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Attorney General Ellen F. Rosenblum

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AG MYERS FILES JUDGMENT AGAINST PFIZER FOR $60 MILLION CONCERNING IT'S MARKETING OF DRUGS CELEBREX & BEXTRA

October 22, 2008

Attorney General Hardy Myers Files Judgment Against Pfizer, Inc. Resolving A Five-Year Investigation Into The Company's Marketing Of Bextra And Celebrex

Oregon, 32 other states and District of Columbia to share in $60 million settlement; Injunctive terms of settlement apply to all Pfizer prescription drugs and biological products

Attorney General Hardy Myers today filed a stipulated judgment with Pfizer, Inc. of New York resolving a five-year multi-state investigation organized and led by the Oregon Attorney General concerning the company's deceptive promotion of the "Cox-2" drugs Celebrex and Bextra. In addition to a $60 million payment to the participating states with Oregon's share being more than $4 million, the judgment filed in Marion County Circuit Court will largely restrict Pfizer's ability to deceptively promote any Pfizer products.

"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," Myers said. "The comprehensive injunctive relief obtained in this case is outstanding and addresses all concerns identified over five years of investigation."

The 33-state 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 anti-inflammatory drugs (NSAIDS) such as Ibuprofen (Advil®) and Naproxen (Aleve®). As the investigation proceeded, additional concerns were raised about 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 not approved by the FDA. While a physician is allowed to prescribe drugs for off-label use, 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 side effects such as bleeding and perforations in the gastrointestinal (GI) system. The Cox-2 drugs Celebrex, Vioxx and Bextra were designed to reduce pain and inflammation without the negative GI side effects of traditional NSAIDS. Despite being significantly more expensive than traditional NSAIDS, Cox-2 drugs have not been shown to be more effective in relieving pain than traditional NSAIDS and neither Celebrex nor Bextra have been 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 lethal skin condition. Due to safety concerns, in 2004 and 2005 respectively, Vioxx and Bextra were withdrawn from the market place and in 2005 FDA required a "black box" safety warning. The toughest FDA warning label, the warning with a black border denotes the serious risk of adverse effects from the drug.

In its complaint, the state alleged that despite the significant safety concerns that led 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 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 FDA's rejection, or disclosing that 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 specialties 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 implicity promoted Bextra off-label.
  • Misrepresenting Bextra's safety.

The complaint also alleged these efforts continued even after Pfizer completed a study that confirmed FDA's reasoning for rejecting 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 and applying to all Pfizer prescription drugs and biological products such as vaccines. 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 comment 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 about the advertisement and must notify the settling states and the District of Columbia 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 if the FDA recommends 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.

Consumers wanting more information about this settlement and Oregon consumer protection in general may call the Attorney General's consumer hotline at (503) 378-4320 (Salem area only), (503) 229-5576 (Portland area only) or toll-free at 1-877-877-9392. The Oregon Department of Justice is online at www.doj.state.or.us.

Contact:

Jake Weigler, (503) 378-6002
Jan Margosian, (503) 947-4333 (media line only) jan.margosian@doj.state.or.us |
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