which involve certain trade-offs and may risk making erroneous inferences about the medical productâs actual clinical effect. This study aims to compare the treatment effects among pivotal trials supporting FDA approval of novel therapeutics based on surrogate markers of disease with those observed among postapproval trials for the same indication.
Methods:
We searched Drugs@FDA and PubMed to identify published randomized superiority design pivotal trials for all novel drugs initially approved by the FDA between 2005 and 2012 based on surrogate markers as primary endpoints and published postapproval trials using the same surrogate markers or patient-relevant outcomes as endpoints. Summary ratio of odds ratios (RORs) and difference between standardized mean differences (dSMDs) were used to quantify the average difference in treatment effects between pivotal and matched postapproval trials.
Results:
Between 2005 and 2012, the FDA approved 88 novel drugs for 90 indications based on one or multiple pivotal trials using surrogate markers of disease. Of these, 27 novel drugs for 27 indications were approved based on pivotal trials using surrogate markers as primary endpoints that could be matched to at least one postapproval trial, for a total of 43 matches. For nine (75.0%) of the 12 matches using the same non-continuous surrogate markers as trial endpoints, pivotal trials had larger treatment effects than postapproval trials. On average, treatment effects were 50% higher (more beneficial) in the pivotal than the postapproval trials (ROR 1.5; 95% confidence interval CI 1.01â2.23). For 17 (54.8%) of the 31 matches using the same continuous surrogate markers as trial endpoints, pivotal trials had larger treatment effects than the postapproval trials. On average, there was no difference in treatment effects between pivotal and postapproval trials (dSMDs 0.01; 95% CI -0.15â0.16).
Conclusions:
Many postapproval drug trials are not directly comparable to previously published pivotal trials, particularly with respect to endpoint selection. Although treatment effects from pivotal trials supporting FDA approval of novel therapeutics based on non-continuous surrogate markers of disease are often larger than those observed among postapproval trials using surrogate markers as trial endpoints, there is no evidence of difference between pivotal and postapproval trials using continuous surrogate markers
Public health implications of changing patterns of recruitment into the South African mining industry, 1973â2012: a database analysis
Civil society leadership in the struggle for AIDS treatment in South Africa and Uganda
Includes abstract.Includes bibliographical references.This thesis is an attempt to theorise and operationalise empirically the notion of âcivil society leadershipâ in Sub-Saharan Africa. âAIDS leadership,â which is associated with the intergovernmental institutions charged with coordinating the global response to HIV/AIDS, is both under-theorised and highly context-specific. In this study I therefore opt for an inclusive framework that draws on a range of approaches, including the literature on âleadershipâ, institutions, social movements and the ânetworkâ perspective on civil society mobilisation. This framework is employed in rich and detailed empirical descriptions (âthick descriptionâ) of civil society mobilisation around AIDS, including contentious AIDS activism, in the key case studies of South Africa and Uganda. South Africa and Uganda are widely considered key examples of poor and good leadership (from national political leaders) respectively, while the Treatment Action Campaign (TAC) and The AIDS Support Organisation (TASO) are both seen as highly effective civil society movements. These descriptions emphasise âtransnational networks of influenceâ in which civil society leaders participated (and at times actively constructed) in order to mobilise both symbolic and material resources aimed at exerting influence at the transnational, national and local levels
Predict, Detect, Diagnose: Confronting Outbreaks of HIV and Other Infectious Diseases Among People Who Use Drugs
Improving Decision-Making about HIV Treatment and Prevention in the United States: Model-Based Approaches
Background The AIDS epidemic in the United States is still the most serious one in the developed world. Though progress has been made in combating the epidemic, there is more to be done in terms of optimizing HIV prevention and treatment. This dissertation explores model-based approaches that may be used to answer, in part, three specific questions for decision makers about HIV services: where along the HIV care continuum is it best to direct efforts to improve clinical outcomes; how to choose among different geographic locations to improve mobile HIV testing, and; what effects does the timing and magnitude of responses to HIV outbreaks have on their costs and trajectories? Methods To address the first question, I used data from the Centers for