Serious Adverse Events PDF Download

Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Serious Adverse Events PDF full book. Access full book title Serious Adverse Events.

Serious Adverse Events

Serious Adverse Events
Author: Celia Farber
Publisher: Chelsea Green Publishing
Total Pages: 259
Release: 2023-03-23
Genre: Health & Fitness
ISBN: 1645022080

Download Serious Adverse Events Book in PDF, ePub and Kindle

“Farber [is] a lucid and courageous witness to the power-play behind the first ‘scamdemic,’ . . . [Her] work is journalism at its best—solid, lucid, and humane, attacking wrongs that few dare touch, and thereby helping right them.” —Mark Crispin Miller, bestselling author and professor of media studies at NYU On April 23, 1984, in a packed press conference room in Washington, DC, the secretary of health and human services declared, “The probable cause of AIDS has been found.” By the next day, “probable” had fallen away, and the novel retrovirus later named HIV became forever lodged in global consciousness as “the AIDS virus.” Celia Farber, then an intrepid young reporter for SPIN magazine, was the only journalist to question the official narrative and dig into the science of AIDS. She reported on the “evidence” that was being continually cited and repeated by health officials and the press, the deadliness of AZT, and Dr. Fauci’s trials on children, infants, and pregnant mothers. Throughout, Faber’s reportage was largely ignored. She was maligned, maliciously attacked, and ultimately canceled. Now, forty years after her original reporting, Farber’s Serious Adverse Events: An Uncensored History of AIDS is reissued with a new foreword by Mark Crispin Miller, shining much-needed light on her groundbreaking work once again. More relevant than ever, this book serves as an essential foundation to understanding its catastrophic sequel: COVID-19. Serious Adverse Events makes clear that the tactics employed at the height of HIV/AIDS—the fearmongering, cancel culture, and “woke” takeover of science, medicine, and journalism—persist today. The response to COVID-19 isn’t new: it is a well-trod and dangerous path in the social landscape. “Groundbreaking work.”—Bob Guccione, Jr., founder of SPIN magazine "Farber’s research give context to the Covid catastrophe which she all but predicted. Despite the medical cartel’s brutal crusade to silence and vilify her, Farber never compromised. . . I’m happy she has lived to experience her own utter vindication. I also love her writing style."—Robert F. Kennedy Jr.


Adverse Events

Adverse Events
Author: Jill A. Fisher
Publisher: NYU Press
Total Pages: 201
Release: 2020-05-12
Genre: Social Science
ISBN: 1479850519

Download Adverse Events Book in PDF, ePub and Kindle

Winner, 2022 Donald W. Light Award for Applied Medical Sociology, given by the Medical Sociology Section of the American Sociological Association Winner, 2021 Robert K. Merton Book Award, given by the Science, Knowledge, and Technology Section of the American Sociological Association 2021 Outstanding Academic Title, Choice Magazine Explores the social inequality of clinical drug testing and its effects on scientific results Imagine that you volunteer for the clinical trial of an experimental drug. The only direct benefit of participating is that you will receive up to $5,175. You must spend twenty nights literally locked in a research facility. You will be told what to eat, when to eat, and when to sleep. You will share a bedroom with several strangers. Who are you, and why would you choose to take part in this kind of study? This book explores the hidden world of pharmaceutical testing on healthy volunteers. Drawing on two years of fieldwork in clinics across the country and 268 interviews with participants and staff, it illustrates how decisions to take part in such studies are often influenced by poverty and lack of employment opportunities. It shows that healthy participants are typically recruited from African American and Latino/a communities, and that they are often serial participants, who obtain a significant portion of their income from these trials. This book reveals not only how social inequality fundamentally shapes these drug trials, but it also depicts the important validity concerns inherent in this mode of testing new pharmaceuticals. These highly controlled studies bear little resemblance to real-world conditions, and everyone involved is incentivized to game the system, ultimately making new drugs appear safer than they really are. Adverse Events provides an unprecedented view of the intersection of racial inequalities with pharmaceutical testing, signaling the dangers of this research enterprise to both social justice and public health.


Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition)

Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition)
Author: Cobert Barton
Publisher: World Scientific
Total Pages: 524
Release: 2019-04-10
Genre: Medical
ISBN: 9813279168

Download Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) Book in PDF, ePub and Kindle

Completely revised and updated, Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, is a how-to manual for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, risk management, quality/compliance, and in government and legal professions.This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance), and provides essential information on drug safety and regulations in the United States, Europe Union, and more, including: recognizing, monitoring, reporting, and cataloging serious adverse drug reactions.Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, teaches the daily practice of drug safety in industry, hospitals, the FDA and other health agencies — both in the United States and around the world — and provides critical information about what to do when confronted with a drug safety problem.


Safe Medical Devices for Children

Safe Medical Devices for Children
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 481
Release: 2006-01-20
Genre: Medical
ISBN: 0309096316

Download Safe Medical Devices for Children Book in PDF, ePub and Kindle

Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children. Mechanical ventilators and other respiratory support devices rescue thousands of fragile newborns every year. Children who once would have died of congenital heart conditions survive with the aid of implanted pacemakers, mechanical heart valves, and devices that close holes in the heart. Responding to a Congressional request, the Institute of Medicine assesses the system for postmarket surveillance of medical devices used with children. The book specifically examines: The Food and Drug Administration's monitoring and use of adverse event reports The agency's monitoring of manufacturers' fulfillment of commitments for postmarket studies ordered at the time of a device's approval for marketing The adequacy of postmarket studies of implanted devices to evaluate the effects of children's active lifestyles and their growth and development on device performance Postmarket surveillance of medical devices used with children is a little investigated topic, in part because the market for most medical products is concentrated among older adults. Yet children differ from adults, and their special characteristics have implications for evaluation and monitoring of the short- and long-term safety and effectiveness of medical devices used with young patients.


Principles and Practice of Clinical Trial Medicine

Principles and Practice of Clinical Trial Medicine
Author: Richard Chin
Publisher: Elsevier
Total Pages: 560
Release: 2008-07-25
Genre: Medical
ISBN: 0080557937

Download Principles and Practice of Clinical Trial Medicine Book in PDF, ePub and Kindle

Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, Principles and Practice of Clinical Trial Medicine covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results. Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine Expert authorship whose experience includes running clinical trials in an academic as well as industry settings Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy


Advances in Patient Safety

Advances in Patient Safety
Author: Kerm Henriksen
Publisher:
Total Pages: 526
Release: 2005
Genre: Medical
ISBN:

Download Advances in Patient Safety Book in PDF, ePub and Kindle

v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.


Ethics Dumping

Ethics Dumping
Author: Doris Schroeder
Publisher: Springer
Total Pages: 134
Release: 2017-12-04
Genre: Philosophy
ISBN: 3319647318

Download Ethics Dumping Book in PDF, ePub and Kindle

This open access book provides original, up-to-date case studies of “ethics dumping” that were largely facilitated by loopholes in the ethics governance of low and middle-income countries. It is instructive even to experienced researchers since it provides a voice to vulnerable populations from the fore mentioned countries. Ensuring the ethical conduct of North-South collaborations in research is a process fraught with difficulties. The background conditions under which such collaborations take place include extreme differentials in available income and power, as well as a past history of colonialism, while differences in culture can add a new layer of complications. In this context, up-to-date case studies of unethical conduct are essential for research ethics training.


