Rep. Markey said, "Allowing, even encouraging, military veterans who have already made enormous sacrifices for our country to participate in drug studies that may could cause serious, long-lasting health effects is tantamount to breaking our national promise to honor and support our veterans. These media reports raise serious questions about how the VA is operating these studies and how, or if, it is coordinating with the experts at the Food and Drug Administration. I look forward to prompt answers from the VA."

“As Chairman of the House Committee on Veterans’ Affairs, I plan to hold a hearing in early July – to figure out why it took so long to notify patients of the side effects of the drug that was used in this study. Once the FDA issued a warning that Chantix could lead to suicidal thoughts and aggressive and erratic behavior, the VA should have suspended the study IMMEDIATELY. This is the bureaucratic dynamic in all its glory. I expect VA to respond to this letter and provide useful information on how the VA coordinates drug studies among the veteran community,” said Rep. Filner.

"These findings raise serious questions about what the VA knew and why they delayed in letting veterans know about the dangers of this treatment," Rep. Hodes said. "If the VA put our veterans in danger and did not provide proper notification, it is truly a national disgrace; and, the American people and our veterans deserve accountability."

According to a ABC News/Washington Times investigation released yesterday, June 17^th, the VA encouraged veterans, some suffering from Post Traumatic Stress Disorder (PTSD), to participate in a smoking cessation study involving the drug Chantix that may have exposed these veterans to harmful side effects that could exacerbate their mental health conditions and possibly lead to suicidal thoughts.

Reps. Markey, Filner and Hodes asked for prompt answers to a series of specific questions including:

• Does the VA terminate studies involving drugs that are the subject of advisory notices  and/or formal FDA alerts? 
• Why did the VA fail to mention "suicidal thoughts" as a possible side effect in its notification to study participants on February 29, 2008, when the FDA explicitly listed "suicidal ideation" in its official alert on February 1, 2008? 
• Does the secretary agree that a three-month delay in notification of serious side effects qualifies as a "quick response" for the VA?  If not, what is the VA doing to ensure that such notifications occur more quickly in the future?
• Media reports note that the Pfizer clinical trials for Chantix did not include individuals with "serious psychiatric illnesses."  Did the VA consider this exclusion when choosing to study the drug's effect on a population group that may exhibit some signs of serious psychiatric problems?

A copy of the letter is available HERE.