Testing Drugs on Vulnerable Vets

Last week, ABC News and the Washington Times reported that hundreds of veterans with post-traumatic stress disorder (PTSD) have been enrolled in Department of Veterans Affairs (VA) studies testing smoking cessation drugs, with 143 of these veterans taking Chantix, a drug that has been linked to severe psychiatric symptoms (see posts here, here, and here. The veterans are paid $30 a month for participating.

According to the ABC News/Washington Times report, the VA became aware in November that Chantix had been linked to psychiatric side effects, but waited over three months to notify the veterans of the potential danger. Late last week, the VA disclosed that 26 Serious Adverse Events (SAEs) had occurred during the Chantix study, including 10 of a psychiatric nature.

The ABC News/Washington Times story describes the case of James Elliott, a decorated Army sharpshooter with PTSD who started taking Chantix in November and soon started experiencing hallucinations and suicidal thoughts, unaware that Chantix might be causing them. In February, Elliott was tasered by police who were called to his home after he became confused and psychotic. "Lab rat, guinea pig, disposable hero," said Elliott in describing how he felt he was treated by the VA.

Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said the VA's behavior 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," he said.

Caplan, who reviewed the consent and notification forms for the study at the request of the Washington 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.

Late last week, the VA announced that the study would continue but that it would send a letter to all 32,000 veterans who are taking Chantix, warning them of possible side effects, including suicidal thoughts and behavior. "Our first responsibility is to our veterans," said Veteran Affairs Secretary James Peake, who said he has asked VA doctors to review "the communications process" involving all VA studies using veterans who are suffering from PTSD.

-- PM