After six years of bribing American doctors, pushing antidepressants on children and hiding the heart attack risk of a diabetes drug, the British drug Company GlaxoSmithKline LLC got a slap on the wrist this week.
http://www.huffingtonpost.com/larry-bodine/post_3573_b_1652688.html
•Glaxo agreed to pay $3 billion in fines for improperly pushing antidepressants Paxil and Wellbutrin, and diabetes drug Avandia, for many years. It is a pittance to Glaxo, which had $44 billion in sales in 2011 alone.
•The settlement is billed as "the largest health care fraud settlement in U.S. history." But Glaxo had already saved up to pay the fine. The settlement will barely affect the bottom line and the news of the settlement actually sent the stock price up.
•Glaxo pleaded guilty to health fraud but nobody is going to jail. No executive was even charged.
Kudos to the Department of Justice for nailing Glaxo. "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," said James M. Cole, Deputy Attorney General.
But to a massive operation like Glaxo, the fines amount to a speeding ticket. Admitting to meaningless criminal charges and paying penalties for poisoning consumers is just a cost of doing business.
What Glaxo Did to the Public
Paxil: For four years, Glaxo illegally promoted Paxil for treating depression in patients under age 18, even though the FDA has never approved this use. Glaxo helped in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil was effective in treating depression in patients under age 18, when the study failed to demonstrate efficacy. At the same time, the criminal pharma company hid data from two other studies in which Paxil also failed to help depression in minors.
Meanwhile, Glaxo sponsored dinner programs, lunch programs, spa programs and similar activities to promote the use of Paxil in children and adolescents. Glaxo paid a speaker to talk to an audience of doctors and paid for the meal or spa treatments for the doctors who attended. Glaxo agreed to plead guilty to misbranding Paxil in that its labeling was false and misleading regarding the use of Paxil for patients under 18.
Wellbutrin: For four years Glaxo promoted Wellbutrin, approved at that time only for Major Depressive Disorder, as a treatment for weight loss, sexual dysfunction, substance addictions and Attention Deficit Hyperactivity Disorder, among other off-label uses. The executives at Glaxo paid millions to doctors to speak at and attend meetings, sometimes at lavish resorts, where the off-label uses of Wellbutrin were routinely promoted and also used sales representatives, sham advisory boards, and phony Continuing Medical Education (CME) programs to promote Wellbutrin for these unapproved uses. Glaxo has agreed to plead guilty to misbranding Wellbutrin in that its labeling did not bear adequate directions for these off-label uses.
Avandia: For six years Glaxo lied to the FDA about the safety of Avandia, a diabetes drug, in reports to the FDA that are meant to allow the agency to determine if a drug is safe. The missing information about the risk of heart failure and heart attacks included data regarding post-marketing studies, as well as data regarding two studies undertaken in response to European regulators' concerns about the cardiovascular safety of Avandia. Glaxo has agreed to plead guilty to failing to report data to the FDA and has agreed to pay a criminal fine of $242,612,800 for its unlawful conduct concerning Avandia.
Another criminal pharma company, Abbot Labs, just agreed to pay a pay $1.5 billion in a settlement involving the anti-seizure drug Depakote in May 2012. Abbot was illegally bribing pharmacists to recommend it to defenseless elderly dementia patients for improper uses.
The previous U.S. record for the largest financial penalty paid by a pharmaceutical company for illegal marketing of drugs is the $2.3 billion mark set by Pfizer and its subsidiaries in 2009.
Looking Out for Yourself
If you have taken any drug manufactured by Glaxo -- including Paxil, Wellbutrin or Avandia -- search online and read articles to determine whether you have suffered any of the dangerous side effects. The $3B fines are being paid to the government -- not individual consumers. If you believe you have been damaged by a Glaxo drug, contact a lawyer who has experience dealing with pharmaceutical companies. Pharma companies have vast funds and battalions of lawyers to fight consumer claims, and you should be sure your lawyer has the resources to take on a criminal drug company.
And before you go, leave a comment below about this article and the fines being levied against drug companies. Should pharma companies be given penalties that affect their bottom line? Should individual executives in charge of paying bribes be personally indicted? Tell us what you think.
Cross-posted from Lawyers.com.
