FDA Scientists Request Investigation Into Agency Approval Of Breast Imaging Device

Scientists at FDA have requested that Congress and President-elect Obama investigate their allegations that an FDA official approved the sale of a breast cancer imaging device over the objections of the front-line scientists after receiving a phone call from a Connecticut congressman, according to the New York Times. The Times reports that the call from the congressman and its "effect on what is supposed to be a science-based approval process" represent "only one of many accusations in a trove of documents" the newspaper received regarding disputes within the FDA Office of Device Evaluation.

According to the Times, the documents show through e-mail correspondence that top agency scientists allege that an agency supervisor inappropriately forced them to modify reviews of the iCAD SecondLook Digital Computer-Aided Detection System for Mammography -- a computer device to assist in the detection of breast tumors -- after former Rep. Christopher Shays (R-Conn.) called an agency supervisor a few years ago to voice concerns about the future of the device. According to the Times, the device is used with screening equipment made by Fujifilm Medical Systems, which is based in Shays' former district. According to the FDA documents, the nine scientists involved with the iCAD decision said that the company "never tested the device by the intended users (i.e. radiologists) under the intended conditions of use. This is the most basic and fundamental requirement of all FDA submissions." The risks of iCAD include missed cancers, "unnecessary biopsy or even surgery (by placing false positive marks) and unnecessary additional radiation," according to an internal review.

source: Medical News Today