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Tilting at Windmills

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January 9, 2009

FDA SCIENTISTS SEEK RESCUE... If the FDA's work weren't so important, a story like this wouldn't be quite so painful.

In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the Food and Drug Administration. [...]

In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.

"Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts," the letter said. "Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid."

The scientists added that the FDA's scientific review process has been "corrupted and distorted" by Bush appointees, "thereby placing the American people at risk." They added, "Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around."

The scientists have also claim to have seen FDA managers committing "outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists," and "retaliating" against experts who "refuse to go along."

One has to assume the agency has been pretty thoroughly Bush-ified when scientists are practically begging the incoming president to come rescue them.

Just another item for Obama's clean-up to-do list.

Steve Benen 1:00 PM Permalink | Trackbacks | Comments (18)

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Sounds to me like we could use an attorney general to do a criminal investigation here. Or will Bush, when he pardons the CIA and DOD en masse, also pardon the FDA for all crimes of corruption?

Crankily yours,

Posted by: The New York Crank on January 9, 2009 at 1:08 PM | PERMALINK

i sincerely hope there are family members of these bush thugs who suffer the consequences of their relatives' work.

Posted by: linda on January 9, 2009 at 1:09 PM | PERMALINK

George Lakoff, in a panel discussion I hosted in Second Life, pointed out that this kind of thing is poorly understood because it is not framed correctly. The FDA not enforcing safety and effectiveness, lead painted toys being imported, FEMA made dysfunctional, food tainted with E Coli, airline inspections not performed, EPA regulations not enforced.

These look to us like different stories, and they are reported upon as if they are different stories. But in fact they are all the same story.

Here's the clip. http://virtuallyspeaking.ning.com/video/george-lakoff

Posted by: JayAckroyd on January 9, 2009 at 1:14 PM | PERMALINK

Steve, On Christmas I wished you a long list of whistleblowers in the new year. Consider this one just a Christmas eve stocking stuffer.

to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations

Even the regulations Bush wrote? Or Lester Crawford, who had investments in the companies he regulated?

Posted by: Danp on January 9, 2009 at 1:22 PM | PERMALINK

It shows us how profoundly corrupt and evil the Bush Administration was that the civil servants feared saying anything until the end of this shameful period of our country.

If there is justice, George W Bush will die in prison.

Posted by: freelunch on January 9, 2009 at 1:31 PM | PERMALINK

Is there, at long last, any part of government that Bushco has not wrecked?
Cue Al commenting "We haven't had another terrorist attack."

Posted by: Reverend Dennis on January 9, 2009 at 1:34 PM | PERMALINK

Note that the Supreme Court is busily eviscerating any kind of state-level back up to the FDA's regulatory regime by saying that you can't sue the manufacturer of a medical device that harms you if the device was approved by the FDA because the FDA regulatory regime pre-empts state product liability law.

So, the FDA goes about certifying un-safe products and when they harm consumers the consumers can't sue because, hey, the FDA said the products were safe!

Posted by: Ugh on January 9, 2009 at 1:42 PM | PERMALINK

Ugh (and my sentiment), your comment is a good point and showcases our corrupt SCOTUS. The whole idea of federal law trumping state law is logically supposed to mean, any federal restriction overrules any implied permission given by absence of state law. But it wasn't supposed to mean, that lack of federal law or permission by the federal government implied that the state could not impose a more restrictive law. IOW, permissions and lack of laws are not really "laws" themselves imposing sanctions, but are merely the absence of a legal restriction. Otherwise States couldn't even make anything illegal unless the Fed had already done so. I know, mere absence of a legal prohibition is not the same as a regulatory green light being given, but the principle is essentially the same logic.


Posted by: Neil B ☼ on January 9, 2009 at 1:48 PM | PERMALINK

Good thing, and timing is just right:

'Cause, ya know, Obama would be LIKE SO Unbelievably bored' without this little minor science thingy to deal with'.

BTW, Sure hopes Krugman follows through on Obama's challenge to come up with a solid, pragmatic solution to help the economy. Anyone taking bets on this?

Posted by: Just what Obama needed (not) on January 9, 2009 at 2:13 PM | PERMALINK

Anyone taking bets on this?

I think Krugman's plan is pretty much, "Think of a number and add half."

Posted by: Danp on January 9, 2009 at 2:27 PM | PERMALINK

And, let me guess. If laws were broken...

