Steven Nissen Quotes (23 Quotes)

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.

We could still be wrong. That's what has to happen for this drug to move forward.

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,

Ten of 1,000 patients would die, have a heart attack or a stroke. Those are serious irrevocable events.

That's always been just a dream -- actually making the disease go away.

We've been misled many times by observational studies like this,

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.

There's only one way -- through good science. We know the burden is upon us to do this right.

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.

We've desperately needed this. The entire public confidence in terms of what is safe for pain has been eroded.

I do not think it's wise to approve the drug or see the drug marketed until there's a dedicated cardiovascular safety trial,

The idea here is if you know what happens in the highest risk individuals, you will know how to use the drugs in people at lower risk. We will have 10 times the statistical power of any study ever done of these drugs.

The idea that you would see such a huge benefit so quickly is hard to accept.

When you have that kind of exposure to drugs that are suspicious, it creates a major public health concern.

The results of this analysis are concerning.

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

It's really the next generation. It ought to be a magic bullet.

The drug's benefits are simply to lower blood sugar, something that is not a morbidity and mortality advantage, so my view is that safety has to be very clear before you're going to approve it, and we have 15 other drugs to lower blood sugar, ... In my view, it didn't make any sense to approve the drug.

I think doctors will look at all the information in various studies and see that lower levels provide some benefit. You will see a drift towards more intensive treatment, and I think that's a good thing.

Getting rid of that plaque is a fundamental step in stopping this disease.

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.

I'm not a crusader, I just want the balance between safety and efficacy to be favorable.

I felt that that committee that voted 8-to-1 was simply missing the boat, ... I didn't think they connected the dots.