A more detailed article about the Glaxo/Smith/Kline settlement

[Baitball Blogger]

GSK pleads guilty and agrees to pay $3 billion to settle charges of improper marketing

British healthcare giant GlaxoSmithKline agreed to plead guilty and pay $3 billion to resolve criminal and civil allegations that it illegally promoted prescription drugs and failed to report safety data, according to officials with the U.S. Department of Justice.

The settlement, the largest-ever in a largest health-care fraud case in the U.S., includes a criminal fine of $956.8 million, the Justice Department said today. London-based Glaxo will also forfeit $43 million, the U.S. said.

GSK will plead guilty to marketing the drugs Paxil and Wellbutrin for uses not approved by the U.S. Food and Drug Administration and for failing to report clinical data on Avandia, federal prosecutors said. The company has agreed to admit to the charges, which are misdemeanors, according to filings today by the U.S. in federal court in Boston.

“Today’s historic settlement is a major milestone in our efforts to stamp out health care fraud,” Bill Corr, deputy secretary of health and human services, said in a statement. “For a long time, our health care system had been a target for cheaters.”

http://www.nj.com/business/index.ssf/2012/07/gsk_pleads_guilty_and_agrees_t.html

[JDPriestly]

1. What were the inappropriate uses?

[Baitball Blogger]

2. This is a good question.

It's enough for me to keep an eye on to see this thing develop.

[dmr]

3. This is distrubing - from the above link:

(Highlights are mine)

... snip ...

Glaxo promoted Paxil, which is approved by the FDA for adult use, for the treatment of depression in patients under the age of 18 through sales calls, spa programs, a “false and misleading” medical journal article and “lavish weekend conferences” in Puerto Rico and Hawaii, according to a Justice Department fact sheet.

The company promoted Wellbutrin, a depression medication, for unapproved uses including weight loss, sexual dysfunction and substance abuse. Some sales representatives referred to the drug as “the happy, horny, skinny pill,” according to the fact sheet.

... snip ...

Glaxo also promoted its Advair asthma drug for first-line therapy for mild asthma patients even though it wasn’t approved or medically appropriate for these people, the DOJ said today. The settlement also resolves allegations that the company promoted Zofran, approved only for post-operative nausea, for treatment for morning sickness in pregnant women.

... more at link ...

For pregnant women! Leaves me speechless.

[LuckyLib]

4. Criminal Big Pharma needs to experience more of this kind of crackdown.

And Americans need to step back from "buying into" the real drug culture in this country.

[Baitball Blogger]

5. I always felt that some of us were treated like test subjects.