GSK faces the regulators
July 5, 2012
GLAXOSMITHKLINE has pleaded
guilty to fraud charges brought
against the company by US
regulators and has been sentenced
to pay US$3 billion to American
authorities.
The settlement has been
heralded by the US Justice
Department as the largest
healthcare fraud settlement in
American history.
According to reports, the
settlement involves GSK pleading
guilty to fraudulent activity involving
three of its drugs: the diabetes
medication Avandia, and the
antidepressants Paxil and Wellbutrin.
The charges were initiated after
four former employees of the
company blew the whistle on a
range of improper activities
undertaken by GSK during the
1990’s and up until the mid-2000’s.
These improper practices
included illegally marketing offlabel
uses for Paxil and Wellbutrin,
including promoting the former for
use in patients under 18 when it
had not been FDA approved for use
in those under 18, and the latter
for weight loss, as well as in the
treatment of sexual dysfunction,
drug addiction and ADHD.
“Glaxo sales representatives
sometimes referred to Wellbutrin
as the ‘happy, horny, skinny pill’ as
a way to remind doctors of the
unapproved uses,” the US
Government said.
The regulators also charged GSK
with helping in the publication of a
report which claimed that Paxil
aided in the treatment of depression
in under 18’s, when in fact the trial
did not prove any such thing.
GSK was also charged with
lavishing doctors with holidays,
gifts and spa treatments.
Meanwhile, in relation to Avandia
the Justice Department said that
GSK failed to inform the FDA of
safety data, including two studies
which highlighted issues with the
drug and cardiovascular health.
Speaking in the wake of the
settlement, GSK CEO Andrew Witty
tried to separate the company from
its past actions, saying “Whilst
these originate in a different era for
the company, they cannot and will
not be ignored”.
“On behalf of GSK, I want to
express our regret and reiterate
that we have learnt from the
mistakes that were made,” he added.
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