Reflections of a Vaccinologist: Lessons Learned About What We Can Do to Improve Trust in Vaccines and Vaccine Programs

Journal of the Pediatric Infectious Diseases Society (JPIDS)
Volume 6 Issue 1, March 2017
http://jpids.oxfordjournals.org/content/current

ORIGINAL ARTICLES
Reflections of a Vaccinologist: Lessons Learned About What We Can Do to Improve Trust in Vaccines and Vaccine Programs
Neal A. Halsey
Abstract
Public trust can be improved by learning from past mistakes, by establishing a standing forum for review of new concerns as they arise, and by maintaining a robust vaccine safety system. Developing standard guidelines for reporting causality assessment in case reports would help educate physicians and prevent future unnecessary concerns based on false assumptions of causal relationships.

Trauma for migrant children stranded in Greece

The Lancet
Mar 25, 2017 Volume 389 Number 10075 p1165-1272 e4
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Trauma for migrant children stranded in Greece
The Lancet
A Save the Children report released on March 16 raises alarm about the dire consequences of the deal made between the European Union (EU) and Turkey that limits the number of migrants and refugees entering Europe via Greece. 1 year after the agreement, thousands of people, many escaping Syria or Iraq, are now stranded on Greek islands. They are living in limbo waiting for asylum or passage, prohibited from leaving, and effectively imprisoned. Conditions are said to be appalling with limited infrastructure and facilities. Of the 13 200 migrants and refugees stranded in the Aegean islands, more than 5000 are children, some of whom are unaccompanied or separated from their families. The report calls for the EU and Greece to immediately end the illegal detention of children and to better protect them. But given the extent of the health consequences documented by Save the Children, the medical community also needs to act urgently.

The charity says that children trapped on the Greek islands are showing signs of depression, anxiety, and distress. Bedwetting, nightmares, and aggressive behaviour are increasing. Some children have witnessed deaths, fires, protests, and police violence in the camps. Basic needs for food, water, and sanitation are barely being met, says the report. Shockingly, children as young as 9 years have attempted suicide or self-harm.

Affected children are clearly traumatised. Many will have already fled war, poverty, or persecution. Along the way they may have lost parents or siblings or been separated from them. But instead of treating that trauma, our collective failure has led to their re-traumatisation. At such a crucial time of a child’s development, the physical and mental health effects of this unacceptable detention are devastating. The long-term consequences will be worse. The medical community should act immediately: we must insist on the removal of these children from the camps with their families into safe and humane shelter. We must provide the health care and treatment these children need to recover from their trauma. And we must support all efforts to help them regain their resilience and hope for free and full lives.

Preparing for future global health emergencies

The Lancet
Mar 25, 2017 Volume 389 Number 10075 p1165-1272 e4
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Preparing for future global health emergencies
The Lancet
On March 13–14, Chatham House and the Graduate Institute Geneva-Global Health Centre hosted a roundtable meeting on preparedness for global health crises. Representatives from WHO and the UN, including member states, global health and development agencies, foundations, academia, and non-profit initiatives shared their work and experiences on monitoring preparedness for outbreaks and other public health emergencies.

Several themes emerged. Global preparedness for outbreaks is improving in some regions, and changes to the global response architecture are underway. A broad range of sectors must be involved, from animal and livestock to human health and trade. Current monitoring and tracking of preparedness use indicators from the International Health Regulations (IHR) and a joint external evaluation process for IHR requirements has begun. Tracking for Sustainable Development Goals and the Sendai framework for disaster risk reduction is being considered. Reporting on progress is voluntary, non-existent, or overlapping, and tracking of global commitments and responsibilities is largely absent.

Views differed on how to monitor contributions to global, national, and regional preparedness and mutual accountability, but there was consensus that country-level preparedness, financing, and sharing of information, research, and health technologies are vital. Independent accountability is needed to ensure all stakeholders are acting on their commitments to help raise the profile of preparedness politically. This effort will require an ecosystem of multiple stakeholders, a range of expertise, and diverse data sources.

