Sally Robinson – författare

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.

In recent years, the costs of new drug development have skyrocketed. The average cost of developing a new approved drug is now estimated to be $1.3 billion (DiMasi and Grabowski, 2007). At the same time, each year fewer new molecular entities (NMEs) are approved. DiMasi and Grabowski report that only 21.5 percent of the candidate drugs that enter phase I clinical testing actually make it to market. In 2007, just 17 novel drugs and 2 novel biologics were approved. In addition to the slowing rate of drug development and approval, recent years have seen a number of drugs withdrawn from the market for safety reasons. According to the Government Accountability Office (GAO), 10 drugs were withdrawn because of safety concerns between 2000 and March 2006 (GAO, 2006). Finding ways to select successful drug candidates earlier in development could save millions or even billions of dollars, reduce the costs of drugs on the market, and increase the number of new drugs with improved safety profiles that are available to patients.

The process for developing new drug and biologic products is extraordinarily expensive and time-consuming. Although large pharmaceutical companies may be able to afford the cost of development because they can expect a large return on investment, organizations developing drugs to treat rare and neglected diseases are unable to rely on such returns.

On June 23, 2008, the Institute of Medicine''s Forum on Drug Discovery, Development, and Translation held a public workshop, "Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies," which sought to explore new and innovative strategies for developing drugs for rare and neglected diseases.

Tuberculosis is one of the leading causes of death in the world today, with 4,500 people dying from the disease every day. Many cases of TB can be cured by available antibiotics, but some TB is resistant to multiple drugs—a major and growing threat worldwide. The Institute of Medicine''s Forum on Drug Discovery, Development, and Translation hosted a workshop on November 5, 2008, to address the mounting concern of drug-resistant TB. The session brought together a wide range of international experts to discuss what is known and not known about this growing threat, and to explore possible solutions.

Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development.

On October 24, 2008, the IOM''s Forum on Drug Discovery, Development, and Translation held "Assessing and Accelerating Development of Biomarkers for Drug Safety," a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development.

Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development.

On October 24, 2008, the IOM''s Forum on Drug Discovery, Development, and Translation held "Assessing and Accelerating Development of Biomarkers for Drug Safety," a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development.

Tuberculosis is one of the leading causes of death in the world today, with 4,500 people dying from the disease every day. Many cases of TB can be cured by available antibiotics, but some TB is resistant to multiple drugs—a major and growing threat worldwide. The Institute of Medicine''s Forum on Drug Discovery, Development, and Translation hosted a workshop on November 5, 2008, to address the mounting concern of drug-resistant TB. The session brought together a wide range of international experts to discuss what is known and not known about this growing threat, and to explore possible solutions.

The process for developing new drug and biologic products is extraordinarily expensive and time-consuming. Although large pharmaceutical companies may be able to afford the cost of development because they can expect a large return on investment, organizations developing drugs to treat rare and neglected diseases are unable to rely on such returns.

On June 23, 2008, the Institute of Medicine''s Forum on Drug Discovery, Development, and Translation held a public workshop, "Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies," which sought to explore new and innovative strategies for developing drugs for rare and neglected diseases.

In recent years, the costs of new drug development have skyrocketed. The average cost of developing a new approved drug is now estimated to be $1.3 billion (DiMasi and Grabowski, 2007). At the same time, each year fewer new molecular entities (NMEs) are approved. DiMasi and Grabowski report that only 21.5 percent of the candidate drugs that enter phase I clinical testing actually make it to market. In 2007, just 17 novel drugs and 2 novel biologics were approved. In addition to the slowing rate of drug development and approval, recent years have seen a number of drugs withdrawn from the market for safety reasons. According to the Government Accountability Office (GAO), 10 drugs were withdrawn because of safety concerns between 2000 and March 2006 (GAO, 2006). Finding ways to select successful drug candidates earlier in development could save millions or even billions of dollars, reduce the costs of drugs on the market, and increase the number of new drugs with improved safety profiles that are available to patients.

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.

Priorities for Health Promotion and Public Health brings together the evidence behind the UK’s public health priorities into one comprehensible textbook.

Taking one theme per chapter, the book examines the social and environmental influences that shape people’s health; health inequalities; poverty and health; mental, emotional and spiritual health; sexual health; physical inactivity; diet; tobacco; alcohol; drugs; weight; cardiovascular disease; cancer; diabetes and dementia. The book takes a holistic approach, combining scientific and epidemiological evidence with the subjective experiences of those who undergo these health journeys. Each chapter explains the causes of poor health and the evidence behind the recommendations for good health and ends by demonstrating the health benefits of positive action. This is a core text for those studying health promotion or public health, and a supplementary text for students of healthcare and social care. The book focusses on adults’ health in the UK, with examples from the four nations, and provides some contextual international information where relevant.

Priorities for Health Promotion and Public Health is an ideal companion for busy practitioners who work across the wider sectors that support people’s health and wellbeing. It is also an essential textbook for students new to health promotion and public health.

Priorities for Health Promotion and Public Health brings together the evidence behind the UK’s public health priorities into one comprehensible textbook.

