Africa CDC   [to 8 Dec 2018]
https://au.int/en/africacdc
No new digest content identified.

China CDC 
http://www.chinacdc.cn/en/
New website launched…no “news” or “announcements” page identified.

National Health Commission of the People’s Republic of China
http://en.nhfpc.gov.cn/
Selected Updates/ Press Releases/ Notices
No new digest content identified.

Announcements
 
 
BMGF – Gates Foundation  [to 8 Dec 2018]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.
 
 
Bill & Melinda Gates Medical Research Institute    [to 8 Dec 2018]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.
 
 
CARB-X   [to 8 Dec 2018]
https://carb-x.org/
CARB-X is a non-profit public-private partnership dedicated to accelerating antibacterial research to tackle the global rising threat of drug-resistant bacteria.
No new digest content identified.
 
 
CEPI – Coalition for Epidemic Preparedness Innovations  [to 8 Dec 2018]
http://cepi.net/
Press releases
Canadian PM, Justin Trudeau, reaffirms commitment to CEPI at the G20
Posted on 02ND DEC 2018 by Mario Christodoulou
In support of the G20 efforts on global health, Canadian Prime Minister, Justin Trudeau, announced an additional CAD10 million contribution to the Coalition for Epidemic Preparedness Innovations (CEPI), which will help us develop new life-saving vaccines to combat emerging infectious diseases…
 
 
EDCTP    [to 8 Dec 2018]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
Latest news
No new digest content identified.
 
 
Emory Vaccine Center    [to 8 Dec 2018]
http://www.vaccines.emory.edu/
No new digest content identified.
 
 
European Medicines Agency  [to 8 Dec 2018]
http://www.ema.europa.eu/ema/
News and press releases
No new digest content identified.
 
 
European Vaccine Initiative  [to 8 Dec 2018]
http://www.euvaccine.eu/news-events
05 December 2018
TDR Clinical Research & Development Fellowships
Deadline for submission: 7 March 2019, 16:00 (GMT)
 
 
FDA [to 8 Dec 2018]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
No new digest content identified.
 
 
December 06, 2018 –
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics
December 04, 2018 –
FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care

 
Fondation Merieux  [to 8 Dec 2018]
http://www.fondation-merieux.org/
Partner event
ASLM 2018 – Preventing and controlling the next pandemic: the role of laboratory
December 10 – 13, 2018 – Abuja (Nigeria)
 
 
Mérieux Foundation co-organized event
Dengue pre-vaccination screening based on serostatus: rapid tests and implementation strategies
January 14 – 16, 2019 – Les Pensières Center for Global Helath, Veyrier du Lac (France)
 
 
Gavi [to 8 Dec 2018]
https://www.gavi.org/
05 December 2018
Harnessing the power of partnerships to benefit maternal, newborn & child health
The Partners Forum for The Partnership for Maternal, Newborn & Child Health represents a landmark opportunity to push for action to improve the health and well-being of women, children and adolescents
New Delhi, India, 5 December – Gavi’s Deputy CEO, Anuradha Gupta, will join over 1,200 representatives from governments, civil society and the private sector at a high-level meeting in New Delhi (12–13 December) to demonstrate the power of partnerships to improve and transform the lives of women, children and adolescents.
Hosted by the Government of India, the Partners’ Forum of The Partnership for Maternal, Newborn & Child Health (PMNCH) will set out to align objectives, strategies and resources, as well as seeking agreement on interventions to improve maternal, newborn, child and adolescent health…
 
 
Mobile phones and digital technology to boost vaccine delivery in Uganda
New collaboration will address vaccine supply challenges in 171 health facilities ensuring that children in the hardest-to-reach areas are protected with vaccines.
Geneva, 4 December 2018 – Thousands of children living in the densely populated districts of Wakiso, Nakaseke and Nakasongola in central Uganda will get better access to life-saving vaccines thanks to a new collaboration between the Uganda Ministry of Health, Gavi, the Vaccine Alliance, UPS and Freight in Time Ltd (FIT). The 18 month pilot project will use a customised mobile app and a wireless temperature monitoring system to help address supply chain challenges in 171 health facilities in three districts with the some of the lowest immunisation coverage and the highest number of unimmunised children in the country…
 
 
GHIT Fund   [to 8 Dec 2018]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that devastate the world’s poorest people. Other funders include six Japanese pharmaceutical
No new digest content identified.
 
 
Global Fund  [to 8 Dec 2018]
https://www.theglobalfund.org/en/news/
02 December 2018
At Mandela 100, Global Fund Builds on South Africa’s Progress against HIV
The Global Fund to Fight AIDS, Tuberculosis and Malaria strengthened its partnership with South Africa in the fight against HIV, announcing a new grant aimed at capitalizing on strong HIV programs to make even greater progress in treatment and prevention, in protecting and promoting human rights, and in strengthening health systems.
The grant, for US$369 million, includes specific efforts aimed at lowering HIV infection rates among adolescent girls and young women who are disproportionately affected by the disease…
 
 
Hilleman Laboratories   [to 8 Dec 2018]
http://www.hillemanlabs.org/
No new digest content identified.
 
 
Human Vaccines Project   [to 8 Dec 2018]
http://www.humanvaccinesproject.org/media/press-releases/
No new digest content identified.
 
 
IAVI  [to 8 Dec 2018]
https://www.iavi.org/newsroom
No new digest content identified.
 
 
IFFIm
http://www.iffim.org/library/news/press-releases/
No new digest content identified.
 
 
IVAC  [to 8 Dec 2018]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
No new digest content identified.
 
 
IVI   [to 8 Dec 2018]
http://www.ivi.int/
IVI News & Announcements
No new digest content identified.
 
 
JEE Alliance  [to 8 Dec 2018]
https://www.jeealliance.org/
No new digest content identified.
 
 
MSF/Médecins Sans Frontières  [to 8 Dec 2018]
http://www.msf.org/
Selected News; Project Updates, Reports
Pakistan
Bringing hope to sufferers of a neglected disease
Project Update 5 Dec 2018
In May, MSF opened a treatment centre for cutaneous leishmaniasis  in Peshawar – its fourth in Pakistan.

Hepatitis C
Appeal lodged against decision to uphold Gilead’s patent on hepatitis C drug
Press Release 5 Dec 2018
Paris – Six organisations, including Médecins Sans Frontières (MSF), have just appealed the European Patent Office’s September decision to uphold US pharmaceutical corporation Gilead Science’s patent on the key hepatitis C drug sofosbuvir.
The appeal – filed by Médecins du Monde (MdM), MSF, AIDES (France), Access to Medicines Ireland, Praksis (Greece) and Salud por Derecho (Spain) – states that the European Patent Office (EPO) should revoke Gilead’s patent because it does not meet the requirements to be a patentable invention from a legal or scientific perspective.
 
 
Democratic Republic of Congo
Ebola spreads further into urban communities and isolated areas in North Kivu
Project Update 3 Dec 2018
The Ebola epidemic continues to spread through the Democratic Republic of Congo (DRC)’s North Kivu province. The newest areas to be affected include the city of Butembo and a number of isolated areas that are hard to reach. So far, 440 people have been infected with the virus, 255 of whom have died. Our teams continue to strengthen their efforts to help bring the epidemic under control.
 
