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Claims of FDA Whistleblower Researchers Dismissed for Second Time

There is certainly internal acrimony and a butting of heads at the FDA, where, for the second time this year, the allegations made by numerous FDA scientists concerning health issues related to CT scanners and other medical devices have been shot down by investigators.

Several of those researchers, who sent letters of concern and complaint to members of Congress, say that the agency terminated their contracts in an act of whistleblower retaliation.

Current and former medical device reviewers have stressed for the past two years that certain new technologies that use radiation to uncover and treat diseases are inordinately risky to many patients. Many of them voiced their concerns to FDA managers, who overruled their opinions. The researchers say that the managers did so improperly, without sufficiently documenting their reasons, and then engaged in acts of intimidation and retaliation against the researchers who went public with their concerns.

The Department of Health and Human Services, under which the FDA operates, ruled last February that the complaints were without merit and that there was "no evidence of retaliation." Owing to clamor from legislators and interest groups in the wake of that ruling, the investigation was reopened, with the inspector general of the department concluding for a second time last month that the FDA acted properly and that the case is formally closed.

FDA spokespersons state that the radiation devices are safe when they are used properly. Injuries that have been observed, they note, likely resulted from improperly trained imaging technicians.

That conclusion rankles with the whistleblowers. One of them, Dr. Julian Nicholas, who was terminated by the FDA after he repeatedly refused to approve a CT scanner, stated that "for the office of the inspector general not to conduct a credible investigation is criminal in itself."

Related Resource: "Feds dismiss misconduct claims at FDA device unit" November 10, 2010

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