DC Medical Malpractice & Patient Safety BlogFDA approves a blood test to diagnose severity of traumatic brain injury
Federal officials offer a glimmer of hope in caring for head injuries, especially the sharp, repeated, and often damaging blows that afflict athletes and which millions worldwide are witnessing, yes, as part of the Winter Olympic Games.
The federal Food and Drug Administration has announced that it has approved a long-awaited blood test that can help doctors determine the severity of traumatic brain injuries. This test will provide a cheaper, easier, more convenient, and likely faster way to handle the rising health bane of concussions, rather than relying on computed tomography or CT scans using big machines and a form of X-rays.
As the New York Times reported:
The test works by measuring the levels of proteins, known as UCH-L1, and GFAP, that are released from the brain into blood and measured within 12 hours of the head injury. Levels of these blood proteins can help predict which patients may have intracranial lesions visible by CT scan, and which won’t. In a statement announcing the approval, the FDA said that the brain trauma indicator was able to predict the presence of intracranial lesions on a CT scan 97.5 percent of the time, and those who did not have such lesions 99.6 percent of the time.
The new procedure, which will be called the Banyan brain trauma indicator, and which was developed with the Pentagon, has advantages over the CT scan. These benefits help explain why the Department of Defense pushed for the development of this test and why the FDA expedited its scrutiny and approval.
CNN reported that the blood test can be given as soon as 15 minutes after an injury and results now take a few hours — though researchers hope to shorten that time, too. The test likely will cost about $150 versus $800 to $1,200 for a CT scan. Further, CT scans are performed with major, pricey hardware that isn’t as convenient and accessible as a blood test, which could be performed more easily and readily on troops in the field or athletes on sporting events’ sidelines. The test has been approved for adult use and work continues to expand its application for youngsters.
And though advances with CT scanning have reduced the devices’ risks, doctors recommend limited exposure to the radiation used in such exams. There have notable device failures, such as an incident in which a Los Angeles hospital self-reported that it found more than 200 cases in which patients were given excessive radiation doses in CT exams.
In my practice, I see not only the major harms that patients suffer while seeking medical services but also the huge damage that can be wreaked on them by dangerous and defective products, including medical devices like CT scanners. I also see how their lives can be upended by brain and spinal cord injuries.
As Banyan Biomarkers, the San Diego firm that developed the head trauma blood test with the U.S. military has noted:
Automobile accidents, falls, sports-related injuries, assaults, and, in the military, improvised explosive devices (IEDs) and combat wounds are common causes of [traumatic brain injuries]. The [CDC] estimates there are more than 2.5 million emergency room visits in the United States as a result of head injuries and TBI is an economic burden of more than $76 billion annually on the healthcare system. Traumatic brain injury is the leading cause of disability and the number one cause of death for young adults.
In these times of deserved and rising concussion-risk awareness, it’s great to see a diagnostic option like a blood test, so CT scans aren’t the only choice. Let’s hope, though, that athletes and their caregivers don’t over-use this alternative and, instead, they test appropriately. Pricey CT procedures already have been targeted by watchdogs due to unnecessary, risky, and inappropriate use.
And, though football has caught a lot of heat for well-founded reasons, head trauma is a peril in many other athletic endeavors, as the Winter Games are amply illustrating. To state the obvious, especially to residents of the more typically winter-bound Washington, D.C., area, ice and snow may look scenic and inviting. They also are hard and slippery, posing head and limb trauma risk for skiers, skaters, and those in sled-like apparatuses. To their credit, the Olympians and those who support them, appear to be taking lots of precautions with helmets and padding and equipment checks. Still, seeing the falls — whether on gust-riddled slopes or in jam-packed ice arenas — and all those skimpy, skin-tight suits, well, let’s hope the energizing and elite talent at the Games takes care with its future even as they quest for glory today.
