Data sharing from pharmaceutical industry sponsored clinical studies: audit of data availability

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 6 Oct 2018 )

Correspondence
Data sharing from pharmaceutical industry sponsored clinical studies: audit of data availability
Clinical trial transparency is important to participants, trialists, publishers, and regulators, and there have been recent major policy changes by the pharmaceutical industry regarding clinical study data sharing. However, it is unknown if these changes are enabling independent researchers to access participant-level data from prominent contemporary clinical trials sponsored by the pharmaceutical industry 2 years after publication of the primary results.
Authors: Ashley M. Hopkins, Andrew Rowland and Michael J. Sorich
Citation: BMC Medicine 2018 16:165
Published on: 28 September 2018
 

 

Human dignity and gene editing – Using human dignity as an argument against modifying the human genome and germline is a logical fallacy

EMBO Reports
Volume 19, Number 10  01 October 2018
http://embor.embopress.org/content/19/10

Opinion
Human dignity and gene editing – Using human dignity as an argument against modifying the human genome and germline is a logical fallacy
A common argument against gene editing the human germline is the notion of dignity as linked to the human genome. But this based on a logical fallacy and should rather prompt us to consider gene editing for therapeutic purposes in order to preserve human dignity.
EMBO Reports (2018) 19: e46789
Iñigo de Miguel Beriain

Beyond the Safe Motherhood Initiative: Accelerated Action Urgently Needed to End Preventable Maternal Mortality

Global Health: Science and Practice (GHSP)
Vol. 6, No. 3  October 03, 2018
http://www.ghspjournal.org/content/current

COMMENTARIES
Open Access
Beyond the Safe Motherhood Initiative: Accelerated Action Urgently Needed to End Preventable Maternal Mortality
Mary Ellen Stanton, Barbara E. Kwast, Theresa Shaver, Betsy McCallon and Marge Koblinsky
Global Health: Science and Practice October 2018, 6(3):408-412; https://doi.org/10.9745/GHSP-D-18-00100
Many countries will need to double, or more than double, their current annual rate of reduction of maternal mortality to ensure sufficient progress toward national targets and the global Sustainable Development Goals. Dedication to the principles and actions of quality, equity, dignity, social justice, and human rights are key.

Human Papillomavirus Vaccine Introduction in South Africa: Implementation Lessons From an Evaluation of the National School-Based Vaccination Campaign

Global Health: Science and Practice (GHSP)
Vol. 6, No. 3  October 03, 2018
http://www.ghspjournal.org/content/current

Open Access
Human Papillomavirus Vaccine Introduction in South Africa: Implementation Lessons From an Evaluation of the National School-Based Vaccination Campaign
Sinead Delany-Moretlwe, Karen F. Kelley, Shamagonam James, Fiona Scorgie, Hasina Subedar, Nonhlanhla R Dlamini, Yogan Pillay, Nicolette Naidoo, Admire Chikandiwa and Helen Rees
Global Health: Science and Practice October 2018, 6(3):425-438; https://doi.org/10.9745/GHSP-D-18-00090
Evaluation of the campaign confirmed its feasibility in this setting: it achieved high coverage, few adverse events, and mostly positive media coverage. However, challenges occurred in data and cold chain management. Future implementation requires improved partnerships between government ministries, simplified informed consent, and closer monitoring of social media messaging.
 

 

Provider Payments And The Receipt Of Human Papillomavirus Vaccine Among Privately Insured Adolescents

Health Affairs
Vol. 37 , No. 10  October 2018
https://www.healthaffairs.org/toc/hlthaff/current

Social Determinants, Drug & Device Prices & More
Research Article  Pharmaceuticals & Medical Technology
Provider Payments And The Receipt Of Human Papillomavirus Vaccine Among Privately Insured Adolescents
Yuping Tsai, Megan C. Lindley, Fangjun Zhou, and Shannon Stokley
1587-1595
Financial concerns such as high vaccine purchase costs and inadequate insurance reimbursement are cited as a key barrier to human papillomavirus (HPV) vaccination of adolescents who are covered by private health insurance

A Systematic Review Of The Food And Drug Administration’s ‘Exception From Informed Consent’ Pathway

Health Affairs
Vol. 37 , No. 10  October 2018
https://www.healthaffairs.org/toc/hlthaff/current
Social Determinants, Drug & Device Prices & More

