FDA Debate Over CT Scans Goes Public
The strenuous internal debate within the FDA regarding the risks posed by CT scans to test for cancer in otherwise healthy patients has gone public. The average lifetime dose to a medical patient of radiation has increased seven times since 1980, mostly due to the increase in CT scans. Scientists concerned about the effects of such an increase are taking their opinions to the public this week at a meeting called by the FDA.
In an extensive series of reports in The New York Times, the battle lines between those who support CT scans for cancer and those who think the risks outweigh the benefits have over time, become sharply drawn. Among those supporting the use of the scans to screen healthy patients are the American College of Radiology and the American Cancer Society. However, the American College of Gastroenterology prefers to recommend the less amusing camera and tube method.
The increasing awareness of the risks of this level of radiation spurred the FDA scientists several years ago to begin demanding more information from manufacturers to prove that their devices actually were effective for such applications such as cancer screening. The Times writes that managers within the agency saw this as changing the rules on the manufacturers midstream. The disagreement intensified when companies such as GE began to seek FDA approval for routine CT scans to screen for cancers of the lung and colon, among others. According to those concerned, such agency acceptance would undoubtedly lead to a large increase in the number of patients having the procedure.
The Times reports the internal friction over the subject grew during 2009, with one manager, Joshua Nipper, disparaging those concerned in a meeting by saying, "We don't need to be reinventing a big bugaboo about radiation." Thanks to the scientists' refusal to back down even though one, Dr. Dr. Julian Nicholas, says he was fired for it, the whole debate has come to the public's attention.
Related Resources:
- Scientists Say F.D.A. Ignored Radiation Warnings (New York Times)
- FDA Eyes Risk of Radiation Overdose in Medical Facilities (FindLaw's Injured)
- Lawsuit Over CT Brain Scan and Radiation Overdose (FindLaw's Injured)
- Defective Medical Devices (provided by Fitts Zehl, LLP)
- Defective Product FAQ (provided by Freeburn & Hamilton, P.C.)