...."Avastin was originally labeled for treatment of breast cancer patients in an expedited fashion based on initial studies that showed the drug produced on average nearly 6 months without tumor progression. So the FDA is now looking a follow-up study that shows an average of about 3 months without tumor progression. These are average time frames, meaning tha many in the studies got more than 6 months or 3 months in the respective studies. The FDA also ooked for new adverse events (side effects) and determined that there are no new safety concerns raised in the trials for breast cancer applications for the drug Avastin.Despite the determination that the drug was safe and effective, the FDA is trying to de-label the drug for use with late stage breast cancer patients by changing the evaluation rules to use the price of the drug to determine its effectiveness. That is rationing. Period. The FDA created a subjective standard they call “clinically meaningful.” Sounds impress
ive
but what does that mean? In the case of Avastin, which has been shown to actually work, the FDA is just saying that the average extension of life of 6 months just isn’t meaningful enough. That is the new rules of the game. The dealer always wins Once the rules have been changed, the shills move in. The Associated Press takes the new subjective language intended to lead people to believe the drug is being de-labled because it doesn’t work and in turns that into actually false information saying that “recent studies finding that the drug did not extend patients’ life spans and also increased the incidence of side effects and other complications.” Patently false."... http://biggovernment.com
/capitolconfidential/2010/07/29/obamacares-rationing-blueprint-associated-press-and-left-wing-bloggers-complete-the-circle/
ive
but what does that mean? In the case of Avastin, which has been shown to actually work, the FDA is just saying that the average extension of life of 6 months just isn’t meaningful enough. That is the new rules of the game. The dealer always wins Once the rules have been changed, the shills move in. The Associated Press takes the new subjective language intended to lead people to believe the drug is being de-labled because it doesn’t work and in turns that into actually false information saying that “recent studies finding that the drug did not extend patients’ life spans and also increased the incidence of side effects and other complications.” Patently false."... http://biggovernment.com
/capitolconfidential/2010/07/29/obamacares-rationing-blueprint-associated-press-and-left-wing-bloggers-complete-the-circle/
No comments:
Post a Comment