August 27, 2010
FDA administrators sought to brush aside evidence that CT scans may be killing thousands of patients a year, say agency scientists.
“I was first ignored, then pressured to change my scientific opinion, and when I refused to do that, I was intimidated and ultimately terminated,” said gastroenterologist and former FDA consultant Julian Nicholas.
The controversy stems from a still-pending application by General Electric (GE) for the approval of CT (computed tomography) scans as tests for colon cancer. GE made the request because although the practice of screening healthy patients with CT scans has become increasingly common, many insurers remains reluctant to pay for it.
- A d v e r t i s e m e n t
When the FDA moved to approve the request with minimum fuss, agency scientists objected that the increased cancer risk from the radiation involved in CT scans would outweigh any potential benefit.
Approval would “expose a number of Americans to a risk of radiation that is unwarranted and may lead to instances of solid organ abdominal cancer,” Nicholas wrote in an email to the agency.
“The increased radiation exposure to the population could be substantial and would raise a serious public health/public policy issue,” agreed FDA medical officer Robert Smith of Yale and Cornell Universities.
Yet these and other scientists say their concerns were dismissed by their supervisors. For example, minutes of one meeting record agency manager Joshua Nipper responding, “We don’t need to be reinventing a big bugaboo about radiation.”
The average U.S. resident is exposed to seven times more non-therapeutic radiation than in 1980. This has been driven in large part by the exploding popularity of CT scans, which expose patients to as much radiation as 400 chest X-rays.
The number of CT scans performed in the United States has increased from three million per year in 1980 to 70 million today. Scientists estimate that this extra radiation exposure kills 14,000 people a year.
Sources for this story include: http://www.nytimes.com/2010/03/29/h….
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