In a groundbreaking suit filed against a pharmaceutical company for allegations of off-label promotion, whistleblowers, Gregory Thorpe and Blair Hamrick, exposed how their former employer, GlaxoSmithKline (GSK) defrauded Medicare, Medicaid, and other government funded health care programs in the marketing of its biggest selling products: Advair, Wellbutrin, Paxil, Lamictal, Zofran, Imitrex, Lotronex, Flovent, Valtrex, and Avandia.
For instance, the company promoted Advair for mild asthma, when in fact the drug’s FDA-approved use is limited to moderate and severe forms of asthma. GSK’s mild asthma campaign reaped huge financial dividends, catapulting the drug into the top five highest revenue-generating drugs in the world. In 2003, a clinical study revealed the dangers of GSK’s campaign, noting that salmeterol — an active ingredient in the drug — actually increased the risk of asthma-related death and other breathing problems. In response, the FDA mandated revisions to the Advair label, including a black box warning of the dangers associated with Advair use in patients with mild asthma. Despite the black box warning, GSK continued to market the drug for mild asthma.
GSK conducted similar off-label promotion and marketing for the other products noted above — falsely representing their FDA-approved uses. The end result of the record-setting settlement was that GSK agreed to plead guilty to criminal conduct and paid $3 billion in criminal and civil fines, penalties, and damages.
