Back in September 2009, Pfizer and its subsidiary Pharmacia & Upjohn Co. Inc. agreed to a $2.3 billion penalty to resolve criminal and civil liability arising from the illegal promotion of its drugs for off-label purposes. Some of the drugs involved were the painkiller Bextra, the anti-psychotic drug Geodon, the antibiotic Zyvox and the anti-epileptic drug Lyrica. (Related: Pfizer pleads guilty to felony crime in fraudulent marketing of Bextra, pays billions in fines.)
Federal officials touted the settlement as a model for tough and effective enforcement – with Kevin Perkins, assistant director of the Federal Bureau of Investigation's (FBI) Criminal Investigative Division at the time, saying it "sends a clear message" to the pharmaceutical industry.
But an investigation by CNN's special investigations unit showed that one of the agency's officials downplayed the story of Big Pharma's influence and power – even in cases where it breaks the laws intended to protect patients.
"Any company convicted of a major health care fraud is automatically excluded from Medicare and Medicaid," the mainstream media outlet said. "Convicting Pfizer on Bextra would prevent the company from billing federal health programs for any of its products. It would be a corporate death sentence."
CNN added that Pfizer's conviction would disrupt the flow of Pfizer products to Medicare and Medicaid recipients. It would also negatively affect Pfizer employees, including those uninvolved in the case, and company shareholders.
The New York-based company then exploited a loophole.
Pfizer and the federal government cut a deal. Instead of charging Pfizer itself, Pharmacia & Upjohn – the subsidiary it acquired in 2003 – would take the blame. This essentially rendered the subsidiary, which was itself a product of a 1995 merger, as a shell company whose only function is to plead guilty.
"As a result, the subsidiary was excluded from Medicare without ever having sold so much as a single pill. [Meanwhile], Pfizer was free to sell its products to federally-funded health programs."
Only GlaxoSmithKline's 2012 settlement of $3 billion over hiding the risks of its diabetes drug Avandia dwarfed Pfizer's penalty. Nevertheless, Pfizer denied wrongdoing on all the allegations and still maintains its ability to do business with the federal government until this very day.
Bextra was among a family of painkillers known as COX-2 inhibitors that were supposed to be safer than generic drugs. However, it was priced 20 times higher than ibuprofen, which was a perfect opportunity for Pfizer to make money. Thus, it planned to sell Bextra as a treatment for acute pain – with marketing managers and sales managers from Pfizer targeting anesthesiologists and surgeons.
"A manager in Florida emailed his sales [representatives] a scripted sales pitch that falsely claimed the Food and Drug Administration (FDA) had given Bextra 'a clean bill of health' all the way up to a 40mg dose, which is twice what the FDA actually said was safe," CNN's investigation team claimed.
The team also unearthed internal documents showing how Pfizer and its subsidiary used a medical education budget amounting to millions of dollars to pay hundreds of doctors. The medical professionals were reportedly paid to tout Bextra.
The FDA deemed Bextra unsafe for patients at high risks of heart attacks and strokes in 2001. However, it allowed the use of Bextra to treat arthritis and menstrual cramps. Promoting drugs for "off-label" uses puts patients at risk – and what Pfizer did with Bextra is tantamount to breaking the law.
Lewis Morris, chief counsel at the Department of Health and Human Services' Office of the Inspector General, remarked that Pfizer "pushed the envelope so far past any reasonable interpretation of the law that it's simply outrageous."
BigPharmaNews.com has more stories about Pfizer and other drug companies.
Watch this video that discusses Pfizer's fraud, negligence and criminal acts.
This video is from the Wake Up to Reality channel on Brighteon.com.
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