Design of Effective Homeless Initiatives for Veterans and other at-risk populationsPresentation Transcript
IHMA & IHMF: Sister Organizations Translating Science into Medical Practice and Public Policy to Create Healthcare Solutions for the 21st Century Using Aerospace Medicine in 21st Century Medical PracticeDesign of Effective Homeless Initiatives for Veterans and other at-risk populationsReal Solutions for Restoring a Veteran’s Work Capability, Greatly Reducing Homelessness and Disability, and Restoring Quality of Life Stephen D. Reimers, MS, PE Chief Financial Officer, IHMF William A. Duncan, Ph.D. Vice President of Development, IHMF
Veteran Casualty Crisis: Source of Performance Challenges in Veteran Programs Military Med Confused: PTSD shares symptoms with Mild-TBI! sleep cycle disruption, irritability, and difficulty concentrating About 600,000 IEF/IOF war veterans blast/concussion casualties MOST DO NOT RECOGNIZE THEY HAVE A BIOLOGICAL INJURY!
This is not because they were not “STRONG” enough to take it!
It is not a moral weakness!
Each Untreated Casualty Costs $60,000 per year in safety net, substance abuse & incarceration costs & lost tax revenue Each Casualty that Returns to Work Is a $10,000 minimum Annual Revenue Source to Federal, State and Local governments Reduced Need for Services HBOT (biological repair) Treatment is paid for within 14 months Each Active Duty Rescued-$2.6 million per veteran over lifetime
National Emergency: A War Casualty Crisis Service members in the All-Volunteer Force are some of the best and brightest in the nation; risk-takers, leaders! If left untreated, a veteran’s brain injury destroys their life. They are a Casualty of War as much as if they had been left on the battlefield Divorce, unemployment, disability, substance abuse, incarceration, homelessness, suicide Cascade steep for the first 2 years and continues downhill thereafter Virtually ALL Homeless Veterans have a brain injury It costs society more per war casualty not to treat them End of World War II: by 1949 1/3 of all persons in prison were combat veterans Vietnam: 66% of prisoners today in jail for violent crimes “harmed someone they knew.” We Do Not Need to Repeat the Tragedies of Previous Wars!
Veteran Employment Picture Veteran Unemployment Rate & Discouraged Worker Rate EXCEEDS that of their non-serving peers! March 12, 2010 (Last Comprehensive Report) 165,000 unemployed 319,000 not in the labor force (Discouraged Workers) LAPD has had many MP ARNG return who are not redeployable to the field as working police officers Many Casualties are Hidden in the System But these are America’s BEST & BRIGHTEST!
The Effective Veterans Employment Program Places Veterans in Careers to match skills and interests Uses Executive Recruiter Tools Uses Computer Software to Identify Aptitudes, Interests, Talents and Capabilities Screens for mTBI Injuries & PTSD & refers to effective treatment Tracks program outcomes under IRB-approved study so accurate success & metrics can be reported. Coordinates and Cooperates with Other non-profit organizations and Veterans Service Organizations to use the unique talents of each.
Real Solutions Are Here Today! Current medical interventions being applied are ineffective at solving underlying problems Effective and safer medical interventions are available and deployable NOW These new interventions must integrate well with current best practices.
