Monday, July 02, 2012

Drug maker settles criminal charges for 3 billion

Bonnie and Steve: In the largest settlement ever made between and a drug company and a government, GlaxoSmithKline (GSK) pled guilty to three misdemeanor criminal charges related to its unlawful marketing of two antidepressants — Paxil and Wellbutrin — and failure to provide the US Food and Drug Administration with data about safety problems with the diabetes pill Avandia. GSK will pay $3 billion dollars for damages.

The criminal information says the company promoted Paxil as safe and effective for treatment of depression in kids and teens, despite FDA not having approved that use and plenty of evidence to the contrary. In 2003, FDA warned against the use of Paxil in teens because of a heightened risk of suicide.

Despite a lack of FDA approval, Wellbutrin was touted as good for treating conditions ranging from ADHD to obesity at a time when the drug had only been cleared to treat major depression. They also talked up the drug as a remedy for the side effects of other antidepressants, including sexual dysfunction. The feel-good spiel even had its own unofficial tagline, according to the government:
"GSK sales representatives sometimes referred to Wellbutrin as 'the happy, horny, skinny pill' " when touting its unapproved uses.

Other parts of the agreement settlement cover civil matters, ranging from overcharging Medicaid for drugs to paying kickbacks to doctors.

The lengthy indictment can be found at this link.

We could not believe how many new clients came to us, especially during a span from 1994-2003, who were taking Wellbutrin for off-label uses.

While this may sound like a huge amount for a settlement, GSK surely made much more from the drugs' sales. This settlement is more of a body blow than a knockout punch. Let it be a grim reminder of the depth and depravity some companies will exercise to make a buck. What's worse is their actions not only affected adults, but children.

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