Research Article  Ethics
A Systematic Review Of The Food And Drug Administration’s ‘Exception From Informed Consent’ Pathway
William B. Feldman, Spencer Phillips Hey, and Aaron S. Kesselheim
1605-1614
Abstract
In 1996 the Food and Drug Administration (FDA) created an “exception from informed consent” (EFIC) pathway for trials conducted on people incapacitated by life-threatening conditions with a therapeutic time window too narrow for reliable surrogate consent. The goals were to promote therapeutic innovation and encourage rigorous but ethical experimentation on this vulnerable population. To evaluate outcomes of this pathway, we reviewed the complete FDA docket of EFIC trials from the past two decades, encompassing forty-one trials. Among the 46,964 patients included in this review, ninety-six percent were enrolled without consent, and fewer than 1 percent withdrew before the primary endpoint. Two (8 percent) of the twenty-four superiority trials demonstrated a benefit from the experimental interventions. Many interventions were associated with adverse effects, including increased mortality, neurological deficits, and myocardial infarctions. Nearly one-third of US patients in EFIC trials were African American. While EFIC trials have yielded medical advances, investigators in future trials must pay better attention to managing withdrawals and ensuring fair demographic representation.

Civil society participation in global public private partnerships for health

Health Policy and Planning
Volume 33, Issue 8, 1 October 2018
https://academic.oup.com/heapol/issue/33/8

Original Articles
Civil society participation in global public private partnerships for health
Katerini Tagmatarchi Storeng; Antoine de Bengy Puyvallée
Health Policy and Planning, Volume 33, Issue 8, 1 October 2018, Pages 928–936, https://doi.org/10.1093/heapol/czy070
Abstract
The growth of global public-private partnerships for health has opened up new spaces for civil society participation in global health governance. Such participation is often justified by the claim that civil society organizations, because of their independence and links to communities, can help address democratic deficits in global-level decision-making processes. This article examines the notion of ‘civil society engagement’ within major public–private partnerships for health, where civil society is often said to play a particularly important role in mediating between public and private spheres. How do major global health partnerships actually define ‘civil society’, who represents civil society within their global-level decision-making bodies, and what formal power do civil society representatives hold relative to other public and private-sector partners? Based on a structured analysis of publicly available documents of 18 of the largest global public–private partnerships for health, we show that many of them make laudatory claims about the value of their ‘civil society engagement’. Most use the term ‘civil society’ to refer to non-governmental organizations and communities affected by particular health issues, and state that they expect these actors to represent the needs and interests of specific populations in global-level decisions about strategies, funding models and policies. Yet, such civil society actors have a relatively low level of representation within the partnerships’ boards and steering committees, especially compared with private-sector actors (10.3 vs 23.7%). Moreover, there is little evidence of civil society representatives’ direct and substantial influence within the partnerships’ global-level governing bodies, where many decisions affecting country-level programmes are made. Rather, their main role within these partnerships seems to be to implement projects and advocate and raise funds, despite common discourses that emphasise civil society’s watchdog function and transformative power. The findings suggest the need for in-depth research into the formal and informal power of civil society within global health governance processes.

Safety issues from a Phase 3 clinical trial of a live-attenuated chimeric yellow fever tetravalent dengue vaccine

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 14, Issue 9 2018
http://www.tandfonline.com/toc/khvi20/current

article commentary
Safety issues from a Phase 3 clinical trial of a live-attenuated chimeric yellow fever tetravalent dengue vaccine
Scott B. Halstead
Pages: 2158-2162
Published online: 14 May 2018

The Human Vaccines Project: Towards a comprehensive understanding of the human immune response to immunization

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 14, Issue 9 2018
http://www.tandfonline.com/toc/khvi20/current

article commentary
The Human Vaccines Project: Towards a comprehensive understanding of the human immune response to immunization
Stacey L. Wooden & Wayne C. Koff
Pages: 2214-2216
Published online: 28 Jun 2018

Public health responses during measles outbreaks in elimination settings: Strategies and challenges

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 14, Issue 9 2018
http://www.tandfonline.com/toc/khvi20/current

review
Public health responses during measles outbreaks in elimination settings: Strategies and challenges
Paul A. Gastañaduy, Emily Banerjee, Chas DeBolt, Pamela Bravo-Alcántara, Samia A. Samad, Desiree Pastor, Paul A. Rota, Manisha Patel, Natasha S. Crowcroft & David N. Durrheim
Pages: 2222-2238
Published online: 11 Jul 2018
 

Nipah virus infection: a deadly disease emerging in India

International Journal of Community Medicine and Public Health
Vol 5, No 10 (2018)  October 2018
http://www.ijcmph.com/index.php/ijcmph/issue/view/43

Editorial
Nipah virus infection: a deadly disease emerging in India
Ramesh Verma, Mukesh Dhankar, Avneet Singh, Vinod Chayal, Raj Kumar, Rohit Dhaka, Kapil Bhalla, Ginni Agrawal, Gopal Kumar
DOI: 10.18203/2394-6040.ijcmph20183951

