An estimated 600,000 veterans are suffering from TBI and PTSD, the signature injury of the wars in Iraq and Afghanistan. Military medicine has spent billions on therapies with drugs and other interventions that have little or no effect on healing the brains injured by modern combat, IEDs, and repeated exposure to war. NBIRR is a Clinical Trial under the strictest medical guidelines meant to prove the safety and efficacy of HBOT while treating 1,000 patients. HBOT currently is not covered by insurance. The fact is that HBOT has already healed hundreds of patients with a variety of injuries, including TBI and PTSD. The next step is to run a rigorous scientific study to prove that HBOT, in fact, improves the quality of life of brain-injured patients during and after treatment with hyperbaric oxygen. The hope is that, with this evidence and scientific validation, the VA, Congress and the public will insist that the VA, DOD and the military medical system recognize the need and the moral imperative to insure treatments with HBOT. Without the trial, the military medical community will continue to refuse to recognize that HBOT is medically sound, safe, effective and vastly less expensive and more humane than treating veterans with drugs for life.
1. Healing America’s Wounded Warriors Luke Beckman Executive Director, TBI & PTSD Project, Director of Outreach and Social Media, International Hyperbaric Medical Foundation lukembeckman@gmail.com, 650-740-5853, http://www.razoo.com/story/Nbirr
2. Overview Why are so many wounded? What is Post-Traumatic Stress Disorder/Traumatic Brain Injury (PTSD/TBI)? What will this cost the American taxpayer? What are we currently doing? What is Hyperbaric Oxygen Therapy (HBOT)? What is the National Brain Injury Rescue and Rehabilitation (NBIRR) Project? How do we properly heal our veterans?
3. Our Veterans Need Help As of Jan. 2010, 1.9 million service members had deployed to Iraq and Afghanistan. It is estimated that 1/3 of these service members suffer from Traumatic Brain Injury (TBI), Post-Traumatic Stress Disorder (PTSD), and/or depression. 600,000 service members Source: RAND Corporation
4. Why so many injured? Improvised Explosive Devices (IEDs) are responsible for 60% of all American combat casualties in Iraq and 50% of all combat casualties in Afghanistan. Modern battlefield medicine is able to keep more service members alive after major injuries. Many service members have both visible and hidden injuries from head trauma- especially from the blast waves from IEDs. Source: http://www.fas.org/sgp/crs/weapons/RS22330.pdf
5. What are Traumatic Brain Injury (TBI) and Post-Traumatic Stress Disorder (PTSD)? Both TBI & PTSD are closely related, and in many cases, directly related. Explosions, by way of direct impact or form a blast wave, injures the brain- usually when it ricochets off of the skull. Blast-induced TBI is different than traditional brain injuries because of compounded PTSD causal factors Many symptoms of TBI are identical to symptoms of PTSD Depression Anxiety Forgetfulness Sleep difficulties Difficulty concentrating Muscle spasms Irritability Headache Nausea Fatigue Affects both the military and civilians
6. What does this mean for U.S. security? We have 600,000 service members with wounds to the head (whether they show it or not) Most of these individuals experience mild to severe psychological and physical symptoms yet still serve on the frontlines We do not yet have a way to heal these wounds
7. What are the military costs of PTSD/TBI to American taxpayers? These values do not include the costs of replacing trained soldiers with new ones *Cost only accounts for direct military war-fighting operations Source: http://www.fas.org/sgp/crs/natsec/RL33110.pdf
8. Cost of Traumatic Brain Injury (TBI) in American society as a whole Source: Johns Hopkins Medicine
16. What is Hyperbaric Oxygen Therapy (HBOT)? The process of breathing in 100% pressurized oxygen. Used daily for 13 FDA-approved conditions Stroke, diabetic foot wounds, burns, crush injuries, carbon monoxide poisoning, etc…
17. Why isn’t HBOT used widely? HBOT at 1.5 atmospheres is not covered by insurance and military personnel cannot afford a full treatment cycle. Active opposition and stalling from the US military for a myriad of reasons (reasons below actually stated in open dialogue)- none of which are rational and/or true HBOT for TBI and PTSD is dangerous. HBOT is not clinically proven to work. HBOT is not an FDA-approved device for TBI or PTSD You haven’t done a clinical trial with a placebo as part of the protocol. No matter how much evidence you gather, it is not backed by clinical trials. These people would have gotten better anyway. The brain cannot be healed. You can’t prove that it was HBOT that caused the improvements. If it worked, military medicine would have already adopted it. We haven’t studied it enough. You’re biased in favor of HBOT; therefore, anything you say is suspect. Too many of the patients who say they have a problem really don’t. You’re out of your league. DOD will run the studies their way. You’re giving these patients false hope. HBOT leads to premature aging and Alzheimer's. We’ve spent over a billion dollars on research and studies. We’re doing all that is humanly possible. The most logical argument is that if HBOT is proved effective, thousands of soldiers could be pulled off the front lines for treatment Our current policy is to provide them with dozens of drugs- used off-label.
