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Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation
Libro usado en buenas condiciones, por su antiguedad podria contener señales normales de uso
424 pages, Paperback
First published January 1, 2003
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Displaying 1 - 13 of 13 reviews
August 4, 2013
I want to say this book was a real "page-turner", but since it took me three months to finish it, that wouldn't be very accurate :)
I think the main reason that it took me so long to finish is because it was painful at times: "plus ça change, plus c’est la même chose".** The FDA was started in 1903, and since then there has been a continuous back-and-forth between business interests and government regulatory interests: greed vs the common good. That's obviously an oversimplification. The FDA has often erred, and has been subject over the years to bad directors and has at time given in too much to industry pressure, etc. Those failures pale by comparison to what I consider criminal, unethical behavior at times on the part of pharmaceutical and medical equipment companies. "The FDA was always accommodating itself to the warring demands of science and business, and to the minefield of political Washington" (p. 236). Recognizing the dysfunctional influences brought to bear on the FDA, and how today's issues mirror those of 100 years ago, is really disheartening.
I had hoped to gain a good overall historical perspective of the FDA, and to understand its organizational set-up (in great part because I'd like to get a better grasp on what my lawyer-daughter is involved with there!). The book fell down a bit in those areas. It often was very anecdotal instead of giving an overview, though I realize that that made it more readable and interesting. ("Salad dressing, the number one source of fat in the diet of American women..." etc).
Things I did enjoy learning: 1) the FDA started as the Bureau of Chemistry at the USDA and is now two steps below Cabinet level (someday I'd love to see a chart of all the agencies and government organizations in DC and how they intersect - way too complex); 2) The US "drug lag" no longer exists, despite protestations by political extremists; 3) Anyone who wants to diminish the FDA's authority to review and withhold drugs should be forced to read the chapter on AIDS ("The Modern Plague"), though the earlier chapter on Thalidomide would also be good assigned reading; 4) The workings of Congressional committees, judicial reviews....all good information. I shouldn't have started listing all the good information this book provides - there is so much.
The last chapter, "Greed and Goodness", tries to summarize human nature, and how "good" people do "bad" things if they are distant from those affected by their decisions (this is support for having independent regulators). It provides a good, brief reading for an interesting discussion.
In my rating system, an improvement over Goodreads, I give this 4.5 out of 5 possible stars. A rating system of 5 stars just doesn't offer enough differential. Nobody should put a one or two star book down here, as why would you bother finishing it, and five stars indicates that it's the perfect book. Essentially you're left with 3 or 4 stars as a choice, and that's insufficient, IMHO.
++++++++++++++
**"The Supreme Court's decision in the Johnson case was met with disbelief and outrage, and President William Taft quickly drafted a message to Congress asking for immediate passage of a bill to override the Supreme Court decision" (p 60). This was in 1912.....why do we think our problems with government today are worse than they ever have been?
I think the main reason that it took me so long to finish is because it was painful at times: "plus ça change, plus c’est la même chose".** The FDA was started in 1903, and since then there has been a continuous back-and-forth between business interests and government regulatory interests: greed vs the common good. That's obviously an oversimplification. The FDA has often erred, and has been subject over the years to bad directors and has at time given in too much to industry pressure, etc. Those failures pale by comparison to what I consider criminal, unethical behavior at times on the part of pharmaceutical and medical equipment companies. "The FDA was always accommodating itself to the warring demands of science and business, and to the minefield of political Washington" (p. 236). Recognizing the dysfunctional influences brought to bear on the FDA, and how today's issues mirror those of 100 years ago, is really disheartening.
I had hoped to gain a good overall historical perspective of the FDA, and to understand its organizational set-up (in great part because I'd like to get a better grasp on what my lawyer-daughter is involved with there!). The book fell down a bit in those areas. It often was very anecdotal instead of giving an overview, though I realize that that made it more readable and interesting. ("Salad dressing, the number one source of fat in the diet of American women..." etc).
Things I did enjoy learning: 1) the FDA started as the Bureau of Chemistry at the USDA and is now two steps below Cabinet level (someday I'd love to see a chart of all the agencies and government organizations in DC and how they intersect - way too complex); 2) The US "drug lag" no longer exists, despite protestations by political extremists; 3) Anyone who wants to diminish the FDA's authority to review and withhold drugs should be forced to read the chapter on AIDS ("The Modern Plague"), though the earlier chapter on Thalidomide would also be good assigned reading; 4) The workings of Congressional committees, judicial reviews....all good information. I shouldn't have started listing all the good information this book provides - there is so much.
