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Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA
 
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Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA [Format Kindle]

Daniel Carpenter

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The U.S. Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? And how exactly does it wield its extraordinary power? Reputation and Power traces the history of FDA regulation of pharmaceuticals, revealing how the agency's organizational reputation has been the primary source of its power, yet also one of its ultimate constraints.

Daniel Carpenter describes how the FDA cultivated a reputation for competence and vigilance throughout the last century, and how this organizational image has enabled the agency to regulate an industry as powerful as American pharmaceuticals while resisting efforts to curb its own authority. Carpenter explains how the FDA's reputation and power have played out among committees in Congress, and with drug companies, advocacy groups, the media, research hospitals and universities, and governments in Europe and India. He shows how FDA regulatory power has influenced the way that business, medicine, and science are conducted in the United States and worldwide. Along the way, Carpenter offers new insights into the therapeutic revolution of the 1940s and 1950s; the 1980s AIDS crisis; the advent of oral contraceptives and cancer chemotherapy; the rise of antiregulatory conservatism; and the FDA's waning influence in drug regulation today.

Reputation and Power demonstrates how reputation shapes the power and behavior of government agencies, and sheds new light on how that power is used and contested.

Some images inside the book are unavailable due to digital copyright restrictions.


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Amazon.com: 4.2 étoiles sur 5  5 commentaires
4 internautes sur 5 ont trouvé ce commentaire utile 
5.0 étoiles sur 5 Masterful work on FDA 24 juillet 2011
Par Jonathan Chaus - Publié sur Amazon.com
Format:Broché|Achat vérifié
This is a masterful work. Carpenter examines the historical development of FDA power. He shows how it leveraged crises to increase its own power; but that it did so only after it had developed substantial expertise, procedures, and networks. He notes first that the FDA is (was) an extraordinarily strong bureaucracy; the seems at odds with conventional explanations of the United States as having a weak administrative state. He argues that traditional political science explanations, such as agency capture, do not explain how the FDA could achieve this. Instead, he suggests that a reputation-based analysis gets us much further.

The book has two parts. The first part is an in-depth examination of the accumulation of power. It includes analysis the agency norms, and how it established a gatekeeping power. In the 1930's "nostrums" could be marketed at will. By the 1960's, they had to go through testing procedures and efficacy standards established by the FDA. The second part examines how the politics of reputation interacts with firms, academics, teaching hospitals, and members of Congress in various stages of the drug-approval process, including the pre- and post-approval stages. The FDA has managed to alter the behavior of firms, including how they conduct experiments (such as 3 phases of testing), who is accredited to run the experiments, what controls must be used, and what paperwork must be kept to document findings.

The range of sources, and the amount of evidence collected in this work is astonishing. Further, his theory of reputation and networks has a wide range of applicability.
1 internautes sur 1 ont trouvé ce commentaire utile 
5.0 étoiles sur 5 Must Read Eye-opener 2 juin 2013
Par ChrystinP - Publié sur Amazon.com
Format:Broché|Achat vérifié
I'm in the pharmaceutical research business and this book was a real eye-opener. It's a complex read and best taken in small bites to grasp all of the intricacies.
4.0 étoiles sur 5 Textbook review 10 juillet 2013
Par Dana M. Black - Publié sur Amazon.com
Format:Broché|Achat vérifié
I liked this book, very thorough. The binding did come apart prior to the quarter ending though. A very good read on FDA's past and present.
8 internautes sur 14 ont trouvé ce commentaire utile 
4.0 étoiles sur 5 Senior FDA staff cite this book. 21 juillet 2010
Par Bruce_in_LA - Publié sur Amazon.com
Format:Broché
Dr. Joshua Sharfstein, Deputy Commissioner of the FDA, highly recommended this book to the audience of an FDA workshop on July 19, 2010.
1 internautes sur 23 ont trouvé ce commentaire utile 
3.0 étoiles sur 5 800,000,000 Reasons Why, You Don't Get the Cure......!!! 24 juin 2012
Par Southern Jameson West - Publié sur Amazon.com
Format:Broché|Achat vérifié
Dear Readers ( and all 15 who work for the FDA )

3 May 2014

now it's 19
and you still don't have your cure.
right?
Best Regards

23 Feb. 2014
still in denial........................???
keep it up, they don't care about you.
they just want to preserve their organization...........................!!!
Best Regards

3 January 2014..........and how about Colorado legalizing pot?

Now what the FDA going to do?

Best Regards

Reads like "The Warren Commission"........that's the first comment.

Back in 2000, I lobbied the U.S. Congress about the non-toxic cure for cancer........!!!
Guess what they had to say........???
Nothing......!!!
They said nothing.......!!!
Repeat.......nothing.....!!!

2 Feb. 2013: And the poor scientists still can't control their discoveries any better than Galileo could more than 500 years ago.

0 to 11 still doesn't change the fact that you can't get the non-toxic cure for cancer from your FDA hospital.

Sorry to "rain" on your parade.

Best Regards

sjw

14 Nov. 2012.................!!!

Now, as of a few days ago, some of the states of the Union want to legalize marijuana........!!!

Now what's the FDA gonna do..................................???

Told ya so......................!!!

now watch the " fur fly".......................!!!

Thanks and Best Regards

"Actus Reus, Mens Rea"

Keep on dreaming.......................!!!

and Dear 0 out of 1 and dear zero out of two and zero out of three................and everyone else

........ it's a whitewash and those that are on the "inside" know this.

