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Secretary Reinforces VA's Commitment to Research Safety and Veteran Focus
Date:7/9/2008

, Chantix, is in fact considered to be the most effective medication available for smoking cessation with six million prescriptions written.

Peake noted any veterans receiving Chantix in the study or anywhere in the VA had been put on the drug by their doctors as an individual doctor-patient decision, with continued monitoring the health status. As information within the VA and by the FDA suggested potential psychological side effects were being seen in some patients taking Chantix, Clinical providers were notified promptly. Not only were letters sent by researchers to members of the study, but, additionally, a letter has been sent to every veteran prescribed Chantix by the VA discussing possible side-effects, encouraging them to contact their provider immediately if they experience side effects and assuring them that the VA will help them find another way to quit smoking if they are concerned about Chantix or are having side effects.

More than 60 FDA approved drugs could have adverse effects that may include "suicidal ideation and suicidal behavior," Peake said. "If VA were to withhold these medications from our patients with mental health issues, we would have great difficulty treating them. Weighing the risk -- and all drugs have risks -- against the benefit with the best information available is what the doctor and patient do as a drug is prescribed."

The Secretary also addressed allegations implying VA research is somehow compromised by outside entities such as drug companies and universities calling it ridiculous. The smoking cessation study was solely funded by the VA, with no outside funding. VA research is approved by VA's Office of Research and Development and does not require approval from the Secretary, including this smoking cessation study. The scientific review and human subjects protection processes ensure that VA research addresses specifically and only the purpose of the study.

Peake has also directed four internal inves
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SOURCE U.S. Department of Veterans Affairs
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