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Mardi, 19 Octobre 2010 13:02

Is Army Overhyping Its 'Breakthrough' Brain-Injury Test?

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Army brass last week declared a triumph over diagnosing traumatic brain injuries, hyping a simple new blood test they say can catch the trauma before it becomes more severe; before telltale symptoms manifest; or before troops sustain a second concussion.

But with one small study and a history of expensive, under-peforming “breakthrough” treatments for brain injuries, this latest test still has a ways to go before it’ll be worth bragging about.

“This is a breakthrough,” Col. Dallas Hack, director of the Army’s Combat Casualty Care Research Program, tells CNN. “It can make a significant benefit for mankind.”

That’s high praise for a blood test that military-funded docs have only tried on 34 patients, none of them troops and all of them already admitted to hospital and diagnosed with concussions. The test, developed by Banyan Biomarkers, detects two blood proteins that don’t appear in the blood of uninjured people. Researchers think the proteins are released into the blood when the brain undergoes a startling blow, like getting rattled around in a Humvee that rolls over a roadside bomb.

If it works, the test would be a gamechanger for the Pentagon. Known as “the signature wound” of the wars in Iraq and Afghanistan, traumatic brain injuries have skyrocketed among troops. In 2003, around 80 troops a month suffered TBIs. This year, according to the Pentagon’s Monthly Medical Surveillance Report, around 450 monthly TBIs were reported during battle.

Thousands more ailing troops go unnoticed, often because current TBI screening tests are “basically a coin flip,” as Lieutenant General Eric Schoomaker, the Army’s surgeon general, put it. The military has invested $1.7 billion into TBI research since 2007. But docs are still struggling to figure out what triggers the injuries in the first place, and how they impact the brain.

Just last month, it was reported that independent medical experts who studied the Navy SEALs’ new, much-touted “instant brain injury test” had given it a failing grade. In fact, the neuroassessment tool yielded more false positives than even the military’s current, much-maligned TBI screening program.

That said, the Army’s blood test would be a major improvement on both current military screenings and the SEALs’ test. Both of those are based on neurological symptoms, like headaches and confusion. A blood screening like this one would tap into TBIs before those warning signs show up. And the possibility that biomarkers can diagnose the injuries might help researchers figure out how TBIs affect the brain.

But even without a published study from the Army, independent medical experts are already tempering the Pentagon’s public euphoria.

“Banyan Biomarkers has identified some novel biomarkers in CSF (cerebral spinal fluid) …” Dr. Alan Faden, director of the Center for Shock, Trauma and Anestesiology Research at the University of Maryland School of Medicine, told ABC News. “But at present there are insufficient data to support the ‘hype’ expressed by Col. Hack.”

A larger clinical trial, on 1,200 patients, is expected to conclude by 2013. Its success or failure will be the deciding factor in approval by the Food and Drug Administration. But even before the trial kicks off, Col. Hack says the Army wants prototypes of portable devices that can perform the test in combat.

So it’ll be at least two more years before troops find out whether or not the Army’s “breakthrough” is little more than false hope. And even if troops are  accurately diagnosed, adequate treatment for TBIs remains a mystery. Not to mention that service members often face redeployment, regardless of their damaged gray matter.

Photo: U.S. Army

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Authors: Katie Drummond

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