Tuesday, January 13, 2009 at 9:50 am
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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Senior Writer Karen Tumulty has been TIME's National Political Correspondent since 2001, and has also covered the White House and Congress for the magazine. A native of San Antonio, she is a graduate of the University of Texas at Austin and Harvard Business School, where her career choice has significantly lowered the average salary of her graduating class. But she gets lots of free magazines. Read More »
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Tuesday, January 13, 2009 at 10:11 am
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.
Tuesday, January 13, 2009 at 10:12 am
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.
Tuesday, January 13, 2009 at 10:18 am
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.
Tuesday, January 13, 2009 at 10:19 am
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
Tuesday, January 13, 2009 at 10:21 am
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
Tuesday, January 13, 2009 at 10:23 am
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.
Tuesday, January 13, 2009 at 10:26 am
OT - In case you didn't see this article, KT.
http://www.247wallst.com/2009/01/twelve-major-me.html
Tuesday, January 13, 2009 at 10:31 am
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?
Tuesday, January 13, 2009 at 10:32 am
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.
Tuesday, January 13, 2009 at 10:34 am
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.
Tuesday, January 13, 2009 at 10:39 am
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.
Tuesday, January 13, 2009 at 10:44 am
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!
Tuesday, January 13, 2009 at 10:46 am
textee, you're just phoning it in anymore. C'mon, you can do better.
Tuesday, January 13, 2009 at 10:49 am
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.
Tuesday, January 13, 2009 at 10:51 am
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.
Tuesday, January 13, 2009 at 10:52 am
Also, what Paul D and Donovong said
Tuesday, January 13, 2009 at 10:57 am
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.
Tuesday, January 13, 2009 at 10:57 am
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.
Tuesday, January 13, 2009 at 11:01 am
Hey Flown, where can I get a piece of your hot phlogiston action? The guy in the super luxury apartment isn't taking calls.
Tuesday, January 13, 2009 at 11:03 am
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.
Tuesday, January 13, 2009 at 11:05 am
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.
Tuesday, January 13, 2009 at 11:06 am
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.
Tuesday, January 13, 2009 at 11:13 am
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.
Tuesday, January 13, 2009 at 11:19 am
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)
Tuesday, January 13, 2009 at 11:19 am
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.
Tuesday, January 13, 2009 at 11:20 am
Off topic for AMC fans. She tweets that she has a job.
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anamariecox Starting work next week as Air America's National Correspondent
Tuesday, January 13, 2009 at 11:20 am
KT - are you watching the hearings? It's sort of freaky that Chelsea's standing up behind her mother. What's that about.
Tuesday, January 13, 2009 at 11:21 am
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.
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It's generous to attribute their actions to ignorance. Venality is a better candidate.
Tuesday, January 13, 2009 at 11:22 am
Jayack - haha. Looks like the joke's on those who thought AMC was in John McCain's pocket. No?
Tuesday, January 13, 2009 at 11:24 am
K-Tum, "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." But isn't that true everywhere else as well? I think that is our larger point.
Tuesday, January 13, 2009 at 11:25 am
kathy, Chelsea is sitting.
Tuesday, January 13, 2009 at 11:25 am
If you want an underreported story of the day check out Josh over at TPM and his story that led me to this report on Brad Schlozman who evidently politicized the Civil Rights section of the Justice Dept but also lied to Congress about it. I am reading through the report right now and some of the stuff he put in emails is unbelievable. How did he not think he would get caught? Basically he wouldn't hire any dirty hippies and damm near referred to them as dirty hippies.
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http://www.usdoj.gov/oig/special/s0901/final.pdf
Tuesday, January 13, 2009 at 11:26 am
What jay #24 said. Forest, trees, all that.
Tuesday, January 13, 2009 at 11:26 am
kathy: is she standing? it looks like she is just on a particularly high chair. also, i'm distracted by the fact that HRC is wearing what have come to be known as "the pelosi pearls."
Tuesday, January 13, 2009 at 11:27 am
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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I have a relative who works for the EPA, who says the people who are left feel this way, but that many people have moved on, not able to stand being told, on a routine basis, to not follow the law.
Tuesday, January 13, 2009 at 11:29 am
I'll say this: those Cialis tubs don't work. By the time I drag them up the mountain, I'm too tired to even talk to, much less satisfy my wife.
Tuesday, January 13, 2009 at 11:29 am
Pelosi pearls:
http://pearlsociety.typepad.com/my_weblog/2007/03/pelosis_pearls.html
I think I read somewhere that the Speaker's cost something like $30k.
Tuesday, January 13, 2009 at 11:35 am
Just finished Fallows' Breaking the News. Remarkable how unchanged the world of the traditional media is 12 years later.
