Study Shows That Cumulative Force of Head Impacts are the Best Predictors of CTE

In a recent study, researchers at Harvard Medical School and Boston University’s Chronic Traumatic Encephalopathy Center examined the causes and severity of CTE in football players and found that the number of and the cumulative force of head impacts are the best predictors of CTE.  This study, which looked at 631 brains, found that 71 percent had CTE.  The football players that were considered to have experienced the greatest cumulative force of head impacts were shown to have the worst forms of CTE. 

While diagnosed concussions on their own weren’t associated with increased CTE risk, they continue to be a silent epidemic in this country and abroad.  An estimated 69 million people sustain a traumatic brain injury (TBI) from all causes every year worldwide.  The greatest incidence per 100,000 people occurs in North America (1299 per 100,000 people).[1]  Concussions are the most frequent TBI.  

Concussions are caused by a direct or indirect blow, bump or jolt to the head. This sudden movement can cause the brain to bounce around inside the skull, which can result in chemical changes in the brain and sometimes stretching and other damage to brain cells. 

Concussion symptoms include chronic headaches, depression, problems with thinking and memory, vision and balance issues, and sleep disorders. Symptoms can be debilitating and can persist for days to months or even years, affecting personal, work and school lives. Up to one third of patients do not fully recovery from their concussions.

The Harvard-Boston University study raises awareness of the critical need for continued steps to reduce the risk in football and other contact sports.  However, no matter how safe we make sports, head impacts won’t be entirely eliminated for our athletes. Similarly, our servicemen and women, the elderly, traffic accident and abuse victims and others will continue to sustain head injuries.  CTE and debilitating post-concussion symptoms will continue to cause severe impairment and suffering long after sustaining the injuries unless we find effective treatments.

At the same time that we are reducing the risk of head traumas, we must also double down on our efforts to find potential treatments.

[1]  https://pubmed.ncbi.nlm.nih.gov/29701556/

The High Incidence of Concussions Among Seniors is Reason for Concern, but New Treatments May Be on the Way

The leading cause of injury for older adults is falling, with over 1 in 4 older adults reporting a fall each year, according to the Centers for Disease Control. The elderly also suffer concussions at far higher rates than any other group; falls are the primary cause.  

While concussions in seniors have a greater impact and result in more serious symptoms,   there is  some positive news about concussions. In a handful of laboratories around the country, scientists are developing and testing medicines to help repair brain damage from concussions, whether because of falls, other kinds of accidents or on the sports field.

A concussion, also known as a mild traumatic brain injury (mTBI) is caused by a direct or indirect blow to the head that disrupts the normal function of the brain. Symptoms of a concussion include headaches, nausea, sensitivity to light and sound, memory problems and depression.  While most people recover from concussions within a few weeks, some 20 to 30%  will experience ongoing symptoms lasting months to years after injury.

There are over three million hospital emergency room visits for concussions every year in the U.S.. Because many concussions are not reported, the three million documented cases are just the tip of the iceberg. An estimated 15 to 20 million people a year with concussions do not seek medical help and, as a result, go undiagnosed.   In a CBS News story, which drew attention to this issue in seniors, an  emergency room physician and geriatric specialist at Ohio State University Hospital, Lauren Southerland, stated “It’s not unusual for a 25-year-old athlete who received a blow to his head, to get a more thorough evaluation for a concussion than an elderly retiree.” 

Media attention on concussion risk in sports, such as football and hockey, has further heightened awareness of the long-term risks of concussions, and, recently, the CDC has been casting a spotlight on concussions and seniors.  The CDC’s National Center for Injury Prevention and Control has fall prevention resources for seniors, caregivers, healthcare providers and health departments.

Working Towards Effective Treatments

Despite the prevalence of concussions over many decades and advances in so many areas of medicine, there have been few advances in concussion treatment.  Prevention measures in all realms of life are a positive step and doubtless can and will continue to be improved, but even with these measures, concussions will not be eliminated.  Effective therapeutic treatments and may be closer at hand, thanks to advances in molecular biology and in our understanding of how the brain works.

Currently there are a number of companies working on concussion medicines intended to treat symptoms and underlying damage.  Our company, Oxeia Biopharmaceuticals is in Stage 2 clinical trials.

Previous work has found that a concussion causes damage inside the brain, particularly to glial cells, that in part disrupts the flow of information from one part of the brain to another. Central to Oxeia’s treatment is a hormone called ghrelin, which is a molecule that has neuroprotective properties and helps stabilize energy production and use in brain cells.

If all goes well, doctors could be prescribing the first drug to specifically treat concussions in as few as five years.

This will be a huge milestone because fewer than two decades ago, little was known about the serious effects of concussions, even though the condition was recognized in the 10th century by the Persian physician, Rhazes, in the 10th century. For researchers and others who work hard to bring a breakthrough medicine to market, the effort is often personal. The founders, researchers and physicians of our company have experienced concussions in their personal lives and understand the debilitating symptoms can significantly impair normal activity. New treatment options for patients are greatly needed.  Rest is not enough.

Preventing Fatal and Serious Injuries Caused by Distracted Driving

April was National Distracted Driving Awareness Month. Let’s get serious about preventing distracted driving accidents every month. While there are many potential distractions that interfere with driving – changing stations on the radio, talking on your phone,  and eating, to name a few – texting is one of the most dangerous and common distractions.  The National Transportation Highway Transportation Safety Administration (NHTSA) says that at 55 mph, taking your eyes off the road for five seconds to send or read a text is the equivalent of driving the full length of a football field with your eyes closed. 

Although many states have laws that are intended to prevent distracted driving, the CDC reports that nine people are killed every day in the U.S. as a result of a distracted driver.  According to the NHTSA, over 3100 people (8.2% of all fatal accidents) were killed in motor vehicle accident involving a distracted driver in 2021, a 12% increase over 2020.  325,000  were injured in crashes involving a distracted driver in 2020. The injured include not only drivers and occupants of the driver’s and other vehicles, but also pedestrians and bicyclists.

