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Yehuda Handelsman Part 6, FDA Approving New Drugs




In part 6, the conclusion of this Exclusive Interview, Dr. Yehuda Handelsman talks with Diabetes in Control Publisher Steve Freed during the AACE 2017 convention in Austin, Texas about the ultimate good that came from the failure of Avandia.

Yehuda Handelsman, MD, FACP, FACE is a past president of the American College of Endocrinology and Medical Director of the Metabolic Institute of America in Tarzana, CA.

 

Transcript of this video segment:

Steve: So, I don’t want to keep you to keep you too much longer, but I love sitting here talking to you. I don’t get opportunity to talk to someone as infamous as you are. (laughter) you know so. Couple of years ago, Dr. Nisan started this thing with avandia and it caused heart attacks.

Yehuda:  Yeah, I told you avandia killed people for few years. It stopped, FDA said it doesn’t kill anymore. You cannot even buy it anymore, but it doesn’t kill anymore.              

Steve: Yeah, but because of that though, the FDA requires all new diabetes drugs to go through cardiovascular trials. And that’s the reason why we found that SGLT2. If it wasn’t for Dr. Nisan, we would have never done that.

Yehuda: Yes, so Steve, for wrong reasons we have got the best credit. We all love those trials. I will tell you, even the companies that were faced with this huge investment, and those trials were very expensive, even those companies are now really appreciative of a lot of data. Seeing the effect on kidney, seeing true side effect profile, there are lot of things that are going on. FDA get some report and they slapped them with one warning after another warning. There are some long-term trials. CANVAS has up to 7 years of data, that’s great. GLP1 coming out end of this year or beginning next year. We will see lots of data so the data we will see it’s not only on the mortality, not only on cardiac event but you’re looking at the looking at kidneys. We need to see what happened with eyes, we need to understand neuropathy, we need to understand the bones, liver. So many stuff that we want to understand.

Steve: One quick last question, are you looking forward to any news coming out of ADA next month?

Yehuda: Well, CANVAS. I think CANVAS is a big thing. There was some other interesting stuff but CANVAS is probably biggest thing. We are all waiting to see what’s going to happen.

Steve: I want to thank you for your time. Very interesting and I am sure we have all learned something new today. Thank you

Yehuda:  Thank you, Steve.

Steve: Enjoy the rest of your stay here.

Yehuda: Thanks.

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