Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA (Princeton Studies in American Politics)

Dear Readers ( and all 15 who work for the FDA )3 May 2014now it's 19and you still don't have your cure.right?Best Regards23 Feb. 2014still in denial........................???keep it up, they don't care about you.they just want to preserve their organization...........................!!!Best Regards3 January 2014..........and how about Colorado legalizing pot?Now what the FDA going to do?Best RegardsReads 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 Regardssjw14 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 aboutwhen 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 theresearch 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 RegardsAll 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, pharmaceuticalsand 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 wentto the Supreme Court of The United States in 1979 in the form of "Rutherford v. The U.S.A. Where of coursethe whole idea of Laetrile and any other "emergency medicine" for the terminally ill was "shot down" byThurgood 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'sSo that according to this precedent you have absolutely no legal rights to any other medicines beyond what theF.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 physicianwith 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 bankersgood 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 isthat 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.EpistemologyIt 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 RegardsSouthern Jameson Westp.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.

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.

Some what of a tough read. However, it is loaded with facts and history. It's a good book that's definitely worth the read. Reading it a second time helps clarify some of the ideas

This was very hard book for me to follow. It was required for a class, I appreciate the principles but a condensed version would be helpful

great for coursework, really interesting analysis of growth and development of FDA and organizational structure.

Bought the book for a class, but thoroughly enjoyed it. Very informative. Long winded at times, but well worth the read!

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.

Dr. Joshua Sharfstein, Deputy Commissioner of the FDA, highly recommended this book to the audience of an FDA workshop on July 19, 2010.

This book is a brilliant account of the workings and the role of the FDA in the regulation of the US and global pharmaceutical industry, and this is clearly shown from the other reviews. I knew little about the pharmaceutical industry but bought the book because I am interested in regulatory organisations. The book uses the example of the FDA to develop a more general argument: that managing their reputation becomes a core activity of regulators in modern industrial economies (what some of my friends would call "late modernity") and viewing their actions as being directed to defend and improve reputation is more insightful than either an idealist belief that they are trying to do the right thing or that they are captured by interest groups. The book puts forward a persuasive reputation based view of regulatory power: regulators' power does not come as a gift from the state, but instead is derived from their reputation and the legitimacy it confers. In the UK these processes were seen recently in the inquiries into Morecambe Bay University Hospitals, where it appeared the Care Quality Commission, the health service regulator, were thinking about their reputation when they were responding to the unfolding crisis and that the damage to their reputation that ensued weakens their power to regulate.