Frances Oldham Kelsey, the FDA, and the Battle Against Thalidomide


Book Description

In the early 1960s, Dr. Frances Oldham Kelsey of the U.S. Food and Drug Administration became one of the most celebrated women in America when she prevented the deadly sedative thalidomide from entering the U.S. market. Her lifesaving work there became the basis for the FDA's current drug approval protocols. This biography brings to light the efforts and legacy of a pioneering woman in science whose contributions are still influential today.




Sympathy for the Devil


Book Description

Gary Acton is a London oncologist and his book offers a unique insight into the chaotically unpredictable world of cancer medicine and the biotechnology industry.




A Heart Afire


Book Description

A deeply compelling biography of the pioneering children’s heart doctor Helen Taussig, who helped start heart surgery and became a global force against preventable suffering. In A Heart Afire, Patricia Meisol renders a moving portrait of the indomitable pediatrician and global patient activist Helen Taussig (1898–1986), who famously gathered and publicized evidence linking thalidomide to birth defects, leading to US drug safety laws. Taussig also developed the Blalock-Taussig shunt (along with Alfred Blalock) for infants with congenital heart defects. Spanning Taussig’s childhood in Boston, her struggle with dyslexia, her progressive hearing loss, her research contributions, and the founding of her own fledgling children’s heart clinic, this book chronicles Taussig’s ambition, tenacity, and formidable work ethic. As Meisol shows, Taussig not only saved lives, but also set a bold precedent for other women doctors in the twentieth century, who were largely excluded from medicine. Meticulously researched and intimately told, A Heart Afire is unique in its use of a fifty-year-long campaign by Taussig’s followers for a worthy memorial portrait and shows how views of women doctors have evolved. Meisol reveals Taussig as an authentic American hero, one who embodies the Emersonian ethic of developing oneself, following the processes of nature, and serving the public. A fiercely independent thinker, Taussig infused herself and her ideas into the medical culture, paving the way not only for other professional women but also for patients then and now to advocate for themselves. Offering an indispensable look at health care as a universal human right, A Heart Afire is a beacon and a blueprint for creating a more just and compassionate world of medicine.




On Ordinary Heroes and American Democracy


Book Description

True American heroes need not have superhuman abilities nor do they need to act alone. Heroism in a democracy is different from the heroism of myths and legends, writes Gerald Pomper in this original contribution to the literature of U.S. politics. Through the remarkable stories of eight diverse Americans who acted as heroes by "just doing their jobs" during national crises, he offers a provocative definition of heroism and fresh reasons to respect U.S. institutions and the people who work within them. This new paperback edition includes photographs, an introductory chapter on American heroism after 9/11, a survey of the meanings of heroism in U.S. popular culture, and an original concluding theory of "ordinary" heroism.




FDA Consumer


Book Description




Inside the FDA


Book Description

The forces that shape America's most powerful consumer agency Because of the importance of what it regulates, the FDA comes under tremendous political, industry, and consumer pressure. But the pressure goes far beyond the ordinary lobbying of Washington trade groups. Its mandate-one quarter of the national economy-brings the FDA into the middle of some of the most important and contentious issues of modern society. From "designer" babies and abortion to the price of prescription drugs and the role of government itself, Inside the FDA takes readers on an intriguing journey into the world of today's most powerful consumer agency. In a time when companies continue to accuse the FDA of nitpicking and needlessly delaying needed new drugs, and consumers are convinced that the agency bends to industry pressure by rushing unsafe drugs to market, Inside the FDA digs deep to reveal the truth. Through scores of interviews and real-world stories, Hawthorne also shows how and why the agency makes some of its most controversial decisions as well as how its recent reaction to certain issues-including the revolutionary cancer drug Erbitux, stem cell research, and bioengineering of food-may jeopardize its ability to keep up with future scientific developments. Inside the FDA takes a closer look at the practices, people, and politics of this crucial watchdog in light of the competing pressures and trends of modern society, revealing what the FDA is supposed to do, what it actually does-and fails to do-who it influences, and how it could better fulfill its mandate. The decisions that the FDA makes are literally life and death. Inside the FDA provides a sophisticated account of how this vitally important agency struggles to balance bureaucracy and politics with its overriding mission to promote the country's health.




