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.
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.
benefit hard huge quickly
The idea that you would see such a huge benefit so quickly is hard to accept.
gotten low
It could be that we've gotten LDL down as low as we can.
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?
magic next ought
It's really the next generation. It ought to be a magic bullet.
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.