A nod to yesterday’s Progress Report for pointing me to this Washington Times story. It’s about veterans with post-traumatic stress disorder (PTSD) being given the drug Chantrix in a Veterans Administration study about smoking cessation. Chantrix has a record of causing or exacerbating mental instability, and someone somewhere had to be nuts (to use the technical, clinical term) to ever consider giving it to guys with PTSD without informing them fully of the risks, but that is indeed what they did.

When someone else figured out those vets really should be told about what they were taking, however, it took three months to get the information out to them. The VA’s Miles McFall called that an “incredibly quick response for a governmental institution.”

Everyone who thinks three months is a quick response when you’re sick and have been giving something that can make you sicker, raise your hand.

I thought so.

The reason McFall gave for not informing the study participants immediately was,

“We don’t have the authority to just send directly to patients material that has not been approved by the IRB (Institutional Review Board) sites…”

The last time I checked, IRBs existed to protect the welfare of study participants. That their regulations would prevent full disclosure to research subjects for three months—three months during which the drug could do serious damage to the vets—is ludicrous and reprehensible.

A little more than a month ago I posted about another medical SNAFU. In that post I suggested the inclusion, in all such regulations, of something I gave the working title of Humanitarian Reasonable Override. There needs to be a mechanism for moving not just quickly, but immediately. It’s simply a travesty that the lack of authority to protect people’s live and health in such a situation could have ever become codified.

It’s high time to change that.

Peace. And good health.

Deborah Alicen