HCV division and the FDA

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anonymous

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Surprised there are no people posting. What is going on with the HCV division with the FDA warning of liver failure and death on the "newish" HCV products? pushing forward for the new products to come soon or downsizing or both?
 




We received a warning letter. 26 patients 7 deaths others needed transplant. Did not help the cause. We have meeting this week. Curious to see how we are going to spin this. Poor HIV reps getting laid off asked to go meeting come home defend VPak and then go pins salt in January. Nice job HQ. the rest of us I HCV will then witness the downward spiral of VPak when ESI tells us they added Harvoni. Exclusive will go out the window based on this warning letter. What a mess. I plan to enjoy my friends at the meeting and will return to interviewing when I get home. Been with Abbott and Abbvie my how things have changed.
 




















anonymous said:
We received a warning letter. 26 patients 7 deaths others needed transplant. Did not help the cause. We have meeting this week. Curious to see how we are going to spin this. Poor HIV reps getting laid off asked to go meeting come home defend VPak and then go pins salt in January. Nice job HQ. the rest of us I HCV will then witness the downward spiral of VPak when ESI tells us they added Harvoni. Exclusive will go out the window based on this warning letter. What a mess. I plan to enjoy my friends at the meeting and will return to interviewing when I get home. Been with Abbott and Abbvie my how things have changed.
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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?
 




Abbvie, great job destroying an entire market with race to the bottom strategy. Glad you all have Butkus jerseys. Now please exit to the right and let real companies play.
 




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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Bloomberg Business October 22 article titled
AbbVie's Hepatitis C Drugs Label Changed After Patient Deaths
 




The Sharks have sniffed blood. Lawyers are on this already. Lawsuits forthcoming ABBV, Insurance Companies, Specialty Pharmacies and Physicians. id your the rep here you may also have some liability. If you deviated from they label or worked with a SP to get things filled good luck. Of your boss gave you instruction to deviate from the marketing plan. You may want to consult an attorney and file suit. What a mess
 




anonymous said:
The Sharks have sniffed blood. Lawyers are on this already. Lawsuits forthcoming ABBV, Insurance Companies, Specialty Pharmacies and Physicians. id your the rep here you may also have some liability. If you deviated from they label or worked with a SP to get things filled good luck. Of your boss gave you instruction to deviate from the marketing plan. You may want to consult an attorney and file suit. What a mess
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Even if our RM and DM told us to do it?
 












this is the issue with most companies. It's all about the profit and not the patient or the truth. You have the data, you know what stage these patients had, they are going to be F3/F4 patients in there that Express Scripts required "preferred" Abbvie product over the gold standard Harvoni and Sovaldi. The shoe has dropped and the more you attemp to minimize this, the bigger and more inclusive the lawsuit will be. ESI is trying to get their skin out of this game but you "medical director" have you name all over this exclusive agreement to save money at the expense of patients lives. Hope you all get Prison Justice.
 




anonymous said:
this is the issue with most companies. It's all about the profit and not the patient or the truth. You have the data, you know what stage these patients had, they are going to be F3/F4 patients in there that Express Scripts required "preferred" Abbvie product over the gold standard Harvoni and Sovaldi. The shoe has dropped and the more you attemp to minimize this, the bigger and more inclusive the lawsuit will be. ESI is trying to get their skin out of this game but you "medical director" have you name all over this exclusive agreement to save money at the expense of patients lives. Hope you all get Prison Justice.
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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?
 




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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We were asked to push the envelope. Also none of deaths in the early Harvoni trials were actually attributed to Harvoni. His deaths were from other reasons. I believe one was a OD. Other may have been an accident. Those don't count. We will be sued.
 








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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It's all about the ritonavir - - - look at the package insert regarding liver toxicity!! I heard from a pharma colleague that V Pak may be dropped by ESI! Then there will be no Rxs!!
 












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