Administration has triumphed in ways that not even its founding champion, Theodore Roosevelt, could have anticipated. Today, the FDA monitors products from 95,000 businesses, representing more than $1 trillion worth of goods, and it prevents hundreds of hazardous drugs, medical devices, and food products from reaching the market each year. In the first full-length history of the nation's most important regulatory agency, Washington Post health and science reporter Philip J. Hilts describes the FDA's battles, from their forays against toxic old-time "elixirs" to current controversies about AIDS medications.
Hilts closes Protecting America's Health by tentatively suggesting that, "after the conservative storm, the FDA was back to steering a more usual course." I am not so sure. But I fully support his judgment that the FDA, despite its flaws, plays an essential role in protecting health. Anyone prone to sneer at "government bureaucrats" should visit the FDA and meet some of the doctors and scientists who bring great expertise and a commitment to public service to bear on some of the most daunting safety issues in our society. — Thomas J. Moore
Philip J. Hilts, a veteran reporter on medical matters, authoritatively chronicles the permanent struggle between greed and social responsibility in Protecting America's Health. He skillfully reconstructs how a handful of concerned people, including Theodore Roosevelt, with his desire to civilize capitalism, and Dr. Frances Oldham Kelsey, the government heroine who banned thalidomide from America, took the nation's health to heart and helped to prolong lives once lost to or shortened by quackery. — Peter Pringle
Protecting America's Health is a thoroughly documented history of a century of federal food and drug regulation. Hilts, a former science writer for The Times and the author of Smokescreen: The Truth Behind the Tobacco Industry Cover-Up, writes both with a historian's attention to piecemeal dissection and analysis and with the flourish and vividness of an experienced journalist aware of the drama inherent in the story he is telling. — Sherwin B. Nuland
A century ago, store shelves were filled with products that were rotten, useless or even deadly. Today, we can be relatatively confident that "no cholesterol" on a product label really means what it says, and that the terms "fresh," "beef" and "reduces fever" accurately describe a product's contents or use. These protections, now taken for granted, have been the work of what is arguably the nation's most important regulatory agency, the Food and Drug Administration. Hilts (Scientific Temperaments), a health and science reporter who's written for the Washington Post and the New York Times, wonderfully documents the history of the FDA from its start in the administration of Teddy Roosevelt through various crises and triumphs to the deregulatory climate of recent years. From the start, FDA officials battled entrenched business interests. Industry argued that regulation hurt profits, stymied research and kept potentially beneficial products from reaching markets quickly. How the FDA doggedly prevailed against this tide of opposition is a story of persistence, political maneuvering and make-it-up-as-you-go pragmatism. As Hilts shows, strong policies often emerged in the wake of tragedies or scandals: the case of thalidomide, a drug introduced in the late 1950s as a sedative and to relieve morning sickness but that caused pregnant women to give birth to severely deformed infants (the number is conservatively estimated at 8,000), shocked the world and led to congressional hearings and a strict new drug approval law. Even so, industry continues to lobby aggressively against regulation. Hilts has little sympathy for industry's point of view and has the facts to support this position. As the federal government once again starts talking about cuts, this book offers a sober reminder of the importance of maintaining vigorous protections against the dangers of profit-motivated decisions. Photos not seen by PW. (Apr. 2) Copyright 2003 Reed Business Information.
An agency with almost unparalleled power, the Food & Drug Administration (FDA) is both widely celebrated and widely reviled. Paradoxically, its authority is tenuous. In the face of unremitting attacks, it must labor for its own survival while championing consumer safety. Businesses accuse the FDA of delaying the development and availability of life-saving products, while consumers accuse it of colluding with businesses and failing to protect against predatory industry practices. Drawing on extensive research and more than 200 interviews, Hilts, a veteran, award-winning science writer, effectively debunks common criticisms of the FDA. He offers an important perspective on the agency's long history of glorious victory and deadly failure while providing profound insight into issues emerging at the intersection of science, business, and ethics. It is strange, however, that Hilts does not discuss several recent FDA controversies, for example, the furiously disputed safety of the artificial sweetener, aspartame, and of food irradiation, both FDA-approved. Still, those who ponder the mysteries of human nature that too often lead to the sacrifice of human safety for economic gain will find much of value here. Strongly recommended for public and academic libraries. [Previewed in Prepub Alert, LJ 11/1/02.]-Noemie Maxwell, King Cty. Lib. Syst., Seattle Copyright 2003 Reed Business Information.
Chicanery, greed, politics, battles won and lost: welcome to the Food and Drug Administration. New York Times science reporter Hilts (Memory's Ghost, 1998, etc.) has no doubts about the need for an independent FDA to protect the public's health, and he has no qualms about identifying the forces that have attempted to thwart its mission. From passage of the Food and Drug Act of 1906, shortly after Upton Sinclair's The Jungle aroused public outrage over the meatpacking industry, to passage of the Kefauver-Harris amendments in 1962, spurred by furor over the thalidomide disaster, Hilts shows how commerce, politics, and events have shaped the evolving role of the FDA. Born in the Progressive Era as the US Department of Agriculture's Bureau of Chemistry but hobbled by minimal budgets and authority, the FDA had little effectiveness until the Food, Drug, and Cosmetic Act of 1938, sparked by public concern over children's deaths caused by sulfanilamide, gave it the job of checking drugs before they went to market. Hilts examines the growth of the giant pharmaceutical industry, the rise of a conservative movement opposed to government regulation, and the policies and styles of FDA commissioners. He shows how controlled scientific studies became the standard for determining a drug's safety and effectiveness and how the often-beleaguered agency's professionalism was established. Among the many battles he recounts were those over package-insert information, nutrition labeling on processed foods, silicone breast implants, development of AIDS drugs, and recall of drugs hazardous to health but profitable to pharmaceutical companies. Common sense, says Hilts, demands that businesses, whose first job isprofits, be countered by a regulatory agency whose first job is public safety. As imperfect as the FDA is, he states, duly noting the payoff scandals of the late 1980s, its work remains essential. Rousing and readable: sure to brings smiles at the FDA and howls of protest from industry lobbyists. Agent: Gloria Loomis/Watkins Loomis Agency
Philip J. Hilts, a veteran reporter on medical matters, authoritatively chronicles the permanent struggle between greed and social responsibility in Protecting America's Health. He skillfully reconstructs how a handful of concerned people, including Theodore Roosevelt, with his desire to civilize capitalism, and Dr. Frances Oldham Kelsey, the government heroine who banned thalidomide from America, took the nation's health to heart and helped prolong lives once lost to or shortened by quackery. . . . Always fully in command of the science and the politics, Hilts's history of the agency's turbulent times is informative and rewarding.Washington Post
As the federal government once again starts talking about cuts, this book offers a sober reminder of the importance of maintaining vigorous protections against the dangers of profit-motivated decisions.Publishers Weekly