Today, I am pleased to announce that the Justice Department and our law enforcement partners have reached an historic $3 billion resolution with the pharmaceutical manufacturer GlaxoSmithKline, LLC, to resolve multiple investigations into the company’s sales, marketing, and pricing practices. This action constitutes the largest health care fraud settlement in United States history. ~ Deputy Attorney General James M. Cole
The case involves two antidepressants sold in the U.S. by the British pharmaceutical company GlaxoSmithKline(GSK), Paxil and Wellbturin, as well as false claims about the diabetes drug Avandia.
Deputy Attorney General James M. Cole explained that under the agreement just announced,
GSK will plead guilty to criminal charges and pay $1 billion in criminal fines and forfeitures for illegally marketing and promoting the drugs Paxil and Wellbutrin for uses not approved by the FDA – including the treatment of children for depression, and the treatment of other patients for ailments ranging from obesity, to anxiety, to addiction and ADHD – and for failing to report important clinical data about the drug Avandia to the Food and Drug Administration. GSK will pay an additional $2 billion to resolve civil allegations that it caused false claims to be submitted to federal health care programs for these and other drugs as a result of the company’s illegal promotional practices and payments to physicians. This settlement also resolves a civil investigation of the company’s alleged underpayment of rebates that were required under the Medicaid Drug Rebate Program. [emphasis mine]
The criminal complaint, filed in Massachusetts, claims GSK promoted Paxil as safe in treating depression for teens and children, despite the 2003 FDA warning against its use in this population. (You might want to see the post “‘The Reports of My Death Are Greatly Exaggerated’: As Is the Correlation of Antidepressants With Suicide” on how accurate those warnings turned out to be.)
They’re also in deep weeds for heavily promoting the use of Paxil through a force of 1900 sales reps who made personal calls to doctors, encouraging them to prescribe the med.
Additionally, although it only had FDA approval to treat depression, the company advertised that Wellbutrin could treat ADHD, obesity, additions, and sex and sexual dysfunction.
In a truly elegant touch, the Wellbutrin sales reps referred to the drug as ’the happy, horny, skinny pill’ to remind doctors of its possible (unapproved) uses.
The settlement is breaking news, and you’ll see more coming out about it the entire day. Some trustworthy sources–beside the complaint–are below, and in “Related Articles”: Glaxo To Plead Guilty To 3 Charges In Sweeping Health Settlement (http://www.npr.org/blogs/health/2012/07/02/156116607/glaxo-pleads-guilty-to-3-charges-in-sweeping-health-settlement)
- Glaxo to Plead Guilty, Pay $3 Billion to U.S. to Resolve Fraud Allegations (http://online.wsj.com/article/SB10001424052702304299704577502642401041730.html)
- Deputy Attorney General James M. Cole Speaks at the GSK Press Conference (http://www.justice.gov/iso/opa/dag/speeches/2012/dag-speech-1207021.html)
Related articles
- GlaxoSmithKline ‘guilty of fraud’ (bbc.co.uk)
- reuters: DEVELOPING: GlaxoSmithKline Plc has agreed to plead… (shortformblog.com)
- GlaxoSmithKline Reaches Plea Agreement Over Drug Labeling – Bloomberg (bloomberg.com)
AllUCanBe
July 2, 2012
Hi Candida,
As always, your very thorough posts are so informative. I’m a little confused on this one though in that they were fined for promoting uses not approved by the FDA, and yet your previous article you mention in this post indicates the drugs do NOT increase suicidal thoughts or suicide in youth? No pharmaceutical should be promoted for uses other than FDA approved so I’m glad they did get fined as this will hopefully prevent other companies from this practice.
Maybe I’m not reading it correctly? Hope you’ll clarify!
Barb Hildebrand
candidaabrahamson
July 2, 2012
You’re on astute–and loyal–reader (and thank you for your kind words)! Although my research–based on solid scientific studies–indicates that the FDA warnings may have been misguided, they still stand; they have not been withdrawn. As such, the FDA warning against prescribing most antidepressants to youths still stands, in a very-serious black-box warning. That being from on high, GSK had no right to market the Paxil to children, something I’m most certain they knew. And I believe that when they did it there was little research out yet indicating, as I found, that the possible danger to children might be overblown by the warnings, so it just gets, as they say, “worser and worser.”
Please let me know, Barb, if that clarifies.
All the best,
Candida
AllUCanBe
July 2, 2012
Thanks for your quick response! I wanted to clarify before sharing your post on my FB fanpage. There are so many “extremists” who are totally opposed to any antidepressants being used in youth and teens that I wanted to make sure before I posted it.
I’m certain GSK knew what they were doing too and now they really get the message it’s never to be done when not FDA approved. Makes you wonder if a $3 billion fine outweighs the sales they’ve made, but a precendent setting amount regardless.
I used to work for a pharmaceutical company many moons ago, only in a medical secretary capacity, but we had to jump through huge hoops to get drugs passed for uses of any kind, both in Canada where I live and the U.S. Much clinical testing had to be done and all adverse reactions reported strictly.
As so often occurs, the media gets wind of something and without any real knowledge, run with the story with sensationalized headings and content without any vetting at all. I guess it’s better to err on the side of caution with the potentially misguided black box warning. More clinical trials obviously need to be done as suicide and youth are of real concern.
Wished there was some solid and substantiated way to have correct information put out by all involved. The media in this case did seem to get that it was being blown out of proportion, but that’s alway hit and miss. Sounds like the FDA is uncertain, yet took the extraordinary step to black box warning it. For the patient, it certainly does not instill confidence that anyone knows what the heck they’re doing, and with so many up in arms over medicating, this will just add fuel to their fire and cause, and you can bet they will not promote that most of these antidepressants do NOT increase suicidal ideation or suicide in youth and teens.
Good that GSK got their wrists slapped, bad that those anti-pharma/anti-meds will run with this.
billgncs
July 2, 2012
so the shareholders are blitzed, not sure if anyone goes to jail. If that’s true then only the grannies with that stock in their managed 401k’s are punished.
Dorothy
July 2, 2012
thanks for posting…sad that as usual we are the guinea pigs and the CEOs walk away with not even a guilty conscience