18. The US military is concerned about frontline readiness The US Army has fears about troops “leaving the fight” when they hear that treatments exist for their head injuries There's more TBI/PTSD out there than reported Soldiers have not been reporting claims and the Army isn't keeping track Without baseline data there is no way to "prove" that TBI and/or PTSD existed [Congress has mandated that baseline tests be given] Far too many new cases would be suspicious claims The system could not handle the surge of claimed injuries Once the "true" nature of TBI/PTSD occurrence was known, the volunteer Army would be threatened Asizeable number of boots-on-the-ground in Afghanistan would have to be pulled out of the line for past injury and every time a new injury occurred, again threatening the volunteer force. Several military combatant commanders are, however, pushing very hard to get their soldiers treated.
19. NBIRR is the Solution The National Brain Injury Rescue and Rehabilitation (NBIRR) Project has been launched to carry out a clinical trial for HBOT to treat TBI/PTSD Approved by the Western Institutional Review Board- the “Gold Standard” of medical review Case study of 1,000 patients to build the pool of data to conduct proper analysis Treatments have begun on a sporadic basis with remarkable results using 1.5 atmospheres of pressure (HBOT 1.5)
20. What does HBOT 1.5 mean? Patient enters chamber (enclosed glass tube) and lies down Breathes 100% oxygen, at 1.5 atmospheres of pressure, for one hour 40 sessions over six weeks Patients typically begin to experience positive symptoms after 20 sessions 30-day break 40 more sessions
21. What is HBOT’s potential effect on the brain? 84% of coma patients have awoken with exposure to HBOT 1.5 HBOT is the only non-hormonal FDA-approved treatment known to repair and regenerate human tissue. HBOT repairs and regenerates tissue by two oxygen-dependent processes Activates growth factors at the DNA level Improves blood supply to wounds throughout the body.
22. Initial treatment results are encouraging Consistent results: All patients who have been treated to-date by HBOT 1.5 have been able to return to pre-injury jobs MRI and SPECT scans show dramatic increased production in previously-damaged areas of the brain Automated Neurological Assessment Metrics show significant improved performance in treated service members
23. What do improved test scores really mean? When comparing behavior after treatment to after the injury was sustained… Both simple and complex reaction time is faster Learning and memory is improved Headaches subsided Sleep patterns and length is improved Depression is decreased Cognitive functioning is improved
24. How do we scale, test, and validate this therapy? HR396 was written and proposed on the U.S. House of Representatives floor but removed from the DoD appropriations bill Would have mandated a five-year pilot program to attempt new treatments like HBOT in wounded veterans All injured veterans would have been notified Army lobbying removed this bill from the overall funding package Over 80 facilities are registered and approved with the IRB study- they can treat 1,000 patients in under six months. With the enactment of the NBIRR study, Bayesian analysis on a small number of patients will likely demonstrate results on how the rest of treatments will proceed This study on service members is the first step to generating the data set to allow the FDA to approve HBOT for TBI in the civilian population
25. What is the cost and where does the money go? Using free-standing, approved clinics will save millions of dollars One hour in a private hospital chamber costs around $1,300 One hour in an NBIRR-approved clinic chamber (all are lined up, ready to go) costs $200 This is a $88,000 savings for every patient treated Total treatment cost per patient is $20,000 from start to finish 1000 patients will be enrolled in the study (lasting six months total) Administrative fees over the six months across the entire country Total cost is $20,000,000 ($20,000 x 1000)
27. What stands in our way? Tricare and the VA will not reimburse HBOT treatments because they are not FDA-approved for brain injury Note: NONE of the drugs currently used and paid for by Tricare and the VA to treat our brain injured veterans are FDA- approved to treat TBI.
28. What arethe ultimate end goals? Demonstrate the efficacy of HBOT in treating TBI/PTSD and in doing so… Ensure that Tricare and the VA accept HBOT 1.5 for treating TBI as a covered medical procedure Heal our 600,000+ brain injured veterans and get them back to functional lives Expand healthcare coverage across civilian insurance providers and ensure treatment to 7,000,000+ civilians suffering from TBI
29. How can you help? Donate money to fund the study 20,000,000 people donating $1 funds the entire study 1,000,000 people donating $20 funds the entire study 100,000 people donating $200 funds the entire study 16,000 people donating $1,000 funds the entire study The average American spends… $323 per year on tobacco $457 on alcohol $558 on personal care $2,698 on entertainment
30. Think about it 17 veterans are killing themselves every day We can heal the brain It only takes $20 100% of your donation goes directly to treating wounded veterans Donate Here: http://www.razoo.com/story/Nbirr
31. Thank you for caring… Luke Beckman Executive Director, TBI & PTSD Project, Director of Outreach and Social Media, International Hyperbaric Medical Foundation lukembeckman@gmail.com, 650-740-5853 http://www.razoo.com/story/Nbirr This We’ll Defend SemperFi Honor, Courage, Commitment Service Before Self SemperParatus