 
NIH  [to 8 Dec 2018]
http://www.nih.gov/news-events/news-releases
December 4, 2018
NIH researcher presents encouraging results for gene therapy for severe sickle cell disease
— This study is part of decades of research on sickle cell disease that have opened the door to novel genetic approaches to curative therapies.
A scientist from the National Institutes of Health will present promising, early results from a human clinical trial testing a novel gene replacement therapy in people with severe sickle cell disease. Preliminary findings suggest that the approach has an acceptable level of safety and might help patients consistently produce normal red blood cells instead of the sickle-shaped ones that mark this painful, life-threatening disease.
The experimental treatment involves removing hematopoietic stem cells from the patients’ bone marrow or blood and adding a therapeutic beta globin gene, which is defective in people with sickle cell disease. The cells are then returned to the patients, leading to the production of anti-sickling hemoglobin (T87Q).
Current data from the ongoing HGB-206 Phase 1 multicenter nationwide study will be presented at the 60th Annual Meeting of the American Society of Hematology (ASH), Dec. 1-4, in San Diego…
 
 
PATH  [to 8 Dec 2018]
https://www.path.org/media-center/
No new digest content identified.
 
 
Sabin Vaccine Institute  [to 8 Dec 2018]
http://www.sabin.org/updates/pressreleases
No new digest content identified.
 
 
UNAIDS [to 8 Dec 2018]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
4 December 2018
South Africa launches campaign to expand access to HIV treatment
On World AIDS Day, South Africa launched a multidisease national wellness campaign to accelerate screening and testing for HIV, tuberculosis, sexually transmitted infections and noncommunicable diseases, including hypertension and diabetes. The campaign, known as Cheka Impilo, is a direct response to the call by the President of South Africa, Cyril Ramaphosa, during his first State of the Nation address in February 2018 to initiate an additional 2 million people on HIV treatment by 2020, find 88 000 missing tuberculosis cases annually and screen 7 million people for noncommunicable diseases in the first year…
 
 
UNICEF  [to 8 Dec 2018]
https://www.unicef.org/media/press-releases
Selected Press Releases/Reports/Statements
Statement
Humanitarian assistance continues to prevent a massive human catastrophe in Yemen but it is not enough
UN agencies warn that an urgent scale up of humanitarian assistance is needed to save lives
07/12/2018
 
 
Press release
Refugee and migrant children and youth report severe deprivations while on the move – UNICEF
UNICEF releases alarming data from poll of nearly 4,000 refugee and migrant children and youth ahead of Global Compact for Migration Summit in Marrakech
07/12/2018
 
 
Vaccine Confidence Project  [to 8 Dec 2018]
http://www.vaccineconfidence.org/
No new digest content identified.
 
 
Vaccine Education Center – Children’s Hospital of Philadelphia  [to 8 Dec 2018]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.
 
 
Wellcome Trust  [to 8 Dec 2018]
https://wellcome.ac.uk/news
Opinion | 6 December 2018
Social science research: a much-needed tool for epidemic control
João Rangel de Almeida
Portfolio Development Manager Wellcome
To control epidemics, it’s essential to understand the contexts where they take place. Social researchers are helping to uncover ethical and practical challenges that are critical to the people caught in the middle of an outbreak.
 
 
Explainer | 5 December 2018
Research saves lives in epidemics like Ebola
Protecting the people of the Democratic Republic of the Congo from Ebola takes a chain of responders from all over the world. With one outbreak earlier this year over, and a second ongoing, research has been at the heart of the response.
 
 
Q&A | 4 December 2018
What are human infection studies and why do we need them?
Human infection studies have the power to rapidly accelerate the development of much-needed vaccines and treatments. In this Q&A, we explain what they are, how they work and why they are important.
 
 
News | 3 December 2018
Second global call to action against drug-resistant infections
Wellcome has co-hosted a second global event, in Ghana, to help drive pioneering action to stop the rise and spread of superbugs.
 
 
The Wistar Institute   [to 8 Dec 2018]
https://www.wistar.org/news/press-releases
No new digest content identified.
 
 
World Organisation for Animal Health (OIE)   [to 8 Dec 2018]
http://www.oie.int/en/for-the-media/press-releases/2018/
No new digest content identified. 

::::::

 
BIO    [to 8 Dec 2018]
https://www.bio.org/insights/press-release
No new digest content identified.
 
 
DCVMN – Developing Country Vaccine Manufacturers Network  [to 8 Dec 2018]
http://www.dcvmn.org/
No new digest content identified.
 
 
IFPMA   [to 8 Dec 2018]
http://www.ifpma.org/resources/news-releases/
05 December 2018
R&D biopharmaceutical industry revamp ethical code to apply as base line of industry behavior worldwide
: New R&D biopharmaceutical industry Code of Practice comes into effect on 1 January 2019.
:: Changes reflect increasingly complex dilemmas faced by R&D biopharmaceutical industry professionals which call just as much for rules, as for strong ethical values that can build a culture of trust.
:: New Code of Practice aims to improve guidance to IFPMA members on how to conduct business when interacting with the healthcare community worldwide.

04 December 2018
David A. Ricks Elected New President of the International Federation of Pharmaceutical Manufacturers & Associations
:: David A. Ricks, Chairman and Chief Executive Officer, Eli Lilly and Company, takes over as President of IFPMA from Ian C. Read, Chairman of the Board and Chief Executive Officer, Pfizer.
:: New President to highlight the need for forward-looking policies that encourage innovation, as well as strengthened health systems in order to sustain the last-half century’s hard-won global health gains.
:: The outgoing President leaves a legacy of biopharmaceutical collaborative firsts: Access Accelerated, Pat-INFORMED and AMR Industry Alliance.
 
 
PhRMA    [to 8 Dec 2018]
http://www.phrma.org/press-room
No new digest content identified.

Journal Watch

   Vaccines and Global Health: The Week in Review continues its weekly scanning of key peer-reviewed journals to identify and cite articles, commentary and editorials, books reviews and other content supporting our focus on vaccine ethics and policy. Journal Watch is not intended to be exhaustive, but indicative of themes and issues the Center is actively tracking. We selectively provide full text of some editorial and comment articles that are specifically relevant to our work. Successful access to some of the links provided may require subscription or other access arrangement unique to the publisher.

If you would like to suggest other journal titles to include in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org

American Journal of Tropical Medicine and Hygiene
Volume 99, Issue 6, 2018
http://www.ajtmh.org/content/journals/14761645/99/6

Articles
Do Incarcerated Populations Serve as a Reservoir for Tuberculosis in South Africa?
Alana Sharp, J. Travis Donahoe, Amanda Milliken, Jacqueline Barocio, Salome Charalambous and Zoë M. McLaren
https://doi.org/10.4269/ajtmh.17-0652

Annals of Internal Medicine
4 December 2018 Vol: 169, Issue 11
http://annals.org/aim/issue

Original Research
Long-Term Protection After Fractional-Dose Yellow Fever Vaccination: Follow-up Study of a Randomized, Controlled, Noninferiority Trial
Anna H.E. Roukens, MD, PhD *; Karlijn van Halem, MD *; Adriëtte W. de Visser, BSc; Leo G. Visser, MD, PhD
Abstract
Background:
Outbreaks of yellow fever and a frequently depleted vaccine stock increase demand for a dose-sparing strategy. A fractional dose of 17D yellow fever virus (17D-YFV) vaccine has been shown to be noninferior to the standard dose in inducing seroprotection.
Objective:
To evaluate whether fractional-dose vaccination can confer long-term immunity.
Design:
10-year follow-up of a subgroup of a randomized, controlled, noninferiority trial. (Dutch Trial Register: NTR7094 [current study] and ISRCTN46326316 [original study])
Setting:
The Netherlands.
Participants:
Seventy-five of 155 participants in the original trial provided a blood sample for this study. These 75 participants had received primary vaccination with 17D-YFV vaccine 10 years before. Forty received a 0.1-mL fractional dose intradermally, and 35 received the standard 0.5-mL dose subcutaneously.
Measurements:
Virus-neutralizing antibody responses were measured by a plaque reduction neutralization test.
Results:
Thirty-nine of 40 (98% [95% CI, 89% to 100%]) participants had protective levels of yellow fever–neutralizing antibodies more than 10 years after receiving a fractional dose of 17D-YFV vaccine compared with 34 of 35 (97% [CI, 87% to 100%]) in the standard-dose group.
Limitation:
Only 48% of participants from the original trial participated in this study.
Conclusion:
Intradermal administration of a one-fifth dose of yellow fever vaccine induced a protective immune response that lasted for 10 years after vaccination. Persons receiving a fractional dose of yellow fever vaccine do not require a booster vaccination for long-term protection against yellow fever.
Primary Funding Source:
Leiden University Medical Center and the International Society of Travel Medicine.

