initially discussed and considered for approval, but it is important to make sure we have
in place a follow-up system that if something starts to show up in one of these groups that
has not been adequately studied, we will find the signal early rather than 10 years from
now when someone writes a paper like was written about one of the other drug classes a
few years ago that caused a big furor as to what’s being going on for the last 10 years, the
answer to which we are still are not entirely sure.
disease. The progression of diabetes itself with its complication, say the development of
autonomic neuropathy, probably increases the risk. The use of complex medical
regimens with multiple drugs that have not been fully studied in the circumstances in
which they are used, there may very well be some drug interactions that we don’t
mentioned earlier that if they don’t have already established cardiovascular disease, I am
probably paraphrasing this wrong, their risk of having a coronary event is low. Can you
comment on why then several major scientific organizations actually view diabetes as
already a CHD risk? My memory is failing here, if anybody on the panel remembers the
Statin trial of CARDS, which was in type 2 diabetics, was that a primary prevention
population? I think it was. I could be wrong. If it was a primary prevention population,
that is actually a patient population of diabetes where they don’t already have established
So it isn’t reasonable to try and cover all of these things before a drug gets
Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com
studies in the past year is that cardiovascular complications of diabetes are probably
more complex than we had previously thought.
DR. BURMAN: Yes, Dr. Parks.
DR. PARKS: I actually wanted to ask Dr. Teerlink a question. When you
There are a variety of things that can increase risk at various stages of the