The Spectre Haunting GE a Business Week Article
Many MRI patients are injected with a GE dye to enhance images. If they have weak kidneys, they might develop a rare and sometimes fatal diseasesnip:
The U.S. Food & Drug Administration has required since May 2007 that makers of contrast agents use a stern “black box” warning cautioning physicians to weigh carefully the benefits and risks for patients with weak kidneys. Screening out people with kidney problems appears to eliminate the danger of NSF. But the FDA has not said GE’s product is any more problematic than those of its competitors. The agency reached that conclusion even after two of its staff doctors—in findings disclosed here for the first time—determined that Omniscan is riskier than its rivals. GE had urged the FDA to treat all of the agents as equally risky.
Now one of the nation’s leading imaging-safety experts, Dr. Emanuel Kanal, a professor at the University of Pittsburgh Medical Center, says that the FDA’s decision to lump all contrast agents together is “inappropriate and indefensible.” Kanal warns that the government’s position potentially “endangers American citizens.” The FDA, while defending its stance, says it will meet with Kanal to look at fresh data. (Kanal isn’t working for any of the parties in the lawsuits.)
/snip
There are “skeptics” about who feel that suspicion of governmental agencies (in this case the FDA) and “Big Pharma” come under the “tinfoil hat” category, who have asked me in all seriousness: “Why would a drug company do anything that would cause it to lose patients?
Ummmm…. how about:
No comments:
Post a Comment