Underplayed Story of the Day
We have argued here before that fixing the FDA should be at the top of Barack Obama's priority list. This story--easy to miss back on A14 of the New York Times--underscores why:
An official at the Food and Drug Administration overruled front-line agency scientists and approved the sale of an imaging device for breast cancer after receiving a phone call from a Connecticut congressman, according to internal agency documents.
The legislator's call and its effect on what is supposed to be a science-based approval process is only one of many of accusations in a trove of documents regarding disputes within the agency's office of device evaluation.
The larger issue is this:
Diana Zuckerman, president of the National Research Center for Women and Families, said the Bush administration had “finally made the device approval process so meaningless that it's intolerable to the scientists who work there.” Ms. Zucker, a longtime critic of the agency's device approval process, particularly as it relates to breast implants, added, “Virtually everything gets approved, no matter what.”
The F.D.A. has a three-tiered approval process for medical devices that, depending on their newness or complexity, requires varying amounts of proof.
A growing chorus of critics contends that the agency requires few devices to complete the most rigorous of these reviews and instead allows most devices to be cleared with minimal oversight. In 2007, 41 devices went through the most rigorous process, compared with 3,052 that had abbreviated reviews.
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1
This is just the sort of story which when piled on all the other bad news just makes one feel overwhelmed. I'm afraid that the American appetite for instantaneous results is going to obscure the fact that our problems are going to have to be whittled and picked at a bit at a time. It will be interesting to see how long the actual (as opposed to press driven) honeymoon lasts. Lord knows that we can certainly do without the sort of endless distraction that things like the Blago/Burris story represent.
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2
Oh, it's better than that. Thanks to Rigel v. Medtronic, because of the FDA "approval" process, if the device later injures or kills someone due to faulty design, they're out of luck - can't sue. All your claims preempted to us.
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3
Bush has damaged so many agencies, it will take years to repair the damage and improve morale. The GOP base is so scientifically illiterate that they do not recognize the studies requires to prove that a device actually performs as described and provides benefit.
Palin, and more recently McCain, criticized funding of fruit fly research. Both are unaware of the fact that simple fruit flies are an important tool in genetic research.
Because of a lack of knowledge by the GOP hierarchy, most science oriented government agencies will require repair under Obama.
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4
The FDA is also involved in food - we need to worry about more than raw poultry. I realize that there are accidents, but wonder how much things like this outbreak are a result of cutbacks in personnel and change in administrative philosophy.
http://www.washingtonpost.com/wp-dyn/content/article/2009/01/12/AR2009011202800.html
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5
And, of course, there's the high quality of the appointments that this Administration made in some key slots:
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http://www.time.com/time/nation/article/0,8599,361521,00.html -
6
Someone please check the FDA files to see whether the agency has approved my phlogiston generator yet. That, and the goat-gland implant technique – the response to my radio ads has become overwhelming.
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7
OT - In case you didn't see this article, KT.
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8
ivb:
argh. fortunately for me, i've got all my money invested in flownover's phlogiston generator, so i'm set. who needs, like, a paycheck?
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9
The political activists at the political advocacy group the New York Times issue a press release that is dutifully and enthusiastically swallowed and regurgitated by thier like-minded political activists at Time magazine. I suspect that Time magazine will not be the only political advocacy group to swallow blindly and regurgitate this press release issued by the New York Times.
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10
I agree that this is a problem. However, this is only the 1004th listing I have seen of what absolutely-positively-indubitably-has-to-be Obama's highest priority. Which, of course, means that there will be plenty of advocates whining about the fact that their Priority One! ended up somewhere lower on the list.
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11
The list of regulatory failures is long and growing. The NY Times had an article yesterday about the lack of regulation of what constitutes "organic" in the dry cleaning industry. The most widely-used chemical, perchloroethylene or perc, is implicated in health problems among employees, and the "green" substitutes touted by many dry cleaners may not be much better. But hey, government is the problem, not the solution, right?
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For textile regulation nerds, there's more on my blog. -
12
The political activists at the political advocacy group the New York Times...
Both the employees at the New York Times and the FDA (except its loyal Bushie political appointees) are all members of the New Class and must be stopped before they take over the country. Science, professional standards and following the law--the nerve!
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13
textee, you're just phoning it in anymore. C'mon, you can do better.
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14
KT - the article you cite in 5 is appalling. One of the personal tolls for me of this administration is that I've come to be so suspicious of anything religious. When I acknowledge to anyone that I'm a Christian I feel like I have to swaddle the admission in all sorts of caveats. This goes way beyond the simple truth that in any faith tradition there are a great many threads, and that it's not enough to just say "I'm a Christian" in order for people to have some idea what part religion might play in my life.
