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Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation
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Review
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 MedicineThis fascinating look at the inside story [of the FDA] reveals how disastrous unfettered capitalism would be without reasonable regulation.--BooklistProtecting 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 ProspectProtecting 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 AssociationPhilip 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 ReviewPhilip 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 PostAs 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
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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 Edward M. KennedyPhil 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
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Product details
Paperback: 422 pages
Publisher: The University of North Carolina Press; 1 edition (September 27, 2004)
Language: English
ISBN-10: 0807855820
ISBN-13: 978-0807855829
Product Dimensions:
6.1 x 1 x 9.2 inches
Shipping Weight: 1.8 pounds (View shipping rates and policies)
Average Customer Review:
4.5 out of 5 stars
17 customer reviews
Amazon Best Sellers Rank:
#1,019,239 in Books (See Top 100 in Books)
Hilts' readable book is the best introduction I know to the history and politics of FDA regulation. That history, as Hilts retells it, is a spiral. Clearly, there have been significant regulatory innovations since the days of T.R., and Hilts takes us through the key turning points. At the same time, the same core arguments about the virtues of regulation and the virtues of free markets recur.Specialists will find some of the retelling oversimplified, and Hilts' own position (some will say "bias") is always clear. Nonetheless, there is no better first immersion into these issues, a terrific foundation for more nuanced analysis.
Fantastic book! The content is very informative from a historical aspect and very entertaining from a reader's aspect. As an aspiring pharmacist, I particularly liked the content. There are numerous parallels between the history of the FDA and the Obamacare legislation currently going on. Great read for anyone. As a disclaimer, this is a very liberal book. Conservatives will either hate it and stop reading or find themselves a little more liberal by the end of it.
This book contains iformation about how the FDA came to be from the days of one man working to prove preservatives unsafe to what it is today. Although the author seems a little biased at times, he definitely has his own political ideas, the book is easy to read and very interesting.
I think this is a really interesting book. It provides a lot of information about the history of the FDA and I found it to be an enjoyable read. The author uses a lot of examples, research, and personal interviews to present the content.
Excellent condition
much better than I thought.This used book almost new. Just little highlighter chirography on it. Hope these marks are the important points in the examination. aha~ just a dream
This was an assigned book for school. I was bored by the book.
Philip J. Hilts is a journalist who has also written books such as Smoke Screen: The Truth Behind the Tobacco-Industry Cover-Up,Rx for Survival: Why We Must Rise to the Global Health Challenge,Memory'S Ghost: The Nature Of Memory And The Strange Tale Of Mr. M, etc. He wrote in the Introduction to this 2003 book, "The FDA was born in a period of reform, but it was opposed bitterly because it was clear that the organization represented a precedent... The new agency was the people's investigator, with the specific mission of intervening on behalf of citizens and against businesses when necessary... This book describes the most significant events in the history of the Food and Drug Administration." (Pg. xii)He notes, "In the end, the [Pure Food and Drug Act of 1906] DID succeed in establishing two points: first, that the federal government was the agency that should take on widespread commercial abuses; second, that both patent medicines and regular formulas used by physicians should be counted as drugs..." (Pg. 54) But in the 1920s, "Anyone could concoct a medicine in his kitchen and sell it, with no testing required as long as it didn't contain narcotics or one of a few listed poisons. (Potentially fatal ingredients used in medicine were not counted as poisons at the time, only those so toxic that they killed IMMEDIATELY). If the new kitchen concoction turned out to be so damaging or fatal to some consumers, the maker was not required to pull it off the market, either... At most, the FDA could begin a court action that, if contested, could last for some years and result in a miniscule fine. At the end of it all, the maker would give his concoction a new name and start all over again." (Pg. 75)He observes that "The regulations and the government shepherding of the drug business did what the free market failed for at least sixty years to do---it weeded out the brutal, the stupid, and the needless that prevented the pharmaceutical industry from becoming a great engine of discovery and sales. The tough markets had prevented companies from carrying out expensive and detailed research. The laying down of the scientific standard had come first, and the creation of the modern pharmaceutical industry followed. A scientific standard, administered by some body outside industry itself, was the essential ingredient." (Pg. 106-107)He points out, "The topic of drug profits was not within the balliwick of the Food and Drug Administration. The FDA does not have any authority to regulate drug prices, or any of the economics of the industry... Its authority centers on the products themselves: whether they are safe, whether they work, whether they are advertised honestly." (Pg. 130) Later, he states, "The agency was beginning to be a business-style hierarchy of managers with goals and strategies. Though it would never go away, the internal feud over how tough the FDA should be in drug review had quieted. Companies now had large teams of scientists and goals of their own in medical discovery." (Pg. 201)He admits, however, that "During the late 1980s the more upright generic companies began to notice that generic drugs did not seem to be approved on a first-come, first-served basis. Some shot through while others languished. Some seemed to be assigned to lenient reviewers, others were judged more stringently... [Companies] got hints from FDA officers that something was expected in return for speedy approvals... The scandal was first made public when, in May 1989, hearings were held by the Subcommittee on Oversight and Investigations... Eventually... Fifty-five employees of fifteen generic drug companies were convicted of felonies, along with five FDA officials." (Pg. 253-254)He concludes, "The FDA began as an agency to protect consumers from cheats: it has evolved into the body that sets the scientific marks against which progress is measured. It is fair to say that the FDA is not brilliant in all respects. The agency has suffered from bad leadership at times, and a lack of support in Congress... The agency has failed to press for a single independent and reliable source of data on drugs and their dangerous side effects. The FDA has nevertheless effectively handled many parts of its increasingly complicated role. It has created a base of medical testing, and has stood for public health standards against storms of self-interest... and is as broad and open an agency as seems possible in this conservative time in American history." (Pg. 337)This book may have more "history" and less discussion of "current controversial issues" than some readers might prefer, but for anyone wanting a largely "sympathetic" history of the FDA, this book will be of great value.
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