On Monday, July 2, 2012, GlaxoSmithKline pled guilty to 3 misdemeanor criminal counts and settled civil liabilities concerning prescription drugs Paxil, Wellbutrin and Avandia. GSK and its CEO have done well to respond with contrition and a commitment to make things right. According to government allegations, here's what happened:
- GSK unlawfully marketed the wildly popular Paxil to children and adolescents, which had FDA approval to treat depression only for adults. While GSK was targeting children, Paxil was flying off the shelves: Paxil sales surpassed $1.8 billion in both 2001 and 2002. It became one of the top 10 selling drugs and for a time the most commonly used selective serotonin reuptake inhibitors.
- Wellbutrin, approved as an antidepressant, was unlawfully marketed as a wonder drug for weight loss and sexual dysfunction. Carmen Ortiz, the U.S. Attorney for the District of Massachusetts, said GSK hired a "public relations firm to create a buzz about getting skinny and how you could have more sex simply by using this drug."
- For Avandia, a diabetes drug, GSK failed to provide certain safety data to the FDA so the agency could determine if the drug continues to be safe for its approved indications.
America is more medicated and spending more money on prescription drugs than ever before. The most recent data from the Centers for Disease Control indicates that prescription use by children and adults is on the rise, and spending for prescription drugs was $234.1 billion in 2008 -- more than double what was spent in 1999. When a company like GSK is selling more drugs to more people, using fraud to sell even more drugs looks downright greedy– all at the expense of sick and suffering Americans.
Apologize, Be Visionary and Clean House. GSK was no doubt braced for the government to make a public spectacle of the ordeal and issue a tongue-lashing. GSK responded the right way and made little attempt to minimize or recharacterize what it did. Indeed, there is no "positive" about a $3 billion criminal and civil fine (unless you're the government). The penalty is so enormous and the conduct so egregious, attempting to do anything but accept full responsibility would be wholly inconsistent with GSK's guilty plea and settlement.
Here's how GSK responded:
1. Press release. While a wordy headline makes no mention of "fraud" or "criminal" (nor is there an expectation that it would), GSK puts the $3 billion out front: "GlaxoSmithKline concludes previously announced agreement in principle to resolve multiple investigations with US Government and numerous states; Final settlement of $3bn covered by existing legal provisions announced in November 2011. Fundamental changes to US compliance, marketing and selling procedures implemented in recent years."
2. CEO Statement (within press release):
- Apology. CEO Andrew Witty was apologetic, expressed regret and his intention to act in the interest of patients. Anything short of a full scale, unequivocal apology would have been viewed as insufficient, even offensive.
- Distance between alleged conduct and CEO's tenure. Witty distanced GSK's past bad acts by noting they "originate in a different era for the company," but acknowledged that they "cannot and will not be ignored." Witty became CEO in 2008 – most of the alleged conduct occurred between 1999-2007.