Representatives of the International Hyperbaric Medical Association Testify Before House Veterans Affairs Committee

“Evidence Presented on Safe and Cost-Effective Solution to Traumatic Brain Injury/Post Traumatic Stress Syndrome (TBI/PTSD”)

WASHINGTON, July 21 /PRNewswire-USNewswire/ — Today, Paul G. Harch, M.D., representing the International Hyperbaric Medical Association, presents research data from case reports and a prospective study to the House Committee on Veterans Affairs. Recent research is demonstrating that Hyperbaric Oxygen Therapy at 1.5 atmospheres helps heal blast-induced brain injury and PTSD in U.S. Veterans.

According to Dr. Harch, “Modern medicine has no other treatments for traumatic brain injury or post-traumatic stress disorder that are as effective as hyperbaric oxygen therapy when the correct dose and protocol are used.” Hyperbaric oxygen therapy is over 50 years old, and is approved for 13 indications, including non-healing wounds throughout the body and three types of brain injury.

Dr. Harch will be presenting preliminary findings from the LSU HBOT 1.5 Pilot study (LSU IRB #7051) which was funded by private citizens and charities that serve injured veterans. The first half of the HBOT 1.5 protocol produced the following significant improvements in Veterans: a 15 point IQ increase (p<0.001) (the difference between a laborer and an engineer); a 40% reduction in post-concussion symptoms [p=0.002 (np) ]; a 30% reduction in PTSD symptoms (p<0.001); a 51% decrease in indices of depression (p<0.001), and a 25 percentile increase in working memory. These results and the associated improvements in brain blood flow on functional brain imaging were consistent with changes in memory and blood vessel density achieved in an animal model that employed an earlier version of the HBOT 1.5 protocol. The imaging changes, in particular, argue strongly against the placebo effect as an explanation for the cognitive and symptom improvements. The vast majority of study subjects have returned to duty, work or school, and experienced quality of life improvements. The study findings are further supported by improvements in brain injured active duty service members treated with the HBOT 1.5 protocol by Drs. Eddie Zant and James Wright (USAF, retired).  In the Zant/Wright case series all of the Airmen were retained in the service. This retention saved the government millions of dollars in future medical care, disability payments, and recruiting/training costs to replace the injured Airmen.

Traumatic Brain Injury (TBI) is considered the signature injury of the Iraq and Afghanistan Wars, and it is estimated that over 600,000 are suffering from TBI, PTSD, depression, or a combination thereof.  Hundreds of thousands may be undiagnosed and untreated.  Many have become unemployed, homeless, incarcerated, or even suicidal because of their wounds.  This treatment, if delivered in a timely fashion, may prevent many of the consequences of TBI.

Dr. Harch will also announce details of the National Brain Injury Rescue and Rehabilitation Project (NBIRR), a national multi-center study sponsored by the International Hyperbaric Medical Foundation. The study is recruiting patients with chronic TBI, PTSD, or both diagnoses and offer the full HBOT 1.5 protocol to all subjects entered. Information about the NBIRR study and Western IRB Protocol #20090761, can be found at http://www.nbirr.org and http://www.clinicaltrials.gov or by calling (800) 288-9328.

The House VA committee’s “Round Table” discussion with Dr. Harch and others can be viewed on webcast at: http://veterans.house.gov/ at 10 a.m. Eastern Time on July 21, 2010.

Surviving Teen from Horrific Santa Fe Accident Regains Brain Function with HBOT

Santa Fe, NM (MMD Newswire) — Exactly one year ago, a drunken driver traveling in the wrong lane crashed into a car carrying five Santa Fe teenagers instantly killing four of them.

The fifth teen — 16-year-old Avree Koffman, who was driving — was airlifted to University Hospital in Albuquerque in critical condition. The crash occurred about 12:10 a.m. on Old Las Vegas Highway (6/29/09). Six months later, when it was clear to both Avree and father that her TBI left her severally impaired, she began receiving hyperbaric oxygen therapy in Santa Fe at New Mexico’s only free-standing hyperbaric facility (hbotnm.com).

Avree was treated along with Iraqi vets, such as Eric Schei, a woman hit by lightening and another teenager with Gardasil vaccine induced encephalitis. Avree received a neurocognitive test before and after her treatments. Her verbal memory improved 13%; visual memory improved 33 %; visual motor speed improved by 41%. What these remarkable improvements don’t reveal is that the now 17 year old Avree has her life back. She is preparing to attend college and her depression has lifted.

