Leslie Pray – författare

All pharmaceutical products have inherent risks, and their use involves trade-offs between their therapeutic benefits and their risks. However, the public has a limited understanding of the benefits and risks of drugs, and many individuals believe that drugs approved by the U.S. Food and Drug Administration (FDA) carry no risks. The FDA is responsible for evaluating and balancing the potential risks of drugs with their potential benefits. Assessing, managing, and communicating the benefit-risk profile of a pharmaceutical product is a complex and nuanced scientific, political, and sociological challenge. Once the assessment is made, the FDA is then responsible for managing how to communicate these risks and make healthcare decisions based on them.

To explore these issues, the Forum on Drug Discovery, Development, and Translation conducted a public workshop entitled Understanding the Benefits and Risks of Pharmaceuticals, with the broad goals of gaining a better understanding of the current system used to evaluate benefit and risk, and to identify opportunities for improvement. This workshop was held in Washington, D.C., on May 30-31, 2006. The benefit-risk profiles of pharmaceuticals are constantly evolving as new data are collected throughout the life cycle of a drug. Discussions during the workshop focused on the following: (1) premarket assessment, during which clinical trial data are used to assess benefit and risk; (2) communication of that information to prescribing physicians and their patients; (3) healthcare decisions made by prescribing physicians and their patients; and (4) the accumulation of benefit-risk information from postmarketing experience, which feeds back into the other phases. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary explains in detail the discussions during this workshop.

As the principal agency regulating food, drugs, medical devices, and biological products used by Americans, the U.S. Food and Drug Administration (FDA) serves one of the most critical consumer protection functions of the federal government. The FDA''s reach is enormous, regulating products that represent roughly 25 percent of all consumer spending in the United States. Since 1992, however, federal funding for the agency has diminished, and the FDA''s Center for Drug Evaluation and Research (CDER) currently relies on the fees it receives from the industry it regulates to fund the majority of its drug regulation functions. Prescription drug safety is receiving heightened press coverage and congressional scrutiny as a result of recent, highly publicized events, such as the recall of Vioxx because of its link to heart attacks, and the link between certain antidepressants (selective serotonin reuptake inhibitors, or SSRIs) and an increased risk of suicidal ideation in children.

Legal regulations and manufacturers'' monitoring practices have not been enough to prevent contamination of the national food supply and protect consumers from serious harm. In addressing food safety risks, regulators could perhaps better ensure the quality and safety of food by monitoring food production not just at a single point in production but all along the way, from farm to table.

Recognizing the troubled state of food safety, the Institute of Medicine''s (IOM) Food Forum met in Washington, DC, on September 9, 2008, to explore the management of food safety practices from the beginning of the supply chain to the marketplace.

In the food industry, scientists are exploring the potential of nanotechnology to enhance the flavor and other sensory characteristics of foods, introduce antibacterial nanostructures into food packaging and encapsulate and deliver nutrients directly into targeted tissues, among other applications. However, as with any new technology, along with the benefits, there is the potential for unanticipated adverse effects. There is still a great deal to learn about any health outcomes related to introducing nanosized materials into foods and food packaging materials. Developing nanotechnology into a safe, effective tool for use in food science and technology will require addressing these and other questions. Assuring consumer confidence will be equally important to the success of this new emerging technology. The Institute of Medicine held a one-day workshop, summarized in this volume, to further explore the use of nanotechnology in food. Specifically, the workshop was organized around three primary topic areas: (1) the application of nanotechnology to food products; (2) the safety and efficacy of nanomaterials in food products; and (3) educating and informing consumers about the applications of nanotechnology to food products.

In the food industry, scientists are exploring the potential of nanotechnology to enhance the flavor and other sensory characteristics of foods, introduce antibacterial nanostructures into food packaging and encapsulate and deliver nutrients directly into targeted tissues, among other applications. However, as with any new technology, along with the benefits, there is the potential for unanticipated adverse effects. There is still a great deal to learn about any health outcomes related to introducing nanosized materials into foods and food packaging materials. Developing nanotechnology into a safe, effective tool for use in food science and technology will require addressing these and other questions. Assuring consumer confidence will be equally important to the success of this new emerging technology. The Institute of Medicine held a one-day workshop, summarized in this volume, to further explore the use of nanotechnology in food. Specifically, the workshop was organized around three primary topic areas: (1) the application of nanotechnology to food products; (2) the safety and efficacy of nanomaterials in food products; and (3) educating and informing consumers about the applications of nanotechnology to food products.

