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Author: Gerald Posner
Publisher: Simon and Schuster
ISBN: 1501152041
Category : Business & Economics
Languages : en
Pages : 816
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Book Description
Award-winning journalist and New York Times bestselling author Gerald Posner reveals the heroes and villains of the trillion-dollar-a-year pharmaceutical industry and delivers “a withering and encyclopedic indictment of a drug industry that often seems to prioritize profits over patients (The New York Times Book Review). Pharmaceutical breakthroughs such as antibiotics and vaccines rank among some of the greatest advancements in human history. Yet exorbitant prices for life-saving drugs, safety recalls affecting tens of millions of Americans, and soaring rates of addiction and overdose on prescription opioids have caused many to lose faith in drug companies. Now, Americans are demanding a national reckoning with a monolithic industry. “Gerald’s dogged reporting, sets Pharma apart from all books on this subject” (The Washington Standard) as we are introduced to brilliant scientists, incorruptible government regulators, and brave whistleblowers facing off against company executives often blinded by greed. A business that profits from treating ills can create far deadlier problems than it cures. Addictive products are part of the industry’s DNA, from the days when corner drugstores sold morphine, heroin, and cocaine, to the past two decades of dangerously overprescribed opioids. Pharma also uncovers the real story of the Sacklers, the family that became one of America’s wealthiest from the success of OxyContin, their blockbuster narcotic painkiller at the center of the opioid crisis. Relying on thousands of pages of government and corporate archives, dozens of hours of interviews with insiders, and previously classified FBI files, Posner exposes the secrets of the Sacklers’ rise to power—revelations that have long been buried under a byzantine web of interlocking companies with ever-changing names and hidden owners. The unexpected twists and turns of the Sackler family saga are told against the startling chronicle of a powerful industry that sits at the intersection of public health and profits. “Explosively, even addictively, readable” (Booklist, starred review), Pharma reveals how and why American drug companies have put earnings ahead of patients.
Author: Gerald Posner
Publisher: Simon and Schuster
ISBN: 1501152041
Category : Business & Economics
Languages : en
Pages : 816
Get Book Here
Book Description
Award-winning journalist and New York Times bestselling author Gerald Posner reveals the heroes and villains of the trillion-dollar-a-year pharmaceutical industry and delivers “a withering and encyclopedic indictment of a drug industry that often seems to prioritize profits over patients (The New York Times Book Review). Pharmaceutical breakthroughs such as antibiotics and vaccines rank among some of the greatest advancements in human history. Yet exorbitant prices for life-saving drugs, safety recalls affecting tens of millions of Americans, and soaring rates of addiction and overdose on prescription opioids have caused many to lose faith in drug companies. Now, Americans are demanding a national reckoning with a monolithic industry. “Gerald’s dogged reporting, sets Pharma apart from all books on this subject” (The Washington Standard) as we are introduced to brilliant scientists, incorruptible government regulators, and brave whistleblowers facing off against company executives often blinded by greed. A business that profits from treating ills can create far deadlier problems than it cures. Addictive products are part of the industry’s DNA, from the days when corner drugstores sold morphine, heroin, and cocaine, to the past two decades of dangerously overprescribed opioids. Pharma also uncovers the real story of the Sacklers, the family that became one of America’s wealthiest from the success of OxyContin, their blockbuster narcotic painkiller at the center of the opioid crisis. Relying on thousands of pages of government and corporate archives, dozens of hours of interviews with insiders, and previously classified FBI files, Posner exposes the secrets of the Sacklers’ rise to power—revelations that have long been buried under a byzantine web of interlocking companies with ever-changing names and hidden owners. The unexpected twists and turns of the Sackler family saga are told against the startling chronicle of a powerful industry that sits at the intersection of public health and profits. “Explosively, even addictively, readable” (Booklist, starred review), Pharma reveals how and why American drug companies have put earnings ahead of patients.
Author: Peter Gotzsche
Publisher: CRC Press
ISBN: 1908911123
Category : Medical
Languages : en
Pages : 251
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Book Description
PRESCRIPTION DRUGS ARE THE THIRD LEADING CAUSE OF DEATH AFTER HEART DISEASE AND CANCER. In his latest ground-breaking book, Peter C Gotzsche exposes the pharmaceutical industries and their charade of fraudulent behaviour, both in research and marketing where the morally repugnant disregard for human lives is the norm. He convincingly draws close co
Author: Ben Goldacre
Publisher: Macmillan
ISBN: 0865478066
Category : Business & Economics
Languages : en
Pages : 479
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Book Description
Originally published in 2012, revised edition published in 2013, by Fourth Estate, Great Britain; Published in the United States in 2012, revised edition also, by Faber and Faber, Inc.
