Merrill Goozner reports that an FDA advisory panel has called for "new warnings that will dramatically scale back the use of anti-anemia drugs if the warnings are heeded by the nation's oncologists. You've seen those television ads. They show beaming older cancer patients playing with their grandkids. Why? Now they have the energy because of J&J's Procrit and Amgen's Aranesp."
One FDA reviewer said: "Improved quality of life, fatigue and other symptoms associated with anemia has not been established in properly conducted, randomized, double-blind, placebo-controlled trials." On top of that, two trials were ended early because of concerns over increased mortality. Another trial showed increased mortality and signs of cancer spreading.
The FDA heard patient stories such as this one Goozner cites: "How is it possible that something that was supposed to help me might have made things worse?" asked Lilla Romeo, a 60-year-old breast cancer patient who's been battling the disease since 2000. The false hope offered by the ads run by the companies was "both insulting and cruel," she said.
He also quotes Richard Pazdur, head of the FDA cancer drugs division: ""They (the FDA) have to give the American people a good explanation for why these ads were allowed to continue."
Posted by schwitz at May 11, 2007 07:29 AM | TrackBack