Check out Morton D. Davis', "Game Theory", where in the final part of the book ( Chap. 6, p. 163 ) he talks about
when the game involves more than two players. Enter the "coalition".
Who are the players here?......the FDA. the A.M.A....the Pharmaceutical Industries...the N.C.I.....not to mention the
research hospitals........the patient?????....they're the last to know....then there's K street....then there's the Banks on Wall Street...how about the U.S. Supreme Court?....then there's the governments..... more than one..there's your coalition.....this book doesn't talk about this....!!!....the "fight" ladies and gentlemen is fixed.......Best Regards

All those states that legalized Laetrile were crazy???

Sorry you don't like the review.
But what I am writng is the truth.
The truth they do not tell you.

They spent more than 12+ billion USD to find the Higgs boson and they can't find a cure for your cancer?
Sorry, but I think there's a problem in all of this.

First off, I admire the attempt. In that respect it is a "nice book" to have on one's shelf.( all the Academicians you know will tell you no doubt how admirable and enobling your "monument" to higher learning.

But I've got to say it reads like a "rush to judgement".
Quack cures? So what are all those Americans doing who are running to China towns in the U.S.A. to get Chinese medicine and acupuncture, some of it now paid by their medical insurance claims, no less?
What does the FDA say about that?

And it does speak volumes about the business of people, their medical needs, pharmaceuticals
and how we all need "protection". The F.D.A. was some kind of "cracker-barrel" concoction of F.D.R.'s "New Deal".
( Should remind the Republicans and their "Tea Party" friends who keep screaming "Freedom"...well in this case sorry but "they're ain't any" )
Was it Lord Acton who said: " Absolute Power Corrupts Absolutely"...?
I think so.
However what I did learn to my delightful surprise in this book, I think Chapter Six is that Laetrile went
to the Supreme Court of The United States in 1979 in the form of "Rutherford v. The U.S.A. Where of course
the whole idea of Laetrile and any other "emergency medicine" for the terminally ill was "shot down" by
Thurgood Marshall and his "gang".

The Mayo clinic said "it has been tested. it is ineffective".
Ever heard of "fudging" and experiment?
Just because they wear white coats, they've still all signed non-disclosure non-circumvention contracts.
They have to do that to get the job to pay back their 100,000USD they owe the bank for their Ph.d's

So that according to this precedent you have absolutely no legal rights to any other medicines beyond what the
F.D.A. specifies. ( not even a glass of water, if someone claims for example that " drinking water will help prevent/cure cancer". Individuals have no rights to even speculate. That's what Marshall's opinion says.

So now comes the "aberration" in the whole idyllic scheme, enter VIOXX.
Where were the "gate-keepers" there?
see: Snigdha Prakash: "All The Justice Money Can Buy: Corporate Greed on Trial"
according to her even the Federal Judiciary put a "lock-down" on the limits that Merck had to pay out.
Protecting both Merck and the F.D.A at the same time.

Nobody went to jail.................!!!
Nobody got criminally charged with even manslaughter........!!!
Notwithstanding the fact that there was mens rea as well as actus reus.............!!!

Nowhere in the book do I see reported the price tag for getting one's new drug/medicine approved by the F.D.A.( I mean tell the people the whole truth about how "their F.D.A." really runs, how it really operates )
That would be 600 to 800 million U.S.D. on the spot.
While the medical report that is required for each new drug I can probably get for 2500USD from some poor research physician
with and M.D. and a PhD....!!!
2500USD compared with 800 million....!!!
Is it beginning to sink in....???
This aspect of the "noble" gate-keppers the book doesn't talk about.
Oh yes, the F.D.A. want money!!!
Who's got that kind of money? ( What they do with the money is anyone's guess....party down in Naussau??)
The bond market in New York does, but you'll have a tough time getting it, if your new medicine puts one of the investment bankers
good clients out of business.
The "fight" is fixed Ladies and Gentlemen of the Jury.
You don't get the medicine you need, you get what they tell you you can have.
End of story.
The conclusion that I am stating here is just the opposite to what Daniel Carpenter would like to believe or perhaps have us believe and that is
that the F.D.A. does not run on scientific principles. If that were the case there would never have been a "VIOXX" catastrophe.
Rather the F.D.A. runs on politics, pure and simple.
"Legal" doesn't necessarily mean that the medicine works. That's beside the point.

Epistemology

It never fails to astound me whenever I think about all of the great scientists in mathematics, physics and chemsitry, Nobel Prize winners who when they were afflicted with some life-threatening disease simply "followed the line-up" to an F.D.A. hospital when most of those medical "experts" they consulted knew far, far less about a molecule or polymer than did these emminent scientists. It's down to a matter of epistemology. Simply ask yourself questions like: "Is there more out there?", "Could there be more out there?", "Am I being told all of the facts?". "If I am not being told all of the facts, then why not?" Think about it.

Best Regards
Southern Jameson West

p.s. they did the same thing to Galileo some 400 years ago.
He was the guy who found out by experiment that Aristotle's opinion(to the best of out knowledge Aristotle never tried the experiment) was wrong about the rate of accelaration of freely falling bodies.
And the authorities at that time forced him to recant. The point is if you don't try the experiment but simply rely on someone else's opinion you still don't really "know". Knowledge vs. Opinion ( see Plato in "The History of Western Philosophy", by Bertrand Russell )

Even Hollywood creates movies that pander to these absurd unscientific statements that the F.D.A. and other institutes make about how to treat cancer.
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&quote;
Reputationunderstood as a set of symbolic beliefs about an organization, beliefs embedded in multiple audiencescomprises &quote;
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The difference between pre-market (ex ante) and post-market (ex post) regulatory power is crucial. &quote;
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&quote;
The idea is that power exists not only in broad formal authority to direct the behavior of others (directive power) but also in appearances that are less obvious: the ability to define what sorts of problems, debates, and agendas structure human activity (gatekeeping power), and the ability to shape the content and structure of human cognition itself (conceptual power).21 &quote;
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