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One of those whistleblowers, Dr. Julian Nicholas, said he has never been interviewed by the inspector general's office. Nicholas, an Oxford-trained intestinal specialist, said that his contract as a medical reviewer was terminated after he repeatedly opposed approving a CT scanner for routine colon cancer screening. Nicholas said that he objected to exposing otherwise healthy patients to the cancer risks of routine radiation scans.
"It's hard for me to believe this was a bona fide investigation when they haven't even contacted the people who reported these violations," said Nicholas, now a practicing gastroenterologist at the Scripps Clinic in San Diego. "Such a huge amount of money is at stake and so many people are affected, that for the (office of inspector general) not to conduct a credible investigation is criminal in itself."
FDA's device leadership shared the results of the latest investigation with employees last week, according to a Nov. 5 e-mail obtained by The Associated Press.
The e-mail was written by Dr. Jeffrey Shuren, head of the FDA's Center for Devices and Radiological Health, to members of his staff. In it he said the investigation found no evidence of retaliation against the scientists who complained nor of "material violation of rules with respect to documenting significant decisions."
Shuren pointed out in his e-mail that the FDA hired a private contractor last spring to review the device unit's structure and make recommendations for improving relations between scientists and management. The contractor recommended changes in internal communications and training opportunities, Shuren said.
Copyright 2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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