Lorcaserin published in NEJM:worlds' most prestigious clinical journal
By far the most prestigious clinical publication in the world is NEJM (impact factor 53.5) vs the distant second Lancet (impact factor 33.6). One has to ask why the authors behind Qnexa would choose Lancet to publish over NEJM as Arena did.
The only logical conclusion is that Qnexa (CONQUER trial) would have been rejected by NEJM. Arena was always confident that lorcaserin was the best, which is why they chose the best journal to publish their landmark study.
The FDA is no fool. They are laughing at Kaul for harping on lorcaserin and blindly trying to pin the valvulopathy tail. Qnexa never conducted any signicant echocardiogram studies to evaluate what happens to their patient's heart valves after taking it for 1 year. Instead Arena has performed 80,000 echos. These echos showed a statistically non significant trend slight increase in valve stress across all 4 valves of the heart (4 chambers remember?) vs placebo. Is is entirely due to the change in body habitus of the patients who lost the most weight. Just ask any cardiologist, are echos clearer in obese or thin patients. Compare a dot matrix printer to a laser jet, or regular to HDTV.
In patients who took fen/phen the valve damage occurred in the aortic valve because this is the valve experiencing the most stress in the heart due to high flow and high pressure dynamics. Physiologically, it does not make sense for all the heart valve to become more stressed or damaged over time. This would occur congenitally before birth during the embryonic stage in utero. Therefore, to postulate that lorcaserin can produce this change after just 1 to 2 years goes against all known mechanisms of embryology, physiology, and pathology.
If ever VVUS is forced to undergo similar echo trials, the same findings will result regarding slight increase in all heart valve stress/valvulopathy. It is even reasonable that more will be found since more weight loss produces a higher definition of the heart valve images on echo.
You see, the FDA already knows which is the safer drug. The valvulopathy was never what held lorcaserin back. It was the tumor issue. Now that it was put to rest via the briefing docs, we can look forward to full early approval without the need for REMS.
The only thing I can see FDA requiring ARNA to do after the approval is to conduct a post Market surveillance which they should do for all drugs anyways. By the way Eisai will pick up 90% of the tab.
Lastly, the ad comm was notable for a couple of clowns. First is Caprisi who came totally unprepared because he was going to vote no anyways. A few panelist didn't know the difference between an echocardiogram vs electrocardiogram. It's like saying you cant tell the difference between an iPad vs a toddlers leapfrog. What a joke! Thankfully there were quite a few intelligent people invited by the FDA (who actually read the BD) and delivered an impartial scientific judgement.
Get ready for lorcaserin. It is coming to a local pharmacy and will not need a triplicate DEA Rx. There is absolutely no addictive properties to this molecule. It can treat addiction. We all need lorcaserin.
--> copied from cardiodr99 yahoo message board
That's why doctors will prescrive Lorcaserin the most and that's why ARNA will be approved by the FDA (June) and later this year in Europe.
You're absolutely right about the importance of the journal where you are allowed to publish. I think this should (and will) be read by institutional investors.
My target for Lorc: at least $20 and after the EMEA has approved it as well: $35
