Thursday 12 July 2012

GlaxoSmithKine pleads guilty to criminal charges of fraudulent promotion of its drugs - pays US Government US$3 billion settlement



The Lancet 7 July 2012:

On July 2, UK-based GlaxoSmithKine (GSK) agreed to plead guilty to criminal charges of fraudulent promotion of its drugs and pay the US Government a settlement of US$3 billion. If accepted, this will be the largest fine imposed on a drug company, surpassing the $2·3 billion paid by Pfizer for inappropriate marketing in 2009. The amount adds to GSK's $750 million settlement in 2010 over manufacturing quality.

What is particularly egregious about GSK's fraud is the calculated deceit and potential human cost of its aggressive and misleading marketing. For instance, while evidence was emerging that showed an increased suicide risk in adolescents prescribed selective serotonin reuptake inhibitors for depression, GSK was actively encouraging off-label prescription of paroxetine to individuals younger than 18 years. This was not an isolated incident; off-label use was also encouraged for bupropion. For rosiglitazone, safety data were withheld from the US Food and Drug Administration and altered, potentially delaying restrictions on the drug's use and putting people to whom it was prescribed at increased risk of cardiovascular complications. The company is also accused of cheating Medicare. Such behaviour is not only illegal, it is immoral.

As Machiavelli observed, “he who seeks to deceive will always find someone who will allow himself to be deceived”. Sadly, in the case of GSK, this has involved doctors who were all too ready to be beguiled by illegal kickbacks and lavish hospitality…

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