A study on the immunisation status and the factors responsible for incomplete immunization amongst children of age group 0-12 months coming to a tertiary care hospital (IGIMS)

International Journal of Community Medicine and Public Health
Vol 5, No 10 (2018)  October 2018
http://www.ijcmph.com/index.php/ijcmph/issue/view/43

Original Research Articles
A study on the immunisation status and the factors responsible for incomplete immunization amongst children of age group 0-12 months coming to a tertiary care hospital (IGIMS)
Shivani Sinha, Sanjay Kumar, Sanjay Kumar Chaudhary, Setu Sinha, Varsha Singh, Seema Kumari
DOI: 10.18203/2394-6040.ijcmph20183969

Addressing the Tuberculosis Epidemic – 21st Century Research for an Ancient Disease

JAMA
October 2, 2018, Vol 320, No. 13, Pages 1297-1396
http://jama.jamanetwork.com/issue.aspx

Viewpoint
Addressing the Tuberculosis Epidemic – 21st Century Research for an Ancient Disease
Anthony S. Fauci, MD
JAMA. 2018;320(13):1315-1316. doi:10.1001/jama.2018.12852
In this Viewpoint, Anthony Fauci summarizes the National Institute of Allergy and Infectious Diseases’ (NIAID’s) 2018 Strategic Plan for Tuberculosis (TB), which comprises investments in development of point-of-care diagnostics, vaccines, shorter-duration therapeutics, and infrastructure for systems biology and “omics” approaches to the infection.

 

Crossing the Global Health Care Quality Chasm – A Key Component of Universal Health Coverage

JAMA
October 2, 2018, Vol 320, No. 13, Pages 1297-1396
http://jama.jamanetwork.com/issue.aspx

Viewpoint
Crossing the Global Health Care Quality Chasm – A Key Component of Universal Health Coverage
Donald Berwick, MD; Megan Snair, MPH; Sania Nishtar, PhD, FRCP
JAMA. 2018;320(13):1317-1318. doi:10.1001/jama.2018.13696
In this Viewpoint, Don Berwick and colleagues summarize a 2018 National Academies of Sciences, Engineering, and Medicine (NASEM) report on global health care quality emphasizing that universal access will yield improvements in population health only when paired with quality reforms characterized by systems design, transparency, collaboration, anticipatory care, evidence-based decisions, and continuous feedback and learning.

Rotavirus Vaccination and the Global Burden of Rotavirus Diarrhea Among Children Younger Than 5 Years

JAMA Pediatrics
October 2018, Vol 172, No. 10, Pages 897-996
http://archpedi.jamanetwork.com/issue.aspx

Original Investigation
Rotavirus Vaccination and the Global Burden of Rotavirus Diarrhea Among Children Younger Than 5 Years
Christopher Troeger, MPH; Ibrahim A. Khalil, MD; Puja C. Rao, MPH; et al.
JAMA Pediatr. 2018;172(10):958-965. doi:10.1001/jamapediatrics.2018.1960
This analysis of data from the Global Burden of Disease Study examines the extent of rotavirus infection and associated deaths among children younger than 5 years worldwide and whether the rotavirus vaccine has reduced the diarrhea-associated mortality.

 

HIV Pre-Exposure Prophylaxis Medication for Adolescents and Young Adults: A Position Paper of the Society for Adolescent Health and Medicine

Journal of Adolescent Health
October 2018 Volume 63, Issue 4, p377-518
https://www.jahonline.org/issue/S1054-139X(17)X0025-6

Position Paper
HIV Pre-Exposure Prophylaxis Medication for Adolescents and Young Adults: A Position Paper of the Society for Adolescent Health and Medicine
Society for Adolescent Health and Medicine
p513–516
Published in issue: October 2018

Discovering Invisible Truths

Journal of Virology
October 2018; Volume 92,Issue 20
http://jvi.asm.org/content/current

Gem
Discovering Invisible Truths
Ilaria Capua
The rise of populist movements worldwide is challenging science and motivating scientists to join the debate and enter politics. Based on my experience, taking a public stand will not come without slanderous personal and institutional attacks as an attempt to shake scientific credibility.

