Treating Brain Injury and PTSD in Veterans

Healing America’s Wounded WarriorsLuke BeckmanExecutive Director, TBI & PTSD Project, Director of Outreach and Social Media, International Hyperbaric Medical Foundationlukembeckman@gmail.com, 650-740-5853, http://www.razoo.com/story/Nbirr

OverviewWhy 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?

Our Veterans Need HelpAs 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 membersSource: RAND Corporation

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

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 factorsMany symptoms of TBI are identical to symptoms of PTSDDepressionAnxietyForgetfulnessSleep difficultiesDifficulty concentratingMuscle spasmsIrritabilityHeadacheNauseaFatigueAffects both the military and civilians

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 frontlinesWe do not yet have a way to heal these wounds

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 operationsSource: http://www.fas.org/sgp/crs/natsec/RL33110.pdf

Cost of Traumatic Brain Injury (TBI) in American society as a wholeSource: Johns Hopkins Medicine

What treatments is the military using to treat brain injured veterans?Exercise

Medication (individuals often take up to 20 different types of drugs daily)

NONE of the drugs currently used and paid for by Tricare and the VA to treat brain injured veterans are FDA-approved to treat TBI (only Paxil and Zoloft are approved to treat PTSD) Where will we be 10 years from now?Total cost of $1.35 Trillion dollars to American taxpayers using current methodologiesAn estimated 15,500 veterans have committed suicide since Aug 2008 (17 suicides per day)The military openly declares they have a suicide epidemicAlmost all drugs that are prescribed (Note: they are prescribed off-label) for PTSD carry Black-Box warnings against sustained use because of increased risk of suicideUsing current treatments, a person who is reduced to 70% brain capacity often increases to 74% and still remains heavily dependent and addicted to medications.

What alternatives exist?Hyperbaric Oxygen Therapy

What is Hyperbaric Oxygen Therapy (HBOT)?The process of breathing in 100% pressurized oxygen.Used daily for 13 FDA-approved conditionsStroke, diabetic foot wounds, burns, crush injuries, carbon monoxide poisoning, etc…

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 trueHBOT for TBI and PTSD is dangerous.HBOT is not clinically proven to work.HBOT is not an FDA-approved device for TBI or PTSDYou 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 treatmentOur current policy is to provide them with dozens of drugs- used off-label.

The US military is concerned about frontline readinessThe US Army has fears about troops “leaving the fight” when they hear that treatments exist for their head injuriesThere's more TBI/PTSD out there than reportedSoldiers have not been reporting claims and the Army isn't keeping trackWithout 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 claimsThe system could not handle the surge of claimed injuriesOnce the "true" nature of TBI/PTSD occurrence was known, the volunteer Army would be threatenedAsizeable 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.

NBIRR is the SolutionThe National Brain Injury Rescue and Rehabilitation (NBIRR) Project has been launched to carry out a clinical trial for HBOT to treat TBI/PTSDApproved by the Western Institutional Review Board- the “Gold Standard” of medical reviewCase study of 1,000 patients to build the pool of data to conduct proper analysisTreatments have begun on a sporadic basis with remarkable results using 1.5 atmospheres of pressure (HBOT 1.5)

What does HBOT 1.5 mean?Patient enters chamber (enclosed glass tube) and lies downBreathes 100% oxygen, at 1.5 atmospheres of pressure, for one hour40 sessions over six weeksPatients typically begin to experience positive symptoms after 20 sessions30-day break40 more sessions

What is HBOT’s potential effect on the brain?84% of coma patients have awoken with exposure to HBOT 1.5HBOT is the only non-hormonal FDA-approved treatment known to repair and regenerate human tissue. HBOT repairs and regenerates tissue by two oxygen-dependent processesActivates growth factors at the DNA levelImproves blood supply to wounds throughout the body.

Initial treatment results are encouragingConsistent results: All patients who have been treated to-date by HBOT 1.5 have been able to return to pre-injury jobsMRI and SPECT scans show dramatic increased production in previously-damaged areas of the brainAutomated Neurological Assessment Metrics show significant improved performance in treated service members

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 fasterLearning and memory is improvedHeadaches subsidedSleep patterns and length is improvedDepression is decreasedCognitive functioning is improved

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 billWould have mandated a five-year pilot program to attempt new treatments like HBOT in wounded veteransAll injured veterans would have been notifiedArmy lobbying removed this bill from the overall funding packageOver 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 proceedThis 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

What is the cost and where does the money go?Using free-standing, approved clinics will save millions of dollarsOne hour in a private hospital chamber costs around $1,300One hour in an NBIRR-approved clinic chamber (all are lined up, ready to go) costs $200This is a $88,000 savings for every patient treatedTotal treatment cost per patient is $20,000 from start to finish1000 patients will be enrolled in the study (lasting six months total)Administrative fees over the six months across the entire countryTotal cost is $20,000,000 ($20,000 x 1000)

What is the cost and where does the money go?

What stands in our way?Tricare and the VA will not reimburse HBOT treatments because they are not FDA-approved for brain injuryNote: 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.

Treating Brain Injury and PTSD in Veterans

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Treating Brain Injury and PTSD in Veterans