Brilinta Approval Day

Posted by Jeff Berk; BOLT International


First a piece of serious business.  Well, mostly serious.  Matt Anderson introduced me to David Cook’s book and website, Golf’s Sacred Journey a.k.a. Links of Utopia.  I suck at golf.  I like it.  But this book isn’t really about golf, even though it’s played out through a golfer’s perspective.  It’s a short read – about 160 pages.  Sorry, Obama.  There aren’t any pictures for you to look at.  For some of you, it will remind you of what you already knew.  For others, it will open a completely new horizon.  And for some…  Well, you’ll get there when you get there.  BTW, DON’T go to the link until you’ve first read the book.  This is like when your momma advised you not to stick your tongue on the frozen lamp post.  I’m just sayin’.



Artist’s rendering of Margaret Hamburg.  Note that this whirling dervish was captured using a really, really fast shutter speed. I’m a professional so I can safely record the event.  Don’t try to take this photo at home.  You’re more than likely going to sprain your shutter finger.



Well, hooray for Peggy.  July 20 2011 officially became Brilinta Approval Day, as moving with her typical blazing speed she finally acknowledged what everybody else this side of Mawlawi already knew:  ticagrelor provides a survival  advantage vs clopidogrel in acute coronary syndrome (ACS).  But trying to maintain some semblance of relevance (like her boss???) she did insist on black boxing some arbitrary nonsense limiting aspirin co-administration to 100 mg.  Seriously.  You’ve got to ask yourself, why didn’t EMEA have a problem with the drug last year?  And why did the Canadians set the aspirin range to 75 – 150 mg?   I’ve pondered over this for a good, long while and all that I could come up with is: Peggy, you are dumb woman.  And it’s not just me; here’s what one of BOLT’s Interventional Cardiology Thought Leaders had to say the day before you finally got to “yes”:


“I find the whole thing ridiculous, the whole US, not US aspirin dose thing I just think it is absurd.  If they wanted to talk about dyspnea or things like that, and I don’t like the side effect profile, or I am worried about gout that is fine.  But this is ridiculous, the idea that there is something intrinsically different about Americans.  It is just the vagaries of chance.  And now it has gotten steam and there are smart people who actually think this is important.  But, yes, I think they absolutely should approve it and they will approve it.  It has taken far too long to get on the market for a drug that has a huge impact on mortality.  There have been a lot of individuals that have not benefited from this drug when it should have come out.  I will be shocked if it doesn’t get through”.


Hey Peggy!  How many preventable strokes happened during the extra year that it took you to learn what a P2Y12 antagonist is?  Love on ya, muah, muah.



PS… For the record, I don’t have any financial interest in AstraZeneca.  They’re not even close to my favorite pharmaceutical companies.  And while I’m thrilled that Chipoltle now offers omeprazole as an additive to their burritos, it’s generic, and so I barely give AZ credit for that magic pill anymore.  Frankly, they’ve done nothing for me lately.  I can’t even remember if they’re a client of mine.  Net, today’s diatribe is completely unbiased.  And oh, by the way, ticagrelor’s offset time is nowhere near as impressive as AZ makes it out to be.  But that’s going to be a topic that I’ll expound on in the antithrombotics / antiplatelets report that BOLT will publish next week.  So if you want a little more juice, and a little less sarcasm, whip out your credit card circa August 5th.



Categories: acute coronary syndrome, antiplatelets, Cardiovascular
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