Chatham House and the Graduate Institute will contribute to this ecosystem through a new Monitoring and Accountability for Preparedness initiative (MAP-Global Health Crises). Harvard University and the US National Academy of Sciences have convened a meeting to advance these discussions on April 18, and meetings are planned by others. The Geneva meeting is a good first step towards identifying the stakeholder ecosystem required to ensure that countries and the global community continue to strengthen their collective preparedness for the health crises that will inevitably arise.

Socioeconomic status and the 25 × 25 risk factors as determinants of premature mortality: a multicohort study and meta-analysis of 1·7 million men and women

The Lancet
Mar 25, 2017 Volume 389 Number 10075 p1165-1272 e4
http://www.thelancet.com/journals/lancet/issue/current

Articles
Socioeconomic status and the 25 × 25 risk factors as determinants of premature mortality: a multicohort study and meta-analysis of 1·7 million men and women
Silvia Stringhini, Cristian Carmeli, Markus Jokela, Mauricio Avendaño, Peter Muennig, Florence Guida, Fulvio Ricceri, Angelo d’Errico, Henrique Barros, Murielle Bochud, Marc Chadeau-Hyam, Françoise Clavel-Chapelon, Giuseppe Costa, Cyrille Delpierre, Silvia Fraga, Marcel Goldberg, Graham G Giles, Vittorio Krogh, Michelle Kelly-Irving, Richard Layte, Aurélie M Lasserre, Michael G Marmot, Martin Preisig, Martin J Shipley, Peter Vollenweider, Marie Zins, Ichiro Kawachi, Andrew Steptoe, Johan P Mackenbach, Paolo Vineis, Mika Kivimäki for the LIFEPATH consortium
1229
Open Access
Abstract
Background
In 2011, WHO member states signed up to the 25 × 25 initiative, a plan to cut mortality due to non-communicable diseases by 25% by 2025. However, socioeconomic factors influencing non-communicable diseases have not been included in the plan. In this study, we aimed to compare the contribution of socioeconomic status to mortality and years-of-life-lost with that of the 25 × 25 conventional risk factors.
Methods
We did a multicohort study and meta-analysis with individual-level data from 48 independent prospective cohort studies with information about socioeconomic status, indexed by occupational position, 25 × 25 risk factors (high alcohol intake, physical inactivity, current smoking, hypertension, diabetes, and obesity), and mortality, for a total population of 1,751,479 (54% women) from seven high-income WHO member countries. We estimated the association of socioeconomic status and the 25 × 25 risk factors with all-cause mortality and cause-specific mortality by calculating minimally adjusted and mutually adjusted hazard ratios [HR] and 95% CIs. We also estimated the population attributable fraction and the years of life lost due to suboptimal risk factors.
Findings
During 26.6 million person-years at risk (mean follow-up 13.3 years [SD 6.4 years]), 310,277 participants died. HR for the 25 × 25 risk factors and mortality varied between 1.04 (95% CI 0.98–1.11) for obesity in men and 2.17 (2·06–2·29) for current smoking in men. Participants with low socioeconomic status had greater mortality compared with those with high socioeconomic status (HR 1.42, 95% CI 1.38–1.45 for men; 1.34, 1.28–1.39 for women); this association remained significant in mutually adjusted models that included the 25 × 25 factors (HR 1.26, 1·21–1.32, men and women combined). The population attributable fraction was highest for smoking, followed by physical inactivity then socioeconomic status. Low socioeconomic status was associated with a 2.1-year reduction in life expectancy between ages 40 and 85 years, the corresponding years-of-life-lost were 0.5 years for high alcohol intake, 0.7 years for obesity, 3.9 years for diabetes, 1.6 years for hypertension, 2.4 years for physical inactivity, and 4.8 years for current smoking.
Interpretation
Socioeconomic circumstances, in addition to the 25 × 25 factors, should be targeted by local and global health strategies and health risk surveillance to reduce mortality.
Funding
European Commission, Swiss State Secretariat for Education, Swiss National Science Foundation, the Medical Research Council, NordForsk, Portuguese Foundation for Science and Technology.

