In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.

For millennia, human survival depended on our innate abilities to fight pathogens and repair injuries. Only recently has medical science prolonged longevity and improved quality of life. Physicians and academic researchers contribute to such progress, but the principal contributor is private industry that produces the tools – drugs and medical devices – enabling doctors to prevent and cure disease. Heavy regulation and biology’s complexity and unpredictability make medical innovation extremely difficult and expensive. Pharmaphobia describes how an ideological crusade, stretching over the last quarter century, has used distortion and flawed logic to make medical innovation even harder in a misguided pursuit of theoretical professional purity. Bureaucrats, reporters, politicians, and predatory lawyers have built careers attacking the medical products industry, belittling its critical contributions to medical innovation and accusing it of non-existent malfeasance: overselling product value, flaunting safety and corrupting physicians and academics who partner with it. The mania has imposed “conflict-of-interest” regulations limiting or banning valuable interactions between industry and physicians and researchers and diverting scarce resources from innovation to compliance. The victims are patients suffering from cancer, dementia, and other serious diseases for which new treatments are delayed, reduced, or eliminated as a result of these pointless regulations. With breathtaking detail, Thomas Stossel shows how this attack on doctors who work with industry limits medical innovation and inhibits the process of bringing new products into medical care.

"Change is no stranger to us in the twenty-first century. All of us must constantly adjust to an evolving world, to transformation and innovation. But for many thousands of creative artists, a torrent of recent changes has made it all but impossible to earn a living. A persistent economic recession, social shifts, and technological change have combined to put our artists-from graphic designers to indie-rock musicians, from architects to booksellers-out of work. This important book looks deeply and broadly into the roots of the crisis of the creative class in America and tells us why it matters. Scott Timberg considers the human cost as well as the unintended consequences of shuttered record stores, decimated newspapers, music piracy, and a general attitude of indifference. He identifies social tensions and contradictions-most concerning the artist's place in society-that have plunged the creative class into a fight for survival. Timberg shows how America's now-collapsing middlebrow culture-a culture once derided by intellectuals like Dwight Macdonald-appears, from today's vantage point, to have been at least a Silver Age. Timberg's reporting is essential reading for anyone who works in the world of culture, knows someone who does, or cares about the work creative artists produce"--

In this book, Nobel Laureate Merton Miller presents a sustained attack on the popular view that modern financial innovations have created excessive market volatility to the detriment of individual savers and business investors, and that regulation is essential in such forms as higher margin requirements, taxes on trading, and perhaps even closing down the future market.

The United States enjoys an established and essentially unchallenged role in the field of surgery. In this sweeping history of American surgical practice, renowned surgeon Seymour I. Schwartz, MD, describes how surgery in this country advanced from the comparatively crude practices of pioneering physicians in the pre-Columbian and colonial eras to its current level of preeminence in scientific surgery today.Of interest to the layperson and professional alike, Dr. Schwartz's engrossing narrative brings to life the personalities and sometimes dramatic conflicts that led to breakthrough contributions. In the nineteenth century, for example, the many colorful characters and surgical innovations included: a surgeon in a small Kentucky community who successfully removed a huge tumor from a woman's abdomen without anesthesia; the three individuals who each laid claim to the development of ether anesthesia; and the first successful gallbladder operation. Turning to the twentieth century, Dr. Schwartz highlights the evolution of vascular surgery, cardiothoracic surgery, and organ transplantation. Many great innovators made crucial contributions, including the Nobel Prize winners Alexis Carrel, who developed a method to sew vessels together, and Joseph Murray, who worked on kidney transplantation in Boston.Complete with an array of intriguing illustrations, this definitive work will captivate general readers with its engaging narrative and will inform medical professionals through its solid historical research and medical expertise.

Peter Gay's inquiry into the ideas and sensibilities which dominated nineteenth-century culture is one of the great achievements in modern historical writing. This is the fifth volume. Peter Gay's The Bourgeois Experience: Victoria to Freud has revolutionized our thinking about the nineteenth century as a whole and particularly about its dynamo - the middle classes. Gay's achievement is to summarize the interior life, the mentality of the nineteenth century. In uncovering the roots of modernism, he shows us a hidden side of the Victorian era. The Victorians we meet in this volume are not the stodgy, complacent characters of drawing room comedy. They are instead a varied crowd, from the capitalists in the top tier of the bourgeoisie eager to be recognized as gentlemen or, better yet, dubbed as nobility, to those at the bottom of the pile, the clerks and craftsmen mortally afraid of sinking into the mass of the proletariat. What they share is an anxiety, driven by their concern to advance up the social pyramid or at least to maintain the status they have achieved. Some of the individuals in this richly peopled narrative turn on their own class, none more bitterly than Gustave Flaubert; others celebrate their success, whether in Manchester or Munich, by sponsoring symphony orchestras or establishing museums; still others become cultural hunters and gatherers, turning their newly acquired fortunes to the private accumulation of art, ranging from the "safe" works of the old masters to the daring innovations of the Impressionists. The stage is thus set for the explosion of modernism accompanied by an inevitable reaction against the subversive avant-garde of artists, composers, and writers as varied as Cezanne, Picasso, Stravinsky, Shaw, Ibsen, and Zola. No one reading this concluding volume of Peter Gay's magnificent reevaluation of the nineteenth century will ever again use the term Victorian as a synonym for dull.

