The drug in question is Bextra, known by its generic name valdecoxib. Bextra was manufactured primarily by Pfizer subsidiary Pharmacia & Upjohn. The Food and Drug Administration (FDA) approved Bextra in 2001 for treating arthritis and menstrual cramps.
The FDA did not approve Bextra for treating acute pain. Studies showed it was not more powerful than ibuprofen. Regardless, Pfizer still instructed its sales representatives to lie to doctors and tell them that Bextra could be used to treat acute and surgical pain at doses well above those approved by the FDA. (Related: Pfizer has a shockingly long history of engaging in illegal activities and human experimentation.)
Pfizer was also aware of certain adverse effects associated with taking higher doses of Bextra. These included risks to the kidney, heart and skin. Pfizer did not tell its sales representatives to inform doctors of these potential side effects. In fact, these side effects convinced the FDA to withdraw the drug in 2005, just six years after it was unveiled and just four after it was approved by the FDA.
"Among other things, Pfizer did the following: Pfizer invited doctors to consultant meetings, many in resort locations. Attendees expenses were paid; they received a fee just for being there," said Michael K. Loucks, the acting U.S. Attorney for the District of Massachusetts at the time and the lead prosecutor of the case.
The $2.3 billion fine was, at the time, the largest healthcare fraud settlement in the history of the Department of Justice. The fine included a criminal fine of $1.195 billion paid by Pfizer. At the time, it was the largest criminal fine ever imposed for any matter. Pharmacia & Upjohn also agreed to forfeit $105 million, pushing the total criminal resolution to $1.3 billion.
In addition to this, Pfizer agreed to pay $1 billion to resolve civil allegations under the False Claims Act for illegally promoting Bextra and three other drugs – Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug.
This illegal marketing scheme caused false claims to be submitted to Medicare and Medicaid programs for uses that were not "medically accepted indications" and therefore were not actually covered.
Of the $1 billion civil settlement, the federal government received $668,514,830 for how much the federal Medicare program paid for off-label Bextra purchases. State Medicaid programs received the remaining $331,485,170.
"Among the factors we considered in calibrating this severe punishment was Pfizer's recidivism," said Loucks. When Pfizer was fined $2.3 billion in 2009, it was Pfizer's fourth settlement with the U.S. government over illegal marketing activities since 2002.
As part of the settlement, Pfizer also agreed to enter into a corporate integrity agreement with the Department of Health and Human Services' Office of Inspector General. This agreement was intended to put in place procedures and reviews to prevent this kind of conduct from appearing again.
"The size and seriousness of this resolution … reflect the seriousness and scope of Pfizer's crimes," said Loucks. "Pfizer violated the law over an extensive time period. Furthermore, at the very same time Pfizer was in our office negotiating and resolving the allegations of criminal conduct by its then newly acquired subsidiary, Warner-Lambert, Pfizer was itself in its other operations violating those very same laws."
Learn more about the illegal activities of Big Pharma companies like Pfizer at BigPharmaNews.com.
Watch this episode of the "Zolna Report" as host Gabe Zolna talks about how the FDA approved Pfizer's Bextra and then pulled it from the market a few years later.