Growing awareness of the risks of scanning led F.D.A. scientists several years ago to begin demanding more and better information from manufacturers to prove that their devices actually were effective for such clinical applications as cancer screening and mapping blood flows in the brain.The problem is that these CT scans expose you to a lot of radiation, so a lot of scientists say we shouldn't use them unless we are pretty sure there is something wrong. But the manufacturers want everyone to use them, early and often, and they'd like the government to pay for it: "hundreds of millions of dollars annually."
But agency managers responded that suddenly changing the rules for the devices would be inappropriate and unfair to manufacturers, documents and interviews show.
General Electric, one of the biggest makers of the devices, told F.D.A. managers that the company wanted CT scans approved for colon cancer screenings because Medicare officials and private insurers were “actively discussing whether to reimburse for use of CTC for screening asymptomatic individuals” and “to assist their customers in reimbursement for procedures,” internal agency documents show.Great work Gardiner Harris!