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Executive Summary. CAPSTONE. Arresting the Military Suicide Epidemic through Intervention with Hyperbaric Oxygen Therapy (HBOT) The Center for Translational Medicine a nd International Hyperbaric Medical Foundation. October 2013. The Bottom Line up Front.

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Presentation Transcript
slide1

Executive Summary

CAPSTONE

Arresting the Military Suicide Epidemic through Intervention with

Hyperbaric Oxygen Therapy (HBOT)

The Center for Translational Medicine

and

International Hyperbaric Medical Foundation

October 2013

slide2

The Bottom Line up Front

We are taking action against the unprecedented suicide epidemic afflicting U. S. Veterans.There are 22 military suicides a day, over 8,000 a year. Another 45 military a day – more than 16,000 a year – attempt suicide and fail. Many suicides come from or are motivated by the hundreds of thousands of battlefield casualties who suffer from Traumatic Brain Injury (TBI, the signature injury of Afghan and Iraq wars) and Post Traumatic Stress Disorder (PTSD) and remain disabled and untreated. Despite $1.5+ billion and seven years, the Army has yet to design and develop, let alone discover and deploy, an effective treatment for the disabling symptoms and effects of TBI/PTSD brain injury. Our current success in the use of Hyperbaric Oxygen Therapy (HBOT) to treat and help heal over 125 wounded servicemen and women, and the worldwide science behind the use of HBOT for TBI/PTSD, argues for action to TREAT NOW. We need $2.5M to fund the CAPSTONE Project.

CAPSTONE

Arresting the Military

Suicide Epidemic

slide3

Suicide Epidemic: The Problem

Suicides among veterans are at 22+ per day; another 1,300+ attempt suicide every month. Nearly 40% of OIF/OEF veterans are diagnosed with a mental illness – and that’s just those who ask for help. One third receive minimal care; another third receive no care at all. Estimates are that over 600,000 veteran servicemen and women are injured and are denied effective treatment.

Nearly 5 million people in the US are suffering with brain injury and psychological problems. That number grows by ~250,000 each year.

The VA, DoD and medicine in general fail to adequately coordinate and integrate tracking, diagnosis, prescriptions, treatment, analysis and follow-on adjustments. The VA estimates its case backlog at ~800,000.

CAPSTONE

Arresting the Military

Suicide Epidemic

slide4

The Center for Translational Medicine (CTM)

and

International Hyperbaric Medical Foundation (IHMF)

CAPSTONE Mission. The CTM and IHMF are using HBOT, integrative medicine and adaptive clinical trials to treat brain-injured combat veterans and others to head off the suicide epidemic, improve quality of care, and conduct science to improve patient diagnoses, treatments, support and quality of life.

Cardinal Rule in an Epidemic: Early Detection, Early Response

CAPSTONE

Arresting the Military

Suicide Epidemic

slide5

The Concept:

The Capstone Alliance is formed from qualifying HBOT-capable civilian clinics across the country. Your contribution will fund immediate treatment and analysis of data from TBI/PTSD casualties. It will also lay the groundwork for a definitive FDA Clinical Trial. From this project, military and Veteran communities, Congress, DOD, VA, and FDA – as well as citizens across the country – will be able to see and understand that the tragic and disgraceful U. S. military suicide epidemic can – and must – be quickly and cost-effectively reversed. Cost effective, immediate civilian treatment of TBI/PTSD casualties is available now. The FDA Clinical Trial can then produce the approval necessary to make HBOT treatment widely available under a new, approved indication.

CAPSTONE

Arresting the Military

Suicide Epidemic

slide6

The Treatment:

HBOT has been formally approved for 14 applications by the FDA. These applications provide dramatic healing action to a number of injuries, especially wound healing. Oxygen under pressure has been applied to Navy divers for the brain injury “decompression sickness” for over 60 years. At 1.5 atmospheres as used for TBI/PTSD, HBOT is accepted as safe; and 15 years of repeated success in treating brain injury off label and a wealth of documented data and science have established both its safety and efficacy. The Army and the VA deny this treatment to the wounded for political and economic reasons, despite overwhelming science and evidence.