Current DoD-VA Reimbursed Drug Treatments: Only 2 On-Label!Clear Cause of Suicide Epidemic! There is no drug currently approved by the FDA to treat TBI. The only drugs approved for PTSD are Zoloft and Paxil. All other treatment with drugs for these conditions is off-label and intended to treat symptoms. In fact, a significant percentage of psychiatric medications are prescribed off-label. Further, the use of antipsychotics in these patients is often as a chemical restraint. The following list of drugs are FDA approved for psychiatric and neurologic disorders. The great majority of these drugs have been and are currently prescribed by DoD Medicine off-label for TBI/PTSD in the service members Dr. Harch has treated with HBOT 1.5 in New Orleans.Neurology: Psychiatry Alzheimer's Anti-anxiety Ebixa Lectopam Klonopin Tranxene Neurontin Valium Lyrica Topamax Dalmane Symmetrel Psychiatry (Con’t) Antidepressents (All Black Label Warning Suicide) Celexa Lexapro Prozac Luvox *Paxil *Zoloft Cymbalta Effexor Wellbutrin Remeron Desyrel Antimanic Tegretol Lamictal Eskalith Topamax Depakote Antipsychotics Clozaril Zyprexa Seroquel Risperdal Geodon Abilify *FDA Approved for PTSD All these carry a black label warning for suicidality in those under age 25! The Veteran Suicide Rate is 120 per week (CDC Numbers)
Typical Multiplace Hyperbaric Chamber Typical Monoplace Hyperbaric Chamber Hyperbaric Medicine is approved for 13 indications and treatment is reimbursed by all major third party payers including Medicare, Tricare and the Veterans Administration. Hyperbaric oxygen therapy is the only non-hormonal treatment approved by the FDA for biologically repairing and regenerating human tissue. It is FDA-approved and effective for the treatment of 3 kinds of non-healing wounds. It is currently FDA-approved as the primary treatment for 3 different kinds brain injuries: carbon monoxide poisoning, arterial gas embolism, and cerebral decompression sickness. Hyperbaric Oxygen Therapy is not Black-Labeled by the FDA, as are many drugs currently being prescribed for post-traumatic stress disorder or traumatic brain injury. Copyright retained: Paul G. Harch, M.D., 2010 & IHMA
It’s Just Oxygen! Pressure causes oxygen to saturate tissues at 7x to 12x normal breathing. O2 used in thousands of cellular processes Lack of oxygen is bad We know how it works Acutely stops swelling/reperfusion injury Restarts stunned cellular metabolism Regrows Blood Vessels Activates Stem Cells 8x Normal No wound can heal without oxygen Wounds that have not healed do Wounds heal 50% faster with less scar tissue Broken bones 30% faster & 30% stronger
The Specific Science for HBOT 1.5 1977 Study: Holbach & Wasserman: HBOT 1.5 puts the most oxygen into the brain because more triggers an autonomic response to keep extra O2 out! Chronic Stroke patients treated at numerous locations. 1990: Harch treats first demented diver for delayed decompression sickness. Numerous small studies published. (See Memorandum) 2002: US Army verifies HBOT 1.5 repairs white matter damage in children. 2007: Rat HBOT 1.5 study for Chronic TBI published in Brain Research. Human protocol in Animals. First improvement of chronic brain injury in animals in the history of science. August 14, 2008: Briefing to Surgeon General of the Navy & Deputy Commandant, US Marine Corps: 5 blast injured veterans treated. All five made dramatic improvement. Four of five were able to return to duty or civilian full-time employment! Published April 2009 September 2008: US Air Force Hyperbaric Researcher & Special Forces Command Physician treats two airmen. Results verified by ANAM neuropsych test. Both are restored to duty saving the Federal government an estimated $2.6 million each in lifetime costs. They continue their careers. More active duty personnel are treated. Published in January, 2010 in Peer Reviewed Journal (See www.HyperbaricMedicalFoundation.org) March 12, 2010: Report on 15 Blast Injured Veterans under LSU IRB-approved study. Report is clinically and statistically significant and sufficient proof because of dramatic improvement in patients. ½ of protocol given 15 point IQ jump in 30 days p<0.001 40% improvement in Post-concussion Syndrome p=0.002 (np) (10% is considered clinically significant enough to warrant approval and payment for HBOT according to DoD researchers in December 2008. 30% reduction in PTSD p<0.001 51% Reduction in Depression p<0.001 NBIRR-01 Begins Enrolling Patients
Non-Healing Wound of the FootDiabetic Foot Ulcer: This Wagner Grade III was present for oneyear and unresponsive to conventional therapy. 26 HBOT Treatments 1 Day Prior to Scheduled Amputation Hyperbaric Oxygenation prevents 75% of amputations in diabetic patients. Therapy approved by CMS for Medicare upon application by IHMA to CMS for coverage, 2003. These photographs are the property of Kenneth P. Stoller, MD, FAAP Permission given by Dr. Stoller to the IHMA to publish on this CD (2004) Copyright retained: Kenneth Stoller, M.D., 2010 & IHMA 50 HBOT Treatments
Non-Healing Wound of the Brain Physical Abuse - 9 years after Injury - 21 y. female Post-HBOT 1.5 Pre-HBOT 1.5 No wound will heal without oxygen! What is the difference between the diabetic non-healing foot wound and the non-healing brain injury? Essentially nothing. FDA has already approved HBOT for 3 kinds of non-healing wounds and 3 neurological injuries!