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 8 Dec 2018)

Research article
How to assure access of essential RMNCH medicines by looking at policy and systems factors: an analysis of countdown to 2015 countries
In 2000, the Millennium Development Goals set targets for social achievements by 2015 including goals related to maternal and child health, with mixed success. Several initiatives supported these goals includi…
Authors: Jane Briggs, Martha Embrey, Blerta Maliqi, Lisa Hedman and Jennifer Requejo
Citation: BMC Health Services Research 2018 18:952
Published on: 7 December 2018
 
 

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 8 Dec 2018)

Research article
Immunogenicity and safety of a tetanus-diphtheria vaccine and a 13-valent pneumococcal conjugate vaccine after concomitant vaccination in ≥ 50-year-old adults
When two or more vaccines are administered concurrently, there is concern about safety and immunogenicity from vaccine interaction.
Authors: Joon Young Song, Hee Jin Cheong, Ji Yun Noh, Min Joo Choi, Jin Gu Yoon, Saem Na Lee, Seong Hui Kang, Eun Joo Jeong, Yu Mi Jo and Woo Joo Kim
Citation: BMC Infectious Diseases 2018 18:628
Published on: 5 December 2018

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 8 Dec 2018)

Debate
|   6 December 2018
Exploring the ethics of global health research priority-setting
Thus far, little work in bioethics has specifically focused on global health research priority-setting. Yet features of global health research priority-setting raise ethical considerations and concerns related to health justice. For example, such processes are often exclusively disease-driven, meaning they rely heavily on burden of disease considerations. They, therefore, tend to undervalue non-biomedical research topics, which have been identified as essential to helping reduce health disparities. In recognition of these ethical concerns and the limited scholarship and dialogue addressing them, we convened an international workshop in September 2015. The workshop aimed to initiate discussion on the appropriate relationship between global and national levels of health research priority-setting and to begin exploring what might be ethically required for priority-setting at each of those levels.
Authors: Bridget Pratt, Mark Sheehan, Nicola Barsdorf and Adnan A. Hyder

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 8 Dec 2018)

Research article
Cost-effectiveness of vaccination of immunocompetent older adults against herpes zoster in the Netherlands: a comparison between the adjuvanted subunit and live-attenuated vaccines
The newly registered adjuvanted herpes zoster subunit vaccine (HZ/su) has a higher efficacy than the available live-attenuated vaccine (ZVL). National decision-makers soon need to decide whether to introduce H…
Authors: Pieter T. de Boer, Alies van Lier, Hester de Melker, Albert J. M. van Wijck, Jan C. Wilschut, Albert Jan van Hoek and Maarten J. Postma
Citation: BMC Medicine 2018 16:228
Published on: 6 December 2018

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 8 Dec 2018)

Debate
The cholera outbreak in Yemen: lessons learned and way forward
The Yemen cholera outbreak has been driven by years of conflict and has now become the largest in epidemiologically recorded history with more than 1.2 million cases since the beginning of the outbreak in Apri…
Authors: Frederik Federspiel and Mohammad Ali
Citation: BMC Public Health 2018 18:1338
Published on: 4 December 2018

Health and Human Rights
Volume 20, Issue 2, December 2018
https://www.hhrjournal.org/volume-20-issue-2-december-2018/
Issue 20.2 features a special section: Special Section on Human Rights and the Social Determinants of Health and a General Papers section

EDITORIAL 
Deepening the Relationship between Human Rights and the Social Determinants of Health: A Focus on Indivisibility and Power
Kristi Heather Kenyon, Lisa Forman, and Claire E. Brolan
…The CSDH report prompted a special issue in Health and Human Rights in 2010 exploring the relationship between human rights and the social determinants of health.[2] Since then, there have been several critical global policy initiatives, including the Rio Declaration on the Social Determinants of Health (2011) and the Sustainable Development Goals (SDGs) (2015), which affirmed the links made by the CSDH locating the social determinants of health in relation to human rights and the right to health.[3] These complimentary frames are at last connected in rhetoric and policy, but what does this linkage mean in practice, and what progress has been made since 2009?[4]

Health and Human Rights
Volume 20, Issue 2, December 2018
https://www.hhrjournal.org/volume-20-issue-2-december-2018/
Issue 20.2 features a special section: Special Section on Human Rights and the Social Determinants of Health and a General Papers section

Social Medicine in Practice: Realizing the American Indian and Alaska Native Right to Health
Lucas Trout, Corina Kramer, and Lois Fischer

Health and Human Rights
Volume 20, Issue 2, December 2018
https://www.hhrjournal.org/volume-20-issue-2-december-2018/
Issue 20.2 features a special section: Special Section on Human Rights and the Social Determinants of Health and a General Papers section

A Meta-Narrative Literature Synthesis and Framework to Guide Future Evaluation of Legal Empowerment Interventions
Katherine Footer, Michael Windle, Laura Ferguson, Jordan Hatcher, Carrie Lyons, Emma Gorin, Anne L. Stangl, Steven Golub, Sofia Gruskin, and Stefan Baral

Health and Human Rights
Volume 20, Issue 2, December 2018
https://www.hhrjournal.org/volume-20-issue-2-december-2018/
Issue 20.2 features a special section: Special Section on Human Rights and the Social Determinants of Health and a General Papers section

General Papers
Human Subject Research: International and Regional Human Rights Standards
Andrés Constantin
Abstract
This article will place the discussion of human subject research within the larger context of human rights law, both at the international and regional level, and examine existing normative human rights frameworks that can be used to protect research subjects. The traditional approach has commonly focused on the ethical aspects of human subject research and little has been said about the implications of human experimentation on the enjoyment of basic rights. The difference between ethical principles and human rights is clearly determined by the
non-enforceability of ethical norms and the legally binding nature of human rights obligations. A human rights approach to bioethics, and particularly to human subject research, can bring about a defined system and universally accepted set of rules in a field where sociocultural and religious diversity come into play.

Humanitarian Exchange Magazine
Number 73,  October 2018
https://odihpn.org/magazine/mental-health-and-psychosocial-support-in-humanitarian-crises/

Rohingya refugees in Bangladesh: the humanitarian response

More than 700,000 Rohingya refugees have arrived in Bangladesh since 25 August 2017 fleeing violence and persecution in Rakhine State, Myanmar. Over a million are sheltering in overcrowded camps without adequate assistance or protection. Stateless in Myanmar and denied refugee status in Bangladesh, the Rohingya have few rights or freedoms. Monsoons and cyclones are causing landslides, destroying shelters and infrastructure and disrupting services.

This edition of Humanitarian Exchange focuses on the humanitarian response to the Rohingya crisis. In the lead article, Mark Bowden outlines the historical, local and national political context in Bangladesh, and its operational implications. Amal de Chickera highlights the links between statelessness and displacement, and the international community’s failure to prioritise human rights in its dealings both with Bangladesh and with Myanmar. Puttanee Kangkun and John Quinley document the persistent persecution and denial of rights the Rohingya have faced for decades. Jeff Crisp reflects on the premature, involuntary and unsafe return of Rohingya refugees to Myanmar in the 1970s and 1990s, and asks whether this could happen again.

