Did we read this correctly, Dr. Nissen?

 

Dr. Steve Nissen and the Cleveland Clinic may be as close to household names as we have in this business.  In what I find peculiar and incongruous statement, Dr. Nissen was quite vocal yesterday in expressing the Cleveland Clinic’s support for the new SGLT2 class, listing the class on their list of top medical innovations for 2012. Read about it HERE and HERE.

What is absolutely fascinating to me and I’m sure many others reading the links or seeing the story, is his essential dismissal of what an the FDA endocrinology & metabolism panel found were enough concerns to vote 9-6 against Dapagliflozin due to the cancer signals.  Cancer signals.  think about that one, cancer signals, in a relatively small sample size for cancer to show (2 cases in placebo vs. 18 in active arm (9 breast, 9 bladder)).  This is my favorite quote ““Nobody thinks this signal seen on breast cancer is real,” Nissen said. “The bladder cancer signal may simply represent ascertainment bias. Obviously, the issue will need ongoing surveillance, but it may turn out to be a false signal.”  Nobody thinks it is real, Dr. Nissen?

Steve Nissen has singlehandedly killed Avandia which had years of market experience, through his meta-analysis, in which his methods have been called into some question.  This needs to be a subject of an entire discussion in itself. Dr. Nissen, long an advocate for drug safety, seems to be out a limb with this one.

For him to be so bullish about a brand new drug class that is already showing some safety concerns is either incredibly confident/privy to additional data that isn’t available for consumption, or incredibly arrogant.  It almost feels like Cleveland Clinic developed their Innovation list and released it without fully vetting/double checking it, and then had to parade out someone that people knew to defend it. But these are the best and the brightest and Cleveland, correct?  They would never make a mistake, would they?

And not that I am a conspiracy theorist, but I am a cynic, there is a fine line, mind you.   Is it interesting that someone so prominent comes out in support of the SGLT2 class just a week after it was announced the FDA has delayed their decision on Dapa to review more data?  Coincidence?  I’m just saying…

Drop me a line anytime to discuss, aaron@metabolicmarkets.com

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