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July 2, 2012

Record big criminal fine for big drug company involved in big fraud

This new AP article, headlined "GlaxoSmithKline to pay largest health care fraud fine in U.S. history," reports on a notable financial punishment for a corporate criminal. Here are the details:

GlaxoSmithKline will pay $3 billion and plead guilty to promoting two popular drugs for unapproved uses and to failing to disclose important safety information on a third in the largest health care fraud settlement in U.S. history, the Justice Department said Monday.

The $3 billion fine also will be the largest penalty ever paid by a drug company, Deputy Attorney General James M. Cole said. The corporation also agreed to be monitored by government officials for five years to attempt to ensure the company's compliance, Cole said....

"For far too long, we have heard that the pharmaceutical industry views these settlements merely as the cost of doing business," Acting Assistant Attorney General Stuart F. Delery, head of Justice's civil division, said at the news conference. "That is why this administration is committed to using every available tool to defeat health care fraud."...

Prosecutors said GlaxoSmithKline illegally promoted the drug Paxil for treating depression in children from April 1998 to August 2003, even though the FDA never approved it for anyone under age 18. The corporation also promoted the drug Wellbutrin from January 1999 to December 2003 for weight loss, the treatment of sexual dysfunction, substance addictions and attention deficit hyperactivity disorder, although it was only approved for treatment of major depressive disorder.

Justice Department officials also said that between 2001 and 2007 GlaxoSmithKline failed to report to the FDA on safety data from certain post-marketing studies and from two studies of the cardiovascular safety of the diabetes drug Avandia. Since 2007, the FDA has added warnings to the Avandia label to alert doctors about potential increased risk of congestive heart failure and heart attack.

The drug corporation also agreed to resolve civil liability for promoting the drugs Paxil, Wellbutrin, Advair, Lamictal and Zofran for off-label, non-covered uses. The company also resolved accusations that it paid kickbacks to doctors to prescribe those drugs as well as the drugs Imitrex, Lotronex, Flovent and Valtrex....

Of the penalties, $1 billion covers criminal fines and forfeitures and $2 billion is for civil settlements with the federal government and the state governments of Massachusetts and Colorado.

July 2, 2012 at 05:40 PM | Permalink

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Comments

So how many people from the drug selling community go to jail for selling dangerous drugs to kids on this one? Oh, yeah, I guess corporations aren't people after all.

Posted by: Matt | Jul 2, 2012 9:50:26 PM

The FDA does not have an enforcement arm, and refers its cases to the DOJ. Thanks for this story. The Supremacy must buy a few shares in all US drug makers to get standing. Then, it plans to intervene in these cases, by seeking their blockade on constitutional and policy grounds. The Supremacy will then set into motion its standard procedure of seeking the personal destruction of all FDA and DOJ officials involved. They are the Mafia coming to extort money from local merchants, and must be deterred. This case is among several that will end the drug industry in our nation. Liability deters the entire enterprise, as I have amply shown before, not just a defendant.

All patients and their families should be considering violence against the federal officials. They are a threat to the physical survival of patients. The pipeline in several areas of medicine has completely stopped flowing. Only a fool would do business in this expropriating nation, the Commie Obama USA. The pharmaceutical business and research atmosphere is likely more welcoming in Venezuela or North Korea.

Posted by: Supremacy Claus | Jul 2, 2012 10:28:24 PM

When the totally irresponsible FDA put a black box warning that anti-depressants cause suicidal ideas in children and adolescents, pediatricians and family MD's were deterred, and ended their prescriptions. As a result, the suicide rate among adolescents, which had been rapidly dropping, shot up again. People of this ilk are responsible for the needless and highly preventable suicides of thousands of adolescents since that warning. They are mass child killers by their ridiculous and unwarranted anti-scientific bias and hatred.

I believe there is good moral, intellectual and policy justification for the families of adolescent suicides to kill DOJ lawyers and FDA officials. To deter them. One happened to be a friend of the Supremacy and explained how that black box warning came to be. Anti-medication crazies were organized and, in raucous, physically threatening hearings, intimidated and advocated the banning of anti-depressants entirely. The review committee issued this warning as a compromise to appease the thug crazies. The proper response would have been to gas and taser them, not to appease them. Although, a good friend, I demanded his immediate resignation from the review committee, because of the deaths from his irresponsible, appeasement vote. He ironically died quite young, a short time later, of natural causes, not murder.

Posted by: Supremacy Claus | Jul 2, 2012 10:44:59 PM

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