Sally Shevach and colleagues explore how the ‘localisation’ agenda has influenced the operational response, and Kerrie Holloway draws on research by the Humanitarian Policy Group to test the common assumption that local actors necessarily have a better understanding of people’s needs. Nasif Rashad Khan and colleagues and Ashish Banik reflect on their experiences of engaging with the international humanitarian response system. Margie Buchanan-Smith and Marian Casey-Maslen discuss evaluation findings relating to communication and community engagement, a theme taken up by Nick Van Praag and Kai Hopkins, who report on a Ground Truth survey on refugees’ perceptions of assistance. Julia Brothwell discusses the British Red Cross/Bangladesh Red Crescent involvement in disaster preparedness and risk reduction during the monsoon season, and Gina Bark, Kate White and Amelie Janon outline the consequences of long-term exclusion from basic healthcare services in increasing vulnerability to preventable diseases. Matthew Wencel and colleagues round off the issue with reflections on data collection coordination and other challenges associated with monitoring large concentrations of refugees.

International Journal of Epidemiology
Volume 47, Issue 6, 1 December 2018
https://academic.oup.com/ije/issue/47/5

Opinion
Mobilizing an underused resource: cohort studies for population health intervention research
Nancy Edwards; Ronald C Plotnikoff
International Journal of Epidemiology, Volume 47, Issue 6, 1 December 2018, Pages 1730–1733, https://doi.org/10.1093/ije/dyy191

International Journal of Epidemiology
Volume 47, Issue 6, 1 December 2018
https://academic.oup.com/ije/issue/47/5

Methods
Reducing contamination risk in cluster-randomized infectious disease-intervention trials
Robert S McCann; Henk van den Berg; Willem Takken; Amanda G Chetwynd; Emanuele Giorgi
International Journal of Epidemiology, Volume 47, Issue 6, 1 December 2018, Pages 2015–2024, https://doi.org/10.1093/ije/dyy213

IRB: Ethics & Human Research
November-December 2018   Volume: 40 Issue: 6
https://www.thehastingscenter.org/publications-resources/irb-ethics-human-research/

Feature Article
Financial Payments for Participating in Research While Incarcerated: Attitudes of Prisoners
By Divya Ravi, Paul P. Christopher, Eliza J. Filene, Sarah Ailleen Reifeis, and Becky L. White
Abstract: 
The practice of paying prisoners to for their participation in research has long been debated, and the controversy is reflected in the differing policies in the U.S. prison systems. Empirical study of financial payments to inmates who enroll in research has focused on whether this practice is coercive. In this study, we examined whether monetary incentives have the potential to be unduly influential among fifty HIV-positive prisoners. The majority of prisoners surveyed believed that inmates should receive some compensation for their involvement in research and disagreed with statements suggesting that the offer of payment constitutes undue influence. However, a sense of potentially being susceptible to undue influence was significantly higher among participants who had spent a longer time in prison and had less education. Overall, our findings suggest that most prisoners feel that they would be able to make a decision about research enrollment that is not solely based on an offer of monetary payment.

IRB: Ethics & Human Research
November-December 2018   Volume: 40 Issue: 6
https://www.thehastingscenter.org/publications-resources/irb-ethics-human-research/

Article
Broad Consent for Future Research: International Perspectives
By Mark A. Rothstein, Heather L. Harrell, Katie M. Saulnier, Edward S. Dove, Chien Te Fan, Tzu-Hsun Hung, Obiajulu Nnamuchi, Alexandra Obadia, Gil Siegal, and Bartha Maria Knoppers
Abstract:
In the United States, final amendments to the Federal Policy for the Protection of Human Subjects (“the Common Rule”) were published on January 19, 2017, and they will take effect on January 21, 2019. One of the most widely discussed provisions is that for the first time, federal regulations governing research with humans authorize the use of broad consent for future, unspecified research on individually identifiable biospecimens and associated data. Many questions have been raised about broad consent, including what effect it will have on research and whether it adequately protects the interests of research participants.
There are lessons to be learned for the U.S. and other countries by looking to countries that already have experience with broad consent for biobank collection and with the storage and subsequent use of the biospecimens and data.  This article describes how broad consent works in five countries—Canada (in Quebec), Israel, Nigeria, Taiwan, and the United Kingdom—and with different types of biobanks: national biobanks, federated biobanks, and regional biobanks. Evaluating the provisions and challenges of the broad consent approaches in these countries can inform policies for this increasingly used approach to biobank regulation.

IRB: Ethics & Human Research
November-December 2018   Volume: 40 Issue: 6
https://www.thehastingscenter.org/publications-resources/irb-ethics-human-research/

Article
The Ethics of Net-Risk Pediatric Research: Implications of Valueless and Harmful Studies
By David Wendler
Abstract:
Net-risk pediatric research encompasses interventions and studies that pose risks and do not offer a compensating potential for clinical benefit. These interventions and studies are central to efforts to improve pediatric clinical care. Yet critics argue that it is unethical to expose children to research risks for the benefit of unrelated others. While a number of ethical justifications have been proposed, none have received widespread acceptance. This leaves funders with uncertainty over whether they should support and institutional review boards with uncertainty over whether they should approve net-risk pediatric research. To try to answer these questions, this article describes a justification that I previously proposed and considers two objections to it. This analysis reveals that the opportunity to contribute to a valuable project can justify exposing children to risks even though some trials turn out to be valueless and others turn out to be harmful. It follows that, to protect pediatric participants, institutional review boards need to assess whether trials have the potential to collect socially valuable information and whether they are likely to enroll and retain a sufficient number of participants.

JAMA
December 4, 2018, Vol 320, No. 21, Pages 2171-2280
http://jama.jamanetwork.com/issue.aspx

Viewpoint
Evolving Issues in Oncology
Vaccines as an Integral Component of Cancer Immunotherapy
Jeffrey Schlom, PhD; James L. Gulley, MD, PhD
Abstract
It is important to distinguish vaccines designed to prevent cancer from those designed to treat cancer. The mode of action of the human papilloma virus (HPV) vaccine for the prevention of cervical and other HPV-associated malignancies is similar to that of vaccines for the prevention of infectious disease (ie, the induction of antibodies directed against essential components of the microbe). Even though there have been stunning successes in the area of preventive vaccines, the history of therapeutic cancer vaccines, which principally involve the development of cell-mediated immunity (ie, T cells) directed against tumor antigens, has been far more challenging. However, the renaissance of cancer immunotherapy has rendered therapeutic cancer vaccines as a potential integral component of treatment.

JAMA
December 4, 2018, Vol 320, No. 21, Pages 2171-2280
http://jama.jamanetwork.com/issue.aspx

Editorial
Oncology in Transition – Changes, Challenges, and Opportunities
Deborah Schrag, MD, MPH; Ethan Basch, MD, MSc
Abstract
Contemporary challenges and changes in the field of oncology reflect and often magnify medicine more broadly. Morbidity and mortality are often substantial, treatment is expensive, and management is complex necessitating interdisciplinary coordination across every field of medicine. The recent emergence of immunotherapy and adoptive cellular therapy has generated tremendous excitement because these approaches can sometimes achieve cure or durable responses, even in the setting of advanced cancer.

JAMA Pediatrics
December 2018, Vol 172, No. 12, Pages 1111-1208
http://archpedi.jamanetwork.com/issue.aspx

Viewpoint
Need for Automated Interactive Genomic Interpretation and Ongoing Reanalysis
Mahdi Sarmady, PhD; Ahmad Abou Tayoun, PhD
JAMA Pediatr. 2018;172(12):1113-1114. doi:10.1001/jamapediatrics.2018.2675
This Viewpoint discusses advances in genetic testing and the need for automated interactive genomic interpretation and ongoing reanalysis to fully take advantage of those advances.