Single dose moxidectin versus ivermectin for Onchocerca volvulus infection in Ghana, Liberia, and the Democratic Republic of the Congo: a randomised, controlled, double-blind phase 3 trial

The Lancet
Oct 06, 2018 Volume 392 Number 10154 p1167-1278  e10
https://www.thelancet.com/journals/lancet/issue/current

Articles
Single dose moxidectin versus ivermectin for Onchocerca volvulus infection in Ghana, Liberia, and the Democratic Republic of the Congo: a randomised, controlled, double-blind phase 3 trial
Nicholas O Opoku, Didier K Bakajika, Eric M Kanza, Hayford Howard, Germain L Mambandu, Amos Nyathirombo, Maurice M Nigo, Kambale Kasonia, Safari L Masembe, Mupenzi Mumbere, Kambale Kataliko, Jemmah P Larbelee, Mawolo Kpawor, Kpehe M Bolay, Fatorma Bolay, Sampson Asare, Simon K Attah, George Olipoh, Michel Vaillant, Christine M Halleux, Ann
The morbidity and socioeconomic effects of onchocerciasis, a parasitic disease that is primarily endemic in sub-Saharan Africa, have motivated large morbidity and transmission control programmes. Annual community-directed ivermectin treatment has substantially reduced prevalence. Elimination requires intensified efforts, including more efficacious treatments. We compared parasitological efficacy and safety of moxidectin and ivermectin.

Measuring human capital: a systematic analysis of 195 countries and territories, 1990–2016

The Lancet
Oct 06, 2018 Volume 392 Number 10154 p1167-1278  e10
https://www.thelancet.com/journals/lancet/issue/current

Articles
Measuring human capital: a systematic analysis of 195 countries and territories, 1990–2016
Stephen S Lim, Rachel L Updike, Alexander S Kaldjian, Ryan M Barber, Krycia Cowling, Hunter York, Joseph Friedman, R Xu, Joanna L Whisnant, Heather J Taylor, Andrew T Leever, Yesenia Roman, Miranda F Bryant, Joseph Dieleman, Emmanuela Gakidou, Christopher J L Murray
Human capital is recognised as the level of education and health in a population and is considered an important determinant of economic growth. The World Bank has called for measurement and annual reporting of human capital to track and motivate investments in health and education and enhance productivity. We aim to provide a new comprehensive measure of human capital across countries globally.

From the Human Cell Atlas to dynamic immune maps in human disease

Nature Reviews Immunology
Volume 18 Issue 10, October 2018
https://www.nature.com/nri/volumes/18/issues/10

Comment | 04 August 2018
From the Human Cell Atlas to dynamic immune maps in human disease
Scientists involved in the Human Cell Atlas Project describe its potential as a resource for future research and the challenges that lie ahead.
Lorenz Adlung  & Ido Amit

CAR T cells for infection, autoimmunity and allotransplantation

Nature Reviews Immunology
Volume 18 Issue 10, October 2018
https://www.nature.com/nri/volumes/18/issues/10

Review Article | 25 July 2018
CAR T cells for infection, autoimmunity and allotransplantation
This Review explores the challenges and opportunities of taking CARs down new therapeutic roads, in terms of developing chimeric antigen receptors (CARs) for treating infectious disease, autoimmunity and transplant rejection.
Colby R. Maldini, Gavin I. Ellis & James L. Riley
Abstract
Chimeric antigen receptors (CARs) have shown remarkable ability to re-direct T cells to target CD19-expressing tumours, resulting in remission rates of up to 90% in individuals with paediatric acute lymphoblastic lymphoma. Lessons learned from these clinical trials of adoptive T cell therapy for cancer, as well as investments made in manufacturing T cells at commercial scale, have inspired researchers to develop CARs for additional applications. Here, we explore the challenges and opportunities of using this technology to target infectious diseases such as with HIV and undesired immune responses such as autoimmunity and transplant rejection. Despite substantial obstacles, the potential of CAR T cells to enable cures for a wide array of disease settings could be transformational for the medical field.

Being PrEPared — Preexposure Prophylaxis and HIV Disparities

New England Journal of Medicine
October 4, 2018  Vol. 379 No. 14
http://www.nejm.org/toc/nejm/medical-journal

Perspective
Being PrEPared — Preexposure Prophylaxis and HIV Disparities
Robert H. Goldstein, M.D., Ph.D., Carl G. Streed, Jr., M.D., and Sean R. Cahill, Ph.D.
[Initial text]
If current trends persist, one in six U.S. men who have sex with men will be infected with human immunodeficiency virus (HIV) in their lifetime, according to the Centers for Disease Control and Prevention (CDC).1 This prediction highlights the long road ahead if we are to end the spread of HIV in the United States, but it does not tell the full story, which is complicated and nuanced. Of the 39,782 new HIV infections that occurred in the United States in 2016, nearly half were in black or Latino men who have sex with men, and 52% occurred in the South (a region defined by the CDC as Alabama, Arkansas, Delaware, the District of Columbia, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, and West Virginia).1 Preexposure prophylaxis (PrEP) with tenofovir disoproxil fumarate and emtricitabine (TDF–FTC), which the CDC has recommended since 2014 as a safe and very effective method of preventing HIV infection in high-risk populations, is an underused tool for reducing this alarming imbalance…

