AG sues major drugmaker for false advertising

TUCSON — Pfizer misrepresented the risks associated with one of its products and recruited doctors to promote it in order to reap up to $4 billion in sales, a recent lawsuit claims.

The Arizona Attorney General filed a 15-page court complaint recently that alleges New York-based Pfizer Inc. repeatedly deceived consumers to pump up sales of Bextra, which the FDA approved for treatment of arthritis and menstrual pains.

Specifically, the complaint in Pima County Superior Court claims that Pfizer:

• Withheld studies that showed safety risks,
• Deployed an enormous sales staff to promote Bextra’s “off-label” uses,
• Gave improper gifts to physicians in return for their help marketing the product.

Lawyers for state Attorney General Terry Goddard claim the deceptions began in 2001 after the U.S. Food and Drug Administration declined to approve Bextra for all of the “off-label” uses Pfizer was counting on to make Bextra a financial “blockbuster,” the complaint states. It has since settled with the federal government for almost $900 million.

The state claims Pfizer was trying to push Bextra as a treatment for acute and perioperative pain and as a way to reduce gastrointestinal side effects without the research to prove it or tell both sides of the drug’s story.

The controversy involves a line of drugs called COX-2 inhibitors. These drugs block one of two enzymes that make the feeling of pain and inflammation more pronounced.

Three types of this drug received FDA approval, according to the complaint. Pfizer released Celebrex in early 1999, which was followed several months later by Vioxx from Merck, a Pfizer competitor. Vioxx was withdrawn from the market in 2004; Bextra was withdrawn in 2005; and Celebrex was given a “black box” warning on its label for certain risks associated with COX-2 drugs, the complaint states.

Still, Pfizer allegedly persisted in selling Bextra under its new pain-killing role. The state claims it cast negative studies associated with Bextra as a fluke, bought research from advertising agencies it had under contract and, in one case, got positive studies published in a major medical journal before editors could retract it.

It also disclosed only “favorable” data for Bextra, and ran several ad campaigns that touted Bextra as the ideal pain-killer for the “weekend warrior.”

The company “also sought out and developed physician speakers who were high prescribers of Bextra and supported its off-label use,” the complaint claims. “These health care providers were then paid to give lunch or dinner talks relating to off-label use of Bextra.”

Sales staff often accompanied doctors on their presentations, which were usually held at the best restaurants in town, the complaint claims. The most successful doctors were 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.

The state Attorney General is seeking a permanent injunction that bars Pfizer from continuing these alleged practices in Arizona, as well as civil penalties and attorney’s fees. The state is represented by assistant Arizona Attorney General Noreen R. Matts in Tucson.