Non-Healing Wound in the Brain Case Report: Navy SG Meeting - Aug. 2008 25 year old Humvee Machine Gunner 40 HBOT 1.5 treatments (1/2 of the Protocol) Treated in 2008. PTSD disappeared. From living in a dark room since returning from Iraq, he became gainfully employed, turned down ½ of his VA disability, worked and made $39,000 per year, and has returned to college after 2nd 40 treatments.
HBOT 1.5 Restores Brain Blood Flow & Metabolism Scale actually goes from 0 to 2000 so it ENDS at 2000. Those pixels that are hitting near 2000 are red and are the most active, the less metabolically active are "cooler" colors of yellow, green and blue. So if you draw a line across the middle of the scale you can see what pixels are registering at 1000 by the corresponding color. Both pre and post HBOT sets of images are exactly on the same scale. Below is a a quantitative assessment that shows the actually percent increase in up take to an area of the brain quite vulnerable to TBI. Note the mean uptake in the area went from 644 to 1008. Similar changes are evident everywhere else. In ballpark numbers a change from green to red is a doubling of metabolism. Analysis of blast injured veteran in LSU IRB Study # 7051: Edward Fogarty, MD, Neuro-radiologist, Chair, University of North Dakota School of Medicine, (701) 751-9579 40 Treatments: ½ of NBIRR Protocol
Figure 1: The passenger side of the M915 truck showing the damage caused by the IED. Conclusion by article authors: Several aspects of these two cases demonstrate the efficacy of HBO for the airmen treated. Although both airmen had stable symptoms of mTBI/post-concussive syndrome, which had not improved for seven months; substantive improvement was achieved within ten days of HBO treatment. The headaches and sleep disturbances improved rapidly while the irritability, cognitive defects, and memory difficulties improved more slowly. Fortunately both airman had taken the ANAM and presented objective demonstration of their deficits from TBI and their improvements after HBO treatment. Both airmen, who were injured by the same blast sitting side by side, had similar symptom complexes of TBI and improved at similar rates after initiation of HBO treatment. Neither airman had any other form of treatment for TBI. It seems unlikely to the authors that any explanation other than the HBO treatments can be offered for their improvements. “Case report: Treatment of Mild Traumatic Brain Injury with Hyperbaric Oxygen: Colonel James K. Wright, USAF, MC, SFS; Eddie Zant, MD; Kevin Groom, PhD; Robert E. Schlegel, PhD, PE; Kirby Gilliland, PhD”
Public Health Cost of Untreated Brain Insults An estimated 30-40 million working age Americans are living with an untreated brain injury. CDC reports 1.7 million new injuries per year and only 50,000 die. Lost Tax Revenue & Productivity:mTBI patients have ½ of the life-time income of their non-injured counterparts, matched for education, intelligence, etc. Incarceration: 61% County/56% State/45% Fed Mental Illness (w/ Underlying untreated brain insult) National Prison System Cost: 2.3 mil Jail; 5.1 m Supervision $51.7 billion on corrections $29,000 each $10.2 billion for supervision @ $2,000 each Cut cost in half over 10 years: Savings $30 billion Veterans: (33%+ of all deployed) (All with PTSD) Cost? Current ineffective treatments $8,000-$32,000/yr Education (IDEA Children): 50%+ have brain injury. If 20% were brought to normal, savings would be $18 billion per year. Welfare: Almost all women on Welfare (Avg IQ = 85) Homelessness: 100% Vets, 72-80% all others Disability (Worker’s Comp & Social Security): 61,000 TBI, most mentally retarded Nursing Home Residents: Dementia, Stokes Mental Illness: Most traceable to an insult Trafficked & Battered Women & Children: Traumatic Brain Injury Cost to biologically repair and regenerate brain insults: Acute: $200 - $1,000 (59% Reduction in Mortality for Severe) or chronic one time cost $16,000 (80% return to duty, work or school) (CMS Reimbursement Rate)
Saving Real Money: Treating is CheaperScale of Cost of Untreated mTBI to Society For a person sufficiently impaired that he/she cannot work: Lifetime Social Safety Net Costs (approx): $60,000 per year $2,400,000 or more based on 40 year duration Lifetime Loss of tax revenue (approx) Assuming annual income of $75,000 per yr Federal tax = $19,500 per yr(based on 25% total rate) State tax (CA rates) = $3,600 per yr Total over 30 year working life = $693,000
Total cost to governmental entities = $3.09 million per person
If have 150,000 such people, lifetime cost = $463.9 billion
Minimum 30 million estimated Americans living with untreated traumatic brain injury
Source: IHMA Public Policy Brief 2010-1a. Other estimates vary widely, but the overall numbers are all huge.