 

Frontiers in Medicine: Next-Generation Sequencing to Diagnose Suspected Genetic Disorders

New England Journal of Medicine
October 4, 2018  Vol. 379 No. 14
http://www.nejm.org/toc/nejm/medical-journal

Review Article
Frontiers in Medicine: Next-Generation Sequencing to Diagnose Suspected Genetic Disorders
David R. Adams, M.D., Ph.D., and Christine M. Eng, M.D.
The technologies and chemistries underlying next-generation sequencing of DNA are evolving rapidly. This review describes the three main approaches to obtaining a genetic diagnosis through next-generation sequencing, their advantages, and their limitations.

Health system measurement: Harnessing machine learning to advance global health

PLoS One
http://www.plosone.org/
[Accessed 6 Oct 2018 ]

Research Article
Health system measurement: Harnessing machine learning to advance global health
Further improvements in population health in low- and middle-income countries demand high-quality care to address an increasingly complex burden of disease. Health facility surveys provide an important but costly source of information on readiness to provide care. To improve the efficiency of health system measurement, we applied unsupervised machine learning methods to assess the performance of the service readiness index (SRI) defined by the World Health Organization and compared it to empirically derived indices.
Hannah H. Leslie, Xin Zhou, Donna Spiegelman, Margaret E. Kruk
Research Article | published 05 Oct 2018 PLOS ONE
https://doi.org/10.1371/journal.pone.0204958

Oral cholera vaccine coverage during a preventive door-to-door mass vaccination campaign in Nampula, Mozambique

PLoS One
http://www.plosone.org/
[Accessed 6 Oct 2018 ]

Research Article
Oral cholera vaccine coverage during a preventive door-to-door mass vaccination campaign in Nampula, Mozambique
In addition to improving water, sanitation and hygiene (WASH) measures and optimal case management, the introduction of Oral cholera vaccine (OCV) is a complementary strategy for cholera prevention and control for vulnerable population groups. In October 2016, the Mozambique Ministry of Health implemented a mass vaccination campaign using a two-dose regimen of the Shanchol™ OCV in six high-risk neighborhoods of Nampula city, in Northern Mozambique. Overall 193,403 people were targeted by the campaign, which used a door-to-door strategy. During campaign follow-up, a population survey was conducted to assess: (1) OCV coverage; (2) frequency of adverse events following immunization; (3) vaccine acceptability and (4) reasons for non-vaccination.
Cynthia Semá Baltazar, Florentina Rafael, José Paulo M. Langa, Sergio Chicumbe, Philippe Cavailler, Bradford D. Gessner, Lorenzo Pezzoli, Américo Barata, Dores Zaina, Dortéia L. Inguane, Martin A. Mengel, Aline Munier
Research Article | published 03 Oct 2018 PLOS ONE
https://doi.org/10.1371/journal.pone.0198592

 

 

Inoculating science against potential pandemics and information hazards

PLoS Pathogens
http://journals.plos.org/plospathogens/
[Accessed 6 Oct 2018 ]

Opinion
Inoculating science against potential pandemics and information hazards
Kevin M. Esvelt
| published 04 Oct 2018 PLOS Pathogens
https://doi.org/10.1371/journal.ppat.1007286
Abstract
The recent de novo assembly of horsepox is an instructive example of an information hazard: published methods enabling poxvirus synthesis led to media coverage spelling out the implications, efficiently disseminating true information that might be used to cause harm. Whether or not the benefits justified the risks, the horsepox saga provides ample reason to upgrade the current system for screening synthesized DNA for hazardous sequences, which does not cover the majority of firms and cannot reliably prevent the assembly of potentially pandemic pathogens. An upgraded system might leverage one-way encryption to confidentially scrutinize virtually all commercial production by a cooperative international network of servers whose integrity can be verified by third parties. Funders could support participating institutions to ease the transition or outright subsidize the market to make clean DNA cheaper, while boycotts by journals, institutions, and funders could ensure compliance and require hardware-level locks on future DNA synthesizers. However, the underlying problem is that security and safety discussions among experts typically follow potentially hazardous events rather than anticipating them. Changing norms and incentives to favor preregistration and advisory peer review of planned experiments could test alternatives to the current closeted research model in select areas of science. Because the fields of synthetic mammalian virology and especially gene drive research involve technologies that could be unilaterally deployed and may self-replicate in the wild, they are compelling candidates for initial trials of early-stage peer review.

