ABSTRACT

In 2004, Pfizer agreed to plead guilty to two felonies and pay $430 million to settle charges that it fraudulently promoted the epilepsy drug Neurontin for unapproved uses. A drug index, Drugdex, listed no less than 48 off-label uses for Neurontin, and Medicaid was obliged to pay for the drug if being prescribed for one of these uses. Doctors were also paid to lend their names to ghostwritten articles purporting to show that Neurontin worked for unapproved conditions, and a professor requested and received over $300 000 to write a book on epilepsy. The company even insisted on pressing doctors to use much higher doses of Neurontin than those that had been approved, which means higher income for more harm. Pfizer even recognised that unblinding due to adverse events could result in corruption of the study’s validity.