Annual cost estimate presented to 07/21/10 House VA Committee Hearing was $60,000 per patient per year without intervention.
FDA Cleared HBOT Indications HBOT as used by the team is currently in use for 13 FDA-cleared indications (which means the manufacturer or practitioner can advertize those indications) by hundreds of physicians at nearly 1,000 locations across the nation, delivering approximately 10,000 treatments per day. The thirteen accepted indications for HBOT treatment include: 1. Air or gas embolism. 2. CO poisoning, CO poisoning complicated by cyanide poisoning (Neurological) 3. Clostridial myositis and myonecrosis (gas gangrene) 4. Crush injury, compartment syndrome, and other acute traumatic ischemias 5. Decompression sickness (Neurological) Arterial Insufficiency: (Non-Healing Wound) Enhancement of healing in selected problem wounds (includes uses like Diabetic Foot Wounds, Hypoxic Wounds, and other non-healing wounds, etc.) 7. Exceptional blood loss anemia 8. Intracranial abscess (Neurological) 9. Necrotizing soft tissue infections 10. Osteomyelitis (refractory) 11. Radiation tissue damage (soft tissue and bony necrosis) (Non-Healing Wound) 12. Skin grafts and flaps (compromised) (Non-Healing Wound) 13. Thermal burns  Hyperbaric Oxygen Therapy: 1999 Committee Report. Editor, N.B. Hampson. Undersea and Hyperbaric Medical Society, Kensington, MD. See also: Harch PG. Application of HBOT to acute neurological conditions. Hyperbaric Medicine 1999, The 7th Annual Advanced Symposium. The Adams Mark Hotel, Columbia, South Carolina, April 9-10, 1999; and Mitton C, Hailey D. Health technology assessment and policy decisions on hyperbaric oxygen treatment. Int J of Tech Assess in Health Care, 1999;15(4):661-70.
Returning Athletes to Competition U.S. Olympic Team Treated at San Diego IHMF-NBIRR Site Sports Injuries Concussions Summer & Winter Sports U.S. Navy SEALs & SOCOM Members Treated for Fractures Treated for Knee Replacement Treated for TBI and PTSD
Fractures Air Force Research Demonstrated that Fractures heal 30% faster and 30% stronger when Hyperbaric Oxygen is used. Shorter back to work time Stronger Fusion Cost Effective through reduced down time The effect of hyperbaric oxygen on fracture healing in rabbits, completed 2003. J Wright
Retired NFL Player: Age 58Pre-Post HBOT 1.54 NFL Players now treated with similar results Source: MicroCog Assessment-- Independent Evaluation by Amen Clinic.
