July 2015
The NBIRR Coalition: Hyperbaric Oxygen Therapy in Chronic
Traumatic Brain Injury or Post-Traumatic Stress Disorder (NBIRR-1)
We are part of a Coalition involved with trying to get help for brain-injured
wounded warriors using Hyperbaric Oxygen Therapy [HBOT]. For six+ years,
over a dozen people working pro bono have put the Observational Study in
place. It is now approved by the Western Institutional Review Board, the gold
standard for Clinical Trials, and is accepting patients. Sadly, there is no
funding for the study. The military medical community continues to insist
that HBOT is unsafe, despite peer-reviewed conclusions and mounting
worldwide evidence-based medicine. After over a billion dollars already spent
on palliatives and psychoactive drugs that only mask symptoms, the
instances of suicide, homicide, incarcerations, homelessness, family violence,
joblessness and divorce among brain-injured vets continue to mount.
FAQs: NBIRR, IHMF and HBOT
NBIRR: What is it? The National Brain Injury Rescue and Rehabilitation
Project (NBIRR) is an Observational Clinical Trial using Hyperbaric Oxygen
Therapy (HBOT) at 1.5 atmospheres, 100% oxygen, to treat veterans and
others suffering from Traumatic Brain Injury (TBI) and Post Traumatic Stress
Disorder (PTSD). The Trial is under the auspices of the Western Institutional
Review Board (WIRB) and could last as little as one year or as long as three
years. No funding for the trial exists, but over 200 patients have been
successfully treated pro bono. The initial results of NBIRR are in review for
publication in a peer-reviewed journal. These results confirm the safety and
effectiveness of HBOT 1.5 for treating and helping heal TBI and PTSD.
What are the main objectives of NBIRR? Over 700,000 veterans and
active duty service members 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 meant to prove the safety and efficacy of HBOT.
HBOT currently is not covered by insurance, nor will military medicine allow
their HBOT facilities to be used for treatment of TBI or PTSD. The hope is
that the VA, Congress and the public will insist that the VA, DOD and the
medical system recognize the need and the moral imperative to insure
treatments with HBOT, and to begin treatments immediately. Without the
clinical 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
without treating the underlying brain injury.
Who is running NBIRR? A Coalition of Drs., other volunteers and facilities
are currently using their own money to run the observational study. Bios of
the Coalition are below. Over two dozen HBOT facilities nationwide are onboard treating patients or preparing to do so. All of those clinics and others
July 2015
which have expressed interest when funding is available, over 100 civilian
facilities, have enough capacity to immediately begin treating over 1,000
patients in. That treatment could demonstrate HBOT as the primary
intervention strategy to stanch the epidemic of service member suicides,
homicides, incarcerations, divorce and deterioration in the active military
being reassigned over and over to combat.
What is the IHMF? The International Hyperbaric Medical Foundation (IHMF)
is a 501(c)3 public charity. It is the sponsor at the Western Institutional
Review Board (WIRB) for the NBIRR Observational Study aimed at
demonstrating the safety and efficacy of HBOT. IHMF was established in
2003 to improve public health by disseminating scientific knowledge,
promoting, sponsoring, and conducting research of hyperbaric medicine.
IHMF is dedicated to educating the medical community and the general public
about the benefits of hyperbaric medicine, related therapies and training
medical professionals, while assisting individuals in obtaining necessary
hyperbaric treatment. [http://www.hyperbaricmedicalfoundation.org/]
Is HBOT safe and effective? HBOT is used daily and is insured to treat 14
FDA-approved conditions, but not TBI or PTSD. HBOT is prescribed "off-label"
for many medical conditions, including TBI and PTSD. HBOT is used routinely
around the world for TBI and is so safe that it has been deregulated in the
United Kingdom by an Act of Parliament in 2008. Thousands of patients with
brain injuries from stroke, falls, sports injuries or combat have been privately
treated in the U.S. In over 100 cases where Coalition members have recently
treated wounded warriors, each of the combat veterans has demonstrated
significant clinical improvement. 20 of 20 Special Operators about to be
boarded out of the military [at a per-unit cost of over $1.5M each] have been
healed by HBOT sufficiently to be allowed to return to active duty. All had
significant improvement or complete remission of their PTSD/TBI symptoms,
including cessation of their thoughts about suicide. Negative side effects were
negligible, and the effects of HBOT 1.5, to date, appear to be long-lasting.
