Judge says Novartis execs covered up Zometa risks

[Anonymous]

the cover up was known and approved by high ranking officials!!

http://www.pharmalot.com/2011/11/novartis-execs-cover-ups-and-jawbone-damage/

 

[Anonymous]

Wow big surprise , why do you think novartis executives STEAL all those
bonus & award themselves golden parachutes

They will run this company into the ground & they don't care how many employees they fuck over & patients they kill along the way

By the time novartis goes the way of enron you'll have to hire forensic accountants
to unravel the money trail ala madoff

 

[Anonymous]

Zometa is not the only case, just a matter of time until FDA starts digging.

 

[Anonymous]

Just the tip of the iceberg......more to come in 2012 and beyond! Not just the drug aspect; there are other areas of deceit and greed.

 

[Anonymous]

Wow big surprise , why do you think novartis executives STEAL all those
bonus & award themselves golden parachutes

They will run this company into the ground & they don't care how many employees they fuck over & patients they kill along the way

By the time novartis goes the way of enron you'll have to hire forensic accountants
to unravel the money trail ala madoff

Wow!!! Novartis sounds like Merck...

I guess all of big pharma is Evil now....

 

[Anonymous]

Wow big surprise , why do you think novartis executives STEAL all those
bonus & award themselves golden parachutes

They will run this company into the ground & they don't care how many employees they fuck over & patients they kill along the way

By the time novartis goes the way of enron you'll have to hire forensic accountants
to unravel the money trail ala madoff

http://www.bobbarr.org/default.asp?pt=newsdescr&RI=1292

Shaking down drug companies
by Bob Barr
as published in The Atlanta Journal Constitution
Monday, March 14, 2011 at 9:00 AM

A common synonym for the crime of extortion is “shakedown,” and it is a crime under both state and federal law. It is a crime, that is, unless it is the government doing the shaking down. There is perhaps no more graphic illustration of the manner in which the government employs the awesome and far-reaching power of federal law to force corporations into massive monetary settlements, than the explosion in the number of cases brought against pharmaceutical companies in recent years.

Fines paid by pharmaceutical companies to the federal government to settle charges brought against them, has skyrocketed to $4.41 billion (from just $10 million in 1991). Even more revealing is the fact that of the 165 pharmaceutical settlements with the federal government in the past two decades, nearly three-fourths occurred in the past five years. A settlement that might have resulted from an investigation in the 1990s would have averaged $37 million; today the average settlement is $130 million. This is a cash cow that Uncle Sam knows how to milk.

This astronomical – and accelerating — increase in fines has taken place even though there has been no real change in the nature of the alleged infractions committed by the drug companies. Moreover, the basis for securing such huge fines rarely reflect violations of serious federal criminal laws; but rather regulatory discrepancies or failure to meet the intricate and complex “off-label” edicts which the companies are forced to follow. In just the past five years as well, so-called “unlawful promotion” of rules so complex even industry lawyers have a difficult time figuring them out, accounted for more than half of all violations charged to pharmaceutical companies.

The financial risk to the companies is huge, as is the corresponding windfall to the government. Moreover, company “whistleblowers” can become multi-millionaires overnight if their snitching results in a financial payout by the company to the government. And, holding off “blowing the whistle” until substantial sales of a drug has occurred, so as to increase penalties and “rewards,” has the perverse effect of prolonging the alleged “bad” behavior. Unfortunately, last year’s new omnibus health care law only increases the opportunities and incentives for anti-pharmaceutical whistleblowers.

A primary stick employed by the feds to pressure pharmaceutical companies to settle such cases, is the threat of “debarment.” And it is a Big Stick indeed. Placing a pharmaceutical company on the federal “debarment list” amounts to a corporate death sentence, because the company is then ineligible to participate in government medical programs, including Medicare and Medicaid. Without access to such programs, many drug companies would be unable to stay afloat; and the government knows this.

Whether one likes it or not, with the growth of federal health programs in recent decades, state and federal governments represent the largest customers for the majority of pharmaceutical manufacturers. According to the Kaiser Family Foundation, in 2008 nearly 40% of all spending by Americans on prescription drugs came from public payers, including the big boys on the block – Medicare and Medicaid.

Put another way, and looking at just a single major pharmaceutical company – in 2008, Pfizer brought in $19 billion in revenue from gross U.S. sales, and using Kaiser’s 37% figure, the company would be dependent on government contracts for approximately $7 billion. No company, no matter how large or in what industry, could afford to lose $7 billion in sales. The threat of being blacklisted by the government for failure to cave in to settlement pressure is obviously intense.

No one would dispute that pharmaceutical manufacturers must be held to high standards, or that true fraud should be ferreted out and prosecuted aggressively. However, the manner in which the government has chosen to target drug companies and pressure them to cough up huge sums of money in a constant game of regulatory “gotcha,” serves neither the companies nor those who rely on their products well.