Content concerning legal matters is for informational purposes only, and should not be relied upon in making legal decisions or assessing your legal risks. Always consult a licensed attorney in the appropriate jurisdiction before taking any course of action that may affect your legal rights.
http://www.huffingtonpost.com/larry-bodine/post_3573_b_1652688.html
•Glaxo agreed to pay $3 billion in fines for improperly pushing antidepressants Paxil and Wellbutrin, and diabetes drug Avandia, for many years. It is a pittance to Glaxo, which had $44 billion in sales in 2011 alone.
•The settlement is billed as "the largest health care fraud settlement in U.S. history." But Glaxo had already saved up to pay the fine. The settlement will barely affect the bottom line and the news of the settlement actually sent the stock price up.
•Glaxo pleaded guilty to health fraud but nobody is going to jail. No executive was even charged.
Kudos to the Department of Justice for nailing Glaxo. "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," said James M. Cole, Deputy Attorney General.
But to a massive operation like Glaxo, the fines amount to a speeding ticket. Admitting to meaningless criminal charges and paying penalties for poisoning consumers is just a cost of doing business.
What Glaxo Did to the Public
Paxil: For four years, Glaxo illegally promoted Paxil for treating depression in patients under age 18, even though the FDA has never approved this use. Glaxo helped in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil was effective in treating depression in patients under age 18, when the study failed to demonstrate efficacy. At the same time, the criminal pharma company hid data from two other studies in which Paxil also failed to help depression in minors.
Meanwhile, Glaxo sponsored dinner programs, lunch programs, spa programs and similar activities to promote the use of Paxil in children and adolescents. Glaxo paid a speaker to talk to an audience of doctors and paid for the meal or spa treatments for the doctors who attended. Glaxo agreed to plead guilty to misbranding Paxil in that its labeling was false and misleading regarding the use of Paxil for patients under 18.
Wellbutrin: For four years Glaxo promoted Wellbutrin, approved at that time only for Major Depressive Disorder, as a treatment for weight loss, sexual dysfunction, substance addictions and Attention Deficit Hyperactivity Disorder, among other off-label uses. The executives at Glaxo paid millions to doctors to speak at and attend meetings, sometimes at lavish resorts, where the off-label uses of Wellbutrin were routinely promoted and also used sales representatives, sham advisory boards, and phony Continuing Medical Education (CME) programs to promote Wellbutrin for these unapproved uses. Glaxo has agreed to plead guilty to misbranding Wellbutrin in that its labeling did not bear adequate directions for these off-label uses.
Avandia: For six years Glaxo lied to the FDA about the safety of Avandia, a diabetes drug, in reports to the FDA that are meant to allow the agency to determine if a drug is safe. The missing information about the risk of heart failure and heart attacks included data regarding post-marketing studies, as well as data regarding two studies undertaken in response to European regulators' concerns about the cardiovascular safety of Avandia. Glaxo has agreed to plead guilty to failing to report data to the FDA and has agreed to pay a criminal fine of $242,612,800 for its unlawful conduct concerning Avandia.
Another criminal pharma company, Abbot Labs, just agreed to pay a pay $1.5 billion in a settlement involving the anti-seizure drug Depakote in May 2012. Abbot was illegally bribing pharmacists to recommend it to defenseless elderly dementia patients for improper uses.
The previous U.S. record for the largest financial penalty paid by a pharmaceutical company for illegal marketing of drugs is the $2.3 billion mark set by Pfizer and its subsidiaries in 2009.
Looking Out for Yourself
If you have taken any drug manufactured by Glaxo -- including Paxil, Wellbutrin or Avandia -- search online and read articles to determine whether you have suffered any of the dangerous side effects. The $3B fines are being paid to the government -- not individual consumers. If you believe you have been damaged by a Glaxo drug, contact a lawyer who has experience dealing with pharmaceutical companies. Pharma companies have vast funds and battalions of lawyers to fight consumer claims, and you should be sure your lawyer has the resources to take on a criminal drug company.
And before you go, leave a comment below about this article and the fines being levied against drug companies. Should pharma companies be given penalties that affect their bottom line? Should individual executives in charge of paying bribes be personally indicted? Tell us what you think.
Cross-posted from Lawyers.com.
Content concerning legal matters is for informational purposes only, and should not be relied upon in making legal decisions or assessing your legal risks. Always consult a licensed attorney in the appropriate jurisdiction before taking any course of action that may affect your legal rights.
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