Getting rid of that plaque is a fundamental step in stopping this disease. |
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 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. |
I expected the advisory panel to turn the drug down. |
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, |
I felt that that committee that voted 8-to-1 was simply missing the boat, ... I didn't think they connected the dots. |
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. |
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? |
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 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. |
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. |
Physicians ought to take this into account. These drugs are not very forgiving. |
Ten of 1,000 patients would die, have a heart attack or a stroke. Those are serious irrevocable events. |