The F D A Is Dangerous To Your Health
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The F D A Is Dangerous To Your Health
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Author : William P. Hoar
language : en
Publisher:
Release Date : 1976
The F D A Is Dangerous To Your Health written by William P. Hoar and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1976 with Pharmaceutical policy categories.
Hazardous To Our Health
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Author : Robert Higgs
language : en
Publisher: Independent Institute
Release Date : 2016-06-20
Hazardous To Our Health written by Robert Higgs and has been published by Independent Institute this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-06-20 with Law categories.
Some have described the Food and Drug Administration (FDA) as a scientific bureaucracy with police powers. Does a “cult of infallibility” exist within the FDA, leading to decisions that are contrary to the best interests of patients and their physicians? The Food and Drug Administration (FDA) is one of the most powerful of federal regulatory agencies, if not the most powerful. It regulates over 25% of all consumer goods sold in the United States. It makes decisions on a daily basis that affect the lives of millions of people. While the FDA was created to protect the public, how well is it fulfilling this mission and whose interests is it actually protecting? In this book, four outstanding scholars examine how the FDA accumulated its enormous power and what effects it has had on the public. It also explores who actually benefits and loses from FDA actions, and whether alternatives exist to safeguard the health of Americans. This book raises serious questions about the wisdom of giving policing power to scientists with little oversight or appeal process, as the FDA currently does. It also argues forcefully that the FDA unnecessarily delays beneficial medicines and medical devices, many of which are routinely available in Europe, from being available to Americans.
Eating May Be Hazardous To Your Health
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Author : Jacqueline Verrett
language : en
Publisher:
Release Date : 1974
Eating May Be Hazardous To Your Health written by Jacqueline Verrett and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1974 with Technology & Engineering categories.
Stop The Fda
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Author : John Morgenthaler
language : en
Publisher: Smart Publications
Release Date : 1992
Stop The Fda written by John Morgenthaler and has been published by Smart Publications this book supported file pdf, txt, epub, kindle and other format this book has been release on 1992 with Health & Fitness categories.
Challenges For The Fda
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2007-10-02
Challenges For The Fda written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-10-02 with Medical categories.
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. To address these concerns, the FDA in 2005 commissioned the Institute of Medicine (IOM) to conduct an independent assessment of the current U.S. drug safety system. In September 2006, the IOM committee released its report-The Future of Drug Safety: Promoting and Protecting the Health of the Public-which included 25 recommendations for improving the system for drug safety review. The committee identified four major vulnerabilities in the U.S. drug safety system: (1) chronic underfunding; (2) organization problems, particularly inadequate integration of pre-and postmarket data review; (3) a range of technical problems related to the insufficient quantity and quality of postmarket data and inadequate capability to systematically monitor the risks and benefits of drugs after marketing; and (4) unclear regulatory authority and insufficiently flexible regulatory tools. Since the IOM report was issued, the FDA has taken a number of steps toward implementing the recommended improvements. Like many government agencies, however, the FDA is financially strained by its existing responsibilities, and fully implementing the recommended improvements to the drug safety system would require significant financial commitments.The IOM report addressed some of the costs associated with its recommendations, but left many unanswered questions about the resources required to fully achieve the envisioned improvements. To better understand the types and magnitude of resources required to achieve the goals of the IOM report, the IOM's Forum on Drug Discovery, Development, and Translation convened a 1-day symposium in March 2007. Challenges for the FDA: The Future of Drug Safety, Workshop Summary explains the presentations and discussions in seven key areas: addressing the FDA's resource challenges; strengthening the scientific base of the agency; integrating pre- and postmarket review; enhancing postmarket safety monitoring; conducting confirmatory drug safety and efficacy studies; enhancing the value of clinical trial registration; and enhancing the FDA's postmarket regulation and enforcement.
The Fda Psychiatric Drugs
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Author : Joan Esherick
language : en
Publisher: Simon and Schuster
Release Date : 2014-09-02
The Fda Psychiatric Drugs written by Joan Esherick and has been published by Simon and Schuster this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-09-02 with Juvenile Nonfiction categories.
