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Fwd: FDA Corruption Letter Authenticated

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>Mon, 15 Mar 2010 07:23:48 -0400 (EDT)

>Kay Ness <kyness

>Kay Ness <kyness

>Kay Ness <kyness

>FDA " Corruption " Letter Authenticated

>

>VITAL FDA " Corruption " Letter Authenticated: Lawyers, Start Your Engines

>

> Sun Mar 14, 2010 12:26 pm ((PDT))

>

>Lawyers who want to sue drug companies will be

>drooling over the news that the FDA has

>'certified' a 2009 letter sent anonymously by

>FDA staff to President Obama describing 'systemic

>corruption and wrongdoing that permeates all levels of FDA.'

>

><http://industry.bnet.com/pharma/10007170/fda-corruption-letter-authenticated-l\

awyers-start-your-engines/>http://industry.bnet.com/pharma/10007170/fda-corrupti\

on-letter-authenticated-lawyers-start-your-engines/

>

>

>

>

>FDA " Corruption " Letter Authenticated: Lawyers, Start Your Engines!

>

>By Jim Edwards | Mar 12, 2010

>

>

>Lawyers who want to sue drug companies will be

>drooling over the news that the FDA has

>'certified' a 2009 letter sent anonymously by

>FDA staff to President Obama describing 'systemic

>corruption and wrongdoing that permeates all levels of FDA.'

>

>The FDA's official recognition of

><http://i.bnet.com/blogs/cert-fda-letter-to-the-president-4-2-09-and-trans-team\

-1-7-09.pdf>

>the letter

>

>http://i.bnet.com/blogs/cert-fda-letter-to-the-president-4-2-09-and-trans-team-\

1-7-09.pdf?tag=content;selector-perfector

>means that lawyers who want to use it to

>demonstrate that the FDA isn't perfect won't have

>to go through weeks of tedious discovery demands

>to find someone at the FDA who can officially

>say, 'Yup, we sent that.' That's going to be a

>headache for drug companies who often defend

>their drugs in court by saying, 'Hey, the FDA

>said this product was fine and we did everything

>they asked ­ so it's not fair to hold us responsible.'

>

>Plaintiffs' lawyers can now hold up the letter

>in court and argue that drug companies have been

>on notice that the FDA is riddled with politics,

>conflicts of interest and outright corruption,

>and is, as the letter says, 'fundamentally broken.'

>

>The letter made headlines when

>

><http://online.wsj.com/article/SB123142562104564381.html>

>it was sent last year to John Podesta

><http://online.wsj.com/article/SB123142562104564381.html>

>of Obama's transition team.

>http://online.wsj.com/article/SB123142562104564381.html

>Written by a group of scientists on FDA letter

>head ­ but with their names blacked out for fear

>of retaliation ­ the letter describes a

>nightmare of bungling and self-dealing among higher-ups at

>the drug safety agency. It begs Obama to step in and reform the shop:

>

>Â… many other FDA managers who have failed to

>protect the American public, who have violated

>laws, rules, and regulations, who have

>suppressed or altered scientific or technological findings

>and conclusions, who have abused their power and

>authority, and who have engaged in illegal

>retaliation against those who speak out, have

>not been held accountable and remain in place.

>

>The letter cites three dark chapters in FDA history:

> * Former chief Andrew von Eschenbach's

>interference with the approval of a knee device.

> * The approval of a breast cancer detection

>device by director of the Office of Device

>Evaluation Donna-Bea Tillman even though all FDA

>experts voted against it, following a phone call

>from Connecticut congressman Christopher Shays.

> * And the approval by Daniel Schultz of a

>medical device that prevents tissue scarring

>against the unanimous opinion of his scientific staff.

>

>According to

><http://www.awkolaw.com/drugs.html>

>Doug Kriese, who sues drug companies, 'Consumers

>have been given a slight fighting chance now

>against [the] 'FDA Defense,' based on this certification.'

>

>Still unanswered: Who wrote the thing.

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