Pfizer 's participation in the cover-up of the deadly side effects of Bextra surely contributed to its membership. Because the drug was promoted and sold off-label for so many unapproved uses, the company made hundreds of millions of dollars in pure profits during Bextra 's short life on the market. However, experts predict that when all is said and done, the total amount of the drug 's damage to consumers will be in the billions.
It is now apparent that Pfizer knew Bextra was associated with extremely harmful side effects long before it was yanked off the market. However, Pfizer had good reason to stall its inevitable removal after Vioxx was recalled.
Bextra was on the market for about 3.5 years, but did not reach its full sales potential until Vioxx was eliminated from the competition. After the Vioxx recall, in one month alone, Bextra prescriptions went from 1.15 million in September 2004, to 1.48 million in October. All total for 2004, Pfizer generated sales of about $1.3 billion.
The marketing history of Bextra involves a train of suspicious conduct. On November 16, 2001, the drug's original maker, Pharmacia won FDA approval for treatment of pain associated with osteoarthritis, adult rheumatoid arthritis and menstrual pain only and immediately went into overdrive promoting the drug for off-label use.
An FDA Talk Paper on the agency 's web site on November 15, 2002, announced new warnings on Bextra and said, "labeling is being updated with new warnings following postmarketing reports of serious adverse effects including life-threatening risks related to skin reactions -- including Stevens Johnson Syndrome, and anaphylactoid reactions. "
The following month, the "Congress of California Seniors, " filed a lawsuit against Pharmacia in a Superior Court in Los Angeles, alleging the company had illegally promoted Bextra for off-label use.
According to the group, after the FDA refused a request to approve Bextra for pain related to impacted molars, Pharmacia helped fund a study that claimed Bextra could be useful in fighting acute dental pain and got it published in dental journals which led to the suit alleging secretive encouragement of 'off label ' uses and attempting to circumvent the FDA 's refusal.
On November 2, 2003, after a year-long analysis of prescribing records, Knight-Ridder reported that more than half of Bextra pills sold were for off-label use.
About 5 months later, on March 14, 2004, Pfizer disclosed in a regulatory filing that the Justice Department was investigating the company's marketing practices of Bextra for uses not approved by the FDA.
In October, 2004, the New England Journal of Medicine carried two editorials calling for renewed scrutiny of all Cox-2 inhibitors to assess whether the other drugs also caused heart problems.
The FDA 's inaction was also noted by the Washington Post pointing out that in the late 1990s, the FDA took action when safety concerns were raised by withdrawing 10 drugs within 3 years. "But until the Vioxx withdrawal, only one other drug had been pulled since the Bush administration began, leading some to conclude that the agency had made a quiet policy change that emphasized "benefit" and sought to manage "risk" less intrusively," the Post said on April 11, 2005.
As it turns out, Pfizer knew Bextra was every bit as dangerous as Vioxx and that the incidence of heart attack and stroke among patients using Bextra was more than 2 times that of patients taking placebos, which was revealed in a study presented on November 9, 2004, during the annual meeting of the American Heart Association in New Orleans.