Adverse Drug Event Reporting

Adverse Drug Event Reporting
Author: Board on Health Sciences Policy
Publisher: National Academies Press
Total Pages: 0
Release: 2007-04-12
Genre: Medical
ISBN: 9780309102766

Download Adverse Drug Event Reporting Book in PDF, ePub and Kindle

Recent concerns about the unexpected adverse effects of marketed drugs, such as COX-2 (cyclooxygenase-2) inhibitors or specific statins, raise concerns not only about reporting these events during premarket studies, but also about the responsibility for ongoing surveillance of drugs once they are on the market. Sometimes serious adverse drug reactions are fully appreciated only after a drug has been on the market for years. Therefore, when a drug is approved and released to the market, large numbers of patients will be exposed before all the potential adverse effects have been identified and thoroughly studied. Currently, there is no clearly defined process for addressing safety questions about drugs after premarketing research has occurred. In November 2005, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation convened a workshop to explore issues associated with the reporting of ADEs. The workshop addressed the following questions: How can ADEs be effectively identified, particularly when the adverse effects are rare? How can the direct, causal effects of drugs be distinguished from simple associations? How can health-care professionals and their patients' aid in the identification of drug-related adverse events? How can knowledge of ADEs be more effectively used in clinical practice? Adverse Drug Event Reporting reviews current sources of information on adverse drug events, including the FDA's MedWatch program and the AERS, institutional review boards, and the CMS. This report considers the ways that consumers and advocacy groups can be involved in reporting adverse events, and discusses drug interactions, problems with current databases for capturing and evaluating interactions, and difficulties in communicating information about adverse drug interactions. This report also describes new requirements for information contained on drug labels and how labels can be used to communicate information about risks and drug interactions to consumers and practitioners.


Vaccine Safety Forum

Vaccine Safety Forum
Author: Board on Health Promotion and Disease Prevention
Publisher: National Academies Press
Total Pages: 71
Release: 1997-07-24
Genre: Medical
ISBN: 0309538572

Download Vaccine Safety Forum Book in PDF, ePub and Kindle

On November 6, 1995, the Institute of Medicine's Vaccine Safety Forum convened a workshop on detecting and responding to adverse events following vaccination. Workshop speakers and participants discussed the difficulties in detecting adverse events, current adverse events detection and response methods and procedures, suggestions for improving the means of detecting and responding to adverse events following vaccination, and future areas of research. This document represents a summary of that workshop.


To Err Is Human

To Err Is Human
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 312
Release: 2000-03-01
Genre: Medical
ISBN: 0309068371

Download To Err Is Human Book in PDF, ePub and Kindle

Experts estimate that as many as 98,000 people die in any given year from medical errors that occur in hospitals. That's more than die from motor vehicle accidents, breast cancer, or AIDSâ€"three causes that receive far more public attention. Indeed, more people die annually from medication errors than from workplace injuries. Add the financial cost to the human tragedy, and medical error easily rises to the top ranks of urgent, widespread public problems. To Err Is Human breaks the silence that has surrounded medical errors and their consequenceâ€"but not by pointing fingers at caring health care professionals who make honest mistakes. After all, to err is human. Instead, this book sets forth a national agendaâ€"with state and local implicationsâ€"for reducing medical errors and improving patient safety through the design of a safer health system. This volume reveals the often startling statistics of medical error and the disparity between the incidence of error and public perception of it, given many patients' expectations that the medical profession always performs perfectly. A careful examination is made of how the surrounding forces of legislation, regulation, and market activity influence the quality of care provided by health care organizations and then looks at their handling of medical mistakes. Using a detailed case study, the book reviews the current understanding of why these mistakes happen. A key theme is that legitimate liability concerns discourage reporting of errorsâ€"which begs the question, "How can we learn from our mistakes?" Balancing regulatory versus market-based initiatives and public versus private efforts, the Institute of Medicine presents wide-ranging recommendations for improving patient safety, in the areas of leadership, improved data collection and analysis, and development of effective systems at the level of direct patient care. To Err Is Human asserts that the problem is not bad people in health careâ€"it is that good people are working in bad systems that need to be made safer. Comprehensive and straightforward, this book offers a clear prescription for raising the level of patient safety in American health care. It also explains how patients themselves can influence the quality of care that they receive once they check into the hospital. This book will be vitally important to federal, state, and local health policy makers and regulators, health professional licensing officials, hospital administrators, medical educators and students, health caregivers, health journalists, patient advocatesâ€"as well as patients themselves. First in a series of publications from the Quality of Health Care in America, a project initiated by the Institute of Medicine