Steven Nissen
Steven Nissen
Steven E. Nissen, is a cardiologist, researcher and patient advocate. He is chairman of cardiovascular medicine at the Cleveland Clinic, in Cleveland, Ohio...
balance safety
I'm not a crusader, I just want the balance between safety and efficacy to be favorable.
approve dedicated safety until wise
I do not think it's wise to approve the drug or see the drug marketed until there's a dedicated cardiovascular safety trial,
magic next ought
It's really the next generation. It ought to be a magic bullet.
bit black cause hands tremble
I want to cause people's hands to tremble a little bit before they write that (prescription). The only way I know how to do that is to put it in a black box.
disease dream
That's always been just a dream -- actually making the disease go away.
studies
We've been misled many times by observational studies like this,
far paradigm push
We wanted to push the paradigm as far as you can go.
happen move
We could still be wrong. That's what has to happen for this drug to move forward.
burden good
There's only one way -- through good science. We know the burden is upon us to do this right.
attack events heart patients serious ten
Ten of 1,000 patients would die, have a heart attack or a stroke. Those are serious irrevocable events.
approval approved attacks diabetes doubling dropped events favor fda health heart million public risk serious treated type vote
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.
beginning heart inexorable merely revolution slowing treatment truly
This may be the beginning of a real revolution in the treatment of heart disease. We're not merely slowing down the inexorable progression but truly reversing the disease. It's very exciting.
confidence entire needed pain public safe terms
We've desperately needed this. The entire public confidence in terms of what is safe for pain has been eroded.
creates exposure health major public
When you have that kind of exposure to drugs that are suspicious, it creates a major public health concern.