Attorney General Steve Six today filed a stipulated judgment with Pfizer Inc. resolving a five-year investigation by 33 states concerning the company's promotion of the "Cox-2" drugs Celebrex® and Bextra®.
In addition to a $60 million payment to the participating states, the judgment filed in the Shawnee County District Court will largely restrict Pfizer's ability to deceptively promote all 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. The comprehensive injunctive relief obtained in this case is outstanding and addresses all concerns identified over five years of investigation," Six said.
Kansas will receive $740,649 from the judgment. The judgment requires that the payment be used by Kansas for attorneys' fees and litigation costs, to increase consumer education, and to increase the enforcement of consumer protection laws.
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 anti-inflammatory drugs (NSAIDS), such as Ibuprofen (Advil®) and naproxen (Aleve®). 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 place and FDA required a "black box" safety warning for Celebrex.
In its Complaint, Kansas 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 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 implicitly promoted Bextra off-label.
· Misrepresenting Bextra's safety.
Kansas also 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 the 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.
"While this money will help increase consumer education and the enforcement of our Consumer Protection Act, I'm particularly pleased with the additional protections that will restrict Pfizer's ability to use deceptive advertising and promotions," Six said.
In addition, the judgment requires Pfizer to submit all "direct-to-consumer" (DTC) television drug advertisements to the 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 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 Kansas on today's settlement are: Alaska, Arizona, Arkansas, California, Connecticut, Florida, District of Columbia, Idaho, Illinois, Iowa, Maine, 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.
Consumers wanting more information about this settlement and Kansas consumer protection in general may call the 1(800) 432-2310.