The last chapter, "Greed and Goodness", tries to summarize human nature, and how "good" people do "bad" things if they are distant from those affected by their decisions (this is support for having independent regulators). It provides a good, brief reading for an interesting discussion.
In my rating system, an improvement over Goodreads, I give this 4.5 out of 5 possible stars. A rating system of 5 stars just doesn't offer enough differential. Nobody should put a one or two star book down here, as why would you bother finishing it, and five stars indicates that it's the perfect book. Essentially you're left with 3 or 4 stars as a choice, and that's insufficient, IMHO.
++++++++++++++
**"The Supreme Court's decision in the Johnson case was met with disbelief and outrage, and President William Taft quickly drafted a message to Congress asking for immediate passage of a bill to override the Supreme Court decision" (p 60). This was in 1912.....why do we think our problems with government today are worse than they ever have been?
October 6, 2007
Really nice history of the FDA -- what they do, how our current system of drug evaluation has evolved over time, political/lobbying pressures they have to deal with.
December 25, 2022
The friendly side of the FDA
As with many institutions, the FDA serves a perceived needed purpose. This book is a history of why the agency was needed and its design. It is filled with horror stories and how the FDA came to the rescue. Some of these stories even scared me as I recognized the products and or brands. The chapter “Capitalism in Crisis” reads more like a political statement against capitalism than an “FDA is out to help” statement.
What they do not say is that the FDA is the Government to the point that they can carry guns and badges. Now with the fast pace of drug and device invention, the FDA is needed more than ever. The other side of the coin is that they have become an unwatched agency that can and does set its own rules to how a business can do its job down to describing the data field that is to be stored in their computer. Their regulations read like a phone book of conflicting statements (with no recourse). And you can be shut down on a whim if you do not follow the regulations as interpreted by their agent as they are the law.
The book contains an excellent set of notes. They are divided into chapters. And there is a fair index. For people who like pictures, there are eight pages of monochrome photographs.
The author has written several articles on medicine for various periodicals.
As with many institutions, the FDA serves a perceived needed purpose. This book is a history of why the agency was needed and its design. It is filled with horror stories and how the FDA came to the rescue. Some of these stories even scared me as I recognized the products and or brands. The chapter “Capitalism in Crisis” reads more like a political statement against capitalism than an “FDA is out to help” statement.
What they do not say is that the FDA is the Government to the point that they can carry guns and badges. Now with the fast pace of drug and device invention, the FDA is needed more than ever. The other side of the coin is that they have become an unwatched agency that can and does set its own rules to how a business can do its job down to describing the data field that is to be stored in their computer. Their regulations read like a phone book of conflicting statements (with no recourse). And you can be shut down on a whim if you do not follow the regulations as interpreted by their agent as they are the law.
The book contains an excellent set of notes. They are divided into chapters. And there is a fair index. For people who like pictures, there are eight pages of monochrome photographs.
The author has written several articles on medicine for various periodicals.
July 12, 2017
This is very readable and very well researched. It should not be cited for the facts presented, because there are some errors (and very few facts have associated endnotes for verification). I would recommend that researchers use it as an initial read for the lay of the land and then work on verifying anything that they want to use. (Of course, Carpenter's academic treatment is far more careful and thorough.) The book suffers in places from a lack of objectivity.
March 18, 2016
"In the end, Dr. Janet Woodcock, chief of the FDA's center for drug evaluation, acknowledged the FDA failure with Rezulin. She had hoped that the issuing of warnings and information would get doctors to be cautious, and that tests would help avoid trouble for patients. But neither proved reliable. Doctors neither heeded the warnings nor, in the vast majority of cases, did they ever test their Rezulin patients for signs of trouble. (Of course, the warnings came even as the company was continuing a massive advertising campaign including direct payments to doctors for switching their patients to Rezulin, so perhaps the failure of the cautions might have been expected.)" (p.334) This book is a good survey of the origin and history of the Food and Drug Administration. Published in 2003, it is, of course, out-dated. The above excerpt may in part explain some of the rationale behind the 2010 Sunshine Act. The author rightly regards Harvey W. Wiley and David Kessler as heroes. This was a tough and disturbing read for me because of the many and tawdry controversies it had to deal with in order to tell its story. But I would certainly recommend it to anyone with an interest in public (or personal) health - or with any desire to become a health professional.