JAMA Pediatrics
December 2018, Vol 172, No. 12, Pages 1111-1208
http://archpedi.jamanetwork.com/issue.aspx

Editorial
Defining the Value of Treatments of Rare Pediatric Conditions
Lisa A. Prosser, PhD
JAMA Pediatr. 2018;172(12):1123-1124. doi:10.1001/jamapediatrics.2018.3343
Abstract
In this issue of JAMA Pediatrics, Whittington et al1 present a comprehensive analysis of the projected long-term outcomes and cost-effectiveness of a chimeric antigen receptor T-cell therapy, tisagenlecleucel, for relapsed or refractory leukemia in children; this is the first gene therapy approved by the US Food and Drug Administration. The study uses a modeling approach and highlights 2 critical issues in defining value for an innovative treatment with limited evidence: the methodological challenges of applying economic evaluation techniques to rare pediatric conditions and reliably assessing value and affordability for very costly new treatments (in this case, $475 000 per patient).

Journal of Evidence-Based Medicine
Volume 11, Issue 4  Pages: 217-291  November 2018
https://onlinelibrary.wiley.com/toc/17565391/current

COMMENTARY
The “architect analogy” of evidence‐based practice: Reconsidering the role of clinical expertise and clinician experience in evidence‐based health care
Arsenio Paez
Pages: 219-226
First Published: 16 November 2018
Abstract
The role of expertise in evidence‐based medicine (EBM) and practice (EBP) has long been debated. In the early years of the EBP movement, the role of expertise and experience were diminished in clinical decision‐making. However, the concepts of EBP are evolving. A more nuanced view of the value of clinician expertise, based on experience and clinical judgement, has emerged. This article proposes that clinical expertise does not belong within the evidence hierarchy’s decision‐making pyramid as the lowest form of evidence, but rather alongside it, representing a complementary source of knowledge that supports the processes of EBP. An “Architect Analogy of EBP” is proposed as a new model by which to describe this relationship. In this analogy, the clinician’s use of expertise is likened to the role of an architect, using evidence as building blocks in the construction of the client’s edifice, representing the patients’ health and wellbeing. Much as an architect carefully designs the edifice in consultation with the client’s needs and preferences, choosing appropriate material (evidence), rejecting faulty material, and ensuring construction stays on course, the clinician must sort through a plethora of sometimes contradictory evidence, evaluate its merits and appropriateness for the patients’ unique biopsychosocial circumstances and values, and monitor the effects of interventions on patients’ health and wellbeing. The expertise of practitioners, as the architects of EBP, is an important supporting source of knowledge that facilitates the “Five Steps of EBP,” informs and facilitates EBP, and supports patient‐centred care.

Journal of Pharmaceutical Policy and Practice
https://joppp.biomedcentral.com/
[Accessed 8 Dec 2018]

Review
|   4 December 2018
Patent challenges in the procurement and supply of generic new essential medicines and lessons from HIV in the southern African development community (SADC) region.
Authors: Ellen F. M. ‘t Hoen, Tapiwanashe Kujinga and Pascale Boulet
Abstract
High medicines prices increasingly pose challenges for universal access to treatments of communicable and non-communicable diseases. New essential medicines are often patent-protected which sustains high prices in many countries, including in low- and middle-income countries. To respond to the HIV/AIDS crisis of the late nineties and to increase access to antiretroviral treatment, certain flexibilities contained in the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS flexibilities) have been clarified and in some respects strengthened at the global level. They have been applied by a number of countries to ensure access to lower-priced generic medicines to treat HIV/AIDS. Governments in the South African Development Community (SADC) have also used TRIPS flexibilities to gain access to lower-priced generic medicines. This paper documents 15 instances of the use of TRIPS flexibilities by eight SADC Member States during the period 2001–2016. Of those, six concerned least developed countries (LDCs) that declared non-enforcement of pharmaceutical patents pursuant to a new LDC transition provision. All instances occurred in the context of medicines procurement for HIV treatment. Such flexibilities can, however, also be used to overcome patent barriers to gain access to generic medicines for other diseases, including NCDs. The SADC, being a regional bloc with over 50% least developed country Members, can make use of the regional exception, a TRIPS flexibility that facilitates the production or procurement of generic medicines to the benefit of the entire region. SADC’s Pharmaceutical Business Plan proposes strategies for increased collaboration and pooled procurement of medicines.

The Lancet
Dec 08, 2018 Volume 392 Number 10163 p2413-2514
https://www.thelancet.com/journals/lancet/issue/current

Editorial
CRISPR-Cas9: a world first?
The Lancet
On Nov 26, when the world heard the claims that the first genetically edited children had been born, the reaction was one of deep and profound shock. He Jiankui announced on the eve of the Second International Summit on Human Genome Editing in Hong Kong that the CRISPR-Cas9 gene editing technique had been used to edit the genome of twin girls born earlier that month in China. It seemed that the world had changed weeks ago and we were just catching up.

Although human germline editing has been done, the embryos have never been allowed to develop to full term. The CRISPR-Cas9 technique is in its infancy and data is still emerging on the potential for off-target gene editing and mosaicism, meaning that not all copies of the target gene are edited. Targeting the CCR5 gene has also been widely criticised. The girls, whose genomes were apparently healthy before editing, were born to an HIV-negative mother and an HIV-positive father, however, CCR5 is just one of the potential route for HIV entry into the cell, which is not the most common HIV cell-entry pathway within Chinese populations. This was also not a situation of unmet medical need, since there are well-established and effective ways to prevent transmission of HIV or to treat it. Moreover, the role of CCR5 in the immune system is not fully understood, the girls may be more susceptible to other infections. It has become clear that this is really is no more than a human experiment, a proof of concept unlikely to confer any real benefit to the recipients but with unknown and potentially incredibly serious risks.

The international response to this experiment has been swift, with widespread condemnation and criticism. The Chinese Academy of Medical Sciences, Chinese Academy of Engineering, and Chinese Academy of Sciences called attention to the prohibition of genetic manipulation of human gametes, zygotes, and embryos for reproductive purposes in China, and called for stronger ethics committees and better ethical education. Marcia McNutt and Victor Dzau, presidents of the US National Academies of Sciences and Medicine respectively, issued a joint statement raising deep concerns that the researcher did not follow the National Academies 2017 recommendations or other international norms of scientific conduct, and stressed the need for more specific standards and principles agreed by the international community.

Since the announcement, the scientific community has begun to reflect more deeply. Many experts had suggested that this development was imminent. Were we guilty of looking away and allowing this to happen? Not according to Dominic Wilkinson, neonatologist and professor of medical ethics from the University of Oxford, who told The Lancet “this was not a case of science outpacing ethical guidance or the law. There were guidelines in place that warned against research of this sort. This appears to be a researcher who had no interest in attending to ethical guidelines relating to scientific research.” Wilkinson asserts that these researchers have undermined the contract that scientists have with society; that contract allows research in situations where the risk to the patient is clearly calculated and the implications to the community at large have been appropriately considered. By ignoring these risks, this research team has potentially undermined community trust in research and technology and this threatens the research endeavour more generally along with research into this potentially important technology.

Scientific culture has long been to accredit individuals with steps forward instead of recognising group achievement or incremental progress. This has created an ethos of celebrity in academia, which has sometimes rewarded maverick behaviour. The increasing speed of scientific research—from conference late breakers to techniques for rapid and public dissemination of research that come with less critical oversight—adds to a constant fear of getting scooped. These factors, combined with strong incentives for research and a less regulated research framework, have created an atmosphere in which some scientists seem ready to act outside of clear ethical frameworks.

Although it seemed like the world had changed overnight with the birth of these twin girls, it will be the reaction of the scientific and wider communities that has the power to determine the path of these irrevocable changes. How this case is handled will set a precedent for the future, determining in part whether this development ultimately accelerates progress towards a useful and safe therapeutic intervention or whether the consequences of the broken compact between science and society will be to delay this and other innovative technologies.

