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...
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.
black box discuss future information informing needs obtained order people risks
We can't just discuss future strategies, we need to discuss what needs to be done now about the risks and informing people about them. I think a black box is in order that could be removed if information is obtained that does not implicate the drugs.
disease rid step stopping
Getting rid of that plaque is a fundamental step in stopping this disease.
advisory expected health potential public turn
I expected the advisory panel to turn the drug down. When they didn't, I was really surprised. And so I now had a potential public health catastrophe in the waiting,
advisory expected turn
I expected the advisory panel to turn the drug down.
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,
creates exposure health major public
When you have that kind of exposure to drugs that are suspicious, it creates a major public health concern.
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.
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.
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.
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.