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kathy, I really don't see any revenue models that will support operations the size of the NYTimes AND will generate the margins a publicly traded company must generate. I've honestly come to think that while the "information wants to be free" element of the web has accelerated the collapse, but that, in the end, it's impossible to square "journalism" with sufficiently high quarterly earnings. There is a public service element to what newspapers do that is simply not consonant with the requirements of maximizing shareholder value on a quarterly basis. Cutting costs by laying people off is a death spiral.
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I very much enjoy the tactile experience of reading the Times in the morning. I'm wondering if I'll be doing that in 2010.
Tuesday, January 13, 2009 at 11:38 am
From the pearl link:
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"This holiday season, we sold a lot more South Sea pearl strands, expensive ones in the $20,000 and up range: in white, golden, or Tahitian,"
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I've been to a Tahitian pearl farm. (My Twitter background (jayackroyd) is a tahitian sunset.) I find it interesting that there is no longer any mention of "real" vs "cultured" pearls, and that cultured pearls command these prices.
Tuesday, January 13, 2009 at 11:38 am
sgw, I beat you to Schlozman at #18.
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ha.
Tuesday, January 13, 2009 at 11:39 am
wvng - KT - I stand corrected, happily. It sure looked weird to me.
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pourme- I hope somebody's collecting these for the Swampland book: Pourmecoffee and protect your keyboard
Tuesday, January 13, 2009 at 11:41 am
KT:
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1) Thanks so much for this post, it's well worth considering.
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2) I love your use of the editorial "we" (We have argued here before...)
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3) As always, your response to commentary is greatly appreciated
Tuesday, January 13, 2009 at 11:42 am
Jay - so how do you see us maintaining an investigative press?
Tuesday, January 13, 2009 at 11:42 am
pourme, what if your wife was wearing those pearls and pantsuit?
Tuesday, January 13, 2009 at 11:45 am
Question. How many of the republican senators in Hillary's hearing agree with W yesterday, that the US is currently respected in the world?
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Real love-fest going on in that room.
Tuesday, January 13, 2009 at 11:50 am
Here's a pearl of wisdom from the pearl site, in answer to a question about how people in the Middle Ages tried to improve the sheen on their pearls:
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One method used until this century in Europe was to run the pearl "through a chicken": allowing the chicken to swallow the pearl, then anxiously watching for its re-emergence at the other end. The stomach acids would have dissolved the outer layer, hopefully resulting in a prettier pearl.
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I'm sure there's a useful political metaphor in there somewhere.
Tuesday, January 13, 2009 at 11:53 am
jayackroyd, I think the GOP gets bought off by those with whom the GOP actually shares common ground. Palin and McCain do not understand the importance of fruit flies in genetic research. Orrin Hatch would prefer not to have an FDA at all.
If you believe that the market will cure all ills and that government oversight is bad, then science becomes secondary. I can turn on my TV and watch a company sell a "male enhancement" product that contains who knows what, but does not require FDA regulation. Previously I saw a compound for headaches that was just some goo rubbed on the forehead. No safety or efficacy data required.
To be sure there is profit to be made by being scientifically illiterate, but I do believe that the GOP hierarchy and base are less understanding of scientific data.
Tuesday, January 13, 2009 at 11:57 am
I have had a pretty innocent comment "in moderation" since 11:05 AM. Is there any rationale to what gets held and for how Long?
Tuesday, January 13, 2009 at 11:58 am
rmrd, you might send pourme a note about that "male enhancement" product. He seems to need some help in performance after vigorous exercise.
Tuesday, January 13, 2009 at 12:14 pm
Jay - so how do you see us maintaining an investigative press?
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I'll leave aside the remarks about having needed an investigative press for the last eight years, and been left wanting.
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I really don't know. My guess is that we'll go back to the media being frank advocates of the people who pay for the publications, and that this idea of newspapers as a civic duty of deep pocketed locals will go away. Fallows' book is worth reading. One of the things he says (writing in 1996) is that the teevee newspeople are trying to be entertainers, rather than news providers. He argues that this is a very bad strategy, while lucrative for now, real entertainers like sportspeople and singers are more likely to win this contest.
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Another point he makes is that because the real money is on the teevee (even as a guest, because it drives up your speaking fees), print journalists try to get on the teevee--weakening the quality of their reporting and writing. Now, that may have changed because there may be more restrictions on speaking fees since then. There may be more publications following the Post's policies (that Broder violated....). But, nonetheless, getting on the teevee does seem to be an objective of many people writing in print.
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And the teevee is bad for journalism. I have not been able to watch local news for at least a decade. I can barely stand to see what Wolf is shouting about on any given day--and that's my primary teevee news watching.
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Fallows argues for partnership between papers and people, in a way that he probably would not argue now, since he was writing pre-blog (but very technophilic and aware of newsgroups and the commercial online discussion groups). That's still not gonna get you a Colombo news bureau covering a Tamil uprising, but if there is a demand for news, it will somehow get filled.
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And, as I said, it's not as if the current model is doing a bang-up job.