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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.
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
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.
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
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.
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.
Get your highest score possible on the MPJE® with detailed state-specific guidance! Complete coverage of 20 states, plus federal regulations! Pharmacy Law is the perfect way to prepare for the MPJE Exam. It delivers a rigorous review of pharmacy-related statutes, rules, and regulations that impact pharmacy practice in twenty states as well as a summary of federal regulations that pertain to pharmacy law. Federal coverage includes summaries of must-know legislation such as the Federal Controlled Substances Act, the Federal Food, Drug & Cosmetics Act, and other relevant federal guidelines. State-specific chapters discuss important topics such as renewal of pharmacists’ licenses, qualifications, prescription transfers, inventory requirements, record-keeping, and prescriptive authority. Each chapter concludes with practice scenarios and questions with appropriate explanations. The Review You Need to Excel in These States: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, North Carolina, New Jersey, Ohio, Oregon, Pennsylvania, South Carolina, Texas & Wisconsin. Watch for future supplements with additional states.
In recent years, many factors have combined to change the operating environment of the international pharmaceutical industry leading to greater specialisation and sophistication. This new edition will give an update of the different opportunities in drug discovery and development and the scientific, medical or other specialist training needed to accomplish them. The scope of this edition has been broadened to encompass all major roles, including marketing and sales.