The most common injuries caused by distracted driving are head trauma, broken bones and internal bleeding.  In fact, car accidents of all types are among the most common causes of traumatic brain injury or TBIs.  Even concussions, or so-called mild traumatic brain injuries, can cause years and years of debilitating symptoms, including headaches, dizziness, blurred vision, light and noise sensitivity, as well as issues with concentration, memory  and mood.

Using common sense while driving can eliminate many of the distractions that cause accidents,  preventing needless death and injury for hundreds of thousands every year.  AAA offers these ten sensible tips[1] to avoid distractions while driving:

10. Fully focus on driving. Do not let anything divert your attention, actively scan the road, use your mirrors and watch out for pedestrians and cyclists.

9. Store loose gear, possessions and other distractions that could roll around in the car, so you do not feel tempted to reach for them on the floor or the seat.

8. Make adjustments before you get underway. Address vehicle systems like your GPS, seats, mirrors, climate controls and sound systems before hitting the road. Decide on your route and check traffic conditions ahead of time.

7. Finish dressing and personal grooming at home – before you get on the road.

6. Snack smart. If possible, eat meals or snacks before or after your trip, not while driving. On the road, avoid messy foods that can be difficult to manage.

5. Secure children and pets before getting underway. If they need your attention, pull off the road safely to care for them. Reaching into the backseat can cause you to lose control of the vehicle.

4. Put aside your electronic distractions. Don’t use cell phones while driving – handheld or hands-free – except in absolute emergencies. Never use text messaging, email functions, video games or the internet with a wireless device, including those built into the vehicle, while driving.

3. If you have passengers, enlist their help so you can focus safely on driving.

2. If another activity demands your attention, instead of trying to attempt it while driving, pull off the road and stop your vehicle in a safe place. To avoid temptation, power down or stow devices before heading out.

1. As a general rule, if you cannot devote your full attention to driving because of some other activity, it’s a distraction. Take care of it before or after your trip, not while behind the wheel.

[1] https://exchange.aaa.com/safety/distracted-driving/tips-for-preventing-distracted-driving/

Protecting our Youth Athletes from Concussion is a Top Priority

The month of April is a lot of things to a lot of people.  We can celebrate Military Child Month, Stress Awareness Month, Garden Month and even Financial Literacy Month.  But here at Oxeia, we take special note that April is National Youth Sports Safety Month. 

1.35 million kids are seen in emergency rooms every year for sports related injuries, says Safe Kids Worldwide.  According to their report that studied the 14 most popular sports, concussions account for 163,000 of those ER visits, or 12 percent.  That’s a concussion-related ER visit every three minutes.  Clearly, not enough is being currently done to raise awareness about the dangers of sports-related concussions can do to the brains of our young athletes. 

Most of us are unlikely to attend an educational forum or seminar on young athletes and concussions to mark Youth Sports Safety Month.  That’s okay.  Instead, parents should take the time to educate themselves about concussions.  Understand what a concussion is, the symptoms to look for, when to get medical care, when to return to normal activity and more.  Think about middle and high school students that you may know… or may even be raising. They are likely not yet able to make informed decisions about the risks they are taking on the playing field, making it all the more important that parents make informed decisions for their children, as well as have the ability to spot concussion symptoms on and off the playing field.

Here are some things to keep in mind for your young athlete:

•       Although the numbers and percentages of concussions from boys’ American high school football vary among studies, they agree that football is the leading cause of concussions. For girls, the leading cause of concussions in high school sports is soccer.[1]

•       A recent Centers for Disease (CDC) study reports that youth tackle football athletes ages 6 to 14 sustained 15 times more head impacts when compared to flag football athletes during a practice or game.  They sustained 23 times more high-magnitude head impact.

•       Another CDC study found that youth tackle and flag football athletes sustained two times more head impacts during a game than during a practice.

•       Go to the CDC Heads Up website to learn more about how parents can lower your child’s chances of sustaining a concussion, how to spot a concussion, what to do if you suspect your child has a concussion and more.  

Physical activity and team sports offer important physical fitness and social and emotional skills.  While whether or not your child plays a sport is an individual decision, measures to reduce the number of sports-related concussions in our youth should be a top priority. 

School Spring Sports and Concussion

A recent MedStar Health survey showed that concussion safety is top of mind for parents heading into spring sports season. 93% have concerns about concussions compared to just over half of parents in a 2019 study. The survey of parents also found that 91% believed that coaches should have concussion protocol and CPR training.

At the same time that parents have a heightened awareness of the possible long-term and often debilitating effects of concussions, the study also revealed a, perhaps, surprising confusion over concussion management.  According to the study a vast majority, 89% of respondents believe that it’s essential to stay awake after sustaining a concussion.  In fact, keeping concussion patients awake or waking them every hour or two was the standard of care up until about a decade ago. Today, CT and MRI scans can rule out a more serious injury.

65% of respondents also believe that helmets prevent concussions.  While some product manufacturers make this claim, studies don’t back up this claim. Helmets are, in fact, designed to decrease the possibility of a skull fracture or serious injury to the brain.  Believing that helmets are concussion-proof can lead to players taking greater risks, increasing their chances of sustaining a head injury.   

Despite increased media attention to concussions, almost half of the respondents believed that concussions occur solely from a direct hit to the head.  Concussions can be caused by a hit to the head or a rapid acceleration-deceleration movement that causes the brain to bounce around inside the skull.  We commonly think of these jolts to the head occurring in car accidents with whiplash, but they are common in many sports, as well.

On a positive note, the survey results indicate that a vast majority of respondents understand that athletes need to be taken out of play or practice after sustaining a concussion.  However, 13% believed that an athlete can stay in the game after a head injury if they don’t lose consciousness.  According to the Centers for Disease Control, most people do not lose consciousness after a concussion.

The heightened parental awareness of the seriousness of concussion is a positive step, but as this survey reveals there is still work to be done to further parents’ understanding of how concussions are sustained, the effectiveness of helmets and treatment post-concussion.  When an athlete sustains a concussion he or she should be seen by a doctor for tests and possible referral to specialists. Instructions from the doctor(s) should be followed carefully and athletes should not return to play until a doctor with concussion experience clears the athlete to participate in athletic activities again.  Learn more at the CDC’s Heads Up for Sports website.