About 100,000 sessions are undertaken a year in UK community centers and
since the first started operating just 32 years ago, over 3 million sessions
have been completed without a significant incident.
What is an HBOT 1.5 Protocol? A patient enters a chamber at 1.5
atmospheres and breathes 100% oxygen for one hour. This is repeated 40
times over 6 weeks. After a 30-day interim, another 40 treatments are
administered. Typically, the patient begins to experience positive signs within
the first 20 treatments. Oxygen in prescribed dosages works for a variety of
external and internal injuries. The oxygen acts as a catalyst in healing
wounds -- including wounded brains -- that often fail to respond to other
medical and surgical practices and that lack the blood circulation and bloodoxygen levels necessary to heal.
Is HBOT safe? The procedure is safe, effective and used worldwide for
multiple purposes. DOD and the VA long ago accepted that HBOT is safe.
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Hundreds of thousands of HBOT treatments are performed around the world
yearly. The US Navy and the SEALs routinely use HBOT for a whole gamut of
ailments, especially for the bends, near-drowning, crush and other injuries.
The bulk of research on TBI began with treating deep-sea divers. The Federal
Drug Administration has already approved the use of HBOT for fourteen
medical conditions, including non-healing diabetic foot wounds, crush
injuries, carbon monoxide poisoning, exceptional blood loss, and tissue
transfer for complex wound reconstruction. HBOT has saved injured service
members or veterans from expensive, painful, life-altering, and potentially
life-threatening amputation of an arm, leg, hand or foot.
What are the obstacles? Lack of insurance puts HBOT out of reach of most
veterans. Resistance to the demonstrated efficacy of HBOT by the military
medical community has driven the coalition to undertake a clinical study to
answer their charge that it is not medically effective. There is still resistance
to medical “proof” using MRIs and SPECT scans and numerous tests
demonstrating to the satisfaction of scientists worldwide that HBOT helps
heal damaged brains. Success stories are both encouraging and scientifically
validated. Unfortunately, HBOT is still sufficiently misunderstood even by the
medical community that only practitioners, those being healed and their
families, and a small Coalition of private citizens can attest to the results.
NBIRR is one more scientific attempt to demonstrate with evidence-based
medicine that HBOT works to safely and effectively treat and heal TBI and
PTSD.
BIOS of the NBIRR Coalition
Hon Martin R. Hoffmann, Secretary of the Army, 1975-1977
Mr. Hoffmann graduated from Princeton University and the University of Virginia Law School.
Mr. Hoffmann served the U.S Government as General Counsel to the Atomic Energy
Commission; as Special Assistant to the Secretary and the Deputy Secretary of Defense; as
General Counsel to the Department of Defense; and as Secretary of the U.S. Army [under
President Ford]. He served and managed a number of Law Firms, and served on a number of
corporate boards. He served for six years full-time as a Pro Bono Consultant to the NBIRR
Consortium for the Cause of Brain Injured (TBI/PTSD) Military and Military Veteran casualties.
Secretary Hoffmann passed away on July 14, 2014. His passion and ethical compass kept him
focused until the end on the well-being of Service members.
The Honorable Patt Maney, BG, USAR (ret.)
Judge Maney is a War Veteran who was wounded by an IED while serving in OEF. After 15
months convalescing in Walter Reed, he was showing little progress. Heroic interventions allowed
GEN Maney to be treated in a private hospital with HBOT 1.5. He is now back serving as an
elected Judge in Okaloosa County, FL where he has helped institute Veterans Courts. He was
recently named Patriot of the Year by the Military Order of the Purple Heart for his volunteer work
on behalf of veterans and his contributions to the community.
James K. Wright, MD Colonel USAF, (ret.)
Dr. Wright graduated from the University of Chicago and the University of Chicago Medical
School. He completed medical fellowships at Harvard Medical School and in Hyperbaric Medicine
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at Brooks Air Force Base, Texas. He is board certified in Surgery, Plastic Surgery, Hand Surgery,
and Undersea and Hyperbaric Medicine. He spent 28 years in the Air Force and directed
hyperbaric clinical research at the USAF School of Aerospace Medicine for four years before
moving to the 720th Special Tactics Group, Air Force Special Operations Command. Since
retiring from the Air Force in 2010 Dr. Wright has devoted his volunteer efforts to the NBIRR
project. He is the author or co-author of 32 publications of which twelve deal with hyperbaric
oxygen. He is currently the lead investigator and Study Director of the observational Clinical Trial
of the National Brain Injury Rescue and Rehabilitation (NBIRR) study of Hyperbaric Oxygen for
the International Hyperbaric Medical Foundation.