Savings Directly to Worker’s Comp Funds Recovery of Disabled Persons On the Roles, War Veterans who have returned to Law Enforcement Service Prevention of Long Term Disability through “Routine” treatment provided to improve neurological longevity A single or series of HBOT treatments post-concussion without regard to “diagnostic” based on best-clinical practice Known damage that accumulates over time. Not symptomatic but cumulative “Athletic” or “Sports Medicine” injuries, Falls, Fractures, Motor Vehicle Accidents, Altercations, “Significant Emotional Event” such as a shooting COLLECTED UNDER IRB-APPROVED PROTOCOLS No Placebos! BAYESIAN ANALYSIS provides Real-time Feedback & Best Practices. Comparison with Historical Costs For normal market cost of hyperbaric treatment at CMS Facility Rate
Evidence-based Medicine Real Evidence-based Medicine Three Principles Clinical Expertise Medical Evidence (Lowest to Highest) Only Humans Count: Anecdote, Case Study, Case Series, Single Center then Multicenter Observational (Bayesian Level I), Randomized Controlled (RCT Level I) Invitro, Invivo, animal research counts to explain not determine Patient Preference Saves Money: Rationalizes Disparate Evidence & Focus on Effective & Efficient Treatments Nihilistic Evidence-based Medicine: Only RCTs count. Clinical Expertise & Patient Preference have no bearing. If you do not have an RCT, you have no evidence. Bias toward patentable processes and restriction of available treatment. Expensive! Cochrane Reviews are being paid for by BC/BS, Aetna & others and are following these recommendations to restrict treatment options.
HR396: TBI Treatment Act Changes Focus from “Bureaucratic Decision” on Health Care Coverage to: “What Actually Worked for the Patient?” ALL TREATMENT MODALITIES INCLUDED Outlines a “Rational” Way of Determining What Works and What Doesn’t HC Provider is ONLY paid if the treatment works (True Pay for Performance) All data is collected under OHRP Rules for Patient Protection Provides Valid Evidence-based Medicine data very inexpensively! (10% of the cost of Standard NIH-funded Study!) As a Principle of Federal Law, the Bill Radically Alters the Ability of Patients to get Effective Treatment!
HR 396: TBI Treatment Act Subject must have TBI or PTSD and be a Veteran under 66 Voluntarily Treated by Civilian Physician ANY FDA-approved or Cleared Treatment (Any Purpose) Must Improve to be Paid Neuropsych Testing (IQ, ANAM, CNS Vital Signs, etc.) Standardized Instruments (PCS, PTSD, Depression Scales) Neurological Imaging (Functional MRI, SPECT, QEEG) Clinical Examination (Coma State, Gate & Balance) Must be Enrolled in IRB-approved Study No Discrimination Against Practitioner for Any Reason Paid 30 days after presentation of valid bill to MM or VA
International Hyperbaric Medical Foundation Conducts Scientific Research: Uses Medical Information & Treatment Access Act principles to create New Scientific Information then Used by IHMA to Create New Indications (First was Diabetic Foot Wound, 2003) John Eisenberg Treatment Registry (JETR) for Off-Label Use of Approved Drugs and Devices Set up to permit other medical specialties to use the JETR Just like American Airlines and IBM worked together to create the Airline Reservation System, used by Every Airline to make Reservations. Reimbursement Assistance for Sites:Administrative and Legal Team under Contract to assist with reimbursement for patients under IHMF-sponsored JETR studies
John Eisenberg Treatment RegistryDynamic Translational Medical Practice Research Available to ANY Medical Society or Practitioner Group who wishes to organize a study (Admin Costs to Study Organizer!) Off-label use of FDA-approved or cleared drugs or devices Nutritional Protocols Acupuncture Environmental Medicine Protocols Surgical Protocols Bayesian Analysis Adaptive Clinical Trial Design Study Design Assistance with Cooperative Partners Relationship with Western IRB Data Safety Monitoring Board OHRP approved Human Research Certification through CITI
NBIRR-01: Principles 1,000 patient observational multi-center study of Military or Civilian subjects with an Independent diagnosis of mild-moderate TBI/PTSD.(Patients MUST be >6 months post injury in the “chronic” stage, and ages 18-65.) Bayesian data analysis (Level 1 Evidence) IRB-Oversight Patient is their own control Methodology of “Comparative Effectiveness Research” outlined in Obama Health Care Plan. Methodology of “Coverage with Evidence” at CMS Multiple objective measures: ANAM, CNS-Vital Signs, Post- Concussion Syndrome Scale, PTSD Scale, Depression Scale All Participants get Real Services (No Placebo) Third Party Payment is therefore justified. Therefore cost of “research” is limited to the administrative overhead costs necessary in addition to the treatment costs, about 10% of treatment cost. John Eisenberg Treatment Registry Integrated Software with built-in metrics Secure & Web Based Low Cost Research ($16,000 per patient = $16 million w/ $1.6 million Admin) Treatment Normally Paid 1/3rd of the time. Reimbursement Likelihood Increased Under IRB-approved study!