At the same time that parents have a heightened awareness of the possible long-term and often debilitating effects of concussions, the study also revealed a, perhaps, surprising confusion over concussion management.  According to the study a vast majority, 89% of respondents believe that it’s essential to stay awake after sustaining a concussion.  In fact, keeping concussion patients awake or waking them every hour or two was the standard of care up until about a decade ago. Today, CT and MRI scans can rule out a more serious injury.

65% of respondents also believe that helmets prevent concussions.  While some product manufacturers make this claim, studies don’t back up this claim. Helmets are, in fact, designed to decrease the possibility of a skull fracture or serious injury to the brain.  Believing that helmets are concussion-proof can lead to players taking greater risks, increasing their chances of sustaining a head injury.   

Despite increased media attention to concussions, almost half of the respondents believed that concussions occur solely from a direct hit to the head.  Concussions can be caused by a hit to the head or a rapid acceleration-deceleration movement that causes the brain to bounce around inside the skull.  We commonly think of these jolts to the head occurring in car accidents with whiplash, but they are common in many sports, as well.

On a positive note, the survey results indicate that a vast majority of respondents understand that athletes need to be taken out of play or practice after sustaining a concussion.  However, 13% believed that an athlete can stay in the game after a head injury if they don’t lose consciousness.  According to the Centers for Disease Control, most people do not lose consciousness after a concussion.

The heightened parental awareness of the seriousness of concussion is a positive step, but as this survey reveals there is still work to be done to further parents’ understanding of how concussions are sustained, the effectiveness of helmets and treatment post-concussion.  When an athlete sustains a concussion he or she should be seen by a doctor for tests and possible referral to specialists. Instructions from the doctor(s) should be followed carefully and athletes should not return to play until a doctor with concussion experience clears the athlete to participate in athletic activities again.  Learn more at the CDC’s Heads Up for Sports website.

CONCUSSIONS ARE MORE THAN JUST A BUMP ON THE HEAD

While the Covid-19 pandemic temporarily shielded other disease and injury from view, they didn’t go away. One of those is brain injury, generally known as concussion or mild traumatic brain injury (mTBI). Once considered relatively harmless and treated by simple rest and rehabilitation, concussions are now widely recognized as a major ongoing public health issue. Concussion remains one of the main causes of loss of work or school time and it’s been known to lead to alcohol and drug abuse and domestic violence.

Concussion can be caused by blunt force trauma, repeated blows to the head, falls, vehicular accidents, explosions, military combat operations and training or physical assault, to name a few. According to the U.S. Centers for Disease Control and Prevention, almost three million patients with suspected brain injury visit the emergency room every year in the U.S. Other studies put the number much higher at 5 million, with as many as 2.4 million of these with mTBI. The numbers may even be higher with additional studies suggesting that as many as 50 percent of concussions go unreported.

These traumatic events send an energy shockwave through the skull leading to the depolarization of brain cells and metabolic dysregulation. Sometimes axons, the communicating arm of nerve cells, can be stretched and damaged as the brain moves within the skull from the concussive forces. In more severe brain injury, bleeding may occur causing inflammation, brain swelling and further damage.

Interestingly, concussions and other neurodegenerative diseases such as Alzheimer’s, dementia and Parkinson’s disease share a similar molecular pathology including mitochondrial dysfunction, where the ability of the mitochondria to convert sugar into energy for the brain is disrupted.  Understanding this biology may lead to the design and development of targeted therapeutic solutions.

We must accelerate our efforts toward finding a therapeutic for concussion.  Let’s see more players from the medical establishment, government, sports, and investment and large pharmaceutical companies commit to meaningful action to support finding effective treatments for concussions. Rest is not enough.

Vishal Bansal, M.D., F.A.C.S., is the Chief Scientific Officer and Co-founder at Oxeia Biopharmaceuticals and Director of Trauma Surgery at Scripps Mercy Hospital in San Diego.  Oxeia is a Boston-based clinical stage biotech company focused on the development of its lead molecule, OXE103, for the treatment of concussion.  The company is conducting Phase 2 human clinical studies for OXE103.

It’s March Madness Time: What’s the Concussion Risk in Basketball?

The effect of concussions on pro athletes has been investigated in many sports over the past couple of decades.  The concussion incident rate in pro football was recognized as a true health risk around the turn of the millennium and concern has been mounting as we learn about the potential long-term and often debilitating effects of concussions impacting players. 

Other sports, like hockey and soccer, are also reckoning that concussions are threatening the health and well-being of their players.  What about basketball?

The media haven’t covered  concussions in basketball to the same extent as football.  Similarly, few sports concussion studies have included the game of hoops.  But just because basketball concussions aren’t being studied or covered extensively, doesn’t mean they aren’t happening.  In response to concussions in basketball, both the NBA and the NCAA have implemented protocols guiding return to play after concussions.

University of Connecticut women’s basketball star Caroline Ducharme is a case in point.  As March Madness fever hit, Ducharme’s ability to play was in doubt.  She has a history of getting concussions and was sidelined and in concussion protocol while coping with concussion symptoms – migraines, neck pain and sensitivity to light and noise.  UConn Huskies women’s basketball fans worried about her missing 13 games this winter, and even after it was announced that she would play in March Madness, many wondered about her ability to compete in the season’s grand finale.

A study published in The Orthopedic Journal of Sports Medicine in 2019 noted that there is concussion risk in basketball.  They reported  that 189 concussions were reported to the NBA from 1999 to 2018.  Concussion incidence in NBA players is approximately 17 instances per season. 

Maybe the concussion numbers in pro basketball don’t rival the numbers in the NFL, but that doesn’t mean players should worry less.  Concussions in school basketball are especially high.

Basketball is the most popular sport for youth ages 8 to 19.  Basketball is second to football in school sports concussions.  Body-to-body contact such as setting hard screens and taking charges, hard falls and whiplash injuries are serious concerns.  Neural Effects analyzed data for 2018-2019 from the National High School Sports-Related Injury Surveillance Study. According to the study girl high school basketball players have higher rates of concussions than boys. Boys had a total of over than 9,000 concussions while girls experienced more than 17,000 concussions.