"Through intimate encounters with the life and work of five contemporary gay male directors, this book develops a framework for interpreting what it means to make a gay film or adopt a gay point of view. For most of the twentieth century, gay characters and gay themes were both underrepresented and misrepresented in mainstream cinema. Since the 1970s, however, a new generation of openly gay directors has turned the closet inside out, bringing a poignant immediacy to modern cinema and popular culture. Combining his experienced critique with in-depth interviews, Emanuel Levy draws a clear timeline of gay filmmaking over the past four decades and its particular influences and innovations. While recognizing the 'queering' of American culture that resulted from these films, Levy also takes stock of the ensuing conservative backlash and its impact on cinematic art, a trend that continues alongside a growing acceptance of homosexuality. He compares the similarities and differences between the 'North American' attitudes of Todd Haynes, Gus Van Sant, and John Waters and the 'European' perspectives of Pedro Almodovar and Terence Davies, developing a truly expansive approach to gay filmmaking and auteur cinema."--Jacket

Father of the birth control pill, developer of antihistamines, founder of biomedical companies, teacher of world-class chemists, best-selling novelist.... As The Scientist notes, "Few can match Carl Djerassi's juggling act for success and longevity". Here is Djerassi's remarkable autobiography. Blending vivid descriptions of the lucrative world of drug development with controversial chapters on the politics of contraception and poignant disclosures about his personal life, this book tells the story of one of the most productive and socially conscious chemists working today. The Pill, Pygmy Chimps, and Degas' Horse tells how Djerassi, while still in his twenties and leading a small team in an obscure laboratory in Mexico City, used a locally grown yam first to synthesize cortisone and then, within twelve months, to create the first steroid effective as a birth control pill. Dubbed for this latter work "the father of the pill", a title he often shares with Gregory Pincus and John Rock, who performed the biological and clinical studies to confirm the pill's efficacy in humans, Djerassi has spent a lifetime thinking and rethinking, discussing and debating, the social, economic, and biological consequences of the changed attitudes toward contraception engendered by the pill. In two riveting chapters entitled "The Pill at Twenty" and "The Pill at Forty: What Now?" Djerassi recounts the fascinating history of the pill's journey from its first days in the laboratory to widespread public use--from being hailed as an agent of the sexual revolution to condemnation as an agent of the new promiscuity, to being accused of being an expression of the scientific community's sexism (Why was there no malebirth control pill?). And then, in a powerful consideration of where the politics of contraception have taken us, he discusses why so few innovations in contraception are being investigated today, and why even fewer are making their way to the public. The Pill, Pygmy Chimps, and Degas' Horse chronicles Djerassi's many successful careers in science, business, the academy, and the arts (he is a published poet and novelist, as well as the founder of an artists' colony). His growing appreciation for the soft side of science--its human and humane aspects--have long been reflected in the courses he teaches at Stanford, in the plot of his novel, Cantor's Dilemma, and in his decision to found one of the first environmentally aware pesticide companies. In this intellectually challenging book, the reader is let into the fertile mind and psyche of one of the few Renaissance men of twentieth-century science.

Leaders in War present unique first-person perspectives across the spectrum of American combat operations during the 1991 Persian Gulf War. From division commanders to platoon leaders, the authors deliver an insider's view of tough leadership challenges, tragic failures, and triumphant victories. Leaders in War captures the essence of the post-Cold War US Army: how an all-volunteer army, equipped with new weapons systems and adjusting to new battle doctrine, mounted one of history's most successful military campaigns. Described here are the details of the tremendous logistical challenges, innovations in intelligence, ground combat operations from platoon to division, and a wide range of combat support operations. Leaders in War focuses not just on the successes, but on the failures as well, in operations ranging from violent tank battles against the vaunted Iraqi Republican Guard to train-and-fill operations thousands of miles away. Leaders in War illustrates how US Army leaders adapted to the psychological strains of combat, the fog of war, unforeseeable challenges, and the fury of tank warfare during the Persian Gulf War.

