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Table of Contents

September 2011

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Why Drug Safety Should Not Take a Back Seat to Efficacy
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In this month’s editorial, the PLoS Medicine Editors argue that methodological challenges in monitoring the safety of prescription medications should not mean that drug safety be considered less important a topic of study than efficacy. The Editors also highlight the debates that continue about the best ways to meaningfully synthesize and interpret data on the possible harmful effects of drugs—for example, how passive surveillance systems (spontaneous reports of suspected adverse reactions) should be improved, whether new drugs should go through a phased launch process with enhanced safety evaluations, and how appropriate risk mitigation strategies are for drugs with safety concerns. Also published this month, a research article by Patricia McGettigan and David Henry reevaluates the evidence from observational studies on the cardiovascular risk associated with non-steroidal anti-inflammatory drugs (NSAIDs). In this systematic review report, the authors provide estimates of the comparative risks with individual NSAIDs at typical doses in community settings. The authors conducted literature searches and pooled adjusted estimates of relative risks (RRs) for cardiovascular events with use of individual NSAIDs, by dose, and in populations with low and high background risks and compare individual drugs in pairwise analyses generating ratios of relative risks (RRRs).

Image Credit: Kristine Paulus at flickr.com

Editorial

Why Drug Safety Should Not Take a Back Seat to Efficacy

The PLoS Medicine Editors

PLOS Medicine: published September 27, 2011 | https://doi.org/10.1371/journal.pmed.1001097

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  1. Cardiovascular Risk with Non-Steroidal Anti-Inflammatory Drugs: Systematic Review of Population-Based Controlled Observational Studies

Perspective

African Malaria Control Programs Deliver ITNs and Achieve What the Clinical Trials Predicted

Thomas P. Eisele, Richard W. Steketee

PLOS Medicine: published September 6, 2011 | https://doi.org/10.1371/journal.pmed.1001088

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  1. Net Benefits: A Multicountry Analysis of Observational Data Examining Associations between Insecticide-Treated Mosquito Nets and Health Outcomes

Health in Action

Strengthening the Informed Consent Process in International Health Research through Community Engagement: The KEMRI-Wellcome Trust Research Programme Experience

Mwanamvua Boga, Alun Davies, Dorcas Kamuya, Samson M. Kinyanjui, Ester Kivaya, Francis Kombe, Trudie Lang, Vicki Marsh, Bibi Mbete, Albert Mlamba, Sassy Molyneux, Stephen Mulupi, Salim Mwalukore

PLOS Medicine: published September 13, 2011 | https://doi.org/10.1371/journal.pmed.1001089

Policy Forums

Assessing and Strengthening African Universities' Capacity for Doctoral Programmes

Imelda Bates, Richard Phillips, Ruby Martin-Peprah, Gibson Kibiki, Oumar Gaye, Kamija Phiri, Harry Tagbor, Sue Purnell

PLOS Medicine: published September 13, 2011 | https://doi.org/10.1371/journal.pmed.1001068

Informing the 2011 UN Session on Noncommunicable Diseases: Applying Lessons from the AIDS Response

Peter Lamptey, Michael Merson, Peter Piot, K. Srinath Reddy, Rebecca Dirks

PLOS Medicine: published September 6, 2011 | https://doi.org/10.1371/journal.pmed.1001086

Towards Improved Measurement of Financial Protection in Health

Rodrigo Moreno-Serra, Christopher Millett, Peter C. Smith

PLOS Medicine: published September 6, 2011 | https://doi.org/10.1371/journal.pmed.1001087

Guidelines and Guidance

Setting Research Priorities to Reduce Global Mortality from Childhood Pneumonia by 2015

Igor Rudan, Shams El Arifeen, Zulfiqar A. Bhutta, Robert E. Black, Abdullah Brooks, Kit Yee Chan, Mickey Chopra, Trevor Duke, David Marsh, Antonio Pio, Eric A.F. Simoes, Giorgio Tamburlini, Evropi Theodoratou, Martin W. Weber, Cynthia G. Whitney, Harry Campbell, Shamim A. Qazi, and the WHO/CHNRI Expert Group on Childhood Pneumonia

PLOS Medicine: published September 27, 2011 | https://doi.org/10.1371/journal.pmed.1001099

