In 2005, the U.S. Food and Drug Administration (FDA) and European regulators formally asked Pfizer, Inc. to suspend sales of <"http://www.yourlawyer.com/topics/overview/bextra">Bextra in the United States and Europe.Â As a result, Pfizer announced it would halt sales of the drug in the United States and the European Union countries immediately. The FDA stated that the risksâ€”a high rate of heart attacks, strokes, other cardiovascular injuries, and Stevens Johnson Syndromeâ€”posed by Bextra outweighed its benefits.Â Now, the Zonie Report has published a piece discussing yet another lawsuit involving Pfizer, this time over deception in marketing.
Zonie is reporting that the Arizona Attorney General filed a 15-page court complaint that alleges that Pfizer repeatedly conned consumers to increase Bextra sales; the lawsuit states that Pfizer misrepresented Bextra risks, enlisting doctors to promote the drug to increase sales.Â The FDA approved Bextra for â€œtreatment of arthritis and menstrual pains.â€Â According to Zonie, the lawsuit says that Pfizer:Â â€œWithheld studies that showed safety risks, deployed an enormous sales staff to promote Bextraâ€™s â€œoff-labelâ€ uses, and gave improper gifts to physicians in return for their help marketing the product.â€
Lawyers for the Attorney General claim that the â€œdeceptions began in 2001â€ following the FDAâ€™s declination of Bextra approval for all of the â€œoff-labelâ€ uses for which Pfizer was seeking approval, said Zonie, which added that Pfizer settled with the federal government for nearly $900 million.Â The stateâ€™s suit also alleges that Pfizer was looking to promote Bextra for treatment for â€œacute and perioperative painâ€ and also to help with â€œgastrointestinal side effects,â€ all without appropriate and complete research.
Zonie notes that the controversy involves COX-2 inhibitors, medications that block pain and inflammation and that the complaint states that three COX-2 inhibitors received FDA approval.Â Pfizer released Celebrex in early 1999; soon after Merck released Vioxx.Â In 2004, Merck removed Vioxxâ€”known generically as Rofecoxibâ€”after data from a clinical trial found an increased risk of heart attack and stroke, blood clots, and other cardiovascular complications.Â The complaint states that, in 2004, Bextra was withdrawn and Celebrex received a â€œblack boxâ€ label warning, notes Zonie.
Despite looming lawsuits, Pfizer apparently continued to sell Bextra as a pain killer andâ€”according to the Zonie report regarding the contents of the complaintâ€”minimized the findings of a negative study, bought research from advertising agencies with which it contracted, and arranged for the publication of positive studies publish in a major medical journal before editors were able to retract the piece.Â Also, according to the Zonie piece, Pfizer also only disclosed â€œfavorableâ€ Bextra data, running ad campaigns promoting Bextra as the â€œideal pain-killerâ€ for the â€œweekend warriorâ€; and â€œalso sought out and developed physician speakers who were high prescribers of Bextra and supported its off-label use,â€ according to the complaint. â€œThese health care providers were then paid to give lunch or dinner talks relating to off-label use of Bextra,â€ Zonie quoted from the complaint.
Zonie noted that the complaint detailed how sales staff would join doctors on their presentations, with the most successful doctors â€œrewarded with â€˜preceptorshipsâ€™ in which they received up to $500 to allow Bextra sales reps to accompany them on their rounds or in the operating room,â€ said Zonie.Â The state Attorney General is seeking a permanent injunction barring Pfizer from continuing these alleged practices in Arizona.