It’s Complicated: The 2014–2015 U.S. Measles Outbreak and Parents’ Vaccination Beliefs, Confidence, and Intentions

Risk Analysis          
Volume 38, Issue 10  Pages: 2011-2241  October 2018
https://onlinelibrary.wiley.com/toc/15396924/current

Original Research Article
It’s Complicated: The 2014–2015 U.S. Measles Outbreak and Parents’ Vaccination Beliefs, Confidence, and Intentions
Michael A. Cacciatore, Glen J. Nowak, Nathaniel J. Evans
Pages: 2178-2192
First Published: 06 June 2018
Abstract
While it seems intuitive that highly visible vaccine‐preventable disease outbreaks should impact perceptions of disease risk and facilitate vaccination, few empirical studies exist to confirm or dispel these beliefs. This study investigates the impact of the 2014–2015 Disneyland measles outbreak on parents’ vaccination attitudes and future vaccination intentions. The analysis relies on a pair of public opinion surveys of American parents with at least one child under the age of six (N = 1,000 across each survey). Controlling for basic demographics, we found higher levels of reported confidence in the safety and efficacy of childhood vaccinations in our follow‐up data collection. However, this confidence was also accompanied by elevated levels of concern toward childhood vaccines among American parents. We then examined how different subgroups in the population scored on these measures before and after the outbreak. We found that parents with high levels of interest in the topic of vaccines and a child who is not fully upto date with the recommended vaccination schedule reported more supportive attitudes toward vaccines. However, future intentions to follow the recommended vaccination schedule were not positively impacted by the outbreak. Possible explanations for these results and implications for vaccination outreach are discussed.

 

Urbanization and humidity shape the intensity of influenza epidemics in U.S. cities

Science         
05 October 2018  Vol 362, Issue 6410
http://www.sciencemag.org/current.dtl
Special Issue – Diving within Saturn’s rings

Reports
Urbanization and humidity shape the intensity of influenza epidemics in U.S. cities
By Benjamin D. Dalziel, Stephen Kissler, Julia R. Gog, Cecile Viboud, Ottar N. Bjørnstad, C. Jessica E. Metcalf, Bryan T. Grenfell
Science05 Oct 2018 : 75-79 Open Access
Seasonal flu epidemics are more diffuse in larger cities and more intense in smaller cities, where climate has a stronger influence on transmission.
Seasonal flu by ZIP code
Influenza virus strikes communities in northern latitudes during winter, straining health care provision almost to the breaking point. Change in environmental humidity is a key driver, but many other seasonal and social factors contribute. Dalziel et al. obtained a geographical distribution of doctor visits for influenza-like illness for more than 600 U.S. cities (see the Perspective by Wallinga). Some ZIP codes regularly experienced sharply defined peaks of cases, or intense epidemics, and others showed a longer, more diffuse influenza season. The surges tended to occur in smaller cities with less residential density and lower household incomes. Larger, more densely populated cities had more-diffuse epidemics, presumably because of higher rates of personal contact, which makes influenza transmission less subject to climate variation.
Abstract
Influenza epidemics vary in intensity from year to year, driven by climatic conditions and by viral antigenic evolution. However, important spatial variation remains unexplained. Here we show predictable differences in influenza incidence among cities, driven by population size and structure. Weekly incidence data from 603 cities in the United States reveal that epidemics in smaller cities are focused on shorter periods of the influenza season, whereas in larger cities, incidence is more diffuse. Base transmission potential estimated from city-level incidence data is positively correlated with population size and with spatiotemporal organization in population density, indicating a milder response to climate forcing in metropolises. This suggests that urban centers incubate critical chains of transmission outside of peak climatic conditions, altering the spatiotemporal geometry of herd immunity.

Regulating 3D-printed medical products

Science Translational Medicine
03 October 2018  Vol 10, Issue 461
http://stm.sciencemag.org/

Perspective
Regulating 3D-printed medical products
By Laura M. Ricles, James C. Coburn, Matthew Di Prima, Steven S. Oh
Science Translational Medicine03 Oct 2018 Restricted Access
There are a number of key considerations in the U.S. regulatory landscape regarding approval of 3D-printed medical devices and biologics.
Abstract
Additive manufacturing [also known as three-dimensional (3D) printing] is the layer-wise deposition of material to produce a 3D object. This rapidly emerging technology has the potential to produce new medical products with unprecedented structural and functional designs. Here, we describe the U.S. regulatory landscape of additive manufactured (3D-printed) medical devices and biologics and highlight key challenges and considerations.