CAPSTONE

Arresting the Military

Suicide Epidemic

slide7

CAPSTONE: The Costs

The cost of the Capstone effort and FDA trial startup totals $2,500,000. The HBOT 1.5 treatment (with robust data collection) for 60 subjects, based on 40 treatments each, totals $1,250,000. Administrative costs for the Capstone trial and startup costs for the clinical trial total $1,250,000. Negotiations with the FDA will determine the design and additional funding required for an acceptable, new application FDA-sanctioned trial.

By way of contrast, the expected costs of sustaining an untreated TBI/PTSD patient for life are conservatively estimated at $30,000 per year over an estimated 50-year remaining life span, nearly $1.5M per patient. Thus, the cost to treat and heal TBI/PTSD wounded warriors with HBOT is less than 2% of the costs to leave them untreated.

The costs to society in terms of suicide, homelessness, joblessness, injury to families, incarceration and social and medical services – to say nothing of the reduced quality of life for the wounded and their loved ones – are incalculable.

CAPSTONE

Arresting the Military

Suicide Epidemic

slide8

The Resistance:

The Army is the leader for the U. S. government effort to address the TBI/PTSD casualty and suicide epidemic. HBOT use has been stalled for years by a negative attitude toward HBOT and the Army’s traditional resistance to change. The Army has a deservedly negative reputation for failure to address major epidemics of wartime wounding: witness the 1970s Vietnam Agent Orange 22-year delay to recognize and treat the wounded, and the 1990s Gulf War Syndrome delay in treating that continues to this day. The Congress has been unwilling to date to take dispositive action on TBI/PTSD.

The standard of care by the military in treating brain injury includes over 100 drugs. 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. All are being used "off-label." Nearly all of the anti-depressants carry FDA Black Box warnings urging caution in 17-24 year olds because of the increased risk of suicide. The costs run into the billions.

CAPSTONE

Arresting the Military

Suicide Epidemic

slide9

The CAPSTONE Alliance Team:

  • The Honorable Martin R. Hoffman, Former Secretary of the Army
  • Robert Mozayeni, MD, Director, Translational Medicine Group
  • Stephen N. Xenakis, MD, Brigadier General USA (ret.), Founder CTM
  • The Honorable PattManey, BG, USAR (ret.), Judge in Okaloosa County, FL
  • Paul G. Harch, MD, Director, LSUHSC/Medical Center of Louisiana, New
  • Orleans Hyperbaric Medicine and Wound Care Department
  • Stephen D. Reimers, P.E., Secretary/Treasurer of IHMF and the sponsor of
  • NBIRR, the IHMF and owner of Reimers Systems
  • ADM Tim Fanning, Navy League
  • Robert L. Beckman, Ph.D., Chief Knowledge Officer, Center for Translational
  • Medicine

CAPSTONE

Arresting the Military

Suicide Epidemic

slide10

Scientific and Evidence-Based Medicine underlying CAPSTONE

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

[2] HYPERBARIC OXYGEN THERPAY FOR CHRONIC COGNITIVE IMPAIRMENTS DUE TO TRAUMATIC BRAIN INJURY- RANDOMIZED PROSPECTIVE TRIAL. Rahav Boussi-Gross1, Haim Golan3. Gregori Fishlev1, Yair Bechor1, Olga Volkov3, Jacob Bergan1, Mony Friedman1, Eshel Ben-Jacob2,4,5, ShaiEfrati 1,2,

1The Institute of Hyperbaric Medicine, 2Research and Development Unit and 3Nuclear Medicine institute, AssafHarofeh Medical Center, Zerifin 70300, Israel affiliated to Sackler School of Medicine, Tel-Aviv University, Tel-Aviv 69978, Israel. 4School of Physics and Astronomy, 5The Raymond and Beverly Sackler Faculty of Exact Sciences, Tel-Aviv University,Tel-Aviv 69978, Israel.

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

[4] 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"

[5] Dr. George Mychaskiw II, DO, FAAP, FACOP, Editor-in-Chief of the Journal of Hyperbaric Medicine, the most prestigious journal on Hyperbaric Medicine in the world.

[6] 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.

