WASHINGTON (AP) - A former Food and Drug Administration scientist said Tuesday his job was eliminated after he raised concerns about the risks of radiation exposure from high-grade medical scanning.
Dr. Julian Nicholas said at a public hearing that he and other FDA staffers "were pressured to change their scientific opinion," after they opposed the approval of a CT scanner for routine colon cancer screening. Nicholas said that he objected to exposing otherwise healthy patients to the cancer risks of radiation.
After FDA officials pushed ahead with plans to clear the device, Nicholas, now a physician at the Scripps Clinic in San Diego, said he and eight other staffers raised their concerns with the division's top director Dr. Jeffrey Shuren last September. The device apparently is still under review.
"Scientific and regulatory review process for medical devices was being distorted by managers who were not following the laws," Nicholas said. A month later Nicholas' position was terminated, he said.
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Hundreds of studies have linked certain types of radiation, including the type used in medical imaging, to cancer that can surface decades later.
FDA medical reviewer Dr. Robert Smith, a colleague of Nicholas who also presented at Tuesday's public meeting, said he hoped the FDA would learn a lesson from Nicholas' testimony.
"Science must not be ignored, suppressed or distorted as that endangers the public," Smith told the audience.
Smith, who still works for the agency, supported Nicholas' conclusion that CT scanning for colon cancer should be rejected on safety grounds. ...
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