Some FDA scientists are indicating that their warnings about the risks of radiation exposure from CT scans were ignored by FDA managers, leading to unnecessary health problems and dangers for patients.
The allegations are expected to be presented at two days of public hearings beginning today in Gaithersburg, Maryland. The FDA hearings will focus on reducing the risks of unnecessary radiation exposure. However, a story by the New York Times says that a number of FDA scientists will use the conference to expose how some agency managers failed to heed their concerns that overuse of radiation scanning procedures was endangering the public.
The New York Times received documents from FDA scientists and medical officers showing that agency experts objected to plans to approve an application by General Electric that would allow the use of CT scans to look for colon cancer, but those objections went unheard. The application, however, is still under review.
Concerns about radiation exposure risks were sparked by a revelation late last year that more than 200 patients were subjected to overexposure to radiation at Cedars-Sinai Medical Center in Los Angeles. The FDA uncovered numerous other cases at different hospitals as a result of the Cedars-Sinai investigation, leading to a new radiation exposure reduction initiative announced in late February.
The initiative seeks to reduce the risk of radiation exposure from medical procedures through promotion of the safe use of medical devices, by providing support for informed clinical decision-making, and by making patients more aware of their total radiation exposure. The FDA is also considering increased requirements for computed tomography (CT) scanners and fluoroscopic devices that would call for increased safeguards and training to protect against radiation overexposure.
But Dr. Julian Nicholas, a gastroenterologist working under contract for the FDA, said he was forced out when he suggested that approving CT scan for colon cancer screening could lead to more Americans being overexposed to radiation. Nicholas and others say they will present their concerns at the public hearing, where they will be on the record.
In December, FDA issued interim guidance on radiation exposure for health care professionals and radiologists. The guidance advised them to review procedures and CT scan settings, and to be thorough in checking the amount of dosage prescribed for each CT scan patient.