Arizona Bextra Lawsuit Charges Pfizer In 2005, the U.S. Food and Drug Administration (FDA) and European regulators formally asked Pfizer, Inc. to suspend sales of Bextra in the United States and Europe. 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 risks—a high rate of heart attacks, strokes, other cardiovascular injuries, and Stevens Johnson Syndrome—posed by Bextra outweighed its benefits. 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. The FDA approved Bextra for “treatment of arthritis and menstrual pains.” According to Zonie, the lawsuit says that Pfizer: “Withheld studies that showed safety risks, deployed an enormous sales staff to promote Bextra’s “off-label” uses, and gave improper gifts to physicians in return for their help marketing the product.”
the FDA’s declination of Bextra approval for all of the “off-label” uses
Lawyers for the Attorney General claim that the “deceptions began in 2001” following the FDA’s declination of Bextra approval for all of the “off-label” uses for which Pfizer was seeking approval, said Zonie, which added that Pfizer settled with the federal government for nearly $900 million. The state’s suit also alleges that Pfizer was looking to promote Bextra for treatment for “acute and perioperative pain” and also to help with “gastrointestinal side effects,” 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. Pfizer released Celebrex in early 1999; soon after Merck released Vioxx. In 2004, Merck removed Vioxx—known generically as Rofecoxib—after data from a clinical trial found an increased risk of heart attack and stroke, blood clots, and other cardiovascular complications. The complaint states that, in 2004, Bextra was withdrawn and Celebrex received a “black box” label warning, notes Zonie.
Despite looming lawsuits, Pfizer apparently continued to sell Bextra as a pain killer and—according to the Zonie report regarding the contents of the complaint—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.
Pfizer also only disclosed “favorable” Bextra data
Also, according to the Zonie piece, Pfizer also only disclosed “favorable” Bextra data, running ad campaigns promoting Bextra as the “ideal pain-killer” for the “weekend warrior”; and “also sought out and developed physician speakers who were high prescribers of Bextra and supported its off-label use,” according to the complaint. “These health care providers were then paid to give lunch or dinner talks relating to off-label use of Bextra,” 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 “rewarded with ‘preceptorships’ in which they received up to $500 to allow Bextra sales reps to accompany them on their rounds or in the operating room,” said Zonie. The state Attorney General is seeking a permanent injunction barring Pfizer from continuing these alleged practices in Arizona.