TREAT NOW: TREAT NOW: Arresting Suicide, Rescuing Injured War Veterans, while Improving Readiness for

the State’s National Guard, Military, Veterans and State Residents

November 2013

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Indiana Veteran Recovery Plan Indiana Veteran Recovery Plan

Indiana Veteran Recovery Plan Indiana Veteran Recovery Plan

• Description of the problemDescription of the problem– Indiana has over 500,000 veterans– 166,470 Vietnam Veterans– 125,804 Gulf War Veterans as of Nov ’12– 21,000+ ING part of Gulf War vets.– TBI/PTSD for combat arms is 50-75%– Suicide epidemic in DOD at 22+ per day

• IN has 50.6 to 55.2 thousand w/ TBI/PTSDIN has 50.6 to 55.2 thousand w/ TBI/PTSD2

Indiana Veteran Recovery Plan Indiana Veteran Recovery Plan

Proposed Approach: Proposed Approach:

• Hyperbaric Oxygen Therapy (HBOT), under scientific protocol, combined with psychological counseling.

• Medication only when needed.

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Indiana Veteran Recovery Plan Indiana Veteran Recovery Plan

Facts bearing on the problem:Facts bearing on the problem:

• Cost to Indiana based upon OK University study is $40,000 per patient per year. Fed costs add an additional $20,000 per year.

• Translates to $3.04 to $3.31 Billion $3.04 to $3.31 Billion annually.annually.

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Indiana Veteran Recovery Plan Indiana Veteran Recovery Plan • Other Facts bearing on this problem:Other Facts bearing on this problem:

– 22+ suicides & 44 additional failures daily– HBOT is not yet FDA approved– 4 HBOT studies by VA and DOD conclude

wrongly that HBOT does not work. Studies and interpretation of results are FLAWED!

– TBI Act has passed House last 3 years 100%– Governor Pence voted for TBI Act.– [Senate Armed Services Committee] refuses

to [consider] TBI Act!5

Evidence-Based Medicine and Science Continue to Mount:

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George Wolf, David Cifu, Laura Baugh, William Carne, and Leonardo Profenna. The Effect of Hyperbaric Oxygen on Symptoms after Mild Traumatic Brain Injury. JOURNAL OF NEUROTRAUMA 29:2606–2612 (November 20, 2012).

Army Trials Report from UHMS Conference, June 2013. Press Release: " DoD announces results of first three DoD-Sponsored trials using hyperbaric oxygen for mild traumatic brain injury"

Paul G. Harch, et al. A Phase I Study of Low-Pressure Hyperbaric Oxygen Therapy for Blast-Induced Post-Concussion Syndrome and Post-Traumatic Stress Disorder. JOURNAL OF NEUROTRAUMA 29:168–185 ( January 1, 2012).

Colonel James K. Wright, Eddie Zant, Kevin Groom, Robert E. Schlegel, Kirby Gilliland. Case report: Treatment of mild traumatic brain injury with hyperbaric oxygen. UHM 2009, Vol. 36, No. 6 – 391.

Paul G Harch, Edward F Fogarty, Paul K Staab, and Keith Van Meter. Case report: Low pressure hyperbaric oxygen therapy and SPECT brain imaging in the treatment of blast-induced chronic traumatic brain injury (post-concussion syndrome) and post traumatic stress disorder. Published: 9 June 2009 Cases Journal 2009, 2:6538. September 2013.

Rockswold, Rockswold, Zaun and Liu. A prospective, randomized Phase II clinical trial to evaluate the effect of combined hyperbaric and normobaric hyperoxia on cerebral metabolism, intracranial pressure, oxygen toxicity, and clinical outcome in severe traumatic brain injury. Journal of Neurosurgery, Jun 2013 / Vol. 118 / No. 6 / Pages 1317-1328

The International Hyperbaric Medical Foundation. Summary report from, “The National Brain Injury Rescue and Rehabilitation Trial – a multicenter study of hyperbaric oxygen for mild traumatic brain injury." January 2013.

Efrati S, Fishlev G, Bechor Y, et al. Hyperbaric oxygen induces late neuroplasticity in post stroke patients - randomized, prospective trial. PLoS One 2013;8:e53716.

Rahav Boussi-Gross, Haim Golan. Gregori Fishlev, Yair Bechor1, Olga Volkov, Jacob Bergan, Mony Friedman, Eshel Ben-Jacob, Shai Efrati. HYPERBARIC OXYGEN THERPAY FOR CHRONIC COGNITIVE IMPAIRMENTS DUE TO TRAUMATIC BRAIN INJURY- RANDOMIZED PROSPECTIVE TRIAL. Tel-Aviv University, Tel-Aviv 69978, Israel. Nov. 15, 2013.