This protocol used to treat Avree is the exact protocol the International Hyperbaric Medical Association began sharing with DoD in 2001 and testified to Congress about in 2002 and twice in 2004. This effort is called the National Brain Injury Rescue & Rehabilitation Project (NBIRR). NBIRR will directly impact the greatest public health crisis of our age, untreated brain insults including traumatic brain injury. Federal, state and local budgets are paying for the consequences of modern medicine failing to treat brain insults with protocols that biologically repair brain damage. Lost performance and aberrant behavior of injured individuals costs billions and billions each and every year in entitlement, prison, education, and safety net programs, not to mention the challenges faced by current and past combat veterans.

Hyperbaric Oxygen Therapy (HBOT) is FDA-cleared for many kinds of non-healing wounds and is the only FDA-approved non-hormonal treatment approved to repair and regenerate human tissue. It causes a biological repair to tissue damaged by a lack of oxygen or compromised circulation and signals DNA to begin the healing process. Tricare and VA reimburse for most hyperbaric indications, including non-healing wounds, but do not routinely pay for treatment for persons who recover or make significant improvement from their brain injuries after they have been treated with HBOT.

Prior to treatment, Avree wouild have had to go on full disability because of her  brain injury symptoms. An anonymous donor provided $3000 to get Avree treated and the Hyperbaric Medical Center of New Mexcio provided the bulk of her treatments as a public service. Avree’s  recovery was a significant savings to New Mexico and the Federal Government.

Mild TBI Results in a Loss of Lifetime Income and Loss of Tax Revenue
It has been calculated that a High School graduate who experiences a mild TBI will lose $1,081,243.00 (Present Value) in life-time earnings which translates to $273,554.48 in lost tax revenue (FICA + 10% income tax) or $6,838 for Enlisted member per year.

For those that have a Bachelor’s degree or could have gotten a Bachelor’s degree before injury, the loss of revenue from a mild TBI is $1,873,413.00 over their life time, $473,973.49 in taxes over their life time or $11,849 per year.

Therefore, the estimated 600,000 war veterans that RAND corporation estimates have an untreated TBI (as reflected by symptoms of mTBI/PTSD/Depression), is conservatively estimated $4.8 billion in lost tax revenue per year. This assumes all of them are gainfully employed at something.

Unfortunately, we know this not to be true, as many of them have already entered the criminal justice system (reports are up to 10% of county jail inmates), 154,000 of them are homeless, and recent reports listed 184,000 were unemployed.

An examination of the homeless veteran population gives us an idea of the magnitude of the problem, and how HBOT, biologically repairing these persons, could help the Treasury. Current programmatic costs from the stimulus package were for $3 billion in distributed on a per-capita basis. The stimulus money plus $2.4 billion in lost tax revenue is $5.4 billion PER YEAR in revenue drain. If this group were treated with HBOT for a one-time cost of $2.4 billion, and 80% of them were able to return to work or school, the savings would be $4.3 billion per year in programmatic costs and increased tax revenue. Remember that most of these veterans are under 25.)

Many of those who are unemployed have experienced blast-related injuries, as outlined in the RAND report. Many of them, due to suffering a mild-TBI, are under-employed and would enjoy income gains if properly treated with a biological repair treatment like HBOT. This lost revenue and these programmatic costs are certainly a drain on the U.S. economy and the Treasury.

Payment for this biological repair treatment for brain injury is the single largest obstacle to having it available in the medical system. One thousand HBOT centers are doing 10,000 treatments every workday across the nation. Most treatments are delivered to heal non-healing wounds.

Note that there is more evidence for HBOT  than there was for angioplasty or tPA for acute stroke treatment, when both of these therapies were reimbursed by Medicare. The scientific studies were conducted later that showed these two therapies were clinically effective. It was deemed too great a risk to patients to withhold these “promising” treatments. That is the case with HBOT as well, because two years from now many of those leaving the service will have lost their families, be incarcerated, homeless, unemployed, on disability, or have committed suicide. Those are much more difficult concurrent problems to address than simply biologically repairing their brain injury.

HBOT is not new, it has simply been unrecognized
HBOT has been used for 80 years to heal neurological conditions, as well as problem or non-healing wounds. Much of its mechanisms of action have not been understood until the last 20 years, due to advances in molecular biological and neurological imaging. HBOT is the only FDA-approved non-hormonal treatment for biological repair of damaged tissue. HBOT for brain injury apparently repairs non-healing wounds in the brain, just as it does in other parts of the body, when the correct oxygen dose is used. Many consider it “off-label” or not one of the 13 FDA-cleared indications. HBOT for these neurological injuries actually fits under item number 6 on the FDA-approved indications list, “Arterial Insufficiency,” sharing that spot with other chronic non-healing wounds like diabetic foot wounds, hypoxic wounds, bed sores, etc. From the imaging and animal studies done to date, it is apparent that HBOT 1.5 is repairing non-healing wounds in the brain, just as it does diabetic foot wounds or radiation necrosis, or the other tissues in the body.

