A massive $3 million fine was the sum required to settle the various criminal charges and civil penalties brought against the global healthcare company GlaxoSmithKline. Charges against the giant company involved the failure to report certain safety data, the marketing of their product Paxil for unapproved uses such as sexual dysfunction and weight conditions, as well as the improper marketing of their other drugs Wellbutrin and Avandia. The company went so far as to publish a misleading medical journal about the Paxil drug.
GlaxoSmithKline, encouraged and bribed healthcare providers to prescribe Paxil (known in the US as Seroxat) to children despite the fact that the drug had not been approved for use by under 18 year olds. The drug, commonly used as an anti-depressant in the UK, is not recommended for children’s use due to its proven ineffectiveness in treating depression in young people, in addition to its potential side effects such as suicidal thoughts. Financial bribes, as well as Madonna concert tickets and Hawaiian vacations, were offered by the uber-rich company’s sale force to persuade medics to encourage the drug’s prescription.
GSK has faced similar charges in the past for misrepresentation of data and marketing drugs for non-approved uses, yet these charges were not enough to deter the company from committing offenses once more. Given that the company grossed $29 billion alone from its drugs – Paxil, Wellbutrin and Avandia, one would have to question the effect of a $3 million fine in terms of having a deterrent effect.
GSK is now facing a lawsuit from the Maryland Attorney General over a claim that the state overpaid GSK by at least $38 million for their diabetes drug Avandia. A meta-analysis was released in 2007 by cardiologist Steve Nissen which highlighted previously unknown risks such as an increase in heart failure conditions such as strokes and heart attacks. The Maryland lawsuit also alleges that the drugmaker withheld data showing that Avandia and two other of their diabetes drugs – Avandamet and Avandaryl – “dramatically” increase the chances that a patient will suffer a heart attack or other serious adverse events. Despite knowing these risks, GSK promoted the drugs as being safe to use. Failing to show this safety data to the FDA, prevented independent researchers from verifying and assessing accurate results. Maryland Attorney General Doug Gansler claims that as a result of this withholding of data, GSK mislead state bodies with regard to the safety and efficacy of their product. Concern over the safety of the drug is increased due to the large percentage of Maryland state residents suffering from diabetes- currently 9%.