Chantix Scandal Prompts Changes at VAJul 10, 2008 | Parker Waichman LLP
Following revelations that it enrolled combat veterans with Post Traumatic Stress Disorder (PTSD) in a Chantix trial without warning participants of the drugs' suicide risks, the Department of Veterans Affairs is now reviewing drug protocols for such veterans.
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.
A few weeks ago, ABC News, in conjunction with The Washington Times, aired an investigative report which revealed that veterans enrolled in a Chantix clinical trial - all diagnosed with PTSD - had not been told that the drug was linked to depression, suicide and psychotic behavior. According to the ABC News report, hundreds of Iraq war vets with PTSD were recruited by the VA and paid $30.00 per month to participate in a Chantix behavioral study. Even after the FDA issued its Chantix Early Communication in November, the VA did not notify study participants of its association with suicide. It wasn’t until the FDA issued its second warning, and Pfizer sent out its own alert, that the VA acted. But even then, the VA’s notice didn’t specifically mention suicide.
Following the outcry that resulted from the ABC report, VA Secretary James Peake told a Washington Times reporter that he was personally sending new warning letters to the 940 veterans in the study and some 31,000 other veterans who have been prescribed Chantix by the VA.
A review by the VA Office of Inspector General found that researchers in the study "did not ensure that patients involved in the smoking cessation study were notified of the risk of suicidal thoughts or behavior in a timely manner."
The ABC News report quickly caught the attention of Congress, and yesterday, Peake appeared before the House Committee on Veterans' Affairs to explain the VA's handling of the Chantix trial. Peake has said he "wished" the VA had not taken so long to warn veterans being used in the Chantix test. Peake said his department will now review all drugs prescribed by the VA to veterans with PTSD. Part of that review will be to examine the risks of medications on PTSD vets and to review proper notification procedures.
Committee chair Bob Filner (D-Ca) asked Peake repeatedly why the Chantix study hasn't been ceased. But Peake said that until the VA's internal review on the handling of Chantix is completed, there is no reason to take further action.