http://news.sciencemag.org/scienceinsid ... spotl.html
Of course this begs the question of why these devices were being approved despite negative reviews....... I wonder if there will be any sort of followup investigation......The integrity of the scientific review process appears to be at the heart of recent allegations that Food and Drug Administration (FDA) officials spied electronically on whistleblowers—including scientists, an engineer, and a statistician—trying to expose alleged flaws in the agency's approval process for cancer-screening devices.
Specifically, they said that "since 2006, FDA physicians and scientists have recommended five times not to approve mammography CAD [computer-aided detection] devices" because they failed to detect breast cancer and led to invasive and unnecessary follow-up work. FDA managers pushed for approving the devices anyway, allegedly "ordering, coercing, and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along."
In March 2009, FDA asked another physician (not part of the FDA nine) to review a colonoscopy device that used computed tomography (CT). The CT device already had FDA approval for some applications, but the manufacturer wanted it used as a general, population-wide screening tool for colon cancer. The physician rejected this use, arguing that the device did not work well and that, because each examination involved getting the equivalent of 800 x-rays, the device might actually cause a small increase in cancer. The FDA approved the device, and the physician complained vociferously.
Rosie