Research Priorities for Mental Health and Psychosocial Support in Humanitarian Settings

Wietse A. Tol, Vikram Patel, Mark Tomlinson, Florence Baingana, Ananda Galappatti, Catherine Panter-Brick, Derrick Silove, Egbert Sondorp, Michael Wessells, Mark van Ommeren

PLOS Medicine: published September 20, 2011 | https://doi.org/10.1371/journal.pmed.1001096

Research Articles

Cost-Effectiveness of Early Versus Standard Antiretroviral Therapy in HIV-Infected Adults in Haiti

Serena P. Koenig, Heejung Bang, Patrice Severe, Marc Antoine Jean Juste, Alex Ambroise, Alison Edwards, Jessica Hippolyte, Daniel W. Fitzgerald, Jolion McGreevy, Cynthia Riviere, Serge Marcelin, Rode Secours, Warren D. Johnson, Jean W. Pape, Bruce R. Schackman

PLOS Medicine: published September 20, 2011 | https://doi.org/10.1371/journal.pmed.1001095

Net Benefits: A Multicountry Analysis of Observational Data Examining Associations between Insecticide-Treated Mosquito Nets and Health Outcomes

Stephen S. Lim, Nancy Fullman, Andrew Stokes, Nirmala Ravishankar, Felix Masiye, Christopher J. L. Murray, Emmanuela Gakidou

PLOS Medicine: published September 6, 2011 | https://doi.org/10.1371/journal.pmed.1001091

Related Articles

  1. African Malaria Control Programs Deliver ITNs and Achieve What the Clinical Trials Predicted

Cardiovascular Risk with Non-Steroidal Anti-Inflammatory Drugs: Systematic Review of Population-Based Controlled Observational Studies

Patricia McGettigan, David Henry

PLOS Medicine: published September 27, 2011 | https://doi.org/10.1371/journal.pmed.1001098

Related Articles

  1. Why Drug Safety Should Not Take a Back Seat to Efficacy

Dissecting Inflammatory Complications in Critically Injured Patients by Within-Patient Gene Expression Changes: A Longitudinal Clinical Genomics Study

Keyur H. Desai, Chuen Seng Tan, Jeffrey T. Leek, Ronald V. Maier, Ronald G. Tompkins, John D. Storey, and the Inflammation and the Host Response to Injury Large-Scale Collaborative Research Program

PLOS Medicine: published September 13, 2011 | https://doi.org/10.1371/journal.pmed.1001093

IL28B, HLA-C, and KIR Variants Additively Predict Response to Therapy in Chronic Hepatitis C Virus Infection in a European Cohort: A Cross-Sectional Study

Vijayaprakash Suppiah, Silvana Gaudieri, Nicola J. Armstrong, Kate S. O'Connor, Thomas Berg, Martin Weltman, Maria Lorena Abate, Ulrich Spengler, Margaret Bassendine, Gregory J. Dore, William L. Irving, Elizabeth Powell, Margaret Hellard, Stephen Riordan, Gail Matthews, David Sheridan, Jacob Nattermann, Antonina Smedile, Tobias Müller, Emma Hammond, David Dunn, Francesco Negro, Pierre-Yves Bochud, Simon Mallal, Golo Ahlenstiel, Graeme J. Stewart, Jacob George, David R. Booth, for the International Hepatitis C Genetics Consortium (IHCGC)

PLOS Medicine: published September 13, 2011 | https://doi.org/10.1371/journal.pmed.1001092

Alcohol Consumption at Midlife and Successful Ageing in Women: A Prospective Cohort Analysis in the Nurses' Health Study

Qi Sun, Mary K. Townsend, Olivia I. Okereke, Eric B. Rimm, Frank B. Hu, Meir J. Stampfer, Francine Grodstein

PLOS Medicine: published September 6, 2011 | https://doi.org/10.1371/journal.pmed.1001090

Living Alone and Alcohol-Related Mortality: A Population-Based Cohort Study from Finland

Kimmo Herttua, Pekka Martikainen, Jussi Vahtera, Mika Kivimäki

PLOS Medicine: published September 20, 2011 | https://doi.org/10.1371/journal.pmed.1001094