Archive for 6 julio 2012

Moral decay at GSK reaps record US$3 billion fine : The Lancet

julio 6, 2012

Moral decay at GSK reaps record US$3 billion fine

The Lancet

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.

Multibillion-dollar fines are inadequate to tackle misconduct when penalties can be paid from post-tax profits. Indeed, there seems to be such an arrogance about money, that on the same day that GSK was being fined $3 billion, the Association of the British Pharmaceutical Industry argued that the UK Government should reinvest the $5 billion expected from NHS drug savings back into the industry. GSK and other drug companies have come adrift from the standards of the societies they seek to serve. They need to rediscover corporate citizenship, beginning with the individual integrity and accountability of their employees.

vía Moral decay at GSK reaps record US$3 billion fine : The Lancet.

GlaxoSmithKline Agrees to Pay $3 Billion in Fraud Settlement –

julio 2, 2012

Buenos muchachos.

GlaxoSmithKline Agrees to Pay $3 Billion in Fraud Settlement –

“The British drugmaker GlaxoSmithKline agreed to plead guilty to criminal charges and pay $3 billion in fines for illegally promoting the antidepressants Paxil and Wellbutrin and for failing to report safety data about the diabetes drug Avandia, federal prosecutors announced Monday.

The settlement marks the largest payment ever by a drug company, eclipsing the previous record of $2.3 billion set by Pfizer in 2009, the government said.”

“The company illegally promoted the use of Paxil in children and, in the case of Wellbutrin, marketed it for weight loss and sexual dysfunction when it was approved only to treat major depressive disorder.”

“Justice Department officials also said that between 2001 and 2007 GlaxoSmithKline failed to report to the FDA on safety data from certain post-marketing studies and from two studies of the cardiovascular safety of the diabetes drug Avandia.”