CAPSTONE

Arresting the Military

Suicide Epidemic

slide11

Summary & Call to Action

CAPSTONE can help interrupt the soldier brain injury cycle of discharge, homelessness, joblessness, violence, incarceration and potential suicide

With immediate funding, CAPSTONE can pioneer in partnerships in integrated, comprehensive treatment of TBI & PTSD

A comprehensive medical record can be coordinated and integrated throughout diagnosis, prescriptions, treatment, analysis and follow-on adjustments with eventual cessation of over-drugging

Multidimensional analysis of whole-person data across cohorts of patient types can yield individualized care pathways

CAPSTONE will leverage new analytic techniques that will shorten the cycle of adoption of treatments that are safe and effective

Through CAPSTONE, the civilian sector must intervene, treat and heal, and force the military, the Congress and the medical community to do the right thing: TREAT NOW

CAPSTONE

Arresting the Military

Suicide Epidemic

slide12

Additional Explanations

CAPSTONE

Arresting the Military

Suicide Epidemic

what is hyperbaric oxygen therapy hbot
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.]

Safe, effective and scientifically validated worldwide

What is Hyperbaric Oxygen Therapy (HBOT)?

CAPSTONE

Arresting the Military

Suicide Epidemic

how it works 5 769 ways of cellular processes studied
Upregulates growth factors

Reduces edema/swelling

Promotes neural pathway growth

Activates senescent neurons [“sleeping”, not dead]

Increases neuronal energy [ATP]

Downregulates inflammation

Reduces reperfusion injury [not enough O2]

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

*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.

CAPSTONE

Arresting the Military

Suicide Epidemic

slide15

Accepted HBOT Indications

1.     Air or Gas Embolism2.    Carbon Monoxide Poisoning       Carbon Monoxide Poisoning Complicated By Cyanide Poisoning3.    ClostridialMyositis and Myonecrosis (Gas Gangrene)4.    Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemias5.    Decompression Sickness6.    Arterial Insufficiencies:             Central Retinal Artery Occlusion            Enhancement of Healing In Selected Problem Wounds7.    Severe Anemia8.    Intracranial Abscess9.    Necrotizing Soft Tissue Infections10.  Osteomyelitis (Refractory)11.   Delayed Radiation Injury (Soft Tissue and Bony Necrosis)12.  Compromised Grafts and Flaps13.  Acute Thermal Burn Injury 14. Idiopathic Sudden Sensorineural Hearing Loss

(New! approved on October 8, 2011 by the UHMS Board of Directors)

CAPSTONE

Arresting the Military

Suicide Epidemic

slide16

CAPSTONE Underlying Technologies

Core grounding in integrative medicine Workflows and Business Rules. Integrative and translational medicine require clarity about every aspect of patient care.

The CareVector Platform (CVP™) Repository forms the basis for collecting and analyzing all knowledge across the CTM.

The Collaboration Forum. The platform contains a "blog space" where participants in the practice -- or across all practices -- can post, confer, share and read based on communities of interest.

Health Navigator. Up-to-the-minute status reports based on patient data input.

The Analytic Engine and Reporting. Bayesian calculators and statistical packages.

Home Stream (tm). Wireless connections to mobile devices to allow on-demand and rule-based communication and inquiries about patient health and actions.

The Neuropsychiatric Conditions and Infectious Diseases Registries. More comprehensive collection and analysis of multidimensional data.

CAPSTONE

Arresting the Military

Suicide Epidemic

slide17

Going Forward

Accelerate Reg. approval of HBOT 1.5 through funded treatments and approach to FDA

Accelerate USG initiation of widespread, funded treatment of battle casualties with HBOT

Accelerate Insurance Industry coverage of TBI and PTSD symptoms and treatments with HBOT

Accelerate efficacy of Integrated, translational medicine –based TBI and PTSD treatment with HBOT 1.5 as foundation

Develop coordinated multi-vets organization, multi-media search for  wounded and illegally/improperly separated TBI/PTSD casualties

Provide argument for forward-area treatment of wounded during current one-day post-blast stand down period

CAPSTONE

Arresting the Military

Suicide Epidemic

slide18

Transforming Clinical Pathways

Diagnostics

Treatment

Plan

Collaboration

Throughout:

Doctor – Patient – Support Network

Workflows and Processes

Protocols

  • Indications:
  • Psychological/
  • Neurocognitive
  • Metabolic &
  • Infection; Genetic
  • Environmental:
  • Toxins
  • EMF
  • Psychiatric: Include
  • Social
  • Family

History:

Fully-Informed Consent

Therapies

On- and

Off-label

21st EMR

CareVector Platform

Statistics,

Clusters Bayesian etc.

Web-Enabled

Analysis & Feedback

Track & Monitor

CAPSTONE

Arresting the Military

Suicide Epidemic

c