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Vermont To Receive $2 Million And Advertising Restrictions In Attorney General Settlement With Pfizer Inc

CONTACT: Julie Brill, Assistant Attorney General, (802) 828-3658

October 22, 2009 - Vermont will receive over $2 million dollars from a settlement between pharmaceutical company Pfizer Inc and the Vermont Attorney General’s Office. Attorney General William H. Sorrell today filed a Stipulated Judgment with Pfizer Inc resolving a five-year investigation by 33 states and the District of Columbia concerning the company’s promotion of the drugs Celebrex® and Bextra®. “This Judgment, along with our other recent drug cases, should send a strong message to the pharmaceutical industry that we will not tolerate deceptive and misleading drug promotion. The comprehensive injunctive relief obtained in this case is outstanding and addresses all concerns identified over five years of investigation,” Attorney General Sorrell said.

In addition to a $60 million payment to the participating states, with Vermont’s share being over $2 million, the Judgment filed in the Washington Superior Court will restrict Pfizer from deceptively promoting all Pfizer products. The multistate investigation focused on Pfizer’s aggressive, deceptive and unlawful campaign to promote two of its non-steroidal anti-inflammatory drugs, Celebrex and Bextra, including promotion of Bextra “off-label” for uses that had been expressly rejected by the federal Food and Drug Administration (FDA). While a physician is allowed to prescribe drugs for off-label uses, law prohibits pharmaceutical manufacturers from marketing their products for off-label uses.

Cheap, generically available traditional non-steroidal anti-inflammatory drugs have been used for many years to treat pain and inflammation; however, they have the potential to cause serious gastro intestinal side effects such as bleeds and perforations. Drugs such as Celebrex and Bextra, made by Pfizer, and Vioxx, made by Merck & Co., Inc., were designed to reduce pain and inflammation without negative side effects. Although significantly more expensive, those three drugs have not been shown to be more effective in relieving pain or to significantly reduce side effects as compared to Ibuprofen and Naproxen. Moreover, there are significant concerns that Celebrex, Bextra, and Vioxx increase the risk of serious cardiovascular adverse events such as heart attacks and strokes. Bextra also carries a risk of a serious and sometimes fatal skin condition. In 2004, due to safety concerns, Bextra and Vioxx were withdrawn from the market, and FDA required a “black box” safety warning for Celebrex.

The Judgment generally prohibits Pfizer from deceptive and misleading advertising and promotion of any Pfizer drug, requires Pfizer to register all clinical trials, post clinical trial results, and to submit all “direct-to-consumer” (DTC) television drug advertisements to the Food and Drug Administration (FDA) for approval and comply with any FDA comment before running the advertisement.

For further information on this case, see the court documents posted on the Attorney General’s website at: www.atg.state.vt.us under “Prescription Drugs".

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