The Lancet
Dec 08, 2018 Volume 392 Number 10163 p2413-2514
https://www.thelancet.com/journals/lancet/issue/current

Comment
A global accountability mechanism for access to essential medicines

Mariângela Simão, Veronika J Wirtz, Lubna A Al-Ansary, Suzanne Hill, John Grove, Andrew L Gray, Claudia Nannei, Lisa Hedman, Pamela Das, Hans Hogerzeil

Access to affordable, quality-assured essential medicines is a prerequisite for effective universal health coverage.1,2  Efforts to ensure comprehensive access to essential medicines have been hindered by a dearth of information. Most monitoring efforts have focused on measurement of a prespecified list of essential medicines in health facilities. Measures of affordability in private and public health facilities have relied on periodic surveys, usually by non-governmental organisations (NGOs) or academia3 The quality of medicine products and of prescribing practice, as well as patients’ use of essential medicines, have been assessed even less often. Pharmaceutical expenditure in the public and private sector is not prioritised in national systems, and is rarely reported.4 Without systematic data reporting on national pharmaceutical expenditure, there is a lack of attention to access to essential medicines in major reports such as the World Health Statistics.5 The 2015 Millennium Development Goals Task Force report concluded that tracking progress on access to essential medicines was impossible, given the absence of country-level data.6, 7

When target measurements are used to improve access, a robust monitoring and accountability system is needed—eg, the three-step framework recommended by Paul Hunt, former UN Special Rapporteur on the Right to Health, that involves appropriate collection of data, independent review, and the necessary corrective action.8 The Lancet Commission on Essential Medicines Policies made an initial proposal for such a framework.1 Independent review and corrective action are important components of an accountability mechanism, as shown by UNAIDS’ HIV progress reports9 and work in reproductive, maternal, newborn, child, and adolescent health.10

Members of the Lancet Commission on Essential Medicines Polices and WHO have discussed options for such a framework. A global accountability mechanism for monitoring access to essential medicines must take account of major global trends—eg, strengthening patient-centred primary health care; efficient country-led horizontal health systems, including prevention and treatment of non-communicable diseases; systems of risk-sharing, pre-payment, and social health insurance; and greater attention to the quality of care, the quality of health products, the skills and attitudes of health workers, and cost-effective treatment. Civil society is also demanding better data collection, transparency, and systems of accountability to promote equity and good governance.11 Greater reliance on routine data facilitated by new technologies, including mobile applications, should enable countries to generate timely information on a continuous basis.

The focus of accountability should move away from measuring only availability of medicines towards the effectiveness, quality, and efficiency of patient-centred comprehensive primary care services, which encompasses equitable access to essential medicines. To advance this agenda, indicators are therefore needed that are sensitive to differences in access on the basis of gender, ethnicity, education, residential location, and wealth quintile. WHO has already provided resources to assist national programmes in applying an equity lens.12, 13 Under the aegis of WHO, medicine access indicators should now be developed in close collaboration with member states, academia, and civil society, consisting of a small set of screening indicators supported by more detailed diagnostic and progress indicators.

Further high-level discussions between WHO, the Lancet Commission, other UN agencies, and NGOs have led to the identification of four priorities to ensure the development of a global Accountability Mechanism for Access to Essential Medicines (abbreviated as 2A2M). First, high-level political support is needed through the definition of the accountability structure and operating mechanisms, taking into consideration the roles and responsibilities of national governments, academic partners, and civil society. Second, the strategic generation, analysis, and use of prioritised data for decision making is vital, with a strong focus on national capacity building and leveraging existing technical support programmes. Third, technological advances in data collection must be adopted, building on the principles of the Health Data Collaborative and existing data platforms and recognising variability in national digital maturity. Finally, global advocacy is needed to ensure the engagement of all relevant technical and financial contributors at national and international levels.

A global accountability mechanism for access to essential medicines that is nationally applicable and feasible will take several years to achieve. However, experiences in HIV and reproductive, maternal, newborn, child, and adolescent health have shown that it can be done, provided a clear political mandate and the necessary financial and technical resources are ensured, together with country leadership and the engagement of civil society and academic institutions.

VJW reports grants from Sandoz International GmbH and from the International Federation of the Pharmaceutical Manufacturer Associations outside the submitted work. HH reports personal fees from WHO, Health Action International, and Access to Medicines Index 2018, outside the submitted work. PD is Senior Executive Editor, The Lancet. We declare no other competing interests. The authors alone are responsible for the views expressed in this Comment and they do not necessarily represent the views, decisions, or policies of the institutions with which they are affiliated.

The Lancet
Dec 08, 2018 Volume 392 Number 10163 p2413-2514
https://www.thelancet.com/journals/lancet/issue/current

Review
The 2018 report of the Lancet Countdown on health and climate change: shaping the health of nations for centuries to come
Nick Watts, Markus Amann, Nigel Arnell, Sonja Ayeb-Karlsson, Kristine Belesova, Helen Berry, Timothy Bouley, Maxwell Boykoff, Peter Byass, Wenjia Cai, Diarmid Campbell-Lendrum, Jonathan Chambers, Meaghan Daly, Niheer Dasandi, Michael Davies, Anneliese Depoux, Paula Dominguez-Salas, Paul Drummond, Kristie L Ebi, Paul Ekins, Lucia Fernandez Montoya, Helen Fischer, Lucien Georgeson, Delia Grace, Hilary Graham, Ian Hamilton, Stella Hartinger, Jeremy Hess, Ilan Kelman, Gregor Kiesewetter, Tord Kjellstrom, Dominic Kniveton, Bruno Lemke, Lu Liang, Melissa Lott, Rachel Lowe, Maquins Odhiambo Sewe, Jaime Martinez-Urtaza, Mark Maslin, Lucy McAllister, Slava Jankin Mikhaylov, James Milner, Maziar Moradi-Lakeh, Karyn Morrissey, Kris Murray, Maria Nilsson, Tara Neville, Tadj Oreszczyn, Fereidoon Owfi, Olivia Pearman, David Pencheon, Steve Pye, Mahnaz Rabbaniha, Elizabeth Robinson, Joacim Rocklöv, Olivia Saxer, Stefanie Schütte, Jan C Semenza, Joy Shumake-Guillemot, Rebecca Steinbach, Meisam Tabatabaei, Julia Tomei, Joaquin Trinanes, Nicola Wheeler, Paul Wilkinson, Peng Gong, Hugh Montgomery, Anthony Costello

The Lancet Countdown: tracking progress on health and climate change was established to provide an independent, global monitoring system dedicated to tracking the health dimensions of the impacts of, and the response to, climate change. The Lancet Countdown tracks 41 indicators across five domains: climate change impacts, exposures, and vulnerability; adaptation, planning, and resilience for health; mitigation actions and health co-benefits; finance and economics; and public and political engagement.

This report is the product of a collaboration of 27 leading academic institutions, the UN, and intergovernmental agencies from every continent. The report draws on world-class expertise from climate scientists, ecologists, mathematicians, geographers, engineers, energy, food, livestock, and transport experts, economists, social and political scientists, public health professionals, and doctors…

Nature 
Volume 564 Issue 7734, 6 December 2018
http://www.nature.com/nature/current_issue.html

Editorial | 05 December 2018
How to respond to CRISPR babies
The claims from He Jiankui that he has used gene editing to produce twin girls demand action. A new registry of research is a good start.

Nature Medicine
Volume 24 Issue 12, December 2018
https://www.nature.com/nm/volumes/24/issues/12

Editorial | 06 December 2018
Diversifying clinical trials
Scientific common sense and social justice dictate that the safety and efficacy of new therapies must be tested in the patient populations in need of treatment. Yet a recent study found that African Americans have been dramatically underrepresented in US clinical trials for cancer drugs. Efforts to increase the participation of minorities in clinical trials must become a priority for all drug developers.

