I would like to thank the Members of the Committee, our witnesses, and all those in the audience for being here today.

I was appalled when the Washington Times published an article revealing that the VA was and continues to use Chantix in Cooperative Studies Program #519 - “Smoking Cessation Treatment for Veterans with PTSD.”  Some Veterans with Post-Traumatic Stress Disorder (PTSD) enrolled in a VA smoking cessation study were being, and continue to be, administered Chantix.

Chantix received FDA approval on May 11, 2006.  However, on November 20, 2007, the FDA issued an early communication about an ongoing safety review of Chantix.  It revealed that FDA had received reports of “suicidal thoughts and aggressive and erratic behavior in patients who have taken Chantix.”  At this point, the VA should have suspended the study and immediately notified all patients of the possible dangers.

The loss of a single veteran to suicide is a tragedy.  Since December 2007, this Committee has held two hearings regarding the issue of veterans’ suicide.  This is why I fail to understand why the VA did not react when the FDA issued the early communication concerning the dangerous side effects of Chantix.

On February 1, 2008, the FDA issued a Public Health Advisory stating:  “Chantix may cause worsening of current psychiatric illness even if it is currently under control and may cause an old psychiatric illness to occur…symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about orattempted suicide.”

But it failed to mention the fact that Chantix may lead to suicidal ideation or attempted suicide.  This fact was buried in the consent form.

Regardless, the warning was too late for Mr. Elliott, an Army veteran of OIF.  In February, he suffered a psychotic episode that led to a confrontation with the police.  Mr. Elliott, I appreciate your appearance before the Committee today and look forward to your testimony.

This is merely the latest incident in a series of events, from the suicides in Dallas to the e-mail suggesting VA providers downgrade the diagnosis of PTSD to “adjustment disorders” to the e-mail downplaying the epidemic of suicides in the VA, that have caused me and the other members of this Committee to question the VA’s accountability measures and also the Department’s dedication to addressing the mental health needs of our returning servicemembers.

Today we will look at VA’s procedures for handling human research subjects, determine whether they were followed in the design and execution of the smoking cessation study and explore whether there was adequate oversight of the study.  Furthermore, I want to investigate VA’s responsibility to respond to FDA advisories and VA’s decision to continue to use Chantix, a suicide-inducing drug, on veterans with PTSD.

But in a much larger sense, we use this hearing today to ask the VA when are you going to take responsibility, when will you hold people responsible for the numerous issues that have been identified over the last few months.

We see this in an email sent from Temple, Texas, stating that “given that we are having more and more compensation seeking veterans, I’d like to suggest that you refrain from giving a diagnosis of PTSD straight out.  Consider a diagnosis of Adjustment Disorder.” 

We see this in Dallas, where, after four patients committed suicide this year, the psychiatric ward was forced to close.  We see this time and time again, where we hear soothing words like “responsibility” and “accountability,” but we do not see action.  Talk is indeed cheap, especially when it comes to the safety and well-being of our veterans.

It seems to me, and to other members of this committee, that the VA continues to follow the same old pattern…deny, deny, deny.  And then when caught and confronted…cover up, cover up, cover up…or tend to try and minimize the importance of the issue, or show the veteran as an anomaly.  But no one is held accountable and the system goes on.

When questioned, the VA immediately wants to defend “the process.”  When is the VA going to understand that it is not about the process, but about the veteran?  When will the VA stop being the veterans adversary and start being the veterans advocate?

We are talking about people…we are talking about our veterans.  Don’t defend your process…defend our veterans…our heroes.

The VA waited until February 29, 2008, to send a letter and new consent form to study participants to notify them of the dangers associated with Chantix.  The letter informed patients that they may experience “an increase in psychiatric symptoms such as anxiety, nervousness, tension, depression as well as untoward changes in behavior.”