Disease Control and Prevention and the North American AIDS Cohort Collaboration on Research and Design from 2009-2012 to estimate the distribution of time spent in and dropout probability from stages in the continuum of HIV care. I used these estimates to develop a queueing model for the expected number of patients found in each stage of the cascade. To assess how to improve the detection of new cases of HIV infection, I conducted simulations to assess four alternative approaches to mobile HIV testing in three hypothetical geographic zones. The approaches are distinguished from one another by how they manage the tradeoff between exploration and exploitation in zone selection and how they process the information obtained from previous days of testing. They include: 1) Thompson sampling (TS), an adaptive Bayesian search algorithm; 2) an explore-thenexploit (ETE) strategy; 3) a strategy using only prior information; and; 4) a performance benchmarking strategy with access to perfect information. Finally, to explore the costs and epidemiologic trajectories of nascent HIV epidemics, I developed a simple stochastic model of an outbreak in a small population and used this approach to analyze the costs associated with implementation of a comprehensive contact-tracing, syringe exchange, and antiretroviral treatment (ART) intervention in Scott County, Indiana, the site of a recent HIV outbreak among people who inject drugs. I examined the effects of an intervention initiated in March 2015, when the major state response began and compared them to those of a hypothetical response initiated at the start of the outbreak in November 2014. Results The queueing model estimates that individuals spend an average of about 3.1 months following HIV diagnosis before being linked to care, or dropping out of care with a probability of 8%. Those who link to care wait an additional 3.7 months on average before getting their second set of laboratory results (indicating retention in care) or dropping out of care with probability of almost 6%. Those retained in care spent an average of almost one year before achieving viral suppression on antiretroviral therapy or dropping out with an average probability of 13%. For patients who achieved viral suppression, the average time suppressed on ART was 4.5 years. Comparisons of alternative mobile HIV testing strategies indicated that TS outperformed ETE 63% of the time, with 15% more new cases identified on average than ETE. This was within 90% of the benchmark established by the strategy with perfect information. Using last year's prevalence as prior information performed poorly compared to the other strategies. In sensitivity analyses, TS outperformed ETE in almost all circumstances. In assessing the response to the Scott County HIV outbreak, a hypothetical intervention in November 2014 using contact tracing and syringe exchange efforts at the levels used in the actual response in March 2015 resulted in a 14% decrease in total mean costs. Starting these programs earlier with an enhanced response make a greater impact on costs, with earlier introduction of an expanded syringe exchange program having the most dramatic economic effects. As syringe exchange coverage is increased, further reductions in costs are gained. Earlier intervention, particularly with expanded syringe exchange, slows the growth of epidemic, but does not stop it unless coverage of syringe exchange is in excess of 90%. Conclusions These model-based approaches suggest that: 1) HIV interventions will be most effective if they focus on more rapidly identifying newly infected individuals, and increasing the fraction of them retained in care who achieve viral suppression; 2) Thompson sampling should be further investigated for use in HIV testing programs and; 3) an earlier and more robust response to the outbreak in Scott County, Indiana would have substantially reduced total costs of the epidemic
Public health implications of changing patterns of recruitment into the South African mining industry, 1973â2012: a database analysis
Abstract Background The triple epidemic of silicosis, tuberculosis and HIV infection among migrant miners from South Africa and neighbouring countries who have worked in the South African mining industry is currently the target of regional and international control efforts. These initiatives are hampered by a lack of information on this population. Methods This study analysed the major South African mining recruitment database for the period 1973 to 2012 by calendar intervals and demographic and occupational characteristics. Changes in area of recruitment were mapped using a geographic information system. Results The database contained over 10 million contracts, reducible to 1.64 million individuals. Major trends relevant to health projection were a decline in gold mining employment, the major source of silicosis; increasing recruitment of female miners; and shifts in recruitment from foreign to South African miners, from the Eastern to the Northwestern parts of South Africa, and from company employees to contractors. Conclusions These changes portend further externalisation of the burden of mining lung disease to home communities, as miners, particularly from the gold sector, leave the industry. The implications for health, surveillance and health services of the growing number of miners hired as contractors need further research, as does the health experience of female miners. Overall, the information in this report can be used for projection of disease burden and direction of compensation, screening and treatment services for the ex-miner population throughout Southern Africa