Paul G. Harch, MD
Dr. Harch is the Director, LSUHSC/Medical Center of Louisiana, New Orleans Hyperbaric
Medicine and Wound Care Department. A graduate of the Johns Hopkins University School of
Medicine, Dr. Harch is a hyperbaric medicine, diving, and emergency medicine physician who is a
Diplomat of the American Board of Hyperbaric Medicine and the Board of Certification in
Emergency Medicine of the American Board of Physician Specialties. In recognition of his
accomplishments in clinical practice, teaching, and research he was awarded fellowship status in
the American College of Hyperbaric Medicine in 1997. He also received the Edgar End Award
from the American College of Hyperbaric Medicine in 1994 and the Richard A. Neubauer Award
for Excellence in Hyperbaric Oxygen Therapy in Pediatric Neurology in 2003. Dr. Harch is the first
President of the International Hyperbaric Medical Association (established in 2001) and President
of the International Hyperbaric Medical Foundation. He has lectured and presented his work at
numerous scientific meetings throughout the U.S. and overseas.
Robert Mozayeni, MD, Director, Translational Medicine Group
Dr. Mozayeni is a graduate of the Leadership in Medicine 6-yr program at Union College and
Albany Medical School. He did his post graduate medical training in Internal Medicine and
Rheumatology at Yale University. He was a Senior Staff Fellow in the National Heart, Lung and
Blood Institute while simultaneously holding a clinical appointment as the Rheumatology Fellow in
the National Institute of Arthritis and Musculoskeletal Diseases. He was also on the medical staff
at the NIH Clinical Center during the same time period. He presently serves as Director and VP of
Translational Medicine for the International Hyperbaric Medical Foundation. His current practice
also includes Hyperbaric Oxygen Therapy for Traumatic Brain Injury.
William Duncan, Ph.D., Director of Legislative Affairs,
International Hyperbaric Medical Association (IHMA)
Dr. William A. Duncan, a former Army officer, serves as President of Capitol Strategy
Consultants, Inc., where he represents clients on healthcare, biomedical research, veterans,
Department of Defense, and criminal justice and public health arenas. His clients benefit from his
extensive background in the congressional appropriations process and heath care regulations. In
the medical realm, Dr. Duncan supervised numerous legislative priorities including National
Institutes of Health reforms for setting research priorities, expansion on biomedical research
infrastructure, AHRQ and evidence-based medicine initiatives, NIH and CDC initiatives in
environmental medicine, amputee services, and addressing chronic disease including diabetes
and public health. He dealt with Centers for Medicare & Medicaid services problems, including
getting CMS to approve a new indication for hyperbaric oxygen to reduce diabetic foot
amputations, reducing the regulatory burden on health care, prescription drug, and FDA issues.
Stephen D. Reimers, P.E.
Mr. Reimers is an MIT-trained Professional Engineer. He is a former member of a Navy
Experimental Diving Unit with an extensive background in breathing and compression
technologies. He has 37 years experience as President/Owner of Reimers Consultants, Reimers
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Engineering, Inc., Reimers Systems, Inc., and Hyperbaric Clearinghouse, Inc. and has been
responsible for the design of over $40,000,000 of currently installed clinical hyperbaric facilities.
He is the current Chair of the prestigious PRESSURE VESSELS FOR HUMAN OCCUPANCY
(PVHO) and Secretary/Treasurer of the sponsor of NBIRR, the International Hyperbaric Medical
Foundation.
Robert L. Beckman, Ph.D., Chief Knowledge Officer,
CareVector, LLC
ROBERT L. BECKMAN, Ph.D., has been building knowledge management systems most of his
professional career, primarily in the Intelligence Community and DOD. He is currently helping to
run the Clinical Trial researching TBI and PTSD in brain-injured wounded warriors. He is
responsible for sustaining the national network of hyperbaric clinics as well as improving the
technology platform for data collection and analysis. He is a former USAF KC-135 pilot and a
Vietnam Veteran. www.treatnow.org beckmanr88@gmail.com (703) 346-8432