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Sunday, September 25, 2016

By Lena Groeger, ProPublica.org

On Monday, the Department of Justice announced that drug company GlaxoSmithKline agreed to pay a $3 billion fine, the largest health care fraud fine in the history of the United States. This fine is just the latest in a string of drug company penalties for improper promotion of drugs for “off-label,” or unapproved, uses. Here we take a look at six recent multi-million dollar fines that drug companies have agreed to pay for inappropriately, and in some cases illegally, promoting prescription drugs.

Eli Lilly

Jan 2009

Eli Lilly was fined $1.42 billion to resolve a government investigation into the off-label promotion of the anti-psychotic Zyprexa. Zyprexa had been approved for the treatment of certain psychotic disorders, but Lilly admitted to promoting the drug in elderly populations to treat dementia. The government also alleged that Lilly targeted primary care physicians to promote Zyprexa for unapproved uses and “trained its sales force to disregard the law.”

Pfizer

Sept 2009

Pfizer was fined $2.3 billion, then the largest health care fraud settlement and the largest criminal fine ever imposed in the United States. Pfizer pled guilty to misbranding the painkiller Bextra with “the intent to defraud or mislead”, promoting the drug to treat acute pain at dosages the FDA had previously deemed dangerously high. Bextra was pulled from the market in 2005 due to safety concerns. The government alleged that Pfizer also promoted three other drugs illegally: the anti-psychotic Geodon, an antibiotic Zyvox, and the anti-epileptic drug Lyrica.

AstraZeneca

April 2010

AstraZeneca was fined $520 million to resolve allegations that it illegally promoted the anti-psychotic drug Seroquel. The drug was approved for treating schizophrenia and later for bipolar mania, but the government alleged that AstraZeneca promoted Seroquel for a variety of unapproved uses, such as aggression, sleeplessness, anxiety, and depression. AstraZeneca denied the charges but agreed to pay the fine to end the investigation.

Merck

Nov 2011

Merck agreed to pay a fine of $950 million related to the illegal promotion of the painkiller Vioxx, which was withdrawn from the market in 2004 after studies found the drug increased the risk of heart attacks. The company pled guilty to having promoted Vioxx as a treatment for rheumatoid arthritis before it had been approved for that use. The settlement also resolved allegations that Merck made false or misleading statements about the drug’s heart safety to increase sales.

Abbott

May 2012

Abbott was fined $1.5 billion in connection to the illegal promotion of the anti-psychotic drug Depakote. Abbott admitted to having trained a special sales force to target nursing homes, marketing the drug for the control of aggression and agitation in elderly dementia patients. Depakote had never been approved for that purpose, and Abbott lacked evidence that the drug was safe or effective for those uses. The company also admitted to marketing Depakote to treat schizophrenia, even though no study had found it effective for that purpose.

GlaxoSmithKline

July 2012

GlaxoSmith Kline agreed to pay a fine of $3 billion to resolve civil and criminal liabilities regarding its promotion of drugs, as well as its failure to report safety data. This is the largest health care fraud settlement in the United States to date. The company pled guilty to misbranding the drug Paxil for treating depression in patients under 18, even though the drug had never been approved for that age group. GlaxoSmithKline also pled guilty to failing to disclose safety information about the diabetes drug Avandia to the FDA.

Source: The Department of Justice.

  • RobGinChicago

    “GlaxoSmithKline agreed to pay a $3 billion fine, the largest health care fraud fine in the history of the United States.” $3 billion fine after making $18 billion off of the practice? Hell, the DOJ could slap me around all they want if I could keep $15 billion in ill-gotten gains.

  • This is the American way and it’s time to change these misleading and dangerious practices. How dare these same companies maintain that due to their high cost of developement they need to charge more for their drugs in the USA than they do in other markets and then need to practice this kind of dispicable fraud on top of it.

  • AdirondackAnnie

    If, when a drug company is fined for doing something illegal with a drug (for example, promoting using it for unapproved diseases), the government would STOP paying for that drug with Medicare or Medicaid (there are usually other drugs made by other companies that could take their place) that would make these companies STOP these illegal practices. The only thing that will stop drug companies is to hurt their pocketbooks really bad and these fines seem to be just a cost of doing business for them.

  • howa4x

    This is the least of what they do. big pharma is in a cabal with the doctors and hospitals to make drugs that don’t cure you but rather maintain your illness and never actually bring you back to perfect health. Pick any illness you want. Cancer: the drug companies started the war on cancer in the 70’s and have billions in federal and private dollars funneled to them and in certian cancers the needle moved slightly in terms of pairents in remission. Now they are realizing that your own immune system with some help may provide the best results, but how many did they burn,cut and poison to get to this point. Heart disease: You can take all the high blood pressure medication your doctor prescribes for ever and don’t forget the side effects that needs other medication, or change your diet and expecise more, which doctors never discuss with you.. Independent tests shows that niacin is just as good to control colestoral as any satin. I could go on but wont. The bottom line is billions are being made off your illness so why rock the boat, and since the 1st 20 cents out of every dollar spent in health care goes to wall st as profit, so you can see why no one wants to really cure you. If RICO was applied to the drug companies all their CEOs would be in prison. These are the people that fund the Republicans. They work well together becauae neither of them has a moral compass, since the Republican answer is more de regulation.

    • tokoloshi27

      You’re forgetting the other administrations’ involvement since the seventies, but that aside, you didn’t mention that Big P finances the Federal oversight of the drug approval system directly. FDA and Main Stream Health-care (AMA etc.) is in their pocket by defining diseases by their “treatment”. Is it any wonder that the Pharma piece is just as messed up as the rest of the medical system?

      Big (insert corporations) always support who they think will win or at least hurt them less, they backed Obama big time in 08. A great reason (among many) to lobby for comprehensive campaign finance reform.

      • howa4x

        big pharma has created 32 thousand drugs and the FDA with limited staff depend on their research and testing. the basic problem is that we are all seen as potential profit centers, no matter who is in power

  • I’m sure these guys are republicans.

  • Day after day, time after time we hear the wail of those who think that all of industry needs to be left alone to regulate themselves and for the rest of the world to lay off interferring with their efforts to conduct business. HORSE SHIT! Their is little to no recognition of ethics, morals, or non-criminal behaviour by corporations these days. There is not a evening goes by that somewhere a class is held for Continuing Education for Doctors, Nurse Practioners, Ect that does not Pimp some medication and at the same time offer such goodies as vacations where ever you want If you sell their product.
    Bankers, Investment Councilors, Educators, Private Prisons, they all have their scams. All showing that certain people are incapable of running an honest enterprise. It is time that these cockroaches be stepped on.