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

AUTHOR: Philip J. Hilts
ISBN: 037540466X

SHORT DESCRIPTION: Emerging out of Theodore Roosevelt's desire to civilize capitalism, the Food and Drug Administration was created to stop the trade in adulterated meats and quack drugs. This history of the agency takes readers back to its beginnings, and makes...

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         Editorial Review

Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation
- Book Review,
by Philip J. Hilts


From 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. Copyright 2003 Reed Business Information, Inc.


From Library Journal
A health/science reporter for the New York Times, Hilts tracks the growth of the federal agency charged with protecting our health.Copyright 2002 Reed Business Information, Inc.


From the New England Journal of Medicine, October 16, 2003
The Food and Drug Administration (FDA) is one of the most misunderstood, underfunded, and important government agencies. In largely invisible ways, the FDA safeguards our food, drugs, cosmetics, and medical devices. In an engaging style, journalist Philip Hilts details a century of scientifically grounded work by the FDA and the commissioners who shaped the agency. He nimbly moves chronologically through FDA history, using key examples to illustrate shifts in power and policy. Several themes recur throughout the book. One is the tension between business interests and public health. From the first hints of regulation in the early 20th century, trade groups have lobbied for reduced enforcement. Seldom do consumers act similarly. A second theme is the persistence and inventiveness of quackery. Patent medicine's dubious claims look remarkably similar to some health-related claims made for supplements and herbal products. A third theme is the evolution of changes in regulatory power. Almost every law strengthening the FDA passed because of a constellation of events: a proposed law, of which the public was aware, languished in Congress, and then serious injury or death spurred Congress to act. A fourth theme is the "drug lag," real or imagined. Once a serious problem, the situation improved in the 1990s largely because the FDA itself worked with industry to facilitate quicker approval of drugs, not because of increased allocations. Stories of deaths from sulfanilamide elixir in 1937, of problems caused by chloramphenicol in the 1950s, and of the near-disaster of thalidomide in the 1960s are all recounted. One of the strongest sections of the book examines the attempts of the "New Right" to dismantle the FDA in 1994. The account of political maneuvering is fascinating, from the witnesses flown in by pharmaceutical groups, none of whom were denied treatment because of FDA policy, to conference committee meetings, in which a group predicated on bipartisan support could not, and would not, advance policy to diminish the FDA's power. Other items regulated by the FDA, however, including medical devices, cosmetics, food, and biologics, are not mentioned in the book. We read about the results of a 1976 law requiring safety testing for new medical devices, yet we learn nothing about the problems caused by the Dalkon Shield that led to that decision. The agreement to regulate vitamins in the 1970s, which generated more mail to Capitol Hill than did the impeachment hearings of President Richard Nixon, passes without notice. Some of these omissions reflect the author's sources. Hilts acknowledges the historians in the FDA's history office yet does not properly credit the FDA's oral-history collection, which he used effectively and extensively. The holes in his story mirror holes in that historically valuable collection; concomitantly, the FDA's strength in collecting interviews from its former commissioners and former field investigators is reflected in the rich text. At heart, Hilts sees the FDA as negotiating between scientific standards that are intended to protect our health and, on the other side, pressures from industry. 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. Gwen Kay, Ph.D.Copyright © 2003 Massachusetts Medical Society. All rights reserved. The New England Journal of Medicine is a registered trademark of the MMS.


From Booklist
Hilts traces the history of the Food and Drug Administration, which began as a small regulatory agency in the late nineteenth century in response to the proliferation of quack patent medicines and widespread adulteration of processed food. In its efforts to ensure our medicines are adequately tested to be certain of safety and effectiveness, this often understaffed and underfunded agency has constantly had to deal with powerful resistance both from big business and from political allies of the pharmaceutical industry. Hilts makes a strong case that the FDA, although suffering from a public image of bureaucratic inflexibility, is our most important governmental consumer advocacy group. After lifesaving drugs such as antibiotics were developed, many drug companies tried rushing newer, lethal combinations to market without sufficient testing. The worst offenders tried to conceal prior knowledge of serious side effects from the FDA, pushing thalidomide and other harmful drugs on an unsuspecting public. This fascinating look at the inside story reveals how disastrous unfettered capitalism would be without reasonable regulation. David Siegfried
Copyright © American Library Association. All rights reserved