The production of consumption: addressing the impact of mineral mining on tuberculosis in southern Africa
<p>Abstract</p> <p>Background</p> <p>Miners in southern Africa experience incident rates of tuberculosis up to ten times greater than the general population. Migration to and from mines may be amplifying tuberculosis epidemics in the general population.</p> <p>Discussion</p> <p>Migration to and from mineral mines contributes to HIV risks and associated tuberculosis incidence. Health and safety conditions within mines also promote the risk of silicosis (a tuberculosis risk factor) and transmission of tuberculosis bacilli in close quarters. In the context of migration, current tuberculosis prevention and treatment strategies often fail to provide sufficient continuity of care to ensure appropriate tuberculosis detection and treatment. Reports from Lesotho and South Africa suggest that miners pose transmission risks to other household or community members as they travel home undetected or inadequately treated, particularly with drug-resistant forms of tuberculosis. Reducing risky exposures on the mines, enhancing the continuity of primary care services, and improving the enforcement of occupational health codes may mitigate the harmful association between mineral mining activities and tuberculosis incidence among affected communities.</p> <p>Summary</p> <p>Tuberculosis incidence appears to be amplified by mineral mining operations in southern Africa. A number of immediately-available measures to improve continuity of care for miners, change recruitment and compensation practices, and reduce the primary risk of infection may critically mitigate the negative association between mineral mining and tuberculosis.</p
Achieving a fair and effective COVID-19 response: An open letter to Vice-President Mike Pence, and other federal, state and local leaders from Public Health and Legal Experts in the United States
Experts in public health, law, and human rights, with experience in previous pandemic responses, write to
set forth principles and practices that should guide the efforts against COVID-19 in the US. It is essential that all
institutions, public and private, address the following critical concerns through new legislation, institutional
policies, leadership and spending
Reducing Sexual Violence by Increasing the Supply of Toilets in Khayelitsha, South Africa: A Mathematical Model
<div><p>Background</p><p>Sexual violence is a major public health issue, affecting 35% of women worldwide. Major risk factors for sexual assault include inadequate indoor sanitation and the need to travel to outdoor toilet facilities. We estimated how increasing the number of toilets in an urban township (Khayelitsha, South Africa) might reduce both economic costs and the incidence and social burden of sexual assault.</p><p>Methods</p><p>We developed a mathematical model that links risk of sexual assault to the number of sanitation facilities and the time a woman must spend walking to a toilet. We defined a composite societal cost function, comprising both the burden of sexual assault and the costs of installing and maintaining public chemical toilets. By expressing total social costs as a function of the number of available toilets, we were able to identify an optimal (i.e., cost-minimizing) social investment in toilet facilities.</p><p>Findings</p><p>There are currently an estimated 5600 toilets in Khayelitsha. This results in 635 sexual assaults and US35 million) and reduce sexual assaults to 446. Higher toilet installation and maintenance costs would be more than offset by lower sexual assault costs. Probabilistic sensitivity analysis shows that the optimal number of toilets exceeds the original allocation of toilets in the township in over 80% of the 5000 iterations of the model.</p><p>Interpretation</p><p>Improving access to sanitation facilities in urban settlements will simultaneously reduce the incidence of sexual assaults and overall cost to society. Since our analysis ignores the many additional health benefits of improving sanitation in resource-constrained urban areas (e.g., potential reductions in waterborne infectious diseases), the optimal number of toilets identified here should be interpreted as conservative.</p></div
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