Welcome to Medications.com

I noticed that the FDA turned down approval for Merck's Cordaptiv...

Posted at 1:17 PM on May 01, 2008 by concernedcitizen, #30092
I noticed that the FDA turned down approval for Merck's Cordaptive. That was the niacin cholesterol drug that came with it's own chemical to control the side effect of facial flushing. I noticed that they were in clinical trials for montelukast's effect on preventing heart disease. So I guess that Merck is trying to capitalize on the "inflammation" angle that is mentioned below. Who shows up for these clinical trials? http://clinicaltrials.gov/ct2/show/NCT00379808?term=%22montelukast%22+and+%22heart%22&rank=1 The surgeons can do liver and kidney transplants but there won't be enough organs to go around for all of us who get sold all of these drugs. But nobody does brain transplants. What are the people on montelukast long term going to do? And there will be many, many more of them if Merck gets approval for preventing heart disease. ----------------------------------- http://blog.pharmexec.com/2008/05/01/mercks-cordaptive-a-nasty-surprise/ "The Merck drug was a nice piece of innovation: Kim’s elves figured out what causes niacin’s worst side effect, facial flushing, and developed a spanking new chemical, laropiprant, to control it. But since the cholesterol market is not exactly under served by pharma, you could also surmise that FDA is getting bearish on innovation there (more about that later).’s John Carey, apparently the only reporter not to be surprised, offers a must-read analysis of the situation. http://www.businessweek.com/bwdaily/dnflash/content/apr2008/db20080429_182260.htm “Add it all up and the FDA’s decision shouldn’t be seen as coming out of the blue. Cordaptive offers no big improvement over niacin alone—while introducing a new, unknown risk. And even the benefits of niacin’s effect on cholesterol may not be that big.” “The decision also comes at a time when the very idea of cholesterol-lowering is under increasing scientific attack. Yes, doctors know that the statin class of cholesterol-lowering drugs, like Lipitor, do prevent heart disease and heart attacks. But there’s growing evidence that a big chunk of the benefits of statins comes from reducing inflammation,” writes John Carey.
REPLY TO THIS POSTING | Private Message me | Add as friend | Flag as inappropriate

Make a reply to this posting:

Type your reply to this side effect post:


Medical advice disclaimer
© 2002-2007, Skylabs Inc.  |  About Us  |  Disclaimer/Terms of Use  |  Advertise  |  Contact Us  |  Site Map  |  Developed by: W3matter.com | Sleep Apnea