Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation / Edition 1

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Overview

A history of the Food and Drug Administration, now the nation's most important regulatory agency. Journalist Philip J. Hilts shows how the agency combats self-serving political and industrial interests and enforces rigorous scientific standards in order to protect American consumers from hazardous medicines, medical devices and foodstuffs. He also observes that FDA regulation, far from stifling innovation--as critics feared--has actually accelerated it.
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Editorial Reviews

From Barnes & Noble
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.
From the Publisher
"Philip J. Hilts's book forcefully captures the complexity and the drama of the government's attempt to oversee the imperfect science of medical treatment. It is a genuinely important book, rich in history, accurate in detail, unflinching in analysis. Above all, it causes us to think differently about the FDA, which has so often served as a convenient whipping boy for frustrated constituencies across the political spectrum."--Jerome Groopman, M.D., The New Republic

"[Hilts] writes both with a historian's attention to 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 Nuland, M.D., New York Times Book Review

"Protecting America's Health is a history of the FDA from its origins as a tiny office within the Department of Agriculture in the nineteenth century to the battles over tobacco and AIDS during the 1990s. A lesser writer might have produced a dreary tome on such a topic. But Hilts . . . brings his story to life by populating it with characters worth rooting for--and, in some cases, against."--The American Prospect

"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

"Protecting America's Health is a well-researched, well-documented, and well-indexed history of an agency whose policies and decisions are respected and emulated throughout the world."--Journal of the American Medical Association

"Because history does repeat itself, and because we depend on the FDA to ensure our safety, this book is important. Those who are curious about what the FDA can and cannot do will enjoy the revelations and thought-provoking argument."--New England Journal of Medicine

"This fascinating look at the inside story [of the FDA] reveals how disastrous unfettered capitalism would be without reasonable regulation."--Booklist

"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

The New York Times
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
The Washington Post
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
The Los Angeles Times
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
Publishers Weekly
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.
Library Journal
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.
Kirkus Reviews
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
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Product Details

  • ISBN-13: 9780807855829
  • Publisher: The University of North Carolina Press
  • Publication date: 9/27/2004
  • Edition description: 1
  • Edition number: 1
  • Pages: 424
  • Sales rank: 927,899
  • Product dimensions: 5.86 (w) x 9.22 (h) x 1.08 (d)

Meet the Author

Philip J. Hilts is a health and science journalist who has been a correspondent for the New York Times and the Washington Post. He is author of four previous books, the most recent of which is Smokescreen: The Truth Behind the Tobacco Industry Cover-Up.
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Read an Excerpt

