I have the distinct pleasure of attending every game of the Pittsburgh Steelers, so I'm there on the sideline every week. And then I also have the fortune of running a large research team that also helps lead a national consortium. So I'm going to talk a little bit about where the puck's going, but I just have three take-home messages from the next several minutes. And if we think about what we can do best, then the ounce of prevention is worth a pound of cure, so we have to continue to focus on ways that we can limit the risk of concussion in our athletes. Then I'm going to tell you about something that is now coming through the pipeline and will be hitting your hospitals very soon, which is we have now gotten three blood tests over the finish line at the FDA where we can now diagnose a concussion through a blood test. So we're very close, we are, to that being a reality for the sideline or locker room evaluation of concussion. And then I just want to finish up with a touch point on personalized care because we're seeing a radical shift in mental health disorders in adolescents and young adults and how that factors into what's happening in the management of concussion. But we should also take a moment to remind ourselves that we're actually pretty good, and we should take some comfort in the fact that we've come a long way, and I think that the National Football League sets the standard for focus on player health and safety across the full spectrum of sports medicine, inclusive of concussions and spine injuries. But football is at risk, right? And Teddy Roosevelt is credited as being also the president who saved football and kick-started a series of processes that now culminate in what is known as the NCAA, but also changed the game into what we know the game to be now. And we have come a long way from the moment when 18, 19 college kids were dying every year playing football. There are 30 healthcare providers in NFL Stadium on game day to provide immediate care. That's obviously not practical at the collegiate, scholastic, or recreational level. But here's an amazing factoid, which is that in 2021, 40% of concussion evaluations in the NFL were triggered by athlete self-report. That's amazing. And that represents a massive paradigm shift in the athlete's understanding of what this condition is and what the implications of that are. And I now view 40% as the floor, that our goal should be that this number rises over and over and over again. And I thought that was a fantastic point about officials being an important adjunct to healthcare providers in identifying the concussed athlete. We need everybody engaged, but the athlete himself or herself should be first and foremost the advocate for their own health. So 40%, in my opinion, is now the floor in the NFL, and we need to get all aspects of sport at all levels to this 40% floor as we rise upward. But I guess my question would be, how many people in this room have actually had a conversation with a football player about which helmet they wear? So we need to get to the point that this is also the floor. And we know, and it's been one of the glorious manifestations of the NFL's focus on player health and safety, that the data acquisition, not just on helmets, but the use of these helmets by position in scenarios, now arms us with much more effective ways to counsel football players on the appropriate helmet for them. So if you aren't doing this back home, this is something that you need to be considering making a priority. Are the football players for whom I am responsible wearing the appropriate helmet? Dr. Stills talked a lot about the Guardian Cap this morning, so I won't repeat things, but I will point out something that also is a charge to everyone in this room, which is the introduction of the Guardian Cap into the National Football League began through one of these head health tech challenges. And our engineer colleagues, our bioengineering colleagues, need us to guide them about what is clinically relevant, whether you're talking about hips, knees, shoulders, or heads. And so when there are moments that you're approached by engineers, give them an audience, and you just might find a collaboration that then leads to a grant from the NFL that then leads to a change in the way that the game is played and prepared for, which is exactly what happened with the Guardian Cap. Because after they won the head health challenge, it went from being one-offs of folks doing research on this into the big boys got involved. And Ann and Jeff from UVA, who are really fantastically brilliant, then introduced the sophistication of this testing to deliver the data that showed that the Guardian Cap was the superior option of the ones tested. And then that is how, and then it showed across different scenarios, it also showed a reduction in the risk of a spine injury in biomechanical testing. So not only does it reduce the risk of concussion, it reduces the risk of a spine injury. And it's a sense for it that gets introduced into the pre-season in 2022. Then you had players realizing that they didn't feel the same. They felt better after going through practices wearing the Guardian Cap. And so a bunch of them continued to wear it throughout the season during practice. And now you know, and you heard this morning, it's getting expanded for 2023. All right, so this detecting concussion with a blood test, something that probably missed all of your radar, but five years ago was a monumental moment when we got the first FDA approved blood test for concussions over the finish line. It was 18 plus years in the making. It was more than $100 million of investment by the Department of Defense to make this happen. And being a part of the team that put this together, the irony is that the test was cleared by the FDA before we were able to publish the paper about it, which shows you that there had to have been a profit motive behind this. I have no personal stake in anything that I'm talking about, just to be clear. This is just a passion of mine wanting to change the practice of medicine. And the problem with that first test in 2018 is it's a core lab test and it takes four to six hours, which no one is going to sit around waiting six hours for a test when you're trying to figure out if someone has a concussion. But then the big boys started to get involved and Abbott as a Fortune 500 company said, look, we're going to make this a clear focus of our company. They have this new eye statility platform that can deliver a result in less than 15 minutes. So the first time this ever happened was in my emergency room on