March 5, 2011
The book specifically follows the history of the FDA, but it is a must read for anyone who would like to understand how the legitimate regulatory role of government interacts with the political process. The book does an excellent job of explaining how the political process undermines science (though the author then launches into a small polemic against the right when the anti-scientific nature of social persuasion is more insidious than that).
If one has only a few minutes to get the broader message from this book, I would suggest chapters 13 and the epilogue. For more about how the new science of risk interacts with policy and political decision making, I would suggest Science Policy, Ethics, and Economic Methodology by Shrader-Frechette.
If one has only a few minutes to get the broader message from this book, I would suggest chapters 13 and the epilogue. For more about how the new science of risk interacts with policy and political decision making, I would suggest Science Policy, Ethics, and Economic Methodology by Shrader-Frechette.
July 17, 2016
Full review to follow. Notes:
-dry at times, but interesting
-would have benefitted from inclusion of more specific dates throughout the book
-a separate list of the FDA commissioners and landmark legislation regarding the FDA would have been helpful to refer to
-the author's political preferences are a bit too blatant (even if I agree with them)
-"case stories" about the horrors that preceded the establishment of the FDA, and that continued to plague the FDA as it sought to collect strength through legislation, were aptly recounted and kept things interesting
-dry at times, but interesting
-would have benefitted from inclusion of more specific dates throughout the book
-a separate list of the FDA commissioners and landmark legislation regarding the FDA would have been helpful to refer to
-the author's political preferences are a bit too blatant (even if I agree with them)
-"case stories" about the horrors that preceded the establishment of the FDA, and that continued to plague the FDA as it sought to collect strength through legislation, were aptly recounted and kept things interesting
March 4, 2016
Well written book on the history of the FDA. The author does a great job weaving together history, story telling, and politics. The historical cases that led to our current system are disturbing and fascinating. The author draws the reader in through descriptive and shocking stories. Slow going at times but let's face it, it is about Federal regulations. Oh, and most of all...this book makes me thankful I wasn't born in 1900's...or early 1960's...in Germany.
September 10, 2010
very informative, good writing, very readable.
November 24, 2013
Slow going, but worth it.
March 30, 2015
Fascinating - very informative!
August 19, 2008
Revealing history of the FDA.
November 7, 2018
The books gives an animated account of the world's most respected healthcare regulator. Right from the formation, FDA had to fight not just scientific, but political battles too. From tackling the strong lobby of makers of useless medicines, to testing drugs with the rigor of science, the regulator had its work cut out. Besides having an illustrious President, Theodore Rossevelt , as one of its founding force,FDA found in Wiley an illustrious first commissionar. He openly sparred with industry and held his ground even in front of his top boss, the President.
The books also documents the increase in FDA's powers with the passing of new laws, especially the Food, Drugs and Cosmetics Act under Kennedy administration. Thereafter, while the pharmaceutical industry developed a strong R&D base, lot of harmful drugs still reached FDA's table and beyond, to the public. Here the author very deftly explains the role of FDA reviewers and pressure on the regulator to process more drug applications without compromising the safety of public.
The book also tells about the impact of change in administrations on FDA resulting in appointment of new commissioners, each of whom left their mark on the organization.
In the end, the book shows that even as political winds changed and technology underwent sea change, FDA has stood it's ground as a guardian of the health of commonfolk.
The books also documents the increase in FDA's powers with the passing of new laws, especially the Food, Drugs and Cosmetics Act under Kennedy administration. Thereafter, while the pharmaceutical industry developed a strong R&D base, lot of harmful drugs still reached FDA's table and beyond, to the public. Here the author very deftly explains the role of FDA reviewers and pressure on the regulator to process more drug applications without compromising the safety of public.
The book also tells about the impact of change in administrations on FDA resulting in appointment of new commissioners, each of whom left their mark on the organization.
In the end, the book shows that even as political winds changed and technology underwent sea change, FDA has stood it's ground as a guardian of the health of commonfolk.
Displaying 1 - 13 of 13 reviews