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FDA accused of politicizing science

By Shaun Conway Jan 13 2009, 06:50 AM

Do you fear retribution from coworkers for doing your job? Do you ignore safety standards for political gain? Do you keep safe products off the market for political reasons?

If so, you may work at the Food and Drug Administration (FDA) - at least according to a letter from nine "rogue" FDA scientists addressed to the Obama transition team.

In the letter, the scientists described a work place where President Bush's FDA managers "ordered, intimidated and coerced scientists to manipulate their research results in violation of federal law."  

Calling the agency "fundamentally broken," the scientists implored President-elect Obama to make removing the political climate at the FDA a top priority.

The biggest concern addressed in the letter was the scientific review process for medical devices. The process had been "corrupted and distorted by current FDA managers, thereby placing the American people at risk," said the scientists. Allegedly, FDA managers at times excluded scientists from product meetings because of manufacturers' concerns that the scientists would be biased. The scientists also charged that managers without proper training, experience or knowledge determined the appropriateness and safety of products.

Referencing an internal investigation into the concerns raised in the letter, the nine scientists stated: "no one was held accountable, no appropriate or effective actions have been taken, and the same managers who engaged in the wrongdoing remain in place and have been rewarded and promoted." And despite complaints to superiors and outside actors such as Congress, "the atmosphere does not yet exist at FDA where honest employees committed to integrity and the FDA mission can act without fear of reprisal."

In a statement given to CNN, the FDA said they are investigating the allegations.

The timing of the letter is certainly interesting, as it brings to light the underpinnings of FDA culture needing change just after Tom Daschle's first Congressional appointment hearing as the nominee to head the Department of Health and Human Services.  During his hearing, Daschle said that both he and the new president "expect key decisions at the FDA to be made on the basis of science - period."  If that's the case, it looks like Daschle may have his work cut out for him.

Also Interesting:

 

Read More: Health And Human Services (HHS), U.S. Congress, Public Health, Others

 
 
 
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COMMENT

kayo
January 13, 2009 10:09 AM

not surprising. i think they are as influenced by outside sources as anyone else. there are things that are available in other countries, but not in the US. and the whole thing with corn syrup- they should do studies on those effects. you cant buy a bleepin food item that doesnt have corn syrup in it. but then again, i am one of those that thinks marijuana is a big deal, not from a moral standpoint, but bc it might cut into alcohol and tobacco profits.

Karen Belinger
November 1, 2009 12:19 AM

Does the President know

the magnitude of product safety

issues going on at the FDA?

chris: one already exists www.totalrecallinfo.com  more SJ Suber: Create an independent exclusive personal barcode system that when an item is scanned at ac...  more Woodrow: Amazing technology, with nothing but wild claims and anecdotal evidence to back it up. The...  more

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