GlaxoSmithKline agrees to $3 billion settlement with Justice Department in largest sum of its kind over health care fraud

(CBS News) Pharmaceutical giant GlaxoSmithKline will plead guilty and pay $3 billion in the largest settlement of health care fraud in U.S. history, the Justice Department announced Monday.

The settlement will resolve criminal and civil liability from the company's unlawful promotion of certain prescription drugs. The company is to plead guilty to a three-count criminal information, including two counts of introducing misbranded antidepressant drugs Paxil and Wellbutrin to interstate commerce and one count of failing to report safety data about the diabetes drug Avandia to the FDA. The criminal complaints will total $1 billion.

GSK will also pay $2 billion to resolve civil liabilities relating to Paxil, Wellbutrin and Avandia, as well as other drugs and also resolves allegations of pricing fraud.

The Justice Department said GlaxoSmithKline unlawfully promoted Paxil for treating depression in patients under 18 without FDA approval for pediatric use. The U.S. also alleged the company published and distributed a misleading medical journal article misrepresenting the drug's efficacy in treating depression in adolescents, also sponsoring dinners, spa programs and other activities to promote that use.

The Justice Department also contends that in 2003, GSK paid millions to doctors to promote Wellbutrin, approved at the time for depression, for off-label uses by funding meetings, sometimes at lavish resorts.

For Avandia, the U.S. alleged GSK failed to report certain safety data between 2001 and 2007 that have since led to "black box" warning labels of about the drug's potential to increase risk for heart failure and heart attack.

"Today's multi-billion dollar settlement is unprecedented in both size and scope. It underscores the Administration's firm commitment to protecting the American people and holding accountable those who commit health care fraud," James M. Cole, deputy attorney general, said in a statement. "At every level, we are determined to stop practices that jeopardize patients' health, harm taxpayers, and violate the public trust - and this historic action is a clear warning to any company that chooses to break the law."

The settlement marks the end of an extensive investigation involving the FDA, FBI and Department of Health and Human Services.

"Today brings to resolution difficult, long-standing matters for GSK," CEO Sir Andrew Wittey said in a company statement. "Whilst these originate in a different era for the company, they cannot and will not be ignored. On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made."

[BerkLaw]

Kudos to the two whisleblowers who helped save lives with their fight against GSK. Consumers should be outraged by the truly appalling conduct of this company. Drugs are dangerous, and such blatant misinformation should be punished with severe sanctions. Patient's lives should not be traded for profits and simply considered the cost of doing business.

Read more at www.thecorporateobserver.com

[ToTrue]

I realize most people just can't wrap their heads around facts (just look at how many people still believe in gods!) but here it goes;

December 1998
After two years and $800,000, a panel of four independent experts appointed by Judge Sam C. Pointer, overseer of implant lawsuits in the Federal courts, concludes that scientific evidence so far has failed to show that silicone breast implants cause disease.

June 1999
The Institute of Medicine releases a 400-page report prepared by an independent committee of 13 scientists. They conclude that although silicone breast implants may be responsible for localized problems such as hardening or scarring of breast tissue, implants do not cause any major diseases such as lupus or rheumatoid arthritis. Congress had asked the Institute to set up the committee.

Aug. 30, 2011 -- A panel of expert advisors to the FDA has been asked to solve a mystery: What happened to thousands of women who enrolled in studies designed to evaluate rare complications that might arise years after they received silicone gel breast implants?

In June, after a preliminary review of study data, the FDA concluded that breast implants were largely safe and effective but were not "lifetime devices," citing high reoperation rates for complications like hardening of the breast and rupture of the implant.

That review also found no evidence that silicone implants were linked to rare problems like breast cancer or connective tissue diseases,"

and no, 1995 Dow-corning doesn't exists anymore than the concept "you're car" is true after someone steals it from you. The car you owned might exist but it's not yours and the name Dow-corning exists but it's assets were stolen and society never righted that wrong.

[marychgo]

Like a lot of others here, I'd LOVE to see the top guys responsible for this spend at least a LITTLE time in jail! (Along with the bankers responsible for the Crash of 2008!)

[ToTrue]

How little we learn. Dow-Corning was sued for 5 billion dollars ending in 1998. The company was bankrupted, jobs lost, investments ruined along with many good scientists reputations. What do we know now? Their was never and link nor danger from all the diseases women and lawyers alleged. Now we're doing the same to this company.

Mankind is doomed.

[MagnaCartaUK]

Time to remember Thalidomide, amongst many other examples. The prime motivation of private companies is profit - there's nothing wrong with healthy profit - but when people's health, the consequences of corporate wrong-doing and unethical standards have to paid for by others, then whose fault is that? All that was being asked, and now demanded, is that companies act within a reasonable and acceptable manner. If they won't comply, then whose fault is it when they suffer the consequences for the disgusting actions THEY themselves CHOSE to bring about? They elected to be deceitful, placed innocent people in danger, and if it's allowed to happen again it could be YOU that one day suffers. Don't show compassion to them, for they would show none to you. 'You will know thine enemy by the deeds that will condemn him'.

