The will of #Congress? Permissive #regulation and the #strategic use of #labeling for the anti- #influenza #drug #Relenza (Soc Stud Sci., abstract)

[Source: US National Library of Medicine, full page: (LINK). Abstract, edited.]

Soc Stud Sci. 2019 Nov 19:306312719890015. doi: 10.1177/0306312719890015. [Epub ahead of print]

The will of Congress? Permissive regulation and the strategic use of labeling for the anti-influenza drug Relenza.

Mulinari S1, Davis C2.

Author information: 1 Department of Sociology, Lund University, Lund, Sweden. 2 Department of Global Health and Social Medicine, King’s College London, UK.

 

Abstract

Through an analysis of the FDA’s approval of the controversial anti-influenza drug Relenza (zanamivir), we interrogate distinct social scientific theories of pharmaceutical regulation. We investigate why, despite internal negative opinions and an Advisory Committee’s non-approval recommendation, the FDA approved Relenza in the late 1990s. Based on a close reading of FDA documents, we show how agency officials guided the manufacturer’s analyses and participated in constructing a tenuous argument for approval. We show how regulators may strategically design drug labels that can justify their permissive regulation. We consider the explanatory power of official accounts and alternative, partially overlapping, theories of pharmaceutical regulation in the Relenza case, and develop new insights into the institutional dynamics of regulator-industry relations. We find little or no evidence that the FDA was primarily driven by public health concerns, pressure from disease-based patient activism, or a consumerist and neoliberal regulatory logic, although some of these explanations provided managers with convenient rhetoric to rationalize their actions. Rather, we argue that the Relenza case highlights contradictions between a scientific culture at FDA, conducive to rigorous product evaluations, and the agency’s attempts to accommodate higher-level political (i.e. Congress) and industry demands conducive of permissive regulation – consistent with some aspects of reputational and capture theories, as well as with corporate bias theory.

KEYWORDS: Food and Drug Administration; corporate bias; influenza; pharmaceutical industry; regulation; regulatory capture

PMID: 31739775 DOI: 10.1177/0306312719890015

Keywords: Society; Politics; Public Health; USA.

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#Drug #Decriminalization: A Matter of #Justice and #Equity, Not Just Health (Am J Prev Med., abstract)

[Source: American Journal of Preventive Medicine, full page: (LINK). Abstract, edited.]

Drug Decriminalization: A Matter of Justice and Equity, Not Just Health

Hakique N. Virani, MD1, Rebecca J. Haines-Saah, PhD2

DOI: https://doi.org/10.1016/j.amepre.2019.08.012

Published online: November 15, 2019

 

Abstract

Since 2016, more than 10,300 Canadians have died of an apparent opioid-related overdose, with the majority involving fentanyl or fentanyl analogs.1 This unprecedented public health crisis has decreased life expectancy at birth in the country’s most affected provinces of Alberta and British Columbia.2 Concerned by this epidemic of overdoses, Canadian advocates for drug policy reform have welcomed the recent recommendation from British Columbia’s Provincial Health Officer that drug possession for personal use be decriminalized.

© 2019 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Keywords: Opioids; Illicit drugs; Society; Canada.

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#TB, #HIV, and viral #hepatitis #diagnostics in eastern #Europe and central #Asia: high time for integrated and people-centred services (Lancet Infect Dis., abstract)

[Source: The Lancet Infectious Diseases, full page: (LINK). Abstract, edited.]

Tuberculosis, HIV, and viral hepatitis diagnostics in eastern Europe and central Asia: high time for integrated and people-centred services

Masoud Dara, MD  †, Soudeh Ehsani, MD, Antons Mozalevskis, MD, Elena Vovc, MD, Daniel Simões, MPH, Ana Avellon Calvo, PhD, Jordi Casabona i Barbarà, PhD, Otar Chokoshvili, MPH, Irina Felker, PhD, Sven Hoffner, PhD, Gulmira Kalmambetova, PhD, Ecatarina Noroc, MD, Natalia Shubladze, PhD, Alena Skrahina, MD, Rasim Tahirli, MD, Prof Tengiz Tsertsvadze, PhD,

Published: November 15, 2019 / DOI: https://doi.org/10.1016/S1473-3099(19)30524-9

 

Summary

Globally, high rates (and in the WHO European region an increasing prevalence) of co-infection with tuberculosis and HIV and HIV and hepatitis C virus exist. In eastern European and central Asian countries, the tuberculosis, HIV, and viral hepatitis programmes, including diagnostic services, are separate vertical structures. In this Personal View, we consider underlying reasons for the poor integration for these diseases, particularly in the WHO European region, and how to address this with an initial focus on diagnostic services. In part, this low integration has reflected different diagnostic development histories, global funding sources, and sample types used for diagnosis (eg, typically sputum for tuberculosis and blood for HIV and hepatitis C). Cooperation between services improved as patients with tuberculosis needed routine testing for HIV and vice versa, but financial, infection control, and logistical barriers remain. Multidisease diagnostic platforms exist, but to be used optimally, appropriate staff training and sensible understanding of different laboratory and infection control risks needs rapid implementation. Technically these ideas are all feasible. Poor coordination between these vertical systems remains unhelpful. There is a need to increase political and operational integration of diagnostic and treatment services and bring them closer to patients.

