Thanks to Scott for the link to this Associated Press article:
FDA scientists complain to Obama of ‘corruption’
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.“The
purpose of this letter is to inform you that the scientific review
process for medical devices at the FDA has been corrupted and distorted
by current FDA managers, thereby placing the American people at risk,”
said the letter, dated Wednesday and written on the agency’s Center for
Devices and Radiological Health letterhead.
The letter goes on to read:
“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.”
Top FDA managers “committed the most outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along,”
And my favorite quote from the letter is:
“Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around,”
Big ups to all the federal scientist who had the courage to stand up to the FDA and their backers, Big Pharma.
