FDA - READ THIS : QUALITY ISSUES ARE BAD IN NOVARTIS

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Want to know ?

These are the facts:

2 First-Time Clinical Protocols were NOT filed with the FDA as required.
In addition, 5 Clinical Trial Extensions were NOT filed, either.

16% of Protocol Amendments were NOT filed.... that's a whopping 219 Amendments !!!

10% of all Investigators were not checked - that's 1041 investigators....bet some rotten apples were among them.

and 70% of ALL Transfer Obligations were not filed ( or 359 of these !!! )

Were Patients hurt ?

YES.

For example, in one case:
SOPs for Protocol Interactive Voice Response System were not followed.
As a result, during a trial, patients were started at a higher dose, kept at a higher dose, and not titrated downwards.
These group of patients, who trusted Novartis with their lives, experienced Adverse Events which would have been totally avoided if, if, if....someone would have care enough to follow the Standard Operating Procedures.

Why all this happenned ?

Because, all the focus have been in "speed" ,"innovation", "LEAN"....

What are they going to do about it ?

JAJAJA...running like headless rats to "dot the i's and cross the t's"...
and on August 30th, our "fearless" senior managers are meeting with the FDA to BEG FOR MERCY....and show them all the nice things they have done to remedy the situation.

Oh !
Forgot to tell you.....obviously, some heads will roll in the process...
Many heads will roll
Unfortunately, those managers who are truly responsible for the problem are not only staying, but getting promoted.
 






This is too funny !

Sounds like Novartis is back in business again !!!!

I am glad I left that fucked-up company a year ago....feel sorry for my mates that stayed behind and are putting up with all the bull-shit from Basel

Too bad, that the patients were not informed of all these fuck-ups before enrolling in a Novartian clinical trial.....

...oh well....who cares...patients, rats, petri-dishes...all the same crap as far as Basel is concerned !
 






Anonymous said:
Want to know ?

These are the facts:

2 First-Time Clinical Protocols were NOT filed with the FDA as required.
In addition, 5 Clinical Trial Extensions were NOT filed, either.

16% of Protocol Amendments were NOT filed.... that's a whopping 219 Amendments !!!

10% of all Investigators were not checked - that's 1041 investigators....bet some rotten apples were among them.

and 70% of ALL Transfer Obligations were not filed ( or 359 of these !!! )

Were Patients hurt ?

YES.

For example, in one case:
SOPs for Protocol Interactive Voice Response System were not followed.
As a result, during a trial, patients were started at a higher dose, kept at a higher dose, and not titrated downwards.
These group of patients, who trusted Novartis with their lives, experienced Adverse Events which would have been totally avoided if, if, if....someone would have care enough to follow the Standard Operating Procedures.

Why all this happenned ?

Because, all the focus have been in "speed" ,"innovation", "LEAN"....

What are they going to do about it ?

JAJAJA...running like headless rats to "dot the i's and cross the t's"...
and on August 30th, our "fearless" senior managers are meeting with the FDA to BEG FOR MERCY....and show them all the nice things they have done to remedy the situation.

Oh !
Forgot to tell you.....obviously, some heads will roll in the process...
Many heads will roll
Unfortunately, those managers who are truly responsible for the problem are not only staying, but getting promoted.
Click to expand...

Poster #7--if you're legitimate, then you need to forward this. The FDA needs to be made aware of what this company has done, and Novartis needs to pay for it. Reps in the field are out there presenting clinical data to physicians, and heaven only knows what the real truth is. Funny how a company-sponsored trial can make a drug look like it should be added to the water.
 






FDA already know about this.
Obvioulsly not very happy

Dr Constance Cullity - at the Office of Compliance - received a letter dated June 15, 2010 from Novartis, informing the FDA of the violations.

Too bad patients had to suffer and pay a price for a company's poor compliance practices.

Not sure if the FDA will take strong actions against Novartis.
They should.
 






There was a message today from Orloff this morning ------ ALL the countries have major quality issues and have two weeks to fix.

Meantime...an inspection underway from EU Health Authorities
 












comment from the FDA safety reviewer:

"It is unusual that routine testing such as sodium, potassium and bicarbonate
were not analyzed in the phase 2 and 3 studies of a new molecular entity. I find this
troublesome. The fact that data on electrolytes at the time of ECG changes during first
dose monitoring are not available is disturbing."

unbelievable ...
 






Okay folks...do NOT panic. Management is indeed away of the situation and is also aware of other regulatory issues at hand. Some are more urgent than others. It is painfully evident that the people in place right now cannot deliver the demands made by both management AND the FDA. They chose not to bite the hand that feeds them which is understandable. The FDA will no doubt get ugly about the findings.

To address the crisis, we are seeking new talent to take the company through this difficult time. There will be multiple announcements in the next few weeks demonstrating our desire to remedy the situation AND create a culture of compliance.

Your support during this cultural shift is appreciated. Keep telling us what is going wrong so we can work together to fix it FAST.
 






Getting itDone4U said:
Okay folks...do NOT panic. Management is indeed away of the situation and is also aware of other regulatory issues at hand. Some are more urgent than others. It is painfully evident that the people in place right now cannot deliver the demands made by both management AND the FDA. They chose not to bite the hand that feeds them which is understandable. The FDA will no doubt get ugly about the findings.

To address the crisis, we are seeking new talent to take the company through this difficult time. There will be multiple announcements in the next few weeks demonstrating our desire to remedy the situation AND create a culture of compliance.

Your support during this cultural shift is appreciated. Keep telling us what is going wrong so we can work together to fix it FAST.
Click to expand...


Guess what - the FDA is going to get very ugly on this. And they should.

