June 18, 2008 – It’s time that the House and Senate committee chairs investigate the Department of Veterans Affairs for medical ethics. As a three-month Washington Times/ABC News investigation revealed Tuesday, the VA is testing drugs with sometimes-severe side effects on hundreds of military veterans, including many post-traumatic stress syndrome patients, in trials whose risks the participants may not fully recognize. Evidence of troublingly slow risk assessment and predatory-sounding enticements for Iraq and Afghanistan veterans are the chief shortcomings that beg Galen’s principle: “First, do no harm.” The lives of service-member participants are too important, and the integrity of government post-traumatic stress disorder research is too vital, for the federal government to be taking these manifest risks.
The scope of the problem is potentially very large, even systemic. The federal government has conducted 25 drug tests on veterans with post-traumatic stress disorder and carried out 300 studies on the disorder itself. (An estimated 300,000 Iran and Afghanistan veterans suffer from the disorder or from depression.) There are at least five test drugs bearing warnings about suicide or suicidal thoughts. Also, 4,796 military veterans are enrolled in post-traumatic stress disorder studies – including 940 in the smoking cessation study that raised red flags. One-hundred-forty-three veterans in this study take Chantix, which is made by Pfizer Inc. and is the drug-cessation drug under special scrutiny in The Washington Times/ABC News investigation. The potential side effects of Chantix include neuropsychiatric symptoms, such as suicidal thoughts and depressed mood. Twenty-one veterans have reported adverse side effects because of Chantix – and the drug is still being used in VA studies.
“Lab rat” is how one Iraq veteran describes his experience in the VA’s volunteer medical experiments – and little wonder. Former Army sharpshooter James Elliott of Silver Spring was not informed of the serious potential side effects of Chantix until after a post-traumatic stress disorder recurrence that resulted in a potentially lethal encounter with police. The Iraq veteran assumed the study would follow safe protocols when he signed up for a chance to quit his habit of three packs of cigarettes a day and to receive the $30 monthly enticement. But soon, his nightmares and stress reactions returned with suicidal thoughts, to the point that his fiance called the police fearing Mr. Elliott might hurt himself. In the resulting standoff, police Tasered the armed Mr. Elliott, who recollects in an interview: “I would have shot me.”
Why was a distressed veteran, who served 15 months in Iraq, not informed of Chantix’s serious potential side effects until after this potentially lethal encounter?
Chantix was a moving target, but the federal government was much too slow to respond. In November, the Food and Drug Administration (FDA) issued its first warning about Chantix. On Jan. 18, Pfizer updated its warning label: “[P]atients who are attempting to quit smoking with Chantix should be observed for serious neuropsychiatry symptoms, including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.” Yet it was not until Feb. 29 that the VA wrote to veterans and issued its own warning about “untoward changes in behavior” and side effects, including “anxiety, nervousness, tension, depression, thoughts of suicide, and attempted and completed suicide.”
According to the FDA, nearly 40 suicides and more than 400 incidents of suicidal behavior have been linked to Chantix. But it took three months for the Chantix warning to make its way through the VA system and to the patients, as this week’s Washington Times/ABC News study showed. It was during that time Mr. Elliott relapsed into post-traumatic stress.
Too many lives were put at unnecessary risk – veterans’ lives and those of neighbors, family and law enforcers – in a pattern that could easily recur unless and until the VA is better managed. At the very least, the VA should end the trials of Chantix.
The lax communications regarding the Chantix trials are unconscionable. The federal government can do better: It must do better.
The changes coming to bear at institutions like Walter Reed Army Medical Center and VA medical facilities are welcome. But human life is more important. This is a prime opportunity for those in Congress who strive for improved oversight of the executive branch. James Elliott’s story is not one the government should allow to be repeated.