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The Pfizer Papers features new reports written by WarRoom/DailyClout research volunteers, which are based on the primary source Pfizer clinical trial documents released under court order and on related medical literature. The book shows in high relief that Pfizer’s mRNA COVID-19 vaccine clinical trial was deeply flawed and that the pharmaceutical company knew by November 2020 that its vaccine was neither safe nor effective. The reports detail vaccine-induced harms throughout the human body, including to the reproductive system; show that women suffer vaccine-related adverse events at a 3:1 ratio; expose that vaccine-induced myocarditis is not rare, mild, or transient; and, shockingly, demonstrate that the mRNA vaccines have created a new category of multi-system, multi-organ disease, which is being called “CoVax Disease.” Despite the fact that Pfizer committed in its own clinical trial protocol to follow the placebo arm of its trial for twenty-four months, Pfizer vaccinated approximately 95 percent of placebo recipients by March 2021, thus eliminating the trial’s control group and making it impossible for comparative safety determinations to be made. Just as importantly, The Pfizer Papers makes it clear that the US Food and Drug Administration knew about the shortfalls of Pfizer’s clinical trial as well as the harms caused by the company’s mRNA COVID vaccine product, thus highlighting the FDA’s abject failure to fulfill its mission to “[protect] the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.” The Pfizer Papers offers an in-depth look at how Big Pharma, the US government, and healthcare entities stand protected behind the broad legal immunity provided by the Public Readiness and Emergency Preparedness Act (PREP Act) when creating, prescribing, and administering vaccines; and, under that shield of protection, do what is best for their bottom lines rather than for the health and well-being of Americans.
Today, more than 75 percent of pharmaceutical drug trials in the United States are being conducted in the private sector. Once the sole province of academic researchers, these important studies are now being outsourced to non-academic physicians. According to Jill A. Fisher, this major change in the way medical research is performed is the outcome of two problems in U.S. health care: decreasing revenue for physicians and decreasing access to treatment for patients. As physicians report diminishing income due to restrictive relationships with insurers, increasing malpractice insurance premiums, and inflated overhead costs to operate private practices, they are attracted to pharmaceutical contract research for its lucrative return. Clinical trials also provide limited medical access to individuals who have no or inadequate health insurance because they offer "free" doctors' visits, diagnostic tests, and medications to participants. Focusing on the professional roles of those involved, as well as key research practices, Fisher assesses the risks and advantages for physicians and patients alike when pharmaceutical drug studies are used as an alternative to standard medical care. A volume in the Critical Issues in Health and Medicine series, edited by Rima D. Apple and Janet Golden
The idea for this manual came from Pfizer in the US, which provided the Clinical Trials Centre at The University of Hong Kong, Hong Kong SAR, PR China with a nonbinding grant for its development. The general project layout protocol was accepted by Pfizer in July 2009. Pfizer has not in any way interfered with the project, except for providing nonbinding comments to the final product. The entire text of this manual was written by Johan PE Karlberg. Marjorie A Speers provided considerable and essential comments on the contents and the first and subsequent drafts. A group of international human research protection experts mostly working in non-profit institutions or organisations - see Contributors for details - reviewed and provided important comments on the contents and final draft. It was solely created with the intention to promote human research protection of participants in clinical trials. This manual will be translated into numerous languages and is provided free of charge as an electronic file over the Internet (http://www.ClinicalTrialMagnifier.com) and offered in print for a fee. The objective beyond this project is to establish educational activities, developed around the manual, and jointly organised with leading academic institutions worldwide.
The Immunization Safety Review Committee was established by the Institute of Medicine (IOM) to evaluate the evidence on possible causal associations between immunizations and certain adverse outcomes, and to then present conclusions and recommendations. The committee's mandate also includes assessing the broader societal significance of these immunization safety issues. While all the committee members share the view that immunization is generally beneficial, none of them has a vested interest in the specific immunization safety issues that come before the group. The committee reviews three immunization safety review topics each year, addressing each one at a time. In this fifth report in a series, the committee examines the hypothesis that exposure to polio vaccine contaminated with simian virus 40 (SV40), a virus that causes inapparent infection in some monkeys, can cause certain types of cancer.
"A timely, fair-minded and crisply written account."—New York Times Book Review Vaccine juxtaposes the stories of brilliant scientists with the industry's struggle to produce safe, effective, and profitable vaccines. It focuses on the role of military and medical authority in the introduction of vaccines and looks at why some parents have resisted this authority. Political and social intrigue have often accompanied vaccination—from the divisive introduction of smallpox inoculation in colonial Boston to the 9,000 lawsuits recently filed by parents convinced that vaccines caused their children's autism. With narrative grace and investigative journalism, Arthur Allen reveals a history illuminated by hope and shrouded by controversy, and he sheds new light on changing notions of health, risk, and the common good.
There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop.