IRB Workflow John Eisenberg Treatment Registry Provides Structure forN-BIRR HBOT 1.5 Clinical Research PlatformPowered by CareVector® Supports Multi-Site Observational Study Online Data Entry Forms available World-Wide Security Roles protect patient privacy DoD ANAM Test Scores & Record all Diagnostics Monthly Web-based Reporting & Analysis All Patients get Real Treatment (No Placebo) NO BARRIER To 3rd Party Reimbursement EBM & Bayesian Analysis Permits Rapid Publication, Approval by FDA of New Indication, Treatment Payment
Sponsor: International Hyperbaric Medical FoundationLocations for N-BIRR HBOT 1.5 Study N=1,000 Sites with Confirmed Investigators Sites Being Planned Sites Being Planned as Mobile Units Under an Investigator Investigators with Capacity for 2,000 Treatments per Day Anticipate 1,000 veterans or service personnel being able to return to full duty status every 150 days. 90 total sites have sufficient equipment, training and skill to join the effort and treat these casualties. 1,000 could be brought on line. NBIRR Study Sponsored by Int’l Hyperbaric Medical Foundation
NBIRR: Why Bayesian Analysis?
New Application of Probability Mathematics Published in 1763 of Reverend Thomas Baves (1702–1761). FDA Final Acceptance in 2010.
Accepted by the FDA-Devices Division for Level 1 Evidence in 2006, with a final rule published in 2010.
Approx 50% of all new applications to the FDA for new devices or new applications for existing devices/drugs use this methodology.
Hyperbaric Oxygen is Delivered in a Device.
Bayesian Analysis was Adopted by FDA after repeated failures of randomized-Controlled Trials to provide valid data.
Bayesian Analysis now used by VA, CDC, and throughout HHS to quickly answer health and other program performance questions.
Very effective, at low cost, in disease states where the disease trajectory over time is predictable. Not a “one size fits all tool”.
Not a good choice when looking at the effects of a new molecule.
However, the time trajectory of chronic mTBI is VERY predictable. Once a patient is 6 months post injury, change in status occurs VERY slowly. Consequently, the NBIRR study design is appropriate.
Bayesian Methodology Uses the Known and Compares Intervention Result Example: “Graduation” from Homeless Program in California 43% (“Best” Program may be 57%) Addition of Biological Repair of NBIRR protocols result is 80% return to work, duty, or school Expected Placement Earnings Known by Region Expected Retention at new job is known. Because of 15 point IQ increase, plus increase in executive function, Expected Homeless program incorporating NBIRR is expected to be higher.
Adaptive Clinical Trial Design:Allows Development of the Most Effective Protocol to Treat Brain Injury & Brain Insults When the Bayesian HBOT 1.5 NBIRR biological-repair protocol baseline is established, then treatment modules can be added until an entire Integrative Medicine Protocol is developed for maximum patient recovery Example: Post-Traumatic Stress Disorder All sites have base-line improvement of 30% reduction A site adds a module with IRB-approval Result is better than baseline. One or more sites assigned the new program Results verify incremental improvement Program adapted at all sites and “Treatment Protocol” is advanced NBIRR software allows for direct comparison of the “intake” condition of veterans tagged with PTSD. ENTIRE PROTOCOL IS UPDATED AND REFINED!
IHMF Stands Ready to Help Our Team Leaders have decades of experience with Hyperbaric Medicine Our Team Leaders have over 20 years of experience treating Brain Injury with this protocol The NBIRR-01 Study is IRB-approved The Study is Listed at www.ClinicalTrials.gov The National Call Center Number is: (800) 288-9328 We have numerous clinics throughout the nation We Are Helping to Solve the Real Problems of Brain Injured Persons with Biological Repair for their Injury