- The Washington Times - Wednesday, March 31, 2010

A former Food and Drug Administration scientist said Tuesday that his job was eliminated after he raised concerns about the risks of radiation exposure from high-grade medical scanning.

Dr. Julian Nicholas told an audience of imaging specialists that he and other FDA staffers “were pressured to change their scientific opinion” by managers in the agency’s medical device division.

Dr. 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, in September.

“Scientific and regulatory review process for medical devices was being distorted by managers who were not following the laws,” Dr. Nicholas said. A month later, Dr. Nicholas’ position was “terminated,” he said.

The charges about suppression of scientific dissent within FDA are not the first, and come at an inopportune time for the agency.

Tuesday’s meeting was designed to kick off FDA’s campaign to reduce radiation exposure from medical scanning. The agency is seeking input from physicians and manufacturers on additional safety controls and training to improve CT scanners and other medical imaging devices.

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 Dr. Nicholas who also presented at Tuesday’s public meeting, said he hoped the FDA would learn a lesson from his colleague’s testimony.

Agency spokesman Dick Thompson said in a statement that the FDA’s inspector general looked into Dr. Nicholas’ charges of retaliation against agency scientists and did not pursue further action or investigation. The agency’s policies do not allow staffers to be penalized for expressing scientific views, he added.

“It is not uncommon for scientists, both internal and external to the agency, to disagree on the safety and effectiveness of products under review or on the steps needed to achieve public health goals,” the FDA statement said.

Dr. Nicholas, an Oxford University-trained intestinal specialist, raised specific concerns about the safety and effectiveness of CT screening for colon cancer, also known as a “virtual colonoscopy.”

CT scans provide detailed, three-dimensional images of the body, but at a cost: One CT chest scan carries as much radiation as nearly 400 chest X-rays, according to the FDA.

As a reviewer of medical device applications, Dr. Nicholas repeatedly rejected a manufacturer’s request to market a CT scanner specifically for colon cancer screening. Dr. Nicholas said he is legally barred from naming the manufacturer or discussing the details of its application.

Dr. Nicholas said he was ridiculed by agency managers for “raising the bugaboo of radiation.”

Medical professionals are divided over the usefulness of the so-called virtual colonoscopy, which was designed as a less-invasive alternative to colonoscopy.

The American Cancer Society and the American College of Radiology endorse the procedure for its potential to boost screening for colon cancer, the country’s second leading cancer killer.

But some insurers and the government’s own Medicare program refuse to pay for the procedure, questioning its effectiveness and the rationale of exposing healthy patients to radiation.

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