HCV division and the FDA

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anonymous said:
Where did you get 7 deaths information? Cite your source? There are no 7 deaths published ANYWHERE. 10 of the 26 were serious requiring liver transplant or death, but not specific on mentioning how many died. So where can I look at your source for that info?
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All 26 were serious AEs. A serious AE is any AE leading to death or hospitalization (any patient that decompensates will be admitted to the hospital). Of the 10 patient number quoted to Sales by Lootsie, 7 were deaths and 3 were liver transplants.
 








anonymous said:
Wow. You're flinging some serious accusations here bucko! The MAJORITY of the cases reported to the FDA that were serious (10) 8 were from outside the U.S. In areas where there were programs that allowed providers to have patients on both medicines BEFORE they were FDA approved. The other cases were A mix of both US and outside U.S. But did not result in liver transplant or death just various degrees of liver injury. There was an article published recently that said Harvoni has had deaths too - so be careful what you say ... Bucko...and Bloomberg said 7 deaths occurred out of the 10, but the FDA did not say that in their letter so not sure where that specific info came from. No one is minimizing this FDA warning letter - it's pretty self explanatory for providers and their staff to understand. So please STOP yelling at everyone saying were are screwed - we are minimizing this issue - we are going to have multiple lawsuits filed and express scripts is going to get rid of us. AASLD is coming up soon - interesting to see what the national liver thought leaders have to say about this issue. Whatever comes from that meeting will have a positive or negative impact on the medicines in question. Let's just see what happens instead of speculating shall we?
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What you are saying here is not quite accurate. ALL of the 26 patients were a "serious AE." When you decompensate you end up in the hospital. A serious AE is one that leads to either death or hospitalization.

Of the 10 patient number you were initially told about by Lootsie, 7 died and 3 had a liver transplant.

Even though there was a difference in the language related to Moderate liver disease (CPB) between the US and EU labels (not recommended vs not studied), it doesn't really matter where the patients came from. They were still on the drug. Because some were from the EU does not diminish the issue. What is more impactful is looking at these 26 cases vs the total number of Patients Rx'd Viekira (something around 18,000, well over half of those are cirrhotics I would say). 26/18,000 x 100 = 0.14% overall incidence. Quite low in my opinion and will get lower now that providers will now use the drug where indicated and followed appropriately during therapy.
 








guess what?? Just got home from a long days work of call after call of damage control to find a stupid trick or treat canister with candy and shit I don't need.... What I need is a BIG bottle of Vodka!! Now that would've been helpful - NOT that stupid waste of money gesture. Another bad move upper management!! Really??
Like that's going to make me say ohhhh it's ok ...thanks for fucking up my livelihood!
 




anonymous said:
guess what?? Just got home from a long days work of call after call of damage control to find a stupid trick or treat canister with candy and shit I don't need.... What I need is a BIG bottle of Vodka!! Now that would've been helpful - NOT that stupid waste of money gesture. Another bad move upper management!! Really??
Like that's going to make me say ohhhh it's ok ...thanks for fucking up my livelihood!
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Almost feels like adding insult to injury.
 




anonymous said:
guess what?? Just got home from a long days work of call after call of damage control to find a stupid trick or treat canister with candy and shit I don't need.... What I need is a BIG bottle of Vodka!! Now that would've been helpful - NOT that stupid waste of money gesture. Another bad move upper management!! Really??
Like that's going to make me say ohhhh it's ok ...thanks for fucking up my livelihood!
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What do you bet that Mike small delivered it in person?!
 




anonymous said:
guess what?? Just got home from a long days work of call after call of damage control to find a stupid trick or treat canister with candy and shit I don't need.... What I need is a BIG bottle of Vodka!! Now that would've been helpful - NOT that stupid waste of money gesture. Another bad move upper management!! Really??
Like that's going to make me say ohhhh it's ok ...thanks for fucking up my livelihood!
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Agree! I want to put that candy up Lootsie where the sun don't shine!! F'ing joke! HCV is run like a kindergarten!!! SOS!
 