Blast Exposure Induces Post Traumatic Stress Disorder-Related Traits in a Rat Model of Mild Traumatic Brain Injury. Gregory A. Elder, Nathan P. Dorr, Rita De Gasperi, Miguel A. Gama Sosa, Michael C. Shaughness, Eric Maudlin-Jeronimo, Aaron A. Hall, Richard M. McCarron, and Stephen T. Ahlers. Journal of Neurotrauma.

Research Report: Hyperbaric oxygen therapy improves spatial learning and memory in a rat model of chronic traumatic brain injury. Paul G. Harch, Christopher Kriedt, Keith W. Van Meter, Robert James Sutherland, BRAIN RESEARCH 1174 (2007) 120-129.

TBI/PTSD SymptomsTBI/PTSD Symptoms

• Immediate– Headache– Slight confusion– Assessed– Off line for 2-3 days

• Delayed – 3 weeks +– Irritability– Sleep disturbances– Headaches– Memory difficulties– Cognitive difficulties– Clumsy

• Threatened with job loss

Confidentiality Statement on page 1 applies.

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What HBOT isWhat HBOT is

• 100% oxygen under pressure

• 1.5 – 2/0 ATA for brain injury

• 40-80 1 hr treatments • 1-2 HBOT per day• Used for more than

100 years for brain injury [first use in US by Roebling

while building the Brooklyn bridge, 1870s. Dates to 1600s.]

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How it works - 5,769+* waysHow it works - 5,769+* ways(~# of cellular processes studied)

• Up-regulates growth factors• Reduces edema/swelling• Promotes neural pathway

growth• Activates senescent neurons

[“sleeping”, not dead]• Increases neuronal energy

[ATP]• Down-regulates inflammation• Reduces reperfusion injury

[not enough O2]

*Rink C, Roy S, Khan M, Ananth P, Kuppusamy P, Sen CK, Khanna S. Oxygen-sensitive outcomes and gene expression in acute ischemic stroke. J Cereb Blood Flow Metab. 2010 Feb 10.

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HBOT FDA approved treatment uses.HBOT FDA approved treatment uses.1) Air or gas embolism2) Carbon monoxide poisoning3) Gas gangrene4) Traumatic ischemias – crush injury, compartment syndrome5) Decompression sickness6) Arterial insufficiencies7) Severe anemia8) Intracranial abscess9) Necrotizing soft tissue infections10) Refractory osteomyelitis11) Delayed radiation injury12) Compromised flaps and grafts13) Acute thermal burn injury14) Problem wounds15) Retinal ischemic disease

HBOT has been used for >100 years to treat brain injury

BLUE are conditions much like brain injury

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NBIRRNBIRRNational Brain Injury Rescue and Rehabilitation ProjectNational Brain Injury Rescue and Rehabilitation Project

• Planned for 1000 patients with mTBI and/or PTSD

• All receive HBOT 1.5• Early results encouraging• 5 Hoosiers have

participated and all have very positive results

• Over 30 locations now participating

• All participants have improved

• Most improved in every measure

• Most improved substantially

• No participants worsened• Results are durable

NBIRR Study, see: http://www.clinicaltrials.gov/ct2/show/NCT01105962

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ANAM Scores ImproveANAM Scores Improve

• 1st 12 consecutive patients with TBI

• All received HBOT

• All improved in nearly every measure

• Results are % improvement in ANAM scores

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ANAM ScoresANAM Scorespre-injury, post-injury, after HBOT

100%

50%

0

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HBOT recipients trend back to normalHBOT recipients trend back to normal

0

20

40

60

80

100

Pe

rce

nti

le

Back to Normal Test (N=18)

Avg time elapsed = 108 days

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Personal Health Questionnaire-9 Personal Health Questionnaire-9

00.5

11.5

22.5

Little interest or pleasure in doing things

Feeling down, depressed, or

hopeless

Trouble falling or staying asleep, or sleeping too

much

Feeling tired or having little

energy

Poor appetite or overeating

Feeling bad about yourself -or that you are a failure or have let yourself or

your family down

Trouble concentrating on things, such as

reading the newspaper or

watching television

Moving or speaking so

slowly that other people could have noticed?

