(29 quotes found)
“I treated this as a public health emergency, ... A drug that had an 8-to-1 vote in favor of approval and that could any day be approved by the FDA to be used by any of 18 million Americans with type 2 diabetes was, by my analysis, doubling of risk of serious irrevocable cardiovascular events like death, heart attacks and stroke. I dropped everything.”
Steven Nissen
“Ten of 1,000 patients would die, have a heart attack or a stroke. Those are serious irrevocable events.”
“The idea that you would see such a huge benefit so quickly is hard to accept.”
“We've been misled many times by observational studies like this,”
“We could still be wrong. That's what has to happen for this drug to move forward.”
“This panel was asleep at the switch.”
“The idea here is if you know what happens in the highest risk individuals, you will know how to use the drugs in people at lower risk. We will have 10 times the statistical power of any study ever done of these drugs.”
“We've desperately needed this. The entire public confidence in terms of what is safe for pain has been eroded.”
“There's only one way -- through good science. We know the burden is upon us to do this right.”
“Physicians ought to take this into account. These drugs are not very forgiving.”