Preferences for health economics presentations among vaccine policymakers and researchers

Vaccine
Volume 36, Issue 42   Pages 6249-6360 (8 October 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/42
[New issue; No digest content identified]

 
Vaccine
Volume 36, Issue 43  Pages 6361-6456 (15 October 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/43
Research article  Abstract only
Preferences for health economics presentations among vaccine policymakers and researchers
John S. Richardson, Mark L. Messonnier, Lisa A. Prosser
Pages 6416-6423
Purpose
Measure the preferences of decision makers and researchers associated with the Advisory Committee on Immunization Practices (ACIP) regarding the recommended format for presenting health economics studies to the ACIP.

From Google Scholar & other sources: Selected Journal Articles, Newsletters, Dissertations, Theses, Commentary

From Google Scholar & other sources: Selected Journal Articles, Newsletters, Dissertations, Theses, Commentary

Journal of Global Oncology

  1. 4_suppl_2 (October 1 2018)

Track 1 – Motivating Prevention and Healthy Behaviours
HPV Vaccination and Cervical Cancer Screening in Taiwan
MJ Chen, CY Wu, R Chen, YW Wang
Abstract
Background and context: Cervical cancer has been one of the most important cancers over the last 3 decades in Taiwan, and it still is among the top 10 cause of death for women. Aim: The aim of the policy was to achieving the following KPIs: HPV vaccine inoculation rate to 60%; 30-69 year Papanicolaou test screening rate ≥ 70%; and cervical cancer mortality dropped to 3.3/105 (baseline 1995 = 11/105). Strategy/Tactics: We provided annual Pap test for all women aged 30 years or more since 1995 and encourage women to screen at least every 3 years. We will introduce national HPV vaccination program for girls aged 13 years later this year. Program/Policy Process: We used a coordinated multichannel delivery system including clinical and community approaches that empower people to access services. The cost of treatment was covered by the universal health insurance. Our vaccination program started from whom are likely to have less access to screening later in life since 2011, and some cities/counties initiated their own vaccination program. Our national HPV vaccination aims to increase the inoculation rate to 60%. Outcomes: The standardized cervical cancer incidence rate decreased by 66%, from 25 per 100,000 in 1995 to 8.5 per 100,000 in 2014. The standardized mortality rate fell by 70% between 1995 and 2016, from 11 to 3.3 people per 100,000. In 2015, the total inoculation rate was about 38%. According to the Vaccine Adverse Effect Reporting System, the HPV vaccine is very safe. Among almost 820,000 doses inoculated from 2010 to 2016, the number of adverse effect was 2107 (0.25%). What was learned: The policy combined HPV vaccination and national Papanicolaou test screening strategies are successful. The implementation of the act, funding allocation, information system, health education to target population and medical staff as well as media advocacy, were keys to success.
 
 
Frontiers in Veterinary Science 
doi: 10.3389/fvets.2018.00259
Review Article
Efficacy and safety of BCG vaccine for control of tuberculosis in domestic livestock and wildlife
BM Buddle, HM Vordermeier, MA Chambers…
Bovine tuberculosis (TB) continues to be an intractable problem in many countries, particularly where “test and slaughter” policies cannot be implemented or where wildlife reservoirs of Mycobacterium bovis infection serve as a recurrent source of infection for domestic livestock. Alternative control measures are urgently required and vaccination is a promising option. Although the M. bovis bacille Calmette-Guérin (BCG) vaccine has been used in humans for nearly a century, its use in animals has been limited, principally as protection against TB has been incomplete and vaccination may result in animals reacting in the tuberculin skin test. Valuable insights have been gained over the past 25 years to optimise protection induced by BCG vaccine in animals and in the development of tests to differentiate infected from vaccinated animals (DIVA). This review examines factors affecting the efficacy of BCG vaccine in cattle, recent field trials, use of DIVA tests and the effectiveness of BCG vaccine in other domestic livestock as well as in wildlife. Oral delivery of BCG vaccine to wildlife reservoirs of infection such as European badgers, brushtail possums, wild boar and deer has been shown to induce protection against TB and could prove to be a practical means to vaccinate these species at scale. Testing of BCG vaccine in a wide range of animal species has indicated that it is safe and vaccination has the potential to be a valuable tool to assist in the control of TB in both domestic livestock and wildlife.

 

Media/Policy Watch

Media/Policy Watch
This watch section is intended to alert readers to substantive news, analysis and opinion from the general media and selected think tanks and similar organizations on vaccines, immunization, global public health and related themes. Media Watch is not intended to be exhaustive, but indicative of themes and issues CVEP is actively tracking. This section will grow from an initial base of newspapers, magazines and blog sources, and is segregated from Journal Watch above which scans the peer-reviewed journal ecology.
 
