British pharmaceutical giant GlaxoSmithKline (GSK) recently agreed to pay a record-breaking $3 billion settlement for the improper marketing of many dangerous pharmaceuticals, including Paxil. Federal regulators say that the drugmaker marketed several of its drugs for unapproved, off-label uses. This type of marketing is common among large drugmakers and is unlikely to stop despite massive fines levied against these companies, according to commentators such as former New York attorney general Eliot Spitzer.
"What we're learning is that money doesn't deter corporate malfeasance," Spitzer said. "The only thing that will work, in my view, is CEOs and officials being forced to resign and individual culpability being enforced."
Spitzer filed a similar lawsuit against GSK in 2004 regarding its improper marketing of Paxil, an antidepressant.
Authorities allege that GSK marketed Paxil to minors and helped fabricate a medical journal article that misreported Paxil's effectiveness in pediatric patients. Clinical evidence shows that not only is Paxil ineffective in treating depression among minors, but the drug also increases the risk of suicide in patients under 24. It is unclear how many patients' deaths are linked to the inappropriate marketing of Paxil or other GSK drugs.
"Children, teenagers and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers and young adults who do not take antidepressants to treat these conditions," the warning label on Paxil now states. Other serious side effects of Paxil may include uncontrollable shaking, bloody stools and vomit, seizures, and hallucinations.
In our next post, we will discuss other GSK drugs that were improperly marketed for off-label uses.
Source: The New York Times, "Glaxo Agrees to Pay $3 Billion in Fraud Settlement," Katie Thomas and Michael S. Schmidt, July 2, 2012