GlaxoSmithKline to pay $3bn in US drug fraud scandal
GlaxoSmithKline (GSK) is to pay $3bn (£1.9bn) in the largest healthcare fraud settlement in US history.
The drug giant is to plead guilty to promoting two drugs for unapproved uses and failing to report safety data about a diabetes drug to the Food and Drug Administration (FDA).
The settlement will cover criminal fines as well as civil settlements with the federal and state governments.
The case concerns the drugs Paxil, Wellbutrin and Avandia.
Deputy US Attorney General James Cole told a news conference in Washington DC that the settlement was "unprecedented in both size and scope".
GSK, one of the world's largest healthcare and pharmaceuticals companies, admitted to promoting antidepressants Paxil and Wellbutrin for unapproved uses, including treatment of children and adolescents.
The illegal practice is known as off-label marketing.
The company also conceded charges that it held back data and made unsupported safety claims over its diabetes drug Avandia.
In addition, GSK has been found guilty of paying kickbacks to doctors.
"The sales force bribed physicians to prescribe GSK products using every imaginable form of high-priced entertainment, from Hawaiian vacations [and] paying doctors millions of dollars to go on speaking tours, to tickets to Madonna concerts," said US attorney Carmin Ortiz.
As part of the settlement, GSK agreed to be monitored by government officials for five years.
GSK said in a statement it would pay the fines through existing cash resources.
Andrew Witty, the firm's chief executive, said procedures for compliance, marketing and selling had been changed at GSK's US unit.
"We have learnt from the mistakes that were made," Mr Witty said. "When necessary, we have removed employees who have engaged in misconduct." [I suppose he thinks he's funny!]
Drugs bust
Drugs bust
“If you trust in yourself, and believe in your dreams, and follow your star. . . you'll still get beaten by people who spent their time working hard and learning things and weren't so lazy.”
Re: Drugs bust
If anyone cared why we pay twice as much for crappy care they would care about this.
yrs,
rubato
yrs,
rubato
Re: Drugs bust
Doctors swear an oath to practice medicine; why are these MDs not prosecuted, or at least disciplined by their professional peers?"The sales force bribed physicians to prescribe GSK products using every imaginable form of high-priced entertainment, from Hawaiian vacations [and] paying doctors millions of dollars to go on speaking tours, to tickets to Madonna concerts," said US attorney Carmin Ortiz.
MDs get way too much undeserved deference from the public.
For me, it is far better to grasp the Universe as it really is than to persist in delusion, however satisfying and reassuring.
~ Carl Sagan
~ Carl Sagan
Re: Drugs bust
They went to Madonna concerts, haven't they suffered enough!?!
“If you trust in yourself, and believe in your dreams, and follow your star. . . you'll still get beaten by people who spent their time working hard and learning things and weren't so lazy.”
Re: Drugs bust
Paxil is known as Aropax in Aus, and Seroxat in the UK.
prescribing information hereAlthough Aropax is not recommended for children under 18 years of age the most common unwanted effects in children under 18 are:
decreased appetite
tremor (uncontrollable trembling)
sweating
hyperactivity
hostile/unfriendly behaviour
agitation
changing emotions, including crying, changes in mood, trying to harm themselves, thoughts of suicide and attempting suicide.
This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
http://www.gsk.com.au/products_prescrip ... px?view=64
http://hcp.gsk.co.uk/products/seroxat/p ... ation.html
Adults aged 18 years and over only:
Major depressive episode:
•20 mg/day
•Review 3 – 4 weeks of initiation of therapy and adjust if necessary
•If insufficient response increase dose gradually in 10 mg increments to a maximum of 50 mg/day
•Treat for at least 6 months
Obsessive compulsive disorder:
•40 mg/day
•Starting dose 20 mg/day increased gradually in 10 mg increments
•Maximum dose 60 mg/day
Panic disorder:
•40 mg/day
•Starting dose 10 mg/day increased gradually in 10 mg increments
•Maximum dose 60 mg/day
Children and adolescents under 18 years:
•SEROXAT should not be used in children and adolescents under 18 years of age due to increased risk of suicidal behaviour and hostility and because efficacy in this age group has not been sufficiently demonstrated.
“If you trust in yourself, and believe in your dreams, and follow your star. . . you'll still get beaten by people who spent their time working hard and learning things and weren't so lazy.”
Re: Drugs bust
The fine sounds big until you read that sales of Avandia alone exceeded $10 billion. In order for drug companies to see such fines as more than just another cost of doing business, they should be forced to turn over all revenues (note, I did not say profits) for all drugs whose sales depended even in small part on illegal practices.
"Hang on while I log in to the James Webb telescope to search the known universe for who the fuck asked you." -- James Fell