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Tuesday, August 13, 2013

Progesterone Treatment for TBIs in Final Trial Before USDA Approval


Car accidents, falls, and even sports-related accidents are some of the causes of 1.7 million traumatic brain injuries (“TBIs”) experienced by Americans every year.

TBIs have caused 52,000 deaths and cost more than $60 billion, according to the U.S. Centers for Disease Control and Prevention.

 And for those with a moderate or severe brain injury, there's little help.

BHR Pharma is currently conducting Phase III trial of a study with support from the American Brain Injury Consortium and the European Brain Injury Consortium which tests the hypothesis that the hormone progesterone can reduce the number of TBI related deaths or severe disability. 

This study that began in 2010 has doctors in 21 countries comparing severely brain-injured patients who receive an intravenous progesterone infusion to those who receive a placebo infusion. The study is designed to test the hypothesis that the hormone progesterone can reduce mortality and disability if administered right after a TBI.  Patients must begin the infusion within four hours of the injury, with outcomes assessed after six months.

The Phase III trial is expected to end this summer after enrolling 1,180 patients.  Results should be available in 2014.

Phase III is the last round of testing a treatment must go through before approval can be requested from the U.S. Food and Drug Administration.  That approval could come as early as the end of 2014, said Neta Nelson, global project director of the study and vice president of project management.

Small amounts of progesterone are found in the brains of both women and men, suggesting that it has neuroprotective as well as reproductive functions.

Experts believe progesterone appears to affect multiple physiologic processes that follow an acute injury.  It reduces the cerebral swelling that leads to brain cells dying off.  Progesterone also may blunt cellular damage from free radicals and promote myelin production in damaged nerve cells.
 

Monday, January 28, 2013

Obama Concerned About Brain Injuries in Football

The Super Bowl is just around the corner and brain injuries in the sport are getting almost as much attention as the teams themselves.  Even President Obama has weighed in on the subject, saying that as a parent, he’s not sure he’d allow a son to play.  “I’m a big football fan, but I have to tell you if I had a son, I’d have to think long and hard before I let him play football.”  Obama said in an interview with the New Republic.  “And I think that those of us who love the sport are going to have to wrestle with the fact that it will probably change gradually to try to reduce some of the violence.  In some cases, that may make it a little bit less exciting, but it will be a whole lot better for the players, and those of us who are fans maybe won’t have to examine our consciences quite as much.”      
The NFL has taken most of the public criticism for head injuries, with former players suffering the consequences of years of hard blows.  However, Obama said his greater concern is for amateur players who aren’t getting paid and may not have as full an appreciation of the risks.

“I tend to be more worried about college players than NFL players in the sense that the NFL players have a union, they’re grown men, they can make some of these decisions on their own, and most of them are well-compensated for the violence they do to their bodies,” Obama said.  “You read some of these stories about college players who undergo some of these same problems with concussions and so forth and then have nothing to fall back on. That’s something that I’d like to see the NCAA think about.”

The NFL has stayed a step ahead of the NCAA, both in enforcing rules designed to limit hits to the head and in treating players who suffer concussions.  But fans of football at every level should be prepared for more political pressure on the sport to dramatically reduce hits to the head.