 

[Anonymous]

http://www.bobbarr.org/default.asp?pt=newsdescr&RI=1292

Shaking down drug companies
by Bob Barr
as published in The Atlanta Journal Constitution
Monday, March 14, 2011 at 9:00 AM

A common synonym for the crime of extortion is “shakedown,” and it is a crime under both state and federal law. It is a crime, that is, unless it is the government doing the shaking down. There is perhaps no more graphic illustration of the manner in which the government employs the awesome and far-reaching power of federal law to force corporations into massive monetary settlements, than the explosion in the number of cases brought against pharmaceutical companies in recent years.

Fines paid by pharmaceutical companies to the federal government to settle charges brought against them, has skyrocketed to $4.41 billion (from just $10 million in 1991). Even more revealing is the fact that of the 165 pharmaceutical settlements with the federal government in the past two decades, nearly three-fourths occurred in the past five years. A settlement that might have resulted from an investigation in the 1990s would have averaged $37 million; today the average settlement is $130 million. This is a cash cow that Uncle Sam knows how to milk.

This astronomical – and accelerating — increase in fines has taken place even though there has been no real change in the nature of the alleged infractions committed by the drug companies. Moreover, the basis for securing such huge fines rarely reflect violations of serious federal criminal laws; but rather regulatory discrepancies or failure to meet the intricate and complex “off-label” edicts which the companies are forced to follow. In just the past five years as well, so-called “unlawful promotion” of rules so complex even industry lawyers have a difficult time figuring them out, accounted for more than half of all violations charged to pharmaceutical companies.

The financial risk to the companies is huge, as is the corresponding windfall to the government. Moreover, company “whistleblowers” can become multi-millionaires overnight if their snitching results in a financial payout by the company to the government. And, holding off “blowing the whistle” until substantial sales of a drug has occurred, so as to increase penalties and “rewards,” has the perverse effect of prolonging the alleged “bad” behavior. Unfortunately, last year’s new omnibus health care law only increases the opportunities and incentives for anti-pharmaceutical whistleblowers.

A primary stick employed by the feds to pressure pharmaceutical companies to settle such cases, is the threat of “debarment.” And it is a Big Stick indeed. Placing a pharmaceutical company on the federal “debarment list” amounts to a corporate death sentence, because the company is then ineligible to participate in government medical programs, including Medicare and Medicaid. Without access to such programs, many drug companies would be unable to stay afloat; and the government knows this.

Whether one likes it or not, with the growth of federal health programs in recent decades, state and federal governments represent the largest customers for the majority of pharmaceutical manufacturers. According to the Kaiser Family Foundation, in 2008 nearly 40% of all spending by Americans on prescription drugs came from public payers, including the big boys on the block – Medicare and Medicaid.

Put another way, and looking at just a single major pharmaceutical company – in 2008, Pfizer brought in $19 billion in revenue from gross U.S. sales, and using Kaiser’s 37% figure, the company would be dependent on government contracts for approximately $7 billion. No company, no matter how large or in what industry, could afford to lose $7 billion in sales. The threat of being blacklisted by the government for failure to cave in to settlement pressure is obviously intense.

No one would dispute that pharmaceutical manufacturers must be held to high standards, or that true fraud should be ferreted out and prosecuted aggressively. However, the manner in which the government has chosen to target drug companies and pressure them to cough up huge sums of money in a constant game of regulatory “gotcha,” serves neither the companies nor those who rely on their products well.

We make billions on the drugs and pay millions in fines.
Sounds like a good business plan to me, so what if patients get hurt, just as long as my golden parachute opens, I could care less.

 

[Anonymous]

We make billions on the drugs and pay millions in fines.
Sounds like a good business plan to me, so what if patients get hurt, just as long as my golden parachute opens, I could care less.

Do you have a unique thought that wasn't first conceived on a bumper-sticker? Tort-reform is what America needs. You people are the same MORONS who complain about the price of drugs with apparently no idea how these LUDICROUS LAW-SUITS contribute to that problem. Dealing with you MORONS is like dealing with children..... PATHETIC

 

[Anonymous]

http://www.bobbarr.org/default.asp?pt=newsdescr&RI=1292

Shaking down drug companies
by Bob Barr
as published in The Atlanta Journal Constitution
Monday, March 14, 2011 at 9:00 AM

A common synonym for the crime of extortion is “shakedown,” and it is a crime under both state and federal law. It is a crime, that is, unless it is the government doing the shaking down. There is perhaps no more graphic illustration of the manner in which the government employs the awesome and far-reaching power of federal law to force corporations into massive monetary settlements, than the explosion in the number of cases brought against pharmaceutical companies in recent years.

Fines paid by pharmaceutical companies to the federal government to settle charges brought against them, has skyrocketed to $4.41 billion (from just $10 million in 1991). Even more revealing is the fact that of the 165 pharmaceutical settlements with the federal government in the past two decades, nearly three-fourths occurred in the past five years. A settlement that might have resulted from an investigation in the 1990s would have averaged $37 million; today the average settlement is $130 million. This is a cash cow that Uncle Sam knows how to milk.

