June 19, 2008 -- Responding to an ABC News/Washington Times investigation, the Veterans Administration plans to inform 32,000 veterans that they are using a drug linked to suicide or violent behavior.
All of the veterans enrolled in the Chantix study suffered from Post Traumatic Stress Disorder (PTSD) and had been recruited, with monthly $30 payments, for a behavioral study with the drug.
Veterans Affairs Secretary James Peake told Washington Times reporter Audrey Hudson Thursday that he was personally sending new warning letters to the 940 veterans in the study and some 31,000 other veterans who have been prescribed Chantix by the VA.
"Our first responsibility is to our veterans," said Peake, who said he has asked VA doctors to review "the communications process" involving all VA studies using veterans who are suffering from PTSD. Some 400,000 veterans are being treated for PTSD.
The Bush White House had initially defended the VA's handling of the Chantix experiment.
"The VA is doing everything they can to be mindful of the safety of these veterans in all their programs and try to help them." said Deputy White House Press Secretary Tony Fratto at a briefing on Tuesday after the ABC News report aired.
"This is the Veterans Administration, under wonderful leadership by Secretary Peake, who is interested in the health and safety of these veterans that are under his care, and every other member of that VA system is the same," said Fratto.
In contrast, Secretary Peake said he "wished" the VA had not taken so long to warn veterans being used in the Chantix test.
One of the veterans in the Chantix study, James Elliott, of suburban Washington, suffered a mental breakdown and near-lethal confrontation with police which he blames on Chantix.
VA doctors say there is no evidence Chantix was responsible.
Elliott's incident with police occurred in February, after the VA knew of the possible risks, but before it had notified veterans.
Elliott said the failure of the VA to inform him of Chantix's possible side effect made him feel like "a guinea pig, lab rat, disposable hero."
"It hurts me to have anyone think we would treat our veterans as lab rats," Peake said.
Peake also revealed that there had been 26 "severe adverse effects" in the Chantix test group of veterans, including three cases of contemplated suicide.
Chantix has been linked to at least 40 suicides and 400 attempted suicides in the population at large, according to the FDA which published its first alert Nov. 20, 2007.
The FDA issued a second warning, and there was an alert from the drug's maker, Pfizer, before the VA finally began to warn veterans in the study on Feb. 29, 2008.
But even then, the VA omitted the word "suicide" from the cover letter sent to veterans.
Secretary Peake said the new VA warning letter he is sending will specify that suicide is one of the possible side-effects of Chantix.
"I have no problem putting suicide in there, myself," said Peake.
He said the VA would not hesitate to stop the study if needed, as some in Congress have demanded.
"We're not enrolling new people in this study," he said, but there are no plans to stop the current project.
"Chantix is an FDA-approved drug," Peake said, "and we're trying to find the best way to support smoking cessation."
But Peake said there was no evidence to suggest the study should be stopped.