Review
“Ann Hulbert’s book is that rarest of things–a really intelligent, sophisticated, and knowledgeable book about childrearing. She tells the fascinating, complicated, and often surprising story of a distinctively American phenomenon–the child-raising expert. By weaving together the histories of the men who gave advice and the women who took it (or didn’t), she provides an important corrective to the simplicities of the typical ‘baby books’. More, her subtle and wide-ranging knowledge of the science, history, and politics of child-rearing provides real insight into the dilemmas individual parents, and the nation, face today.”
–Alison Gopnik, coauthor of The Scientist in the Crib: Minds, Brains, and How Children Learn

“Ann Hulbert’s unfailing generosity and kindness toward experts, parents, and children alike result in a book of incisive ideas as well as wonderful stories about raising children. Raising America immeasurably enhances our ability to understand the mixture of our own confusions and good intentions, both as parents and as veterans of our family pasts.”
–Christine Stansell, author of American Moderns

“Ann Hulbert is one of the most astute observers of American cultural mores. She casts a discerning eye on our peculiar reverence for child-rearing experts. Over the last century American children have been unwitting research subjects, their parents the researchers, with the experts offstage writing the scripts on how to raise better if not perfect children. The story she tells is at once touching and troubling. Nobody does this better.”
–Jean Bethke Elshtain, author of Jane Addams and the Dream of American Democracy

“Were I to recommend one book to a new parent, it wouldn’t be a how-to manual, but rather Ann Hulbert’s diverting and thoroughly illuminating study, Raising America . . . . It’s a fine-grained survey of all the major American child-rearing experts, but it’s also something more: a kind of secret history of the times, laying out the symbiosis between the growing culture of expertise and parental anxiety.”
–Steven Metcalf, The New York Observer

“Lucidly written . . . thought-provoking . . . Not merely an account of a “century of advice” but also a history of the ways in which our ideas about families, women, childhood and adult responsibility have and have not shifted over the course of a hundred years. Hulbert’s achievement is to examine our hopes and fears as they are played out in the lives of our children and to understand how we have come to determine the proper time to pick up a crying baby.”
–Francine Prose, front cover, L.A. Times Book Review

Raising America is a generation-by-generation history of advice, and the joy of this book is in how successfully Hulbert renders the taste and smell of the circus. Here are the same kinds of runaway and pediatric best-sellers as we have today . . . the same folksy Dr. Feelgoods. . .”
–Sandra Tsing Loh, The Atlantic Monthly

“Provocative and informative . . . a model of lay scholarship . . . Here is the story of how Drs. Hall and Holt begat Drs. Gesell and Watson, who begat Dr. Spock and even Dr. Seuss, and how they in turn spawned an entire mini-industry of parenting experts . . . With a flair for wordplay and a taste for irony, Hulbert documents the upbringings of the experts themselves, the fluctuations in their advice and the details of their downfalls.”
Publishers Weekly

“Hulbert could hardly have taken on a more ambitious assignment, and for the most part she succeeds beautifully. She has fit her prodigious material around five of the century’s conferences on childhood, focusing on the generations of experts who have guided us through this increasingly materialistic, increasingly meritocratic and increasingly messy business. . . Her history is fascinating as it reflects the tensions and anxieties of a century.”
–Stacy Shiff, front cover, New York Times Book Review

"I commend Phil Hilts for this important work. It deserves to be read by every American concerned about the quality of health care in our society and the protection of families from food and pharmaceutical products that could jeopardize their health."