[BWB2020]

How little you learned.

Dow-Corning was sued for defective silicone implants that leaked silicone into people's flesh.

The defect is not in dispute.

The injuries were indeed deforming, some absolutely hideous.

This is also not in dispute.

The only debate was between scientists as to the extent of the symptoms that could be directly linked to having petroleum-based chemicals in your system.

As for the bankruptcy, Dow-corning is still in business, FYI, making huge profits selling other products.

Re "jobs", it seems that you are into human sacrifice, that it is OK for businesses to cause injury, even death, to people who have done no wrong, for the sake of profit, that any activity is ok as long as you can call it a "job".

There are some jobs that need to be lost, those that depend on active wars, for example, and in this case, jobs manufacturing products known to be defective, where the defect puts those using them, even as recommended by the manufacturer, in unnecessary, life-threatening danger.

As far as being doomed, every human ever born is doomed to die, so that "revelation" of yours is certainly nothing new.

[MagnaCartaUK]

Yet another example of how desperate these greedy, money-obsessed companies can be - and all the more sad for it being a British company. Frankly I expect far better conduct than this. It's indicative of a far greater culture however, and one that's needs addressing; - that means not just reacting to unscrupulous corporate behaviour after the damage is done, but ensuring it doesn't happen in the first place, and with lengthy prison sentences for C.E.OS, their Boards, and any minion they get to do their dirty-worky by proxy. We've had bankers ruin the World financial system - with all the knock-on effects, and people from every background affected. It's interesting to note how reluctant governments are when it comes to addressing THAT problem - and by their non-action, effectively allow themselves to be black-mailed. Pharmaceutical companies who can't control their drooling, clawing greed present a more distinct danger - that to life itself, and harm to individuals - many of whom are extremely vulnerable. THAT is unforgiveable - and the punishment required should involve a prison sentence - even if the person(s) who sanctioned it are no longer with the company. Governments World-wide should impose decency where none exists, business-schools need to be forced to promote it where it doesn't exist, or the public will do it for them. We expect and demand better - and without execption or excuses.

[Choons]

Drug companies keep pushing more and more toxic drugs on the public just so they can maintain high profits while the drug is under patent protection. They pay off doctors to prescribe these poisons. The FDA knows full well that people are being harmed by these expensive "blockbuster" drugs when they could actually benefit more from cheap off-patent drugs that have proven safety records over decades of use.

All this $3 billion fine on GSK does is raise the poison prices higher for consumers. Investigate the FDA's complicity in approving dangerous drugs and allowing payola to go to doctors if public health really is such a concern.

[BWB2020]

To think that the legendary James Brown was bankrupted behind accusations of practicing "payola" to DJs working at radio stations he himself owned!

[drdavid hill]

Glaxo and drug companies are another face of what is wrong with modern society. Like the bankers they put greed and profit above human suffering. Both these days have no empathy with society. Indeed most big corporations place the bottom-line above long-term sustainability of the human experience for short-term gain. When natural resources get to a state where there is not enough to go around, possibly only then will they see the madness in their quest for greater wealth year in, year out. For this mentality will be the eventual death of us and most probably with the greed dictate, during this present century at the unprecedented rate that the world is consuming its finite resources. The only thing that is going up is global debt and where global society is heading for a head on collision with up to 10 billion humans by mid-century (only 38 years away now) and where there will not be enough to go around. Are we really that mad to let these global institutions and the powerful few to destroy our very existence it has got to be asked? Bad things I am afraid are around the corner but industrialists, politicians and bankers do not give a damn for human civilization. If they did they would see the sheer madness that they sow in the land of gathering unplenty. For those who are interested an interesting web-link concerning our huge pharmaceutical companies is - http://foolscrow.wordpress.com/2010/07/27/return-to-nuremberg-big-pharma-must-answer-for-crimes-against-humanity/

And another where they killed off the only strategy to stop bird flu through Nature magazine doing their dirty work is - http://avian-influenza.cirad.fr/content/download/1931/11789/file/Kennedy-F-Shortridge.pdf

Dr David Hill
Chief Executive
World Innovation Foundation

[Wisconsin_Army_Veteran]

The VA is trying to push Wellbutrin onto people with PTSD Now also. I wonder if their Dr.s are getting kickbacks also

[Choons]

Wellbutrin is a stimulant. It makes a lot of people edgy and anxious. Definitely NOT what you want happening in a highly trained soldier suffering PTSD.

[Mathion]

"On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made."

Let me rephrase that into English from Cropratese: "On behalf of GSK" (BEcause we're an LLC and you can't touch the guys who really did this), I want to express our regret (that we got caught defrauding and killing people) and reiterate that we have learnt from the mistakes that were made (so next time, we pay more for the politicians on BOTH sides, instead of just the GOP)."

I now return you to your level of spin...

[TimeToEvolve]

We can hang them or we can try them and THEN hang them. "Corporations are people my friend" - Mitt Robmee, 2012