PROMOTING BRILINTA IN PRIMARY CARE OFFICES! HUGE COMPLIANCE VIOLATION!

Anonymous

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Tell me, how can a company that has been under a Corporate Integrity Agreement for years,
justify promoting Brilinta to Primary Care physicians, WHEN IT HAS NO INDICATION FOR USE IN PRIMARY CARE??
 

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Because all doctors treat patients that have had a heart attack. Usually, patients are DC and told to follow-up with both cardiology and their primary care.

The "follow up" with PC is just to let them know the situation. Brilinta has NO indication that a PC could use to initiate therapy in that setting, at least according to a hospital rep that I've known for years told me. This rep also told me that the PC reps will have to do Brilinta programs. Just another example of AZ trying to revitalize a another failed drug.

I smell another DOJ investigation. Get into ONC, it's much safer.
 




The "follow up" with PC is just to let them know the situation. Brilinta has NO indication that a PC could use to initiate therapy in that setting, at least according to a hospital rep that I've known for years told me. This rep also told me that the PC reps will have to do Brilinta programs. Just another example of AZ trying to revitalize a another failed drug.

I smell another DOJ investigation. Get into ONC, it's much safer.

Its called awareness. PCP is a physician. Also circulates in local community, plays golf, socializes, etc. If/when a conversation arises about a disease state or patient type, or even in normal consultation with a specialist, here is a simple example: "what is this brilanta, what does it do..?" That gets the specialists to speak about B, which also has effect of reinforcing to himself/herself why they are using it.

It seems they want everyone in that orbit, even secondary and tertiary non-prescribing contacts to be potential influencers. Seems they want everyone in the cycle of care to be aware and have knowledge of B, even if they are not a prescriber.
 




Its called awareness. PCP is a physician. Also circulates in local community, plays golf, socializes, etc. If/when a conversation arises about a disease state or patient type, or even in normal consultation with a specialist, here is a simple example: "what is this brilanta, what does it do..?" That gets the specialists to speak about B, which also has effect of reinforcing to himself/herself why they are using it.

It seems they want everyone in that orbit, even secondary and tertiary non-prescribing contacts to be potential influencers. Seems they want everyone in the cycle of care to be aware and have knowledge of B, even if they are not a prescriber.
it SEEMS they are clueless bordering on dangerously out of touch.
 




it SEEMS they are clueless bordering on dangerously out of touch.

I totally agree. Then again, of all the millions of sperm cells vying for a target, eventually, it only takes 1 to get through. All the others are expendable, but until one gets through, they all be swimming as hard and as fast as they can to get to the intended target. For a sperm cell whose ONLY purpose is to do that, well, that's great for the 1 that gets there, and the others die without a thought of "mm didn't get through..so what else can I do?". Nope, game over.

for a rep, a human, with a brain, and ambition and a need for satisfaction and purpose not just once, but on a regular basis, this all becomes so much timelessness. That's why you really do have to shut off your brain when you start the day. Just do the robotic checkboxes, smile, go home. Lather rinse repeat tomorrow.
 




Remember Jupiter? Direction from brand team was hand out the closed envelopes to targeted customers, yet when the defecation hit the circulating oscillator, the PSS's were the ones that bore the brunt.

The genius in charge of Crestor at that time......LN. Still w/ AZ as part of global diabetes franchise. I think a global VP. scary stuff.
 




Remember Jupiter? Direction from brand team was hand out the closed envelopes to targeted customers, yet when the defecation hit the circulating oscillator, the PSS's were the ones that bore the brunt.

The genius in charge of Crestor at that time......LN. Still w/ AZ as part of global diabetes franchise. I think a global VP. scary stuff.

Great point! AZ will suspend it's own compliance rules when it benefits AZ. Now the PC reps will be doing Brilinta programs targeting primary care. The Jupiter comparison is a good one. back then the reps did what they were told, and some were fired for just that. Now, PC reps are once again sticking their necks in the noose. Better think twice AZ about pushing Brilinta to PC physicians!
 




Great point! AZ will suspend it's own compliance rules when it benefits AZ. Now the PC reps will be doing Brilinta programs targeting primary care. The Jupiter comparison is a good one. back then the reps did what they were told, and some were fired for just that. Now, PC reps are once again sticking their necks in the noose. Better think twice AZ about pushing Brilinta to PC physicians!

When the Jupiter studies were handed out in the "sealed envelopes" Touchstone allowed for written comments. Those that make comments about the paper were ID'ed and many fired. Those of us that stopped making customer comments passed through the system. If you were not around in those days talk to someone who was. People got fired for doing their jobs as they were told. This is a really sad part of the history of this troubled company.
 




Great point! AZ will suspend it's own compliance rules when it benefits AZ. Now the PC reps will be doing Brilinta programs targeting primary care. The Jupiter comparison is a good one. back then the reps did what they were told, and some were fired for just that. Now, PC reps are once again sticking their necks in the noose. Better think twice AZ about pushing Brilinta to PC physicians!

AZ could give a shit about compliance when it comes to money. With AZ, "the end justifies the means".
 