Keywords: Public Health; European Region; TB; HIV/AIDS; Viral hepatitis.

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#Development, #environmental #degradation, and #disease spread in the #Brazilian #Amazon (PLOS Biol., abstract)

[Source: PLOS Biology, full page: (LINK). Abstract, edited.]

OPEN ACCESS / PERSPECTIVE

Development, environmental degradation, and disease spread in the Brazilian Amazon

Marcia C. Castro , Andres Baeza, Cláudia Torres Codeço, Zulma M. Cucunubá, Ana Paula Dal’Asta, Giulio A. De Leo, Andrew P. Dobson, Gabriel Carrasco-Escobar, Raquel Martins Lana, Rachel Lowe, Antonio Miguel Vieira Monteiro, Mercedes Pascual, Mauricio Santos-Vega

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Published: November 15, 2019 / DOI: https://doi.org/10.1371/journal.pbio.3000526 / This is an uncorrected proof.

 

Abstract

The Amazon is Brazil’s greatest natural resource and invaluable to the rest of the world as a buffer against climate change. The recent election of Brazil’s president brought disputes over development plans for the region back into the spotlight. Historically, the development model for the Amazon has focused on exploitation of natural resources, resulting in environmental degradation, particularly deforestation. Although considerable attention has focused on the long-term global cost of “losing the Amazon,” too little attention has focused on the emergence and reemergence of vector-borne diseases that directly impact the local population, with spillover effects to other neighboring areas. We discuss the impact of Amazon development models on human health, with a focus on vector-borne disease risk. We outline policy actions that could mitigate these negative impacts while creating opportunities for environmentally sensitive economic activities.

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Citation: Castro MC, Baeza A, Codeço CT, Cucunubá ZM, Dal’Asta AP, De Leo GA, et al. (2019) Development, environmental degradation, and disease spread in the Brazilian Amazon. PLoS Biol 17(11): e3000526. https://doi.org/10.1371/journal.pbio.3000526

Published: November 15, 2019

Copyright: © 2019 Castro et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Funding: The National Socio-Environmental Synthesis Center (SESYNC) under funding from the National Science Foundation (DBI-1639145) supported this work. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: The authors have declared that no competing interests exist.

Abbreviations: DETER, Detection of Deforestation in Real Time; EIA, environmental impact assessment; EMBRAPA, Brazilian Agricultural Research Corporation; INPE, Instituto Nacional de Pesquisas Espaciais; NMCP, National Malaria Control Program; OTCA, Organización del Tratado de Cooperación Amazónica; PAHO, Pan American Health Organization

Provenance: Not commissioned; externally peer reviewed.

Keywords: Public Health; Environmental disasters; Emerging Diseases; Infectious Diseases; Brazil; Amazon.

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#Risk #factors, #awareness of disease and use of #medications in a deprived population: differences between #indigent natives and undocumented #migrants in #Italy (J Pub Health, abstract)

[Source: Journal of Public Health, full page: (LINK). Abstract, edited.]

Risk factors, awareness of disease and use of medications in a deprived population: differences between indigent natives and undocumented migrants in Italy

Gianfrancesco Fiorini, Cesare Cerri, Flavia Magri, Luca Chiovato, Laura Croce, Antonello E Rigamonti, Alessandro Sartorio, Silvano G Cella

Journal of Public Health, fdz123, https://doi.org/10.1093/pubmed/fdz123

Published: 08 November 2019

 

Abstract

Background

Undocumented migrants experience many health problems; a comparison with a suitable control group of natives living in the same socio-economic conditions is still lacking.

Methods

Demographic data and data on risk factors, chronic conditions and dietary habits were obtained for 6933 adults (2950 Italians and 3983 undocumented migrants) receiving medical assistance from 40 non-governmental organizations all over the country.

Results

Attributed to the fact that these were unselected groups, differences were found in their demographic features, the main ones being their marital status (singles: 50.5% among Italians and 42.8% among migrants; P < 0.001). Smokers were more frequent among Italians (45.3% versus 42.7% P = 0.03); the same happened with hypertension (40.5% versus 34.5% P < 0.001). Migrants were more often overweight (44.1% versus 40.5% P < 0.001) and reporting a chronic condition (20.2% versus 14.4% P < 0.001). Among those on medications (n = 1354), Italians were fewer (n = 425) and on different medications. Differences emerged also in dietary habits.