anonymous said:
Agree! I want to put that candy up Lootsie where the sun don't shine!! F'ing joke! HCV is run like a kindergarten!!! SOS!
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Shipping all of us that canister was like a slap in the face. I have a spouse and grown children that were like "you're kidding ... Right". The money that was wasted on those blows my mind and yes, very juvenile too! Thought about it for a second and realized I shouldn't expect this leadership to understand what's appropriate - I wish they would have given those canisters to a homeless shelter or women/children shelter for pete's sake.
 








anonymous said:
guess what?? Just got home from a long days work of call after call of damage control to find a stupid trick or treat canister with candy and shit I don't need.... What I need is a BIG bottle of Vodka!! Now that would've been helpful - NOT that stupid waste of money gesture. Another bad move upper management!! Really??
Like that's going to make me say ohhhh it's ok ...thanks for fucking up my livelihood!
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Ha! Maybe that's how Haas got his promotion...did Chantel deliver it?
 












anonymous said:
What's the death toll at? Abbvie and Express Scripts should be ashamed of themselves.
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- what's the death toll with Harvoni (there have been deaths)? Sim-Sof? Don't throw stones in glass houses! Express scripts is standing behind Viekira because the national thought leaders have put the record straight about the FACTS regarding the drug. Also, express scripts has filled over 10,000 scripts so far and has not had the reported AE's that the FDA had (majority of AE's were from OUTSIDE the U.S.). The key take away from this whole announcement the FDA provided - VP and Technivie DO NOT have a black box warning. Don't wrote the medicines for patients it's not indicated for or contraindicated in. It's a good drug and Abbvie Patient Assistance is helping many out that couldn't get drug through Gilead. Where it appropriate it works very well with great SVR results.
 




anonymous said:
- what's the death toll with Harvoni (there have been deaths)? Sim-Sof? Don't throw stones in glass houses! Express scripts is standing behind Viekira because the national thought leaders have put the record straight about the FACTS regarding the drug. Also, express scripts has filled over 10,000 scripts so far and has not had the reported AE's that the FDA had (majority of AE's were from OUTSIDE the U.S.). The key take away from this whole announcement the FDA provided - VP and Technivie DO NOT have a black box warning. Don't wrote the medicines for patients it's not indicated for or contraindicated in. It's a good drug and Abbvie Patient Assistance is helping many out that couldn't get drug through Gilead. Where it appropriate it works very well with great SVR results.
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Yeah, the TLs have set the record straight... Unless ABBV is paying them a shit ton in fees for P2P talks, nobody prescribes VPak. Hell, even on restricted formulary through ESI Harvoni/Sovaldi still beats the shit out of VPak. Face it, it's a piece of shit like management at ABBV. And now, back to rep la-la-land.
 








anonymous said:
- what's the death toll with Harvoni (there have been deaths)? Sim-Sof? Don't throw stones in glass houses! Express scripts is standing behind Viekira because it's ridiculously cheap and they don't care what doctors and patients want. Also, express scripts has filled over 10,000 scripts so far and has not had the reported AE's that the FDA had (majority of AE's were from OUTSIDE the U.S.). The key take away from this whole announcement the FDA provided - VP and Technivie DO NOT have a black box warning. Don't wrote the medicines for patients it's not indicated for or contraindicated in. It's a good drug and Abbvie Patient Assistance is helping many out that couldn't get drug through Gilead. Where it appropriate it works very well with great SVR results.
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Fixed it for ya.
 




anonymous said:
- what's the death toll with Harvoni (there have been deaths)? Sim-Sof? Don't throw stones in glass houses! Express scripts is standing behind Viekira because the national thought leaders have put the record straight about the FACTS regarding the drug. Also, express scripts has filled over 10,000 scripts so far and has not had the reported AE's that the FDA had (majority of AE's were from OUTSIDE the U.S.). The key take away from this whole announcement the FDA provided - VP and Technivie DO NOT have a black box warning. Don't wrote the medicines for patients it's not indicated for or contraindicated in. It's a good drug and Abbvie Patient Assistance is helping many out that couldn't get drug through Gilead. Where it appropriate it works very well with great SVR results.
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VPak is done. Merck is knocking at your door. Gilead's Pan GT 1,2,3,4,5,6 out next summer. 1 pill 98% SVR. Merck will have renal patient and Gilead the lions share. ESI will contract with both. Your contract will expire or be canceled. The VPak experience has been a shit show. You can't succeed with a 1 rx a week. Some weeks in some territories 0!
 




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