Taking one theme per chapter, the book examines the social and environmental influences that shape people’s health; health inequalities; poverty and health; mental, emotional and spiritual health; sexual health; physical inactivity; diet; tobacco; alcohol; drugs; weight; cardiovascular disease; cancer; diabetes and dementia. The book takes a holistic approach, combining scientific and epidemiological evidence with the subjective experiences of those who undergo these health journeys. Each chapter explains the causes of poor health and the evidence behind the recommendations for good health and ends by demonstrating the health benefits of positive action. This is a core text for those studying health promotion or public health, and a supplementary text for students of healthcare and social care. The book focusses on adults’ health in the UK, with examples from the four nations, and provides some contextual international information where relevant.

Priorities for Health Promotion and Public Health is an ideal companion for busy practitioners who work across the wider sectors that support people’s health and wellbeing. It is also an essential textbook for students new to health promotion and public health.

Principles and Practice of Health Promotion and Public Health brings together the disciplines and fields of study that inform the work of promoting health into one book and provides many examples of practice.

It starts with understanding ourselves and our health and continues with chapters on working in health promotion and public health; epidemiology; research methods and evidence-based practice; health psychology; communicating health; health education; health promotion; public health; health protection; arts and health; tackling tobacco, alcohol and drugs; tackling overweight; promoting health in workplaces and promoting health within the National Health Service. Together these communicate the core principles of how to prevent disease and promote health when working with individuals, communities and populations in any country across the world. The book focusses on adults’ health and includes international and UK examples. Principles and Practice of Health Promotion and Public Health complements Priorities for Health Promotion and Public Health, published in 2021. Both are core texts for those studying health promotion or public health and supplementary texts for students of healthcare and social care. They are ideal for public health practitioners and members of the wider public health workforce.

Principles and Practice of Health Promotion and Public Health brings together the disciplines and fields of study that inform the work of promoting health into one book and provides many examples of practice.

It starts with understanding ourselves and our health and continues with chapters on working in health promotion and public health; epidemiology; research methods and evidence-based practice; health psychology; communicating health; health education; health promotion; public health; health protection; arts and health; tackling tobacco, alcohol and drugs; tackling overweight; promoting health in workplaces and promoting health within the National Health Service. Together these communicate the core principles of how to prevent disease and promote health when working with individuals, communities and populations in any country across the world. The book focusses on adults’ health and includes international and UK examples. Principles and Practice of Health Promotion and Public Health complements Priorities for Health Promotion and Public Health, published in 2021. Both are core texts for those studying health promotion or public health and supplementary texts for students of healthcare and social care. They are ideal for public health practitioners and members of the wider public health workforce.

Educating Children with Life-Limiting Conditions supports teachers who are working with children with life-limiting or life-threatening conditions in mainstream schools by providing them with the core knowledge and skills that underpin effective practice within a whole-school and cross-agency approach. Mainstream schools now include increasing numbers of children with life-limiting or life-threatening conditions, and this accessible book is written by a team comprised of both education and health professionals, helping to bridge the gap between different services.

Recognising the complexity of individual cases, the authors communicate key principles relating to the importance of communication, multi-professional understanding and working and proactive planning for meeting the needs of any child with a life-limiting or life-threatening condition that can be applied to a range of situations.

Reflective activities and practical resources are provided and are also available to download. This book will be of interest to teachers in mainstream schools, as well as teachers, SENCOs and senior leaders in all school settings, school nurses, children’s nurses and allied health professionals.

Educating Children with Life-Limiting Conditions supports teachers who are working with children with life-limiting or life-threatening conditions in mainstream schools by providing them with the core knowledge and skills that underpin effective practice within a whole-school and cross-agency approach. Mainstream schools now include increasing numbers of children with life-limiting or life-threatening conditions, and this accessible book is written by a team comprised of both education and health professionals, helping to bridge the gap between different services.

Recognising the complexity of individual cases, the authors communicate key principles relating to the importance of communication, multi-professional understanding and working and proactive planning for meeting the needs of any child with a life-limiting or life-threatening condition that can be applied to a range of situations.

Reflective activities and practical resources are provided and are also available to download. This book will be of interest to teachers in mainstream schools, as well as teachers, SENCOs and senior leaders in all school settings, school nurses, children’s nurses and allied health professionals.

Expansive in scope, the Handbook illustrates how language, law and concepts about human rights impact the way that disability policy is framed and implemented. Chapters use the lenses of human rights, welfare, health and economic inclusion to address contemporary policy questions such as globalization and technology. Grounded in lived experiences, the Handbook interweaves personal narratives from people with disabilities which provide important insights into how policy impacts opportunity and point to future possibilities for the influence of human rights on policy change. As narrative author Karla Garcia Luiz reflects, ‘We often share situations that make us feel lonely, exhausted, insecure, questioning ourselves.... When we share, we realize that these feelings are collective and, [in]naming them we re-signify them and, thus, we strengthen ourselves for political action’.

Informed by international, comparative experiences, this Handbook will be an engaging and perceptive resource for students and scholars of sociology and social policy, health and welfare studies and disability policy. With diverse examples from across the Global North and South, it will also appeal to people working in social policy who are looking to develop and reform policies to be more inclusive, accessible and progressive towards people with disabilities.