Basketball concussions don’t tend to have the drama of football concussion injuries, but they are a concern and parents and coaches need to recognize a possible concussion and take appropriate action.  The Center for Disease Control’s “Heads Up Concussion in Sports Guide for Coaches” is a good place to educate both coaches and parents about concussions.. 

Senator Mitch McConnell’s Concussion is a Strong Reminder:We Need to Do More to Find Effective Treatments

We see a lot about concussions in sports and over the past few years there’s been more reporting on concussions in the military, as well. Concussions from falls, however,  don’t make noise – unless as was the case with Senator Mitch McConnell – it happens to someone famous.  Despite the silence when it comes to concussions from falls,  falls are the leading cause of concussion. Falls are responsible for almost half of TBI-related hospitalizations. 

Falls are even more ubiquitous among people 65 and older. The CDC reports that more than 80,000 seniors have a TBI every year and more than half of these are from falls.  Common symptoms for concussion sufferers include headaches, confusion, dizziness, memory and visions problems and fatigue. Fortunately, most seniors with a concussion will recover fully within a couple of months.  However, if we consider that in the general population nearly half of concussion sufferers continue to have at least one symptom one-year post-injury, this doesn’t bode well for our senior population.  Add to that research that suggests there may be a link between TBI and cognitive decline.   With the aging baby boomer population, we are likely to see more concussions related to falls, an increasing burden on our healthcare system and caregivers and skyrocketing medical costs unless we take proactive steps.

When we consider that in the U.S. the number of persons older than 65 years is expected to increase from about 35 million in 2000 to an estimated 71 million in 2030, it’s clear we need to do more in the areas of prevention to reduce the risk of and numbers of falls, diagnostics to quickly and accurately detect concussions and treatment that will treat both the symptoms and underlying damage caused by a concussion.  We hope that Senator McConnell will see a full and rapid recovery, but let’s consider his fall and concussion a strong reminder that Congress and the Administration need to be doing more to prevent, diagnose and treat concussions.

Michael Wyand, DVM, PhD, is the CEO of Oxeia Biopharmaceuticals. Oxeia is conducting Phase 2 human clinical studies for its therapeutic drug, OXE-103, to treat concussions. 

Let’s Not Fail our Veterans: It’s Time to Find a Cure for Concussions

Patricia Kime and Rebecca Kheel’s article, Lost Years and Missed Opportunities: How the Pentagon Squandered the Chance to Combat Brain Injuries shone a light on TBI as “the signature wound” of post-911 wars and “one of the biggest factors” in suicide among veterans. 

Despite the end of the conflicts in Iraq and Afghanistan, the problem of suicides among those who served persists.  Whereas there’s been a  slight decline over the past two years in suicides nationwide, the number of suicides in the military has increased.  From 2015 to 2020 suicides increased by 40 percent, according to the Department of Defense.  More recent research, reports that 30,177 active personnel and veterans who served post 9/11 died by suicide in 2021. 

Concussions, also known as mild traumatic brain injury (mTBI), are the most common type of TBI for members of the military. The Department of Defense reported 430,000 head injuries among active-duty military between 2001 and 2018 with the vast majority ­82% – classified as mTBI.

Now recognized as an epidemic, mTBI has become one of the highest priorities in public health because of its tremendous costs and possible long-term consequences. The government is keenly aware of the impact concussions have on service members and veterans.  Both the Department of Defense and the Veterans Administration have sponsored programs to enhance the understanding of what causes concussions, as well as identify treatments and recovery protocols for mTBI. The Senate and House National Defense Authorization Act for 2022 directs increased funding for brain injury research.   

Tapping military might is logical to advancing research and finding effective therapeutic treatments for mTBI.  Our military has a special ability to get the job done.  Like the working committees formed to combat Covid-19, the military has the might to galvanize disparate groups of professionals to share research and resources to power ahead for solutions.  The private sector players, many of which are biopharma start-ups, will gladly welcome the Pentagon leadership and participation in advancing clinical trials.

Effective treatments for mTBI can also result in significant cost savings.  While symptoms disappear for many concussion sufferers within days, research indicates that almost 40% of mTBI patients have post-concussion symptoms (PCS) lasting more than three months.  A study examining recovery of PCS patients found only 27% of their population eventually recovered.

These often debilitating symptoms require ongoing physical, speech, cognitive, vision, occupational and/or drug therapies for our active military and veterans.   Studies have also linked mTBI with depression and PTSD, and repeated mTBIs with various neurodegenerative diseases.  For example, studies have shown that veterans with a history of mTBI have a 56% higher risk of developing Parkinson's disease within 12 years of their injury,

Many of these impairments can negatively affect readiness and job performance for active military and ongoing problems for employment, as well as for families and the larger community.

Progress toward a treatment for TBI to help our servicepeople and veterans will also be a boon to the public at large.  In the past couple of decades, awareness about the dangers of concussions has led to extensive news coverage of active and retired professional football players, and other athletes.  Today our citizens are more likely to realize that a slip in the bathtub or a car crash, can lead to injuries that are not seen by the naked eye.  The costs of treating concussion for the general public are already staggering.  The American Association of Neurological Surgeons puts annual direct and indirect costs of the full spectrum of TBIs – from mild to severe – are $76.5 billion.  Approximately 75% of all TBIs are mTBI.

As New York Senator Kristen Gillibrand remarked at a December 2017 Senate Armed Services Committee meeting; “If the military figures this out, then the rest of us can too.”

Michael Wyand, DVM, PhD, is the CEO of Oxeia Biopharmaceuticals. Oxeia is conducting Phase 2 human clinical studies for its therapeutic drug, OXE-103, to treat concussions. 