Or the opposite -being so fidgety or restless that you have been

moving around a lot more than

usual

Thoughts that you would be better off dead

or hurting yourself in some

way

sco

re

PHQ-9 Test Results

N = 18Avg HBOT = 44Avg elapsed time = 85 daysTotal score avg 13 → 3

Post-HBOT

Suicidal thoughtseliminated

Pre-HBOT

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Preliminary Clinical ObservationsPreliminary Clinical Observations

• Every patient with TBI improves with HBOT• Improvement is durable• The earlier you treat, the more complete the recovery• More severe TBI requires more HBO treatments• HBOT reduces or removes the need for medication• PTSD associated with TBI (2/3 of military PTSD cases)

improves with HBOT

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Interim Results SummaryInterim Results Summary

• All mood measures improve

• ANAM /performance scores improve

• Vital Signs Improve toward Pre-Injury Status

• HBOT recipients trend back to normal on cognitive, emotional and physical scales

• Suicidal thoughts reported to disappear

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Indiana Veteran Recovery Plan Indiana Veteran Recovery Plan • PHASE1

– Governor Executive Order• State responsible to deliver medical care and recover

costs for doing so.• NG Commanders may activate SM [spell out]to receive

treatment.• Does not preclude AC[spell out] or Reservist.• Direct state health resources to begin coordination to

effect biological repair treatment and adjunctive therapies under direction of IU Medical and International Medical Foundation (IHMF) National Brain Injury Rescue & Rehabilitation (NBIRR) Project

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Indiana Veteran Recovery Plan Indiana Veteran Recovery Plan

• PHASE1– General Assembly

• Establish a revolving IVRP Trust w/ $5 million [per year? Total?] for 5 yrs.

• Direct IU medical to oversee treatment and collect before & after testing. Notify state insurance POC.

• Direct State Insurance POC to pay for treatment at MEDICAR rates to the 30+ facilities in IN that currently provide HBOT after IU Medical approves.

• File from state to federal for full reimbursement to replenish fund. (1921 Veterans Bureau Act)

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Indiana Veteran Recovery Plan Indiana Veteran Recovery Plan

• PHASE1– Revolving IVRP Trust manager and IU Med

• Report performance to Gov., Senate, & House annually.

• Dissolve trust 60-90 days after FDA approves treatment as a “standard of care”.

– IDVA to contact and publicize to all veteran service organizations, veterans, and military in state: ACTIVE CAMPAIGN TO I.D. BRAIN INJURED

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Indiana Veteran Recovery Plan Indiana Veteran Recovery Plan • PHASE 2

– Legislature study establishment and operation of additional facilities:

• Indiana Veterans Home (W. Lafayette)Indiana Veterans Home (W. Lafayette)• Camp AtterburyCamp Atterbury• Locations would be state owned.• Excellent location and use at existing facilities• Reasonable distance for vets

– IDVA to seek federal grant to cover capital costs

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"Hyperbaric oxygen is a safe, easily used treatment that, in many cases, has resulted in a dramatic improvement in the symptoms of patients with [TBI]. Every day we are…. gathering more data validating its efficacy.… I feel, as do many of my colleagues, that there is sufficient clinical and research evidence to justify the use of [HBOT] as a standard-of-care treatment for [TBI] that should be reimbursed by CMS and Tricare…. I have no doubt that, over the next several years, [HBOT] will be proven beyond a reasonable doubt to be one of the most effective treatments for [TBI]…. There is a preponderance of evidence now to justify the use and funding for the treatment….”

Dr. George Mychaskiw II, DO, FAAP, FACOP, Editor-in-Chief Chair, Department of Anesthesiology, Nemours Children’s Hospital, Orlando, Florida USA. The Journal of Hyperbaric Medicine is the most prestigious journal on Hyperbaric Medicine in the world.

Questions?Questions?From the time he first heard men marching to a cadence call, Eddie Wright had one dream in life, and that was to be a United States Marine. And as a Marine serving in Iraq, his company was ambushed in Fallujah (7 April 2004). He was knocked out when a rocket propelled grenade hit his Humvee. When he came to, he saw that both his hands were gone and his leg was badly wounded.

He couldn’t fire his weapon, he could barely move, and he was bleeding to death. But he had the strength of mind to lead the men under his command, and that is exactly what he did. He kept them calm, he showed them how to stop the bleeding in his leg, he told them where to return fire, he had them call for support, and he got them out of there alive.

His composure under fire that day earned him the Bronze Star with Valor device. But if you ask him, “What did you get it for?”, he’ll tell you, “Just for doing my job.” When Maj Gen Jones asked him why he didn't pass out from blood loss, he looked the General in the eye and said, "Sir, I couldn't pass out.  I was in charge."

After a long recovery, Eddie continued to serve as a martial arts instructor at the Marine Corps Martial Arts Center of Excellence at Quantico. He resigned from his beloved Marine Corps a few years ago, but he still lives by the motto: “Once a Marine, always a Marine.”

Eddie Wright is the son of the NBIRR P.I., Dr. Jim Wright.

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