WASHINGTON – The Veterans Affairs Department did not adequately warn veterans — some of whom suffered from combat-related psychological disorders — who participated in an anti-smoking study that involved a medication that can induce suicidal tendencies, a researcher told FOX News.
A joint report by The Washington Times and ABC News was critical of the study, and detailed how one returning soldier — Maryland resident James Elliott — who participated in the study might have averted a violent arrest had he known the side-effects of the anti-smoking drug Chiantix.
White House spokesman Tony Fratto, responding to the reports Tuesday, called it some of the "more irresponsible reporting I've ever seen," saying the story was distorted by focusing too heavily on the experience of one veteran and suggesting that was the experience for everyone in the study.
"We care for vets," Fratto said, adding that VA is "doing everything it can to be mindful of the (patients') safety."
The Times reported that nearly 1,000 veterans were enrolled in a recent study of various anti-smoking drugs, 143 of whom were prescribed Chiantix, which can cause psychotic episodes in some patients and induce suicidal feelings. VA, however, did not mention the possible suicidal side effects initially.
And when the FDA issued a warning regarding possible side effects of suicidal feelings, it took three months for the VA to alert patients enrolled in the study.
Tom Moore, a researcher with the independent Institute for Safe Medication Practices, worked on a Chiantix study for the Food and Drug Administration. He told FOX News the FDA's research did not include those who suffered from mental illness. He said the VA should have issued stronger warnings than it did.
Elliott, the Maryland veteran, did not find out about the side effects until after a psychotic episode ended in his arrest following a police standoff. He was tasered when he reached for a concealed handgun, the Times reported. He was given $30 a month for his participation in the study.
According to the report, the VA defended its use of the study, but admitted the bureaucratic process slowed its ability to notify patients of news related to Chiantix. VA has since changed some of the language it uses on consent forms.
"We believe that we took responsible action by informing the clinicians who are the people most in touch with the patients to be on the lookout for any potential side effects and respond appropriately," said Miles McFall, who oversees the VA's post-traumatic stress disorder program, according to the Times.
The federal government is running several other studies on PTSD-diagnosed veterans, the report says.
With respect to the anti-smoking study, the VA now advises potential study participatnts that the drugs could cause "changes in behavior, anxiety, nervousness, tension, depression, thoughts of suicide and attempted and completed suicide." The previous letter did not include the mention of suicide.
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