Have you ever thought about the doctors and patients who trusted you? Well, if only money count$, who care$.

Good luck finding new 'talent' - great people won't stay long in this bullying company. Why do you think do people sue you - because you're so nice, respectful, and you do listen?! Enjoy the kool-aid, think again.

Besides, who would want to clean this stinking toilet now? Who would want to be in a company with such a disturbed attitude towards ethics and compliance on its public record? Class action, warning letters, inspections - it all goes back to the very same issue: the problem is YOU, this company is rotten in its core but that is not going to change. All the rest is cosmetics. Pleeeease stop boring us with this 'cultural change - together we can' BS propaganda talking. Trust and credibility is long gone. Right now this is a matter of protecting the public from your sloppy work.
 






You want to know who is responsible ?

The Head of Development and the Head of the Company.

They are both in place....and one, even now got promoted to be the big-Boss and head the whole Novartis Corporation.....

So ...they will blame everyone bellow them....point fingers bellow, claim ignorance...ect...

BUT THE TRUTH : only a few folks should be fired (if not jailed) for their incompetent management skills.....

Instead....they will be there, continue to be there, and get their fat paychecks every month !

Fucked-up Company.
 






I heard that Dr Darlene Jody - who is the Medical VP looking after Neurosciences and FTY / Gilenia....RESIGNED LAST WEEK !

They are begging her to stay on the company for another year.
But she is suing them for discrimination, something about not getting a promotion to a top job in Basel
The talk in EH is that she brought her team of lawyers to a meeting with HR

Anyone knows anything more ?
 






Kool-aid4U said:
Guess what - the FDA is going to get very ugly on this. And they should.

Have you ever thought about the doctors and patients who trusted you? Well, if only money count$, who care$.

Good luck finding new 'talent' - great people won't stay long in this bullying company. Why do you think do people sue you - because you're so nice, respectful, and you do listen?! Enjoy the kool-aid, think again.

Besides, who would want to clean this stinking toilet now? Who would want to be in a company with such a disturbed attitude towards ethics and compliance on its public record? Class action, warning letters, inspections - it all goes back to the very same issue: the problem is YOU, this company is rotten in its core but that is not going to change. All the rest is cosmetics. Pleeeease stop boring us with this 'cultural change - together we can' BS propaganda talking. Trust and credibility is long gone. Right now this is a matter of protecting the public from your sloppy work.
Click to expand...

You speak very well--the sentiments of many in this "bullying" company. The goal of several years ago to become "the most admired pharmaceutical company" in the world is
now simply a Novaris pipe dream. It will never happen.
 






Kool-aid4U said:
Guess what - the FDA is going to get very ugly on this. And they should.

Have you ever thought about the doctors and patients who trusted you? Well, if only money count$, who care$.

Good luck finding new 'talent' - great people won't stay long in this bullying company. Why do you think do people sue you - because you're so nice, respectful, and you do listen?! Enjoy the kool-aid, think again.

Besides, who would want to clean this stinking toilet now? Who would want to be in a company with such a disturbed attitude towards ethics and compliance on its public record? Class action, warning letters, inspections - it all goes back to the very same issue: the problem is YOU, this company is rotten in its core but that is not going to change. All the rest is cosmetics. Pleeeease stop boring us with this 'cultural change - together we can' BS propaganda talking. Trust and credibility is long gone. Right now this is a matter of protecting the public from your sloppy work.
Click to expand...

So when is this stuff going to hit, and what is the real impact? Will it make ripples through the "research world," or will it make the major news programming? As a rep on the front lines, I'd kind of like to know what we're up against. We'll never get the true story from within as it trickles down.
 












..updates....

stay tune.....all of Safety is in Basel this week, we got none of them here in NJ....because there is a major inspection going on by EMEA (or is it FDA ???)
 






This is a fascinating thread to read. Being one from Medical, I've heard of the aforementioned "fat loser". While the description may be harsh, I'm pretty sure I know who this is and I've long heard of her history of bumbling through and turning this "blockbuster" into a huge mess. It may work out in the end, but the pain hasn't even started. We're going to have to do some serious soothsaying with our KOLs in the field on this, to be sure. I wish everyone luck here.
 






If the OIG and FDA are smart - which they are, they will see that this very significant breach of compliance in the way clinical studies were (not) submitted is actually part of the non-compliant culture of Novartis across many different disciplines. The settlement of the sexual discrimination case is another example of this culture.

OIG- look deeper. You shall see. I promise you that. It is not just the clinical trial programs. It is embedded within everything that is done. Senior management is so non-compliant is oozes from their skin. Plaintiff attorneys would have a field day if they ever got a hold of what lurks here.
 






Anonymous said:
If the OIG and FDA are smart - which they are, they will see that this very significant breach of compliance in the way clinical studies were (not) submitted is actually part of the non-compliant culture of Novartis across many different disciplines. The settlement of the sexual discrimination case is another example of this culture.

OIG- look deeper. You shall see. I promise you that. It is not just the clinical trial programs. It is embedded within everything that is done. Senior management is so non-compliant is oozes from their skin. Plaintiff attorneys would have a field day if they ever got a hold of what lurks here.
Click to expand...

From Europe: Look mate your non-compliance is nothing compared to our non-compliance. What goes on over this side of the pond makes you lot look like a right bunch of amateurs - get your act together (or not) - you are a disgrace to the general culture of NVS exploitation, opacity and "lets see what we can get away with". Before you know it, you'll be demanding ethics, fair treatment of associates and a speak up culture - then where will we be?
 






I fell into a burning ring a fire.
I went down, down, down
and the flames lept higher
and it burns, burns, burns
this ring of fire, this ring of fire.

Is it Winter in Basel? Feels like Summer!
 






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