GSK Pleads Guilty
Pharmaceutical giant GlaxoSmithKline recently plead guilty to health care fraud and agreed to pay the largest settlement of its kind ever – $3 billion. The plea included three separate counts, two involving putting misbranded antidepressants (Paxil and Wellbutrin) on the market, and one count of failing to report safety information to the FDA concerning the increased risk of heart attack and failure with diabetes drug Avandia. Fines for the criminal counts total $1 billion. In addition, the company will pay a $2 billion fine for civil liabilities stemming from these drugs and others.
The Justice Department leveled a number of alarming charges. GSK was accused of pricing fraud, promoting Paxil for use by teenagers without FDA approval and persuading doctors to prescribe Wellbutrin for off label use (weight loss) by hosting meetings at lavish hotels in 2003.
While this is the largest settlement ever of its kind, and the Justice Department reports that it recovers $15 for every dollar spent on prosecuting these kinds of cases, critics contend that the penalties are insufficient to deter illegal behavior for companies with pockets as deep as big pharma. The speculation is that only when the individuals that make the decisions that lead to illegal actions are personally targeted will we see a change. On the other hand, historically, excepting the occasional Bernie Madoff, the people truly responsible rarely pay the price of malfeasance. Prosecuting the top of the food chain would have to become the rule…not the exception.
Does the end justify the means?
Another possible consideration is that doing an end run around the FDA may be beneficial to patients. One example of logical progression is Wellbutrin, a drug approved for use as an antidepressant. It is a well known trade secret that it was regularly recommended to diabetes patients for weight loss. Since depression is also often tied to diabetes, and one of the effects of Wellbutrin is to suppress cravings, it makes a certain sense to ask leading questions, diagnose depression, and write a prescription that may help control or avoid depression whether it exists or not, and at the same time curb cravings to help the patient lose weight. From a logical, and even a help standpoint, it sounds perfectly reasonable.
So the question becomes: How dangerous is this practice? Maybe the FDA moves too slowly on some things, especially where the drug is already approved for other use. What’s your opinion on this? Do you side with the law…or with the doctors just trying to do right by their patients…and enjoy some cushy vacations at the expense of big pharma in the meantime?