Using Medicines Wisely


Book Description

PROVIDES INFORMATION ABOUT DRUGS THAT HAVE SAVED MILLIONS BUT HAVE ALSO DAMAGED THE LIVES OF MANY HEALTH FOODS-AN ENTICING ALTERNATIVE TO DRUGS, DISCUSSES THE SPECIAL NEEDS OF WOMEN IN GETTING THE BEST AND SAFEST DRUG OR CONTRACEPTIVE AND PROVIDES A COMPLETE GUIDE TO THE SIDE EFFECTS OF THE 51 MORE PRESCRIBED DRUGS.




Burger's Medicinal Chemistry, Drug Discovery and Development, 8 Volume Set


Book Description

Burger’s Medicinal Chemistry, Drug Discovery and Development Explore the freshly updated flagship reference for medicinal chemists and pharmaceutical professionals The newly revised eighth edition of the eight-volume Burger’s Medicinal Chemistry, Drug Discovery and Development is the latest installment in this celebrated series covering the entirety of the drug development and discovery process. With the addition of expert editors in each subject area, this eight-volume set adds 35 chapters to the extensive existing chapters. New additions include analyses of opioid addiction treatments, antibody and gene therapy for cancer, blood-brain barrier, HIV treatments, and industrial-academic collaboration structures. Along with the incorporation of practical material on drug hunting, the set features sections on drug discovery, drug development, cardiovascular diseases, metabolic diseases, immunology, cancer, anti-Infectives, and CNS disorders. The text continues the legacy of previous volumes in the series by providing recognized, renowned, authoritative, and comprehensive information in the area of drug discovery and development while adding cutting-edge new material on issues like the use of artificial intelligence in medicinal chemistry. Included: Volume 1: Methods in Drug Discovery, edited by Kent D. Stewart Volume 2: Discovering Lead Molecules, edited by Kent D. Stewart Volume 3: Drug Development, edited by Ramnarayan S. Randad and Michael Myers Volume 4: Cardiovascular, Endocrine, and Metabolic Diseases, edited by Scott D. Edmondson Volume 5: Pulmonary, Bone, Immunology, Vitamins, and Autocoid Therapeutic Agents, edited by Bryan H. Norman Volume 6: Cancer, edited by Barry Gold and Donna M. Huryn Volume 7: Anti-Infectives, edited by Roland E. Dolle Volume 8: CNS Disorders, edited by Richard A. Glennon Perfect for research departments in the pharmaceutical and biotechnology industries, Burger’s Medicinal Chemistry, Drug Discovery and Development can be used by graduate students seeking a one-stop reference for drug development and discovery and deserves its place in the libraries of biomedical research institutes, medical, pharmaceutical, and veterinary schools.







The Drug Trial


Book Description

Winner of the Writers' Trust of Canada's Shaughnessy Cohen Prize for Political Writing and the Canadian Science Writers' Association's Science in Society Book Award. Poison-pen letters, possible medical misconduct and a swirl of competing accusations that led to two inquiries – the Olivieri affair ended careers and shook the international research establishment. A riveting anatomy of Canada’s most controversial drug trial, by the medical journalist who helped break the story. In August 1998, a medical scandal erupted in the national and international media whose consequences still reverberate. A charismatic young doctor named Nancy Olivieri, working with young people who suffered from a rare blood disorder, stated that she had discovered serious problems with an experimental drug manufactured by Canada’s largest drug company, Apotex. Though her research contract required her to remain silent, she decided she had no choice but to warn the patients enrolled in her trials. Apotex retaliated by cancelling her research and slamming her reputation. In the aftermath, Olivieri became a whistleblower applauded in academia and the media for standing up to powerful corporate interests. The Olivieri affair spawned two inquiries and multiple lawsuits, but the full story of Canada’s biggest science scandal has never been told – until now. In the hands of psychiatrist and medical journalist Miriam Shuchman, the debacle over the pill called L1 is revealed as a modern morality play in which every crack in the system of scientific research, corporate financing and peer review stands out in stark relief. By talking with the people whom both Olivieri and Apotex wanted to heal – the young men and women struggling to have normal lives despite debilitating treatment – Shuchman also brings us the moving story of the toll on patients’ health when battles break out among the physicians and researchers aiming to heal them.