--Senator Ted Kennedy


"Phil Hilts has written a compelling history of one of the most important, but least appreciated, institutions in America.  The writing is crisp and the narrative enlivened with telling anecdotes and colorful characters. This is a 'must read' for anyone interested in the history of public health in America."
-- Congressman Henry Waxman 


Review
?Ann Hulbert?s book is that rarest of things?a really intelligent, sophisticated, and knowledgeable book about childrearing. She tells the fascinating, complicated, and often surprising story of a distinctively American phenomenon?the child-raising expert. By weaving together the histories of the men who gave advice and the women who took it (or didn?t), she provides an important corrective to the simplicities of the typical ?baby books?. More, her subtle and wide-ranging knowledge of the science, history, and politics of child-rearing provides real insight into the dilemmas individual parents, and the nation, face today.?
?Alison Gopnik, coauthor of The Scientist in the Crib: Minds, Brains, and How Children Learn

?Ann Hulbert?s unfailing generosity and kindness toward experts, parents, and children alike result in a book of incisive ideas as well as wonderful stories about raising children. Raising America immeasurably enhances our ability to understand the mixture of our own confusions and good intentions, both as parents and as veterans of our family pasts.?
?Christine Stansell, author of American Moderns

?Ann Hulbert is one of the most astute observers of American cultural mores. She casts a discerning eye on our peculiar reverence for child-rearing experts. Over the last century American children have been unwitting research subjects, their parents the researchers, with the experts offstage writing the scripts on how to raise better if not perfect children. The story she tells is at once touching and troubling. Nobody does this better.?
?Jean Bethke Elshtain, author of Jane Addams and the Dream of American Democracy

?Were I to recommend one book to a new parent, it wouldn?t be a how-to manual, but rather Ann Hulbert?s diverting and thoroughly illuminating study, Raising America . . . . It?s a fine-grained survey of all the major American child-rearing experts, but it?s also something more: a kind of secret history of the times, laying out the symbiosis between the growing culture of expertise and parental anxiety.?
?Steven Metcalf, The New York Observer

?Lucidly written . . . thought-provoking . . . Not merely an account of a ?century of advice? but also a history of the ways in which our ideas about families, women, childhood and adult responsibility have and have not shifted over the course of a hundred years. Hulbert?s achievement is to examine our hopes and fears as they are played out in the lives of our children and to understand how we have come to determine the proper time to pick up a crying baby.?
?Francine Prose, front cover, L.A. Times Book Review

?Raising America is a generation-by-generation history of advice, and the joy of this book is in how successfully Hulbert renders the taste and smell of the circus. Here are the same kinds of runaway and pediatric best-sellers as we have today . . . the same folksy Dr. Feelgoods. . .?
?Sandra Tsing Loh, The Atlantic Monthly

?Provocative and informative . . . a model of lay scholarship . . . Here is the story of how Drs. Hall and Holt begat Drs. Gesell and Watson, who begat Dr. Spock and even Dr. Seuss, and how they in turn spawned an entire mini-industry of parenting experts . . . With a flair for wordplay and a taste for irony, Hulbert documents the upbringings of the experts themselves, the fluctuations in their advice and the details of their downfalls.?
?Publishers Weekly

?Hulbert could hardly have taken on a more ambitious assignment, and for the most part she succeeds beautifully. She has fit her prodigious material around five of the century?s conferences on childhood, focusing on the generations of experts who have guided us through this increasingly materialistic, increasingly meritocratic and increasingly messy business. . . Her history is fascinating as it reflects the tensions and anxieties of a century.?
?Stacy Shiff, front cover, New York Times Book Review

"I commend Phil Hilts for this important work. It deserves to be read by every American concerned about the quality of health care in our society and the protection of families from food and pharmaceutical products that could jeopardize their health."

--Senator Ted Kennedy


"Phil Hilts has written a compelling history of one of the most important, but least appreciated, institutions in America.  The writing is crisp and the narrative enlivened with telling anecdotes and colorful characters. This is a 'must read' for anyone interested in the history of public health in America."
-- Congressman Henry Waxman 


Book Description
Emerging out of the era of the robber barons and Theodore Roosevelt’s desire to “civilize capitalism,” the Food and Drug Administration was created to stop the trade in adulterated meats and quack drugs. In the almost one hundred years since, it has evolved from a squad of eleven inspectors dogging dishonest tradesmen into America’s most important regulatory agency, keeping tabs on the products of about 95,000 businesses and more than $1 trillion worth of goods annually.

This book shows how the agency combats self-serving political and industrial interests and protects Americans from hazardous medicines, medical devices, and foodstuffs while enforcing rigorous scientific standards. Hilts takes us back to the FDA’s beginnings, when it confronted businesses that acknowledged no limitations on what could be brought to market or on the claims they could make for a product. With the coming of the FDA, our government, for the first time, was able to force the removal of toxic elixirs from the shelves and to insist on accurate labeling.