We acknowledge the Western/Northern bias in this initial selection of titles and invite suggestions for expanded coverage. We are conservative in our outlook in adding news sources which largely report on primary content we are already covering above. Many electronic media sources have tiered, fee-based subscription models for access. We will provide full-text where content is published without restriction, but most publications require registration and some subscription level.
 
 
The Atlantic
http://www.theatlantic.com/magazine/
Accessed 6 Oct 2018  
Science
A Controversial Virus Study Reveals a Critical Flaw in How Science Is Done
After researchers resurrected a long-dead pox, some critics argue that it’s too easy for scientists to make decisions of global consequence.
Ed Yong
Oct 4, 2018

BBC
http://www.bbc.co.uk/
Accessed 6 Oct 2018  
[No new, unique, relevant content]

 
The Economist
http://www.economist.com/
Accessed 6 Oct 2018  
[No new, unique, relevant content]

 
Financial Times
http://www.ft.com/home/uk
Accessed 6 Oct 2018  
[No new, unique, relevant content]

 
Forbes
http://www.forbes.com/
Accessed 6 Oct 2018
[No new, unique, relevant content]

Foreign Affairs
http://www.foreignaffairs.com/
[No new, unique, relevant content]

Foreign Policy
http://foreignpolicy.com/
Accessed 6 Oct 2018  
Trump Stealthily Seeks to Choke Off Funding to U.N. Programs
| 2 October 2018
Leaked emails and behind-the-scenes battles show how the administration, after failing to slash congressional aid, used bureaucratic levers to stifle money flows.

The Guardian
http://www.guardiannews.com/
Accessed 6 Oct 2018
[No new, unique, relevant content]

 
New Yorker
http://www.newyorker.com/
Accessed 6 Oct 2018
[No new, unique, relevant content]

 
New York Times
http://www.nytimes.com/
Accessed 6 Oct 2018
Five New Ebola Cases Confirmed in Eastern Congo-Health Ministry
Oct. 6, 2018
KINSHASA — The Congolese health ministry on Saturday reported a further five confirmed cases of Ebola in the east of the Democratic Republic of Congo, blaming the higher-than-normal daily increase on community resistance to disease response efforts.
The current epidemic in Congo’s North Kivu and Ituri provinces has seen 140 confirmed cases since July, 108 of whom have died, according to the ministry’s daily bulletin, which has been reporting an average of one to two new confirmed cases per day in recent weeks.
The ministry said the five new cases were located in the regional hub of Beni, where attacks by rebel groups in the area and local mistrust of the Ebola response campaign have disrupted treatment and vaccination programmes.
“The town of Beni has become the new focus point of the disease, registering the highest percentage of cases reported in recent weeks following community resistance of certain families,” it said in a statement.

Polish Lawmakers Approve More Talks on Banning Vaccinations
By The Associated Press
Oct. 4, 2018
WARSAW, Poland — Lawmakers from Poland’s conservative ruling party have approved further parliamentary discussion over a controversial plan to abolish compulsory vaccinations for children, including those against serious diseases such as polio, measles, tuberculosis, rubella and whooping cough.
A civic group that proposed the plan argues that the vaccinations can be hazardous to small children and insists that parents should be allowed to refuse it.
The vaccinations are currently compulsory in Poland and the Health Ministry has warned that abolishing them would pose a threat to the health of individuals as well as the whole community.
Parliament’s lower house voted 252-158 with two abstentions Thursday to send the issue to parliamentary groups for further discussion.

Wall Street Journal
http://online.wsj.com/home-page?_wsjregion=na,us&_homepage=/home/us
Accessed 6 Oct 2018
[No new, unique, relevant content]

Washington Post
http://www.washingtonpost.com/
Accessed 6 Oct 2018
[No new, unique, relevant content]
 

Think Tanks et al

Think Tanks et al
 
Brookings
http://www.brookings.edu/
Accessed 6 Oct 2018
[No new relevant content]

Center for Global Development  
http://www.cgdev.org/page/press-center
Accessed 6 Oct 2018
October 5, 2018
Ten Years of Aid Transparency – Fulfilling the Dream of Accra
Aid and development transparency has come a long way in ten years. In this, the first of a two-part blog series, we look back at the origins of the aid transparency movement. We reflect on the original vision of those who conceived the idea, and the journey to date including some of the successes achieved along the way.
Owen Barder and Gary Forster

CSIS
https://www.csis.org/
Accessed 6 Oct 2018
[No new relevant content]

Council on Foreign Relations
http://www.cfr.org/
Accessed 6 Oct 2018
[No new relevant content]