Winners of the Paul Ehrlich Prize The dramatic story of the married scientists who founded BioNTech and developed the first vaccine against COVID-19. Nobody thought it was possible. In mid-January 2020, Ugur Sahin told Özlem Türeci, his wife and decades-long research partner, that a vaccine against what would soon be known as COVID-19 could be developed and safely injected into the arms of millions before the end of the year. His confidence was built upon almost thirty years of research. While working to revolutionize the way that cancerous tumors are treated, the couple had explored a volatile and overlooked molecule called messenger RNA; they believed it could be harnessed to redirect the immune system's forces against any number of diseases. As the founders of BioNTech, they faced widespread skepticism from the scientific community at first; but by the time Sars-Cov-2 was discovered in Wuhan, China, BioNTech was prepared to deploy cutting edge technology and create the world’s first clinically approved inoculation for the coronavirus. The Vaccine draws back the curtain on one of the most important medical breakthroughs of our age; it will reveal how Doctors Sahin and Türeci were able to develop twenty vaccine candidates within weeks, convince Big Pharma to support their ambitious project, navigate political interference from the Trump administration and the European Union, and provide more than three billion doses of the Pfizer/BioNTech vaccine to countries around the world in record time. Written by Joe Miller—the Financial Times’ Frankfurt correspondent who covered BioNTech’s COVID-19 project in real time—with contributions from Sahin and Türeci, as well as interviews with more than sixty scientists, politicians, public health officials, and BioNTech staff, the book covers key events throughout the extraordinary year, as well as exploring the scientific, economic, and personal background of each medical innovation. Crafted to be both completely accessible to the average reader and filled with details that will fascinate seasoned microbiologists, The Vaccine explains the science behind the breakthrough, at a time when public confidence in vaccine safety and efficacy is crucial to bringing an end to this pandemic.
In the United States, some populations suffer from far greater disparities in health than others. Those disparities are caused not only by fundamental differences in health status across segments of the population, but also because of inequities in factors that impact health status, so-called determinants of health. Only part of an individual's health status depends on his or her behavior and choice; community-wide problems like poverty, unemployment, poor education, inadequate housing, poor public transportation, interpersonal violence, and decaying neighborhoods also contribute to health inequities, as well as the historic and ongoing interplay of structures, policies, and norms that shape lives. When these factors are not optimal in a community, it does not mean they are intractable: such inequities can be mitigated by social policies that can shape health in powerful ways. Communities in Action: Pathways to Health Equity seeks to delineate the causes of and the solutions to health inequities in the United States. This report focuses on what communities can do to promote health equity, what actions are needed by the many and varied stakeholders that are part of communities or support them, as well as the root causes and structural barriers that need to be overcome.
Immunization during pregnancy with currently recommended vaccines prevents infection in the mother, the unborn fetus, and the young infant, and there is an increasing focus from different stakeholders to use this approach for other infections of importance to protect these vulnerable groups. The aim of this Maternal Immunization book is to provide a contemporary overview of vaccines used in pregnancy (and the lactation period), with emphasis on aspects of importance for the target groups, namely, rationale for the use of vaccines in pregnancy, safety, immunogenicity (immunology), timing to vaccinate, repeat doses, protective effects in the mother, fetus, and infant, and public acceptance and implementation, of existing and of future vaccines. - Provides an overview of a quickly evolving topic. This will benefit the reader who wishes to rapidly become informed and up-to-date with new developments in this field - Suitable to a broad audience: scientific researchers, obstetricians, gynecologists, neonatologists, vaccinators, pediatricians, students, and industry. Maternal vaccination impacts a wide range of specialists - Allows health care professionals/researchers to gain insight into other aspects of vaccination in pregnancy outside of their specialism - Is coauthored by specialists from multiple disciplines, providing a diverse view of the subject, increasing its interest and appeal - Creates awareness of the current developments in this area of medicine and of the potential of maternal vaccination to improve the health of mothers and infants worldwide
Among the many who serve in the United States Armed Forces and who are deployed to distant locations around the world, myriad health threats are encountered. In addition to those associated with the disruption of their home life and potential for combat, they may face distinctive disease threats that are specific to the locations to which they are deployed. U.S. forces have been deployed many times over the years to areas in which malaria is endemic, including in parts of Afghanistan and Iraq. Department of Defense (DoD) policy requires that antimalarial drugs be issued and regimens adhered to for deployments to malaria-endemic areas. Policies directing which should be used as first and as second-line agents have evolved over time based on new data regarding adverse events or precautions for specific underlying health conditions, areas of deployment, and other operational factors At the request of the Veterans Administration, Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis assesses the scientific evidence regarding the potential for long-term health effects resulting from the use of antimalarial drugs that were approved by FDA or used by U.S. service members for malaria prophylaxis, with a focus on mefloquine, tafenoquine, and other antimalarial drugs that have been used by DoD in the past 25 years. This report offers conclusions based on available evidence regarding associations of persistent or latent adverse events.