It is important to note that from a public health standpoint, the breakthrough that has been made on HBOT, will, long and short term, create the greatest single improvement to the entitlement spending budgets of federal, state and local governments since 1923 when the first federal safety-net milk subsidy program was established. Today it is well known that 50% of all IDEA children, 70-82% of all homeless persons (and nearly 100% of all homeless veterans), 50% of everyone in prison, in drug treatment programs, on welfare, or struggling through the vocational rehabilitation programs, have an untreated brain injury or brain insult.

Note that according to CDC, 1.2 million people per year experience a brain injury. Most TBI’s happen between 1 and 4 and 15-19. Of the number that live (50,000 per year die as a result of their injuries), an estimated 30 million are working age in our society. The lost tax revenue alone from this many people, earning under their potential, is conservatively estimated at $8,900 each or $99 billion in tax revenue. Obviously if just the prison system population were able to be cut by 1/2 over the next ten years, the savings would be nearly $26 billion per year.

Safety
HBOT 1.5 is noted by DoD in the official White Paper for the December 5-6, 2008 “Consensus Conference on HBOT for TBI” as follows: “Side effects from HBOT are uncommon, and severe or permanent complications are rare, especially at the doses of HBOT used “off-label” for TBI patients (approximately 1.5 atm abs for 60 minutes.), compared to HBOT for HHS covered indications (2 to 2.4 atm abs for 120 to 90 minutes.)”

For the mild traumatic brain injury patient, clinical experience demonstrates this treatment is far less risky to patients than leaving them untreated. It is far less costly to society to treat them than to lose earnings and tax revenue, pay for social safety net costs, prison costs, etc.

Conclusion
Helping solve untreated traumatic brain injury, brain insults, and PTSD will be a huge improvement in the lives of millions. The IHMA has already prepared and presented material to CMS so that they would pay for hyperbaric oxygen treatments for diabetic foot wounds. This treatment prevents 75% of all diabetic foot amputations. It is estimated that during the coming year about 13,500 amputations will be prevented, with a savings of an estimated $298 million per year in Medicare spending. Savings started in 2003. Right now only about 11% of patients who could benefit from HBOT to prevent amputations are receiving that treatment. A far smaller percentage are receiving HBOT biological repair treatment for their brain injuries.

There is no patent possible on oxygen, so none of these treatment funds go to royalty payments. IHMA is not making any income from having gotten CMS to approve diabetic foot wounds, but Medicare beneficiaries and the treasury are both benefiting. It is good public policy to reduce the costs of the current health care system, while massively improving outcomes. That is what the IHMA and her sister organization, the International Hyperbaric Medical Foundation, are dedicated to.

Kenneth P. Stoller, M.D., FACHM
President, IHMA

Hyperbaric Medical Center New Mexico (www.hbotnm.com)
404 Brunn School Rd #D
Santa Fe, NM 87505
505 9558560

San Francisco Institute for Hyperbaric Medicine (www.sfhbo.com)

185 Berry Street
Suite 4801
San Francisco, California 94107

email: info@sfhbo.com
Phone: 415-513-5813
or
Dr. William Duncan 703 505-7530

Teen from Horrific Santa Fe Accident Regains Brain Function with HBOT

Hyperbaric chamber may treat TBI

By Amy McCullough – Staff writer
Posted : Wednesday Mar 31, 2010 19:09:33 EDT

The Defense Department hopes to find a better treatment for the 100,000 troops who have been diagnosed with mild Traumatic Brain Injury since 2003, and it’s looking at hyperbaric chambers — often used in cases of carbon monoxide poisoning — for the answer.

Although there have been studies looking at the impact these pressurized oxygen chambers have on TBI patients, none have been able to definitively answer whether hyperbaric oxygen can reduce or eliminate chronic symptoms of TBI such as headaches, memory loss and mood swings. A new clinical trial, which is expected to begin in January 2011, is designed to do just that.

The study, conducted by the Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, in Virginia, and the Army Research and Materiel Command, in Maryland, is expected to run for at least 18 months. It will include about 300 participants, mostly soldiers and Marines, and will build upon other ongoing studies on TBI treatment, said Col. Richard Ricciardi, director of the research evaluation and quality assurance and surveillance directorate at DCoE.

Five sites will participate in the study: Fort Carson, Colo.; Camp Pendleton, Calif.; Camp Lejeune, N.C.; Brooks City-Base, Texas; and possibly Fort Hood, Texas, although negotiations are still ongoing there, Ricciardi said.

