Steven E. Nissen (born 1948) is an American cardiologist, researcher and patient advocate. He was chairman of cardiovascular medicine at the Cleveland Clinic, in Cleveland, Ohio.[1] (wikipedia)
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?
We've desperately needed this. The entire public confidence in terms of what is safe for pain has been eroded.
It's really the next generation. It ought to be a magic bullet.
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.
I felt that that committee that voted 8-to-1 was simply missing the boat, ... I didn't think they connected the dots.
Getting rid of that plaque is a fundamental step in stopping this disease.
Ten of 1,000 patients would die, have a heart attack or a stroke. Those are serious irrevocable events.
I do not think it's wise to approve the drug or see the drug marketed until there's a dedicated cardiovascular safety trial,
When you have that kind of exposure to drugs that are suspicious, it creates a major public health concern.
It could be that we've gotten LDL down as low as we can.