When the Jupiter studies were handed out in the "sealed envelopes" Touchstone allowed for written comments. Those that make comments about the paper were ID'ed and many fired. Those of us that stopped making customer comments passed through the system. If you were not around in those days talk to someone who was. People got fired for doing their jobs as they were told. This is a really sad part of the history of this troubled company.
The Jupiter fiasco and the strategy behind the sealed envelopes was the work of the macho duo of MT and J.C. and LN jumped in to show that she could be as aggressive and macho as they were. They fed off of each other and then pushed the blame onto PSSs and a few DSMS and RSDs who thought they were simply following orders. It was Watergate but it stopped short of reaching the people responsible for creating the environment and the tools that let to the FDA reprimands. I know because I was there when all of this played out.
 




The Jupiter fiasco and the strategy behind the sealed envelopes was the work of the macho duo of MT and J.C. and LN jumped in to show that she could be as aggressive and macho as they were. They fed off of each other and then pushed the blame onto PSSs and a few DSMS and RSDs who thought they were simply following orders. It was Watergate but it stopped short of reaching the people responsible for creating the environment and the tools that let to the FDA reprimands. I know because I was there when all of this played out.

I was around at this time too. We had teleconferences and meetings about this. Management "winked" at us about not talking about it. Yeah right. It was a real shame that the people that came up with this strategy were not held accountable. Some poor schmuck of a rep doing their job like they were told to do gets fired. It was a terrible time for the sales force.
 




Am I missing something here?

The FDA indications are in ACS. There is no such thing as a "primary care" indication for any product. What the hell are you thinking?

Will the money spent on an awareness campaign make a difference? That is what should be debated here, not some STUPID statement about primary care indications. jeeez people use your brain.

Our job is to talk about the "on label" indications and nothing more.

I can explain it TO you, but I can't understand it FOR you.
 




Am I missing something here?

The FDA indications are in ACS. There is no such thing as a "primary care" indication for any product. What the hell are you thinking?

Will the money spent on an awareness campaign make a difference? That is what should be debated here, not some STUPID statement about primary care indications. jeeez people use your brain.

Our job is to talk about the "on label" indications and nothing more.

I can explain it TO you, but I can't understand it FOR you.

Not exactly. With Vimovo, a simple combination, it was a compliance violation to call on certain physicians. Some MD's were blocked for no real reason. Both components of Nexium had pediatric indications, but Vimovo did not. How many PC docs initiate ACS therapy? Their speciality will likely never to do it. Your specific point about a specific PC indication is correct., but AZ has placed restrictions on certain specialties in the past.

Brilinta should not be promoted in the PC area. Period.
 




Prediction: second quarter Brilinta SG&A expenses will be greater than sales revenues! Nothing like a loss-leader that doesn't lead anything! Execs should all be stripped of their vaunted MBAs!
 








I was around at this time too. We had teleconferences and meetings about this. Management "winked" at us about not talking about it. Yeah right. It was a real shame that the people that came up with this strategy were not held accountable. Some poor schmuck of a rep doing their job like they were told to do gets fired. It was a terrible time for the sales force.
Of course they expected people to talk about it. You hand a Physician something in a sealed envelope and they will ask "what is this?" Oh Doctor I can't tell you what is in it you will just have to read it for yourself." Sure thing. And AZ prides itself on being compliant with regulations and policies except for certain people, RIGHT??
 




The instructions were to only hand the physician the envelopes (2) if they asked a question. Clearly the hope was that a question would be asked, and even if not, there was potentially some perceived clinical benefit to providing the "sealed" information.

I recall reps opening the envelops and discussing what was inside, yet if nothing was documented, nothing happened.

As others have noted, if a rep made mention in comments (as per management instruction) they were often the ones in trouble and in some cases terminated. There were instances where reps and even managers requested more envelopes!

Standard procedure would have been to provide a medical technical inquiry as per SOP. No envelopes. End of story.

The shame is that reps became scapegoats for an issue that was generated further up the chain. This insulated those responsible by letting subordinates take the fall to provide evidence that corrective action had indeed been administered.
 




I was with the company during this time and this post is exactly what happened.



The instructions were to only hand the physician the envelopes (2) if they asked a question. Clearly the hope was that a question would be asked, and even if not, there was potentially some perceived clinical benefit to providing the "sealed" information.

I recall reps opening the envelops and discussing what was inside, yet if nothing was documented, nothing happened.

As others have noted, if a rep made mention in comments (as per management instruction) they were often the ones in trouble and in some cases terminated. There were instances where reps and even managers requested more envelopes!

Standard procedure would have been to provide a medical technical inquiry as per SOP. No envelopes. End of story.

The shame is that reps became scapegoats for an issue that was generated further up the chain. This insulated those responsible by letting subordinates take the fall to provide evidence that corrective action had indeed been administered.
 




The instructions were to only hand the physician the envelopes (2) if they asked a question. Clearly the hope was that a question would be asked, and even if not, there was potentially some perceived clinical benefit to providing the "sealed" information.

I recall reps opening the envelops and discussing what was inside, yet if nothing was documented, nothing happened.

As others have noted, if a rep made mention in comments (as per management instruction) they were often the ones in trouble and in some cases terminated. There were instances where reps and even managers requested more envelopes!

Standard procedure would have been to provide a medical technical inquiry as per SOP. No envelopes. End of story.

The shame is that reps became scapegoats for an issue that was generated further up the chain. This insulated those responsible by letting subordinates take the fall to provide evidence that corrective action had indeed been administered.

1000% correct! I pray that the DOJ will come after AZ for promoting Brilinta in primary care offices!