VA Testing

VA TESTING….From the Washington Times:

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.

I’m having a hard time figuring out if this story has uncovered something genuinely troubling, or if it’s a trashy piece of sensationalism. The Times reports that the VA is involved in several studies that target returning veterans with PTSD (post-traumatic stress disorder), but that’s because the VA is trying to figure out how to treat PTSD — as it should. It’s also true that many anti-depressants, as well as other psychiatric drugs, have cognitive side effects in some patients that are sometimes severe. But that doesn’t mean these drugs shouldn’t be tried as PTSD therapies or that conducting clinical studies on PTSD patients is improper, and the Times doesn’t suggest that. So what’s the VA doing wrong?

It turns out that the entire rest of the story boils down to one thing: a single vet out of a group of 143 who suffered a psychotic episode while using the anti-smoking drug Chantix. Here’s the timeline: in November the FDA issued a warning that Chantix patients should be monitored for “behavior or mood changes” and the VA passed this warning along to the clinicians involved in the Chantix study. In early February the FDA issued a formal alert, and in late February the VA sent a letter to patients in the study telling them about Chantix’s side-effects.

Now, it’s possible that the VA should have acted more quickly here, and it’s also true that their warning letter to patients seems to have underplayed the problems (it warns of “anxiety, nervousness, tension and depression,” but doesn’t mention suicidal thoughts). Still, it was only three months between the initial preliminary warning and the letter sent out to participants, and only one person out of 143 in the VA study reported suicidal thoughts.

So I’m not sure what to think of this. Is the VA genuinely being careless with vulnerable vets? Or did they act properly and the small incidence of side effects is simply unavoidable in these kinds of studies? I’d like to hear from some people with serious experience in this kind of thing before I make up my mind.

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