Does a longer life mean a healthier life? The number of adults over 65 in the United States is growing, but many may not be aware that they are at greater risk from foodborne diseases and their nutritional needs change as they age. The IOM''s Food Forum held a workshop October 29-30, 2009, to discuss food safety and nutrition concerns for older adults.

Does a longer life mean a healthier life? The number of adults over 65 in the United States is growing, but many may not be aware that they are at greater risk from foodborne diseases and their nutritional needs change as they age. The IOM''s Food Forum held a workshop October 29-30, 2009, to discuss food safety and nutrition concerns for older adults.

Globalization is by no means a new phenomenon; transcontinental trade and the movement of people date back at least 2,000 years, to the era of the ancient Silk Road trade route. The global spread of infectious disease has followed a parallel course. Indeed, the emergence and spread of infectious disease are, in a sense, the epitome of globalization. Although some experts mark the fall of the Berlin Wall as the beginning of this new era of globalization, others argue that it is not so new. The future of globalization is still in the making. Despite the successful attempts of the developed world during the course of the last century to control many infectious diseases and even to eradicate some deadly afflictions, 13 million people worldwide still die from such diseases every year.On April 16 and 17, 2002, the Forum on Emerging Infections held a working group discussion on the influence of globalization on the emergence and control of infectious diseases. The contents of the unattributed sections are based on the presentations and discussions that took place during the workshop. The Impact of Globalization on Infectious Disease Emergence and Control report summarizes the presentations and discussions related to the increasing cross-border and cross-continental movements of people and how this could exacerbate the emergence and global spread of infectious diseases. This report also summarizes the means by which sovereign states and nations must adopt a global public health mind-set and develop a new organizational framework to maximize the opportunities and overcome the challenges created by globalization and build the necessary capacity to respond effectively to emerging infectious disease threats.

An estimated forty million people carry the human immunodeficiency virus (HIV), and five million more become newly infected annually. In recent years, many HIV-infected patients in wealthy nations have enjoyed significantly longer, good-quality lives as a result of antiretroviral therapy (ART). However, most infected individuals live in the poorest regions of the world, where ART is virtually nonexistent. The consequent death toll in these regions—especially sub-Saharan Africa—is begetting economic and social collapse.

To inform the multiple efforts underway to deploy antiretroviral drugs in resource-poor settings, the Institute of Medicine committee was asked to conduct an independent review and assessment of rapid scale-up ART programs. It was also asked to identify the components of effective implementation programs.

At the heart of the committee''s report lie five imperatives:

Legal regulations and manufacturers'' monitoring practices have not been enough to prevent contamination of the national food supply and protect consumers from serious harm. In addressing food safety risks, regulators could perhaps better ensure the quality and safety of food by monitoring food production not just at a single point in production but all along the way, from farm to table.

Recognizing the troubled state of food safety, the Institute of Medicine''s (IOM) Food Forum met in Washington, DC, on September 9, 2008, to explore the management of food safety practices from the beginning of the supply chain to the marketplace.

As the principal agency regulating food, drugs, medical devices, and biological products used by Americans, the U.S. Food and Drug Administration (FDA) serves one of the most critical consumer protection functions of the federal government. The FDA''s reach is enormous, regulating products that represent roughly 25 percent of all consumer spending in the United States. Since 1992, however, federal funding for the agency has diminished, and the FDA''s Center for Drug Evaluation and Research (CDER) currently relies on the fees it receives from the industry it regulates to fund the majority of its drug regulation functions. Prescription drug safety is receiving heightened press coverage and congressional scrutiny as a result of recent, highly publicized events, such as the recall of Vioxx because of its link to heart attacks, and the link between certain antidepressants (selective serotonin reuptake inhibitors, or SSRIs) and an increased risk of suicidal ideation in children.

All pharmaceutical products have inherent risks, and their use involves trade-offs between their therapeutic benefits and their risks. However, the public has a limited understanding of the benefits and risks of drugs, and many individuals believe that drugs approved by the U.S. Food and Drug Administration (FDA) carry no risks. The FDA is responsible for evaluating and balancing the potential risks of drugs with their potential benefits. Assessing, managing, and communicating the benefit-risk profile of a pharmaceutical product is a complex and nuanced scientific, political, and sociological challenge. Once the assessment is made, the FDA is then responsible for managing how to communicate these risks and make healthcare decisions based on them.