Individuals getting the experimental treatment will breathe 100 percent oxygen while inside the hyperbaric chamber at 1.5 atmospheres of pressure — about the same amount of pressure you would feel if you dived 20 to 25 feet below water. The theory is that the pressure created by the chamber causes oxygen in the blood to dissolve, allowing more oxygen to flow through the body and repair damaged tissue.

A control group will feel 1.3 atmospheres of pressure inside the chamber but will breathe regular air, which will dissolve at the regular rate. Although the pressures are slightly different, officials say participants who have not received hyperbaric oxygen before won’t know the difference.

The chambers will hold three to 16 participants. Each person will be asked to sit in the chamber for one hour a day, five days a week for 40 sessions. The study is primarily looking at service members who suffered a TBI about four to six months ago, and are going through the healing process, he said.

Soldiers interested in participating in the study should talk to their health care provider to see if there are clinical trials available in their area and whether they are a candidate for those trials. See www.clinicaltrials.gov for a complete listing of government-run clinical trials

Hyperbaric Oxygen Therapy Study to be launched

March 18th, 2010

Originally developed to help deep-sea divers suffering from brain compression illness, hyperbaric oxygen therapy (HBOT) is now being tested for the treatment of traumatic brain injury victims. The study, sponsored by the International Hyperbaric Medical Foundation, will take place among fifteen sites throughout the United States and will involve almost 1,000 patients. Everyone involved will be treated 80 times over a period of five months. So what is HBOT? It’s quite simple, really. It involves breathing 100% oxygen while under increased atmospheric pressure in an enclosed space. This pure oxygen, in turn, increases the amount of oxygen in one’s bloodstream and therefore traveling to one’s bodily organs and tissues. A preliminary study undertaken at the LSU Interim Public Hospital in New Orleans showed a “15-point increase in IQ in little more than a month, great reduction in depression, four times the expected improvements in … headaches and sleep disturbances, and great improvements in post-traumatic stress disorder” among the 40 patients involved. Though all 40 of these men and women were veterans who had sustained TBI’s at war, both veteran and civilian citizens will be recruited for the upcoming larger-scale study

Study to look at ways to treat TBI

March 17, 2010 - Jeff Stoffer the American Legion

Dr. Paul Harch, a Louisiana State University researcher who is leading a study on use of hyperbaric oxygen treatment for traumatic brain injury. On March 15, Jacob Gadd, assistant director for Program Management in The American Legion Veterans Affairs & Rehabilitation Division, participated in a conference call on hyperbaric oxygen treatment of traumatic brain injury. The International Hyperbaric Medical Foundation conducted the conference calls with Dr. Paul Harch, a Louisiana State University researcher leading the study, and Dr. James Wright, a retired Air Force colonel in charge of research on hyperbarics for the Air Force.Traumatic brain injury (TBI) and post traumatic stress disorder (PTSD) are often referred to as the “signature wounds” of the wars in Iraq and Afghanistan. Doctors used hyperbaric oxygen treatment decades ago mainly for treatment of divers. However, Harch’s recent study of 15 cases of veterans afflicted with blast injuries found, “a 15-point increase in IQ in little more than a month, 51 percent reduction in depression, 40 percent clinically significant improvement levels of post-concussion systems such as headaches and sleep disturbances, and a 30 percent improvement in PTSD. The Hennepin County Medical Center in Minneapolis also conducted a relative study, Hyperbaric Oxygen Shows Potential Benefit for Patients with Traumatic Brain Injury, in January. The study found a significant benefit from hyperbaric oxygen treatment to improve brain metabolism and its ability to recover from injury. The findings were recently published in the Journal of Neurosurgery. Additionally, the study showed that cells need oxygen to fuel metabolism for cellular growth and repair. After a traumatic brain injury, there’s a direct correlation between clinical outcome and the degree to which a brain’s metabolism is restored. Dr. Gaylan Rockswold, who conducted the study stated, “in previous research we learned that the brain’s energy is improved and maintained with hyperbaric oxygen treatment, but this study confirms that hyperbaric oxygen treatment has a major impact in terms of increased energy production.” The International Hyperbaric Medical Foundation launched their new nationwide study this week at 15 sites within Florida, California, Louisana, Texas, Oklahoma, New Mexico, Arizona, Virginia, Maryland, Washington and South Carolina. They are asking for 1,000 individuals to participate in the study. To participate in the study or receive more information, go to http://www.hyperbaricmedicalfoundation.org/. The American Legion does not have an official position on hyperbaric oxygen treatment for treatment of TBI and PTSD at this time. However, the Legion will continue to monitor the research and study by Harch’s team and continue to urge VA and DoD to fully explore options for research and treatment for the signature wounds of Iraq and Afghanistan.