Imagine taking a medication meant to heal you only to discover that the drug rotted your bones, made your teeth fall out, and filled you with a radioactive element called radium. Pittsburgh industrialist Eben Byers didn't have to imagine. It happened to him, and he died as a result. Mr. Byers fell victim to "patent medicines" sold in the early twentieth century. Patent medicine quackery and other medical tragedies prompted the United States government to form an agency that could protect patients and consumers from mislabeled or dangerous medicines, cosmetics, and foods. That agency is the U.S. Food and Drug Administration (FDA). Most drugs and medical treatments sold in North America today, including drugs used to treat psychological disorders, are regulated by this consumer protection agency. Many people diagnosed with depression, panic attacks, schizophrenia, ADHD, and other psychological disorders lead normal lives because they are treated with psychiatric drugs approved by the FDA. But what are psychiatric drugs? Where do they come from? How do they work? What does it take for the FDA to approve them? Why do we have the FDA? Perhaps most important, does FDA approval guarantee safety? Loaded with case studies and user-friendly illustrations, this readable text answers these and other questions as it examines a brief history of mental disorders and their treatment. In its pages, you will learn about the origins of the FDA, the FDA drug approval process, the structure and chemistry of the brain, psychiatric drugs and how they work, adverse reactions, and alternative treatments. Come learn about the drug approval process. Next time you reach into your medicine cabinet, you'll be glad you did.
Pain Management And The Opioid Epidemic
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2017-09-28
Pain Management And The Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-09-28 with Medical categories.
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.
Putting Patients First
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Author : Jennifer Bard
language : en
Publisher:
Release Date : 2014
Putting Patients First written by Jennifer Bard and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014 with categories.
The danger to the health of patients taking drugs) recently on the market after being approved by the Food and Drug Administration (FDA) is well documented. While there may be problems inherent to the drug itself, what is emerging as a more serious issue is possible “drug-drug interactions (DDIs)” between a newly approved drug and the drugs already being taken by the patient. Researchers at Stanford University recently noted that “DDIs cause nearly 74,000 emergency room visits and 195,000 hospitalizations in the USA.” This situation is not due to laxity by the FDA so much as it reflects the current state of health care. As Professor Barbara Evans explains, the FDA plays the role as “gatekeeper” in assessing the safety and efficacy of drugs, and other products, before they go on the market but as a matter of “realism” because “[t]he gate is intrinsically porous, and safety cannot be achieved by fighting that fact but rather by responding to it.” Indeed, concerns about the problem resulted in Congress extending the FDA's ability to require manufacturers to conduct their own research studies to assess the safety and efficacy of the drugs they sell not just before seeking FDA approval but afterwards as well. Yet despite the awarding of these new powers, there is still no comprehensive mechanism in place to gather the information needed to protect or warn patients who receive these prescriptions. So although the FDAA gives the FDA the authority to require sponsors to conduct post-market clinical trials if it is aware of “a known serious risk related to the use of the drug involved” it also authorizes the FDA to “[a]ssess signals of serious risk related to the use of the drug.” This article proposes ways in which the FDA can use this power to promote and protect the public's health. There have been numerous reports by or commissioned by the FDA or other government and private entities. The goal of this article is to gather this information, re-affirm why change is necessary, suggest two additional measures that so far have not been proposed, the addition of whistleblower protection and greater use of electronic medical and pharmaceutical records, and explain why the FDA could make these changes itself rather than await action from Congress. It is the claim of this article that although the phenomena of the emergence of post- approval hazards is inevitable, the FDA can do far more to protect patients by using its legal authority to require post- market surveillance for all, not some, newly approved products. Moreover, it can increase the likelihood of relevant information coming to its attention sooner by targeting the specific groups who are likely to have early knowledge of harms caused by new drugs: the sponsors, health care providers, patients, and the FDA itself.
Bottle Of Lies
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Author : Katherine Eban
language : en
Publisher: HarperCollins
Release Date : 2020-06-23
Bottle Of Lies written by Katherine Eban and has been published by HarperCollins this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-06-23 with Medical categories.
A NEW YORK TIMES BESTSELLER New York Times 100 Notable Books of 2019 New York Public Library Best Books of 2019 Kirkus Reviews Best Health and Science Books of 2019 Science Friday Best Books of 2019 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.
Medical Devices And The Public S Health
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-10-25
Medical Devices And The Public S Health written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-10-25 with Medical categories.
Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.