Understanding the relationship between energy balance and obesity is essential to develop effective prevention programs and policies. The International Agency for Research on Cancer convened a Working Group of world-leading experts in December 2015 to review the evidence regarding energy balance and obesity, with a focus on low- and middle-income countries, and to consider the following scientific questions: (i) Are the drivers of the obesity epidemic related only to energy excess and/or do specific foods or nutrients play a major role in this epidemic? (ii) What are the factors that modulate these associations? (iii) Which types of data and/or studies will further improve our understanding? This book provides summaries of the evidence from the literature as well as the Working Group's conclusions and recommendations to tackle the global epidemic of obesity.
This book provides an evaluation of measures to reduce exposure to highly toxic and carcinogenic contaminants in staple diets in Africa as well as parts of Asia and Latin America. Many of the poorest people in these regions are exposed to the pervasive natural toxins, aflatoxins and fumonisins, on a daily basis by eating their staple diet of groundnuts, maize, and other cereals. Exposure to mycotoxins at these high levels substantially increases mortality and morbidity. Aflatoxins are a cause of human liver cancer, and fatalities from acute aflatoxin poisoning outbreaks occur in Africa and Asia. The International Agency for Research on Cancer convened a Working Group of world-leading experts to review the health effects of aflatoxins and fumonisins and to evaluate intervention measures. The panel concluded that these mycotoxins not only are a cause of acute poisoning and cancer but also are a likely contributor to the high levels of stunting in children in affected populations. The Working Group also identified effective measures to reduce exposure in developing countries. The panel evaluated 15 interventions, considering the strength of the evidence as well as its completeness and its transferability at an individual, community, or national level. Four of the interventions were judged to be ready for implementation: improvement of dietary diversity; crop sorting; post-harvest measures, including improved storage; and, in Latin America for maize, optimized nixtamalization. These recommendations would be relevant for investment of public, nongovernmental organization, and private funds at the scale of the subsistence farmer, the smallholder, and through to a more advanced value chain.
In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators. The CIOMS V Working Group has generated proposals for pragmatic approaches to dealing with such issues as: classification and handling of individual safety case reports from a variety of sources (spontaneous consumer reports solicited reports literature the Internet observational studies and secondary data bases disease and other registries regulatory ADR databases and licensor-licensee interactions); new approaches to case management and regulatory reporting practices (proper clinical evaluation of cases incidental vs other events patient and reporter identifiability seriousness criteria expectedness criteria case follow-up criteria and the role and structure of case narratives); improvements and efficiencies in the format content and reporting of periodic safety update reports (PSURs) (including results of an industry survey on PSUR workloads and practices; proposals for high case volume and long time-period reports simplification of certain PSURs summary bridging reports addendum reports license renewal reports for EU and Japan dealing with old products and other technical details); determination and use of population exposure (denominator) data (sources of data and a guide to analytical approaches for a variety of circumstances).The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process. In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals.
At any point in the drug development process, systematic reviews and meta-analysis can provide important information to guide the future path of the development program and any actions that might be needed in the post-marketing setting. This report gives the rationale for why and when a meta-analysis should be considered, all in the context of regulatory decision-making, and the tasks, data collection, and analyses that need to be carried out to inform those decisions. There is increasing demand by decision-makers in health care, the bio-pharmaceutical industry, and society at large to have access to the best available evidence on benefits and risks of medicinal products. The best strategy will take an overview of all the evidence and where it is possible and sensible, combine the evidence and summarize the results. For efficacy, the outcomes generally use the same or very similar predefined events for each of the trials to be included. Most regulatory guidance and many Cochrane Collaboration reviews have usually given more attention to assessment of benefits, while issues around combining evidence on harms have not been as well-covered. However, the (inevitably) unplanned nature of the data on safety makes the process more difficult. Combining evidence on adverse events (AEs), where these were not the focus of the original studies, is more challenging than combining evidence on pre-specified benefits. This focus on AEs represents the main contribution of the current CIOMS X report. The goal of the CIOMS X report is to provide principles on appropriate application of meta-analysis in assessing safety of pharmaceutical products to inform regulatory decision-making. This report is about meta-analysis in this narrow area, but the present report should also provide conceptually helpful points to consider for a wider range of applications, such as vaccines, medical devices, veterinary medicines or even products that are combinations of medicinal products and medical devices. Although some of the content of this report describes highly technical statistical concepts and methods (in particular Chapter 4), the ambition of the working group has been to make it comprehensible to non-statisticians for its use in clinical epidemiology and regulatory science. To that end, Chapters 3 and 4, which contain the main technical statistical aspects of the appropriate design, analysis and reporting of a meta-analysis of safety data are followed by Chapter 5 with a thought process for evaluating the findings of a meta-analysis and how to communicate these.
Extreme weather and climate events, interacting with exposed and vulnerable human and natural systems, can lead to disasters. This Special Report explores the social as well as physical dimensions of weather- and climate-related disasters, considering opportunities for managing risks at local to international scales. SREX was approved and accepted by the Intergovernmental Panel on Climate Change (IPCC) on 18 November 2011 in Kampala, Uganda.
In recent years public expectations for rapid identification and prompt management of emerging drug safety issues have grown swiftly. Over a similar timeframe, the move from paper-based adverse event reporting systems to electronic capture and rapid transmission of data has resulted in the accrual of substantial datasets capable of complex analysis and querying by industry, regulators and other public health organizations. These two drivers have created a fertile environment for pharmacovigilance scientists, information technologists and statistical experts, working together, to deliver novel approaches to detect signals from these extensive and quickly growing datasets, and to manage them appropriately. In following this exciting story, this report looks at the practical consequences of these developments for pharmacovigilance practitioners. The report provides a comprehensive resource for those considering how to strengthen their pharmacovigilance systems and practices, and to give practical advice. But the report does not specify instant solutions. These will inevitably be situation specific and require careful consideration taking into account local needs. However, the CIOMS Working Group VIII is convinced that the combination of methods and a clear policy on the management of signals will strengthen current systems. Finally, in looking ahead, the report anticipates a number of ongoing developments, including techniques with wider applicability to other data forms than individual case reports. The ultimate test for pharmacovigilance systems is the demonstration of public health benefit and it is this test which signal detection methodologies need to meet if the expectations of all stakeholders are to be fulfilled.
This report contains the main discussion points and general conclusions and recommendations from the third session of the Working Group convened from 20-21 August 2019 in FAO headquarters, Rome, Italy. The working group considered a range of issues including: a brief review of the process of preparation of the first report on The State of the World’s Aquatic Genetic Resources for Food and Agriculture; (SoWAqGR); the preparation of a GPA on AqGR (GPA); the development of a global information system on aquatic genetic resources including a registry of farmed types; the development of a strategic approach to work on AqGR at FAO; and reviewed its terms of reference (ToR) and update its workplan. A series of recommendations were made to FAO and to the Committee on Fisheries’ sub-committee on aquaculture.
