GlaxoSmithKline, UK pharmaceutical company, are to pay a record $3bn settlement following US regulators’ charges of aggressive marketing and selective use of data from clinical trials. The company has been found to have promoted drugs beyond their authorized use, leading to what has become known as the largest ever case of US healthcare fraud.
GSK had budgeted £2.2bn for the cost of the case however the release of court documents on Monday which showed the illegal encouragement of doctors to use products such as Wellbutrin, Paxil and Advair revealed that this figure was optimistic.
Doctors had been invited to training weekends in exotic locations, including a “training session” in Jamaica on the use of Wellbutrin. Following such entertainment, doctors were encouraged to promote its use for “off-label” functions, suggesting its prescription for erectile dysfunction and weight loss.
GSK’s activities covertly paid doctors, such as entertainer Drew Pinsky, to encourage the use of drugs for alternative functions. In 1999 Pinsky was paid $275,000 indirectly over just two months.
A poll conducted by the company itself suggested that the response to the events was dramatic, showing that 12 per cent of attendees felt more comfortable prescribing children and adolescents with Paxil as a result, despite the GSK not being authorised to market use of the drug for those under the age of 18.
The GSK went beyond the uses outlined by the US Food and Drug Administration and the incurred fine is the highest in a series of escalating settlements in the US.
GSK's chief executive Sir Andrew Witty has expressed his regret and emphasised that GSK “have learnt from the mistakes that were made”.