Chapter 1
Dr. Wiley's Time
In April 1863, a tall, stringy young fellow named Harvey Washington Wiley, wearing a suit of knobby homespun, strode out of his Indiana farmhouse and set off for college five miles down a dirt road. He had announced his leaving without preliminaries: "Father, I'm going to Hanover College." Though his father was a part-time farmer and needed Harvey at home, he did not object.
Harvey started his hike optimistically. But by the time he reached the outskirts of the village where the college lay, apprehension filled his chest. He imagined himself, the poorly dressed farmer boy, entering the cultured village and "being a butt for all the students and a laughingstock in the eyes of the faculty." But he knew that if he turned back, it would be the last he would see of education. After years of firelight reading and all it had inspired-his parents read aloud such rich tales as Uncle Tom's Cabin and a biography of Napoleon Bonaparte-young Wiley had to take the chance. He walked into the town.
He was moving as America did at the time. In the first half of his life, two-thirds of the nation still worked on farms. But the flight from the land had begun. Soon, a majority of Americans would be living on crowded avenues and in city tenements, and by the second half of Wiley's life, America as imagined by the Founding Fathers was disappearing. (Today the category "farmer" is not even included in census forms.)
A new regime was rising, in which the nation was led by men of business and their new, large operations, called combinations at the time-the first sturdy examples of that new kind of organization, the corporation. These werecompanies with a national reach, great sums of money available for action and investment, a rank of powerful officers, and-another new phenomenon created by business-big bureaucracy.
The commercial market, and new attitudes toward money in particular, freed people of the dominance of social systems that were hereditary and thus largely unchangeable. The new system made possible social movement based on the accumulation of money. With the coming of the capitalist markets and the corporations, average wealth increased across the country, though not in the heartland. Where hundreds of small packing plants existed, now only a few remained in major cities; where thousands of local mills had once ground grain, now a fraction as many operated, though they were much larger. Locally produced foods were now shipped into the great maw of city factories, and returned in cans and jars, watered down, preserved, and cheap.
Machines were being invented and applied in every field, and factories built around these hissing, tapping objects. Workers were lined up to feed and operate them. Out the other side came profit. The creation of goods en masse was soon matched by the ability to move them. Great distances were shrunk by rapid transport. But at the same time, another kind of distance between people was growing. People who had once made food, clothing, medicines, and simple tools for themselves or their neighbors no longer did. The modern estrangement between the people who create goods and the people who consume them now emerged. The corporations were developing a reputation not only for lack of accountability, but also for ruthlessness in competition and hardness toward their workers. There was a fear that the money-centered values of the great combines and their owners would soon displace personal decency and honor.
For Harvey Wiley and many of his generation, the nation's plunge
into modern life was a plunge into deep waters. The coming of free-
dom in commerce, and advancement in science and technology, was thrilling. But the raw side of the new business seemed a direct challenge to morality.
At the farmers' Grange meetings in the second half of the nineteenth century, the talk was of ruthless companies, falling prices, and power slipping away from the farmers as corporations took greater and greater shares of their markets. The voice of the farmers, originally one of stability, was becoming a national voice of protest.
Wiley would become one of the first and best spokesmen for some ideas that arose at that time to find a solution to the growing crisis of money and morals. He and other progressives believed strongly: First, that progress was essential and desirable. Second, that business was a great engine of progress, along with science and education, and should be greatly encouraged. Third, that business had shown in the nineteenth century it could not well serve two masters-it could not seek profit with a single-minded energy and at the same time take care that citizens were protected from the injustices and injuries that its actions or products might cause. The new kind of business could not, in other words, honestly police itself. Fourth, that because the new corporations had grown to such great size and influence, the policing of businesses should be done by government, the only other organization in society of sufficient weight to confront business successfully if needed. These ideas produced fierce arguments at the time, and still do.
Wiley would become a creator of the first regulatory agency, the FDA, which was intended to confront business directly when it strayed beyond the bounds. Its mission was to provide a simple public service: to ensure that the foods and drugs sold in America were safe and wholesome for consumption. The FDA, as a "government regulatory agency," is now spoken of by some with a hiss or a dismissive smirk. But such negativity is born of a modern prejudice, one that is based largely on a misunderstanding of the FDA's mission and its history.
Wiley ambled off the farm an unlikely figure for fame. He was taller than six feet and quite awkward. Gifted with some oratorical talent, he was still very nervous before groups. He was religiously fervent while intellectually adventurous in ways that could and did offend the pious.
He was from Republican Township, the sixth of seven children who grew up on a farm of 125 acres. Two ravines that cut the farm ran down to a creek, which emptied into the Wabash River, not far from where it joined the mighty Ohio. Young Wiley could hear the shriek of whistles as steamboats came up the river and, on a clear day, could see the black columns of smoke from their stacks. His father, Preston Pritchard Wiley, a lay minister and self-educated man, was not much of a farmer. His mother, Lucinda Maxwell, had had only three months of schooling but on her own had become fully literate despite the extent of her daily chores.
Preston and Lucinda Wiley drank in knowledge the way the thirsty drink water. They looked forward to what the world might be, and their children in it. The Wileys educated each of their children, including their daughters. They spent money for important books, and periodicals that took weeks to arrive. Preston taught himself Greek so that he could study the New Testament in the original. A grandfather of Lucinda's left Kentucky not long after the Revolutionary War because of his anger over the slave trade; he moved to Indiana with the slaves he had acquired and set them free upon arrival.
In the Wiley family, Christianity was vital. There was no activity on Sunday; even punishments with the switch were held over for Monday morning. Preston brought young Harvey with him to the school where he taught. He set the youngster on the floor and drew a large square on the floor with chalk. Harvey was told to stay within it, and apparently he did (he must have been aware at all times of the alternative). He learned to read inside his chalk prison.
