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FDA Scientists Allege
‘Corrupted And Distorted’ Review Process

A group of FDA scientists wrote a letter to the Obama transition team critiquing the way the agency was managed during the Bush 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.

CNN’s Louise Schiavone did a thorough report on Lou Dobbs:

The report details a number of serious charges:

• Scientists and doctors have been threatened and told, on occasion, to ignore FDA regulations.

• Devices have not been properly labeled.

• Managers without appropriate experience have been given authority to make final decisions about device regulation and have done so while ignoring serious safety and effectiveness concerns.

• FDA experts have been excluded from product meetings because manufacturers felt that they were “biased.”

• Manufacturers have been allowed to market their products without FDA approval.

An internal investigation of the charges, the scientists said, has resulted “in absolutely nothing: 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.”

The allegations are serious and disturbing as this alleged behavior, if true, would have a high likelihood of having caused serious harm, even death.

Also disturbing, though, is that nine scientists at the FDA have been sufficiently concerned to write such a letter but did not resign in protest over what they claim has been happening for years.

These are highly credentialed scientists with many opportunities to make a living, yet, somehow, despite the seriousness of their charges, they weren’t willing to quit to make the point.

Now the FDA prior to the hand-over to President Obama was saying it was “actively engaged in a process to explore the staff members’ concerns and take appropriate action.” The CNN report pointed out that Tom Daschle, President-elect Obama’s now-confirmed nominee for Secretary of Health and Human Services, was being urged by the scientists to demand resignations from all senior executives at FDA and allow the new FDA commissioner to clean house.

In his confirmation hearings, Daschle claimed he is committed to a science-driven approach:

“I want to reinstate a science-driven environment,” Daschle said. “I want to take ideology and politics as much as humanly possible out of the process and leave the scientists to do their job.”

We are all in favor of science and, certainly, allegations of top level executives can be investigated and we hope future leadership will be effective.

But if scientists don’t have the personal integrity to stand up and refuse to be part of such serious allegations, our problem is much more serious

In fact, although we are told that the scientists signed their names to the letter, the version that was leaked to CNN and other media did not contain the signatures.

Despite the Kennedyesque flavor of the Obama inauguration, these FDA scientists, unwilling to speak out publicly and with their identities being protected by their friends on the Obama transition team, are hardly profiles in courage.

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