Learning from the Mistakes with Tua Tagovailoa: Let’s Find a Cure for Concussions

It was unbelievably difficult to watch as Miami Dolphins quarterback Tua Tagovailoa took that scary hit to his head during the game against the Cincinnati Bengals on September 29th. Just days earlier after taking a hit to the head in the game against the Buffalo Bills,  fans watched as Tua stumbled and  subsequently left the field.  It seemed obvious as a viewer that he was in the concussion protocol … until we saw him back after halftime.  Should he have even been playing in the game against the Bengals just days after apparently suffering a head injury just a few days earlier?  Despite showing gross motor instability after a hit in the game against the Bills, Tua was not in concussion protocol. 

There are better protocols and other safety measures today then there were just a few years ago, such as independent neurologists at games.  These measures clearly failed Tua. 

There’s no doubt that players have competing interests.  They want to get back into the game, yet maybe – probably – they often  shouldn’t. It’s their careers vs. their health.  There are people out there whose job it is to evaluate the players and make informed decisions about whether it’s safe for them to go back into the game or into concussion protocol.  After the events with Tua, there was an investigation into his injuries, and the NFL and the NFL Players Association have agreed that protocols have to change “to enhance player safety.”  The updated protocol adds ataxia — or gross motor instability — to the list of  symptoms that call for the immediate removal of a player from a game.

There’s so much we don’t yet know about brain injuries, but scientists are learning more every day about brain injuries and how the brain works.  We know, for example,  that often debilitating symptoms can last for months and years. Over the past 20 years research has increasingly linked concussions to neurogenerative conditions, including dementia, Alzheimer’s disease and CTE, a degenerative brain disease.  Scientists at Boston University found CTE in 99% of the brains from former NFL players. 

For me this points to the need to dramatically increase our focus on effective treatment for concussions.  Treatment hasn’t changed much since football was invented back in the 1880s.   Despite huge advances in other areas of medicine, there are currently no effective pharmacological FDA-approved treatments for concussion. I hope to help change that.  Just over five years ago I joined a small clinical stage company, Oxeia Biopharmaceuticals, that has a concussion drug that has shown promising interim results in a Phase 2 clinical trial.

Biopharma companies need entities to advance their research so they can develop treatments for a concussion’s immediate symptoms, as well as the underlying damage.  Perhaps those with a vested interest in finding a cure should step up to the plate.

While Tua’s injuries triggered national debate about concussions and football, if we’re honest with ourselves, much of the appeal of football for players and fans alike is the speed, the power, the hits, the risk, and the violence.  We’re never going to make the game of football 100% safe, but we owe it to football players to make it as risk-free as possible with a combination of safety measures and effective treatments, so that we don’t fail all the future Tua Tagovailoas at every level of football. 

Michael Wyand, DVM, PhD, is the CEO of Oxeia Biopharmaceuticals. Oxeia is conducting Phase 2 human clinical studies for its therapeutic drug, OXE-103, to treat concussions.  www.oxeiabiopharma.com

Crisis on Our Roads: Risky Driving Behavior Is Causing More Fatalities and Brain Injuries

Reckless, aggressive and distracted driving and failure to wear seatbelts all contributed to what Transportation Secretary Pete Buttigieg has called  a crisis on our roads.

Contrary to many people’s expectations that fewer cars on the road and fewer miles traveled would lead to a decrease in traffic accidents, crashes and traffic fatalities started to spike in 2020.  The National Highway Traffic Safety Administration’s (NHTSA) early estimates of traffic fatalities in 2021 showed a continuation of this dangerous trend. The agency estimated that there were about  43,000 traffic deaths in 2021 – the highest number since the data began being collected in 1975.  According to the NHTSA, these spikes may be a result of speeding, not wearing a seat belt and driving under the influence of alcohol or drugs.

What are we seeing in 2022 with more people resuming everyday activities, including  going back to school and work?  Early estimates for the first quarter of 2022 showed another record-breaking 7% increase in motor vehicle fatalities over the same period in 2021.

Some records are meant to be broken. This isn’t one of them. 

There are plenty of accidents where the occupants walk away seemingly unscathed or with minor injuries.  Those with no visible injuries are typically counted as the lucky ones.  But are they?  How many of these accidents result in concussions that go undiagnosed and untreated concussions until sufferers of long-term post-concussion symptoms go to their doctor?  Higher speeds on our roads translate into greater impacts in a crash and a higher likelihood of the brain being traumatized.  One doesn’t have to be knocked unconscious to have suffered a concussion.  In a motor vehicle accident, concussions can be caused when the driver and passengers hit their heads on the windshield or another object, as well as when they are violently thrown forward and backward.  When these traumatic events happen the human brain literally bounces around inside the skull. These abrupt movements can cause the connections between nerve cells to stretch and cause problems with connectivity within the brain. Intra-cranial bleeding may also occur and inflammation can cause brain swelling and further damage.

According to the U.S. Centers for Disease Control and Prevention, almost three million patients with suspected brain injury (from all causes) visit the emergency room every year in the U.S. Other studies put the number much higher at 5 million, with as many as 2.4 million of these with mTBI. The numbers may even be higher with additional studies suggesting that as many as 50 percent of concussions go unreported .

Fortunately, most people recover from their concussions in a few weeks, but as many as one third of patients do not fully recover from their concussions.  Some have debilitating emotional and physical symptoms that continue to plague them for months and years.  Headaches; depression; cognitive, memory, vision and balance issues; and sleep disorders can make it difficult to function at work and at home.  Currently, treatment options for traumatic brain injury (TBI), concussion included, are limited to mostly rest and pain relief. To date there are no effective pharmacological FDA-approved treatments for concussion

Oxeia is among the companies working to develop a much needed therapeutic that will treat the underlying pathology of concussion. However, we are still at least three to five years away from possible FDA approval.  And, even when we have an effective treatment, as the Dutch philosopher Desiderius Erasmus is purported to have said around 1500, “prevention is better than cure.”

Distracted, aggressive, impaired and reckless driving can have severe negative life altering consequences.  Everyone can do his and her part to prevent accidents on the road. The American Red Cross offers these car travel highway safety tips to help make our roads safer and protect yourself and others from becoming the next statistic:

• Buckle up, slow down, don’t drive impaired.

• Be well rested and alert.

