30 ordspråk av Steven Nissen

Steven Nissen

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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?

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

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.

I do not think it's wise to approve the drug or see the drug marketed until there's a dedicated cardiovascular safety trial. We have to put safety first.

It could be that we've gotten LDL down as low as we can.

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.

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

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

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.

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

We wanted to push the paradigm as far as you can go.

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.

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