Among patient populations, the safety and efficacy of new treatments may vary with differences in sex, race, age or lifestyle, for example. Such variation in drug effects can only be detected by carrying out clinical trials on diverse patient populations, an aim that has a long history. In 1993, the US government passed a law that required the National Institutes of Health to ensure that federally funded clinical research prioritize the inclusion of women and minorities. More recently, in 2014, the US Food and Drug Administration (FDA) instituted an action plan that supports industry efforts at improving diversity in clinical trials. The following year, the FDA began publishing a ‘Drug Trials Snapshot’ that includes an analysis of the sex, race and age of clinical trial participants for every new drug approved.

Against this backdrop, the findings of a recent report (https://www.propublica.org/article/black-patients-miss-out-on-promising-cancer-drugs) by the nonprofit news organization ProPublica, co-published with the news outlet STAT, are disheartening. This report analyzed Snapshot data from clinical trials for the 31 cancer drugs approved by the FDA since 2015, comparing the demographics of these trials with the incidence of various cancers by race.

In trials for 24 of these 31 drugs, fewer than 5% of the patients were African American, despite the fact that African Americans make up 13.4% of the US population. For 18 of those drugs, the type of cancer targeted occurs in African Americans at least as frequently as in Americans of European descent. In trials for those types of cancer, on average only 4.1% of patients were African American. And in trials for four multiple myeloma drugs, only 5% of the participants, on average, were African American, whereas 14% of people diagnosed with multiple myeloma are African Americans. A separate study by the FDA that analyzed clinical trials over a longer time frame similarly found that African-American patients make up only 4.5% of participants in multiple myeloma trials (Blood 130, 4352, 2017).

Many reasons have been put forward to explain the difficulties in enrolling African Americans in clinical trials. Chief among them is distrust of the medical establishment and fears of exploitation in medical research in this population (Am. J. Public Health 104, e16–e31, 2014). The infamous Tuskegee Study, in which the US Public Health Service deprived hundreds of African-American men of syphilis treatment so that researchers could study how the disease progressed, has cast a long shadow. In some communities, African Americans may also lack sufficient information regarding what clinical trials can offer and the safeguards in place to protect the privacy of their information. Beyond distrust and lack of information, substantial logistical hurdles can also impede fuller clinical trial participation. For example, some individuals may have limited access to the cancer centers that are the hubs of clinical studies, or they may lack the ability to take time off work to take part in a trial.

Recent findings may contribute to the wariness with which African Americans view medical research (Health Aff. (Millwood) 37, 1605–1614, 2018; https://www.statnews.com/2018/10/01/african-americans-clinical-trials). This report highlighted the high percentage (29%), relative to their proportion of the United States population as a whole, of African Americans included over the last two decades in clinical trials in which patients were not required to give consent. These trials involved, for example, testing emergency medical procedures under conditions where the patient is physically incapable of giving consent. Such studies are often conducted in large medical centers in areas where African Americans may suffer disproportionately from the particular conditions being studied. Nevertheless, for a community in which the issue of consent resonates deeply, the high inclusion rate of African Americans in trials where patient consent was not obtained may undermine attempts to increase their participation in clinical trials.

These efforts must involve ongoing investment by those conducting clinical trials in engaging with and building trust in African-American communities. From a logistical perspective, placing study sites in areas of community outreach may ease the burdens that members of those communities face in order to participate in clinical trials.

New technologies that foster the decentralization of clinical trials may also offer opportunities for increased access for African Americans as well as other minorities not currently well represented in clinical trials. Several recently developed websites offer matchmaking between patients and clinical trials, enabling patients to find appropriate clinical trials no matter where the patients are physically located.

Recent efforts to generate comprehensive health, genomic and lifestyle profiles of the population, such as the All of Us initiative, have heightened awareness of issues of population diversity. Although race is a social construct that does not have a strict relationship to genetics, ensuring a representative sampling of the population across racial and ethnic boundaries is clearly a priority of such studies that requires high levels of engagement with historically neglected communities. With increasing awareness of the roles that genetics and lifestyle play in determining health and drug response, the time is now ripe to prioritize diversity in clinical trials.

PharmacoEconomics & Outcomes News
Volume 817, Issue 1, December 2018
https://link.springer.com/journal/40274/817/1/page/1

Meeting report
Assessing cost effectiveness of pneumococcal conjugate vaccines

PharmacoEconomics & Outcomes News
Volume 817, Issue 1, December 2018
https://link.springer.com/journal/40274/817/1/page/1

Meeting report
Gender-neutral 9-valent HPV vaccine program cost effective

PharmacoEconomics & Outcomes News
Volume 817, Issue 1, December 2018
https://link.springer.com/journal/40274/817/1/page/1

Clinical study
HBV and HCV screening cost effective in migrants

PLoS One
http://www.plosone.org/
[Accessed 8 Dec 2018]

Research Article
Beyond confidence: Development of a measure assessing the 5C psychological antecedents of vaccination
Cornelia Betsch, Philipp Schmid, Dorothee Heinemeier, Lars Korn, Cindy Holtmann, Robert Böhm
Research Article | published 07 Dec 2018 PLOS ONE
https://doi.org/10.1371/journal.pone.0208601

PLoS One
http://www.plosone.org/
[Accessed 8 Dec 2018]

Research Article
The relationship between perceptions and self-paid hepatitis B vaccination: A structural equation modeling approach
Yogambigai Rajamoorthy, Alias Radam, Niazlin Mohd Taib, Khalid Ab Rahim, Abram Luther Wagner, Mudatsir Mudatsir, Subramaniam Munusamy, Harapan Harapan
| published 06 Dec 2018 PLOS ONE
https://doi.org/10.1371/journal.pone.0208402

PLoS One
http://www.plosone.org/
[Accessed 8 Dec 2018]

Research Article
Estimating everyday risk: Subjective judgments are related to objective risk, mapping of numerical magnitudes and previous experience
Hannah A. D. Keage, Tobias Loetscher
| published 05 Dec 2018 PLOS ONE
https://doi.org/10.1371/journal.pone.0207356

Preventive Medicine
Volume 117, Pages 1-114 (December 2018)
https://www.sciencedirect.com/journal/preventive-medicine/vol/117/suppl/C

Behavior Change, Health, and Health Disparities 2018: Tobacco Regulatory Science
Edited by Stephen T. Higgins
This Special Issue of Preventive Medicine (PM) is the 5th in a series on behavior change, health, and health disparities. Unhealthy behavior patterns (i.e., lifestyle choices) including cigarette smoking and other substance abuse, physical inactivity, unhealthy food choices, and non-adherence with recommended medical regimens, undermine U.S. population health by increasing risk for chronic disease and premature death. This Special Issue brings together scholarly contributions from the emerging area of tobacco regulatory science to examine current topics of critical importance to reducing the burden of cigarette smoking on U.S. population health. More specifically, three related topics are examined including (a) the potential for reducing smoking by adopting a national policy that would cap the nicotine content of cigarettes at minimally-addictive levels; (b) increasing scientific understanding of cigarette smoking and other tobacco use among populations that are especially vulnerable to initiating smoking, tobacco addiction, and its adverse health consequences; and (c) the potential of a harm-reduction strategy for reducing the burden of smoking by advocating that those who are unwilling or unable to quit nicotine use substitute electronic cigarettes or other non-combusted sources of nicotine for cigarettes in order to avoid exposure to the other toxins in tobacco smoke that are most responsible for smoking morbidity and mortality. While tremendous progress has been made in reducing overall U.S. smoking prevalence and its adverse health impacts, more needs to be done. This Special Issue offers some ideas that have the potential to make a substantive contribution towards that goal.