• Use caution in work zones.

• Give your full attention to the road. Avoid distractions such as cell phones.

• Observe speed limits – driving too fast or too slow can increase your chance of being in a collision.

• Make frequent stops. During long trips, rotate drivers. If you’re too tired to drive, stop and get some rest.

• Be respectful of other motorists and follow the rules of the road.

• Don’t follow another vehicle too closely.

• If you plan on drinking, designate a driver who won’t drink.

• Clean your headlights, taillights, signal lights and windows to help you see, especially at night.

• Turn your headlights on as dusk approaches, or if you are using your windshield wipers due to inclement weather.

• Don’t overdrive your headlights.

• If you have car trouble, pull off the road as far as possible.

Concussion tied to poor youth academic, emotional and behavioral outcomes

Several recent studies shine a light on the deleterious impact of concussions on our youth.  In one of the studies, researchers from Seattle-based, University of Washington found that those having one or more concussions within the past 12  months had a 25% risk of poor academic standing “experiencing multiple concussions could be particularly harmful on student outcomes.” 

Another study by researchers at the University of Rochester’s Del Monte Institute for Neuroscience revealed that children who suffered a traumatic brain injury have more emotional and behavioral problems than those that do not experience a concussion.  Even those who had mild traumatic brain injuries (also known as a concussion) showed an increased risk (15%) of an emotional or behavioral problem. The risk was the most pronounced in those children that were around 10 years old.

For parents making the decision about whether to allow their children to play a sport is not clear cut.  On the one hand these and other studies about the short- and long-term impacts of concussions warn us away from youth sports, yet on the other hand, studies have consistently shown the physical, mental and social benefits of sports, including  physical health, improved self-confidence, reduced stress, greater concentration, teamwork and peer acceptance.

So, do you allow your child to participate in sports or not?

Neither option is satisfactory.

We have found cures for countless diseases, yet not for concussion.  We can take precautions to minimize the risk of concussion in sports, but concussions don’t only occur on playing fields.  They are commonplace and take place as a result of falls, playground collisions,  motor vehicle accidents, bicycle crashes and more. 

Our company, Oxeia Biopharmaceuticals, is one of a number of companies in the race to find a treatment for concussions, and we support the efforts of all that are searching for a cure.  Oxeia’s drug, OXE103, is being tested in a Phase 2 clinical study at the  University of Kansas Medical Center.  OXE103 is synthetic human ghrelin, an endogenous hormone. OXE103 freely crosses the blood-brain barrier and is now being tested in humans to potentially treat concussions by addressing underlying neuro-metabolic dysfunction and axonal injury. OXE103 uniquely targets the hippocampus region of the brain, an area important for cognition and memory.

We recently reported positive interim results of our Phase 2 trial and are hopeful that our drug will be successful.  However, we are still at least three to five years from when we can expect to see any our therapy approved by the FDA. 

The mostly small clinical stage companies working to develop successful concussion drugs do not have the resources to move the race for the cure along as quickly as we would like.  We need investment from individuals, institutional investors and from the government to bring a treatment to market.  The sooner we get a reliable, proven treatments for concussions, the better not only for parents of young athletes, but for all of us.

Keeping Your Summer Fun and Safe: What to Know About Concussion

June 21st marked the first day of summer 2022.  Summer is a time for outdoor fun and recreation for people of all ages. It’s also a time when hospital emergency rooms see an increase in the number of concussions from those same recreational activities, including bicycling, swimming, diving, rollerblading, skateboarding, ATVs and sports. 

Despite the increased risk of concussion in the summer, staying active is important at all ages and stages of life. Having a safe and healthy summer starts by educating yourself about:

-        safety precautions,

-        how to avoid undue risk,

-        signs of a concussion or other traumatic brain injuries, and

-        when to seek treatment for yourself, a friend or a family member.

Safety precautions and avoiding undue risk will depend upon a number of factors, such as the activities and the ages and experience level of participants.  Precautions include, but are not limited to, wearing a properly fitting helmet, obeying traffic signs and signals  when bicycling, skateboarding or rollerblading; participating in age-appropriate sports and recreational activities; avoiding diving in shallow water or water where you don’t know the depth; and following the rules for sports, recreational activities and equipment that are there to keep you safe.

How do you know if you’ve had a concussion?

Even when you take precautions to avoid injury, concussions can still occur.  A concussion  may result from a bump, blow a jolt to the head. When this happens the human brain literally bounces around inside the skull. Sometimes nerve cells can be twisted or even sheared. Not all blows to the head result in a concussion, which is also known as a mild traumatic brain injury (mTBI.)

While a concussion can cause you to lose consciousness, most people do not.  Most people also recover from symptoms of a concussion in a matter of days or several weeks, but up to one third of concussion patients do not fully recover from their concussions.  Concussion symptoms include chronic headaches, depression, problems with thinking and memory, vision and balance issues, and sleep disorders.[1]

What do you do  if you suspect a concussion was sustained?

Because the symptoms of a concussion can be subtle, it’s critical that you and those around you can recognize the signs and get the medical care needed following injury.  If you suspect that you, a friend or someone in your care sustained a concussion, contact a health provider as soon as possible.  If any of the following danger signs are present, the Centers for Disease Control directs to seek emergency care immediately:

-        have a headache that gets worse and does not go away,

-        experience weakness, numbness, decreased coordination, convulsions, or seizures,

-        vomit repeatedly,

-        have slurred speech or unusual behavior,

-        cannot recognize people or places,

-        get confused, restless, or agitated,

-        lose consciousness, and

-        look very drowsy or cannot wake up. 

For children the danger signs include all of the above, as well as:

-        will not stop crying and

-        are inconsolable and will not nurse or eat.[2]

Your primary care or the emergency department doctor will provide post-concussion evaluation and neurological and cognitive testing. Brain imaging, overnight hospitalization for observation  and/or referrals to specialists may follow the initial medical evaluation.  There is no one size fits all for concussions.  Concussion care requires a personalized treatment plan which may be adjusted throughout the course of your treatment. 