This astronomical – and accelerating — increase in fines has taken place even though there has been no real change in the nature of the alleged infractions committed by the drug companies. Moreover, the basis for securing such huge fines rarely reflect violations of serious federal criminal laws; but rather regulatory discrepancies or failure to meet the intricate and complex “off-label” edicts which the companies are forced to follow. In just the past five years as well, so-called “unlawful promotion” of rules so complex even industry lawyers have a difficult time figuring them out, accounted for more than half of all violations charged to pharmaceutical companies.

The financial risk to the companies is huge, as is the corresponding windfall to the government. Moreover, company “whistleblowers” can become multi-millionaires overnight if their snitching results in a financial payout by the company to the government. And, holding off “blowing the whistle” until substantial sales of a drug has occurred, so as to increase penalties and “rewards,” has the perverse effect of prolonging the alleged “bad” behavior. Unfortunately, last year’s new omnibus health care law only increases the opportunities and incentives for anti-pharmaceutical whistleblowers.

A primary stick employed by the feds to pressure pharmaceutical companies to settle such cases, is the threat of “debarment.” And it is a Big Stick indeed. Placing a pharmaceutical company on the federal “debarment list” amounts to a corporate death sentence, because the company is then ineligible to participate in government medical programs, including Medicare and Medicaid. Without access to such programs, many drug companies would be unable to stay afloat; and the government knows this.

Whether one likes it or not, with the growth of federal health programs in recent decades, state and federal governments represent the largest customers for the majority of pharmaceutical manufacturers. According to the Kaiser Family Foundation, in 2008 nearly 40% of all spending by Americans on prescription drugs came from public payers, including the big boys on the block – Medicare and Medicaid.

Put another way, and looking at just a single major pharmaceutical company – in 2008, Pfizer brought in $19 billion in revenue from gross U.S. sales, and using Kaiser’s 37% figure, the company would be dependent on government contracts for approximately $7 billion. No company, no matter how large or in what industry, could afford to lose $7 billion in sales. The threat of being blacklisted by the government for failure to cave in to settlement pressure is obviously intense.

No one would dispute that pharmaceutical manufacturers must be held to high standards, or that true fraud should be ferreted out and prosecuted aggressively. However, the manner in which the government has chosen to target drug companies and pressure them to cough up huge sums of money in a constant game of regulatory “gotcha,” serves neither the companies nor those who rely on their products well.

In my books, there is a huge difference between off-label promotion and purposefully hiding relevant safety information to patients, HCP and FDA. Shame on those who lied and denied and suppressed emerging safety knowledge! Shame on Execs to approve such behaviour! People like you ruin the reputation of pharma and the hard, compliant work of thousends of employees.

 

[Anonymous]

In my books, there is a huge difference between off-label promotion and purposefully hiding relevant safety information to patients, HCP and FDA. Shame on those who lied and denied and suppressed emerging safety knowledge! Shame on Execs to approve such behaviour! People like you ruin the reputation of pharma and the hard, compliant work of thousends of employees.

Which execs "approved such behavior"? and it is "behavior" NOT "behaviour" you Euro-Trash/Canadian socialist piece-o-crap. Give me names. You have NONE. You know why? Because they don't go after individuals.... they go after corporations. Follow the money... there is NO money in going after individuals. They don't want justice.... THEY WANT MONEY.

 

[Anonymous]

Which execs "approved such behavior"? and it is "behavior" NOT "behaviour" you Euro-Trash/Canadian socialist piece-o-crap. Give me names. You have NONE. You know why? Because they don't go after individuals.... they go after corporations. Follow the money... there is NO money in going after individuals. They don't want justice.... THEY WANT MONEY.

Obviously, your medication does not work. Hope at least your shrink can help you solve your problems. I'll give names to FDA, don't worry, but certainly not to you.

 

[Anonymous]

Look at the US website. It reeks of mis information.The trouble starts with the FDA approved indication. Treatment of bone mets... what the F%$# does that mean. FDA screwed up and NVS exploits it to the hilt. How long do you have to dig into the information on this site to learn that this crap reduces SREs. It is not an anti cancer agent.

 

[Anonymous]

Obviously, your medication does not work. Hope at least your shrink can help you solve your problems. I'll give names to FDA, don't worry, but certainly not to you.

You want names try Dunsire, Elliott, Schmidt, Engelhardt, Epstein and Hohneker for a few.

 

[Anonymous]

You want names try Dunsire, Elliott, Schmidt, Engelhardt, Epstein and Hohneker for a few.

I have worked for and with all of the persons you mentioned. There are definate scumbags within the list, but it must go back to research and regulatory. Dunsire was tough, but a class act. We could use her leadership today. Disappointed with Epstein- I think the buck stops here. Idiot, I mean Elliot was such a bafoon. Schmidt was another class act, sorry that we can't have more like him. Englehardt, all I need to mention is "dialog coach"-- ridiculous. ( I would like to have the money they spent on that one) Hohneker- brilliant, sorry to see him move on, but remember, he came in well after the clinical issues with Z. If you really want the scoop, go talk to the MSLs who originally placed the Z trials. They can tell you exactly what went on when. Dose amendments etc.... It was a very interesting time. I must admit I had some concerns before we put in the CC dose adjustments. I lost some sleep during that time.