We see the subsequent fights the FDA waged, and won, for mandatory testing, and against such conservatives as—in our own time—Ronald Reagan and Newt Gingrich, who tried to curtail regulation. We see how the FDA protected the American consumer from thalidomide and other lethal pharmaceuticals, how it took on the tobacco industry, and how it stumbled in confronting the deadly mysteries of AIDS. And we are given, as well, a litany of extraordinary corporate excesses that the FDA has exposed and successfully battled.

Protecting America’s Health
shows society adapting to both the burgeoning of science and technology and the ascendancy of the capitalist market. It makes startlingly clear the essential role the FDA has played in maintaining and protecting the quality of life—and health—to which the American public has long been accustomed.


From the Inside Flap
Emerging out of the era of the robber barons and Theodore Roosevelt’s desire to “civilize capitalism,” the Food and Drug Administration was created to stop the trade in adulterated meats and quack drugs. In the almost one hundred years since, it has evolved from a squad of eleven inspectors dogging dishonest tradesmen into America’s most important regulatory agency, keeping tabs on the products of about 95,000 businesses and more than $1 trillion worth of goods annually.

This book shows how the agency combats self-serving political and industrial interests and protects Americans from hazardous medicines, medical devices, and foodstuffs while enforcing rigorous scientific standards. Hilts takes us back to the FDA’s beginnings, when it confronted businesses that acknowledged no limitations on what could be brought to market or on the claims they could make for a product. With the coming of the FDA, our government, for the first time, was able to force the removal of toxic elixirs from the shelves and to insist on accurate labeling.

We see the subsequent fights the FDA waged, and won, for mandatory testing, and against such conservatives as—in our own time—Ronald Reagan and Newt Gingrich, who tried to curtail regulation. We see how the FDA protected the American consumer from thalidomide and other lethal pharmaceuticals, how it took on the tobacco industry, and how it stumbled in confronting the deadly mysteries of AIDS. And we are given, as well, a litany of extraordinary corporate excesses that the FDA has exposed and successfully battled.

Protecting America’s Health
shows society adapting to both the burgeoning of science and technology and the ascendancy of the capitalist market. It makes startlingly clear the essential role the FDA has played in maintaining and protecting the quality of life—and health—to which the American public has long been accustomed.


About the Author
Philip J. Hilts has written about medicine for the Washington Post and the New York Times (since 1989). He is the author of Smokescreen: The Truth Behind the Tobacco Industry Cover-Up, Memory’s Ghost: The Nature of Memory and The Strange Tale of Mr. M., and Scientific Temperaments: Three Lives in Contemporary Science, a finalist for the National Book Award. He and his wife live in Brookline, Massachusetts.


Excerpt. © Reprinted by permission. All rights reserved.
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 were companies 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.


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         Book Review

Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation
- Book Reviews,
by Philip J. Hilts

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

FROM OUR EDITORS

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

"Emerging out of the era of the robber barons and Theodore Roosevelt's desire to "civilize capitalism," the Food and Drug Administration was created to stop the trade in adulterated meats and quack drugs. In the almost one hundred years since, it has evolved from a squad of eleven inspectors dogging dishonest tradesmen into America's most important regulatory agency, keeping tabs on the products of about 95,000 businesses and more than $1 trillion worth of goods annually." "This book shows how the agency combats self-serving political and industrial interests and protects Americans from hazardous medicines, medical devices, and foodstuffs while enforcing rigorous scientific standards. Hilts takes us back to the FDA's beginnings, when it confronted businesses that acknowledged no limitations on what could be brought to market or on the claims they could make for a product. With the coming of the FDA, our government, for the first time, was able to force the removal of toxic elixirs from the shelves and to insist on accurate labeling." Protecting America's Health shows society adapting to both the burgeoning of science and technology and the ascendancy of the capitalist market. It makes startlingly clear the essential role the FDA has played in maintaining and protecting the quality of life - and health - to which the American public has long been accustomed.

FROM THE CRITICS

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 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

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

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. Read all 6 "From The Critics" >


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