British pharmaceutical company GlaxoSmithKline (GSK) has agreed to pay $3 billion in the US in criminal and civil fines and plead guilty to misdemeanor criminal charges related to the sale and marketing of its antidepressants Paxil and Wellbutrin and the diabetes drug Avandia in the largest health-care fraud settlement in U.S. history.
The drugs implicated in the historical legal battle between the British firm and the federal government of the US are available in the Greek pharmacies to our great surprise. Paxil being distributed with a different name in Europe (as Seroxat), asthma-related Advair commercially available as Seretide and the antiepileptic drug Lamictal are still to be seen on the shelves in Greece.
Diabetes drug Avandia was withdrawn from our country as well as many other European states in S2010 following a recommendation of the European Medicines.
The Greek GSK subsidiary clarifies, however, that the fines are not related to the effect or side-effects of its medicines, but with the firm’s promotion policies in the past years.
Legal Battle in the US
The British pharmaceutical giant has admitted to misbranding the antidepressants Paxil and Wellbutrin and marketing them for uses not approved by the U.S. Food and Drug Administration (FDA), including the treatment of children for depression and the treatment of ailments such as obesity, anxiety, addiction and ADHD.
In some cases, the company did so despite warnings about possible safety risks from the FDA, such as an increased risk of suicide for children under 18 taking antidepressants.
It also admitted in the settlement that it did not provide the FDA with safety information that indicated its diabetes drug Avandia might cause heart problems.
The drug was eventually pulled off the shelves in Europe and its sale restricted in the U.S.
“At every level, we are determined to stop practices that jeopardize patients’ health; harm taxpayers; and violate the public trust — and this historic action is a clear warning to any company that chooses to break the law,” stated Deputy U.S. Attorney General James Cole.
Trying to regain the public’s trust, GSK CEO Andrew Witty said, “We have fundamentally changed our procedures for compliance, marketing and selling. When necessary, we have removed employees who have engaged in misconduct.”