November 26, 2017, trying to figure out if this drunk person did or did not have a brain injury and we can draw the blood, send it off, figure out the GFAP is 677 and what do you know, they have a positive head CT and they end up in the ICU. So once we figured out that we could make this and adapt this test to a point of care platform for a handheld device that delivers a result in eight minutes. Now the FDA only allows Abbott to say less than 15 minutes, but the fact of the matter is it takes eight minutes to return a result. And now this got over the finish line at the FDA in January of 2021. So we now have a point of care platform that returns a result in well under 15 minutes that tells you whether the person in front of you has a head injury sufficient enough to produce a positive head CT. But that requires plasma, which means you have to centrifuge it. You have to do venipuncture followed by centrifuge. In August, we will finish the test that allows us to skip the centrifuge step. And then we're one step away from going from whole blood to capillary blood, which means that by 2024, we're hoping to have an understanding of whether we can take a finger prick, drop of blood onto a cartridge and within 15 minutes tell you if the person in front of you has sustained a concussion. I told you that our Department of Defense has invested more than $100 million in this. This is already happening in parts unknown all over the world. So the EyeStat and LendMe platform is now forward deployed in theater with medics with the United States military. And if a corporal is injured in theater, that person has their blood tested. Now it's not quite finger prick yet because we haven't gotten that over the finish line at the FDA, but their blood is drawn and it's tested. And within 15 minutes, the medic decides whether that person in front of him returns to duty and returns to theater and returns to the fight. If the test is mildly abnormal, then the soldier is advanced to additional layers of testing. And if it's markedly abnormal, then the soldier is extricated from theater or taken to a higher role of care and is prepared for neurosurgical intervention if necessary. So this is already happening in our military unbeknownst to pretty much everybody. But this is real, this is happening, and this is forward deployed. And the whole goal here is to go from the innovators and the Department of Defense being the early adopters to the point that we can make this a routine test in clinical care, and that's how it's going to end up on the sideline. BARDA is the agency at Health and Human Services that prepares our nation for mass casualty events and domestic terror events, and BARDA knows that if you want something that's going to help you in a mass casualty situation, it has to be something that everybody's using every day in their clinical practice. And so BARDA has given us $60 million in September to now advance this test, not just to tell you who's going to have a positive head CT, but to tell you who simply plain old-fashioned has a concussion or does not have a concussion, has a brain injury, does not have a brain injury. The higher the level, the worse your injury. And then alongside that, to deploy this into every level one trauma center in the United States, and once we get to that point, it'll spill over into every level two, level three urgent care center, et cetera. And once we have that full situational awareness, then this thing is ready for the sideline. So if you're wondering where the puck's going, we're going to replace a lot of what we do by simply taking the finger, pricking it, taking a drop of blood, loading it onto a cartridge and telling if someone has a concussion in under 15 minutes. So you know you're winning when your life's work doesn't get published in New England Journal of Medicine. You know you're winning when it ends up as a Super Bowl commercial. It demands a rapid COVID test because we all deserve an answer. It demands your heart stays connected to your doctor so you know it's beating as it should. And a rapid test to help evaluate concussion in case something were to happen. At Abbott, we fight for these moments, developing life-changing technologies. Sounds pretty cool. My sister sent me that. I didn't even know. But that's cool. And then I'll just finish up by just saying, look, we just heard Jeannie talk about, you know, the fact that we personalize care and concussion. But what I want to remind you or teach you is that you injure the brain that you have. So it's not just that concussions manifest themselves in different ways. They manifest themselves in different ways in different people. And here is the absolutely astonishing thing. We understand that preexisting conditions influence your risk for prolonged protracted recovery. We also know that it should be factored into the way that you're managing people who have a concussion, okay? And we know what ADD does, what the kid with ADD suffers through when he sustains a concussion. But here is the crazy thing. There was a 40% rise in antidepressant medication use amongst U.S. adolescents once COVID hit. 16% of youth now say that they have had a single episode, at least one episode of major depressive disorder in the preceding 12 months. And 60% of kids with major depression receive no treatment at all, okay? So that's 16%. 6% have a substance disorder, 8% carry a diagnosis of ADD. Now we're talking about one-third of people who are teenagers, which means, by the way, that means one-third of college people. And if you're paying attention to what's happening at the NFL Combine, you will notice the explosion in the number of athletes being evaluated for the NFL draft who are on psychoactive medications. It's astonishing the percentage of people that are young and in this country who are dealing with a mental health disorder. And it directly impacts your response to a concussion, your recovery from a concussion, and has to influence the way that we think about how to take care of the person in front of us. So I just want to push that one last thought, which is that, look, the Guardian cap is just one example. There will continue to be more ways that we reduce the risk of a concussion. We're going to deliver to you guys a fascinating and objective assessment of what's happening with the person in front of you. But for the time being, we have to be aware of the explosion in mental health disorders amongst the populations that we care for and the impact that that has on this condition. Thank you.

concussions

blood tests

personalized care

Guardian Cap

mental health disorders