I used to teach in a Christian school - one formed by the merger of a Roman Catholic and Episcopal school - so I'm accustomed to needing to qualify what I mean. I used to teach both science (real science) and religion, and no one there thought there was a contradiction. What the Bush administration has done to the perceptions and acceptance of science is unconsionable, but they haven't done Christianity any big favors either.
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15
I can tell you that at the medical diagnostics company for which I work, the suits are scared stiff about FDA approval. Can't sneeze around here without considering how it will impact the approval process. The FDA may be out of whack, but they still have weight to throw around out in the real world.
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16
Also, what Paul D and Donovong said
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KT - more good news! Pending FDA approval I parked the entire phlogiston marketing investment (including your money) with a guy in NYC who has a perfect record of positive returns. Don't worry that his name rhymes with "laid off;" all my rich friends vouch for him.
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ditto kathy's ditto of "what Paul D and Donovong said." Honestly, is there a single, actual function of the federal government that has not been harmed by Bush et al? One?
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Speaking of which, here's Schlozman. -
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Hey Flown, where can I get a piece of your hot phlogiston action? The guy in the super luxury apartment isn't taking calls.
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20
wvng – I'm sure you can get his contact info from the staff at the SEC. They gave him a clean bill of health when I made my "due diligence" inquiries.
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21
We got textee's poor response to FDA actions and RNC candidate Ken Blackwell stating that homosexuality can be cured (or repressed). Not that Blackwell has ever had any homosexual desires. Palin and McCain battle against fruit flies. The Luddites are flocking to the GOP.
kathy. The Bushites practice Christianism, not Christianity. Rove has stated that he is not a person of faith. Christians, practicing their faith, did what they could to aid people during Katrina. The Bush Christianists, who twist faith to fit a political view, saw no political gain in aiding NOLA and actually went out of their way to punish the city and state. Hayley Barbour and Mississippi got a higher per capita input of funds than Louisiana. Christianist Bush believes that his major error in Katrina was in how the photo-op turned out.
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kathy, wvng, pauld and donovong: I disagree. I do think it is possible to get a running start on fixing the FDA, by putting the right people in the top jobs. (For most of the two Bush terms, it hasn't even had a permanent commissioner, just an acting one.) Every time I have written about the FDA, I have gotten calls from professionals within the agency who say they are horrified by what they are seeing, how ideology and political interest drive the decisionmaking from the top.
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flownover: Happy Days! You will get all this done by the close of business next tuesday, right? I've moved the kids' college savings over into phlogiston futures. -
23
ivb, KT - yikes. several things occur to me.
1) I don't fully understand why this isn't/can't be just a transitional time. Record labels didn't "fail" just because we switched to CD's. Either they made the transition successfully or they didn't. This article would suggest, e.g., that the monitor has failed.
2) This seems like a good time for collusion. Time for media outlets to charge a minimum for their services online. How about setting up something like a paypal account where you have to log in once a week and pay a nickel. This would surely be profitable. $2.50 a year times millions, and no need to print or distribute paper.
3) Or how about a way for blogs that mention an article having to pay a modest amount for distributing (living off) someone else's work. We often underestimate how derivative the popular blogs are.
4) I think I'm glad this is happening under President Obama rather than Bush. Imagine if there were no news outlets reporting what they were doing (however imperfectly they were reporting)
5) There needs to be a way to support reporting, even if we have to reinvent it.
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24
KT - It's good to know you feel this way. My echoing Paul is just that there are so many agencies where this seems to be true - and Bush is now installing his political apointees into board positions. But I sure hope you're right.
I'm not encouraged by the appointment of Vilsack at Agriculture, but I'm hoping that's another one of those appointments where he disarms his potential critics and then comes in for the kill with something bold.
(I'm not convinced, e.g. that naming Gene Robinson was a result of pressure from the left. I think it's more likely that the ground for Robinson was prepared by first naming Warren)
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25
George Lakoff has remarked that stories like this are in the wrong frame--that the FDA corruption is part and parcel with a systemic policy decision to gut the regulatory apparatus and enrich corporations intended to be regulated at the expense of consumers, workers and taxpayers. By treating the story of the gutted FDA as different than the gutted EPA, different than the politicized DOJ and different than the contractors in Iraq, the real point is missed.
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This was a systematic attempt to cripple the government.
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