A final takeaway for the summer

Have fun, stay safe and take any bump, blow or jolt to the head seriously.

[1] https://www.mayoclinic.org/diseases-conditions/concussion/symptoms-causes/syc-20355594

[2] https://www.cdc.gov/traumaticbraininjury/concussion/symptoms.html#danger-signs

KAC Actions to Protect Combat Athletes are a Bold Move; But Let’s Keep Exploring New Options to Fight the Concussion Epidemic

We applaud the Kansas Athletic Commission’s  KAC) recent actions to help protect combat-sport athletes.  Their announcement is a bold first step in turning the tide on the concussion epidemic in Kansas and serves as a model for other states.

The KAC recently passed a measure to implement fighter and corner safety licensing protocols that will bring potentially life-saving education to professional fighters and teams competing in the state of Kansas.  That is something to celebrate.  While this move isn’t a knockout punch to eliminate or treat mild traumatic brain injury (mTBI) in the sport, adding concussion-related questions to the licensing process is a  powerful step forward. 

Fighting is more dangerous than most observers, and many athletes, understand.  About 3.8 million concussions occur in the U.S. each year from sports-related injuries.  While the Center for Disease Control estimates that 5-10% of athletes will experience a concussion in any given sport, [1]those numbers jump  significantly higher for combat sports. According to the Association of Neurological Surgeons, 90% of boxers will sustain a concussion during their careers. [2]

Concussions caused by contact sports are a growing epidemic in our country.  Jolts to the head frequently go unchecked. Many athletes shrug concussions off as nuisance and nothing more.  What may appear to some as a minor inconvenience can result in debilitating symptoms that can last months or  years.  As many as one third of patients do not fully recover from their concussions and those who have had a concussion are at risk of having another one.

Education is our best tool at this time to reduce the number of concussions and make sure that when fighters sustain head injuries, they report their symptoms, undergo a medical evaluation(s) and follow a doctor’s treatment plan before resuming physical activities. 

Promoting awareness about head injury is exactly what KAC hopes to achieve with its new mandate.  KAC announced that they will be partnering with the charity Fighting Foundation to add questions regarding concussions and chronic encephalopathy (CTE) to license applications for fighters and corners.  In their release, KAC indicated that persons involved in combat sports must educate themselves on the risks associated with brain injuries.

“There is no cure for CTE” said Fighting Foundation president Rose Grace, “however there is a cure for ignorance and it starts with our allies in Kansas.”

There is no cure for CTE, nor are there any effective pharmacological FDA-approved treatments for head injuries.  Treatment for concussions is still primitive and focuses on the symptoms rather than on a cure

 Several smaller biopharmaceutical companies like my own, Oxeia Biopharmaceuticals, have been conducting extensive research to treat concussions.  Kansas is playing yet another critical role as it relates to concussions.  The University of Kansas Medical Center is conducting the phase 2 ground-breaking trial for Oxeia’s drug treatment, OXE103,  which could address the underlying pathology of concussion (mTBI). The program seeks qualified volunteers from the Kansas City area to participate in this study which could help people with continued symptoms after sustaining a concussion.  Those interested in the greater Kansas City area interested in participating in the study should visit www.restisnotenough.com.

[1] https://www.uofmhealth.org/conditions-treatments/brain-neurological-conditions/concussion-athletes-neurosport

[2] https://traumaticbraininjury.net/2013/01/14/boxers-and-brain-injuries-a-scary-study/

The Silent Epidemic of Invisible Injuries: Domestic Violence and Traumatic Brain Injury

When you hear the term “traumatic brain injury,” or TBI, you might immediately think of common causes like car accidents, falling or a sports-related injury. Yet, there is another frequent cause of TBIs talked about far less: domestic violence. www.oxeiabiopharma.com

In a March 2022 report by the New York Times, Eve M. Valera, an associate professor of psychiatry at Harvard University and a leading researcher on traumatic brain injuries among survivors of domestic violence, estimated that while hundreds of concussions occur in the NFL each year, there could be nearly 1.6 million annual brain injuries among survivors of domestic abuse. 

This isn’t as surprising when you consider the epidemic of domestic violence. Statistics from the National Coalition Against Domestic Violence show that 1 in 4 women and 1 in 9 men will experience physical violence from their partner. Physical abuse isn’t the only form of domestic violence; emotional abuse, sexual abuse, and financial abuse are among the other ways that an intimate partner will exercise power and control. But physical abuse resulting in traumatic brain injury (TBI)  is frighteningly common. A paper published in the Journal of Aggression, Maltreatment & Trauma in 2019 predicted that upwards of 90% of all people that have a history of domestic violence have symptoms and signs of traumatic brain injury.

Acts of violence that can cause TBIs include hits to the face or head, hitting the head while falling or being shoved, and severely shaking someone (most often recognized in the incredibly dangerous “shaken baby syndrome”). Brain injury can also occur because of strangulation and oxygen deprivation, and as an estimated 50% of domestic violence victims are strangled at some point in the course of their relationship, often repeatedly.

On April 1, 2022, The Protecting Survivors From Traumatic Brain Injury Act was introduced by Senator Catherine Cortez Masto (D-Nev) and Senator Joni Ernst (R-Iowa). The legislation would require HHS to collect data every two years to better document the occurrence of TBI. The immediate goal is to help HHS in “understanding, addressing, and allocating resources to reduce and treat such injuries and the cause of such injuries”. Another important goal of the legislation is to ensure that providers get the training on TBIs so they can help connect survivors to the services they need. Most advocates receive training on trauma and safety planning and oppression, but we don’t have enough training in neuro knowledge or where the local neurorehabilitation services are.

In addition to recent media coverage on this issue, the overdue passage of the Violence Against Women Act (VAWA), and the introduction of The Protecting Survivors From Traumatic Brain Injury Act, there is also movement in the healthcare field.

In February 2022, a report by the National Academies of Sciences, Engineering, and Medicine (NAS) was published and calls for a new classification system for traumatic brain injury. The report criticizes the current system of classifying TBI as either “mild, moderate, or severe” stating that it is outdated and that this diagnosis should be based on the Glasgow Coma Scale, neuroimaging results, and blood biomarker results.