Conclusions

Differences in health conditions exist between native-borns and undocumented migrants, not because of a bias related to socio-economic conditions. Further studies are needed to design sustainable health policies and tailored prevention plans.

chronic diseases, dispensation of medications, poverty, undocumented migrants

Topic: hypertension – diet – adult – chronic disease – demography – habits – health policy – italy – marital status – medical assistance – single person – socioeconomic factors – poverty – overweight – prevention – nongovernmental organizations – smokers

Issue Section: Original Article

© The Author(s) 2019. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)

Keywords: Public Health; Society; Poverty; Migrants; Italy.

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Quantification of the #resilience of primary care #networks by #stress testing the #healthcare #system (Proc Natl Acad Sci USA, abstract)

[Source: Proceedings of the National Academy of Sciences of the United States of America, full page: (LINK). Abstract, edited.]

Quantification of the resilience of primary care networks by stress testing the health care system

Donald Ruggiero Lo Sardo, Stefan Thurner, Johannes Sorger, Georg Duftschmid, Gottfried Endel, and Peter Klimek

PNAS first published November 11, 2019 / DOI: https://doi.org/10.1073/pnas.1904826116

Edited by Timothy George Buchman, Emory University School of Medicine, Atlanta, GA, and accepted by Editorial Board Member Simon A. Levin October 1, 2019 (received for review March 27, 2019)

 

Significance

We shock a full-scale simulation model of a national health care system by locally removing health care providers. We measure resilience of the system in terms of how fast and to what extent it can recover its ability to deliver adequate health services to the population. The model is based on actual regional primary care networks in Austria, where all patients and physicians are represented as anonymized avatars that are calibrated with nationwide data. After removal of a critical fraction of physicians, networks generically undergo a transition from resilient to nonresilient behavior, where it is impossible to maintain coverage for all patients. These “stress tests” allow us to quantify regional health care resilience and identify systemically risky health care providers.

 

Abstract

There are practically no quantitative tools for understanding how much stress a health care system can absorb before it loses its ability to provide care. We propose to measure the resilience of health care systems with respect to changes in the density of primary care providers. We develop a computational model on a 1-to-1 scale for a countrywide primary care sector based on patient-sharing networks. Nodes represent all primary care providers in a country; links indicate patient flows between them. The removal of providers could cause a cascade of patient displacements, as patients have to find alternative providers. The model is calibrated with nationwide data from Austria that includes almost all primary care contacts over 2 y. We assign 2 properties to every provider: the “CareRank” measures the average number of displacements caused by a provider’s removal (systemic risk) as well as the fraction of patients a provider can absorb when others default (systemic benefit). Below a critical number of providers, large-scale cascades of patient displacements occur, and no more providers can be found in a given region. We quantify regional resilience as the maximum fraction of providers that can be removed before cascading events prevent coverage for all patients within a district. We find considerable regional heterogeneity in the critical transition point from resilient to nonresilient behavior. We demonstrate that health care resilience cannot be quantified by physician density alone but must take into account how networked systems respond and restructure in response to shocks. The approach can identify systemically relevant providers.

coevolving networks – dynamics of collapse – robustness – quality of care – patient-sharing network

Keywords: Public Health.

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#Genomic #Epidemiology as a #PublicHealth #Tool to Combat #Mosquito-Borne Virus #Outbreaks (J Infect Dis., abstract)

[Source: Journal of Infectious Diseases, full page: (LINK). Abstract, edited.]

Genomic Epidemiology as a Public Health Tool to Combat Mosquito-Borne Virus Outbreaks

S Pollett, J R Fauver, Irina Maljkovic Berry, M Melendrez, A Morrison, L D Gillis, M A Johansson, R G Jarman, N D Grubaugh

The Journal of Infectious Diseases, jiz302, https://doi.org/10.1093/infdis/jiz302

Published: 10 November 2019

 

Abstract

Next-generation sequencing technologies, exponential increases in the availability of virus genomic data, and ongoing advances in phylogenomic methods have made genomic epidemiology an increasingly powerful tool for public health response to a range of mosquito-borne virus outbreaks. In this review, we offer a brief primer on the scope and methods of phylogenomic analyses that can answer key epidemiological questions during mosquito-borne virus public health emergencies. We then focus on case examples of outbreaks, including those caused by dengue, Zika, yellow fever, West Nile, and chikungunya viruses, to demonstrate the utility of genomic epidemiology to support the prevention and control of mosquito-borne virus threats. We extend these case studies with operational perspectives on how to best incorporate genomic epidemiology into structured surveillance and response programs for mosquito-borne virus control. Many tools for genomic epidemiology already exist, but so do technical and nontechnical challenges to advancing their use. Frameworks to support the rapid sharing of multidimensional data and increased cross-sector partnerships, networks, and collaborations can support advancement on all scales, from research and development to implementation by public health agencies.

Topic: epidemiology – dengue fever – culicidae – disease outbreaks – genome – yellow fever – public health medicine – viruses – surveillance, medical – zika virus

Issue Section: supplement articles

Keywords: Arbovirus; Public Health; Mosquitoes; Genetics.

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