Stop the FDA PDF Download

Author: John Morgenthaler
Publisher: Smart Publications
ISBN: 9780962741883
Category : Health & Fitness
Languages : en
Pages : 196

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Author: Philip J. Hilts
Publisher: UNC Press Books
ISBN: 9780807855829
Category : Aliments
Languages : en
Pages : 0

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Book Description
Emerging out of Theodore Roosevelt's desire to civilize capitalism, the Food and Drug Administration was created to stop the trade in adulterated meats and quack drugs. This history of the agency takes readers back to its beginnings, and makes startlingly clear the essential role the FDA has played in maintaining the quality of life and health to which the American public has long been accustomed.

Author: Dr. Renee Joy Dufault
Publisher: Square One Publishers, Inc.
ISBN: 0757054366
Category : Health & Fitness
Languages : en
Pages : 272

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Book Description
Each year, Americans consume hundreds of food products that contain truly dangerous compounds, including heavy metals, pesticides, and other harmful additives—with the blessing of the FDA. Why is this happening and why haven’t you heard about it? In Unsafe at Any Meal, Dr. Renee Dufault, former food investigator for the Food and Drug Administration, provides the startling answers. While at the FDA, Dr. Dufault discovered that mercury—a highly toxic metal—was contaminating the plumbing systems of many food manufacturing plants. Upon further examination, she discovered that the same mercury was also evident in a number of processed foods commonly sold in supermarkets. When Dr. Dufault revealed these disturbing findings to her superiors, she was told to stop her investigation. Her continued efforts to raise the issue always met with a dead end, so she chose to take an early retirement from the FDA. Dr. Dufault then devoted her energy to making the public aware of the insidious dangers that contaminate our food. In 2010, she founded an organization of scientists to study the scope of this problem and has published numerous research articles on the topic with little fanfare. To expose what still seems to be a well-kept secret by the FDA, she has written Unsafe at Any Meal to provide consumers with the information they need to know. The book begins with the author’s story leading up to the creation of this work. It then describes the various toxic substances that are most commonly found in our food supply, and explains how they affect your genes, health, and the surrounding environment. After examining the Standard American Diet, which is sorely lacking in disease-preventing nutrients, it discusses the country’s trend toward consuming a skyrocketing amount of ingredients that can contain heavy metals. It further shows how exposure to these heavy metals can contribute to conditions such as ADHD or autism. Also included is a helpful guide to reading food labels, recognizing misleading marketing tactics, and knowing what to look for—and what to look out for—in the aisles of your grocery store. Over fifty years ago, Rachel Carson’s book Silent Spring exposed the dangers of DDT in our food supply. Unfortunately, it seems that the problem of food contamination has actually become worse. Backed by research and first-hand experience, Dr. Dufault reveals how the FDA has failed us, and outlines how you can protect yourself and your family by knowing what to avoid and by filling your kitchen with food that is clear of toxins.

Author: Mark Walderhaug
Publisher: Createspace Independent Publishing Platform
ISBN: 9781495203619
Category : Medical
Languages : en
Pages : 292

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Book Description
The Bad Bug Book 2nd Edition, released in 2012, provides current information about the major known agents that cause foodborne illness.Each chapter in this book is about a pathogen—a bacterium, virus, or parasite—or a natural toxin that can contaminate food and cause illness. The book contains scientific and technical information about the major pathogens that cause these kinds of illnesses.A separate “consumer box” in each chapter provides non-technical information, in everyday language. The boxes describe plainly what can make you sick and, more important, how to prevent it.The information provided in this handbook is abbreviated and general in nature, and is intended for practical use. It is not intended to be a comprehensive scientific or clinical reference.The Bad Bug Book is published by the Center for Food Safety and Applied Nutrition (CFSAN) of the Food and Drug Administration (FDA), U.S. Department of Health and Human Services.

Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309459575
Category : Medical
Languages : en
Pages : 483

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Book Description
Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

Author: National Research Council
Publisher: National Academies Press
ISBN: 0309163587
Category : Medical
Languages : en
Pages : 589

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Book Description
Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.

Author: Joseph V. Gulfo
Publisher: Simon and Schuster
ISBN: 1682613917
Category : Business & Economics
Languages : en
Pages : 288

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How do you convert a potentially life-saving new idea into an actual medical product and then make it available to doctors and patients? Joseph Gulfo thought he knew what to do but he thought wrong.

Author: FDA
Publisher: Imp
ISBN:
Category : Medical
Languages : en
Pages : 356

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Book Description
The Bad Bug was created from the materials assembled at the FDA website of the same name. This handbook provides basic facts regarding foodborne pathogenic microorganisms and natural toxins. It brings together in one place information from the Food & Drug Administration, the Centers for Disease Control & Prevention, the USDA Food Safety Inspection Service, and the National Institutes of Health.

Author: National Research Council
Publisher: National Academies Press
ISBN: 030918651X
Category : Medical
Languages : en
Pages : 163

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Book Description
Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

Author: Katherine Eban
Publisher: HarperCollins
ISBN: 0063054108
Category : Medical
Languages : en
Pages : 523

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Book Description
A NEW YORK TIMES BESTSELLER * New York Times Notable Book * Best Book of the Year: New York Public Library, Kirkus Reviews, Science Friday With a new postscript by the author From an award-winning journalist, an explosive narrative investigation of the generic drug boom that reveals fraud and life-threatening dangers on a global scale—The Jungle for pharmaceuticals Many have hailed the widespread use of generic drugs as one of the most important public-health developments of the twenty-first century. Today, almost 90 percent of our pharmaceutical market is comprised of generics, the majority of which are manufactured overseas. We have been reassured by our doctors, our pharmacists and our regulators that generic drugs are identical to their brand-name counterparts, just less expensive. But is this really true? Katherine Eban’s Bottle of Lies exposes the deceit behind generic-drug manufacturing—and the attendant risks for global health. Drawing on exclusive accounts from whistleblowers and regulators, as well as thousands of pages of confidential FDA documents, Eban reveals an industry where fraud is rampant, companies routinely falsify data, and executives circumvent almost every principle of safe manufacturing to minimize cost and maximize profit, confident in their ability to fool inspectors. Meanwhile, patients unwittingly consume medicine with unpredictable and dangerous effects. The story of generic drugs is truly global. It connects middle America to China, India, sub-Saharan Africa and Brazil, and represents the ultimate litmus test of globalization: what are the risks of moving drug manufacturing offshore, and are they worth the savings? A decade-long investigation with international sweep, high-stakes brinkmanship and big money at its core, Bottle of Lies reveals how the world’s greatest public-health innovation has become one of its most astonishing swindles.