Two veteran investigative journalists trace the rise of the modern lobbying industry through the three dynasties—one Republican, two Democratic—that have enabled corporate interests to infiltrate American politics and undermine our democracy. On K Street, a few blocks from the White House, you’ll find the offices of the most powerful men in Washington. In the 1970s, the city’s center of gravity began to shift away from elected officials in big marble buildings to a handful of savvy, handsomely paid operators who didn’t answer to any fixed constituency. The cigar-chomping son of a powerful Congressman, an illustrious political fixer with a weakness for modern art, a Watergate-era dirty trickster, the city’s favorite cocktail party host…these were the sorts of men who now ran Washington. Over four decades, they’d chart new ways to turn their clients’ cash into political leverage, abandoning favor-trading in smoke-filled rooms for increasingly sophisticated tactics like “shadow lobbying,” where underground campaigns sparked seemingly organic public outcries to pressure lawmakers into taking actions that would ultimately benefit corporate interests rather than the common good. With billions of dollars at play, these lobbying dynasties enshrined in Washington a pro-business consensus that would guide the country’s political leaders—Democrats and Republicans alike—allowing companies to flourish even as ordinary Americans buckled under the weight of stagnant wages, astronomical drug prices, unsafe home loans, and digital monopolies. A good lobbyist could kill even a piece of legislation supported by the president, both houses of Congress, and a majority of Americans. Yet, nothing lasts forever. Amidst a populist backlash to the soaring inequality these lobbyists helped usher in, Washington’s pro-business alliance suddenly began to unravel. And while new ways for corporations to control the federal government would emerge, the men who’d once built K Street found themselves under legal scrutiny and on the verge of financial collapse. One had his namesake firm ripped away by his own colleagues. Another watched his business shut down altogether. One went to prison. And one was found dead behind the 18th green of an exclusive golf club, with a bottle of $1,500 wine at his feet and a bullet in his head. A dazzling and infuriating portrait of fifty years of corporate influence in Washington, The Wolves of K Street is a masterpiece of narrative nonfiction—irresistibly dramatic, spectacularly timely, explosive in its revelations, and absolutely impossible to put down.
Two veteran investigative journalists trace the rise of the modern lobbying industry through the three dynasties—one Republican, two Democratic—that have enabled corporate interests to infiltrate American politics and undermine our democracy. On K Street, a few blocks from the White House, you’ll find the offices of the most powerful men in Washington. In the 1970s, the city’s center of gravity began to shift away from elected officials in big marble buildings to a handful of savvy, handsomely paid operators who didn’t answer to any fixed constituency. The cigar-chomping son of a powerful Congressman, an illustrious political fixer with a weakness for modern art, a Watergate-era dirty trickster, the city’s favorite cocktail party host…these were the sorts of men who now ran Washington. Over four decades, they’d chart new ways to turn their clients’ cash into political leverage, abandoning favor-trading in smoke-filled rooms for increasingly sophisticated tactics like “shadow lobbying,” where underground campaigns sparked seemingly organic public outcries to pressure lawmakers into taking actions that would ultimately benefit corporate interests rather than the common good. With billions of dollars at play, these lobbying dynasties enshrined in Washington a pro-business consensus that would guide the country’s political leaders—Democrats and Republicans alike—allowing companies to flourish even as ordinary Americans buckled under the weight of stagnant wages, astronomical drug prices, unsafe home loans, and digital monopolies. A good lobbyist could kill even a piece of legislation supported by the president, both houses of Congress, and a majority of Americans. Yet, nothing lasts forever. Amidst a populist backlash to the soaring inequality these lobbyists helped usher in, Washington’s pro-business alliance suddenly began to unravel. And while new ways for corporations to control the federal government would emerge, the men who’d once built K Street found themselves under legal scrutiny and on the verge of financial collapse. One had his namesake firm ripped away by his own colleagues. Another watched his business shut down altogether. One went to prison. And one was found dead behind the 18th green of an exclusive golf club, with a bottle of $1,500 wine at his feet and a bullet in his head. A dazzling and infuriating portrait of fifty years of corporate influence in Washington, The Wolves of K Street is a masterpiece of narrative nonfiction—irresistibly dramatic, spectacularly timely, explosive in its revelations, and absolutely impossible to put down.
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
Crucible of a Generation tells the story of the fifteen days surrounding the Japanese attack on Pearl Harbor through the pages of eight leading American newspapers. Focusing on publications such as The New York Times and the Chicago Tribune, J. Kenneth Brody paints a vivid picture of U.S. political culture and society at a pivotal moment in the nation's history. Brody considers the papers in full, from headlines to "help wanted" ads, in a text richly illustrated with archival images, wartime posters, and editorial cartoons. The book provides a compelling snapshot of the United States and the role of the media at a time of dramatic tension and global change.
Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more Extensively covers the "study schema" and related features of study design Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers
This "real-world" approach allows students to come away with a realistically informed view of the basis for much of our understanding of nutritional biochemistry.
Based on thousands of citations from peer-reviewed, trade, commercial, and patent literature and interviews with those who have worked in the laboratory, in pilot plants, and in production, Active Packaging for Food Applications provides a state-of-the-art guide to understanding and utilizing these technologies. The book highlights technologies that are currently in commercial use or have the potential to become commercial, including oxygen scavenging, moisture control, ethylene removal from fresh food, antimicrobials, odor removal, and aroma emission. In addition, it explores the pros and cons involved in using antimicrobial agents in package materials. Active Packaging for Food Applications provides you with a detailed guide and reference to the technologies - and their applications - involved in enhancing food and beverage preservation.
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