WASHINGTON, D.C. - U.S. Senator Daniel K. Akaka (D-HI), Chairman of the Veterans' Affairs Committee, issued a statement today regarding VA research on smoking and PTSD. Media outlets recently reported that the Department of Veterans Affairs is testing a drug with potentially dangerous side effects on veterans, including returning servicemembers with mental health disorders.
At issue is whether VA should have notified study participants in November, 2007, when the FDA first learned of Chantix's side-effects, which include suicidal thoughts, and aggressive and erratic behavior. Despite the November warning, participants were not notified until February 29, 2008, three-weeks after a veteran participating in the study was arrested after suffering what reporters described as a mental breakdown.
"VA seems to have followed the letter of the law. However, when studies include veterans who are more vulnerable to dangerous side effects, VA should respond to the enhanced risk with enhanced care and caution.
"Veterans must be immediately informed, especially when they are participating in a study which seeks to determine whether the testing will result in hazardous mental health outcomes."