The epidemiology, pathogenesis, transmission, diagnosis, and management of multidrug-resistant, extensively drug-resistant, and incurable tuberculosis

Lancet Respiratory Medicine
Apr 2017 Volume 5 Number 4 p235-360
http://www.thelancet.com/journals/lanres/issue/current
The Lancet Respiratory Medicine Commission

The epidemiology, pathogenesis, transmission, diagnosis, and management of multidrug-resistant, extensively drug-resistant, and incurable tuberculosis
Keertan Dheda, Tawanda Gumbo, Gary Maartens, Kelly E Dooley, Ruth McNerney, Megan Murray, Jennifer Furin, Edward A Nardell, Leslie London, Erica Lessem, Grant Theron, Paul van Helden, Stefan Niemann, Matthias Merker, David Dowdy, Annelies Van Rie, Gilman K H Siu, Jotam G Pasipanodya, Camilla Rodrigues, Taane G Clark, Frik A Sirgel, Aliasgar Esmail, Hsien-Ho Lin, Sachin R Atre, H Simon Schaaf, Kwok Chiu Chang, Christoph Lange, Payam Nahid, Zarir F Udwadia, C Robert Horsburgh Jr, Gavin J Churchyard, Dick Menzies, Anneke C Hesseling, Eric Nuermberger, Helen McIlleron, Kevin P Fennelly, Eric Goemaere, Ernesto Jaramillo, Marcus Low, Carolina Morán Jara, Nesri Padayatchi, Robin M Warren
291
Summary
Global tuberculosis incidence has declined marginally over the past decade, and tuberculosis remains out of control in several parts of the world including Africa and Asia. Although tuberculosis control has been effective in some regions of the world, these gains are threatened by the increasing burden of multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis. XDR tuberculosis has evolved in several tuberculosis-endemic countries to drug-incurable or programmatically incurable tuberculosis (totally drug-resistant tuberculosis). This poses several challenges similar to those encountered in the pre-chemotherapy era, including the inability to cure tuberculosis, high mortality, and the need for alternative methods to prevent disease transmission. This phenomenon mirrors the worldwide increase in antimicrobial resistance and the emergence of other MDR pathogens, such as malaria, HIV, and Gram-negative bacteria. MDR and XDR tuberculosis are associated with high morbidity and substantial mortality, are a threat to health-care workers, prohibitively expensive to treat, and are therefore a serious public health problem.

In this Commission, we examine several aspects of drug-resistant tuberculosis. The traditional view that acquired resistance to antituberculous drugs is driven by poor compliance and programmatic failure is now being questioned, and several lines of evidence suggest that alternative mechanisms—including pharmacokinetic variability, induction of efflux pumps that transport the drug out of cells, and suboptimal drug penetration into tuberculosis lesions—are likely crucial to the pathogenesis of drug-resistant tuberculosis. These factors have implications for the design of new interventions, drug delivery and dosing mechanisms, and public health policy. We discuss epidemiology and transmission dynamics, including new insights into the fundamental biology of transmission, and we review the utility of newer diagnostic tools, including molecular tests and next-generation whole-genome sequencing, and their potential for clinical effectiveness. Relevant research priorities are highlighted, including optimal medical and surgical management, the role of newer and repurposed drugs (including bedaquiline, delamanid, and linezolid), pharmacokinetic and pharmacodynamic considerations, preventive strategies (such as prophylaxis in MDR and XDR contacts), palliative and patient-orientated care aspects, and medicolegal and ethical issues.

Nature, Volume 543 Number 7646 pp463-582 23 March 2017

Nature
Volume 543 Number 7646 pp463-582 23 March 2017
http://www.nature.com/nature/current_issue.html

Editorial
Trump faces backlash on health-agency cuts
Crippling the US National Institutes of Health might increase resistance to other attacks on science.

Editorial
The FDA chief must not be a proxy for industry
Trump’s pick for the US regulatory agency will bring experience and a clear vision — as well as ties to industry.