Voting then was oral. When his father shouted out his lone anti-slavery vote in the county in 1840, screams of "Nigger!" were directed toward him. Despite the risk, he was a participant in the Underground Railroad that carried slaves to the North and freedom.
The Wileys' sense of justice was at least as strong as their desire for new knowledge. Again and again, they warned their son of the current in society pulling them back toward pre-democratic days. Wealth and power were going increasingly to men of commerce who were willing to use people like farm animals, working them for profit with just enough to keep them going, and sometimes less than that. This was the beginning of the era of the robber barons. Preston approved of innovation, but never at the cost of justice.
Harvey grew up wearing woolens shorn, spun, and woven from the family's sheep. Virtually everything he ate also came from the farm-eggs, butter, corn, wheat, chicken, and mutton. He even planted the newest crop of the time-sorghum; he fed it into a one-horse mill to squeeze out the sugar. But his reading had made him imagine the world at large, and the place in it that he might fill. He imagined becoming a man of learning and then returning, in some way at some time, to bring his knowledge back to the land. It did not take long for the times to intervene. First there was the Civil War, and then the upheaval of economic disruption that drove families from the land to the cities, and in many instances from new hope to new despair.
Wealth in America was rapidly leaving the hands of a large number of landowners and flying into the hands of a few industrialists, reaching the point before the end of the century when about 60 percent of the wealth was in the hands of one percent of the population. Along with the boom in business, the nation found it would have to undergo what began to be called, euphemistically, "cycles"-crashes at regular intervals. There were full depressions in 1873, 1884, and 1893. Perhaps just as important, business and politics had merged into one entity. The era of the common man envisioned not long before had never arrived. The control of politics, once in the hands of kings and hereditary gentry, rapidly passed to a moneyed class. Political corruption was beyond anything easily imagined today. The United States Senate was referred to as the "millionaire's club," and it resembled a convention of industry representatives. Because of strong party control over state legislatures and election rules, it had become common for wealthy men to pay a fee to the party to get themselves nominated and elected to office. "The Senate, instead of representing geographical areas, came to represent economic units," writes historian Sean Cashman. In Congress, it was lumber rather than Michigan, oil rather than Ohio, silver rather than Nevada. There were no public services to speak of, and protests were crushed by private squads or government troops, or both.
All this was transpiring as intellectual, scientific, and technical progress was advancing so rapidly that there is nothing in any corner of history or any civilization to match it.
For Harvey Wiley the times were more than stimulating. In the summer of 1864, when a call went out for volunteers to fight for the Union, he left college and signed up with the 137th Regiment of Indiana volunteers. During his time in uniform, the man in charge of his life was Sergeant Solomon Hampton, a country doctor by trade and a medic in the Union army. Hampton described the farm boy who came to him as "lean, lank, bowlegged, Chinese-eyed, jaundice-skinned," and full of fun. The two men became good friends, and after Wiley finished his studies at Hanover College in 1865, Wiley's first job was as an apprentice to Dr. Hampton in Kentucky.
Wiley studied medicine "and rode over the hills of Trimble County with the doctor on his calls, now to deliver a baby, now to treat a gunshot wound . . . the two young men found each other congenial company and, when work permitted, loved to match wits over a chess board," writes Oscar Anderson. He earned an M.D. from Indiana Medical College, and soon strung together every connection he could to get into Harvard. He earned his bachelor of science there cum laude in less than two years by prodigious work and continual social enterprise. Then he set off for the obligatory tour abroad. He studied under the most brilliant chemists of the time-those in the German universities. When he returned, he obtained a position as the head of the science department at a university just being formed in Lafayette, Indiana, called Purdue University after its financial benefactor. There Wiley created the first student chemistry labs in the state and became a one-man advance in scientific learning for the region.
He continued his own studies, eagerly carrying out chemical analysis of everything he could lay his hands on-dirt, wood, water, cosmetics. But most of all he worked on sugar and the creation of its synthetic base, glucose.
He flourished as a teacher, and took on projects for the state government. His reputation grew. In fact, it quickly grew beyond the capacity of some Indianans to tolerate it. The president of Purdue at the time, Emerson White, was the virtual opposite of Wiley. White, a former local high school teacher, had little understanding of the world outside Indiana and none of science. He was a religious bigot and a man singularly lacking in humor. Under White, it was virtually a requirement that professors be Trinitarians, and they could not say, as Wiley had, that all beliefs should be tolerated. Worse, Wiley insisted that the word "all" included pantheists and atheists as well as monotheists.
Wiley exhorted his students to absorb an "all-permeating ambition to ameliorate the condition of man." Like a preacher, this scientist called his students to action:
Wherever there is want, there is your place to supply; wherever ignorance, there is your place to teach; wherever sickness, there is your place to heal; wherever oppression, there is your place to relieve; wherever injustice, there is your place to vindicate; finally, wherever in the battle of life there is need of hands or nerve or brain, there amidst
the carnage and desolation in the middle of the sulfurous smoke and the hail of death and the tempest of passion and hate, is your place to stand or fall fighting with your face to the foe.
The moment of truth for Wiley at Purdue came when he procured "a nickel-plated Harvard roadster bicycle, with a high front wheel and a small back wheel." He rode it for some time before receiving a summons to appear before the university's board of trustees. One of the trustees read the charges to him. They had "been greatly pleased with the excellence of his instruction" and with his popularity among his pupils. Still, they were "deeply grieved . . . at his conduct. He has put on a uniform and played baseball with the boys, much to the discredit of the dignity of a professor. But the most grave offense of all has lately come to our attention. Professor Wiley has bought a bicycle. Imagine my feelings and those of other members of the board on seeing one of our members dressed up like a monkey and astride a cartwheel riding along our streets." Eventually, after facing similarly absurd conflicts again, Wiley left.