"America is poised to lead the 21st Century, as it led the 20th. That will happen because the country is at a tipping point in the battle for its own renewal, a renewal that will allow America to be exceptional again. Our economy is on the move, fueled by revolutions in energy, immigration, innovation, big data and advanced manufacturing. America's energy independence has set off shockwaves. Just as important are the social transformations that are making the country ever more racially and culturally diverse, younger, a home to immigrants, and the metropolitan centers that foster a rising economic and cultural dynamism. While most other countries struggle profoundly with immigration and religious and racial differences, America's on a path to multicultural identity. Those revolutions in the economy, society and culture and are also producing a new American majority that embraces new values and new politics. Republicans are waging a counter-revolution and that is why America looks gridlocked and why the country is turning to Democrats to take on the country's growing challenges. The economic and social transformations leave people struggling to earn enough and reach the middle class. Families are under stress. Government is corrupted by big money. The American public is demanding the country address the dark side of our progress - and reforms are starting to happen. That is why Democrats will get to lead an era of reform and renewal comparable to the progressive era that mitigated the excesses of the Industrial Revolution. In this incisive book, expert strategist Greenberg draws on years of research and polling to illuminate how America is far from being gridlocked and he articulates a powerful vision of how American politics and America can be renewed"--

Drama Characters: 15 male 3 female It's 1929. Two ambitious visionaries race against each other to invent a device called television." Separated by two thousand miles each knows that if he stops working even for a moment the other will gain the edge. Who will unlock the key to the greatest innovation of the 20th century: the ruthless media mogul or the self-taught Idaho farm boy? The answer comes to compelling life in The Farnsworth Invention the new play from Aaron Sor"

Mr. Chazen is known as an innovator and even a revolutionary, whose ideas changed the face of the apparel industry and retailing forever. The book will provide lessons for everyone in business, as it shows how he and his executives at Liz broke the rules time after time in their pursuit of success -- Pioneering overseas production by American corporations Making consumer choice easier by creating coordinated clothing collections Offering women alternatives to traditional, male-oriented business styles Popularizing designer branding and quality on affordable merchandise Focusing on the end consumer rather than the middleman (in this case the department stores) Growing without advertising Many of his innovations are reflected today in the shopping experience of millions of people around the world: specialized boutiques within larger stores, upscale outlet malls, designer branding on everything, and more. Mr. Chazen's penchant for rule breaking is not limited to business practices but rather extends to career and retirement ideas. For example, he shows how careers are often better nurtured and built up in the hinterlands and away from the New York spotlight. His ideas on a satisfying retirement reflect a "never stop working" approach, and on estate planning a "die broke" philosophy. The book will captivate fashion industry insiders, intrigue general business readers, and enlighten anyone interested in devoting themselves to the entrepreneurial life. In this business memoir, Jerome A. Chazen, tells an extraordinary success story - how, together with designer Liz Claiborne, he took a small startup business and grew it into the largest apparel company in the world. Chazen is one of the most celebrated fashion executives of all time. Through his inventive management of Liz Claiborne, Inc., he created a company beloved by generations of women who enthusiastically dressed themselves for both the workplace and leisure time in Liz Claiborne clothing and accessories. In this book, for the first time, Chazen tells the inside story of the founding of the company, the management tactics and strategies he utilized to propel it into the Fortune 500, the internal struggles and tensions that marked the business' phenomenal growth, an inside look at the processes that made Liz a "rock star" in her time, and revealing insights into what it takes to navigate successfully in one of the most competitive industries in the world. Mr. Chazen shows readers how design and creativity is never enough to ensure success. Only by joining the creative processes to savvy marketing and sales strategies can any company achieve great success. He illustrates how he did it at Liz and shows by example how other companies can do the same and flourish as well.

