Scientists: FDA Fundamentally Broken

January 26th, 2009 | Sources: Wall Street Journal

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In a letter to the Big O’s transition team and Congressional leaders, 9 FDA scientists pleaded that their agency needs to scrub clean a culture in which officials coerce scientists to fudge data and approve devices with no proven benefit.

The scientists assert the agency is “fundamentally broken… there is an atmosphere…in which the honest employee fears the dishonest employee,” in a letter received a few days before the inauguration and reported in the Wall Street Journal.

The scientists are concerned in particular with the FDA’s approval process for medical devices, which they describe as “corrupted and distorted by current FDA managers, thereby placing the American people at risk.”

For example say the scientists, the FDA approved computer-aided mammography detection devices in the absence of evidence that they worked. Since then, FDA scientists have advised repeatedly that the agency should take another look at the evidence, to no avail.

The letter is a follow-up to one sent in October to the House Energy and Commerce Committee in which the scientists reported they had already voiced concerns to Andrew von Eschenbach, the Commissioner during the Bush presidency, and his deputy Bill McConagha.

In November, Committee leaders wrote a letter to von Eschenbach saying they had “received…evidence of…wrongdoing” in his agency, and suggested that certain managers be removed.

But since then the scientists say, no one has been held accountable and some offending managers have actually been promoted.

In response to the accusations, FDA spokesperson Judy Leon says the agency has worked “very closely” with the Big O’s team, and that it is “actively engaged in a process to explore the staff members’ concerns and take appropriate action.”


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