Washington, DC – U.S. Senator Barbara Boxer (D-CA) today sent a letter to Department of Veterans Affairs (VA) Secretary, James Peake, asking him to explain why Chantix – a drug with known psychological side effects – was being tested on veterans with Post-Traumatic Stress Disorder (PTSD) and whether the department deliberately downplayed the seriousness of the side effects. She also called for a moratorium on all such tests until a review of the Chantix trial is completed.
The full text of the letter follows:
June 19, 2008
The Honorable James B. Peake, M.D.
Department of Veterans Affairs
810 Vermont Avenue, N.W.
Washington, DC 20420
Dear Secretary Peake:
I write to express my deep concern over a report that appeared in the Washington Times on June 17, 2008, that the Department of Veterans Affairs (VA) is testing an anti-smoking drug with known serious psychological side effects on veterans with Post-Traumatic Stress Disorder (PTSD). Sadly, this appears to be yet another example of the VA’s lack of concern for the well-being of our nation’s veterans.
First and foremost, I ask that you provide me with an explanation as to why Chantix – a drug that alters brain activity – was tested on veterans with PTSD when so little is known about how PTSD impacts the brain. While developing tools for treating nicotine addiction is important to the health of our veterans, I cannot help but question the need to test smoking cessation pharmaceuticals on a population with a condition we know far too little about.
We should focus our efforts on discovering the relationship between PTSD and the brain before attempting to treat related conditions – such as addiction – with drugs that further impact brain function. While the VA’s National Center for PTSD has made significant strides in developing protocols in diagnosis and treatment, much work remains to be carried out in the area of identifying biological markers for PTSD within the brain.
I also request that you explain why the most serious potential side effect – suicidal thoughts – was not included in a notice provided to study participants. Such an omission is unacceptable and outrageous. Following an FDA alert in late 2007, the drug’s manufacturer, Pfizer, revised its warning label in January to state that “patients who are attempting to quit smoking with Chantix should be observed for serious neuropsychiatric symptoms, including changes in behavior, agitation, depressed mood, suicidal ideation, and suicidal behavior.”
In explaining why the warning notice sent to veterans by the VA failed to include a warning about the risk of suicidal thoughts, VA has claimed that “the more verbiage you use, the more difficult and lengthy it becomes...” I find it hard to believe that the explicit use of the word “suicide” would have been more difficult to interpret than the phrase the VA elected to use – “untoward changes in behavior.” This raises strong questions as to the VA’s intent with this study. One must ask what was so important about continuing it without full disclosure to those who participated.
It would also be prudent to consider the recommendations of Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, including his suggestion that future studies involving veterans with PTSD should receive special approval from the Secretary of Veterans Affairs.
Finally, I urge you, in the strongest possible terms, to institute a moratorium on testing drugs with serious psychological side effects on veterans with mental health conditions, including PTSD. This moratorium should remain in place until a review is conducted of the Chantix trial and additional safeguards are implemented. One must look at the results of the Chantix trial. Of the 143 veterans taking Chantix in the study, twenty-one noted adverse effects from the drug, including one who reported suffering suicidal thoughts.
Thank you for your attention to this very important request. I look forward to your prompt response.
Sincerely,
Barbara Boxer
United States Senator