To explore these issues, the Forum on Drug Discovery, Development, and Translation conducted a public workshop entitled Understanding the Benefits and Risks of Pharmaceuticals, with the broad goals of gaining a better understanding of the current system used to evaluate benefit and risk, and to identify opportunities for improvement. This workshop was held in Washington, D.C., on May 30-31, 2006. The benefit-risk profiles of pharmaceuticals are constantly evolving as new data are collected throughout the life cycle of a drug. Discussions during the workshop focused on the following: (1) premarket assessment, during which clinical trial data are used to assess benefit and risk; (2) communication of that information to prescribing physicians and their patients; (3) healthcare decisions made by prescribing physicians and their patients; and (4) the accumulation of benefit-risk information from postmarketing experience, which feeds back into the other phases. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary explains in detail the discussions during this workshop.

Fungal diseases have contributed to death and disability in humans, triggered global wildlife extinctions and population declines, devastated agricultural crops, and altered forest ecosystem dynamics. Despite the extensive influence of fungi on health and economic well-being, the threats posed by emerging fungal pathogens to life on Earth are often underappreciated and poorly understood. On December 14 and 15, 2010, the IOM''s Forum on Microbial Threats hosted a public workshop to explore the scientific and policy dimensions associated with the causes and consequences of emerging fungal diseases.

Fungal diseases have contributed to death and disability in humans, triggered global wildlife extinctions and population declines, devastated agricultural crops, and altered forest ecosystem dynamics. Despite the extensive influence of fungi on health and economic well-being, the threats posed by emerging fungal pathogens to life on Earth are often underappreciated and poorly understood. On December 14 and 15, 2010, the IOM''s Forum on Microbial Threats hosted a public workshop to explore the scientific and policy dimensions associated with the causes and consequences of emerging fungal diseases.

Obesity is a major public health challenge. More than one-third of the U.S. adult population is considered obese, a figure that has more than doubled since the mid-1970s. Among children, obesity rates have more than tripled over the same period. Not only is obesity associated with numerous medical complications, but it incurs significant economic cost. At its simplest, obesity is a result of an energy imbalance, with obese (and overweight) people consuming more energy (calories) than they are expending.During the last 10-20 years, behavioral scientists have made significant progress toward building an evidence base for understanding what drives energy imbalance in overweight and obese individuals. Meanwhile, food scientists have been tapping into this growing evidence base to improve existing technologies and create new technologies that can be applied to alter the food supply in ways that reduce the obesity burden on the American population. Leveraging Food Technology for Obesity Prevention and Reduction Effort examines the complexity of human eating behavior and explores ways in which the food industry can continue to leverage modern food processing technologies to influence energy intake. The report also examines the opportunities and challenges of altering the food supply—both at home and outside the home—and outlines lessons learned, best practices, and next steps.

Obesity is a major public health challenge. More than one-third of the U.S. adult population is considered obese, a figure that has more than doubled since the mid-1970s. Among children, obesity rates have more than tripled over the same period. Not only is obesity associated with numerous medical complications, but it incurs significant economic cost. At its simplest, obesity is a result of an energy imbalance, with obese (and overweight) people consuming more energy (calories) than they are expending.During the last 10-20 years, behavioral scientists have made significant progress toward building an evidence base for understanding what drives energy imbalance in overweight and obese individuals. Meanwhile, food scientists have been tapping into this growing evidence base to improve existing technologies and create new technologies that can be applied to alter the food supply in ways that reduce the obesity burden on the American population. Leveraging Food Technology for Obesity Prevention and Reduction Effort examines the complexity of human eating behavior and explores ways in which the food industry can continue to leverage modern food processing technologies to influence energy intake. The report also examines the opportunities and challenges of altering the food supply—both at home and outside the home—and outlines lessons learned, best practices, and next steps.

Many potential applications of synthetic and systems biology are relevant to the challenges associated with the detection, surveillance, and responses to emerging and re-emerging infectious diseases. On March 14 and 15, 2011, the Institute of Medicine''s (IOM''s) Forum on Microbial Threats convened a public workshop in Washington, DC, to explore the current state of the science of synthetic biology, including its dependency on systems biology; discussed the different approaches that scientists are taking to engineer, or reengineer, biological systems; and discussed how the tools and approaches of synthetic and systems biology were being applied to mitigate the risks associated with emerging infectious diseases.

