Chantix Worries Prompted Pfizer Lobbyist to Contact VAJul 9, 2008 | Parker Waichman LLP
A lobbyist for Pfizer - once the head of the Department of Veteran's Affairs (VA) - contacted his old agency about keeping Chantix on its drug formulary, even after the smoking cessation drug was linked to suicides. According to the Washington Times, former VA secretary Anthony J. Principi contacted his old colleagues earlier this year, shortly after the federal government banned pilots and air traffic controllers from using Chantix.
In the US, Chantix has been linked to at least 40 suicides and 400 attempted suicides. In November 2007, the Food & Drug Administration (FDA) issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.
In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.
Chantix again made headlines in May, when the Institute for Safe Medication Practices issued a report detailing Chantix adverse event reports to the FDA. The study specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of traffic accidents and falls linked to Chantix. As a result of the Institute’s report, the Federal Aviation Administration banned Chantix use by pilots and air traffic controllers.
According to The Washington Times report, Principi contacted officials at the VA after the Institute released its report. Pfizer claims that all Principi did was pass along requests via e-mail asking whether an internal VA study that examined 27 veterans hospitalized for psychotic episodes while taking Chantix would be made public. A company official told the Times that it doesn't consider that to be lobbying - even though Principi was employed as Pfizer's chief lobbyist.
But e-mails reviewed by The Washington Times also reveal that Mr. Principi forwarded inquiries from Pfizer about Chantix's status on the VA's list of prescribed drugs, at one point stating, "I really hate to be a pain, but I keep getting asked these questions."
This isn't the first time that the VA's dealings concerning Chantix have raised concerns. Last month, it was learned that the agency allowed veterans with Post Traumatic Stress Disorder (PTSD) to be enrolled in a Chantix trial, but waited months after the FDA issued its last suicide warning to notify the trial participants - along with thousands of other veterans prescribed Chantix through the VA - about those dangers.
In fact, it wasn't until a joint ABC News/Washington Times investigation questioned the Chantix clinical trial that the VA sent out a Chantix warning that specifically mentioned suicide.