From the February 2008 Idaho Observer:
We’re the government and we’re here to poison you
A CBS 60 Minutes expose (Feb. 17) on the14-year use of the lethal drug Trasylol revealed the FDA’s failure to protect the public health. The CBS reporter asked Dr. Dennis Mangano, "Doesn’t a drug have to be proven safe before the FDA allows it on the market?"
"No," said Dr. Mangano.
The reporter asked, "Make sure I understand. If the FDA is not certifying a drug as safe, before it goes on the market, what is it doing?" Dr. Mangano replied, "It’s certifying that the drug is effective and that within the small numbers studied, relatively small, it doesn’t appear to be unsafe."
Dr. Mangano estimates that 22,000 patients could have been saved if the FDA removed the heart surgery drug Trasylol two years ago.
The Supreme Court ruled February 20, 2008, that the manufacturer of a federally approved medical device cannot be held liable under state law if the device causes an injury. Justice Scalia wrote that the FDA grants pre-market approval only if it finds there is a "reasonable assurance" of its "safety and effectiveness."
On Feb. 25 the Supreme Court will hear another case involving a state’s rights to protect citizens from dangerous drugs (see page 15) regarding state’s rights to sue drug manufacturers for damage resulting froming from from an FDA