Much as I suspected when I first wrote about Pfizer's attempts to minimize potentially serious neurological side effects of its smoking-cessation drug Chantix, the drugmaker's stonewalling tactics have simply made a bad situation worse. To wit:
- John Spangler, director of Tobacco Intervention Programs at Wake Forest University, told ABC News that Pfizer and the FDA ignored concerns about possible Chantix side effects that he raised more than a year ago. Central to Spangler's case is a 251 patient study that declared Chantix is safe to take for up to a year, which the doctor says was too small ("underpowered," in industry lingo) to support that assertion. Hat tip: Pharmalot.
- Also via Pharmalot, Pfizer sales reps have apparently been playing down Chantix side effects since February -- right about the time the FDA issued a formal warning that the drug might cause "serious neuropsychiatric symptoms." See the chart at right (click for a larger version), which Pharmalot's Ed Silverman dug out of ImpactRx, a market-research firm that tracks the drug industry.
- While this incident doesn't appear to involve Pfizer directly, it still relates to the delay in publicizing warnings about Chantix. A Washington Times/ABC News investigation reports that soldiers with post-traumatic stress disorder taking Chantix as part of a trial at the Department of Veterans Affairs weren't alerted about possible mental-health side effects for three months -- and then only after an Army sharpshooter in the trial suffered a psychotic episode that ended in a confrontation with local police. Hat tip: Pharmagossip.
Don't hold your breath.
Further reading: Pfizer Spins, And Spins Some More on Chantix