VA testing drugs on war veterans

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By Audrey Hudson

One of the nation's premier medical ethicists said the VA's behavior in the anti-smoking study violated basic protections for humans in medical experiments.

"When you're taking advantage of a very vulnerable population, people who have served the country, and the agency that's responsible for their welfare isn't putting their welfare first, that's a pretty serious breach of ethics," said Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania.

In all, nearly 1,000 veterans with PTSD were enrolled in the study to test different methods of ending smoking, with 143 using Chantix. Twenty-one veterans reported adverse effects from the drug, including one who suffered suicidal thoughts, the three-month investigation by The Times and ABC News found.

Mr. Caplan, who reviewed the consent and notification forms for the study at the request of The Times and ABC News, said the VA deserved an "F" and that it has an obligation to end the study, given the vulnerability of veterans with PTSD and the known side effects of Chantix. "Continuing it doesn't make any ethical sense," he said.

The VA continues to test Chantix on veterans, even as reported problems with the drug increase and have prompted at least one other federal agency to take action. On May 21, the Federal Aviation Administration banned airline pilots and air traffic control personnel from taking Chantix, citing the adverse side effects.

The VA responds

VA officials defend their use of veterans in medical studies, saying that helping PTSD sufferers to stop smoking would prolong their lives. As for the three-month delay in notifying its patients about the Chantix problems, the VA said bureaucracy slowed down their warning because the alert letters had to be issued through an Institutional Review Board (IRB) that oversees the experiment at each VA location.

"We don't have the authority to just send directly to patients material that has not been approved by the IRB sites,"said Miles McFall, director of the VA's programs for PTSD sufferers. "We did sense urgency. And we respond to that urgency doing just what we did here, which was, I think, incredibly quick response for a governmental institution.

"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 to respond appropriately," he said.

While Mr. Elliott blames Chantix for his mental breakdown and confrontation with police, VA officials said they cannot be sure.