The NAS report also calls for the formation of a national TBI task force to create the framework and plan to improve the treatment of TBI.

There are no effective pharmacological FDA-approved treatments for head injuries and there is a dearth of research into TBI and domestic violence. We need Congress to support research focused on female IPV victims with head injuries, better data collection and sharing of data so that we understand the full impact of brain injury on all IPV victims and can respond with effective population- and culturally-specific programs for prevention, education, support services and treatment programs. 

Please contact  your senators to impress upon them the need to focus more resources to identify, reduce and effectively treat TBIs in domestic abuse survivors.

Note: For survivors, if you are concerned for your safety or would like to speak with someone about a relationship where you do not feel safe, the National Domestic Violence Hotline is available 24/7 at 1 (800) 799-SAFE; you can also text START to 88788 or chat with someone at their website www.thehotline.org.

Suzanne Dubus is the CEO of the Jeanne Geiger Crisis Center and has led the organization since 1997.  Throughout her career, she has advocated for survivors of domestic violence through programming, innovative approaches, collaboration, policy issues, and systems change. Suzanne was named a Champion of Change by the White House in October 2011. The Geiger Institute was created to help communities prevent domestic violence homicides.

Michael Wyand, DVM, PhD, is the CEO of Oxeia Biopharmaceuticals. Oxeia is conducting Phase 2 human clinical studies for its therapeutic drug, OXE-103, to treat concussions.  www.oxeiabiopharma.com

Oxeia Video Series - Concussion: More About the Unmet Medical Need to Treat Concussions - Part 3

Kartik Shah, Director and Co-founder of Oxeia Biopharmaceuticals talks more about the unmet medical need for effective treatments.

Oxeia Video Series - What is Oxeia?

Oxeia co-founder Kartik Shah talks about Oxeia, how it was started and the people behind the company.

Mountains were moved to develop Covid-19 vaccines. Can the U.S. Military do the same to find a treatment for concussions?

Shock and awe is one way to describe reactions to pharma’s achievement in bringing vaccines to market to combat coronavirus with unprecedented speed.  The availability of nearly limitless funds, well-orchestrated coordination among key players and a genuine sense of urgency propelled one of the greatest medical achievements of our times.  The old drug development paradigm has been transformed; the medical and pharma community is now reevaluating ways to drive innovation faster and more efficiently.  Now is the time for our nation to do the same to help those suffering from concussions, a form of traumatic brain injury (TBI), that impacts countless active servicepeople and veterans, as well as civilians.  The military is ideally situated to drive this charge forward.

Concussions, also known as mild traumatic brain injury (mTBI), are the most common type of TBI for members of the military. Now recognized as an epidemic, mTBI has become one of the highest priorities in public health because of its tremendous costs and possible long-term consequences. These “signature injuries” of the Iraq and Afghan conflicts are very real to active servicemembers, veterans and their families. The Department of Defense reported 430,000 head injuries among active-duty military between 2001 and 2018 with the vast majority ­82% – classified as mTBI.

Finding treatments for these injuries is both a matter of urgent military readiness, as well as a moral obligation.

The government is keenly aware of the impact concussions have on service members and veterans.  Both the Department of Defense and the Veterans Administration have sponsored programs to enhance the understanding of what causes concussions, as well as identify treatments and recovery protocols for mTBI. The Senate and House National Defense Authorization Act for 2022 directs increased funding for brain injury research.   The Senate Arms Committee bill report calls for “robust” therapeutic research for all levels of brain injury as an item of special interest. 

Tapping military might is logical to advancing research and finding treatments for mTBI. I encourage the armed forces to not only continue doing what they are already doing, but also expand their efforts.  Our military has a special ability to get the job done.  Like the working committees formed to combat Covid-19, the military has the might to galvanize disparate groups of professionals to share research and resources to power ahead for solutions.  The private sector players, many of which are biopharma start-ups, will gladly welcome the leadership and support of our military.

Effective treatments for mTBI can also result in significant cost savings.  While symptoms disappear for most concussion sufferers within days or a couple of weeks, research indicates that almost 40% of mTBI patients have post-concussion symptoms (PCS) lasting more than three months.  A study examining recovery of PCS patients found only 27% of their population eventually recovered.

These often debilitating symptoms require ongoing physical, speech, cognitive, vision, occupational and/or drug therapies for our active military and veterans.   Studies have also linked mTBI with depression and PTSD, and repeated mTBIs with various neurodegenerative diseases.  For example, studies have shown that veterans with a history of mTBI have a 56% higher risk of developing Parkinson's disease within 12 years of their injury,

Many of these impairments can negatively affect readiness and job performance for active military and ongoing problems for employment, as well as for families and the larger community.

Progress toward a treatment for TBI to help our servicepeople and veterans will also be a boon to the public at large.  In the past couple of decades, awareness about the dangers of concussions has led to extensive news coverage of active and retired professional football players, and other athletes.  Today our citizens are more likely to realize that a slip in the bathtub or a car crash, can lead to injuries that are not seen by the naked eye.  The costs of treating concussion for the general public are already staggering.  The American Association of Neurological Surgeons puts annual direct and indirect costs of the full spectrum of TBIs – from mild to severe – are $76.5 billion.  Approximately 75% of all TBIs are mTBI.

As New York Senator Kristen Gillibrand remarked at a December 2017 Senate Armed Services Committee meeting; “If the military figures this out, then the rest of us can too.”

Michael Wyand, DVM, PhD, is the CEO of Oxeia Biopharmaceuticals. Oxeia is conducting Phase 2 human clinical studies for its therapeutic drug, OXE-103, to treat concussions. 

Oxeia Video Series - Concussion: The Unmet Medical Need - Part 2

Michael Wyand, CEO of Oxeia Biopharmaceuticals talks more about concussions and the unmet medical need for effective treatments.

Oxeia Video Series - Concussion: The Unmet Medical Need - Part 1

Michael Wyand, CEO of Oxeia Biopharmaceuticals talks more about concussions and the unmet medical need for effective treatments.