Copyright© 2003 by Philip J. Hilts
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Table of Contents

Introduction: The Beginning of Regulation
Prologue: The Challenge 3
Ch. 1 Dr. Wiley's Time 11
Ch. 2 Commerce, Commerce, Commerce 19
Ch. 3 The Progressive Era 35
Ch. 4 The Law Succeeds, and Fails 56
Ch. 5 Capitalism in Crisis 72
Ch. 6 The Birth of the Modern Pharmaceutical Trade 95
Ch. 7 New Drugs, New Problems 108
Ch. 8 The Industry Ascendant 117
Ch. 9 The Grand Bargain 129
Ch. 10 Thalidomide 144
Ch. 11 Science Meets Policy 166
Ch. 12 Partisan Politics 178
Ch. 13 The Limits of Policy 202
Ch. 14 Deregulation 210
Ch. 15 The Medical Officer 224
Ch. 16 The Modern Plague 236
Ch. 17 A Progressive 255
Ch. 18 Drug Lag Revisited 276
Ch. 19 An Anti-regulatory Campaign 291
Ch. 20 The Argument Is Joined 309
Ch. 21 Old-fashioned Politics 325
Epilogue: Greed and Goodness 338
Notes 345
Selected Bibliography 373
Acknowledgments 379
Index 381
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