Public Health Reports
Volume 133 Issue 1_suppl, November/December 2018
https://journals.sagepub.com/toc/phrg/133/1_suppl

From Local Action to National Progress on 5 Major Health Challenges: The Bloomberg American Health Initiative
Guest Editor: Joshua M. Sharfstein, Jessica Leighton, Alfred Sommer and Ellen J. MacKenzie
The articles in this supplemental issue of Public Health Reports provide insight into what it will take for the field of public health to tackle 5 of the most complex and difficult health problems of our time: (1) large numbers of adolescents disconnected from work and school; (2) violence (including gun violence), intimate partner and sexual violence, and suicide; (3) opioid addiction and overdose; (4) a dysfunctional food system associated with obesity; and (5) threats to the environment.
These 5 problems are the central focus of the new Bloomberg American Health Initiative, which MacKenzie et al1 describe in their Commentary. “All 5 areas of focus are serious problems facing the nation, with deep connections to economic and social factors,” they write. “None have quick fixes.”1 Yet there is reason to believe that public health can lead the way toward meaningful progress.
From December 2017 to April 2018, the initiative held 5 national symposia to document the state of understanding and to inform a public health perspective on each challenge. This supplement includes these perspectives, as well as commentaries in the cross-cutting areas of evidence, policy, and equity. Together, these articles provide a road map for efforts to bring public health training to frontline organizations, pursue insights through innovative research, and advance effective programs, policies, and strategies for change…

Risk Analysis          
Volume 38, Issue 12  Pages: 2503-2739  December 2018
https://onlinelibrary.wiley.com/toc/15396924/current
Communicating About Zika

Introduction to Special Series: Communicating About Zika
Dominique Brossard, Kathleen Hall Jamieson William Hallman
Pages: 2504-2506
First Published: 07 December 2018
Perspective
Free Access

Risk Analysis          
Volume 38, Issue 12  Pages: 2503-2739  December 2018
https://onlinelibrary.wiley.com/toc/15396924/current
Communicating About Zika

Chronicling the Risk and Risk Communication by Governmental Officials During the Zika Threat
Marin Pearson Allen
Pages: 2507-2513
First Published: 12 November 2018
Abstract
The unique circumstances surrounding Zika, including the fact that it is both mosquito‐borne and sexually transmissible, brought to the fore concerns about optimal ways to communicate risk in an environment characterized by rapidly evolving knowledge. The difficulty in doing so is magnified by the fact that science‐based health messages from governmental agencies must be developed in an evidence‐based, audience‐participative, and collaborative manner. A recent reminder in JAMA asserted the importance of preparing now for future threats. Understanding how the knowledge and messaging about Zika changed across time should help public health officials prepare for such challenges.

Risk Analysis          
Volume 38, Issue 12  Pages: 2503-2739  December 2018
https://onlinelibrary.wiley.com/toc/15396924/current

Communicating Zika Risk: Using Metaphor to Increase Perceived Risk Susceptibility
Hang Lu, Jonathon P. Schuldt
Pages: 2525-2534
First Published: 27 February 2018

Science         
07 December 2018  Vol 362, Issue 6419
http://www.sciencemag.org/current.dtl

In Depth
What now for human genome editing?
By Jon Cohen
Science07 Dec 2018 : 1090-1092 Restricted Access
Claimed creation of CRISPR-edited babies triggers calls for international oversight.

Science         
07 December 2018  Vol 362, Issue 6419
http://www.sciencemag.org/current.dtl

For China, a CRISPR first goes too far
By Dennis Normile
Science07 Dec 2018 : 1091 Restricted Access
Scientists and ethicists call for strengthened oversight in wake of He Jankui’s announcement.

Tropical Medicine & International Health
Volume 23, Issue 12  Pages: i-iv, 1281-1407  December 2018
https://onlinelibrary.wiley.com/toc/13653156/current

Original Research Papers
Comparison between the traditional (1997) and revised (2009) WHO classifications of dengue disease: a retrospective study of 30 670 patients
Natal Santos da Silva, Eduardo A. Undurraga, Alice Tobal Verro, Maurício Lacerda Nogueira
Pages: 1282-1293
First Published: 03 October 2018
Abstract
Objective
To compare WHO’s traditional (1997) and revised (2009) guidelines for dengue classification, using a large sample of patients of all ages with varying clinical conditions from a dengue‐endemic area in Brazil.
Methods
We compared 30 670 laboratory‐confirmed dengue cases (1998–2012) using both WHO’s dengue classification guidelines. Stereotype ordinal logistic regressions were used to analyse the association between patients’ demographics and signs and symptoms related to dengue infection severity, as defined in the 1997 and 2009 guidelines. We then compared the degree of agreement in dengue classification of both guidelines.
Results
Dengue signs and symptoms in patients were poorly correlated to disease severity as defined by both guidelines (Cramer’s V test <0.2). Hypotensive shock was the exception for both classifications, presenting dependence (Z = 56.42; P < 0.001, and Z = 55.24; P < 0.001) and high agreement (Cramers’s V = 1; P < 0.001, and Cramers’s V = 0.97; P < 0.001) for WHO 1997 and 2009, respectively. Last, we also found substantial agreement in disease classification between both guidelines (Kendall tau‐b = 0.79; P < 0.001), although 2009 guidelines were more sensitive in the detection of severe cases.
Conclusions
We hope our results will inform the debate about dengue classification guidelines, particularly concerning clinical value, study comparability, and ways in which future guidelines can support the clinical management of dengue. Our results suggest that caution should be taken when using WHO guidelines to assess dengue severity to improve clinical management of patients.
Open Access

Tropical Medicine & International Health
Volume 23, Issue 12  Pages: i-iv, 1281-1407  December 2018
https://onlinelibrary.wiley.com/toc/13653156/current

The health consequences of falsified medicines‐ A study of the published literature
Mohammad Sofiqur Rahman, Naoko Yoshida, Hirohito Tsuboi, Naoki Tomizu, Jamie Endo, Onishi Miyu, Yoshio Akimoto, Kazuko Kimura
Pages: 1294-1303
First Published: 06 October 2018
Abstract
Objectives
To analyse and present the literature describing the health consequences of falsified medicines, focusing on mortality and morbidity, as well as the scale of the issue, the geographic extent, the medicines affected, and the harm caused at both the individual and population levels.
Methods
We searched for articles in PubMed, using pre‐optimized keywords ‘(counterfeit OR fake OR bogus OR falsified OR spurious) AND (medicine OR drug)’. Searches up to February 2017 yielded 2006 hits, of which 1791 were full‐length articles in English. Among them, we found 81 papers that qualitatively or quantitatively described 48 incidents in which falsified medicines caused patients to suffer serious adverse effects, injury, symptoms or death.
Results
The distribution of incidents was examined according to the economic status of the countries involved, regional location in the world, therapeutic category of the medicines, number of incidents and victims by year, and characteristics of the falsified medicines. Among the 48 reported incidents, 27 (56.3%) occurred in developing countries and 21 (43.7%) in developed countries. These incidents involved a total of approximately 7200 casualties including 3604 deaths.
Conclusions
Despite the poor quality of much of the reported data, the results of this study indicate that all types of medications have been targeted for falsification, and falsified medicines have had a serious impact on the health of both adults and children worldwide, with similar numbers of incidents in developing and developed countries.

Vaccine
Volume 37, Issue 1  Pages 1-210 (3 January 2019)
https://www.sciencedirect.com/journal/vaccine/vol/37/issue/1

Research article  Full text access
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Vaccine
Volume 37, Issue 1  Pages 1-210 (3 January 2019)
https://www.sciencedirect.com/journal/vaccine/vol/37/issue/1

Research article  Open access
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Vaccine
Volume 37, Issue 1  Pages 1-210 (3 January 2019)
https://www.sciencedirect.com/journal/vaccine/vol/37/issue/1

Research article  Full text access
Impact of implementing a technology platform in community pharmacies to increase adult immunizations rates
Nizar K. Wehbi, Rajvi J. Wani, Donald G. Klepser, Janice Murry, Ali S. Khan
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