New England Journal of Medicine, March 23, 2017 Vol. 376 No. 12

New England Journal of Medicine
March 23, 2017  Vol. 376 No. 12
http://www.nejm.org/toc/nejm/medical-journal

Perspective
Chilling Effect? Post-Election Health Care Use by Undocumented and Mixed-Status Families
K.R. Page and S. Polk
Excerpt
…Today, the ACA’s fate is unclear, with implications for millions of Americans.5 We cannot predict how health care access will be reshaped, yet it’s all but certain that undocumented immigrants who were never eligible for ACA benefits will not have better access to care. Access may be significantly reduced if financial penalties are applied to states or cities that refuse to cooperate with ICE. Overt restrictions on basic public services, such as schools or public health clinics, are unlikely, given that such measures were ruled unconstitutional in the 1990s (California Proposition 187), but access could be restricted by requiring government-issued identification cards or Social Security numbers at federally qualified health centers or health department clinics. In addition, as our pregnant patient showed us, a climate of deportation may dampen the use of existing resources, even among eligible people.5

To reduce barriers to care for immigrant families, the medical and public health community can engage in local and national politics and promote a welcoming, inclusive environment in our practices. Clinicians have access to powerful stories of human suffering and strength. The current climate presents a renewed opportunity to partner with advocacy groups and media to share stories of human experience that counter the Trump administration’s negative narrative about immigrants. The sharing of personal stories about the impact of the temporary immigrant ban through social and mainstream media has energized millions of people to express opposition to the ban. Portraits of scientists and doctors affected by the ban highlighted its unintended consequences for science and health care. Telling human stories is an effective rapid-response tool that we can use to advocate for our patients.

Clinicians and public health practitioners can also join forces to harness the power of data. We can monitor and measure health care utilization and health outcomes. Clinicians can pay attention to patterns in health care utilization among their immigrant patients and communicate worrisome trends to public health professionals. Some markers of child well-being — such as Medicaid enrollment rates among eligible children of foreign-born parents, teen pregnancy rates, uptake of supplemental nutrition assistance programs, school attendance, and bullying reports — are already monitored, allowing comparison of the pre- and post-election periods.

The election’s implications for undocumented adults may be more complicated to evaluate, since these adults are often invisible in conventional databases because of barriers to care and insufficient collection of relevant sociodemographic data (i.e., ethnic background, country of origin, and language preference). It’s important to develop inclusive methods that account for the unique needs of hidden populations. Some existing measures, however, can provide indications of a chilling effect, including utilization of safety-net clinics for sexual and reproductive health care, timeliness of prenatal care, domestic violence reports, and hate crimes (especially assaults resulting in emergency department visits)…

There are many reasons to support equitable access to care for all, regardless of nationality. Objective and scientifically rigorous data analysis will be essential in elucidating the interconnection between immigrants’ health and the public health and health care costs of the United States.

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Editorial
Rotavirus Vaccines — A New Hope
Mathuram Santosham, M.D., M.P.H., and Duncan Steele, Ph.D.
N Engl J Med 2017; 376:1170-1172 March 23, 2017 DOI: 10.1056/NEJMe1701347
[See full text in Milestones section above]

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Original Article
Efficacy of a Low-Cost, Heat-Stable Oral Rotavirus Vaccine in Niger
Sheila Isanaka, Sc.D., Ousmane Guindo, M.D., Celine Langendorf, Pharm.D., M.P.H., Amadou Matar Seck, M.D., Brian D. Plikaytis, M.Sc., Nathan Sayinzoga-Makombe, M.P.H., Monica M. McNeal, M.Sc., Nicole Meyer, M.Sc., Eric Adehossi, M.D., Ali Djibo, M.D., Bruno Jochum, M.S., and Rebecca F. Grais, Ph.D.
N Engl J Med 2017; 376:1121-1130 March 23, 2017 DOI: 10.1056/NEJMoa1609462
Abstract
[See full abstract in Milestones section above]