The idea that the quit-smoking drug Chantix triggers violence and suicide in its users is mostly media hype following the shooting death of New Bohemians guitarist Carter Albrecht, Pfizer (PFE) argued in an Alabama federal court. The company produced a chart (below) showing how complaints to the FDA of adverse events linked to the drug only took off after Albrecht's Sept. 3, 2007, death.
The chart shows how much damage media reports can do to a drug brand, and Pfizer's sensitivity to them. It's not just reputation damage: Pfizer is fighting 275 cases alleging Chantix triggered violent or suicidal harm in patients. The cases are largely a media-generated phenomenon, Pfizer believes.
A study by the Institute for Safe Medication Practices of the FDA adverse event database in 2010 concluded that violence was 18 times more likely to be associated with Chantix (sold as Champix in foreign territories) than the average drug. Pfizer argues that the study is misleadingly inflated because other drugs didn't get the same level of media coverage as Chantix did:
Despite these admitted limitations, the ISMP report acted as a catalyst for this litigation, with one plaintiff attorney reportedly receiving 1,300 inquiries from potential plaintiffs the day after ISMP published the report.Pfizer used the Albrecht killing as the dramatic center of its argument:
For the first 13 months that Chantix was on the market, the number of adverse event reports was not significant, particularly given the millions of patients using the medication. Then the Carter Albrecht incident occurred.
On September 3, 2007, a popular Texas musician named Carter Albrecht and his girlfriend were drinking at a Dallas bar until approximately 3:00 a.m. Once at home, Albrecht reportedly assaulted his girlfriend, and she locked him out of the house. 21 Albrecht then wandered into his neighbor's yard and, for reasons that are unknown, began pounding loudly on his neighbor's back door. The neighbor, thinking Albrecht was a burglar, shot Albrecht in the head, and killed him. Because Albrecht had been taking Chantix at the time, his girlfriend publicly blamed Chantix in the media, claiming that the medication was responsible for Albrecht's behavior and his death.24 The results of Albrecht's autopsy were not available until several days later, but they ultimately showed that Albrecht's blood alcohol level was three times the legal limit.
The publicity surrounding Albrecht's death was followed by an increase in the number of adverse event reports for Chantix, which prompted an FDA Alert that continued the trend of increased reporting, as illustrated below.Here's the chart showing the uptick in reports about Chantix to the FDA:
The killing prompted the FDA to issue an "early warning" about the drug, which only drew more headlines, and thus more adverse event reports. (Indeed, adverse event reports for the drug have fallen off since the media lost interest in Chantix.)
The chart came as part of Pfizer's argument that it should be able to enforce subpoenas against the ISMP, who are working with plaintiffs' lawyers. The judge knocked back the request, saying that it either had all the information it wanted or the material was already public. The judge also complained that Pfizer was trying to snow the court with irrelevant paperwork -- including 66 exhibits, of which the first 52 were irrelevant. She ruled:
The evidentiary submissions contain hundreds of pages irrelevant to current motion ...
The court therefore requests the defendant to ensure its future submissions have some relevance to the motion they are filed to support.Related: