FDA Scientists Say Agency Ignored Radiation Risk

A group of scientists have accused the Food & Drug Administration (FDA) of ignoring dangers posed by using <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">CT scans to screen for colon cancer. According to The New York Times, the scientists plan to speak out tomorrow at a public meeting of experts convened by the FDA to discuss the risk of unnecessary radiation exposure.

CT scans are extremely popular as a diagnostic tool. As we’ve reported previously, use of the scans has tripled in the U.S. since the early 1990s to more than 70 million in 2007. The use of CT scans to diagnose colon cancer – called a virtual colonoscopy – is becoming increasingly popular, but there is little agreement on the safety of such a procedure. According to the Times, both American College of Radiology as well as the American Cancer Society have endorsed the procedure, while the American College of Gastroenterology recommends a direct examination called a colonoscopy.

According to the Times, CT scans can deliver the radiation equivalent of 400 chest X-rays. Though there have always been concerns regarding the cancer risks associated with radiation from CT scans, it hasn’t been clear how high those risks actually are. It is estimated that as many as 14,000 people may die every year of radiation-induced cancers as a result, researchers estimate, the Times said.

According to The New York Times, the FDA hasn’t been able to make up its mind about the safety of virtual colonoscopies, and this has led to a pretty heated dispute at the agency. Now, a group of FDA scientists is planning to testify tomorrow that agency managers ignored or suppressed their concerns about virtual colonoscopy. As a result, the scientist claim hundreds of patients have been endangered needlessly.

The issue became particularly contentious when FDA managers sought to approve an application by General Electric to allow the use of CT scans for colon cancer screenings over the repeated objections of agency scientists, the Times said. After the managers made the recommendation, Dr. Julian Nicholas, a gastroenterologist who trained at Oxford University and the Mayo Clinic and worked under contract with the agency, responded by e-mail that he felt strongly that approving the application could “expose a number of Americans to a risk of radiation that is unwarranted and may lead to instances of solid organ abdominal cancer.” Dr. Robert Smith, a former professor of radiology at both Yale and Cornell and an FDA medical officer, wrote that he agreed with Dr. Nicholas’ assessment.

But, according to the Times, minutes of a May 12, 2009 meeting reveal that one agency manager dismissed the scientists’ concerns by saying, “We don’t need to be reinventing a big bugaboo about radiation.” But Dr. Nicholas refused to back off of his concerns, and told the Times that he was ignored, pressured to change his opinion and intimidated. Because of his stance, Dr. Nicolas says he was ultimately terminated, as the FDA allowed his contract to expire in October. Dr. Nicholas is one of those who plans to tell his story at tomorrows meeting.

While General Electric’s application has yet to be approved, according to The New York Times, an FDA manager began processing the application the day after Dr. Nicholas’ contract with the agency expired.

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