Author: Tom Brody
Publisher: Academic Press
ISBN: 0128146486
Category : Medical
Languages : en
Pages : 671
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Book Description
FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label. - Reveals strategies for winning FDA approval and for drafting the package label - Examples are from one hundred FDA-submissions (NDAs, BLAs) for one hundred different drugs, e.g., for oncology, metabolic diseases, autoimmune diseases, and neurological diseases - This book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely, the data from NDAs and BLAs as published on FDA's website at the time FDA grants approval to the drug
Author: Sonia Shah
Publisher: New Press, The
ISBN: 1595588310
Category : Medical
Languages : en
Pages : 257
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Book Description
Hailed by John le Carré as “an act of courage on the part of its author” and singled out for praise by the leading medical journals in the United States and the United Kingdom, The Body Hunters uncovers the real-life story behind le Carré's acclaimed novel The Constant Gardener and the feature film based on it. "A trenchant exposé . . . meticulously researched and packed with documentary evidence" (Publishers Weekly), Sonia Shah's riveting journalistic account shines a much-needed spotlight on a disturbing new global trend. Drawing on years of original research and reporting in Africa and Asia, Shah examines how the multinational pharmaceutical industry, in its quest to develop lucrative drugs, has begun exporting its clinical research trials to the developing world, where ethical oversight is minimal and desperate patients abound. As the New England Journal of Medicine notes, “it is critical that those engaged in drug development, clinical research and its oversight, research ethics, and policy know about these stories,” which tell of an impossible choice being faced by many of the world's poorest patients—be experimented upon or die for lack of medicine.
Author: Nita K. Pandit
Publisher: Lippincott Williams & Wilkins
ISBN: 0781744784
Category : Medical
Languages : en
Pages : 419
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Book Description
This unique textbook provides an introductory, yet comprehensive overview of the pharmaceutical sciences. It is the first text of its kind to pursue an interdisciplinary approach in this area of study. Readers are introduced to basic concepts related to the specific disciplines in the pharmaceutical sciences, including pharmacology, pharmaceutics, pharmacokinetics, and medicinal chemistry. In an easy-to-read writing style, the book provides readers with up-to-date information on pharmacogenomics and includes comprehensive coverage of industrial drug development and regulatory approval processes. Each chapter includes chapter outlines and critical-thinking exercises, as well as numerous tables and graphs. More than 160 illustrations complement the text.
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Languages : en
Pages : 340
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Book Description
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Languages : en
Pages : 978
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Book Description
Author: Oliver Kayser
Publisher: John Wiley & Sons
ISBN: 3527329943
Category : Science
Languages : en
Pages : 677
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Book Description
This second edition of a very successful book is thoroughly updated with existing chapters completely rewritten while the content has more than doubled from 16 to 36 chapters. As with the first edition, the focus is on industrial pharmaceutical research, written by a team of industry experts from around the world, while quality and safety management, drug approval and regulation, patenting issues, and biotechnology fundamentals are also covered. In addition, this new edition now not only includes biotech drug development but also the use of biopharmaceuticals in diagnostics and vaccinations. With a foreword by Robert Langer, Kenneth J Germeshausen Professor of Chemical and Biomedical Engineering at MIT and member of the National Academy of Engineering and the National Academy of Sciences.
Author: Michael Kinch
Publisher: Simon and Schuster
ISBN: 164313681X
Category : Medical
Languages : en
Pages : 336
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Book Description
From "pharma bros" to everday household budgets, just how did the pharmaceutical industry betray its own history—and how can it return to its tradition of care? It’s an unfortunate and life-threatening fact: one in five Americans has skipped vital prescriptions simply because of the cost. These choices are being made even though we have reached a point in the conveyance of medical options where cancers can be cured and sight restored for those blinded by rare genetic disorders. How, in this time of such advancements, did we reach a point, where people cannot afford the very things that could save their lives? As the COVID-19 global pandemic has pointed out, we need the leadership of scientists, researchers, public health officials and lawmakers alike to guide us through not only in times of a global health crisis, but also during far more mundane times. For the first time in decades, people from all walks of life face the same need for medicine. It is time to discuss the tough questions about drug pricing in an open, honest and, hopefully, transparent manner. But first we must understand how we, as a society, got here. Medicines are arguably the most highly regulated—and cost-inflated—products in the United States. The discovery, development, manufacturing and distribution of medicines is carried out by an ever more complex and crowded set of industries, each playing a part in a larger “pharmaceutical enterprise” seeking to maximize profits. But this was not always the case. The Price of Health is the reveals the story of how the pharmaceutical enterprise took shape and led to the present crisis. The reputation of the pharmaceutical industry is suffering from self-inflicted wounds and its continued viability, indeed survival, is increasingly questioned. Yet the drug makers do not shoulder all the blame or responsibility for the current price crisis. Deeply researched, The Price of Health gives us hope as to how we can still right the ship, even amidst the roiling storm of a global pandemic. How have medicines have been made and distributed to consumers throughout the years? What sea of changes that have contributed to rising costs? Some individuals, actions, and systems will be familiar, others may surprise. Yet the combined implications of these actions for will be surprising and at times shocking to both industry professionals and average Americans alike. Like so much else in human history, the history of the pharmaceutical enterprise is populated mostly by well-intended and even noble individuals and organizations. Each contributed to the formation or maintenance of structures meant to improve the quality and quantity of life through the development and distribution of medicines. And yet systems originally created to do good have often been subverted in ways contrary to the motivations of their creators. Only by understanding this disconnect can we better tackle the underlying problems of the industry head on, preventing foreseeable, and thus avoidable, medical calamities to come.