The Science and Applications of Synthetic and Systems Biology is organized into sections as a topic-by-topic distillation of the presentations and discussions that took place at the workshop. Its purpose is to present information from relevant experience, to delineate a range of pivotal issues and their respective challenges, and to offer differing perspectives on the topic as discussed and described by the workshop participants. This report also includes a collection of individually authored papers and commentary.

More than 16 million children in the United States live in food-insecure households where they are unable to obtain enough food to meet their needs. At the same time, a growing number of children are overweight or obese. Because of these challenges, improving child nutrition has emerged as one of the nation''s most urgent public health needs. The Child and Adult Care Food Program (CACFP), a U.S. Department of Agriculture (USDA) food program, served about 3.3 million children in 2011, as well as more than 124,000 adults who require daily supervision or assistance. Since many children rely on CACFP for the majority of their daily food, the quality of foods provided has the potential to greatly improve the health of the children''s diets. The USDA asked the IOM to review and recommend improvements, as necessary, to the CACFP meal requirements in order to keep them aligned with other federally funded food assistance programs and with the Dietary Guidelines for Americans. The 2011 IOM report, Child and Adult Care Food Program Aligning Dietary Guidance for All, reviewed the program in detail and provided recommendations for improvement.In February 2012, at the request of the USDA, the IOM conducted an additional workshop to examine research methods and approaches that could be used to design and conduct a nationally representative study assessing children''s dietary intake and participation rates in child care facilities, including CACFP-sponsored child care centers and homes. Research Methods to Assess Dietary Intake and Program Participation in Child Day Care: Application to the Child and Adult Care Food Program Workshop Summary is the report that summarizes the workshop.

The leading challenges in public health—ranging from rising obesity rates to the fast-growing population of older adults—are complex and cannot be solved effectively by any one silver bullet or any one sector in isolation. Instead, their solutions require collaborative actions of many sectors, including industry, government, academia, and nongovernmental organizations. To better understand how to build multisectoral food and nutrition partnerships that achieve meaningful public health results, the IOM''s Food Forum held a workshop on November 1-2, 2011, in Washington, D.C.

The workshop brought together stakeholders from various sectors to discuss the benefits and risks of pursuing cross-sector partnerships, foster communication between sectors, and explore opportunities of mutual interest in food and nutrition that are most conducive for partnerships. Participants also discussed the perspectives of the various sectors, key features of successful partnerships, and what needs to be done to facilitate partnership development. This report, Building Public-Private Partnerships in Food and Nutrition: Workshop Summary, summarizes the workshop.

The U.S. food system provides many benefits, not the least of which is a safe, nutritious and consistent food supply. However, the same system also creates significant environmental, public health, and other costs that generally are not recognized and not accounted for in the retail price of food. These include greenhouse gas (GHG) emissions, soil erosion, air pollution, and their environmental consequences, the transfer of antibiotic resistance from food animals to human, and other human health outcomes, including foodborne illnesses and chronic disease. Some external costs which are also known as externalities are accounted for in ways that do not involve increasing the price of food. But many are not. They are borne involuntarily by society at large. A better understanding of external costs would help decision makers at all stages of the life cycle to expand the benefits of the U.S. food system even further. The Institute of Medicine (IOM) and the National Research Council (NRC) with support from the U.S. Centers for Disease Control and Prevention (CDC) convened a public workshop on April 23-23, 2012, to explore the external costs of food, methodologies for quantifying those costs, and the limitations of the methodologies.

The workshop was intended to be an information-gathering activity only. Given the complexity of the issues and the broad areas of expertise involved, workshop presentations and discussions represent only a small portion of the current knowledge and are by no means comprehensive. The focus was on the environmental and health impacts of food, using externalities as a basis for discussion and animal products as a case study. The intention was not to quantify costs or benefits, but rather to lay the groundwork for doing so. A major goal of the workshop was to identify information sources and methodologies required to recognize and estimate the costs and benefits of environmental and public health consequences associated with the U.S. food system. It was anticipated that the workshop would provide the basis for a follow-up consensus study of the subject and that a central task of the consensus study will be to develop a framework for a full-scale accounting of the environmental and public health effects for all food products of the U.S. food system.

