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Another Drug Company Settles With Maine
October 21, 2008
Today, Attorney General Steve Rowe announced the filing of a stipulated judgment with Pfizer Inc. resolving a five-year investigation by 33 states attorneys general concerning the company’s deceptive promotion of the “Cox-2” drugs Celebrex® and Bextra®. The State of Maine will receive approximately $630,000 from the $60 million payment made by Pfizer to the participating states. The agreement, filed in Kennebec County Superior Court, will also curb Pfizer’s ability to deceptively promote all of its products.
“This judgment represents the latest victory for Maine people against pharmaceutical companies that market their drugs for use in an unsafe manner. The broad restrictions on Pfizer’s marketing practices should go a long way to protect the health and safety of Maine people,” Rowe said.
The multistate investigation was initiated in 2003 to determine whether Pfizer and another drug company Pharmacia, subsequently purchased by Pfizer, misrepresented that their jointly sold Cox-2 drug Celebrex was safer and more effective than traditional non-steroidal antinflamatory drugs (NSAIDS) such as Ibuprofen (Advil®) and naproxen (Aleve®). Cox-2 drugs selectively block an enzyme that impedes the production of certain chemicals that cause pain and swelling. As the investigation proceeded, additional concerns were raised regarding Pfizer’s second generation Cox-2 drug Bextra. Ultimately, the investigation concluded that Pfizer engaged in an aggressive, deceptive and unlawful campaign to promote Bextra “off label” for uses that had been expressly rejected by the Food and Drug Administration (FDA). “Off-label” uses are uses that are not approved by the 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 NSAIDS have been used for many years to treat pain and inflammation; however, NSAIDS have the potential to cause serious gastro intestinal (GI) side effects such as bleeds and perforations. The Cox-2 drugs Celebrex, Vioxx and Bextra were designed to reduce pain and inflammation without the negative GI side effects of traditional NSAIDS. Although significantly more expensive than traditional NSAIDS, Cox-2 drugs have not been shown to be more effective relieving pain than traditional NSAIDS and neither Celebrex nor Bextra were ever proven to significantly reduce serious GI adverse events compared to traditional NSAIDS. Moreover, there are significant concerns that all three Cox-2 drugs 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 the FDA required a “black box” safety warning for Celebrex.
In its Complaint, the state alleges that despite the fact that significant safety concerns led the FDA to reject a request to market high dose Bextra for acute and surgical pain, Pfizer conducted a systematic, multi-pronged “off-label” promotional campaign for these very indications the FDA denied by:
• Distributing hundreds of thousands of copies of a positive study from the denied application, as well as other positive studies relating to use of high dose Bextra, without distributing or disclosing the negative study that was the basis for the FDA’s rejection, or disclosing that the FDA had expressly rejected approving Bextra for acute and surgical pain. • Co-opting influential doctors with paid consultancies and lavish weekends at high end resorts. • Distributing hundreds of thousands of samples of high dose Bextra to specialists whose only possible use for high dose Bextra was off-label. • Providing prizes and otherwise encouraging sales representatives to promote Bextra off-label. • Using supposedly non-promotional Continuing Medical Education to promote Bextra off-label. • Using imagery and language in advertisements that implicitly promoted Bextra off-label. • Misrepresenting Bextra’s safety.
The State alleges these efforts continued even after Pfizer completed a study that confirmed the FDA’s reason for rejecting the acute and surgical pain indications for Bextra. This study ultimately contributed to FDA’s decision to withdraw Bextra from the marketplace, even at the low doses that had been previously approved.
Today’s Judgment contains injunctive terms addressing all concerns raised during the investigation regarding both Celebrex and Bextra. Included in the Judgment are terms that will help prevent:
• Deceptive use of scientific data when marketing to doctors.
• “Ghost writing” of articles and studies.
• Failing to adequately disclose conflicts of interest for Pfizer promotional speakers when these consultants also speak at supposedly independent Continuing Medical Education.
• Distributing samples with the intent to encourage off-label prescribing.
• Distributing information about an off-label use when FDA has rejected the off-label use unless Pfizer clearly discloses that FDA rejected the use and FDA’s reason for rejecting. • Distributing off-label studies and articles in a promotional manner. • Providing incentives to sales staff to increase off-label prescribing. • Promoting drugs off label for inclusion in hospital standing orders and protocols. • Using “mentorships” to pay physicians for time spent with Pfizer sales reps. • Using grants to encourage use of Pfizer products. • Using sales personnel to make grant decisions that are supposedly unrelated to promotion and marketing. • Using patient testimonials to misrepresent a drug’s efficacy.
In addition, the judgment requires Pfizer to submit all “direct-to-consumer” (DTC) television drug advertisements to the Food and Drug Administration (FDA) for approval and comply with any FDA comments before running the advertisement. If FDA does not respond within 45 days, Pfizer may run the advertisement but must still comply with any subsequent FDA comments regarding the advertisement and must notify the state that it is running the advertisement without FDA authorization. For any new drug for pain relief, Pfizer must delay direct-to-consumer advertising for up to 18 months should FDA recommend such a delay. Finally, 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 ensure that subjects in Pfizer sponsored clinical trials give adequate informed consent.
Joining Maine in today’s agreement are: Alaska, Arizona, Arkansas, California, Connecticut, Florida, District of Columbia, Idaho, Illinois, Iowa, Kansas, Maryland, Massachusetts, Michigan, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, and Wisconsin.
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NEWS RELEASE October 21, 2008 David Loughran, (207) 626-8577