sorts of stuff, which might not happen to someone else out there in the community, so
they are already a special set. From the pediatric point of view, I understand it’s hard to
find anybody over the age of 17 who dies in an auto accident in this county, who doesn’t
have large vessel beginning disease. So what is coronary artery disease? Is it when you
come in complaining that you are out of breath and your chest hurts? Or is it, I mean,
how are you going to define this? Are you going to cath everybody before you are
allowed in the study? I don’t understand how you would define that. So my attitude
toward this is similar to yours, which is that the biology suggests that there are not going
to be adverse outcomes of this drug but I don’t think we have the data right now to say
things, I am hearing several things here. I am hearing an attempt to create stratification
of who could use this medication. Yet we are dealing with the standard problem that you
have in any trial, which is that these people because of the study but because of also the
doctors who were working in this study were very well cared for.
so far, to say that this drug needs a 20-year study before it can be released out on the
market. I think it’s just, it’s a complicated decision governed by the meeting which
discussed cardiovascular risks. I think that it also is a model for other drugs to follow, so
we have to be very careful of what we do is fair to other drugs where the biology might
be somewhat different.
They were on ACE inhibitors, they were on beta-blockers, they are on all
On the other hand, I don’t think that it’s reasonable, given what we know
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DR. BURMAN: Thank you, let’s see Mike you had a, oh I am sorry;
you were indeed, thank you very much. Dr. Levitsky.
DR. LEVITSKY: So once again, coming at it from the youth end of