DIV Published on the occasion of Richard C. Levin’s retirement as president of Yale University, this captivating collection of speeches and essays from the past decade reflects both his varied intellectual passions and his deep commitment to university life and leadership. Whether discussing the economic implications of climate change or speaking to an incoming class of Yale freshmen, he argues for the vital importance of scholarship and the critical role that universities play in educating students and promoting the overall well-being of our society. This collection is a sequel to The Work of the University , which contained the principal writings from Levin’s first decade as Yale’s president, and it enunciates many of the same enduring themes: forging a strong partnership with the city of New Haven, rebuilding Yale’s physical infrastructure, strengthening science and engineering, and internationalizing the university. But this companion volume also captures the essence of university leadership. In addressing topics as varied as his personal sources of inspiration, the development of Asian universities, and the university’s role in promoting innovation and economic growth, Levin challenges the reader to be more engaged, more creative, more innovative, and above all, a better global citizen. Throughout, his commitment to and affection for Yale shines through. /div

"Are we tired of hearing that fall is a season, sick of being offered fries and told about the latest movie? Yeah. Have we noticed the sly interpolation of Americanisms into our everyday speech? You betcha. And are we outraged? Hell, yes. But do we do anything? Too much hassle. Until now. In That's The Way It Crumbles Matthew Engel presents a call to arms against the linguistic impoverishment that happens when one language dominates another. With dismay and wry amusement, he traces the American invasion of our language from the early days of the New World, via the influence of Edison, the dance hall and the talkies, right up to the Apple and Microsoft-dominated present day, and explores the fate of other languages trying to fend off linguistic takeover bids. It is not the Americans' fault, more the result of their talent for innovation and our own indifference. He explains how America's cultural supremacy affects British gestures, celebrations and way of life, and how every paragraph and conversation includes words the British no longer even think of as Americanisms. Part battle cry, part love song, part elegy, this book celebrates the strange, the banal, the precious and the endangered parts of our uncommon common language"--Amazon.com

Congress is the heart and soul of our democracy, the place where interests are brokered, laws are established, and innovation is turned into concrete action. It is also where some of democracy's greatest virtues clash with its worst vices: idealism and compromise meet corruption and bitter partisanship. The American Congress unveils the rich and varied history of this singular institution. Julian E. Zelizer has gathered together forty essays by renowned historians to capture the full drama, landmark legislation, and most memorable personalities of Congress. Organized around four major periods of congressional history, from the signing of the Constitution to the creation of the Department of Homeland Security, this volume brings a fresh perspective to familiar watershed events: the Civil War, Watergate, the Vietnam War. It also gives a behind-the-scenes look at lesser-known legislation debated on the House and Senate floors, such as westward expansion and war powers control. Here are the stories behind the 1868 vote to impeach President Andrew Johnson; the rise of Jeannette Rankin, the first woman elected to Congress and a leading advocate for pacifism; and the controversy surrounding James Eastland of Mississippi, who carried civil rights bills in his pockets so they could not come up for a vote. Sidebars further spotlight notables including Huey Long, Sam Rayburn, and Tip O'Neill, bringing the sweeping history of our lawmaking bodies into sharp focus. If you've ever wondered how Congress worked in the past or what our elected officials do today, this book gives the engaging, often surprising, answers.

From the bestselling author of Cultural Literacy , a passionate and cogent argument for reforming the way we teach our children "Ought to be read by anyone interested in the education and training of the next generation of Americans."--Glenn C. Altschuler, Boston Globe Why, after decades of commissions, reforms, and efforts at innovation, do our schools continue to disappoint us? In this comprehensive and thought-provoking book, educational theorist E. D. Hirsch, Jr. offers a masterful analysis of how American ideas about education have veered off course, what we must do to right them, and most importantly why . He argues that the core problem with American education is that educational theorists, especially in the early grades, have for the past sixty years rejected academic content in favor of "child-centered" and "how-to" learning theories that are at odds with how children really learn. The result is failing schools and widening inequality, as only children from content-rich (usually better-off) homes can take advantage of the schools' educational methods. Hirsch unabashedly confronts the education establishment, arguing that a content-based curriculum is essential to addressing social and economic inequality. A nationwide, specific, grade-by-grade curriculum established in the early school grades can help fulfill one of America's oldest and most compelling dreams: to give all children, regardless of language, religion, or origins, the opportunity to participate as equals and become competent citizens. Hirsch not only reminds us of these inspiring ideals, he offers an ambitious and specific plan for achieving them.

Part I reproduces the 2nd edition of "The culture of the school and the problem of change"; in part II, Dr. Sarason "revisits" the text.

In 1872, the Qing Empire sent 120 boys to America in the hope that they would unlock the mysteries of Western innovation. They studied at New England's finest schools, befriended luminaries such as Mark Twain and Ulysses S. Grant, and exchanged ideas with their American peers that would change the course of both nations. But when anti-Chinese fervor forced them back home, the young men faced a new set of obstacles, having to overcome a suspicious imperial court and a culture deeply resistant to change. Filled with colorful characters and vivid historical detail, this book unearths the dramatic stories of these young men who led China at the pivotal moment when it teetered between modernity and tradition.--From publisher description.