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...
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.
advisory expected turn
I expected the advisory panel to turn the drug down.
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 asleep committee fda question stand willing
I think the FDA advisory committee was asleep at the switch, ... The question is, did they not get it, or did they get it and were not willing to stand their ground?
disease dream
That's always been just a dream -- actually making the disease go away.
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,
studies
We've been misled many times by observational studies like this,
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.