"we don't want a witchhunt,"
"we need to focus on the future, not the past,"
"we need to come together, not pull apart."

Just like with Bush-Cheney war crimes.

I can't wait until defense attorneys for robbers and muggers start picking up on these defenses. Think it'll work?

Posted by: AlphaLiberal on January 9, 2009 at 2:32 PM | PERMALINK

Danp: LOL--I think that is Krugman's plan, but I seriously wonder if he ready or willing or able to actually sell that extra half to Obama?

I guess my question also is does Krugman have a viable plan in mind? If so, let's hear it!!!

Obama is apparently all ears (and has large ears).

Time for Krugman to heed the call in a real way, and not just whine on the NYT editorial page.
(Although I do love his whining, I must admit).

Posted by: Can Krugman sell his plan? Does he even have one? on January 9, 2009 at 2:52 PM | PERMALINK

Can Krugman - I'm afraid I'm not a big fan of Krugman. Like you, I enjoy reading his columns, and I find him to be very informative. But I don't see him as a problem solver, and I think he tends to let politics get in the way of his intellectual analysis.

Posted by: Danp on January 9, 2009 at 3:27 PM | PERMALINK

Does Krugman have a plan?

Jeez, this is the same old repug campaign shit about how Obama doesn't have any plan except hope.

Go to the NYT and read Krugman's column and blog for the last six months. He's made numerous detailed proposals of his own, not to mention his detailed critiques of Obama's proposals.

Sneer all you want, but "think of a number and add half (or rather double it)" is a pretty good shorthand of a better plan than anything we've got now.

Posted by: Yellow Dog on January 9, 2009 at 3:28 PM | PERMALINK

No-one is sneering, just hoping to seal the deal.

I have no idea how this works, but I was impressed by Obama's 'shout out' to Krugman today.

I say this is a precious invitation and window for Krugman to act on it.

Even if Krugman and/or others feel it's superficial, even if he feels he's already been specific enough--after a President Elect calls on you--well, then have a moral and ethical obligation to submit a proposal to Obama, IMHO.

Regardless of anticipated outcome. Which, btw, could be great. Or could amount to nothing.

Posted by: Krugman needs to heed Obama's call, regardless of history on January 9, 2009 at 4:16 PM | PERMALINK

Yellow Dog - Let me give you an example of how Krugman frustrates me. In his column in today's NYT he says, "Standard estimates suggest that a dollar of public spending raises GDP by around $1.50." He then goes on to argue that Obama should concentrate on this type of spending.

I don't doubt that there is some analysis that finds this generality to be true. But you have to ask, were they looking at projects like Eisenhower's highway project? Can we expect the same result from Don Young's Coconut Road project? What is the continued cost of maintaining these projects?

Meanwhile, if a middle class tax cut raises GDP by only $1.10 (hypothetically), does that mean all middle class tax cuts are equal? Or would a tax cut that encourages people to buy US goods and services do more good than one that merely lets people pay off debt, invest in the stock market, or buy Chinese products at Walmart?

Is there a point where that middle class tax cut ( or even a tax cut for the wealthy) does more benefit than a "public spending" project?

I would argue that Krugman frequently oversimplifies the issues, precisely in this manner.

Posted by: Danp on January 9, 2009 at 4:36 PM | PERMALINK

Broken record, I know, but I've been blogging about the evisceration at the FDA, the CDC and throughout HHS all along. The sole response has been crickets except by the agencies themselves, where most of my readership is - and I always have NSA visitors trolling.

Science and public safety has been intentionally subverted and gutted. Period.

In fact, Rich Carmona, the former Surgeon General, testified to that in great detail, but not one seems to give a good god damn.

You don't have a right to be surprised at this because the public health community and some progressive bloggers have been investigating and reporting this all along with absolutely no support from progressives.

There is real group think becoming dangerously entrenched with A list bloggers serving as a hall of mirrors for their preferred messaging while the evidence goes unexamined, unread and unrecognized.

Posted by: Annie on January 9, 2009 at 6:28 PM | PERMALINK

So you're trying to say this is actually news? Most of us have known for a long time that every Federal agency will need a thorough housecleaning after 8 years of BushCheney mismanagement. It will take, literally, years to flush all the crap they have deposited.

Posted by: bob in fla on January 9, 2009 at 9:39 PM | PERMALINK



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