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Details About the GSK Off-Label Marketing Settlement

In our last post, we discussed a record-breaking fine and criminal penalty lodged against pharmaceutical giant GlaxoSmithKline. The bulk of the allegations involve the promotion and marketing of the drugs Paxil, Wellbutrin, Avandia, and Advair.

Wellbutrin is an antidepressant that was marketed for various unapproved uses such as weight loss and sexual dysfunction.

The drug was only approved to treat severe depressive disorders at the time of off-label marketing. This means that individuals who were taking the potentially dangerous pharmaceutical for off-label uses likely saw no benefit but were exposed to a variety of the drug’s potential side effects, some of which could be serious. Side effects of Wellbutrin can include confusion, seizures hives, and hallucinations.

In the case of Avandia, authorities say that GSK failed to report data regarding studies that showed that the drug could cause severe heart problems in patients. Avandia and another drug called Actos have also been linked to an increased risk of bladder cancer in users.

The New York Times reports that many commentators believe that the $3 billion settlement was inadequate to prevent further wrongdoing by GSK and other drugmakers. The company made over $26 billion from the drugs during the 10-year period of the alleged illegal marketing activities.

“So a $3 billion settlement for half a dozen drugs over 10 years can be rationalized as the cost of doing business,” said the head of a whistle-blowing group.

Source: The New York Times, “Glaxo Agrees to Pay $3 Billion in Fraud Settlement,” Katie Thomas and Michael S. Schmidt, July 2, 2012