FDA scientists seek rescue

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.

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