Serious Adverse Events

Serious Adverse Events PDF Author: Celia Farber
Publisher: Chelsea Green Publishing
ISBN: 1645022080
Category : Health & Fitness
Languages : en
Pages : 259

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Book Description
“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.

Serious Adverse Events

Serious Adverse Events PDF Author: Celia Farber
Publisher: Chelsea Green Publishing
ISBN: 1645022080
Category : Health & Fitness
Languages : en
Pages : 259

Get Book Here

Book Description
“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.

Advances in Patient Safety

Advances in Patient Safety PDF Author: Kerm Henriksen
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 526

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

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

Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) PDF Author: Barton Cobert
Publisher: World Scientific
ISBN: 9813279168
Category : Medical
Languages : en
Pages : 525

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Book Description
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.Related Link(s)

Ethics Dumping

Ethics Dumping PDF Author: Doris Schroeder
Publisher: Springer
ISBN: 3319647318
Category : Philosophy
Languages : en
Pages : 144

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Book Description
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.

The Prevention and Treatment of Missing Data in Clinical Trials

The Prevention and Treatment of Missing Data in Clinical Trials PDF 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.

Principles and Practice of Clinical Trial Medicine

Principles and Practice of Clinical Trial Medicine PDF Author: Richard Chin
Publisher: Elsevier
ISBN: 0080557937
Category : Medical
Languages : en
Pages : 560

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Book Description
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

Adverse Effects of Vaccines

Adverse Effects of Vaccines PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309214351
Category : Medical
Languages : en
Pages : 894

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Book Description
In 1900, for every 1,000 babies born in the United States, 100 would die before their first birthday, often due to infectious diseases. Today, vaccines exist for many viral and bacterial diseases. The National Childhood Vaccine Injury Act, passed in 1986, was intended to bolster vaccine research and development through the federal coordination of vaccine initiatives and to provide relief to vaccine manufacturers facing financial burdens. The legislation also intended to address concerns about the safety of vaccines by instituting a compensation program, setting up a passive surveillance system for vaccine adverse events, and by providing information to consumers. A key component of the legislation required the U.S. Department of Health and Human Services to collaborate with the Institute of Medicine to assess concerns about the safety of vaccines and potential adverse events, especially in children. Adverse Effects of Vaccines reviews the epidemiological, clinical, and biological evidence regarding adverse health events associated with specific vaccines covered by the National Vaccine Injury Compensation Program (VICP), including the varicella zoster vaccine, influenza vaccines, the hepatitis B vaccine, and the human papillomavirus vaccine, among others. For each possible adverse event, the report reviews peer-reviewed primary studies, summarizes their findings, and evaluates the epidemiological, clinical, and biological evidence. It finds that while no vaccine is 100 percent safe, very few adverse events are shown to be caused by vaccines. In addition, the evidence shows that vaccines do not cause several conditions. For example, the MMR vaccine is not associated with autism or childhood diabetes. Also, the DTaP vaccine is not associated with diabetes and the influenza vaccine given as a shot does not exacerbate asthma. Adverse Effects of Vaccines will be of special interest to the National Vaccine Program Office, the VICP, the Centers for Disease Control and Prevention, vaccine safety researchers and manufacturers, parents, caregivers, and health professionals in the private and public sectors.

The Future of Drug Safety

The Future of Drug Safety PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309133947
Category : Medical
Languages : en
Pages : 346

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Book Description
In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.

The Bionic Human

The Bionic Human PDF Author: Frank E Johnson
Publisher: Springer Science & Business Media
ISBN: 1592599753
Category : Technology & Engineering
Languages : en
Pages : 706

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Book Description
An integrated survey of best practices for the management of patients with implanted prosthetic devices and an insightful examination of the epidemiological, societal, and policy issues associated with their use. The devices covered range from breast, penile, vascular, and joint prostheses to cochlear, ossicular, and dental implants, and include cerebrospinal fluid shunts, cardiac valves, stents, and pacemakers. For each device, the authors consider its pros and cons, detail the best current strategies to keep implanted patients healthy, and evaluate the latest and most promising new diagnostic tests, Clinical counterpoints from distinguished authorities at major centers in the United States and Europe are offered throughout. Follow-up recommendations are summarized in a standardized format that allows comparative analysis and lays the foundation for controlled clinical trials and the eventual establishment of evidence-based guidelines.

Human Error in Medicine

Human Error in Medicine PDF Author: Marilyn Sue Bogner
Publisher: CRC Press
ISBN: 1351440209
Category : Technology & Engineering
Languages : en
Pages : 424

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Book Description
This edited collection of articles addresses aspects of medical care in which human error is associated with unanticipated adverse outcomes. For the purposes of this book, human error encompasses mismanagement of medical care due to: * inadequacies or ambiguity in the design of a medical device or institutional setting for the delivery of medical care; * inappropriate responses to antagonistic environmental conditions such as crowding and excessive clutter in institutional settings, extremes in weather, or lack of power and water in a home or field setting; * cognitive errors of omission and commission precipitated by inadequate information and/or situational factors -- stress, fatigue, excessive cognitive workload. The first to address the subject of human error in medicine, this book considers the topic from a problem oriented, systems perspective; that is, human error is considered not as the source of the problem, but as a flag indicating that a problem exists. The focus is on the identification of the factors within the system in which an error occurs that contribute to the problem of human error. As those factors are identified, efforts to alleviate them can be instituted and reduce the likelihood of error in medical care. Human error occurs in all aspects of human activity and can have particularly grave consequences when it occurs in medicine. Nearly everyone at some point in life will be the recipient of medical care and has the possibility of experiencing the consequences of medical error. The consideration of human error in medicine is important because of the number of people that are affected, the problems incurred by such error, and the societal impact of such problems. The cost of those consequences to the individuals involved in medical error, both in the health care providers' concern and the patients' emotional and physical pain, the cost of care to alleviate the consequences of the error, and the cost to society in dollars and in lost personal contributions, mandates consideration of ways to reduce the likelihood of human error in medicine. The chapters were written by leaders in a variety of fields, including psychology, medicine, engineering, cognitive science, human factors, gerontology, and nursing. Their experience was gained through actual hands-on provision of medical care and/or research into factors contributing to error in such care. Because of the experience of the chapter authors, their systematic consideration of the issues in this book affords the reader an insightful, applied approach to human error in medicine -- an approach fortified by academic discipline.