Exploring Health and Environmental Costs of Food: Workshop Summary provides the basis for a follow-up planning discussion involving members of the IOM Food and Nutrition Board and the NRC Board on Agriculture and Natural Resources and others to develop the scope and areas of expertise needed for a larger-scale, consensus study of the subject.

The Food Forum convened a public workshop on February 22-23, 2012, to explore current and emerging knowledge of the human microbiome, its role in human health, its interaction with the diet, and the translation of new research findings into tools and products that improve the nutritional quality of the food supply. The Human Microbiome, Diet, and Health: Workshop Summary summarizes the presentations and discussions that took place during the workshop. Over the two day workshop, several themes covered included:

More than 30 years ago, the Institute of Medicine (IOM) and the National Research Council (NRC) convened a committee to determine methodologies and research needed to evaluate childbirth settings in the United States. The committee members reported their findings and recommendations in a consensus report, Research Issues in the Assessment of Birth Settings (IOM and NRC, 1982). An Update on Research Issues in the Assessment of Birth Settings is the summary of a workshop convened in March, 2013, to review updates to the 1982 report. Health care providers, researchers, government officials, and other experts from midwifery, nursing, obstetric medicine, neonatal medicine, public health, social science, and related fields presented and discussed research findings that advance our understanding of the effects of maternal care services in different birth settings on labor, clinical and other birth procedures, and birth outcomes. These settings include conventional hospital labor and delivery wards, birth centers, and home births. This report identifies datasets and relevant research literature that may inform a future ad hoc consensus study to address these concerns.

One of the many benefits of the U.S. food system is a safe, nutritious, and consistent food supply. However, the same system also places significant strain on land, water, air, and other natural resources. A better understanding of the food-environment synergies and trade-offs associated with the U.S. food system would help to reduce this strain. Many experts would like to use that knowledge to develop dietary recommendations on the basis of environmental as well as nutritional considerations. But identifying and quantifying those synergies and trade-offs, let alone acting on them, is a challenge in and of itself. The difficulty stems in part from the reality that experts in the fields of nutrition, agricultural science, and natural resource use often do not regularly collaborate with each other, with the exception of some international efforts.

Sustainable Diets is the summary of a workshop convened by The Institute of Medicine''s Food Forum and Roundtable on Environmental Health Sciences,Research, and Medicine in May 2013 to engender dialogue between experts in nutrition and experts in agriculture and natural resource sustainability and to explore current and emerging knowledge on the food and nutrition policy implications of the increasing environmental constraints on the food system. Experts explored the relationship between human health and the environment, including the identification and quantification of the synergies and trade-offs of their impact. This report explores the role of the food price environment and how environmental sustainability can be incorporated into dietary guidance and considers research priorities, policy implications, and drivers of consumer behaviors that will enable sustainable food choices.

Caffeine in Food and Dietary Supplements is the summary of a workshop convened by the Institute of Medicine in August 2013 to review the available science on safe levels of caffeine consumption in foods, beverages, and dietary supplements and to identify data gaps. Scientists with expertise in food safety, nutrition, pharmacology, psychology, toxicology, and related disciplines; medical professionals with pediatric and adult patient experience in cardiology, neurology, and psychiatry; public health professionals; food industry representatives; regulatory experts; and consumer advocates discussed the safety of caffeine in food and dietary supplements, including, but not limited to, caffeinated beverage products, and identified data gaps.

Caffeine, a central nervous stimulant, is arguably the most frequently ingested pharmacologically active substance in the world. Occurring naturally in more than 60 plants, including coffee beans, tea leaves, cola nuts and cocoa pods, caffeine has been part of innumerable cultures for centuries. But the caffeine-in-food landscape is changing. There are an array of new caffeine-containing energy products, from waffles to sunflower seeds, jelly beans to syrup, even bottled water, entering the marketplace. Years of scientific research have shown that moderate consumption by healthy adults of products containing naturally-occurring caffeine is not associated with adverse health effects. The changing caffeine landscape raises concerns about safety and whether any of these new products might be targeting populations not normally associated with caffeine consumption, namely children and adolescents, and whether caffeine poses a greater health risk to those populations than it does for healthy adults. This report delineates vulnerable populations who may be at risk from caffeine exposure; describes caffeine exposure and risk of cardiovascular and other health effects on vulnerable populations, including additive effects with other ingredients and effects related to pre-existing conditions; explores safe caffeine exposure levels for general and vulnerable populations; and identifies data gaps on caffeine stimulant effects.