The government is testing drugs with severe side effects like psychosis and suicidal behavior on hundreds of military veterans, using small cash payments to attract patients into medical experiments that often target distressed soldiers returning from Iraq and Afghanistan, a Washington Times/ABC News investigation has found. In one such experiment involving the controversial anti-smoking drug Chantix, the Department of Veterans Affairs (VA) took three months to alert its patients about severe mental side effects. The warning did not arrive until after one of the veterans taking the drug had suffered a psychotic episode that ended in a near lethal confrontation with police.
| Chantix is a new drug whose side effects weren't completely known even after phase III trials. |
Mr. Elliott, a chain smoker, began taking Chantix last fall as part of a VA experiment that specifically targeted veterans with PTSD, opting to collect $30 a month for enrolling in the clinical trial because he needed cash as he returned to school. He soon began suffering hallucinations and suicidal thoughts, unaware that the new drug he was taking could have caused them.
Just two weeks after Mr. Elliott began taking Chantix in November, the VA learned from the Food and Drug Administration (FDA) that the drug was linked to a large number of hallucinations, suicide attempts and psychotic behavior. But the VA did not alert Mr. Elliott before his own episode in February.
In failing to do so, Mr. Elliott said, the VA treated him like a "disposable hero." "You're a lab rat for $30 a month," Mr. Elliott said.
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.
| He's correct: the IRB has to be notified, has to review the data, and has to approve shutting down the study and notifying the patients. |
Mr. McFall said the veterans with PTSD in the anti-smoking study "are at high risk to use tobacco" and the goal of the experiment is to determine how best to deliver treatment - through a mental health counselor or a smoking clinic. Chantix was one of several options tested on the veterans.
Eight pages (six more) at the Washington Times site, D.C.'s 'other paper, including other experiments that "sound like torture" according to the radio.